FR940525-0-00001 FR940525-0-00001 Federal Register ␣/␣Vol. 59, No. 100␣/␣Wednesday, May 25, 1994␣/␣Rules and Regulations Vol. 59, No. 100 Wednesday, May 25, 1994 FR940525-0-00002 FR940525-0-00001 DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 905 [Docket No. FV93&hyph;905&hyph;51FR] Oranges, Grapefruit, Tangerines, and Tangelos Grown in Florida; Revision of Special Purpose Shipment Exemption Provisions for Organic Citrus Fruit AGENCY: Agricultural Marketing Service, USDA. ACTION: Interim final rule with request for comments.

SUMMARY: This interim final rule invites comments on the revision of the administrative rules and regulations of the marketing order for Florida citrus. This rule redefines the term ``Special Purpose Shipper'' to mean those persons who handle citrus fruit which is certified as organically grown under Florida law, and requires such persons to certify that they will limit shipments of such fruit to outlets handling organically grown fruit. This rule more precisely defines organically grown Florida citrus fruit, and may increase the market for organic shipments. This rule was unanimously recommended by the Citrus Administrative Committee (committee), the agency responsible for local administration of the marketing order.

DATES: Effective on May 25, 1994. Comments which are received by June 24, 1994 will be considered prior to issuance of any final rule.

ADDRESSES: Interested persons are invited to submit written comments concerning this action. Comments must be sent in triplicate to the Docket Clerk, Fruit and Vegetable Division, AMS, USDA, room 2525&hyph;S, P.O. Box 96456, Washington, DC 20090&hyph;6456, Fax: (202) 720&hyph;5698. All comments should reference the docket number and the date and page number of this issue of the Federal Register and will be made available for public inspection in the Office of the Docket Clerk during regular business hours.

FOR FURTHER INFORMATION CONTACT: Christian D. Nissen, Marketing Order Administration Branch, Fruit and Vegetable Division, AMS, USDA, P.O. Box 96456, room 2523&hyph;S, Washington, DC 20090&hyph;6456; telephone: 202&hyph;720&hyph;5127; or William G. Pimental, Southeast Marketing Field Office, USDA/AMS, P.O. Box 2276, Winter Haven, Florida 33883; telephone: 813&hyph;299&hyph;4770. SUPPLEMENTARY INFORMATION: This interim final rule is issued under Marketing Agreement and Marketing Order No. 905 (7 CFR part 905) regulating the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida, hereinafter referred to as the order. This order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601&hyph;674), hereinafter referred to as the Act. The Department of Agriculture (Department) is issuing this rule in conformance with Executive Order 12866. This interim final rule has been reviewed under Executive Order 12778, Civil Justice Reform. This interim final rule is not intended to have retroactive effect. This interim final rule will not preempt any state or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule. The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the Secretary a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction in equity to review the Secretary's ruling on the petition, provided a bill in equity is filed not later than 20 days after the date of the entry of the ruling. Pursuant to the requirements set forth in the Regulatory Flexibility Act (RFA), the Administrator of the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. FR940525-0-00003 FR940525-0-00001 The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility. There are about 100 Florida citrus handlers subject to regulation under the marketing order covering oranges, grapefruit, tangerines, and tangelos grown in Florida, and about 11,000 growers of these citrus fruits in Florida. Small agricultural service firms have been defined by the Small Business Administration (13 CFR 121.601) as those having annual receipts of less than $5,000,000, and small agricultural growers are defined as those whose annual receipts are less than $500,000. A minority of these handlers and a majority of the growers may be classified as small entities. The marketing order for Florida citrus provides for the establishment of minimum grade and size requirements. The minimum grade and size requirements are designed to provide fresh markets with fruit of acceptable quality, thereby maintaining consumer confidence for fresh Florida citrus. This helps create buyer confidence and contributes to stable marketing conditions. This is in the interest of producers, packers, and consumers, and is designed to increase returns to Florida citrus growers. The cultural practices of producers of organically grown citrus differ from normal industry practices. Because of these differences, organically grown fruit is usually required to meet a different grade standard under the marketing order. This grade standard pertains only to the external characteristics of the fruit, not the internal quality. The different grade standard is needed to facilitate the marketing of organic citrus. There are indications that organically grown citrus, from a marketing standpoint, are a different commodity than conventionally grown citrus. Organic citrus generally has higher external damage. Organic fruit for the most part is marketed differently, is not mixed with non-organic fruit, appeals only to certain consumers, and is in many respects, a specialized commodity. This action invites comments on changes to the administrative rules and regulations prescribed under the Florida citrus marketing order. This rule more precisely defines organic fruit, and the type of market outlets which organically grown fruit may be sold in, free from certain requirements imposed under the order. These changes were unanimously recommended by the committee at its November 16, 1993 meeting. FR940525-0-00004 FR940525-0-00001 Sections 905.146, 905.147, and 905.148 of the regulations provide terms and conditions under which shippers may ship organically grown Florida citrus fruit, as Special Purpose Shippers, with a conditional release from certain grade requirements issued under §905.52 of the order. When the provisions concerning special purpose shipments were made effective in 1978, there were no laws governing organic fruit and vegetable growers in Florida. A ``Special Purpose Shipper'' was defined under the marketing order as one who had certified that they would handle only citrus fruit which they knew from their own personal knowledge was produced on trees on which only compost, non-acidulated fertilizer such as rock phosphate, dolomite, or ground limestone is used, and to which no chemical insecticide or fungicide had been applied. However, the State of Florida now requires all organically grown fruits and vegetables to be certified. Accordingly, the committee has recommended redefining the term ``Special Purpose Shipper'' in §905.146 to mean a person who handles Florida citrus fruit that is certified by a Florida Department of Agriculture and Consumer Services licensed certifying agent as organically grown under Florida law. This definition reflects that organic fruit has been certified under Florida law, and also provides additional assurance that shippers claiming organic status and utilizing the grade standards for organic fruit qualify to do so. Under Florida law, the Florida Department of Agriculture and Consumer Services licenses independent third parties to act as certifying agents. Growers who intend to sell organic fruit make an application to a certifying agent. The certifying agent inspects and certifies a grower's acreage as being in accordance with Florida law and issues the grower a certificate. The certificate number is transferred to a trip ticket which accompanies any shipments of fruit grown on the certified acreage. When the handler receives the shipment, a copy of the trip ticket is provided to the state inspector indicating that the fruit is certified organic and can be packed using the applicable organic grade standards. The committee also recommended that §905.146 be revised to require Special Purpose Shippers to certify that they will limit their shipments of organically grown citrus fruit to outlets handling organically grown fruits. This replaces the requirement that only outlets registered and approved by the committee could receive such fruit and ends the requirement that receivers of special purpose shipments complete the applicable sections of the Report of Special Purpose Shipments form. The language in §905.146, 905.147, 905.148 concerning Certificates of Privilege is being revised for clarity, and procedural safeguards are being added to §905.147(c) dealing with suspensions or denials of Certificates of Privilege. This rule reflects the committee's and the Department's appraisal of the need to revise the exemption provisions for special purpose shipments, as specified. The Departmental view is that this rule may have a beneficial impact on growers and shippers of organic citrus fruit. Based on the above, the Administrator of the AMS has determined that this rule will not have a significant economic impact on a substantial number of small entities. In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C. chapter 35), the information collection requirements that are contained in this rule have been previously approved by the Office of Management and Budget (OMB) and have been assigned OMB number 0581&hyph;0094. This action will reduce the reporting burden on approximately 95 receivers of special purpose shipments of Florida citrus completing a section of the Report of Special Purpose Shipments form, taking about .04 hour to complete each report. After consideration of all relevant material presented, including the Committee's recommendation, and other available information, it is found that this interim final rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act. FR940525-0-00005 FR940525-0-00001 Pursuant to 5 U.S.C. 553, it is also found and determined, upon good cause, that it is impracticable, unnecessary and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) This rule updates provisions in the regulations; (2) Florida citrus fruit handlers are aware of this rule which was unanimously recommended by the committee at a public meeting and they will need no additional time to comply with the revised requirements; (3) shipment of the 1993&hyph;94 season Florida citrus fruit crop is currently in progress; and (4) the rule provides a 30-day comment period, and any comments received will be considered prior to any finalization of this interim final rule. List of Subjects in 7 CFR Part 905 Grapefruit, Marketing agreements, Oranges, Reporting and recordkeeping requirements, Tangelos, Tangerines. For the reasons set forth in the preamble, 7 CFR part 905 is amended as follows: PART 905_ORANGES, GRAPEFRUIT, TANGERINES, AND TANGELOS GROWN IN FLORIDA 1. The authority citation for 7 CFR part 905 continues to read as follows: Authority: 7 U.S.C. 601&hyph;674. 2. Section 905.146 is revised to read as follows: §905.146 Special purpose shipments. (a) A Special Purpose Shipper is one who handles Florida citrus fruit that is certified by a Florida Department of Agriculture and Consumer Services licensed certifying agent as organically grown under Florida law. In addition, the shipper shall certify that shipments will be limited to outlets handling organically grown fruits. Any such shipments shall be subject to a Certificate of Privilege issued by the committee. (b) To qualify for a Certificate of Privilege, each such shipper must notify the committee prior to the first shipment of certified organically grown Florida citrus fruit in the fiscal period of the shipper's intent to ship such citrus, submit an application on forms supplied by the committee, and agree to other requirements as set forth in §§905.147 and 905.148 inclusive, with respect to such shipments. The shipper shall certify that no claims will be made, written or verbal, concerning any alleged advantages of using, or any alleged superiority of, fruit shipped under a Certificate of Privilege, compared to other Florida produced citrus. (c) Citrus meeting all other applicable requirements may be handled without regard to grade regulations issued under §905.52 under the following conditions: (1) Such fruit meets requirements of the U.S. No. 2 Russet grade and those requirements of the U.S. No. 1 grade relating to shape (form) as such requirements are set forth in the revised U.S. Standards for grades of Florida Oranges and Tangelos (7 CFR 2851.1140 through 2851.1180), the revised U.S. Standards for Florida Tangerines (7 CFR 2851.8180 through 2851.1835), or the revised U.S. Standards for Grades of Florida Grapefruit (7 CFR 2851.750 through 2851.784). Such fruit meets applicable minimum size requirements in effect for domestic shipments of citrus fruits. (2) All such citrus shall be inspected as required by §905.53 by the Federal or Federal-state Inspection Service prior to the time such citrus is shipped from the packing facility, and certified as meeting the applicable requirements. (3) Be reported as required in §905.148. 4. Section 905.147, paragraphs (a) and (c) are revised to read as follows: §905.147 Certificate of privilege. FR940525-0-00006 FR940525-0-00001 (a) Application. Application for Certificate of Privilege by a Special Purpose Shipper shall be made on forms furnished by the committee. Each application may contain, but need not be limited to, the name and address of each handler; a list of certified organic citrus fruit growers, including addresses; a list of receivers; the quantity and variety of citrus to be shipped; a certification to the Secretary of Agriculture and to the committee as to the truthfulness of the information shown thereon; and any other appropriate information or documents deemed necessary by the committee or its duly authorized agents for the purposes stated in §905.146. * * * * * (c) Suspension or Denial of Certificate of Privilege. The committee may investigate the handling of special purpose shipments under Certificates of Privilege to determine whether Special Purpose Shippers are complying with the requirements and regulations applicable to such certificates. Whenever the committee finds that a Special Purpose Shipper or consignee is failing to comply with the requirements and regulations applicable to such certificates, the Certificate of Privilege issued to such Special Purpose Shipper may be suspended or, in the case of an application for the issuance of an initial Certificate of Privilege, may be denied. Such suspension of a certificate shall be for a reasonable period of time as determined by the committee, but in no event shall it extend beyond the end of the current fiscal period. In the case of the denial of an application for the issuance of an initial certificate, such certificate shall be denied until the applicant comes into compliance with the requirements and regulations applicable to such certificates. Prior to suspending or denying an application for a Certificate of Privilege, the committee shall give the shipper or applicant reasonable advance notice in writing of its intention and the facts and reasons therefor, and afford the shipper or applicant an opportunity, either orally or in writing, to present opposing facts and reasons. The shipper or applicant shall be informed of the committee's determination in writing and in a timely manner. 4. Section 905.148 is amended by revising paragraph (a) and the first two sentences in paragraph (b) to read as follows: §905.148 Reports of special purpose shipments under certificates of privilege. (a) Each handler of citrus shipping under Certificates of Privilege shall supply the committee with reports on each shipment as requested by the committee, on forms supplied by the committee, showing the name and address of the shipper or shippers; name and address of the certified organic Florida citrus fruit grower or growers supplying fruit for such shipment; truck or other conveyance identification; the loading point; destination, consignee; the inspection certificate number; and any other information deemed necessary by the committee. (b) One copy of the report on each shipment shall be forwarded by the shipper to the committee within 10 days after such shipment, and two copies of the report shall accompany each shipment to the receiver. Upon the receipt of each shipment, the receiver shall complete the applicable portion of the form and return one copy to the committee within 10 days and one copy shall be retained by the shipper. *␣*␣* Dated: May 18, 1994. Eric M. Forman, Deputy Director, Fruit and Vegetable Division. [FR Doc. 94&hyph;12591 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 3410&hyph;02&hyph;P FR940525-0-00007 FR940525-0-00002 DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Airspace Docket No. 94&hyph;AAL&hyph;03] Revision of Class E Airspace; Juneau and Dillingham, AK AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule.

SUMMARY: This action revises Class E airspace at Juneau and Dillingham, AK. The FAA is preparing to develop and test Differential Global Positioning System (DGPS) instrument approach and departure procedures at the Juneau Airport. Additional controlled airspace starting at 700 feet above the surface (AGL) is needed for instrument flight rules (IFR) departure and arrival operations at the airport. Controlled airspace starting at 1200 feet AGL at Dillingham is being revised so that recently developed instrument flight rule (IFR) holding patterns are in controlled airspace. The areas will be depicted on aeronautical charts to provide a reference for pilots operating in the area.

EFFECTIVE DATE: 0901 u.t.c., August 18, 1994. FOR FURTHER INFORMATION CONTACT: Robert C. Durand, System Management Branch, AAL&hyph;531, Federal Aviation Administration, 222 W. 7th Ave. # 14, Anchorage, AK, 99513&hyph;7587; telephone number: (907) 271&hyph;5898. SUPPLEMENTARY INFORMATION: History On February 23, 1994, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) to revise Class E airspace at Juneau and Dillingham, AK. (59 FR 12876.) The FAA is preparing to develop DGPS instrument approach/departure procedures for the Juneau Airport at Juneau, AK. The proposal was to revise the controlled airspace extending from 700 feet AGL in the Juneau area for IFR operations. Controlled airspace starting at 1200 feet AGL at Dillingham was proposed to be revised so that recently developed IFR holding patterns are contained in controlled airspace. Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No objections to the proposal were received. Airspace Reclassification, in effect as of September 16, 1993, has discontinued the use of the term ``transition area,'' and controlled airspace extending upward from 700 or 1200 feet above ground level is now Class E airspace. Class E airspace designations for airspace areas extending upward from 700 feet or more above ground level are published in Paragraph 6005 of FAA Order 7400.9A dated June 17, 1993, and effective September 16, 1993, which is incorporated by reference in 14 CFR 71.1 (58 FR 36298; July 6, 1993). The Class E airspace designation listed in this document will be published subsequently in the Order. The Rule These amendments to part 71 of the Federal Aviation Regulations revise Class E airspace at Juneau, AK, to provide controlled airspace from 700 feet AGL for IFR DGPS arrival and departure procedures, and revise Class E airspace at Dillingham, AK, to provide controlled airspace from 1200 feet AGL for recently developed IFR holding patterns. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore_(1) is not a ``significant regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71_[AMENDED] FR940525-0-00008 FR940525-0-00002 1. The authority citation for part 71 continues to read as follows: Authority: 49 U.S.C. app. 1348(a), 1354(a), 1510; E.O. 10854, 24 FR 9565, 3 CFR, 1959&hyph;1963 Comp., p. 389; 49 U.S.C. 106(g); 14 CFR 11.69. §71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.9A, Airspace Designations and Reporting Points, dated June 17,1993, and effective September 16, 1993, is amended as follows: Paragraph 6005␣Class E airspace areas extending upward from 700 feet or more above the surface of the earth * * * * * AAL AK E5 Juneau, AK [Revised] Juneau International Airport, AK (Lat. 58 ○21 ’18 ’ ’ N, long. 134 ○34 ’34 ’ ’ W) Coghilan Island NDB (Lat. 58 ○21 ’34 ’ ’ N, long. 134 ○41 ’58 ’ ’ W) Sisters Island VORTAC (Lat. 58 ○10 ’40 ’ ’ N, long. 135 ○15 ’32 ’ ’ W) That airspace extending upward from 700 feet above the surface within an area beginning at lat. 57 ○50 ’00 ’ ’ N, long. 134 ○00 ’00 ’ ’ W; to lat. 58 ○20 ’00 ’ ’ N, long. 134 ○00 ’00 ’ ’ W; to lat. 58 ○39 ’00 ’ ’ N, long. 134 ○47 ’00 ’ ’ W; to lat. 58 ○33 ’00 ’ ’ N, long. 136 ○36 ’00 ’ ’ W; to lat. 57 ○50 ’00 ’ ’ N, long. 135 ○40 ’00 ’ ’ W; to the point of beginning; and that airspace extending upward from 1,200 feet above the surface within a 51-mile radius of Sisters Island VORTAC extending clockwise from the 272 ○ radial to the 145 ○ radial of the VORTAC and within a 23-mile radius of the VORTAC extending clockwise from the 145 ○ radial to the 272 ○ radial; and that airspace extending upward from 12,500 feet MSL within 4 miles each side of the Sisters Island VORTAC 302 ○ radial extending from the 51-mile radius to 51.3 miles northwest of the VORTAC thence widening to 5.2 miles each side of the Sisters Island VORTAC 302 ○ radial to 60 miles northwest of the VORTAC; and that airspace extending upward from 1,200 feet above the surface within 4.4 miles of the Coghilan Island NDB 151 ○ bearing extending from the Sisters Island VORTAC 51-mile radius to 74 miles southeast of the NDB. * * * * * AAL AK E5 Dillingham, AK [Revised] Dillingham Airport, AK (Lat. 59 ○02 ’40 ’ ’ N, long. 158 ○30 ’20 ’ ’ W) Dillingham VOR/DME (Lat. 58 ○59 ’39 ’ ’ N, long. 158 ○33 ’08 ’ ’ W) That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Dillingham Airport and within 3 miles each side of the 205 ○ radial of the Dillingham VOR/DME extending from the 6.6-mile radius to 13.1 miles southwest of the airport; and that airspace extending upward from 1,200 feet above the surface within a 22-mile radius of the VOR/DME extending clockwise from the 308 ○ radial to the 059 ○ radial of the VOR/DME. * * * * * Issued in Anchorage, AK, on May 11, 1994. Gene Cowgill, Acting Manager, Air Traffic Division, Alaskan Region. [FR Doc. 94&hyph;12776 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4910&hyph;13&hyph;M FR940525-0-00009 FR940525-0-00003 14 CFR Part 71 [Airspace Docket No. 94&hyph;AWP&hyph;5] Establishment of Class E Airspace; Ukiah, CA AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule.

SUMMARY: This action establishes Class E airspace at Ukiah, CA. An automated Weather Observing System (AWOS) has been installed at the Ukiah Municipal Airport meeting the criterion for a surface area. Controlled airspace extending from the surface is needed for Instrument Flight Rules (IFR) operations at Ukiah Municipal Airport. The area will be depicted on aeronautical charts to provide a reference for pilots operating in the area.

EFFECTIVE DATE: 0901 u.t.c., December 8, 1994. FOR FURTHER INFORMATION CONTACT: Scott Speer, System Management Branch, AWP&hyph;530, Air Traffic Division, Western-Pacific Region, Federal Aviation Administration, 15000 Aviation Boulevard, Lawndale, California 90261; telephone (310) 297&hyph;0697. SUPPLEMENTARY INFORMATION: History On March 15, 1994, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) to establish Class E airspace at Ukiah, CA. (59 FR 14805). An AWOS has been installed at the Ukiah Municipal Airport, Ukiah, CA. The proposal was to modify controlled airspace from 700 to 1200 feet AGL and to add controlled airspace extending from the surface for IFR operations at Ukiah Municipal Airport. Interested parties were invited to participate in this rulemaking proceedings by submitting written comments on the proposal to the FAA. No objections were received concerning this proposal. The coordinates in the proposal are based on North American Datum 83. Class E airspace designations are published in Paragraphs 6002 and 6005 of FAA Order 7400.9A dated June 17, 1993, and effective September 16, 1993, which is incorporated by reference in 14 CFR 71.1 (58 FR 36298; July 6, 1993). The Class E airspace designations listed in this document will be published subsequently in this Order. The Rule The amendment to part 71 of the Federal Aviation Regulation establishes and amends Class E airspace at Ukiah, CA. This action modifies controlled airspace from 700 to 1200 feet AGL and establishes controlled airspace from the surface for IFR operations at the Ukiah Municipal Airport at Ukiah, CA. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a ``significant regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). Adoption of the Amendment In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71_[AMENDED] 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority: 49 U.S.C. app. 1348(a), 1354(a), 1510; E.O. 10854, 24 FR 9565, 3 CFR 1959&hyph;1963 Comp., p. 389; 49 U.S.C. 106(g); 14 CFR 11.69. §71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of the Federal Aviation Administration Order 7400.9A, Airspace Designations and Reporting Points, dated June 17, 1993, and effective September 16, 1993, is amended as follows: FR940525-0-00010 FR940525-0-00003 Paragraph 6005␣Class E airspace areas extending upward from 700 feet or more above the surface of the earth * * * * * AWP CA E5 Ukiah, CA [Revised] Ukiah Municipal Airport, CA (lat. 39 ○07 ’34 ’ ’ N, long. 123 ○12 ’03 ’ ’ W) Fortuna VORTAC (lat. 40 ○40 ’17 ’ ’ N, long. 124 ○14 ’04 ’ ’ W) Mendocino VORTAC (lat. 39 ○03 ’12 ’ ’ N, long. 123 ○16 ’27 ’ ’ W) Red Bluff VORTAC (lat. 40 ○05 ’56 ’ ’ N, long. 122 ○14 ’11 ’ ’ W) That airspace extending upward from 1,200 feet above the surface within a 17.4-mile radius of the Mendocino VORTAC, excluding that airspace east of the western edge of V&hyph;25 and that airspace bounded by a line from lat. 39 ○32 ’00 ’ ’ N, long. 123 ○33 ’14 ’ ’ W; to lat. 39 ○32 ’00 ’ ’ N, long. 123 ○11 ’34 ’ ’ W; to lat. 39 ○21 ’37 ’ ’ N, long. 123 ○04 ’54 ’ ’ W; to lat. 39 ○19 ’07 ’ ’ N, long. 123 ○07 ’22 ’ ’ W, thence counterclockwise via the 17.4-mile radius of the Mendocino VORTAC to lat. 39 ○19 ’04 ’ ’ N, long. 123 ○25 ’40 ’ ’ W; to lat. 39 ○32 ’00 ’ ’ N, long. 123 ○33 ’14 ’ ’ W. That airspace extending upward from 7,500 feet MSL south of the Red Bluff VORTAC between the 20.9- and 39.1-mile arcs of the Red Bluff VORTAC bounded on the northwest by the northwest edge of V&hyph;199 and on the southeast by the southeast edge of V&hyph;25. That airspace extending upward from 8,500 feet MSL south of the Red Bluff VORTAC bounded on the northeast by a 39.1-mile arc of the Red Bluff VORTAC, on the southeast by the southeast edge of V&hyph;25, on the south and southwest by the north edge of V&hyph;200 and a 17.4-mile arc of the Mendocino VORTAC, and on the northwest by the northwest edge of V&hyph;199. That airspace extending upward from 9,500 feet MSL bounded on the southeast by the northwest edge of V&hyph;199 to lat. 39 ○21 ’37 ’ ’ N, long. 123 ○04 ’54 ’ ’ W; to lat. 39 ○32 ’00 ’ ’ N, long. 123 ○11 ’34 ’ ’ W; to lat. 39 ○32 ’00 ’ ’ N, long. 123 ○33 ’14 ’ ’ W, and on the west by the east edge of V&hyph;27, and on the north by a line 7.8 miles south of and parallel to the Red Bluff VORTAC 291 ○ and Fortuna VORTAC 110 ○ radii. That airspace extending upward from 5,300 feet MSL bounded on the east by the southwest edge of V&hyph;27 and on the west by the west/southwest edge of V&hyph;494. * * * * * Paragraph 6002␣Class E airspace designated as a surface area for an airport * * * * * AWP CA E2 Ukiah, CA [New] Ukiah Municipal Airport, CA (lat. 39 ○07 ’34 ’ ’ N, long. 123 ○12 ’03 ’ ’ W) Within a 4.3-mile radius of the Ukiah Municipal Airport and within 1.8 miles each side of the 348 ○ bearing from the Ukiah Municipal Airport extending from the 4.3-mile radius to 16.2 miles north of the airport and that airspace within 1.8 miles each side of the 007 ○ bearing from the Ukiah Municipal Airport extending from the 4.3-mile radius to 8.6 miles north of the airport and that airspace within 1.8 miles and 2.5 miles east of the 154 ○ bearing from the Ukiah Municipal Airport extending from the 4.3-mile radius to 11.3 miles south of the airport. * * * * * Issued in Los Angeles, CA, on May 11, 1994. Sidney R. Allen, Acting Manager, Air Traffic Division, Western-Pacific Region. [FR Doc. 94&hyph;12777 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4910&hyph;13&hyph;M FR940525-0-00011 FR940525-0-00004 14 CFR Part 71 [Airspace Docket No. 93&hyph;AWP&hyph;22] Revocation of Class D Airspace: Fritzsche Army Air Field (AAF), Ft. Ord, CA AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule; correction.

SUMMARY: This document contains corrections to the final rule published on March 21, 1994. This final rule revoked the Class D airspace at Fritzsche Army Air Field, Ft. Ord, CA, and revised the Salinas, CA Class D airspace. The final rule did not contain language to indicate the part-time status of the Salinas, CA, Class D airspace.

EFFECTIVE DATE: 0901 UTC, April 28, 1994. FOR FURTHER INFORMATION CONTACT: Gene Enstad, Airspace Specialist, System Management Branch, AWP&hyph;530, Air Traffic Division, Western-Pacific Region, Federal Aviation Administration, 15000 Aviation Boulevard, Lawndale, California 90261, (310) 297&hyph;0010. SUPPLEMENTARY INFORMATION: On March 21, 1994, the Federal Aviation Administration (FAA) published a final rule that revoked the Class D airspace at Fritzsche Army Air Field (AAF), Ft. Ord, California, and revised the Salinas Class D airspace (59 FR 13194). In describing the Salinas Class D airspace, the notation to indicate the Salinas Class D airspace as being part-time was inadvertently omitted. This correction to the final rule corrects that omission. Correction of Final Rule Accordingly, pursuant to the authority delegated to me, the publication on March 21, 1994, 59 FR 13194, and the description in FAA Order 7400.9A, which is incorporated by reference in 14 CFR 71.1, are corrected as follows: §71.1 [Corrected] On page 13195, in the first column, the description for ``AWP CA D Salinas, CA'' is corrected to read as follows: AWP CA D Salinas, CA [Revised] Salinas Municipal Airport, CA (Lat. 36 ○39 ’48 ’ ’ N, long. 121 ○36 ’23 ’ ’ W) That airspace extending upward from the surface to but not including 2,500 feet MSL within a 4.3-mile radius of the Salinas Municipal Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory. Issued in Los Angeles, California, on April 11, 1994. Richard R. Lien, Manager, Air Traffic Division, Western-Pacific Region. [FR Doc. 94&hyph;12775 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4910&hyph;13&hyph;M FR940525-0-00012 FR940525-0-00005 14 CFR Part 97 [Docket No. 27714; Amdt. No. 1598] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule.

SUMMARY: This amendment establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

DATES: An effective date for each SIAP is specified in the amendatory provisions. Incorporation by reference-approved by the Director of the Federal Register on December 31, 1980, and reapproved as of January 1, 1982.

ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: For Examination 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which affected airport is located; or 3. The Flight Inspection Area Office which originated the SIAP. For Purchase Individual SIAP copies may be obtained from: 1. FAA Public Inquiry Center (APA&hyph;200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. By Subscription Copies of all SIAPs, mailed once every 2 weeks, are for sale by the Superintendent of Documents, US Government Printing Office, Washington, DC 20402.

FOR FURTHER INFORMATION CONTACT: Paul J. Best, Flight Procedures Standards Branch (AFS&hyph;420), Technical Programs Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 267&hyph;8277. SUPPLEMENTARY INFORMATION: This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description on each SIAP is contained in the appropriate FAA Form 8260 and the National Flight Data Center (FDC)/Permanent (P) Notices to Airmen (NOTAM) which are incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and §97.20 of the Federal Aviations Regulations (FAR). Materials incorporated by reference are available for examination or purchase as stated above. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction of charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number. The Rule This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the content of the following FDC/P NOTAM for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs, the respective FDC/T NOTAMs have been cancelled. The FDC/P NOTAMs for the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Approach Procedures (TERPS). In developing these chart changes to SIAPs by FDC/P NOTAMS, the TERPS criteria were applied to only these specific conditions existing at the affected airports. This amendment to part 97 contains separate SIAPs which have compliance dates stated as effective dates based on related changes in the National Airspace System or the application of new or revised criteria. All SIAP amendments in this rule have been previously issued by the FAA in a National Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Further, the SIAPs contained in this amendment are based on the criteria contained in the TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are unnecessary, impracticable, and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. FR940525-0-00013 FR940525-0-00005 Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore_(1) Is not a ``significant regulatory action'' under Executive Order 12866; (2) is not a ``significant rule'' under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air traffic control, Airports, Navigation (air). Issued in Washington, DC, on April 22, 1994. Thomas C. Accardi, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, part 97 of the Federal Aviation Regulations (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97_STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. app. 1348, 1354(a), 1421 and 1510; 49 U.S.C. 106(g); and 14 CFR 11.49(b)(2). 2. Part 97 is amended to read as follows: FR940525-0-00014 FR940525-0-00005 §§97.23, 97.25, 97.27, 97.29, 97.31, 97.33, and 97.35 [Amended] By amending: §97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; §97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; §97.27 NDB, NDB/DME; §97.29 ILS, ILS/DME, ISMLS, MLS, MLS/DME, MLS/RNAV; §97.31 RADAR SIAPs; §97.33 RNAV SIAPs; and §97.35 COPTER SIAPs, identified as follows: *␣*␣* Effective Date June 23, 1994 1␣ 1State 1City 1Airport 1FDC No. 1SIAP 04/06/94 AK Cold Bay Cold Bay FDC 4/1592 ILS Rwy 14 Amdt 14... 04/06/94 AK Cold Bay Cold Bay FDC 4/1593 Loc/DME BC Rwy 32 Amdt 6... 04/06/94 AK Cold Bay Cold Bay FDC 4/1594 VOR/DME OR TACAN&hyph;A Orig... 04/06/94 AK Cold Bay Cold Bay FDC 4/1595 VOR Rwy 14 Amdt 12... 04/06/94 AK Cold Bay Cold Bay FDC 4/1596 NDB Rwy 14 Amdt 10... 04/08/94 ME Fryeburg Eastern Slopes Regional FDC 4/1624 NDB&hyph;B Orig... 04/08/94 MN Winona Winona Muni-max Conrad Field FDC 4/1627 VOR&hyph;A Amdt 11A... 04/11/94 OH Columbus Port Columbus Intl FDC 4/1654 ILS Rwy 28L Amdt 26... 04/13/94 NV Winnemucca Winnemucca Muni FDC 4/1669 NDB&hyph;A Amdt 1... 04/15/94 MA Norwood Norwood Memorial FDC 4/1676 NDB Rwy 35 Amdt 6... 04/15/94 MA Norwood Norwood Memorial FDC 4/1677 LOC Rwy 35 Amdt 6... 04/18/94 CT Winsor Locks Bradley International FDC 4/1731 VOR OR TACAN Rwy 15, Amdt 2... 04/19/94 MT Choteau Choteau FDC 4/1769 NDB Rwy 23 Orig... [FR Doc. 94&hyph;12778 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4910&hyph;13&hyph;M FR940525-0-00015 FR940525-0-00006 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 103 [Docket No. 92N&hyph;0059] Quality Standards for Foods With No Identity Standards; Bottled Water AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the standard of quality regulation for bottled water to establish an allowable level of 0.005 milligrams per liter (mg/L) for lead in bottled water. FDA also is retaining the existing allowable level of 1.0 mg/L for copper in bottled water. This final rule will ensure both that the minimum quality of bottled water with respect to copper and lead remains comparable to the quality of public drinking water, and that bottled water will be free of any significant lead contamination. This final rule is consistent with FDA's goal of reducing consumers' exposure to lead in drinking water to the extent practicable.

DATES: Effective November 21, 1994. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 103.35(d)(3)(v), effective November 21, 1994. FOR FURTHER INFORMATION CONTACT: Henry S. Kim, Center for Food Safety and Applied Nutrition (HFS&hyph;306), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202&hyph;205&hyph;4681. SUPPLEMENTARY INFORMATION: I. Background Under section 410 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 349), whenever the Environmental Protection Agency (EPA) prescribes interim or revised National Primary Drinking Water Regulations (NPDWR's) under section 1412 of the Public Health Service Act (The Safe Drinking Water Act (SDWA) (42 U.S.C. 300f through 300j-9)), FDA is required to consult with EPA and either amend its regulations for bottled drinking water (§103.35(21 CFR 103.35)) or publish in the Federal Register its reasons for not making such amendments. In the Federal Register of June 7, 1991 (56 FR 26460), EPA published a final rule promulgating NPDWR's that established corrosion control treatment technique requirements for controlling lead and copper levels in public water systems when these contaminants exceed levels of 0.015 mg/L for lead and 1.3 mg/L for copper in more than 10 percent of targeted tap samples. Targeted tap water samples represent samples collected from residences most likely to have lead problems as a result of corrosion in the distribution systems. EPA established treatment technique requirements rather than maximum contaminant levels (MCL's) for lead and copper in drinking water because it believed that treatment technique requirements are more appropriate to control contamination of lead and copper that is largely the result of circumstances beyond the direct control of public water systems (i.e., corrosion in service lines not owned by the systems and in the plumbing of residences and buildings). In addition, EPA established maximum contaminant level goals (MCLG's) of zero for lead and 1.3 mg/L for copper which are based solely on considerations of protecting the public from the adverse health effects of these contaminants in drinking water. In accordance with section 410 of the act, FDA published in the Federal Register of January 5, 1993 (58 FR 389), a proposal to amend the quality standard for bottled water to establish an allowable level of 0.005 mg/L for lead and to retain the existing allowable level of 1.0 mg/L for copper. FDA proposed a lower level of 0.005 mg/L for lead in bottled water than EPA's level of 0.015 mg/L for lead in drinking water that triggers treatment technique requirements. FDA's data showed that most bottlers do not normally experience the significant lead contamination problems from corrosion of materials that are presented by public water distribution systems and residential plumbing (e.g., pipes, faucets, and solder), and that bottlers can produce bottled water products with lead levels below 0.005 mg/L. Furthermore, this level represents the lowest level at which FDA can take enforcement action because it corresponds to the practical quantitation limit (PQL) of the best available analytical methods for determining lead levels in water. Finally, FDA noted that establishing the allowable level for lead at 0.005 mg/L would provide public health protection at least equivalent to that provided by EPA's NPDWR and would ensure that bottled water products are free of significant lead contamination. With respect to the allowable level for copper, the existing allowable level of 1.0 mg/L in bottled water is below EPA's MCLG of 1.3 mg/L and is equivalent to EPA's secondary maximum contaminant level (SMCL), which is based on the aesthetic effects of copper in drinking water. Thus, FDA proposed to retain the existing allowable level to ensure that levels of copper in bottled water meet the safety and aesthetic criteria that EPA has established for copper in drinking water. On November 8, 1990, the enactment of the Nutrition Labeling and Education Act of 1990 (Pub. L. 101&hyph;535) removed standard of quality rulemakings from the coverage of the formal rulemaking procedures in section 701(e) of the act (21 U.S.C. 371(e)). FDA, therefore, proposed the amendments to the bottled water quality standard regulations for lead and copper using notice and comment rulemaking under section 701(a) of the act. Interested persons were given until March 8, 1993, to comment on the proposed regulation. II. Summary of and Response to Comments A. Summary of Comments FDA received approximately 130 responses to the January 5, 1993, proposal. Each of these responses contained one or more comments from industry, consumers, trade associations, Federal government officials, State government agencies, consumer advocacy organizations, and a private research foundation. The comments generally supported the proposal. Many comments addressed issues that are outside the scope of the proposal (e.g., allowable levels for total trihalomethanes, chlorine, and fluoride in the quality standard for bottled water). These comments will not be discussed here. A number of comments suggested modifications to, or were opposed to, various provisions of the proposal. A summary of the suggested changes, the opposing comments, and the agency's responses follows. B. Response to Comments 1. Most comments supported the proposed allowable levels of 0.005 mg/L for lead and 1.0 mg/L for copper in the quality standard for bottled water. One comment, however, stated that the allowable level for lead in bottled water should not be any lower than EPA's corrosion treatment trigger level of 0.015 mg/L for lead in drinking water because this level corresponds to an average lead level of 0.005 mg/L, the level which most bottled waters do not exceed. The comment argued that the fact that 0.005 mg/L is at the lower limit of reliable measurement for lead does not justify setting a standard at that level. The comment further argued that setting a standard for lead in bottled water is not necessary because lead content is not a problem in bottled water. The comment maintained that imposing regulations for the sake of regulation is a problem because of the high costs incurred by diverting FDA resources from significant regulatory concerns. FDA disagrees with this comment. Under section 410 of the act, FDA's approach has been to respond to EPA's promulgation of drinking water regulations under the SDWA by amending the quality standard for bottled water to maintain compatibility with EPA's regulations. FDA concludes that amending the standard for lead in bottled water to 0.005 mg/L is fully compatible and consistent with the EPA standard. Based on the available health effects information, EPA established an MCLG of zero for lead in drinking water. By adopting this MCLG, EPA was in effect saying that if zero lead in drinking water can be achieved, it should be achieved. However, EPA concluded that zero lead in public drinking water could not be achieved because of contamination of the water with lead from corrosion of lead-containing materials in public water distribution systems and in residential plumbing. To control this contamination, EPA established treatment technique requirements which are triggered when more than 10 percent of the targeted tap water samples exceeds 0.015 mg/L for lead. Bottled water, however, generally does not have significant lead contamination problems. FDA conducted a survey of bottled water in 1990 (Ref. 1), and the findings of that survey show that most bottlers are using source waters that are free of significant lead contamination and can readily produce bottled water products with lead levels below 0.005 mg/L, the PQL for lead in water. Consequently, because this level, which is as close to EPA's MCLG of zero as possible, is achievable in bottled water, there is no reason for FDA to rely on EPA's 0.015 mg/L trigger level in establishing an allowable level for lead in bottled water. In fact, in its review and comment on FDA's proposal (before it published in the Federal Register ), EPA stated that the regulatory approach taken by FDA to establish an allowable level of 0.005 mg/L for lead in bottled water is consistent with the intent of the NPDWR for lead in public drinking water (Ref. 4). 2. One comment asserted that there is no safe threshold for lead in drinking water and, because technological resources and knowledge make it feasible to measure lead in water at the 0.002 mg/L level, FDA should establish the allowable level for lead in bottled water at that level. The comment contended that, because large water companies have been testing for lead and reporting lead levels of 0, 0.001, 0.002, 0.003, and 0.004 mg/L to EPA, the PQL is substantially lower than 0.005 mg/L. The comment stated that another organization, which has limited resources and is not in the business of supplying water commercially, uses a laboratory that has found the PQL to be 0.002 mg/L when testing for lead in bottled water. The comment further argued that EPA's PQL concept is theoretically inappropriate for safety determinations because the error theory of laboratory measurements (i.e., the distinction between the standard error of a single measurement and the standard error among a group of measurements) upon which EPA bases its determination of the PQL is misleading. FDA disagrees that EPA's PQL concept is inappropriate. EPA's PQL is set at the lowest concentration for a contaminant that laboratories certified by the States or by EPA for water analyses can reliably measure within specified limits of precision and accuracy under routine laboratory operating conditions. EPA also determines the PQL based on the method detection limit (MDL), which is defined as the lowest concentration of a substance that can be measured with 99 percent confidence that the true value is greater than zero. EPA generally sets the PQL at 5 to 10 times the MDL, depending on the degree of health risk posed by a contaminant (for contaminants like lead that pose a high degree of health risk, EPA sets the PQL at 5 times the MDL), and, if possible, confirms the PQL by interlaboratory performance evaluation studies. Based on EPA's calculation of a 0.001 mg/L MDL for lead by the most sensitive analytical methods available, EPA set the PQL for lead at 0.005 mg/L. EPA confirmed this level by performance evaluation studies that evaluated the ability of EPA, State, and non-EPA and State laboratories to analyze water samples with low lead levels (56 FR 26460 at 26511, June 7, 1991). Although the comment stated that a laboratory used by another organization found the PQL to be 0.002 mg/L for lead in bottled water, it did not provide any data to support that laboratory's determination. Therefore, this comment has not provided an adequate basis upon which to call into question EPA's PQL. In summary, based on the studies conducted by EPA establishing a PQL of 0.005 mg/L for lead in drinking water, FDA finds that an allowable level of 0.005 mg/L for lead in the quality standard for bottled water is appropriate. 3. Another comment stated that, although it strongly endorsed the proposed allowable level for lead in bottled water, FDA should review this standard in a few years because EPA's 1991 rule for lead in drinking water has led to increased analysis for lead in water, and, using the best available methodology, many laboratories can now routinely measure lead levels at 0.001 or 0.002 mg/L in water samples. The comment maintained that measurement of lead in water at these levels may soon be the standard, ``state of the art'' technology, and that it would be appropriate to set the allowable level in bottled water at the limit of detection, i.e., 0.005 mg/L, or no detectable lead, whichever is less. FDA disagrees that establishing the allowable level for lead in bottled water at the limit of detection, i.e., 0.005 mg/L, or no detectable lead, whichever is less, is appropriate. As discussed above, 0.005 mg/L, the PQL for lead in water, represents the lowest concentration that State- or EPA-certified laboratories for water analyses can reliably measure within specified limits of precision and accuracy under routine laboratory operating conditions. FDA recognizes that lead levels in water can be measured below 0.005 mg/L. However, to take an enforcement action based on level of a contaminant in a food, FDA must be able to reliably establish the level of the contaminant in the food. EPA's PQL of 0.005 mg/L has been confirmed by performance evaluation studies as the lowest level of lead in water samples that can be reliably and consistently measured (56 FR 26460 at 26511). Thus, FDA has concluded that reliance on the PQL as the allowable level for lead in bottled water is appropriate. Nevertheless, FDA agrees that technology for analytical methodology is constantly advancing. Reliable measurement of lead levels below 0.005 mg/L in water samples, within specified limits of precision and accuracy under routine laboratory operating conditions, may soon become the general norm. Therefore, FDA agrees with the comment that within the next few years, it should consult with EPA about reevaluating the PQL for lead in water. Moreover, FDA recognizes that, should EPA revise the PQL, FDA will need to consider whether an allowable level for lead in bottled water below 0.005 mg/L is appropriate. 4. A State government agency and a majority of the comments from industry and trade associations opposed the statement in the proposal that if the proposal becomes a final rule, bottlers will be required to test each lot of bottled water to ensure that it contains less than 0.005 mg/L of lead. The comments argued that, because most bottlers are routinely meeting the 0.005 mg/L standard for lead, a requirement for testing each lot of bottled water for lead is not necessary. Furthermore, the majority of the comments argued that testing each lot of bottled water for lead would impose a significant financial burden on the bottled water industry. For example, comments from two trade associations representing bottled water manufacturers maintained that a requirement for testing each lot of bottled water for lead would impose additional annual costs that they estimated at $15,000 for a small bottler and $300,000 for a large bottler. Under the current good manufacturing practice (CGMP) regulations for the processing and bottling of bottled drinking water (part 129 (21 CFR part 129)), bottlers are required to analyze, at least annually, for chemical contaminants, including lead, in a representative sample from a batch or a segment of a continuous production run for each type of bottled drinking water produced during a day's production (§129.80(g)(2)). Therefore, bottlers will not be required to test each lot of bottled water for the presence of lead. The statement that they would, which was inadvertently included in the economic impact analysis, was in error. However, FDA reminds water bottlers that each lot of bottled water must comply with the quality standard for chemical contaminants, and compliance with the minimum annual testing requirements of the CGMP does not exempt a firm from regulatory action if any lot of bottled water does not meet any provision of the chemical quality standard. 5. Several comments recommended that testing for chemical contaminants (e.g., lead and copper) should be more frequent than the required minimum of annual testing. One comment noted that, although FDA has established quality standards for bottled water, it did not set any requirements for monitoring timeframes or submission of results to ensure that bottlers meet the quality standards. Moreover, the comment objected to allowing distribution of a bottled water product that is below the water quality standard, arguing that, given the emphasis on the quality of bottled water verses tap water by the bottled water industry, bottlers are not likely to print a ``substandard'' statement on the label. FDA agrees that bottlers are not likely to market bottled water that would be required to bear a statement of substandard quality with respect to lead. However, FDA notes that the use of such a statement on the label of a food covered by a standard of quality is specifically provided for by section 403(h)(1) of the act (21 U.S.C. 343(h)(1)), if that food falls below the prescribed quality standard. Therefore, FDA cannot preclude the use of the statement of substandard quality. Nonetheless, §103.35(g) provides that any bottled water containing a substance at a level considered injurious to health under section 402 of the act (21 U.S.C. 342) is deemed to be adulterated and may be subject to regulatory action, even if the bottled water bears a label statement of substandard quality. FDA notes that the CGMP regulations for processing and bottling of bottled drinking water (part 129) require that the water to be bottled be obtained from an approved source properly located, protected, and operated; be of a safe, sanitary quality; and be in compliance at all times with the applicable laws and regulations of the government agency or agencies having jurisdiction (§129.35). In addition, §129.35(a) requires that samples of source water be analyzed as often as necessary, but at least once each year, for chemical contaminants, and §129.80(g) requires that each type of bottled water product be analyzed at least annually for chemical contaminants. Moreover, §129.80(h) requires that records of the results for these tests be maintained at the plant for at least 2 years and be available for official review at reasonable times. FDA is not aware of any data or other information that suggests that requiring all bottlers to test for lead more frequently is necessary to ensure that bottled water is safe and of acceptable quality. FDA emphasizes that water bottlers are responsible for ensuring, through appropriate manufacturing techniques and sufficient quality control procedures, that all bottled water products introduced or delivered for introduction into interstate commerce are safe, wholesome, and truthfully labeled, and that they comply with the provisions of the quality standard. Therefore, should any bottler encounter circumstances that would warrant testing for lead more frequently than once per year, the bottler is required to do such testing to ensure the safety and quality of the bottled water. For the reasons stated above, FDA concludes that the testing requirements for contaminants in bottled water contained in the CGMP regulations (part 129) are appropriate and sufficient to ensure the quality and safety of bottled water products. Thus, the agency finds that revision of the CGMP regulations to require more frequent testing for chemical contaminants in bottled water is not necessary at this time. 6. A majority of responses from industry opposed the exemption of mineral water from the lead standard for bottled water. Another comment stated that the lead standard should apply to other types of bottled beverages, including mineral water, soda water, and seltzer. Under the provisions of §103.35, the definition of ``bottled water'' excludes mineral water or any type of soft drink commonly known as soda water. Consequently, these types of products are exempt from the provisions of the quality standard for bottled water, including the allowable level for lead. However, in a proposal to establish a standard of identity for bottled water (57 FR 393, January 5, 1993), FDA proposed to revise the definition for ``bottled water'' in the quality standard to include mineral water. Should FDA adopt that proposal, the allowable level of 0.005 mg/L for lead will apply to mineral water. Even if the agency does not adopt this change, because of the health concerns raised by lead, the agency is likely to take some action to regulate the level of lead in mineral water. In regard to soda water and seltzer, FDA considers these types of products to be soft drinks and not bottled water. Consequently, they are not covered by regulations that address bottled water. The agency's reasons for considering these types of products as soft drinks are fully discussed in its proposal to establish an identity standard for bottled water (57 FR 393 at 395). Soft drinks are subject to regulatory action, however, if they contain a level of lead that may render the food injurious to health. 7. One comment from a trade association representing public water supply agencies recommended that FDA review the latest EPA analytical techniques for determining lead and copper with respect to the use of nitric acid digestion and incorporate this procedure as applicable. In accordance with FDA's responsibilities pursuant to section 410 of the act, FDA consulted with EPA by requesting EPA's review and comment on the proposal to amend the quality standard for lead and copper in bottled water. In response, EPA stated that FDA's regulatory approach for lead and copper in bottled water is consistent with the intent of EPA's NPDWR's for lead and copper and concurred with the analytical methods that FDA cited for determining lead and copper in bottled water (Ref. 4). Furthermore, in EPA Methods 200.7, 200.8, and 200.9, which FDA proposed to incorporate by reference, the sample preparation procedures for measuring lead and copper as total recoverable metals call for a nitric acid or nitric acid-hydrochloric acid digestion. III. Conclusions The agency is adopting the provisions concerning lead and copper in the quality standard for bottled water as proposed (58 FR 389, January 5, 1993). The majority of the comments that the agency received supported the proposal. Furthermore, after carefully considering the comments that the agency received that suggested modifications to, or were opposed to, aspects of the proposal, the agency has determined that no changes are warranted. Therefore, upon the effective date of this rule, November 21, 1994, any bottled water that contains an amount of lead or copper that exceeds the allowable levels will be misbranded under section 403(h)(1) of the act unless the bottled water bears a statement of substandard quality as provided by §103.35(f)(2)(ii). FDA has made one minor change concerning the analytical methods for the determination of lead and copper cited in new §103.35(d)(3)(v). The sources for these methods will be the National Technical Information Services rather than EPA. This change is consistent with the agency's practice of relying on readily available commercial sources for incorporated materials when possible. IV. Environmental Impact The agency previously considered the environmental effects of this rule, as announced in the proposed rule (58 FR 389, January 5, 1993). At that time, the agency concluded that the action would not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's environmental assessment and finding of no significant impact for the proposal were displayed at the Dockets Management Branch at the time of the proposal. FDA has received no new information or comments that would affect the agency's previous determination that there is no significant impact on the human environment, and that an environmental impact statement is not required. V. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96&hyph;354). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because FDA has received no new information or comments that would alter its tentative finding in the proposal that there is no substantive economic issue, the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required. VI. References The following references have been placed on display in the Dockets Management Branch (HFA&hyph;305), Food and Drug Administration, rm. 1&hyph;23, 12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. FDA FY 90 Bottle Water Survey, 1990. 2. FDA internal memorandum of meeting, Discussions on the Analytical Methods for Determination of Lead in Bottled Water, December 20, 1991. 3. ``Twenty Questions Concerning Bottled Water,'' International Bottled Water Association, 1990. 4. James M. Conlon, Drinking Water Standards Division, EPA, letter to Henry S. Kim, February 14, 1992. List of Subjects in 21 CFR Part 103 Beverages, Bottled water, Food grades and standards, Incorporation by reference. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 103 is amended as follows: PART 103_QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS 1. The authority citation for 21 CFR part 103 continues to read as follows: Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 349, 371, 379e). 2. Section 103.35 is amended in the table in paragraph (d)(1)(i) by removing the entries for ``Copper'' and ``Lead,'' by revising the introductory text of paragraph (d)(3), and by adding new paragraphs (d)(3)(i) and (d)(3)(v) to read as follows: §103.35 Bottled water. * * * * * (d) * * * (3) Having consulted with the U.S. Environmental Protection Agency (EPA) as required by section 410 of the Federal Food, Drug, and Cosmetic Act, the Food and Drug Administration has determined that bottled water, when a composite of analytical units of equal volume from a sample is examined by the methods listed in paragraphs (d)(3)(v) and (d)(3)(vi) of this section, shall not contain the following chemical contaminants in excess of the concentrations specified in paragraphs (d)(3)(i) and (d)(3)(ii) of this section. (i) The allowable levels for inorganic substances are as follows: 1Contaminant 1Concentration milligrams per liter (or as specified) Copper 1.0 Lead 0.005 * * * * * (iii) and (iv) [Reserved] (v) Analyses to determine compliance with the requirements of paragraph (d)(3)(i) of this section shall be conducted in accordance with an applicable method and applicable revisions to the methods listed in paragraphs (d)(3)(v)(G) and (d)(3)(v)(H) of this section and described, unless otherwise noted, in ``Methods for Chemical Analysis of Water and Wastes,'' U.S. EPA Environmental Monitoring and Support Laboratory, EPA&hyph;600/4&hyph;79&hyph;020, March 1983, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the National Technical Information Service, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Office of Plant and Dairy Foods and Beverages (HFS&hyph;305), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or at the Office of the Federal Register, 800 North Capitol St., NW., suite 700, Washington, DC. (A)&hyph;(F) [Reserved] ( G ) Copper shall be measured as total recoverable metal without filtration using the following methods: ( 1 ) Method 220.2_Atomic absorption; furnace technique, in ``Methods for Chemical Analysis of Water and Wastes,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 or ( 2 ) Method 220.1_Atomic absorption; direct aspiration, in ``Methods for Chemical Analysis of Water and Wastes,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v) of this section. ( 3 ) Method 200.7_entitled ``Determination of Metals and Trace Elements in Water and Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' Revision 3.3, April 1991, U.S. EPA, Environmental Monitoring and Support Laboratory (EMSL). The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' Office of Research and Development, Washington, DC 20460, (EPA/600/4&hyph;91/010), June 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are available from the National Technical Information Service, U.S. Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the Office of Plant and Dairy Foods and Beverages (HFS&hyph;305), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC. ( 4 ) Method 200.8_entitled, ``Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(G)( 3 ) of this section. ( 5 ) Method 200.9_entitled, ``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 1.2, April 1991, U.S. EPA, EMSL. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(G)( 3 ) of this section. ( H ) Lead shall be measured as total recoverable metal without filtration using the following methods: ( 1 ) Method 239.2_Atomic absorption; furnace technique, from ``Methods for Chemical Analysis of Water and Wastes,'' which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v) of this section. ( 2 ) Method 200.8_entitled, ``Determination of Trace Elements in Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 4.4, April 1991. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' June 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(G)( 3 ) of this section. ( 3 ) Method 200.9_from ``Determination of Trace Elements by Stabilized Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Revision 1.2, April 1991. The revision is contained in the manual entitled ``Methods for the Determination of Metals in Environmental Samples,'' June 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (d)(3)(v)(G)( 3 ) of this section. * * * * * Dated: May 17, 1994. Michael R. Taylor, Deputy Commissioner for Policy. [FR Doc. 94&hyph;12666 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00016 FR940525-0-00007 21 CFR Part 166 [Docket No. 90P&hyph;0025] Margarine; Standard of Identity To Permit Use of Any Form of Oil of Marine Species Affirmed as GRAS or Approved as a Food Additive for This Use AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the U.S. standard of identity for margarine to permit the use of any form of oil of marine species that has been affirmed as generally recognized as safe (GRAS) or approved as a food additive for this use. This action is in response to a petition submitted by the National Fish Meal and Oil Association (NFMOA). FDA believes that this action will provide increased flexibility to manufacturers in the selection of lipid ingredients in margarine and will promote honesty and fair dealing in the interest of consumers.

DATES: Effective July 25, 1994. All products initially introduced or initially delivered for introduction into interstate commerce shall comply on or after this date. FOR FURTHER INFORMATION CONTACT: Nannie H. Rainey, Center for Food Safety and Applied Nutrition (HFS&hyph;158), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202&hyph;205&hyph;5099. SUPPLEMENTARY INFORMATION: I. The Proposal In the Federal Register of August 30, 1990 (55 FR 35439), FDA published a proposal based on a petition from NFMOA, 1525 Wilson Blvd., suite 500, Arlington, VA 22209, to amend the U.S. standard of identity for margarine (§166.110 (21 CFR 166.110)) to permit the use of any form of marine oil that has been affirmed as GRAS or approved as a food additive for this use as an additional optional edible fat or oil ingredient in margarine. Interested persons were given until October 29, 1990, to submit comments. II. The Tentative Final Rule The NFMOA petition was filed under section 701(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)), which requires formal rulemaking in any action for the amendment of a food standard. However, in November 1990, the Nutrition Labeling and Education Act of 1990 (Pub. L. 101&hyph;535) was signed into law, and it removed food standard rulemaking proceedings, except for actions for the amendment or repeal of food standards of identity for dairy products or maple sirup, from the formal rulemaking proceedings of section 701(e) of the act. Therefore, further action on the NFMOA petition would be subject to the informal notice and comment rulemaking proceedings of section 701(a) of the act. Thus, the agency published a tentative final rule in the Federal Register of August 17, 1993 (58 FR 43580), under those procedures. Because there had been an opportunity to comment on the proposal when it was published in 1990, the comment period on that tentative final rule was 30 days. III. Comments FDA received one comment in response to the tentative final rule. This comment, submitted by the petitioner, expressed support for the rule and urged the agency to finalize the rule as soon as possible. NFMOA also stated that it would like to make clear for the record that its petition did not ask FDA to approve the use of any form of marine oil but was instead restricted to ``any safe and suitable form of menhaden oil.'' The comment stated that, nevertheless, it had no objection to FDA's enlargement of the range of oils to be permitted by the amended regulation, from menhaden oil to marine oil, provided that this change does not result in any further delay in the rulemaking proceeding. The agency acknowledges that the petitioner only sought to provide for safe and suitable forms of menhaden oil in margarine. However, FDA believes that it is appropriate to provide for oil of any marine species where such oil has been affirmed as GRAS or approved as a food additive for this use. The broader provision in the standard of identity will eliminate the need to amend the standard of identity for margarine should other oils of marine species be found to be safe and suitable for use in this food. FDA also notes that ingredient labeling will inform consumers of the presence of such oils when used in margarine. Therefore, having received no adverse comments, the agency is revising the margarine standard as proposed in the tentative final rule. The agency believes that providing for optional oils of marine species that have been affirmed as GRAS or listed as a food additive for this use will increase manufacturers' options in the selection of oil ingredients for margarine and will provide for a wider variety of margarine products in the marketplace. Thus, the agency concludes that the proposed change in the standard of identity for margarine will promote honesty and fair dealing in the interest of consumers. Accordingly, after consideration of the comments, the agency is issuing this final rule to amend the standard of identity for margarine in §166.110 as set forth below. IV. Economic Impact FDA has examined the economic implications of this final rule to amend the standard of identity for margarine in 21 CFR part 166 as required by Executive Order (E.O.) 12866 and the Regulatory Flexibility Act (Pub. L. 96&hyph;354). E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). The Regulatory Flexibility Act requires that the agency analyze options for regulatory relief for small businesses. In the August 17, 1993, tentative final rule, FDA announced that it had analyzed the economic impact of the new provision that FDA is adopting under the previous E.O. 12291 and found that it would not have a significant impact. E.O. 12291 compelled agencies to use cost-benefit analysis as a component of decisionmaking. The agency also tentatively concluded in the August 30, 1990, proposal that this action would not result in a significant economic impact on a substantial number of small entities. Manufacturers may continue to produce margarine using current formulations. Thus, no changes are required in formulations unless manufacturers wish to reformulate their products. FDA has received no new information or comments that would alter its tentative finding that there is no substantive economic issue in this rulemaking. Thus, FDA concludes that this is not a major rule as defined by E.O. 12291, nor is it a significant rule as defined by E.O. 12866. In compliance with the Regulatory Flexibility Act, the agency certifies that the final rule will not have a significant impact on a substantial number of small businesses. V. Environmental Impact In the preamble to the August 30, 1990, proposed rule, FDA reported its finding that this action qualified for categorical exclusion under 21 CFR 25.24(b)(1) and that neither an environmental assessment (EA) nor an environmental impact statement was required. As noted in the tentative final rule, FDA received one comment on the proposed rule that claimed that this action would result in increased fishing pressure that could adversely affect the menhaden fishery, and that the agency had not considered this potential impact prior to issuing the proposed rule. Although the comment did not provide evidence to support the contention that the menhaden fishery would be adversely affected, FDA requested an EA from the petitioner. The decision to ask for an EA takes into consideration the agency's assessment of this issue as part of its previous action to affirm partially hydrogenated menhaden oil and hydrogenated menhaden oil as GRAS for use as edible fats or oils (54 FR 38219, September 15, 1989). The agency also has information indicating that the market for menhaden oil as a component of margarine is large, approximately 40 million pounds per year. Based on information in the petitioner's EA submitted for the current action and on the agency's analysis of the reports on the menhaden fisheries issued subsequent to FDA approval of GRAS petition (GRASP 6G0316 (54 FR 38219)), FDA concluded in the August 17, 1993, tentative final rule that the proposed action would not have a significant impact on the menhaden fishery. Amending the margarine standard of identity will not increase the volume of crude menhaden oil that is produced. The only change will be that crude menhaden oil will more often be retained in the United States for further processing into food grade products, instead of being shipped to Europe and elsewhere for this same use. Thus, FDA carefully considered the potential environmental effects of this action, including the effects on the menhaden fishery and concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact, and the evidence supporting that finding, which includes the petitioner's EA, the finding of no significant impact for FDA's approval of GRASP 6G0316 (54 FR 38219), and a copy of ``National Marine Fisheries Service Final Purse-seine Landings of Gulf and Atlantic Menhaden in the 1990 and 1991 Fishing Seasons'' have been placed on file in the Dockets Management Branch (HFA&hyph;305), Food and Drug Administration, rm. 1&hyph;23, 12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. The agency has not received any additional information that would cause it to revise its finding of no significant impact on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 21 CFR Part 166 Food grades and standards, Food labeling, Margarine. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 166 is amended as follows: PART 166_MARGARINE 1. The authority citation for 21 CFR part 166 is revised to read as follows: Authority: Secs. 201, 401, 403, 407, 409, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 347, 348, 371, 379e). 2. Section 166.110 is amended by adding new headings for the introductory text of paragraph (a) and paragraph (c), by revising paragraph (a)(1), and in the introductory text of paragraph (b) and paragraph (d) the headings ``Optional ingredients'' and ``Label declaration'', respectively, are italicized to read as follows: §166.110 Margarine. (a) Description . * * * (1) Edible fats and/or oils, or mixtures of these, whose origin is vegetable or rendered animal carcass fats, or any form of oil from a marine species that has been affirmed as GRAS or listed as a food additive for this use, any or all of which may have been subjected to an accepted process of physico-chemical modification. They may contain small amounts of other lipids, such as phosphatides or unsaponifiable constituents, and of free fatty acids naturally present in the fat or oil. * * * * * (b) Optional ingredients . * * * * * * * * (c) Nomenclature . * * * (d) Label declaration. * * * Dated: May 16, 1994. Michael R. Taylor, Deputy Commissioner for Policy. [FR Doc. 94&hyph;12804 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00017 FR940525-0-00008 21 CFR Part 442 [Docket No. 94N&hyph;0132] Antibiotic Drugs; Cefotetan and Cefotetan Sodium Injection AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the antibiotic drug regulations to provide for the inclusion of accepted standards for a new bulk form of cefotetan, cefotetan, and for its use in a new dosage form of cefotetan sodium, cefotetan sodium injection. The manufacturer has supplied sufficient data and information to establish its safety and efficacy.

DATES: Effective June 24, 1994; written comments, notice of participation, and requests for a hearing by June 24, 1994; data, information, and analyses to justify a hearing by July 25, 1994.

ADDRESSES: Submit written comments to the Dockets Management Branch (HFA&hyph;305), Food and Drug Administration, rm. 1&hyph;23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Peter A. Dionne, Center for Drug Evaluation and Research (HFD&hyph;520), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301&hyph;443&hyph;0335. SUPPLEMENTARY INFORMATION: FDA has evaluated data submitted in accordance with regulations promulgated under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357), as amended, with respect to a request for approval of (1) a new bulk form of cefotetan, cefotetan, and (2) for its use in a new dosage form of cefotetan sodium, cefotetan sodium injection. The agency has concluded that the data supplied by the manufacturer concerning this antibiotic drug are adequate to establish its safety and efficacy when used as directed in the labeling and that the regulations should be amended in 21 CFR part 442 to provide for the inclusion of accepted standards for this product. Environmental Impact The agency has determined under 21 CFR 25.24(c)(6) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. Submitting Comments and Filing Objections This final rule announces standards that FDA has accepted in a request for approval of an antibiotic drug. Because this final rule is not controversial and because, when effective, it provides notice of accepted standards, FDA finds that notice and comment procedure is unnecessary and not in the public interest. This final rule, therefore, is effective June 24, 1994. However, interested persons may, on or before June 24, 1994, submit written comments to the Dockets Management Branch (address above). Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Any person who will be adversely affected by this final rule may file objections to it and request a hearing. Reasonable grounds for the hearing must be shown. Any person who decides to seek a hearing must file (1) on or before June 24, 1994, a written notice of participation and request for a hearing, and (2) on or before July 25, 1994, the data, information, and analyses on which the person relies to justify a hearing, as specified in 21 CFR 314.300. A request for a hearing may not rest upon mere allegations or denials, but must set forth specific facts showing that there is a genuine and substantial issue of fact that requires a hearing. If it conclusively appears from the face of the data, information, and factual analyses in the request for a hearing that no genuine and substantial issue of fact precludes the action taken by this order, or if a request for a hearing is not made in the required format or with the required analyses, the Commissioner of Food and Drugs will enter summary judgment against the person(s) who request(s) the hearing, making findings and conclusions and denying a hearing. All submissions must be filed in three copies, identified with the docket number appearing in the heading of this document and filed with the Dockets Management Branch. The procedures and requirements governing this order, a notice of participation and request for a hearing, a submission of data, information, and analyses to justify a hearing, other comments, and grant or denial of a hearing are contained in 21 CFR 314.300. All submissions under this order, except for data and information prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 442 Antibiotics. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 442 is amended as follows: PART 442_CEPHA ANTIBIOTIC DRUGS 1. The authority citation for 21 CFR part 442 continues to read as follows: Authority: Sec. 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357). 2. New §442.52 is added to subpart A to read as follows: §442.52 Cefotetan. (a) Requirements for certification _(1) Standards of identity, strength, quality, and purity . Cefotetan is (6 R ,7 S )-4-[[2-carboxy-7-methoxy-3-[[(1-methyl-1 H -tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-7-yl]-carbamoyl]-1,3-dithietane- D 2, a -malonamic acid. It is so purified and dried that: (i) Its potency is not less than 950 micrograms and not more than 1,030 micrograms of cefotetan activity per milligram on the anhydrous basis. (ii) Its moisture content is not more than 2.5 percent. (iii) It gives a positive identity test for cefotetan. (2) Labeling . It shall be labeled in accordance with the requirements of §432.5 of this chapter. (3) Requests for certification; samples . In addition to complying with the requirements of §431.1 of this chapter, each such request shall contain: (i) Results of tests and assays on the batch for potency, moisture, and identity. (ii) Samples, if required by the Director, Center for Drug Evaluation and Research: 10 packages each containing approximately 500 milligrams. (b) Tests and methods of assay _(1) Potency . Proceed as directed in §436.216 of this chapter, except use the resolution test solution to determine resolution in lieu of the working standard solution. Perform the assay at ambient temperature, using an ultraviolet detection system operating at a wavelength of 254 nanometers, a column packed with microparticulate (3 to 10 micrometers in diameter) reversed phase packing material such as octadecyl hydrocarbon bonded silicas, a flow rate not exceeding 2.0 milliliters per minute, and a known injection volume of between 10 and 20 microliters. Reagents, working standard solution, sample solution, resolution test solution, system suitability requirements, and calculations are as follows: (i) Reagents _(A) Diluting solution . Mix water:methanol:acetonitrile (90:5:5). (B) Mobile phase . Mix 0.1 M phosphoric acid:glacial acetic acid:methanol:acetonitrile (1700:100:105:105). Filter through a suitable filter capable of removing particulate matter greater than 0.5 micron in diameter. Degas the mobile phase just prior to its introduction into the chromatograph. (ii) Preparation of working standard, sample, and resolution test solutions _(A) Working standard solution . Accurately weigh approximately 50 milligrams of the cefotetan working standard into a 250-milliliter volumetric flask containing 12.5 milliliters of methanol. Swirl the flask for several minutes, then add 12.5 milliliters of acetonitrile. Swirl the flask until the cefotetan is dissolved. Dilute to volume with water to obtain a solution containing approximately 200 micrograms of cefotetan per milliliter. Mix well. Protect the working standard solution from light. (B) Sample solution . Dissolve an accurately weighed portion of the sample with sufficient diluting solution described in paragraph (b)(1)(i)(A) of this section to obtain a concentration of approximately 200 micrograms of cefotetan per milliliter. (C) Resolution test solution . Place 10 milliliters of the working standard solution in a stoppered flask containing a few milligrams of magnesium carbonate. Close the flask and sonicate for 10 minutes. If the solution is not slightly turbid, add more magnesium carbonate and repeat sonication. Filter the turbid solution through a 0.5-micron filter and use within 2 hours. As this solution stands, the tautomer concentration increases. (iii) System suitability requirements _(A) Tailing factor . The tailing factor ( T ) is satisfactory if it is not more than 1.3 at 10 percent of peak height in lieu of 5 percent of peak height. (B) Efficiency of the column . The efficiency of the column ( n ) is satisfactory if it is greater than 1,500 theoretical plates. (C) Resolution . The resolution ( R ) between the peak for cefotetan and its tautomer is satisfactory if it is not less than 2.0. (D) Coefficient of variation . The coefficient of variation ( S r in percent) of five replicate injections is satisfactory if it is not more than 2.0 percent. If the system suitability requirements have been met, then proceed as described in §436.216(b) of this chapter. Alternate chromatographic conditions are acceptable provided comparable system suitability requirements are met. However, the sample preparation described in paragraph (b)(1)(ii)(B) of this section should not be changed. (iv) Calculation . Calculate the micrograms of cefotetan per milligram of sample as follows: ␣ 1Micrograms of cefotetan per milligram 1= 1 A U X P S X 100 2 A S X C U X (100- m ) where: A U = Area of the cefotetan peak in the chromatogram of the sample (at a retention time equal to that observed for the standard); A S = Area of the cefotetan peak in the chromatogram of the cefotetan working standard; P S = Cefotetan activity in the cefotetan working standard solution in micrograms per milliliter; C U = Milligrams of sample per milliliter of sample solution; and m = Percent moisture content of the sample. (2) Moisture . Proceed as directed in §436.201 of this chapter. (3) Identity . Proceed as directed in §436.211 of this chapter using a mineral oil mull prepared as described in §436.211(b)(2). §442.253a [Redesignated from §442.253] 3. Section 442.253 is redesignated as §442.253a and new §§442.253 and 442.253b are added to subpart C to read as follows: §442.253 Cefotetan injectable dosage forms. §442.253b Cefotetan sodium injection. (a) Requirements for certification _(1) Standards of identity, strength, quality, and purity . Cefotetan sodium injection is a frozen, aqueous, iso-osmotic solution of cefotetan and sodium bicarbonate. It contains one or more suitable and harmless buffer substances and a tonicity adjusting agent. Each milliliter contains cefotetan disodium equivalent to 20 milligrams or 40 milligrams of cefotetan per milliliter. Its cefotetan content is satisfactory if it is not less than 90 percent and not more than 120 percent of the number of milligrams of cefotetan that it is represented to contain. It is sterile. It contains not more than 0.17 endotoxin units per milligram of cefotetan. Its pH is not less than 4.0 and not more than 6.5. It passes the identity test. The cefotetan used conforms to the standards prescribed by §442.52(a)(1). (2) Labeling . It shall be labeled in accordance with the requirements of §432.5 of this chapter. (3) Requests for certification; samples . In addition to complying with the requirements of §431.1 of this chapter, each such request shall contain: (i) Results of tests and assays on: (A) The cefotetan used in making the batch for cefotetan potency, moisture, and identity. (B) The batch for cefotetan potency, sterility, bacterial endotoxins, pH, and identity. (ii) Samples, if required by the Director, Center for Drug Evaluation and Research: (A) The cefotetan used in making the batch: 10 packages, each containing approximately 500 milligrams. (B) The batch: ( 1 ) For all tests except sterility: A minimum of 12 immediate containers. ( 2 ) For sterility testing: 20 immediate containers, collected at regular intervals throughout each filling operation. (b) Tests and methods of assay . Thaw the sample as directed in the labeling. The sample solution used for testing must be at room temperature. (1) Cefotetan potency . Proceed as directed in §442.52(b)(1), except prepare the sample solution and calculate the cefotetan content as follows: (i) Preparation of sample solution . Using a suitable hypodermic needle and syringe, remove an accurately measured portion from each container immediately after thawing and reaching room temperature and dilute with mobile phase to obtain a solution containing 200 micrograms of cefotetan per milliliter (estimated). Prepare the sample solution just prior to its introduction into the chromatograph. (ii) Calculation . Calculate the milligrams of cefotetan per milliliter of sample as follows: ␣ 1Micrograms of cefotetan per milligram 1= 1 A U X P S X 100 2 A S X C U X (100- m ) where: A U = Area of the cefotetan peak in the chromatogram of the sample (at a retention time equal to that observed for the standard); A S = Area of the cefotetan peak in the chromatogram of the cefotetan working standard; P S = Cefotetan activity in the cefotetan working standard solution in micrograms per milliliter; C U = Milligrams of sample per milliliter of sample solution; and m = Percent moisture content of the sample. (2) Sterility . Proceed as directed in §436.20 of this chapter, using the method described in paragraph (e)(1) of that section. (3) Bacterial endotoxins . Proceed as directed in the U.S. Pharmacopeia bacterial endotoxins test. (4) pH . Proceed as directed in §436.202 of this chapter, using the undiluted solution. (5) Identity . The high-performance liquid chromatogram of the sample determined as directed in paragraph (b)(1) of this section compares qualitatively to that of the cefotetan working standard. Dated: May 17, 1994. Gayle R. Dolecek, Acting Director, Office of Compliance, Center for Drug Evaluation and Research. [FR Doc. 94&hyph;12667 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00018 FR940525-0-00009 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Proban ® (Cythioate) Tablets AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Miles, Inc. The supplemental NADA provides for the oral use of a 90-milligram (mg) Proban ® (cythioate) Tablet in addition to the currently approved use of the 30-mg tablet.

EFFECTIVE DATE: May 25, 1994. FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for Veterinary Medicine (HFV&hyph;112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301&hyph;594&hyph;0614. SUPPLEMENTARY INFORMATION: Miles, Inc., Agriculture Division, Animal Health Products, P.O. Box 390, Shawnee Mission, KS 66201, filed supplemental NADA 132&hyph;337, which provides for the use of a 90-mg Proban ® (cythioate) tablet in addition to the approved 30-mg tablet for control of fleas on dogs. The supplemental NADA is approved as of April 25, 1994, and the regulations are amended in 21 CFR 520.531 to reflect the approval. Approval of this supplement does not require submission of new safety or effectiveness data. This supplement provides for use of a larger tablet with increased drug concentration to be given at the currently approved use level. However, in accordance with the freedom of information provisions of part 20 (21 CFR part 20) and §514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a freedom of information summary is provided for the revised labeling. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval does not qualify for marketing exclusivity. The additional studies submitted with the supplement were conducted as requested by FDA to correct deficiencies in the original data supporting safety and effectiveness of the 1968 approval, and they were not essential to the approval of this supplement. The agency has determined under 21 CFR 25.24(d)(1)(iii) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 520.531 is amended by removing and reserving paragraph (a) and by revising paragraph (b) to read as follows: §520.531 Cythioate tablets. (a) [Reserved] (b) Sponsors . See No. 000859 in §510.600(c) of this chapter for use of 30- and 90-milligram (mg) tablets and see No. 010042 in §510.600(c) of this chapter for use of 30-mg tablet. * * * * * Dated: May 16, 1994. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 94&hyph;12664 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00019 FR940525-0-00010 21 CFR Parts 520 and 556 Animal Drugs, Feeds, and Related Products; Fenbendazole Suspension AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Hoechst-Roussel Agri-Vet Co. The supplemental NADA provides for oral administration of fenbendazole suspension to goats as an anthelmintic. The regulations are also amended to establish a tolerance for drug residues in edible goat tissues.

EFFECTIVE DATE: May 25, 1994. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV&hyph;133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301&hyph;594&hyph;1644. SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Rt. 202&hyph;206 North, Somerville, NJ 08876, filed a supplemental NADA 128&hyph;620 that provides for oral administration of a suspension containing 10 percent fenbendazole to nonlactating goats for removal and control of stomach and intestinal worms Haemonchus contortus and Ostertagia circumcincta . Also, a tolerance for residues of fenbendazole and its metabolites in edible goat tissues is established. Approval is based in part on data and information in Public Master File (PMF) 5118 established under the Interregional Research Project No. 4 (IR&hyph;4), Northcentral Region, Michigan State University, East Lansing, MI 48824. The supplement is approved as of April 25, 1994, and the regulations are amended in 21 CFR 520.905a and 556.275 to reflect the approval. The basis for approval is discussed in the freedom of information summary. Additionally, the regulations for tolerances and safe concentrations for residues of the drug or its metabolites in cattle and swine are editorially revised to remove any reference to safe concentrations because they are irrelevant for residue monitoring purposes. In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and §514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA&hyph;305), Food and Drug Administration, rm. 1&hyph;23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii), this approval does not qualify for marketing exclusivity because no new clinical or field investigations (other than bioequivalence or residue studies) and no new human food safety studies (other than bioequivalence or residue studies) essential to approval of the supplement were conducted or sponsored by the applicant. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects 21 CFR Part 520 Animal drugs. 21 CFR Part 556 Animal drugs, Foods. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520 and 556 are amended as follows: PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 520.905a is amended by adding new paragraph (d)(3) to read as follows: §520.905a Fenbendazole suspension. * * * * * (d) * * * (3) Goats _(i) Amount . Administer orally 5 milligrams per kilogram of body weight (2.3 milligrams per pound). (ii) Indications for use . For the removal and control of stomach and intestinal worms Haemonchus contortus and Ostertagia circumcincta . (iii) Limitations . Retreatment may be needed after 4 to 6 weeks. Goats must not be slaughtered for food within 6 days following last treatment. Do not use in lactating goats. Federal law restricts this drug to use by or on the order of a licensed veterinarian. * * * * * PART 556_TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342, 360b, 371). 4. Section 556.275 is revised to read as follows: §556.275 Fenbendazole. (a) Cattle and goats . A tolerance 1 of 0.8 part per million is established for parent fenbendazole (the marker residue) in the liver of cattle and goats. 1 As used in this section: ``tolerance'' refers to a concentration of a marker residue in the target tissue selected to monitor for total residues of the drug in the target animal. (b) Swine . A tolerance1 for marker residues of fenbendazole in swine is not needed. Dated: May 17, 1994. Richard H. Teske, Acting Director, Center for Veterinary Medicine. [FR Doc. 94&hyph;12805 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00020 FR940525-0-00011 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Salinomycin, Roxarsone, and Bacitracin Zinc AGENCY: Food and Drug Administration, HHS. ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Hoechst-Roussel Agri-Vet Co. The ANADA provides for using approved single ingredient Type A medicated articles to make Type C medicated broiler feeds containing salinomycin with roxarsone and bacitracin zinc.

EFFECTIVE DATE: May 25, 1994. FOR FURTHER INFORMATION CONTACT: Glenn A. Peterson, Center for Veterinary Medicine (HFV&hyph;128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301&hyph;594&hyph;1602. SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., P.O. Box 2500, Somerville, NJ 08876&hyph;1258, filed ANADA 200&hyph;143 for the use of salinomycin with roxarsone and bacitracin zinc. The ANADA provides for using approved single ingredient Type A medicated articles to make Type C medicated broiler feeds containing 40 to 60 grams per ton (g/t) of salinomycin sodium activity, 34.1 g/t of roxarsone, and 10 to 50 g/t of bacitracin zinc, for the prevention of coccidiosis in broiler chickens caused by Eimeria tenella , E . necatrix , E . acervulina , E . maxima , E . brunetti , and E . mivati , and for increased rate of weight gain and improved feed efficiency. ANADA 200&hyph;143 is as a generic copy of Agri-Bio's NADA 139&hyph;190. ANADA 200&hyph;143 is approved as of May 25, 1994. The regulations are amended in §558.550 Salinomycin (21 CFR 558.550) to reflect the approval. This approval is for use of single ingredient Type A medicated articles to make Type C medicated feeds. Roxarsone is a Category II drug which, as provided in §558.4, requires an approved Form FDA 1900 for making a Type C medicated feed. Therefore, the use of salinomycin, roxarsone, and bacitracin zinc Type A medicated articles to make Type C medicated feeds as provided in ANADA 200&hyph;143 requires an approved Form FDA 1900. In accordance with the freedom of information provisions of part 20 (21 CFR part 20) and §514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA&hyph;305), Food and Drug Administration, rm. 1&hyph;23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.24(d)(1)(ii) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows: PART 558_NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371). §558.550 [Amended] 2. Section 558.550 Salinomycin is amended in paragraph (a)(2) by adding ``(b)(1)(ix),'' after ``(b)(1)(viii)''. Dated: May 17, 1994. Richard H. Teske, Acting Director, Center for Veterinary Medicine. [FR Doc. 94&hyph;12806 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4160&hyph;01&hyph;F FR940525-0-00021 FR940525-0-00012 DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Office of the Secretary 24 CFR Part 888 [Docket Nos. N&hyph;94&hyph;3741; FR&hyph;3686&hyph;N&hyph;02 and N&hyph;94&hyph;3616; FR&hyph;3510&hyph;N&hyph;06] Section 8 Housing Assistance Payments Program_Contract Rent Annual Adjustment Factors and Section 8 Housing Assistance Payments Program; Fair Market Rents; Corrections AGENCY: Office of the Secretary, HUD. ACTION: Notice of final fair market rents; amendments; and notice of revised contract rent annual adjustment factors; corrections.

SUMMARY: This notice makes corrections to the Notice on Section 8 Housing Assistance Payments Program; Fair Market Rents published on April 6, 1994, and also makes corrections to the notice on Section 8 Housing Assistance Payments Program_Contract Rent Annual Adjustments Factors published on April 26, 1994.

EFFECTIVE DATES: The correction to the Fair Market Rents published on April 6, 1994 (59 FR 16408) is effective on April 6, 1994. The correction to the notice of revised contract rent annual adjustment factors published on April 26, 1994 (59 FR 21832) is effective on April 26, 1994. FOR FURTHER INFORMATION CONTACT: Michael R. Allard, Economic and Market Analysis Division, Office of Policy Development and Research (202) 708&hyph;0577 (TDD: (202) 708&hyph;0770). SUPPLEMENTARY INFORMATION: The United States Housing Act of 1937 (1937 Act) requires the Secretary to publish Fair Market Rents (FMRs) periodically, but not less frequently than annually, to be effective on October 1 of each year. The 1937 Act also requires that the assistance contracts signed by owners participating in the Department's Section 8 Housing Assistance Payments programs provide for annual or more frequent adjustment in the maximum monthly rentals for units covered by the contract to reflect changes based on fair market rents prevailing in a particular market area, or on a reasonable formula. The FMR and AAF Notices published on April 6, 1994 (59 FR 16408), and April 26, 1994 (59 FR 21832), respectively, announced the revised FY 1994 FMRs and Annual Adjustment Factors, but contained some technical errors. Accordingly, the following correction is being made in FR Doc. 94&hyph;8212, in the final FY 1994 FMRs published April 6, 1994 (59 FR 16408) as provided in the following table for the specific FMR areas and bedroom sizes indicated: Schedule B_Fair Market Rents for Existing Housing 1FMR area 1Bedrooms 20 21 22 23 24 Medford-Ashland, OR MSA $287 $378 $504 $701 $781 Anchorage, AK MSA 1182 Tulsa, OK MSA 767 Clark Co., AR 262 LaPlata, Co., CO 390 430 567 789 931 Calhoun Co., IA 232 O'Brien Co., IA 167 Breckinridge Co., KY 475 Winona Co., MN 578 Adams Co., NE 604 Box Butte Co., NE 238 Dodge Co., NE 500 Ashe Co., NC 485 Saluda Co., SC 182 330 413 FR940525-0-00022 FR940525-0-00012 Additionally, the AAF notice published in the Federal Register on April 26, 1994 (59 FR 21832), is corrected at pages 21845, 21859 and 21860 as set forth in Appendix A of this notice. Dated: May 18, 1994. Myra L. Ransick, Assistant General Counsel for Regulations. Appendix A Schedule C_Contract Rent Annual Adjustment Factors_Area Definitions Maryland (HUD Region III) CPI Areas: Counties MSA Baltimore, MD: Anne Arundel, Baltimore, Carroll, Harford, Howard, Queen Anne's, Baltimore City, Columbia City Washington (HUD Region X) CPI Areas: Counties PMSA Bremerton, WA: Kitsap PMSA Olympia, WA: Thurston PMSA Portland-Vancouver, OR&hyph;WA: Clark PMSA Seattle-Bellevue-Everett, WA: Island, King, Snohomish PMSA Tacoma, WA: Pierce Metropolitan Counties Benton, Franklin, Spokane, Whatcom, Yakima Nonmetropolitan Counties Adams, Asotin, Chelan, Clallam, Columbia, Cowlitz, Douglas, Ferry, Garfield, Grant, Grays Harbor, Jefferson, Kittitas, Klickitat, Lewis, Lincoln, Mason, Okanogan, Pacific, Pend Oreille, San Juan, Skagit, Skamania, Stevens, Wahkiakum, Walla Walla, Whitman Wisconsin (HUD Region V) CPI Areas: Counties PMSA Kenosha, WI: Kenosha PMSA Milwaukee-Waukesha, WI: Milwaukee, Ozaukee, Washington, Waukesha MSA Minneapolis-St. Paul, MN&hyph;WI: Pierce, St. Croix PMSA Racine, WI: Racine Metropolitan Counties Brown, Calumet, Chippewa, Dane, Douglas, Eau Claire, La Crosse, Marathon, Outagamie, Rock, Sheboygan, Winnebago Nonmetropolitan Counties Adams, Ashland, Barron, Bayfield, Buffalo, Burnett, Clark, Columbia, Crawford, Dodge, Door, Dunn, Florence, Fond du Lac, Forest, Grant, Green, Green Lake, Iowa, Iron, Jackson, Jefferson, Juneau, Kewaunee, Lafayette, Langlade, Lincoln, Manitowoc, Marinette, Marquette, Menominee, Monroe, Oconto, Oneida, Pepin, Polk, Portage, Price, Richland, Rusk, Sauk, Sawyer, Shawano, Taylor, Trempealeau, Vernon, Vilas, Walworth, Washburn, Waupaca, Waushara, Wood. [FR Doc. 94&hyph;12635 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4210&hyph;32&hyph;P FR940525-0-00023 FR940525-0-00013 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [PP 0E3921/R2049; FRL&hyph;4769&hyph;3] RIN 2070&hyph;AB78 Pesticide Tolerance for Bifenthrin AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This document establishes a tolerance for residues of the pesticide bifenthrin in or on the raw agricultural commodity dried hops. The regulation to establish a maximum permissible level for residues of the pesticide was requested in a petition submitted by the Interregional Research Project No. 4 (IR-4). This time-limited tolerance expires on November 14, 1994.

EFFECTIVE DATE: This regulation becomes effective May 25, 1994.

ADDRESSES: Written objections, identified by the document control number, [PP 0E3921/R2049], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, Registration Division (7505W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 6th Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783. SUPPLEMENTARY INFORMATION: In the Federal Register of February 25, 1994 (59 FR 9167), EPA issued a proposed rule that gave notice that the Interregional Research Project No. 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903, had submitted pesticide petition (PP) 0E3921, as amended, to EPA on behalf of the Agricultural Experiment Stations of Idaho, Oregon, and Washington, requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), establish a tolerance for residues of the pesticide befentrhin, (2-methyl [1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on the raw agricultural commodity dried hops at 10.0 parts per million (ppm). There were no requests for referral to an advisory committee received in response to the proposed rule. One comment was received in response to the proposed rule. The comment, which was submitted by E.I. duPont de Nemours & Co., Inc. (Dupont), responded to the Agency's request for comments on the reclassification of dried hops as a raw agricultural commodity. The commenter expressed DuPont's support for the reclassification of all dried fruits as raw agricultural commodities. EPA is currently reviewing a petition from DuPont requesting the revocation of the tolerance established under section 409 of the FFDCA for residues of the fungicide benomyl in raisins and the establshment of a tolerance for benomyl on raisins under section 408 of the FFDCA. DuPont's petition contends that existing section 409 tolerances for raisins are inappropriate since raisins meet the statutory definition of a raw agricultural commodity. Additional information regarding DuPont's petition can be obtained from the notice of receipt for the petition, which was published in the Federal Register of December 2, 1993 (58 FR 63575, Dec. 2, 1993). An evaluation by EPA of the commenter's proposed reclassification of dried fruit (including raisins) as a raw agricultural commodity was not conducted by EPA in association with the IR-4 petition for tolerance for bifentrhin residues on hops. EPA will respond to DuPont's proposed recalssification of raisins in association with the benomyl petition, which is under evaluation by the Agency. The data submitted relevant to the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerance will protect the public health. Therefore, the tolerance is established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs or the rights and obligations or recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 13, 1994. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. By revising §180.442, to read as follows: §180.442 Bifenthrin; tolerances for residues. Tolerances, to expire on November 15, 1994, are established for residues of the pyrethroid bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on the following commodities: ␣ 1Commodity 1Parts per million Cottonseed 0.5 Hops, dried 10.0 Meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep 0.1 Milk 0.02 [FR Doc. 94&hyph;12692 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00024 FR940525-0-00014 40 CFR Part 180 [PP 9F3699, 9F3793 and 9F3799/R2057; FRL&hyph;4771&hyph;1] RIN 2070&hyph;AB78 Pesticide Tolerances for Clofentezine AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This rule establishes tolerances for residues of the insecticide clofentezine in or on the following raw agricultural commodities: peaches, nectarines, almonds, walnuts, apricots and cherries and for clofentezine and its metabolite 3-(2-cloro-4-hydroxphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine in or on meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep and milk. Nor-Am Chemical Co. requested this regulation to establish maximum permissible levels for residues of the insecticide.

EFFECTIVE DATE: This regulation became effective May 13, 1994.

ADDRESSES: Written objections and hearing requests, identified by the document control number, [PP 9F3699, 9F3793, and 9F3799/R2057], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis H. Edwards, Jr., Product Manager (PM) 19, Registration Division (7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 207, CM #2, 1921 Jefferson Davis Highway, Arlington, VA 22202, (703)-305-6386. SUPPLEMENTARY INFORMATION: EPA issued rules, published in the Federal Registers of June 28, 1990 (55 FR 26438), May 15, 1991 (56 FR 22333), and June 12, 1991 (56 FR 26911), which announced that Nor-Am Chemical Co. had submitted pesticide petitions (PP 9F3699, 9F3793, and 9F3799) to EPA requesting that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), establish tolerances for clofentezine in or on peaches at 1.0 part per million (ppm) and nectarines at 1.0 ppm (PP 9F3699); almond hulls at 5.00 ppm, almond nutmeat at 0.5 ppm, walnuts at 0.02 ppm (PP 9F3793); apricots at 1.0 ppm and cherries at 1.0 ppm (PP 9F3799). The Agency established these tolerances with an expiration date of September 30, 1994, to cover residues expected to be present from use during the period of conditional registration for these uses. The conditional registrations were to expire September 30, 1993. The Agency recently extended the conditional registration expiration date to December 31, 1994. The conditional registration required the following information to be submitted. These studies were required because the chronic risk of clofentezine to avian and aquatic species could not be fully evaluated. 1. Avian reproduction studies (bobwhite quail and mallard duck) were required to be repeated. 2. Two aquatic studies, an aquatic invertebrate life-cycle study and a fish life-cycle study, were required. Studies have been submitted and are currently in review, but a final review is not expected to be completed for some time. However, the Agency has conducted a preliminary review of these studies and determined that they are scientifically sound. Therefore, on the basis of Nor-Am's compliance with the requirements of the conditional registration, the Agency is removing the expiration date for the tolerances of the commodities listed above. In the interim, until the Agency is able to complete its final review and risk assessment a conditional registration will remain in effect for the commodities listed above. In the Federal Register of February 9, 1994 (58 FR 42728), the Agency announced receipt of a petition from Nor-Am Chemical Co. requesting to make the tolerances permanent for residues on peaches, nectarines, almonds, walnuts, apricots, and cherries and in or on meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep. No comments were received in response to this notice of filing. As described above, the Agency has decided to remove the expiration date for these tolerances based on Nor-Am's submittal of the studies requested in the conditional registration. Based on the 1-year dog-feeding study with a NOEL of 1.25 mg/kg/day and using a safety factory of 100, the acceptable daily intake (ADI) for humans is 0.013 mg/kg of body weight/day. The current action will contribute .0000519 mg/kg/day of residue to the human diet utilizing an additional 4.0 percent the ADI. This results in a total utilization of 4.5 percent of the ADI. The scientific data submitted in the petitions and other relevant material have been reviewed. The toxicological data considered in support of these tolerances are discussed in detail in previous final rules establishing tolerances for clofentezine referenced earlier in this document, i.e., the Federal Registers of June 28, 1990 (55 FR 26438), May 15, 1991 (56 FR 22333), and June 12, 1991 (56 FR 26911). The nature of residue is understood. An adequate analytical method, high-performance liquid chromatography (HPLC), is available for enforcement. There are presently no actions pending against the continued registration of this chemical. This pesticide is considered useful for the purposes for which the tolerances are sought. Based on the information and data considered, the Agency has determined that the tolerances established by amending 40 CFR part 180 will protect the public health. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register , file written objection and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the feed prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is genuine and substantial issue of fact; there is reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor or the requestor, taking into account uncontested claims or facts to the contrary: and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 17.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to all the requirements of the Executive Order (i.e., Regulatory Impact Analysis, review by the Office of Management and Budget (OMB). Under section 3(f), the order defines ``significant'' as those actions likely to lead to a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also known as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that the rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 13, 1994. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. In §180.446, by revising the introductory texts of paragraphs (b) and (c), to read as follows: §180.446 Clofentezine; tolerances for residues. * * * * * (b) Tolerances are established for residues of the insecticide clofentezine (3,6-bis(2-chlorophenyl)-1,2,4,5-tetrazine) in or on the following raw agricultural commodities: * * * * * (c) Tolerances are established for the combined residues of clofentezine and the 3-(2-chloro-4-hydroxyphenyl)-6-(2-chlorophenyl)-1,2,4,5-tetrazine metabolite in or on the following commodities: * * * * * [FR Doc. 94&hyph;12697 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00025 FR940525-0-00015 40 CFR Part 180 [PP 8F3654/R2064; FRL&hyph;4865&hyph;9] RIN 2070&hyph;AB78 Pesticide Tolerances for 1-[[2-(2,4-Dichlorophenyl)-4-Propyl-1,3-Dioxolan-2-yl]Methyl]-1H-1,2,4-Triazole AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This rule establishes time-limited tolerances (with an expiration date of December 31, 1998) for the fungicide propiconazole, 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1 H -1,2,4-triazole, and its metabolites, determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on the raw agricultural commodities peanuts at 0.2 part per million (ppm), peanut hay at 20.0 ppm, and peanut hulls at 1.0 ppm. This rule to establish the maximum permissible levels for residues of propiconazole in or on the commodities listed above was requested in a petition submitted by the Ciba-Geigy Corp.

EFFECTIVE DATE: This regulation becomes effective May 13, 1994.

ADDRESSES: Written objections, identified by the document control number, [PP 8F3654/R2064], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460.

FOR FURTHER INFORMATION CONTACT: By mail: Steve Robbins, Acting Product Manager (PM) 21, Registration Division (7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 227, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6900. SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the Federal Register of October 12, 1988 (53 FR 39783), which announced that the Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419, had submitted a pesticide petition (PP 8F3654) to EPA requesting that the Administrator, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), propose to amend 40 CFR 180.434 by establishing tolerances for the fungicide 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1 H -1,2,4-triazole and its metabolites, determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on the commodities peanuts at 0.2 ppm, peanut hay at 20.0 ppm, and peanut hulls at 1.0 ppm. The were no adverse comments received by the Agency in response to the notice of filing. Because the above notice published more than 5 years ago, it was republished in the Federal Register of March 30, 1994 (59 FR 14853). There were no adverse comments received by the Agency in response to the republication of the notice of filing. The data submitted in the petition and other relevant materials have been evaluated. The data considered include the following: 1. Plant and animal metabolism studies. 2. Residue data for crop and livestock commodities. 3. Two enforcement methods and multiresidue method testing data. 4. A rat oral lethal dose (LD 50 ) of 1,517 milligrams/kilogram (mg/kg) of body weight. 5. A 90-day rat feeding study with a no-observable-effect level (NOEL) of 12 mg/kg/day. 6. A 90-day dog feeding study with a NOEL of 1.25 mg/kg/day. 7. A rabbit developmental toxicity study with a maternal NOEL of 100 mg/kg/day and a developmental toxicity NOEL of greater than 400 mg/kg/day (highest dose tested (HDT)). 8. A rat teratology study with a maternal toxicity NOEL of 30 mg/kg/day and a developmental toxicity NOEL of 30 mg/kg/day. 9. A two-generation rat reproduction study with a reproductive NOEL of 125 mg/kg/day (HDT) and a developmental toxicity NOEL of 25 mg/kg/day. 10. A 1-year dog feeding study with a NOEL of 1.25 mg/kg/day. 11. A 2-year rat chronic feeding/carcinogenicity study with a NOEL of 5 mg/kg/day with no carcinogenic potential under the conditions of the study up to and including approximately 125 mg/kg, the highest dose tested. 12. A 2-year mouse chronic feeding/carcinogenicity study with a NOEL of 15 mg/kg/day and with a statistically significant increase in combined adenomas and carcinomas of the liver in male mice at approximately 375 mg/kg/day, the highest dose tested. 13. Ames test with and without activation, negative. 14. A mouse dominant-lethal assay, negative. 15. Chinese hamster nucleus anomaly, negative. 16. Cell transformation assay, negative. Data gaps exist concerning dosing in the mouse carcinogenicity study. These data requirements were required under reregistration, pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq. As part of EPA's evaluation of potential human health risks, propiconazole has been the subject of five Peer Reviews and one Scientific Advisory Panel (SAP) meeting. Propiconazole was originally evaluated by the Peer Review Committee on January 15, 1987, and classified as a Group C (possible human) carcinogen with a recommendation made for the quantification of estimated potential human risk using a linearized low-dose extrapolation. The method resulted in the establishment of a Q * of 7.9 X 10 -2 (mg/kg/day) -1 . The Peer Review Committee's decision was presented to the FIFRA Scientific Advisory Panel on March 2, 1988. The Panel did not concur with the committee's overall assessment of the weight-of-evidence on the carcinogenicity of propiconazole. The Panel recommended placing the chemical in Group D, indicating that the Group C classification was based on minimal evidence. The Panel's determination that EPA's Group C classification was based on minimal evidence was due to the fact that the incidence of liver tumors in male mice only occurred when the mice were given an excessive chemical dose. In the second, third, and fourth Peer Reviews that followed, the Peer Review Committee considered recommendations of the SAP as well as rebuttals by the registrant. Its conclusion, however, that propiconazole should be classified as a Group C carcinogen with a quantification of potential human risk remained unchanged. As part of a fifth Peer Review, EPA considered additional information provided by the registrant in support of the registrant's argument that the high dose was excessively toxic in the mouse carcinogenicity study. It further argued that the data from the high dose (2,500 ppm) should not be included in the evaluation of carcinogenic potential of propiconazole. In support of these arguments, the registrant provided two subchronic oral toxicity studies in mice. Ciba-Geigy also provided a reread of the pathology slides from a mouse oncogenicity study which it felt indicated sufficient concurrent liver toxicity at 2,500 ppm to document that this dose was excessive. These findings were not present in the original pathology report. Owing to the inconsistency in Ciba-Geigy's report and the original report, the Agency requested that an independent (third) evaluation of the pathology slides be made to determine if the pathology reported could be confirmed. The results of this (third) pathology evaluation were used in the fifth Peer Review in place of data resulting from the earlier evaluations provided by Ciba-Geigy. The Peer Review Committee considered the following facts regarding the toxicology data on propiconazole in a weight-of-evidence determination of carcinogenic potential: 1. Increased numbers of adenomas (increased trend and pairwise comparison) were found in the livers of male CD1 mice given 2,500 ppm of propiconazole in the diet. 2. The treated animals had earlier fatalities than the controls. 3. The numbers of carcinomas were increased (trend only) in male mice only at the 2,500 ppm dose level. Tumors were not significantly increased at the 500 ppm dose level. Adenomas observed in the treated animals were larger and more numerous than those in controls; however, the tumor type (adenoma) was the same. 4. No excessive number of tumors was found in female mice. 5. In a rat study conducted with acceptable doses of propiconazole, no excessive numbers of tumors were found. The Peer Review Committee determined, based on the additional information submitted by Ciba-Geigy from two 90-day subchronic studies in mice that the 2,500-ppm dose used in the 2-year chronic study exceeded the maximum tolerated dose (MTD) based on the endpoint of hepatic necrosis, and the 500-ppm dose used in the chronic study was inadequate to assess the carcinogenicity of propiconazole. Based on the third pathology evaluation of the chronic study, the Peer Review Committee agreed with Ciba-Geigy's argument that the study showed excessive toxicity at the 2,500 ppm-dose and concluded that the 90-day subchronic studies are a better measure of what would be an MTD. Based upon these findings, the Peer Review Committee agreed that the classification for propiconazole should remain a Group C (possible human) carcinogen and recommended against the previously used Q * ( viz . 0.079) for risk assessment purposes. For the purpose of risk characterization the Peer Review Committee recommended that the reference dose (RfD) approach should be used for quantification of human risk. This decision was based on the disqualification of the high dose (2,500 ppm), making the data inappropriate for the calculation of Q * . Because the middle dose (500 ppm) was not considered sufficiently high enough for assessing the carcinogenetic potential of propiconazole, EPA has requested an additional mouse study at intermediate dose levels in male mice only. EPA does not expect that these data will significantly change the above cancer assessment that propiconazole poses a negligible cancer risk to humans. The reference dose (RfD) for propiconazole is 0.013 mg/kg/day, based on a no-observable-effect level (NOEL) of 1.25 mg/kg/day and an uncertainty factor of 100. The NOEL is taken from a 1-year feeding study in dogs which demonstrated as an effect irritation of the stomach in males. The Agency has evaluated dietary exposure to the fungicide residues based on the proposed tolerances and the commodities which have established tolerances using data on anticipated residues and percent crop treated data. The livestock burden was calculated using anticipated residues in feed items multiplied by the expected percent contribution to the diet. This dietary burden was then compared with available data from feeding studies to determine anticipated residues in meat and milk. Based on current registered uses of this chemical only 7% of the RfD is being utilized for the general U.S. population. The tolerances are expected to elicit only a minor increase in the percent utilization of the RfD for the general U.S. population. The most highly exposed subgroups, nursing and nonnursing infants less than 1 year, have Anticipated Residue Contributions (ARCs) from all published tolerances of 1.97 X 10 -3 and 3.97 X 10 -3 mg/kg bwt/day. These ARCs represent 15% and 31% of the Reference Dose for these subgroups, respectively. The proposed tolerances will add 0.03% and 0.05% of the RfD for nursing and nonnursing infants less than 1 year, respectively. Available data on storage stability of propiconazole in peanuts are unacceptable and must be redone for nutmeat, hulls, and hay. Once review of all required residue data is submitted, the petitioner may resubmit its petition for permanent tolerances. The nature of the residue in plants and animals is adequately understood, and adequate analytical methods (gas chromatography) are available for enforcement purposes. Because of the long lead time for establishing these tolerances and food additive regulations to publication of the enforcement methodology in the Pesticide Analytical Manual, Vol. II, the analytical methodology is being made available in the interim to anyone interested in pesticide enforcement when requested from: Calvin Furlow, Public Information Branch, Field Operations Division (7506C), 401 M St., S.W., Washington, DC 20460. Office location and telephone number: Rm. 1128C, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-5232. The pesticide is considered useful for the purpose for which the tolerances are being sought. For the reasons described above, the Agency is establishing tolerances for residues of 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1 H -1,2,4-triazole and its metabolites, determined as 2,4-dichlorobenzoic acid and expressed as parent compound, in or on the following raw agricultural commodities: peanuts, 0.2 ppm; peanut hay, 20 ppm; peanut hulls, 1 ppm. Because of unacceptable storage stability data on peanuts, the Agency is placing a time limitation on these tolerances. However, based on available data the Agency concludes that the established interim tolerances will protect public health. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register , file written objections with the Hearing Clerk, at the address given above (40 CFR 178.20). The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.127). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or food additive regulations or raising tolerance levels or food additive regulations or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (40 FR 24950). Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB). Under section 3(f), the order defines ``significant regulatory action'' as action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. The Office of Management and Budget has exempted this rule from the requirements of Executive Order 12866. List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedures, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 13, 1994. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. In §180.434(c), by adding and alphabetically inserting three new entries to the table therein, to read as follows: §180.434 1-[[2-(2,4-Dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole; tolerances for residues. * * * * * (c) *␣*␣* ␣ 1Commodity 1Parts per million 1Expiration date ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Peanuts 0.2 12/31/98 Peanuts, hay 20.0 12/31/98 Peanuts, hulls 1.0 12/31/98 ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* [FR Doc. 94&hyph;12698 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00026 FR940525-0-00016 40 CFR Part 180 [OPP&hyph;300330A; FRL&hyph;4864&hyph;6] RIN 2070&hyph;AB78 Methyl Vinyl Ether-Maleic Acid Copolymer and Methy Vinyl Ether-Maleic Acid Copolymer Calcium Sodium Salt; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This document establishes an exemption from the requirement of a tolerance for residues of methy vinyl ether-maleic acid copolymer calcium sodium salt (CAS Reg. No. 62386-95-2) when used as inert ingredients (dispersant and seed-coating adhesive, respectively) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, or animals. This regulation was requested by International Specialty Products.

EFFECTIVE DATE: This regulation becomes effective May 25, 1994.

ADDRESSES: Written objections, identified by the document control number, [OPP-300330A], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, Registration Support Branch (7505W), Registration Division, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 2800 Crystal Drive, North Tower, 6th Floor, Arlington, VA 22202, (703)-308-8393. SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 1994 (59 FR 14820), EPA issued a proposed rule that gave notice that International Specialty Products, 1361 Alps Rd., Wayne, NJ 07470, had submitted pesticide petitions (PPs) 3E4260 and 3E4261 to EPA requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), propose to amend 40 CFR 180.1001(c) and (e) by establishing an exemption from the requirement of a tolerance for residues of methyl vinyl ether-maleic acid copolymer (CAS Reg. No. 25153-40-6) (PP 3E4260) and methyl vinyl ether-maleic acid copolymer calcium sodium salt (CAS Reg. No. 62386&hyph;95&hyph;2) (PP 3E4261) when used as inert ingredients (dispersant and seed-coating adhesive, respectively) in pesticide formulations applied to growing crops, to raw agricultural commodities after harvest, or to animals. There were no comments or requests for referral to an advisory committee received in response to the proposed rule. The data submitted on the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerance exemptions will protect the public health. Therefore, the tolerance exemptions are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 16, 1994. Daniel M. Barolo, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. Section 180.1001(c) and (e) tables are amended by adding and alphabetically inserting the inert ingredient, to read as follows: §180.1001 Exemptions from the requirement of a tolerance. * * * * * (c) *␣*␣* ␣ 1Inert ingredients 1Limits 1Uses ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Methyl vinyl ether-maleic acid copolymer (CAS Reg. No. 25153-40-6), minimum number average molecular weight 75,000 ␣ Dispersant. ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* * * * * * (e) *␣*␣* ␣ 1Inert ingredients 1Limits 1Uses ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Methyl vinyl ether-maleic acid copolymer calcium sodium salt (CAS Reg. No. 62386&hyph;95&hyph;2), minimum number average molecular weight 900,000 ␣ Seed-coating adhesive. ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* [FR Doc. 94&hyph;12695 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00027 FR940525-0-00017 40 CFR Part 180 [PP 9E3752 and 9E3791/R2050; FRL&hyph;4769&hyph;7] RIN 2070&hyph;AB78 Pesticide Tolerance for Cyromazine AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This document establishes a tolerance for combined residues of the insecticide cyromazine and its metabolite melamine in or on the raw agricultural commodities Chinese cabbage and Chinese mustard. The regulation to establish maximum permissible levels for residues of the insecticide was requested in petitions submitted by the Interregional Research Project No. 4 (IR-4).

EFFECTIVE DATE: This regulation becomes effective May 25, 1994.

ADDRESSES: Written objections, identified by the document control number, [PP 9E3752 and 9E3791/R2050], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing request to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson, Registration Division (7505W), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 6th Floor, Crystal Station #1, 2800 Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-8783. SUPPLEMENTARY INFORMATION: In the Federal Register of March 2, 1994 (59 FR 9949), EPA issued a proposed rule that gave notice that the Interregional Research Project No. 4 (IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903, had submitted pesticide petitions (PP) 9E3752 and 9E3791 to EPA on behalf of the Agricultural Experiment Station of Florida, requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), amend 40 CFR 180.414 by establishing tolerances for combined residues of the insecticide cyromazine ( N -cyclopropyl-1,3,5-triazine-2,4,6-triamine) and its metabolite melamine (1,3,5-triazine-2,4,6-triamine), in or on the raw agricultural commodities Chinese cabbage (PP 9E3752) and Chinese mustard (PP 9E3791) at 3.0 parts per million (ppm). The petitioner proposed that these uses of cyromazine be limited to Florida based on the geographical representation of the residue data submitted. Additional residue data will be required to expand the area of usage. Persons seeking geographically broader registration should contact the Agency's Registration Division at the address provided above. There were no comments or requests for referral to an advisory committee received in response to the proposed rule. The data submitted relevant to the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerances will protect the public health. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs or the rights and obligations or recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 11, 1994. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. In §180.414 by adding new paragraph (f), to read as follows: §180.414 Cyromazine; tolerances for residues. * * * * * (f) Tolerances with regional registration, as defined in §180.1(n), are established for the combined residues of the insecticide cyromazine ( N -cyclopropyl-1,3,5-triazine-2,4,6-triamine) and its metabolite melamine (1,3,5-triazine-2,4,6-triamine), calculated as cyromazine, in or on the following raw agricultural commodities: ␣ 1Commodity 1Parts per million Cabbage, Chinese 3.0 Mustard, Chinese 3.0 [FR Doc. 94&hyph;12696 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00028 FR940525-0-00018 40 CFR Part 180 [OPP&hyph;300331A; FRL&hyph;4864&hyph;3] RIN 2070&hyph;AB78 Vinyl Alcohol-Vinyl Acetate-Monomethyl Maleate, Sodium Salt-Maleic Acid, Disodium Salt- g -Butyrolactone Acetic Acid, Sodium Salt Copolymer; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This document establishes an exemption from the requirement of a tolerance for residues of vinyl alcohol-vinyl acetate-monomethyl maleate, sodium salt-maleic acid, disodium salt- g -butyrolactone acetic acid, sodium salt copolymer when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. This regulation was requested by Mitsui Plastics, Inc.

EFFECTIVE DATE: The regulation becomes effective on May 25, 1994.

ADDRESSES: Written objections, identified by the document control number, [OPP-300331A], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Tina Levine, Registration Support Branch (7505W), Registration Division, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: 2800 Crystal Drive, North Tower, 6th Floor, Arlington, VA 22202, (703)-308-8393. SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 1994 (59 FR 14825), EPA issued a proposed rule that gave notice that Mitsui Plastics, Inc., 11 Martine Ave., White Plains, NY 10606, had submitted pesticide petition (PP) 3E4253 to EPA requesting that the Administrator, pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(e)), propose to amend 40 CFR 180.1001(d) by establishing an exemption from the requirement of a tolerance for residues of vinyl alcohol-vinyl acetate-monomethyl maleate, sodium salt-maleic acid, disodium salt g -butyrolactone acetic acid, sodium salt copolymer when used as an inert ingredient (carrier) in pesticide formulations applied to growing crops only. There were no comments or requests for referral to an advisory committee received in response to the proposed rule. The data submitted on the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerance exemption will protect the public health. Therefore, the tolerance exemption is established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 16, 1994. Daniel M. Barolo, Acting Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. Section 180.1001(d) is amended in the table therein by adding and alphabetically inserting the inert ingredient, to read as follows: §180.1001 Exemptions from the requirement of a tolerance. * * * * * (d) *␣*␣* ␣ 1Inert ingredients 1Limits 1Uses ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Vinyl alcohol-vinyl acetate-monomethyl maleate, sodium salt-maleic acid, disodium salt- g -butyrolactone acetic acid, sodium salt copolymer, minimum number-average molecular weight 20,000. ␣ Carrier. ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* * * * * * [FR Doc. 94&hyph;12694 Filed 5&hyph;25&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00029 FR940525-0-00019 40 CFR Part 180 [PP 3F4232/R2062; FRL&hyph;4864&hyph;2] RIN 2070&hyph;AB78 Acetochlor; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This document establishes tolerances for residues of the herbicide acetochlor (2-chloro-2`-methyl-6-ethyl- N -ethoxymethyl acetanilide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor, and expressed as acetochlor equivalents, in or on the raw agricultural commodities (RACs) wheat grain at 0.02 part per million (ppm) and sorghum grain at 0.02 ppm. This regulation was requested by the Acetochlor Registration Partnership and establishes the maximum permissible level for residues of the herbicide in or on the raw agricultural commodities.

EFFECTIVE DATE: This regulation becomes effective May 25, 1994.

ADDRESSES: Written objections, identified by the document control number, [PP 3F4232/R2062], may be submitted to: Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington, DC 20460. A copy of any objections and hearing requests filed with the Hearing Clerk should be identified by the document control number and submitted to: Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, bring copy of objections and hearing requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202. Fees accompanying objections shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.

FOR FURTHER INFORMATION CONTACT: By mail: Robert J. Taylor, Product Manager (PM) 25, Registration Division (7505C), Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Office location and telephone number: Rm. 241, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-305-6800. SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 1994 (59 FR 14824), EPA issued a proposed rule that gave notice that pursuant to petitions by the Acetochlor Registration Partnership (formed by Monsanto Co. and Zeneca Ag. Products (see the Federal Register of March 23, 1994 (13655))) under section 408 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a, it was proposed to establish tolerances for residues of the herbicide acetochlor (2-chloro-2`-methyl-6-ethyl- N -ethoxymethyl acetanilide) and its metabolites containing the ethyl methyl aniline (EMA) moiety and the hydroxyethyl methyl aniline (HEMA) moiety, to be analyzed as acetochlor, and expressed as acetochlor equivalents, in or on the raw agricultural commodities (RACs) wheat grain at 0.02 ppm and sorghum grain at 0.02 ppm. There were no comments or requests for referral to an advisory committee received in response to the proposed rule. The data submitted on the proposal and other relevant material have been evaluated and discussed in the proposed rule. Based on the data and information considered, the Agency concludes that the tolerances will protect the public health. Therefore, the tolerances are established as set forth below. Any person adversely affected by this regulation may, within 30 days after publication of this document in the Federal Register, file written objections and/or request a hearing with the Hearing Clerk, at the address given above (40 CFR 178.20). A copy of the objections and/or hearing requests filed with the Hearing Clerk should be submitted to the OPP docket for this rulemaking. The objections submitted must specify the provisions of the regulation deemed objectionable and the grounds for the objections (40 CFR 178.25). Each objection must be accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the objections must include a statement of the factual issue(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issue(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32). Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency must determine whether the regulatory action is ``significant'' and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Order. Under section 3(f), the order defines a ``significant regulatory action'' as an action that is likely to result in a rule (1) having an annual effect on the economy of $100 million or more, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (also referred to as ``economically significant''); (2) creating serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in this Executive Order. Pursuant to the terms of the Executive Order, EPA has determined that this rule is not ``significant'' and is therefore not subject to OMB review. Pursuant to the requirements of the Regulatory Flexibility Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator has determined that regulations establishing new tolerances or raising tolerance levels or establishing exemptions from tolerance requirements do not have a significant economic impact on a substantial number of small entities. A certification statement to this effect was published in the Federal Register of May 4, 1981 (46 FR 24950). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: May 13, 1994. Douglas D. Campt, Director, Office of Pesticide Programs. Therefore, 40 CFR part 180 is amended as follows: PART 180_[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 346a and 371. 2. By amending §180.470 in the table therein by adding and alphabetically inserting the following commodities, to read as follows: §180.470 Acetochlor; tolerances for residues. * * * * * ␣ 1Commodity 1Parts per million ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Sorghum, grain 0.02 ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* Wheat, grain 0.02 ␣ *␣␣␣␣*␣␣␣␣*␣␣␣␣*␣␣␣␣* [FR Doc. 94&hyph;12699 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6560&hyph;50&hyph;F FR940525-0-00030 FR940525-0-00020 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Care Financing Administration 42 CFR Parts 405, 406, 408, 410, 413, and 418 [BPD&hyph;791&hyph;FC] RIN 0938&hyph;AG64 Medicare Program; Self-Implementing Coverage and Payment Provisions: 1993 Legislation AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Final rule with comment period.

SUMMARY: This rule updates Medicare regulations to conform them to certain self-implementing provisions on coverage of services and payment requirements under the Omnibus Budget Reconciliation Act of 1993 (OBRA 93). OBRA 93 was enacted on August 10, 1993 and several of the cited changes to the statute are already in effect and the others will be shortly. We are also implementing a related provision of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) as necessary for consistency and clarity of the OBRA 93 provisions.

DATES: Effective date: These regulations are effective June 24, 1994. Comment period: Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m., July 25, 1994.

ADDRESSES: Mail written comments (1 original and 3 copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: BPD&hyph;791&hyph;FC, P.O. Box 26676, Baltimore, MD 21207. If you prefer, you may deliver your written comments (1 original and 3 copies) to one of the following addresses: Room 309&hyph;G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore, MD 21207. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code BPD&hyph;791&hyph;FC. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 309&hyph;G of the Department's offices at 200 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: (202) 690&hyph;7890).

FOR FURTHER INFORMATION CONTACT: Matt Plonski, (410) 966&hyph;4662. SUPPLEMENTARY INFORMATION: I. Background On August 10, 1993, the Omnibus Budget Reconciliation Act of 1993 (OBRA 93) (Pub. L. 103&hyph;66) was enacted. This law contains numerous provisions relating to coverage of services and payments for services furnished to Medicare beneficiaries. Some of these provisions are self-implementing; that is, the provisions are stated in terms that neither require nor permit exercise of discretion in implementing them. The plain wording of the law causes a conflict with several of our existing regulations; in other cases, the regulations simply do not take the amendments into account. We are, therefore, making the necessary changes to incorporate the new provisions into regulations. A discussion of the individual legislative provisions and the accompanying regulations follows. II. Reductions in Payments for Skilled Nursing Facility Services_Elimination of Return on Equity for Proprietary Skilled Nursing Facilities A. Legislative Provision Section 1861(v)(1)(B) of the Social Security Act (the Act) provides that proprietary skilled nursing facilities (SNFs) receive, in addition to payments for the costs of providing services, return on equity payments, which provide the investors in the facilities a return on their investment equivalent to what they would have earned had they invested the same amount in specified government securities. Section 13503(c) of OBRA 93 amended sections 1861(v)(1)(B) and 1878(f)(2) of the Act to eliminate payments to SNFs for return on equity capital, applicable to portions of cost reporting periods beginning on or after October 1, 1993. B. Regulations Revision We are revising §413.157(b)(3), Rate of return related to proprietary SNFs, to limit its application to services furnished before October 1, 1993. III. Reductions in Payments for Hospice Services A. Legislative Provision Under section 1814(i) of the Act, we pay for hospice services on a daily rate basis. Payments are adjusted by a market basket percentage increase. Section 13504 of OBRA 93 amended section 1814(i) of the Act to decrease the amount of the market basket (as defined by section 1886(b)(3)(B)(iii) of the Act) percentage increase that will be applied in fiscal years (FY) 1994 through 1997. These decreases are: FY 1994_the market basket percentage increase minus 2 percentage points; FYs 1995 and 1996_the market basket percentage increase minus 1.5 percentage points; and FY 1997_the market basket percentage increase minus .5 percentage points. After FY 1997, the full market basket percentage increase will again apply. B. Regulations Revisions We are revising §418.306, Determination of payment rates, by updating paragraph (b)(2) to exclude FYs 1994 through 1997 from the application of the market basket percentage increase without modification and to add a new paragraph (b)(3) to add the statutory decreases. IV. Reduction in Part A Premium for Certain Individuals With 30 or More Quarters of Social Security Coverage A. Legislative Provision Under section 226(a) of the Act, individuals generally become entitled to benefits under Medicare Part A when they reach age 65 based on hospital insurance (Part A) taxes they paid under the Federal Insurance Contributions Act (FICA) while they were working. By paying the Part A portion of the FICA tax, individuals acquire quarters of coverage (QCs), which are used to insure them for Part A coverage. Insured individuals are not required to pay monthly premiums for Part A coverage. Under section 1818 of the Act, individuals age 65 or over who do not have enough QCs to be insured for premium-free Part A may enroll in the Part A program if they pay a monthly premium. The Part A premium is determined under section 1818(d) of the Act and is based on the actuarial value of benefits under Part A. In addition, under section 1818A of the Act, disabled individuals who lose eligibility for premium-free Part A solely because they have returned to work may enroll in Part A if they pay a monthly premium, the amount of which is determined under section 1818(d). Section 13508 of OBRA 93 amended section 1818(d) to reduce, on a phased-in basis, the amount of the Part A premium for workers with 30 or more QCs and for spouses (including surviving spouses) of these workers with 30 or more QCs after having been married at least one year. The reduction also applies to divorced spouses (including surviving divorced spouses) of workers with 30 or more QCs provided that, at the time the divorce became final, the worker had 30 or more QCs and the marriage had lasted for at least 10 years. The reductions are as follows: 1994_25 percent 1995_30 percent 1996_35 percent 1997_40 percent 1998 and later years_45 percent The reduction will begin with premium payments beginning January 1994. FR940525-0-00031 FR940525-0-00020 B. Regulations Revisions We are adding to §406.32, Monthly premiums, a new paragraph (b)(3) to show the year by year reductions required by the statute and a new paragraph (c) to show the requirements for qualifying for the reduction. We are redesignating paragraph (b)(3) as (b)(4) and revising its contents, which concern rounding off fractions of dollars, to specify that the paragraph applies to the unreduced and the reduced Part A premium. We are redesignating current paragraphs (c) through (f) as (d) through (g), respectively. V. Extension of 10 Percent Reduction in Payments for Capital-Related Costs of Outpatient Hospital Services A. Legislative Provision Under 1861(v)(1)(S)(ii)(I) of the Act, Medicare pays the capital costs of hospitals allocated to outpatient departments on the basis of reasonable cost principles, subject to a 10 percent reduction through FY 1995. (Sole community hospitals and rural primary care hospitals are exempt from these reductions.) Section 13521 of OBRA 93 amended section 1861(v)(1)(S)(ii)(I) of the Act to extend the 10 percent reduction through FY 1998. B. Regulations Revisions We are revising §413.130(j)(1)(ii), Reduction to capital-related costs, to extend to 1998 the year through which the 10 percent reduction applies. VI. Extension of Reduction in Payments for Other Costs for Outpatient Hospital Services A. Legislative Provision Under section 1861(v)(1)(S)(ii)(II) of the Act, Medicare payments for hospital outpatient services made on a reasonable cost basis and the cost portion of outpatient services paid on the basis of a blended amount are both reduced by 5.8 percent through FY 1995. Section 13522 of OBRA 93 amended section 1861(v)(1)(S)(ii)(II) of the Act to extend the application of the reduction through FY 1998. B. Regulations Revisions We are revising §413.124, Reduction to hospital outpatient operating costs, to extend to 1998 the year through which the 5.8 percent reductions apply. VII. Reduction in Payments for Intraocular Lenses A. Legislative Provision Section 1833(i)(2)(A)(iii) of the Act includes in the cost of surgery to insert an intraocular lens during or after cataract surgery a payment that is reasonable and related to the cost of acquiring the class of lens involved. Section 4151 of Public Law 101&hyph;508 (the Omnibus Budget Reconciliation Act of 1990 (OBRA 90)) froze the amount of payment for the lens at $200. Section 13533 of OBRA 93 reduced the payment amount for intraocular lenses inserted during or after cataract surgery in an ambulatory surgical center on or after January 1, 1994 and before January 1, 1999. For that period, the payment is $150. B. Regulations Revisions Our regulations do not contain the specific amounts allowable for intraocular lenses, which are, instead, contained in our administrative guidelines. Therefore, we are making no changes to regulations to implement the legislation. VIII. Payment for Parenteral and Enteral Nutrients, Supplies and Equipment During 1994 and 1995 A. Legislative Provision In the Omnibus Budget Reconciliation Act of 1986 (Public Law 99&hyph;509), section 9340 provided that reasonable charges for parenteral and enteral nutrition supplies and equipment may not exceed the lowest charge levels at which the supplies and equipment are widely and consistently available. Under our regulations at 42 CFR 405.511(c) those levels are set at the 25th percentile of the charges for the items or services, in the locality designated by the carrier for this purpose, during the three month period of July 1 through September 30 preceding the fee screen year for which the item or service was furnished. Section 13541 of OBRA 93 requires that in determining the amount of Part B payment for parenteral and enteral nutrients, supplies and equipment during 1994 and 1995, the charges determined to be reasonable with respect to these items may not exceed the charges determined to be reasonable for them during 1993. B. Regulation Revision As our payment regulations do not specifically address payments for parenteral and enteral nutrients, supplies and equipment, we do not need to revise our regulations to implement this provision of OBRA 93 but will make any necessary changes in our program manuals. IX. Increase in Annual Cap on Amount of Medicare Payment for Outpatient Physical Therapy and Occupational Therapy Services A. Legislative Provision Section 1833(g) of the Act limits the amount payable annually for covered outpatient physical and occupational therapy services provided by independently practicing physical and occupational therapists. Section 6133(a) of the Omnibus Budget Reconciliation of 1989 (OBRA 89) (Pub. L. 101&hyph;239) amended section 1833(g) of the Act to increase the maximum amount of incurred expenses that can be recognized for payment purposes from $500 to $750, for services furnished on or after January 1, 1990, and section 13555 of OBRA 93 amended section 1833(g) of the Act to increase the maximum amount of incurred expenses that can be recognized for payment purposes from $750 to $900, effective for services furnished on or after January 1, 1994. B. Regulations Revisions We are revising paragraph (c)(2) of 42 CFR 410.60, Outpatient physical therapy services: Conditions, to show the various caps since before 1982 through 1994 for physical therapy services furnished by independent physical therapists. There is currently no corresponding regulation section for occupational therapy but we will include the $900 cap when we publish final regulations on those services. FR940525-0-00032 FR940525-0-00020 X. Rural Health Clinics and Federally Qualified Health Centers A. Legislative Provision Under section 1861(aa) of the Act, Medicare pays for services furnished in certain qualified health centers that are known as Federally qualified health centers (FQHCs). Each center is: An entity that is receiving a grant under section 329, 330, or 340 of the Public Health Service Act or is under contract with the recipient of a grant under section 329, 330, or 340 of the Public Health Service Act and meets the requirements for receiving such a grant; or is determined, based on the recommendations of the Health Resources and Services Administration within the Public Health Service, to meet the requirements for meeting such a grant; or was treated by the Secretary as a comprehensive Federally funded health center as of January 1, 1990. Section 13556 of OBRA 93 amended section 1861(aa)(4) of the Act to include as FQHCs outpatient programs and facilities operated by Indian tribes or tribal organizations under the Indian Self-Determination Act (25 U.S.C. 450). The amendment took effect as if included in the enactment of section 4161(a)(2)(C) of OBRA 90, which was effective October 1, 1991. Section 13556 of OBRA 93 also provides that an outpatient health program or facility operated by an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act (25 U.S.C. 1601ff) is included in the Medicare program, effective October 1, 1991. B. Regulations Revision We are adding a new paragraph to the definition of Federally qualified health centers in §405.2401(b) to include outpatient health programs and facilities operated by Indian tribes under the Indian Self-Determination Act or by urban Indian organizations under title V of the Indian Health Care Improvement Act. XI. Reduction in Payments for Epoetin A. Legislation Medicare is the principle purchaser of epoetin (EPO), an anti-anemia drug used by dialysis patients with a specified level of anemia. Section 1881(b)(11)(B) of the Act provides that payments to ESRD facilities are made based on increments of 1,000 unit doses, rounded to the nearest 100 units, with a maximum payment of $11 per 1,000 units. Under section 1861(s)(2)(P) of the Act, Medicare considers as a medical or other health service EPO for home dialysis patients competent to use the drug in the home without medical or other supervision, subject to methods and standards established by the Secretary by regulation for the safe and effective use of the drug, and items related to the use of the drug. Section 13566 of OBRA 93 decreased the maximum payment for EPO to $10 per 1,000 units. OBRA 93 also amended section 1861(s)(2)(P) to remove the word ``home'' from ``home dialysis patients'', the effect of which is to allow coverage of EPO when used at home by dialysis patients who do not dialyze at home. The effective date of section 13566 of OBRA is January 1, 1994. B. Regulations Revision The change in payment rate requires no revision to regulations because we announce the rate in a notice published in the Federal Register rather than in regulations. To implement the provision allowing dialysis patients who do not dialyze at home to use EPO in the home, we are revising §§405.2137, 405.2163, 410.10(k), and 410.52 to show the effective dates of the various sections for use of EPO at home by patients who do not dialyze at home. FR940525-0-00033 FR940525-0-00020 XII. Part B Premium A. Legislative Provision Section 1839(e) of the Act establishes the amount of the Medicare Part B premium at 50 percent of the monthly actuarial rate for enrollees age 65 and over for months in calendar years 1984 through 1990; section 4301 of the Omnibus Budget Reconciliation Act of 1990 added specific premiums for 1991 through 1995 based on Congressional Budget Office estimates, at the time, of premium amounts that would equal 50 percent of that actuarial rate. Section 13571 of OBRA 93 amended section 1839(e) of the Act to again have the premium determined annually so that it equals 50 percent of the monthly actuarial rate for enrollees age 65 and over for calendar years 1996, 1997 and 1998. B. Regulations Revisions To reflect OBRA 90 and 93 we are revising 42 CFR 408.20, Monthly premiums, by adding calendar years 1991 through 1995, and calendar years after 1998, to the heading and content of paragraph (b), which currently contains the methodology for the period July 1976 through December 1983 and the periods after 1990. We are specifying that the rates cited in section 1839(e)(1)(B) of the Act apply to 1991 through 1995. To reflect OBRA 93, we are adding calendar years 1996 through 1998 to the heading and content of paragraph (c), which currently discusses the methodology for determining premiums for calendar years 1984 through 1990. XIII. Waiver of Proposed Rulemaking We ordinarily publish a notice of proposed rulemaking for a regulation in the Federal Register and provide a period for public comment. However, we may waive that procedure if we find good cause that prior notice and comment are impracticable, unnecessary, or contrary to the public interest. As noted earlier, this rule updates our rules to properly reflect explicit statutory requirements that are clear on their face and that we are not interpreting in any way beyond their commonly understood meanings. Without these changes, certain regulation requirements are in conflict with the statute, possibly misleading those who rely on our regulations. In addition, some of the statutory changes included in these regulations have been enacted with retroactive effective dates or effective dates close to the date of enactment of OBRA 93. Under these circumstances, prompt publication of the correct up-to-date rules best serves those governed by these regulations. Because this rule does not create any legal requirements and because publishing a notice of proposed rulemaking here would perpetuate conflicts between clear statutory directives and our regulations, we find that publishing a notice of proposed rulemaking before issuing this final rule would be unnecessary and contrary to the public interest. However, we are providing a 60-day comment period for public comments on the final rule as indicated at the beginning of this rule. XIV. Response to Comments Because of the large number of items of correspondence we normally receive on FR documents published for comment, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, if we proceed with a subsequent document, we will respond to the comments in the preamble to that document. XV. Regulatory Impact Statement We generally prepare a regulatory flexibility analysis that is consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612) unless the Secretary certifies that a final rule will not have a significant economic impact on a substantial number of small entities. For purposes of the RFA, all Medicare-participating facilities are considered to be small entities. Individuals and States are not included in the definition of small entity. Also, section 1102(b) of the Act requires the Secretary to prepare a regulatory impact analysis if a final rule will have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area and has fewer than 50 beds. This final rule with comment period updates our regulations to incorporate numerous self-implementing statutory provisions that are not interrelated. None of the regulations interprets or extends requirements beyond those included in the self-implementing legislation. The amendments to which this rule pertains are already in effect or will go into effect independent of the publication of this rule. Consequently, there are no actions to be taken that would flow from further analyses of the impact of these provisions on entities. Therefore, we are not preparing analyses for either the RFA or section 1102(b) of the Act since we have determined, and the Secretary certifies, that this proposed rule would not result in a significant economic impact on a substantial number of small entities and would not have a significant economic impact on the operations of a substantial number of small rural hospitals. In accordance with the provisions of E.O. 12866, this final rule with comment period was not reviewed by the Office of Management and Budget. XVI. Collection of Information Requirements This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). List of Subjects 42 CFR Part 405 Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays. 42 CFR Part 406 Health facilities, Kidney diseases, Medicare. 42 CFR Part 408 Medicare. 42 CFR Part 410 FR940525-0-00034 FR940525-0-00020 Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Rural areas, X-rays. 42 CFR Part 413 Health facilities, Kidney diseases, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR Part 418 Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements. 42 CFR chapter IV is amended as follows: A. Part 405 is amended as follows: PART 405_FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED 1. Part 405, subpart U is amended to read as follows: Subpart U_Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services a. The authority citation for part 405, subpart U continues to read as follow: Authority: Secs. 1102, 1861, 1862(a), 1871, 1874, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 1395kk, and 1395rr), unless otherwise noted. b. In §405.2137, the introductory statement of paragraph (b)(7) is revised to read as follows: §405.2137 Condition: Patient long-term program and patient care plan. * * * * * (b) Standard: Patient care plan. *␣*␣* (7) Beginning July 1, 1991, for a home dialysis patient, and beginning January 1, 1994, for any dialysis patient, who uses EPO in the home, the plan must provide for monitoring home use of EPO that includes the following: * * * * * c. In §405.2163, introductory paragraphs (g) and (g)(2) are republished and paragraph (g)(2)(i) is revised to read as follows: §405.2163 Condition: Minimal service requirements for a renal dialysis facility or renal dialysis center. * * * * * (g) Use of EPO at home: Patient selection. The dialysis facility, or the physician responsible for all dialysis-related services furnished to the patient, must make a comprehensive assessment that includes the following: * * * * * (2) Conditions the patient must meet. The assessment must find that the patient meets the following conditions: (i) On or after July 1, 1991, is a home dialysis patient or, on or after January 1, 1994, is a dialysis patient; * * * * * 2. Part 405, subpart X is amended as follows: Subpart X_Rural Health Clinic and Federally Qualified Health Center Services a. The authority citation for subpart X is revised to read as follows: Authority: Sec. 1102, 1833, 1861(aa), 1871 of the Social Security Act; 42 U.S.C. 1302, 13951, 1395x(aa), and 1395hh. b. In the definition of ``Federally qualified health center'' in §405.2401(b), the introductory paragraph, and paragraphs (2) and (3) are revised and a new paragraph (4) is added to read as follows: §405.2401 Scope and definitions. * * * * * Federally qualified health center (FQHC) means an entity that has entered into an agreement with HCFA to meet Medicare program requirements under §§405.2434 and_ * * * * * (2) Based on the recommendation of the PHS, is determined by HCFA to meet the requirements for receiving such a grant; (3) Was treated by HCFA, for purposes of part B, as a comprehensive federally funded health center (FFHC) as of January 1, 1990; or (4) Is an outpatient health program or facility operated by a tribe or tribal organizations under the Indian Self-Determination Act or by an Urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act. B. Part 406 is amended as follows: PART 406_HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT 1. The authority citation for part 406 is revised to read as follows: Authority: Secs. 202(t), 202(u) 226, 226A, 1102, 1818 and 1871 of the Social Security Act (42 U.S.C. 402(t), 402(u), 426, 426&hyph;1, 1302, 1395i&hyph;2, and 1395hh) and sec. 3103 of Pub. L. 89&hyph;97 (42 U.S.C. 426a), unless otherwise noted. 2. In §406.32, paragraph (b)(3) is redesignated as (b)(4) and paragraphs (c) through (f) are redesignated as paragraphs (d) through (g), respectively. New paragraphs (b)(3) and (c) are added and redesignated paragraph (b)(4) is revised to read as follows: §406.32 Monthly premiums. * * * * * (b) Monthly premiums: Determination of dollar amount. * * * * * (3) Effective for months beginning January 1994, if an individual meets the requirements in paragraph (c) of this section, the monthly premium determined under paragraph (b)(1) of this section is reduced in each month in which the individual meets the requirements by 25 percent in 1994, 30 percent in 1995, 35 percent in 1996, 40 percent in 1997 and 45 percent in 1998 and thereafter. FR940525-0-00035 FR940525-0-00020 (4) The amount determined under paragraphs (b) (1), (2), or (3) of this section is rounded to the next nearest multiple of $1. (Fifty cents is rounded to the next higher dollar.) (c) Qualifying for a reduction in monthly premium. An individual who qualifies for the reduction described in paragraph (b)(3) of this section must be an individual who_ (1) Has 30 or more quarters of coverage (QCs) as defined in 20 CFR 404.140 through 404.146; (2) Has been married for at least the previous one year period to a worker who has 30 or more QCs; (3) Had been married to a worker who had 30 or more QCs for a period of at least one year before the death of the worker; (4) Is divorced from, after at least 10 years of marriage to, a worker who had 30 or more QCs at the time the divorce became final; or (5) Is divorced from, after at least 10 years of marriage to, a worker who subsequently died and who had 30 or more QCs at the time the divorce became final. * * * * * C. Part 408 is amended as follows: PART 408_PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE 1. The authority citation for part 408 continues to read as follows: Authority: Secs. 1102, 1818, 1837&hyph;1840, 1843, 1871, and 1881(d) of the Social Security Act (42 U.S.C. 1302, 1395i&hyph;2, 1395p&hyph;1395s, 1395v, 1395hh and 1395rr(d)) and the Federal Claims Collection Act (31 U.S.C. 3711). 2. In §408.20, the headings of paragraphs (b) and (c), introductory paragraphs (b)(1) and (c), and paragraph (b)(2) are revised and new paragraph (b)(3) is added to read as follows: §408.20 Monthly premiums. * * * * * (b) Criteria and procedures for the period from July 1976 through December 1983, the period from January 1991 through December 1995, and for periods after December 1998. (1) For periods from July 1976 through December 1983 and after December 1998, the Secretary determines and promulgates as the standard monthly premium (for disabled as well as aged enrollees) the lower of the following: * * * * * (2) For periods after December 1998, the Secretary determines the standard monthly premium in the manner specified in paragraph (b)(1) of this section, but promulgates it in September for the following calendar year. (3) The premiums for calendar years 1991 through 1995 are those amounts as specified by section 1839(e)(1)(B) of the Act as follows: (i) In 1991, $29.90; (ii) In 1992, $31.80; (iii) In 1993, $36.60; (iv) In 1994, $41.10; and (v) In 1995, $46.10. (c) Premiums for calendar years 1984 through 1990 and 1996 through 1998. For calendar years 1984 through 1990 and 1996 through 1998, the standard monthly premium for all enrollees_ * * * * * D. Part 410 is amended as follows: PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS 1. The authority citation for part 410 is revised to read as follows: Authority: Secs. 1102, 1832, 1833, 1834, 1835, 1861 (r), (s), (aa), (cc), and (mm), 1871 and 1881 of the Social Security Act (42 U.S.C. 1302, 1395k, 1395l, 1395m, 1395n, 1395x (r), (s), (aa), (cc), and (mm), 1395hh, and 1395rr). 2. In §410.10, the introductory paragraph is republished and paragraph (k) is revised to read as follows: §410.10 Medical and other health services: Included services. Subject to the conditions and limitations specified in this subpart, ``medical and other health services'' includes the following services: * * * * * (k) Home dialysis supplies and equipment; on or after July 1, 1991, epoetin (EPO) for home dialysis patients, and, on or after January 1, 1994, for dialysis patients, competent to use the drug; self-care home dialysis support services; and institutional dialysis services and supplies. * * * * * 3. In §410.52(a), the introductory paragraph is republished and paragraph (a)(4) is revised to read as follows: §410.52 Home dialysis services, supplies and equipment: Scope and conditions. (a) Medicare Part B pays for the following services, supplies, and equipment furnished to an ESRD patient in his or her home: * * * * * (4) On or after July 1, 1991, epoetin (EPO) for use at home by a home dialysis patient and, on or after January 1, 1994, by a dialysis patient, if it has been determined, in accordance with §405.2163 of this chapter, that the patient is competent to use the drug safely and effectively. * * * * * 4. In §410.60, the heading of paragraph (c) is republished, paragraph (c)(2) is revised to read as follows and footnote 2 is deleted: §410.60 Outpatient physical therapy services: Conditions. * * * * * (c) Special provisions for services furnished by physical therapists in independent practice. * * * * * (2) Limitation on incurred expenses. (i) Before 1982, not more than $100 of reasonable charges incurred in a calendar year are recognized as incurred expenses. (ii) From 1982 through 1989, not more than $500 of reasonable charges incurred in a calendar year are recognized as incurred expenses. (iii) From 1990 through 1993, not more than $750 of reasonable charges incurred in a calendar year are recognized as incurred expenses. (iv) After 1993, not more than $900 of reasonable charges incurred in a calendar year are recognized as incurred expenses. FR940525-0-00036 FR940525-0-00020 E. Part 413 is amended as follows: PART 413_PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES 1. The authority citation for part 413 continues to read as follows: Authority: Secs. 1102, 1122, 1814(b), 1815, 1833(a), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1320a&hyph;1, 1395f(b), 1395g, 13951(a), 1395x(v), 1395hh, 1395rr, and 1395ww). 2. Section 413.124(a) is revised to read as follows: §413.124 Reduction to hospital outpatient operating costs. (a) Except for sole community hospitals, as defined in §412.92, and rural primary care hospitals, the reasonable costs of outpatient hospital services (other than capital-related costs of such services) are reduced by 5.8 percent for services rendered during portions of cost reporting periods occurring on or after October 1, 1990 and before October 1, 1998. * * * * * 3. In §413.130 the introductory paragraph of paragraph (j) is republished and paragraph (j)(l)(ii) is revised to read as follows: §413.130 Introduction to capital-related costs. * * * * * (j) Reduction to capital-related costs. (1) Except for sole community hospitals and rural primary care hospitals, the amount of capital-related costs of all hospital outpatient services is reduced by_ (i) *␣*␣* (ii) 10 percent for portions of cost reporting periods occurring on or after October 1, 1991 through September 30, 1998. * * * * * 4. Section 413.157(b)(3) is revised to read as follows: §413.157 Return on equity capital of proprietary providers. * * * * * (b) General rule. * * * * * (3) Rate of return related to proprietary SNFs. (i) For cost reporting periods beginning on or after October 1, 1985, the rate used in determining the return for SNF services furnished before October 1, 1993 is a percentage equal to the average of the rates of interest described in paragraph (b)(1) of this section. (ii) There is no allowance for return for SNF services furnished on or after October 1, 1993. F. Part 418 is amended as follows: PART 418_HOSPICE CARE 1. The authority citation for part 418 is revised to read as follows: Authority: Secs. 1102, 1812(a)(4) and (d), 1813(a)(4), 1814(a)(7) and (i), 1816(e)(5), 1861(dd) and 1871 of the Social Security Act (42 U.S.C. 1302, 1395d(a)(4) and (d), 1395e(a)(4), 1395f(a)(7) and (i), 1395h(e)(5), 1395x(dd), and 1395hh); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a). 2. In §418.306(b), the introductory language is republished, paragraph (b)(2) is revised and a new paragraph (b)(3) is added to read as follows: §418.306 Determination of payment rates. * * * * * (b) Payment rates. The payment rates for routine home care and other services included in hospice care are as follows: * * * * * (2) Except for the period beginning October 21, 1990 through December 31, 1990, the payment rates for routine home care and other services included in hospice care for Federal fiscal years 1991, 1992, and 1993 and those that begin on or after October 1, 1997, are the payment rates in effect under this paragraph during the previous fiscal year increased by the market basket percentage increase as defined in section 1886(b)(3)(B)(iii) of the Act, otherwise applicable to discharges occurring in the fiscal year. The payment rates for the period beginning October 21, 1990 through December 31, 1990 are the same as those shown in paragraph (b)(1) of this section. (3) For Federal fiscal years 1994 through 1997, the payment rate is the payment rate in effect during the previous fiscal year increased by a factor equal to the market basket percentage increase minus_ (i) 2 percentage points in FY 1994; (ii) 1.5 percentage points in FYs 1995 and 1996; and (iii) 0.5 percentage points in FY 1997. (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare_Hospital Insurance; and Program No. 93.774, Medicare_Supplementary Medical Insurance Program) Dated: February 15, 1994. Bruce C. Vladeck, Administrator, Health Care Financing Administration. Dated: April 7, 1994. Donna E. Shalala, Secretary. [FR Doc. 94&hyph;12461 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4120&hyph;01&hyph;P FR940525-0-00037 FR940525-0-00021 42 CFR Part 413 [BPD&hyph;689&hyph;FC] RIN 0938&hyph;AE80 Medicare Program; Uniform Electronic Cost Reporting System for Hospitals AGENCY: Health Care Financing Administration (HCFA), HHS. ACTION: Final rule with comment period.

SUMMARY: This final rule with comment period implements the provisions of section 4007(b) of the Omnibus Budget Reconciliation Act of 1987, as amended by section 411(b)(6) of the Medicare Catastrophic Coverage Act of 1988, which require the Secretary to place into effect a standardized electronic cost reporting system for all hospitals under the Medicare program. Under this final rule with comment period, all hospitals are required to submit their cost reports, for hospital cost reporting periods beginning on or after October 1, 1989, in a uniform electronic format. The Secretary may grant a delay or a waiver of this requirement where implementation could result in financial hardship for a hospital.

DATES: Effective date: These rules are effective June 24, 1994. Comment date: Comments will be considered if we receive them at the appropriate address, as provided below, no later than 5 p.m. on July 25, 1994. We are accepting comments concerning the requirement in §413.24(f)(4)(ii), that cost reporting software be able to detect changes to the electronic cost report made after the provider has submitted it to the intermediary.

ADDRESSES: Mail written comments (1 original and 3 copies) to the following address: Health Care Financing Administration, Department of Health and Human Services, Attention: BPD&hyph;689&hyph;FC, P.O. Box 7517, Baltimore, MD 21207. If you prefer, you may deliver your written comments (1 original and 3 copies) to one of the following addresses: Room 309&hyph;G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201, or Room 132, East High Rise Building, 6325 Security Boulevard, Baltimore, MD 21207. Because of staffing and resource limitations, we cannot accept comments by facsimile (FAX) transmission. In commenting, please refer to file code BPD&hyph;689&hyph;FC. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in room 309&hyph;G of the Department's offices at 200 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m. (phone: (202) 690&hyph;7890).

FOR FURTHER INFORMATION CONTACT: Thomas Talbott (410) 966&hyph;4592. SUPPLEMENTARY INFORMATION: I. Background Under Medicare, hospitals are paid for inpatient hospital services that they furnish to beneficiaries under Part A (Hospital Insurance). Currently, most hospitals are paid for their inpatient hospital services under the prospective payment systems for operating and capital costs in accordance with sections 1886(d) and (g) of the Social Security Act (the Act) and 42 CFR part 412. Under these systems, Medicare payment is made at a predetermined, specific rate for each hospital discharge based on the information contained on actual bills submitted. Section 1886(f)(1)(A) of the Act provides that the Secretary will maintain a system for reporting costs of hospitals paid under the prospective payment systems. Section 412.52 requires all hospitals participating in the prospective payment systems to meet the recordkeeping and cost reporting requirements of §§413.20 and 413.24, which include submitting a cost report for each 12-month period. The hospitals and hospital units that are excluded from the prospective payment systems are generally paid an amount based on the reasonable cost of services furnished to beneficiaries. The inpatient operating costs of these hospitals and hospital units are subject to the ceiling on the rate of hospital cost increases in accordance with section 1886(b) of the Act and §413.40. Sections 1815(a) and 1833(e) of the Act provide that no payments will be made to a hospital unless it has furnished the information, requested by the Secretary, needed to determine the amount of payments due the hospital under the Medicare program. In general, hospitals submit this information through cost reports that cover a 12-month period. All hospitals participating in the Medicare program, whether they are paid on a reasonable cost basis or under the prospective payment systems, are required under §413.20(a) to ``maintain sufficient financial records and statistical data for proper determination of costs payable under the program.'' In addition, hospitals must use standardized definitions and follow accepted accounting, statistical, and reporting practices. Under the provisions of §§413.20(b) and 413.24(f), hospitals are required to submit cost reports annually, with the reporting period based on the hospital's accounting year. FR940525-0-00038 FR940525-0-00021 II. Legislation Concerning Electronic Reporting On December 22, 1987, the Omnibus Budget Reconciliation Act of 1987, Public Law 100&hyph;203, was enacted. Section 4007 of Public Law 100&hyph;203, which was subsequently amended by section 411(b)(6) of the Medicare Catastrophic Coverage Act of 1988, Public Law 100&hyph;360, added section 1886(f)(1)(B) of the Act, which sets forth several provisions concerning the reporting of hospital information under the Medicare program. Section 1886(f)(1)(B) of the Act applies to hospital cost reporting periods beginning on or after October 1, 1989. Section 1886(f)(1)(B)(i) of the Act provides that the Secretary will place into effect a standardized electronic cost reporting format for hospitals under Medicare. This standardized electronic cost reporting format does not require any additional data from hospitals. Section 1886(f)(1)(B)(ii) of the Act provides that the Secretary may delay or waive the implementation of the electronic format in instances where such implementation would result in financial hardship for a hospital. As an example of a financial hardship situation, this section of the Act specifically mentions hospitals with a small percentage of inpatients entitled to Medicare benefits. III. Provisions of the Proposed Regulations On August 19, 1991, we published a proposed rule (56 FR 41110) to implement sections 1886(f)(1)(B) (i) and (ii) of the Act. We proposed that cost reports be submitted in a standardized electronic format. The hospital's cost report software must be able to produce a standardized output file in American Standard Code for Information Interchange (ASCII) format. All intermediaries have the ability to read this standardized file and produce an accurate cost report. The proposed rule did not require the reporting of any additional information. If a hospital refuses to submit the cost reports electronically, Medicare payments to that hospital may be suspended under the provisions of sections 1815(a) and 1833(e) of the Act. As explained above, sections 1815(a) and 1833(e) of the Act provide that no Medicare payments will be made to a hospital unless it has furnished the information, requested by the Secretary, needed to determine the amount of payments due the hospital under the Medicare program. Section 405.371(d) provides for suspension of Medicare payments to a hospital by the intermediary if the hospital has failed to submit information requested by the intermediary that is needed to determine the amount due the hospital under Medicare. The general procedures that are followed when Medicare payment to a hospital is suspended for failure to submit information that is needed by the intermediary to determine Medicare payment (that is, when a hospital fails to furnish a cost report, furnishes an incomplete cost report, fails to furnish other needed information, or fails to submit a cost report electronically) are located in section 2231 of the Intermediary Manual (HCFA Pub. 13). These procedures include timeframes for ``demand letters'' to hospitals, which in addition to reminding hospitals to file timely and complete cost reports, explain possible adjustments of Medicare payments to a hospital and the right to request a 30-day extension of the due date. If a hospital believes that implementation of the electronic submission requirement would cause a financial hardship, the hospital should submit a written request for a waiver or a delay of these requirements, with supporting documentation, to the hospital's intermediary. IV. Discussion of Public Comments In response to the proposed rule, we received six timely items of correspondence. We have summarized the comments and are presenting them below with our responses. FR940525-0-00039 FR940525-0-00021 A. Requirements for Electronic Submission Comment: A few commenters requested clarification concerning the format for electronic reporting. Response: HCFA provided approved vendors of cost reporting software with a uniform standardized format for the creation of the required ASCII file. This format shows how each unique record must be displayed in the electronic file in terms of worksheet, line, and column position. The specifications required to complete a computerized Medicare Cost Report have been in effect since the inception of the Automated Desk Review (ADR) program in 1983. There are presently three vendors approved by HCFA for the ADR system. Eight other commercial vendors are approved by HCFA for electronic compilation of the Medicare cost report. A hospital may use any of the 11 vendors for purposes of filing an electronically prepared cost report. Each of the 11 vendors must undergo periodic testing in which it develops and submits to HCFA a completed cost report to demonstrate its system's ability to conform to HCFA's display standards. No hospital may file its cost report electronically unless the commercial software system it uses has completed the testing process and been approved by HCFA. In addition, when the provider files the cost report with the intermediary, the cost report must pass edits specified in the Provider Reimbursement Manual, Part II, before the intermediary can accept it. If the cost report fails to pass these edits the intermediary will immediately reject the cost report and return it to the provider for correction. The cost report will be considered late if the provider fails to correct it before the due date. The provider will be subject to withholding of interim payments until the intermediary receives the corrected cost report. Comment: Several commenters questioned the need to file a hard copy cost report in addition to submitting the electronic cost report. Additionally, commenters were concerned with the lack of a written statement certifying the accuracy of the electronic cost report. One commenter suggested that HCFA require providers to submit a written certification with the electronic cost report. Response: We agree with the commenters concerns regarding the need to file a hard copy cost report and the lack of a statement certifying the accuracy of the electronic file. Therefore, effective for cost reporting periods ending on or after October 1, 1994, we are eliminating the requirement that providers file a hard copy of the cost report in addition to the electronic file. In new §413.24(f)(4)(iii), we specify that instead of a hard copy cost report, providers must submit a hard copy of the certification statement, settlement summary, and a statement of certain worksheet totals found within the cost report file. We note that the certification statement provides that in signing the statement, the provider's administrator or chief financial officer is certifying the accuracy of the data contained in the electronic cost report or, if the provider has filed a manually prepared report, in the hard copy cost report. We believe that these changes will reduce the burden on providers and ensure the accuracy of the data contained in the electronic file. However, we also need to ensure that the electronic cost report is not altered once it leaves the provider. Thus, in conjunction with the changes made based on public comment, we are implementing a series of changes designed to preserve the integrity of the electronic cost report once the provider files it with the intermediary. First, we are specifying in new §413.24(f)(4)(ii) that the provider's software must be capable of disclosing that changes have been made to the cost report file after the provider has submitted it to the intermediary. Specifically, electronic cost reporting software will be modified so that the cost report will calculate a ``hash total'', that is, a number representing the sum of the worksheet totals (mentioned above) contained in the provider's as filed cost report. If any data in the electronic file is changed after the hash total is calculated, the electronic file will disclose that a change has been made. We will instruct all automated data reporting vendors to develop the capability to calculate hash totals and disclose changes for all their provider clients. Second, we are specifying in regulations that an intermediary may not alter a cost report once it has been filed by a hospital and must reject any cost report that does not pass all specified edits and return it to the provider for correction. Third, HCFA will make periodic checks to ensure that the totals in the electronic file agree with those totals certified by the provider's administrator or chief financial officer. Because providers may not have anticipated such substantial changes as a result of this rule, we are soliciting comments concerning the requirement in new §413.24(f)(4)(ii) that cost report software be able to disclose changes to the electronic file made after the provider has submitted it to the intermediary. Comment: One commenter requested that the intermediary be required to report back to the provider in electronic cost reporting format the audit adjustments made to the provider's cost report. This would allow providers to readily add the audit adjustments to the electronic cost report for future reference. Response: We recognize the merit of this suggestion and will consider implementing this process in the future. The intermediaries would need additional computer programming to be able to provide hospitals with an electronic file of audit adjustments. We will discuss the commenter's suggestion with the 11 approved vendors of cost report software to determine the extent of additional programming needed and the financial implications. FR940525-0-00040 FR940525-0-00021 B. Waiver Process Comment: Several commenters requested guidance concerning the process for seeking a delay in or waiver from the electronic submission requirement. The commenters also wanted to know under what circumstances HCFA would grant a delay or waiver. Commenters suggested that HCFA define the term ``financial hardship'' as used in the proposed rule. Response: The Provider Reimbursement Manual, part II, section 130, provides the guidelines for requesting a waiver. Basically, the provider must make a written request to the intermediary at least 120 days before the close of the provider's cost reporting period. The intermediary reviews the request and forwards it, with a recommendation for approval or denial, to HCFA's central office within 30 days of receipt of the request. The central office informs the intermediary whether the waiver is approved or denied within 60 days of receipt of the request in the central office. Because of the varying financial circumstances of hospitals and other health care providers that participate in the Medicare program, we believe that it would be inappropriate to establish a definition of ``financial hardship'' or a set of specific criteria that a provider would need to meet to qualify for a waiver of the electronic cost reporting requirement. We believe that the best method for determining whether a provider qualifies for a waiver is to consider requests on a case by case basis. To date, we have received only eight requests for waiver. We believe that the small number of requests indicates that the majority of providers will not experience financial hardship as a result of electronic cost reporting. In addition, in an effort to minimize the number of providers that need a waiver, we developed a software package that will enable the hospital to file an electronic data set to its fiscal intermediary in order to generate an electronic cost report. We are providing the software package to hospitals free of charge. Therefore, we believe that with the availability of the free software, it will be difficult for a provider to demonstrate financial hardship. Comment: A commenter recommended that HCFA provide an automatic waiver of electronic cost report filing in each instance in which a waiver of standard or full cost reporting has been granted, including those cases where full cost reporting has been waived because of a low percentage of Medicare inpatients. Response: HCFA will grant an automatic waiver of electronic cost reporting if a provider is exempt from full or standard cost reporting. To qualify for an automatic waiver of electronic cost reporting, the provider must apply and qualify for an exemption from full or standard cost reporting in accordance with the rules that provide for the exemption. For example, a provider that does not furnish any covered services to Medicare beneficiaries is exempt from filing a full cost report and instead must submit an abbreviated report under §413.24(g). Additionally, a provider with low program utilization may obtain a waiver from filing a full cost report in accordance with §413.24(h). When the intermediary notifies a provider that it qualifies for an exemption from filing a full cost report, the provider also will be notified of the exemption from electronic filing. Providers must apply for a waiver of full cost reporting for each new cost reporting period. Providers that are not exempt from full cost reporting must file for a waiver according to the procedure set forth in section 130 of the Provider Reimbursement Manual, part II, as discussed above. FR940525-0-00041 FR940525-0-00021 C. Sanctions Comment: Commenters requested HCFA's position regarding the penalties assessed against a provider for failing to file its cost report electronically. Response: Sections 1815(a) and 1833(e) of the Act provide that no payments will be made to a hospital unless it has furnished the information requested by the Secretary needed to determine the amount of payments due the hospital under the Medicare program. Section 405.371(d) provides for suspension of Medicare payments to a hospital by the intermediary if the hospital fails to submit a cost report, submits an incomplete cost report, or fails to furnish other needed information. Section 2409.1(A)(1) of the Provider Reimbursement Manual (PRM 15&hyph;I) addresses the procedures an intermediary will follow when a provider fails to submit a cost report or when the cost report is overdue. Unless the provider has received a waiver from electronic cost reporting, the intermediary will consider a timely filed cost report that is not filed electronically as an overdue cost report for purposes of section 2409.1(A)(1). We will update this section of the manual to reflect our position regarding sanctions for failure to file cost reports electronically. D. Cost of Implementation Comment: A commenter disagreed with our statement in the impact analysis of the proposed rule that hospitals would not be significantly affected by electronic cost reporting. The commenter stated that some hospitals had to make expensive changes in personnel or software to comply with the regulations and that the cost of maintaining the required software was an additional burden on providers. The commenter suggested that HCFA pay providers for the cost of implementing the electronic cost reporting requirement including the cost of equipment, software, additional personnel, external consultants, and any related overhead costs. Response: Section 1886(f)(1)(B) of the Act does not authorize HCFA to subsidize any of the costs hospitals incur in implementing electronic cost reporting. However, it does authorize the waiver or delay of the implementation of the electronic format in cases of financial hardship. As discussed above, if computer support required for electronic cost reporting will cause financial hardship, the hospital may request a waiver from electronic filing. V. Provisions of the Final Regulations In this final rule with comment, we are revising the provisions set forth in the proposed rule. Based on public comment, we are eliminating the requirement that providers file a hard copy cost report in addition to the electronic file. Also based on public comment, we are adding a new paragraph (iii) to §413.24(f)(4) to provide that in addition to the electronic file, a hospital must submit hard copies of a settlement summary, a statement of certain worksheet totals found in the electronic file, and a signed statement certifying the accuracy of the electronic file or the manually prepared cost report. In addition to the changes made based on public comment, we are adding a new paragraph (ii) to §413.24(f)(4) to provide the following: •All cost reporting software must be able to disclose that changes have been made to the electronic file after the provider has submitted its cost report to the intermediary. •The intermediary may not alter the cost report once it has been filed by the provider. •The intermediary rejects any cost report that does not pass all specified edits and returns it to the provider for correction. As a result of the above changes to the regulations text, proposed §413.24(f)(4)(ii) has been redesignated as §413.24(f)(4)(iv). VI. Collection of Information Requirements Section 413.24 of this final rule with comment contains information collection and recordkeeping requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These information collection and recordkeeping requirements are not effective until they have been approved by OMB. We have submitted a copy of this final rule with comment to OMB for review of the information collection requirements. Approximately 90 percent of hospitals participating in Medicare have filed electronic cost reports before the effective date of this regulation, that is with cost reporting periods beginning on or after October 1, 1989. These providers will now have to file a diskette containing the required cost report data in a standard format. This diskette will contain input data only. We believe that minimal time would be needed for hospitals to become familiar with the revised software furnished by their cost reporting vendor. The remaining 10 percent of the hospitals previously filed manually prepared cost reports. While these hospitals will initially experience an additional reporting burden, we believe that once they are familiar with electronic reporting, there will no longer be an additional burden and there may even be a decrease in burden since the time needed to compute the cost report will no longer be required. FR940525-0-00042 FR940525-0-00021 VII. Response to Comments Because of the number of items of correspondence we normally receive on Federal Register documents published for comment, we are not able to acknowledge or respond to them individually. We will consider comments we receive by the date and time specified in the ``DATES'' section of this preamble, and, if we proceed with a final rule, we will respond to comments in the preamble to that document. Specifically, we are soliciting comments concerning the requirement in new §413.24(f)(4)(ii) that cost reporting software be able to detect changes made to the electronic file after the provider has submitted it to the intermediary. We will not consider comments concerning provisions that remain unchanged from the August 19, 1991 proposed rule or provisions that were changed based on public comment. VIII. Impact Statement Unless the Secretary certifies that a final rule will not have a significant economic impact on a substantial number of small entities, we generally prepare a regulatory flexibility analysis that is consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 through 612). For purposes of the RFA, all hospitals and small businesses that distribute cost-report software to hospitals are considered to be small entities. Intermediaries are not included in the definition of a small entity. Section 1102(b) of the Act requires the Secretary to prepare a regulatory impact analysis if a final rule may have a significant impact on the operations of a substantial number of small rural hospitals. Such an analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that has fewer than 50 beds and is located outside of a Metropolitan Statistical Area. Under the provisions of §§413.20(b) and 413.24(f), hospitals are required to submit cost reports annually, with reporting periods based on the hospital's accounting year. This is generally a consecutive 12-month period. Section 1886(f)(1)(B)(i) of the Act now requires the use of a standardized electronic cost reporting format for hospitals. There are approximately 11 national software suppliers that distribute cost report software packages to hospitals. In addition, HCFA offers a cost reporting software package that is available at no expense to any hospital that requests it. As discussed in the proposed rule, computer software suppliers and hospitals that purchased their software will not be significantly affected by these provisions. Suppliers will not need to develop new software and hospitals will not need to purchase new software but only revise the software or have the cost report portion of the software revised based on standard format requirements set by HCFA. Although the cost report portion of software packages will be exactly the same, competition among suppliers will not be adversely affected since each offers other features that make its product unique. Hospitals that will be most affected by this final rule with comment period are those that may be unable to afford the equipment to submit electronically. These hospitals might include hospitals that have very few Medicare beneficiaries and small rural hospitals. Hospitals that have access to computer equipment can utilize and benefit from HCFA's free software if they are unable to afford the software that is available from suppliers. However, as stated above, we have received only eight requests for waiver of electronic cost reporting. We believe that the small number of requests indicates that the vast majority of hospitals will not experience financial hardship due to the requirements of this final rule with comment period. In conclusion, this final rule with comment period will not have a significant effect on hospital costs since hospitals will not be required to collect any additional data beyond that which the regulations currently specify; cost-report software is available at no cost from HCFA to any hospital that requests it; and most hospitals have some type of computer equipment through which they are currently submitting electronically prepared cost reports. Hospitals will only be affected to the extent that all would be required to submit cost reports in a standardized electronic format to their respective intermediary. A hospital that does not comply with the provisions of this rule, as specified in the preamble, will be subject to sections 1815(a) and 1833(e) of the Act, which provide that no payments will be made to a hospital unless it has furnished the information requested by the Secretary that is needed to determine the amount of payments due the hospital under Medicare. This final rule with comment period will not have a significant effect on a substantial number of Medicare participating hospitals or software suppliers. Therefore, a regulatory flexibility analysis is not required. We are not preparing a rural impact statement since the Secretary certifies that this final rule with comment period will not have a significant economic impact on the operation of a substantial number of small rural hospitals. In accordance with the provisions of Executive Order 12866, this regulation was not reviewed by the Office of Management and Budget. FR940525-0-00043 FR940525-0-00021 List of Subjects CFR Part 413 Health facilities, Kidney diseases, Medicare, Puerto Rico, Reporting and recordkeeping requirements. 42 CFR part 413 is amended as set forth below: PART 413_PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES A. The authority citation for part 413 is revised to read as follows: Authority: Sec. 1102, 1814(b), 1815, 1833(a), (i), and (n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1395f(b), 1395g, 13951(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww) and sec. 104(c) of Pub. L. 100&hyph;360 as amended by sec. 608(d)(3) of Pub. L. 100&hyph;485 (42 U.S.C. 1395ww (note)); and sec 101(c) of Pub. L. 101&hyph;234 (42 U.S.C. 1395ww (note)). B. A new paragraph (f)(4) is added to §413.24 to read as follows: §413.24 Adequate cost data and cost finding. * * * * * (f) Cost reports. * * * (4) Electronic submission of cost reports. (i) Effective for cost reporting periods beginning on or after October 1, 1989, a hospital is required to submit its cost reports in a standardized electronic format. The hospital's electronic program must be capable of producing the HCFA standardized output file in a form that can be read by intermediary's automated system. This electronic file, which must contain the input data required to complete the cost report and the data required to pass specified edits, is forwarded to the fiscal intermediary for processing through its system. (ii) The fiscal intermediary may not alter the cost report once it has been filed by the hospital. If a cost report does not pass all specified edits, the fiscal intermediary rejects the cost report and returns it to the hospital for correction. The hospital's electronic program must be able to disclose that changes have been made to the electronic cost report after the provider has submitted it to the intermediary. (iii) Effective for cost reporting periods ending on or after October 1, 1994, a hospital must submit a hard copy of a settlement summary, a statement of certain worksheet totals found within the electronic file, and a statement signed by its administrator or chief financial officer certifying the accuracy of the electronic file or the manually prepared cost report. The following statement must immediately precede the dated signature of the hospital's administrator or chief financial officer: I hereby certify that I have read the above certification statement and that I have examined the accompanying electronically filed or manually submitted cost report and the Balance Sheet Statement of Revenue and Expenses prepared by XXXX (Provider Name(s) and Number(s)) for the cost reporting period beginning XXXX and ending XXXX and that to the best of my knowledge and belief, this report and statement are true, correct, complete and prepared from the books and records of the provider in accordance with applicable instructions, except as noted. I further certify that I am familiar with the laws and regulations regarding the provision of health care services, and that the services identified in this cost report were provided in compliance with such laws and regulations. (iv) A hospital may request a delay or waiver of the electronic submission requirement in paragraph (f)(4)(i) of this section if this requirement would cause a financial hardship. The hospital must submit a written request for delay or waiver with necessary supporting documentation to its intermediary at least 120 days prior to the end of its cost reporting period. The intermediary reviews the request and forwards it with a recommendation for approval or denial, to HCFA central office within 30 days of receipt of the request. HCFA central office either approves or denies the request and notifies the intermediary within 60 days of receipt of the request. * * * * * (Catalog of Federal Domestic Assistance Program No. 93.773, Medicare_Hospital Insurance; and Program No. 93.774, Medicare_Supplementary Medical Insurance Program) Dated: August 25, 1993. Bruce C. Vladeck Administrator, Health Care Financing Administration. Approved: May 6, 1994. Donna E. Shalala, Secretary. [FR Doc. 94&hyph;12459 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 4120&hyph;01&hyph;P FR940525-0-00044 FR940525-0-00022 FEDERAL EMERGENCY MANAGEMENT AGENCY 44 CFR Part 62 RIN 3067&hyph;AC25 National Flood Insurance Program; Assistance to Private Sector Property Insurers AGENCY: Federal Insurance Administration, FEMA. ACTION: Interim rule.

SUMMARY: This interim rule amends the National Flood Insurance Program (NFIP) regulations for the ``Write Your Own'' (WYO) Program relating to the marketing of flood insurance policies. This interim rule modifies the Arrangement to encourage increases in the policyholder base and to increase the financial stability of the NFIP.

DATES: Effective date: This interim rule and the offer are effective May 25, 1994. The Financial Assistance/Subsidy Arrangement is applicable with respect to flood insurance policies written under the Arrangement with an effective date of October 1, 1994, and later. Comment Date: July 25, 1994.

ADDRESSES: Comments are requested and should be sent to the Rules Docket Clerk, Office of the General Counsel, Federal Emergency Management Agency, 500 C Street, SW., room 840, Washington, DC 20472, (fax) (202) 646&hyph;4536.

FOR FURTHER INFORMATION CONTACT: Charles M. Plaxico, Jr., Federal Emergency Management Agency, Federal Insurance Administration, 500 C Street, SW., Washington, DC 20742, (202) 646&hyph;3422. SUPPLEMENTARY INFORMATION: The Write-Your-Own (WYO) Program (established in 1983) was authorized pursuant to Subpart C, part 62 of the National Flood Insurance Program (NFIP) regulations and section 1345 of the National Flood Insurance Act of 1968, as amended (Pub. L. 90&hyph;448, 42 U.S.C. 4001, et seq. ). Under the WYO Program, the Standard Flood Insurance Policy (the form and substance of which is approved by the Federal Insurance Administrator (the Administrator)) may be issued in their own names by insurers signatory to Financial Assistance/Subsidy Arrangements. Insurers then are responsible for all aspects of service, including policy issuance to new policyholders and to policyholders insured by them under other lines of property insurance; endorsement and renewal of policies; and the adjustment of claims brought under the policies. The insurers retain a specified amount of the premium for their expenses, including the commissions of agents. Under the Arrangement, the Government provides such additional funds as may be required, over and above the net premium income, for the payment of claims. Once the Arrangement is signed by the authorized official of the private insurer and the Government, it is effective at the beginning of the Government's Fiscal Year on October 1 and runs through the following September 30. Also, in accordance with Article V_Commencement and Termination of the Arrangement, the Federal Insurance Administration (FIA) is required, by June 1 of each year, to publish in the Federal Register the terms for the re-subscription of the Arrangement for the next Arrangement Year. This interim rule amends the National Flood Insurance Program (NFIP) regulations dealing with the marketing of flood insurance policies, at Article II_Undertakings of the Company, paragraph G. of the Arrangement, by requiring the WYO Company to follow marketing guidelines established by the Federal Insurance Administration (FIA). FIA is currently developing marketing guidelines which will then be established in consultation with representatives of the WYO Companies. As a result of the heavy flood losses which occurred in recent years (i.e., Hurricanes Andrew and Iniki in August and September 1992, the Northeaster storm in December 1992, the blizzard of March 1993, and the Midwest flooding in the summer of 1993), FEMA recently had to exercise its borrowing authority for the first time in eight years. While the Program has been growing modestly, greater increases in the policyholder base are needed to provide additional premium dollars to build up the reserves to meet future catastrophic flooding events. Further, large numbers of the victims of recent flood disasters were not protected by flood insurance. Therefore, FEMA has determined that sufficient cause exists for making this rule effective immediately so the revised Arrangement can be the basis of the Offer required by June 1 and that delaying the effective date until after a comment period would be impracticable and contrary to the public interest. However, comments are requested and will be considered before further regulations are issued. Publication of the Arrangement in this interim rule also constitutes, for the WYO Program Arrangement year of October 1, 1994_September 30, 1995, the Administrator's ``Offer to Assist Insurers in Underwriting Flood Insurance Using the Standard Flood Insurance Policy.'' Method of Acceptance of Offer 1. Acceptance of this offer shall be by mailed notice of acceptance or signed Arrangement to the Administrator `prior to midnight EDT September 30, 1994. The notice may be preceded by facsimile transmission (202) 646&hyph;3445 which must be received by midnight EDT September 30, 1994. 2. The facsimile transmission or mailed notice of acceptance to the Administrator must be authorized by an official of the insurance company who has the authority to enter into such arrangements. 3. A duly signed original copy of the Notice of Acceptance (see No. 6 below) must be on file with the Administrator by November 16, 1994. 4. If 1., 2., or 3. above are not satisfied, the acceptance will be considered by the Administrator as conditional and the commitment of NFIP resources to fulfill the ``Undertaking of the Government'' under Article IV of the Arrangement will take a lower priority than those needed to fulfill the requirement of the other participating insurance companies. 5. Send all acceptances of this offer to: Federal Emergency Management Agency, Attn: Federal Insurance Administrator, WYO Program, Washington, DC 20472. 6. In accepting this offer, use the Notice of Acceptance Form set forth below: Notice of Acceptance Form 1994&hyph;1995; Federal Emergency Management Agency; Federal Insurance Administration; Financial Assistance/Subsidy Arrangement (Arrangement) Whereas, in 1994, there was published a Notice of Offer by the Federal Emergency Management Agency to enter into a Financial Assistance/Subsidy Arrangement (hereafter the Arrangement). Whereas, the above cited Arrangement, as published in and reprinted from the Federal Register , does not provide sufficient space to type in the name of the Company. Whereas, the Arrangement may include several individual companies within a Company Group and the Arrangement as published in and reprinted from the Federal Register does not provide sufficient space to type in a list of companies. FR940525-0-00045 FR940525-0-00022 Therefore, the parties hereby agree that this Notice of Acceptance form is incorporated into and is an integral part of the entire Arrangement and is substituted in place of the signature block contained in the Federal Register under Article XVI of the Arrangement. The above mentioned Arrangement is effective in the States in which the insurance company (ies) listed below is (are) duly licensed to engage in the business of property insurance: In witness whereof, the parties hereto have accepted this Arrangement on this XXXXX day of XXXXX , XXX . By: XXXXXXXXX Title: XXXXXXXX The United States of America Federal Emergency Management Agency By: XXXXXXXXX Title: Federal Insurance Administrator National Environmental Policy Act This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared. Executive Order 12898, Environmental Justice The socioeconomic conditions relating to this interim rule have been reviewed and it has been found that no disproportionately high and adverse effect on minority or low income populations result from this interim rule. Executive Order 12866, Regulatory Planning and Review This interim rule is not a significant regulatory action within the meaning of section 2(f) of E.O. 12866 of September 30, 1993, 58 FR 51735. Nevertheless, this interim rule adheres to the regulatory principles set forth in E.O. 12866. Paperwork Reduction Act This rule does not contain a collection of information requirement as described in section 3504(h) of the Paperwork Reduction Act. Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987. Executive Order 12778, Civil Justice Reform This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778. List of Subjects in 44 CFR Part 62 Flood insurance. Accordingly, 44 CFR part 62 is amended as follows: PART 62_SALE OF INSURANCE AND ADJUSTMENT OF CLAIMS Subpart C_Write Your Own (WYO) Companies 1. The authority citation for part 62 continues to read as follows: Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 43 FR 41943, 3 CFR, 1978 Comp., p. 329; E.O. 12127 of Mar. 31, 1979, 44 FR 19367, 3 CFR, 1979 Comp., p. 376. 2. Appendix A is revised to read as follows: Appendix A to Part 62 Federal Emergency Management Agency, Federal Insurance Administration, Financial Assistance/Subsidy Arrangement. Purpose: To assist the company in underwriting flood insurance using the Standard Flood Insurance Policy. Accounting Data: Pursuant to Section 1310 of the Act, a Letter of Credit shall be issued for payment as provided for herein from the National Flood Insurance Fund. Effective Date: October 1, 1994. Issued By: Federal Emergency Management Agency, Federal Insurance Administration, Washington, DC 20472. Article I_Findings, Purpose, and Authority Whereas, the Congress in its ``Finding and Declaration of Purpose'' in the National Flood Insurance Act of 1968, as amended, (``the Act'') recognized the benefit of having the National Flood Insurance Program (the Program) ``carried out to the maximum extent practicable by the private insurance industry''; and Whereas, the Federal Insurance Administration (FIA) recognizes this Arrangement as coming under the provisions of Section 1345 of the Act; and FR940525-0-00046 FR940525-0-00022 Whereas, the goal of the FIA is to develop a program with the insurance industry where, over time, some risk-bearing role for the industry will evolve as intended by the Congress (Section 1304 of the Act); and Whereas, the Program, as presently constituted and implemented, is subsidized, and the insurer (hereinafter the ``Company'') under this Arrangement shall charge rates established by the FIA; and Whereas, this Arrangement will subsidize all flood policy losses by the Company; and Whereas, this Financial Assistance/Subsidy Arrangement has been developed to involve individual Companies in the Program, the initial step of which is to explore ways in which any interested insurer may be able to write flood insurance under its own name; and Whereas, one of the primary objectives of the Program is to provide coverage to the maximum number of structures at risk and because the insurance industry has marketing access through its existing facilities not directly available to the FIA, it has been concluded that coverage will be extended to those who would not otherwise be insured under the Program; and Whereas, flood insurance policies issued subject to this Arrangement shall be only that insurance written by the Company in its own name pursuant to the Act; and Whereas, over time, the Program is designed to increase industry participation, and, accordingly, reduce or eliminate Government as the principal vehicle for delivering flood insurance to the public; and Whereas, the direct beneficiaries of this Arrangement will be those Company policyholders and applicants for flood insurance who otherwise would not be covered against the peril of flood. Now, therefore, the parties hereto mutually undertake the following: Article II_Undertakings of the Company A. In order to be eligible for assistance under this Arrangement the Company shall be responsible for: 1.0 Policy Administration, including 1.1 Community Eligibility/Rating Criteria 1.2 Policyholder Eligibility Determination 1.3 Policy Issuance 1.4 Policy Endorsements 1.5 Policy Cancellations 1.6 Policy Correspondence 1.7 Payment of Agents Commissions The receipt, recording, control, timely deposit and disbursement of funds in connection with all the foregoing, and correspondence relating to the above in accordance with the Financial Control Plan requirements. 2.0 Claims processing in accordance with general Company standards and the Financial Control Plan. The Write Your Own Claims Manual, the Federal Emergency Management Agency Adjuster Manual, the FIA National Flood Insurance Program Policy Issuance Handbook, the Write Your Own Operational Overview, and other instructional material also provide guidance to the Company. 3.0 Reports 3.1 Monthly Financial Reporting and Statistical Transaction Reporting shall be in accordance with the requirements of National Flood Insurance Program Transaction Record Reporting and Processing Plan for the Write Your Own (WYO) Program and the Financial Control Plan for business written under the WYO Program. These data shall be validated/ edited/audited in detail and shall be compared and balanced against Company financial reports. 3.2 Monthly financial reporting shall be prepared in accordance with the WYO Accounting Procedures. 3.3 The Company shall establish a program of self audit acceptable to the FIA or comply with the self audit program contained in the Financial Control Plan for business written under the WYO Program. The Company shall report the results of this self-audit to the FIA annually. B. The Company shall use the following time standards of performance as a guide: 1.0 Application Processing_15 days (Note: If the policy cannot be mailed due to insufficient or erroneous information or insufficient funds, a request for correction or added monies shall be mailed within 10 days); 1.1 Renewal Processing_7 days; 1.2 Endorsement Processing_7 days; 1.3 Cancellation Processing_15 days; 1.4 Correspondence, Simple and/or Status Inquiries_7 days; 1.5 Correspondence, Complex Inquiries_20 days; 1.6 Supply, Materials, and Manual Requests_7 days; 1.7 Claims Draft Processing_7 days from completion of file examination; 1.8 Claims Adjustment_45 days average from receipt of Notice of Loss (or equivalent) through completion of examination. 1.9 For the elements of work enumerated above, the elapsed time shown is from date of receipt through date of mail out. Days means working, not calendar days. In addition to the standards for timely performance set forth above, all functions performed by the Company shall be in accordance with the highest reasonably attainable quality standards generally utilized in the insurance and data processing industries. These standards are for guidance. Although no immediate remedy for failure to meet them is provided under this Arrangement, nevertheless, performance under these standards can be a factor considered by the Federal Insurance Administrator (the Administrator) in determining the continuing participation of the Company in the Program or other action, e.g., limiting the Company's authority to write new business. C. The Company shall coordinate activities and provide information to the FIA or its designee on those occasions when a Flood Insurance Catastrophe Office is established. D. Policy Issuance 1.0 The flood insurance subject to this Arrangement shall be only that insurance written by the Company in its own name pursuant to the Act. 2.0 The Company shall issue policies under the regulations prescribed by the Administrator in accordance with the Act; 3.0 All such policies of insurance shall conform to the regulations prescribed by the Administrator pursuant to the Act, and be issued on a form approved by the Administrator; 4.0 All policies shall be issued in consideration of such premiums and upon such terms and conditions and in such States or areas or subdivisions thereof as may be designated by the Administrator and only where the Company is licensed by State law to engage in the property insurance business; 5.0 The Administrator may require the Company to immediately discontinue issuing policies subject to this Arrangement in the event Congressional authorization or appropriation for the National Flood Insurance Program is withdrawn. FR940525-0-00047 FR940525-0-00022 E. The Company shall establish a bank account, separate and apart from all other Company accounts, at a bank of its choosing for the collection, retention and disbursement of funds relating to its obligation under this Arrangement, less the Company's expenses as set forth in Article III, and the operation of the Letter of Credit established pursuant to Article IV. All funds not required to meet current expenditures shall be remitted to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual. F. The Company shall investigate, adjust, settle and defend all claims or losses arising from policies issued under this Arrangement. Payment of flood insurance claims by the Company shall be binding upon the FIA. G. The Company shall market flood insurance policies in a manner consistent with the marketing guidelines established by the Federal Insurance Administration. Article III_Loss Costs, Expenses, Expense Reimbursement, and Premium Refunds A. The Company shall be liable for operating, administrative and production expenses, including any taxes, dividends, agent's commissions or any board, exchange or bureau assessments, or any other expense of whatever nature incurred by the Company in the performance of its obligations under this Arrangement. B. The Company shall be entitled to withhold as operating and administrative expenses, other than agents or brokers commissions, an amount from the Company's written premium on the policies covered by this Arrangement in reimbursement of all of the Company's marketing, operating and administrative expenses, except for allocated and unallocated loss adjustment expenses described in C. of this Article, which amount shall equal the average of industry expense ratios for ``Other Acq.'' ``Gen. Exp.'' and ``Taxes'' as published in the latest available (as of March 15 of the prior Arrangement year) ``Best's'' Aggregates and Averages Property Casualty, Industry Underwriting_by Lines for Fire, Allied Lines, Farmowners Multiple Peril, Homeowners Multiple Peril, and Commercial Multiple Peril combined (weighted average using premiums earned as weights) calculated and promulgated by the Administrator. Premium income net of reimbursement (net premium income) shall be deposited in a special account for the payment of losses and loss adjustment expenses (see Article II, Section E). The Company shall be entitled to 15% of the Company's written premium on the policies covered by this Arrangement as the commission allowance to meet commissions and/or salaries of their insurance agents, brokers, or other entities producing qualified flood insurance applications and other related expenses. The Company, with the consent of the Administrator as to terms and costs, shall be entitled to utilize the services of a national rating organization, licensed under state law, to assist the FIA in undertaking and carrying out such studies and investigations on a community or individual risk basis, and in determining more equitable and accurate estimates of flood insurance risk premium rates as authorized under the National Flood Insurance Act of 1968, as amended. The Company shall be reimbursed in accordance with the provisions of the WYO Accounting Procedures Manual for the charges or fees for such services. C. Loss Adjustment Expenses shall be reimbursed as follows: 1. Unallocated loss adjustment shall be an expense reimbursement of 3.3% of the incurred loss (except that it does not include ``incurred but not reported''). 2. Allocated loss adjustment expense shall be reimbursed to the Company pursuant to Exhibit A, entitled ``Fee Schedule.'' 3. Special allocated loss expenses shall be reimbursed to the Company for only those expenses the Company has obtained prior approval of the Administrator to incur. D.1. Loss payments under policies of flood insurance shall be made by the Company from funds retained in the bank account established under Article II, Section E and, if such funds are depleted, from funds derived by drawing against the Letter of Credit established pursuant to Article IV. FR940525-0-00048 FR940525-0-00022 2. Loss payments will include payments as a result of awards or judgments for damages arising under the scope of this Arrangement, policies of flood insurance issued pursuant to this Arrangement, and the claims processing standards and guides set forth at Article II, Section A, 2.0 of this Arrangement. Prompt notice of any claim for damages as to claims processing or other matters arising outside the scope of this section (D)(2) shall be sent to the Assistant Administrator of the FIA's Office of Insurance Policy Analysis and Technical Services (OIPATS), along with a copy of any material pertinent to the claim for damages arising outside of the scope of the matters set forth in this section (D)(2). Following receipt of notice of such claim, the General Counsel (OGC), FEMA, shall review the cause and make a recommendation to FIA as to whether the claim is grounded in actions by the Company which are significantly outside the provisions of this section (D)(2). After reviewing the General Counsel's recommendation, the Administrator will make her decision and the Company will be notified, in writing, within thirty (30) days of the General Counsel's recommendation, if the decision is that any award or judgment for damages arising out of such actions will not be recognized under Article III of this Arrangement as a reimbursable loss cost, expense or expense reimbursement. In the event that the Company wishes to petition for reconsideration of the notification that it will not be reimbursed for the award or judgment made under the above circumstances, it may do so by mailing, within thirty days of the notice declining to recognize any such award or judgment as reimbursable under Article III, a written petition to the Chairman of the WYO Standards Committee established under the Financial Control Plan. The WYO Standards Committee will, then, consider the petition at its next regularly scheduled meeting or at a special meeting called for that purpose by the Chairman and issue a written recommendation to the Administrator, within thirty days of the meeting. The Administrator's final determination will be made, in writing, to the Company within thirty days of the recommendation made by the WYO Standards Committee. E. Premium refunds to applicants and policyholders required pursuant to rules contained in the National Flood Insurance Program (NFIP) ``Flood Insurance Manual'' shall be made by the Company from funds retained in the bank account established under Article II, Section E and, if such funds are depleted, from funds derived by drawing against the Letter of Credit established pursuant to Article IV. Article IV_Undertakings of the Government A. Letter(s) of Credit shall be established by the Federal Emergency Management Agency (FEMA) against which the Company may withdraw funds daily, if needed, pursuant to prescribed procedures as implemented by FEMA. The amounts of the authorizations will be increased as necessary to meet the obligations of the Company under Article III, Sections (C), (D), and (E). Request for funds shall be made only when net premium income has been depleted. The timing and amount of cash advances shall be as close as is administratively feasible to the actual disbursements by the recipient organization for allowable Letter of Credit expenses. Request for payment on Letters of Credit shall not ordinarily be drawn more frequently than daily nor in amounts less than $5,000, and in no case more than $5,000,000 unless so stated on the Letter of Credit. This Letter of Credit may be drawn by the Company for any of the following reasons: 1. Payment of claim as described in Article III, Section D; and 2. Refunds to applicants and policyholders for insurance premium overpayment, or if the application for insurance is rejected or when cancellation or endorsement of a policy results in a premium refund as described in Article III, Section E; and 3. Allocated and unallocated Loss Adjustment Expenses as described in Article III, Section C. B. The FIA shall provide technical assistance to the Company as follows: 1. The FIA's policy and history concerning underwriting and claims handling. 2. A mechanism to assist in clarification of coverage and claims questions. 3. Other assistance as needed. Article V_Commencement and Termination A. Upon signature of authorized officials for both the Company and the FIA, this Arrangement shall be effective for the period October 1 through September 30. The FIA shall provide financial assistance only for policy applications and endorsements accepted by the Company during this period pursuant to the Program's effective date, underwriting and eligibility rules. B. By June 1, of each year, the FIA shall publish in the Federal Register and make available to the Company the terms for the re-subscription of this Financial Assistance/Subsidy Arrangement. In the event the Company chooses not to re-subscribe, it shall notify the FIA to that effect by the following July 1. C. In the event the Company elects not to participate in the Program in any subsequent fiscal year, or the FIA chooses not to renew the Company's participation, the FIA, at its option, may require (1) the continued performance of this entire Arrangement for one (1) year following the effective expiration date only for those policies issued during the original term of this Arrangement, or any renewal thereof, or (2) the transfer to the FIA of: FR940525-0-00049 FR940525-0-00022 a. All data received, produced, and maintained through the life of the Company's participation in the Program, including certain data, as determined by FIA, in a standard format and medium; and b. A plan for the orderly transfer to the FIA of any continuing responsibilities in administering the policies issued by the Company under the Program including provisions for coordination assistance; and c. All claims and policy files, including those pertaining to receipts and disbursements which have occurred during the life of each policy. In the event of a transfer of the services provided, the Company shall provide the FIA with a report showing, on a policy basis, any amounts due from or payable to insureds, agents, brokers, and others as of the transition date. D. Financial assistance under this Arrangement may be cancelled by the FIA in its entirety upon 30 days written notice to the Company by certified mail stating one of the following reasons for such cancellation: (1) Fraud or misrepresentation by the Company subsequent to the inception of the contract, or (2) nonpayment to the FIA of any amount due the FIA. Under these very specific conditions, the FIA may require the transfer of data as shown in Section C., above. If transfer is required, the unearned expenses retained by the Company shall be remitted to the FIA. E. In the event the Act is amended, or repealed, or expires, or if the FIA is otherwise without authority to continue the Program, financial assistance under this Arrangement may be cancelled for any new or renewal business, but the Arrangement shall continue for policies in force which shall be allowed to run their term under the Arrangement. F. In the event that the Company is unable to, or otherwise fails to, carry out its obligations under this Arrangement by reason of any order or directive duly issued by the Department of Insurance of any Jurisdiction to which the Company is subject, the Company agrees to transfer, and the Government will accept, any and all WYO policies issued by the Company and in force as of the date of such inability or failure to perform. In such event the Government will assume all obligations and liabilities owed to policyholders under such policies arising before and after the date of transfer and the Company will immediately transfer to the Government all funds in its possession with respect to all such policies transferred and the unearned portion of the Company expenses for operating, administrative and loss adjustment on all such policies. Article VI_Information and Annual Statements The Company shall furnish to the FIA such summaries and analyses of information in its records as may be necessary to carry out the purposes of the National Flood Insurance Act of 1968, as amended, in such form as the FIA, in cooperation with the Company, shall prescribe. The Company shall be a property/casualty insurer domiciled in a State or territory of the United States. Upon request, the Company shall file with the FIA a true and correct copy of the Company's Fire and Casualty Annual Statement, and Insurance Expense Exhibit or amendments thereof, as filed with the State Insurance Authority of the Company's domiciliary State. Article VII_Cash Management and Accounting A. FEMA shall make available to the Company during the entire term of this Arrangement and any continuation period required by FIA pursuant to Article V, Section C., the Letter of Credit provided for in Article IV drawn on a repository bank within the Federal Reserve System upon which the Company may draw for reimbursement of its expenses as set forth in Article IV which exceed net written premiums collected by the Company from the effective date of this Arrangement or continuation period to the date of the draw. B. The Company shall remit all funds not required to meet current expenditures to the United States Treasury, in accordance with the provisions of the WYO Accounting Procedures Manual. C. In the event the Company elects not to participate in the Program in any subsequent fiscal year, the Company and FIA shall make a provisional settlement of all amounts due or owing within three months of the termination of this Arrangement. This settlement shall include net premiums collected, funds drawn on the Letter of Credit, and reserves for outstanding claims. The Company and FIA agree to make a final settlement of accounts for all obligations arising from this Arrangement within 18 months of its expiration or termination, except for contingent liabilities which shall be listed by the Company. At the time of final settlement, the balance, if any, due the FIA or the Company shall be remitted by the other immediately and the operating year under this Arrangement shall be closed. Article VIII_Arbitration A. If any misunderstanding or dispute arises between the Company and the FIA with reference to any factual issue under any provisions of this Arrangement or with respect to the FIA's non-renewal of the Company's participation, other than as to legal liability under or interpretation of the standard flood insurance policy, such misunderstanding or dispute may be submitted to arbitration for a determination which shall be binding upon approval by the FIA. The Company and the FIA may agree on and appoint an arbitrator who shall investigate the subject of the misunderstanding or dispute and make a determination. If the Company and the FIA cannot agree on the appointment of an arbitrator, than two arbitrators shall be appointed, one to be chosen by the Company and one by the FIA. FR940525-0-00050 FR940525-0-00022 The two arbitrators so chosen, if they are unable to reach an agreement, shall select a third arbitrator who shall act as umpire, and such umpire's determination shall become final only upon approval by the FIA. The Company and the FIA shall bear in equal shares all expenses of the arbitration. Findings, proposed awards, and determinations resulting from arbitration proceedings carried out under this section, upon objection by FIA or the Company, shall be inadmissible as evidence in any subsequent proceedings in any court of competent jurisdiction. This Article shall indefinitely succeed the term of this Arrangement. Article IX_Errors and Omissions The parties shall not be liable to each other for damages caused by ordinary negligence arising out of any transaction or other performance under this Arrangement, nor for any inadvertent delay, error, or omission made in connection with any transaction under this Arrangement, provided that such delay, error, or omission is rectified by the responsible party as soon as possible after discovery. However, in the event that the Company has made a claim payment to an insured without including a mortgagee (or trustee) of which the Company had actual notice prior to making payment, and subsequently determines that the mortgagee (or trustee) is also entitled to any part of said claim payment, any additional payment shall not be paid by the Company from any portion of the premium and any funds derived from any Federal Letter of Credit deposited in the bank account described in Article II, section E. In addition, the Company agrees to hold the Federal Government harmless against any claim asserted against the Federal Government by any such mortgagee (or trustee), as described in the preceding sentence, by reason of any claim payment made to any insured under the circumstances described above. Article X_Officials Not to Benefit No Member or Delegate to Congress, or Resident Commissioner, shall be admitted to any share or part of this Arrangement, or to any benefit that may arise therefrom; but this provision shall not be construed to extend to this Arrangement if made with a corporation for its general benefit. Article XI_Offset At the settlement of accounts the Company and the FIA shall have, and may exercise, the right to offset any balance or balances, whether on account of premiums, commissions, losses, loss adjustment expenses, salvage, or otherwise due one party to the other, its successors or assigns, hereunder or under any other Arrangements heretofore or hereafter entered into between the Company and the FIA. This right of offset shall not be affected or diminished because of insolvency of the Company. All debts or credits of the same class, whether liquidated or unliquidated, in favor of or against either party to this Arrangement on the date of entry, or any order of conservation, receivership, or liquidation, shall be deemed to be mutual debts and credits and shall be offset with the balance only to be allowed or paid. No offset shall be allowed where a conservator, receiver, or liquidator has been appointed and where an obligation was purchased by or transferred to a party hereunder to be used as an offset. Although a claim on the part of either party against the other may be unliquidated or undetermined in amount on the date of the entry of the order, such claim will be regarded as being in existence as of the date of such order and any credits or claims of the same class then in existence and held by the other party may be offset against it. Article XII_Equal Opportunity The Company shall not discriminate against any applicant for insurance because of race, color, religion, sex, age, handicap, marital status, or national origin. Article XIII_Restriction on Other Flood Insurance As a condition of entering into this Arrangement, the Company agrees that in any area in which the Administrator authorizes the purchase of flood insurance pursuant to the Program, all flood insurance offered and sold by the Company to persons eligible to buy pursuant to the Program for coverages available under the Program shall be written pursuant to this Arrangement. FR940525-0-00051 FR940525-0-00022 However, this restriction applies solely to policies providing only flood insurance. It does not apply to policies provided by the Company of which flood is one of the several perils covered, or where the flood insurance coverage amount is over and above the limits of liability available to the insured under the Program. Article XIV_Access to Books and Records The FIA and the Comptroller General of The United States, or their duly authorized representatives, for the purpose of investigation, audit, and examination shall have access to any books, documents, papers and records of the Company that are pertinent to this Arrangement. The Company shall keep records which fully disclose all matters pertinent to this Arrangement, including premiums and claims paid or payable under policies issued pursuant to this Arrangement. Records of accounts and records relating to financial assistance shall be retained and available for three (3) years after final settlement of accounts, and to financial assistance, three (3) years after final adjustment of such claims. The FIA shall have access to policyholder and claim records at all times for purposes of the review, defense, examination, adjustment, or investigation of any claim under a flood insurance policy subject to this Arrangement. Article XV_Compliance with Act and Regulations This Arrangement and all policies of insurance issued pursuant thereto shall be subject to the provisions of the National Flood Insurance Act of 1968, as amended, the Flood Disaster Protection Act of 1973, as amended, and Regulations issued pursuant thereto and all Regulations affecting the work that are issued pursuant thereto, during the term hereof. Article XVI_Relationship Between the Parties (Federal Government and Company) and the Insured Inasmuch as the Federal Government is a guarantor hereunder, the primary relationship between the Company and the Federal Government is one of a fiduciary nature, i.e., to assure that any taxpayer funds are accounted for and appropriately expended. The Company is not the agent of the Federal Government. The Company is solely responsible for its obligations to its insured under any flood policy issued pursuant hereto. In witness whereof, the parties hereto have accepted this Arrangement on this XXXXX day of XXXXX , 1993. Company by (Title) The United States of America Federal Emergency Management Agency by (Title) Exhibit A Fee Schedule 1Range (by covered loss) 1Fee Erroneous Assignment $40 Closed Without Payment 125 Minimum for Upton-Jones Claims 800 $0.01 to $600 150 $600.01 to $1,000 175 $1,000.01 to $2,000 225 $2,000.01 to $3,500 275 $3,500.01 to $5,000 350 $5,000.01 to $7,000 425 $7,000.01 to $10,000 500 $10,000.01 to $15,000 550 $15,000.01 to $25,000 600 $25,000.01 to $35,000 675 $35,000.01 to $50,000 750 $50,000.01 to $100,000 1,000 $100,000.01 to $150,000 1,300 $150,000.01 to $200,000 1,600 $200,000.01 to limits 2,000 Allocated fee schedule entry value is the covered loss under the policy based on the standard deductibles ($500 and $500) and limited to the amount of insurance purchased. (Catalog of Federal Domestic Assistance No. 83.100, ``Flood Insurance'') Dated: May 17, 1994. Elaine A. McReynolds, Administrator, Federal Insurance Administration. [FR Doc. 94&hyph;12627 Filed 5&hyph;20&hyph;94; 8:45 am] BILLING CODE 6718&hyph;05&hyph;P FR940525-0-00052 FR940525-0-00023 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 0 [DA 94&hyph;464] Transfer of Continuity of Government and National Security and Emergency Preparedness Functions From the Office of Managing Director to the Field Operations Bureau AGENCY: Federal Communications Commission. ACTION: Final rule.

SUMMARY: This amendment changes the Commission's Rules to incorporate the reorganization between the Office of Managing Director and the Field Operations Bureau. This reorganization improves the effectiveness of the Commission's Continuity of Government (COG) and National Security and Emergency Preparedness (NSEP) activities by integrating them within the field infrastructure, and increasing the technical and administrative support to these activities.

EFFECTIVE DATE: June 24, 1994. FOR FURTHER INFORMATION CONTACT: Terry Johnson, Office of Managing Director, (202) 632&hyph;0923. SUPPLEMENTARY INFORMATION: Amendment of Part 0 of the Commission's Rules to Reflect a Reorganization of the Office of Managing Director and the Field Operations Bureau; Order [DA 94&hyph;464] Adopted: May 5, 1994. Released: May 13, 1994. By the Managing Director: 1. On March 7, 1994, the Commission adopted proposed changes in the organizations of the Office of Managing Director and the Field Operations Bureau. Implementation of the proposed changes requires amendment to Part 0 of the Commission's Rules and Regulations. In adopting the reorganization the Commission delegated authority to the Managing Director to make the attached editorial changes. 2. In order to increase the effectiveness of the Commission's Continuity of Government (COG) and National Security and Emergency Preparedness (NSEP) activities, they are being integrated within the field infrastructure. This will improve the technical and administrative support to these activities. 3. The amendments adopted herein pertain to agency organization. The prior notice procedure and effective date provisions of section 4 of the Administrative Procedures Act are therefore inapplicable. Authority for the amendments adopted herein is contained in sections 4(i) and 5(b) of the Communications Act of 1934, as amended. 4. It is ordered, effective 30 days after publication in the Federal Register that Part 0 of the Rules and Regulations is amended as set forth in the Appendix below. List of Subjects in 47 CFR Part 0 Authority delegated, Organization and functions (Government agencies). Federal Communications Commission. Andrew S. Fishel, Managing Director. Final Rules Part 0 of chapter I of title 47 of the Code of Federal Regulations is amended as follows: PART 0_COMMISSION ORGANIZATION 1. The authority citation for Part 0 continues to read as follows: Authority: Sections 5, 48 Stat. 1068, as amended; 47 U.S.C. 155. §0.11 [Amended] 2. Section 0.11 is amended by removing paragraph (a)(10), and redesignating paragraphs (a)(11) and (a)(12) as paragraphs (a)(10) and (a)(11), respectively. 3. Section 0.91 is amended by revising paragraph (1) to read as follows: §0.91 Functions of the Bureau. * * * * * (1) Administers the Telecommunications Service Priority System with the concurrence of the Field Operations Bureau, and resolves matters involving assignment of priorities and other issues pursuant to part 64 of the rules. FR940525-0-00053 FR940525-0-00023 4. Section 0.111 is amended by adding a new paragraph (o) to read as follows: §0.111 Functions of the Bureau. * * * * * (o) Under the general direction of the Defense Commissioner, coordinate the defense activities of the Commission, and provide support to the Defense Commissioner with respect to his participation in the Joint Telecommunications Resources Board and the National Security Telecommunications Advisory Committee; including recommendation of national emergency plans and preparedness programs covering Commission functions during national emergency conditions. Support the Chief, Common Carrier Bureau on matters involving assignment of Telecommunications Service Priority System priorities and in the administration of that system. The Chief, Field Operations Bureau, or his designee, acts as FCC Defense Coordinator and principal to the National Communications System. 5. Section 0.182 is amended by revising the section heading to read as follows: §0.182 Chief, Field Operations Bureau. 6. Section 0.183 is revised to read as follows: §0.183 Emergency Communications Administration. The Field Operations Bureau coordinates the National Security and Emergency Preparedness (NSEP) activities of the Federal Communications Commission including Continuity of Government Planning and the Emergency Broadcasting System (EBS) and other such functions as may be delegated during a national emergency or activation of the President's war emergency powers as specified in section 706 of the Communications Act; maintains liaison with FCC Bureaus/Offices, other government agencies, the telecommunications industry and FCC licensees on NSEP matters; and, as requested, represents the Commission at NSEP meetings and conferences. 7. Section 0.185 is amended by revising the introductory paragraph and paragraphs (a) and (b) to read as follows: §0.185 Responsibilities of the bureaus and staff offices. The heads of each of the several bureaus and staff offices, in rendering advice and assistance to the Chief, Field Operations Bureau in the performance of his duties with respect to defense activities will have the following duties and responsibilities: (a) To keep the Chief, Field Operations Bureau informed of the instigation, progress, and completion of programs, plans or activities with respect to defense in which they are engaged or have been requested to engage. (b) To render assistance and advice to the Chief, Field Operations Bureau on matters which relate to the functions of their respective bureaus or staff offices. * * * * * §0.231 [Amended] 8. Section 0.231 is amended by removing paragraphs (a), and (b), and (i), and redesignating paragraphs (c) through (h) as paragraphs (a) through (f) and redesignating paragraphs (j) through (l) as paragraphs (g) through (i). 9. Section 0.284 is amended by revising paragraph (a)(4) to read as follows: §0.284 Actions taken under delegated authority. (a) *␣*␣* (4) Matters involving emergency communications, including the issuance of Emergency Broadcast System Authorizations (FCC Form 392)_Field Operations Bureau. * * * * * 10. Section 0.311 is amended by adding paragraphs (g) and (h) to read as follows: §0.331 Authority delegated. * * * * * (g) The Chief, Field Operations Bureau, or his designee, is delegated authority to exempt AM, FM, and Television broadcast licensees from the requirement of installing and maintaining the necessary equipment to receive Emergency Action Notifications and Terminations and arranging for either an associated listening watch, or automated alarm, or both. (See §73.922 of this chapter). (h) The Chief, Field Operations Bureau, or his designee, upon securing concurrence of the General Counsel, is delegated authority to execute, in the name of the Commission, all agreements pertaining to the loan of United States Government property to radio station licensees for national defense purposes. 11. Section 0.332 is amended by revising paragraph (d) to read as follows: §0.332 Actions taken under delegated authority. * * * * * (d) Matters involving emergency communications_Field Operations Bureau. * * * * * [FR Doc. 94&hyph;12604 Filed 5&hyph;24&hyph;94; 8:45 am] BILLING CODE 6712&hyph;01&hyph;M FR940525-0-00054 FR940525-0-00024 DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 625 [Docket No. 940262&hyph;4062; I.D. 050994D] Summer Flounder Fishery AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notification of commercial quota adjustment.

SUMMARY: NMFS announces adjustments to the commercial quota for the 1994 summer flounder fishery. This action complies with regulations implementing the Fishery Management Plan for the Summer Flounder Fishery (FMP), which require quota overages landed in any state to be deducted from that state's quota the following year. The public is advised that a quota adjustment has been made and is informed of the revised state quotas.

EFFECTIVE DATE: May 20, 1994. FOR FURTHER INFORMATION CONTACT: Hannah Goodale, 508&hyph;281&hyph;9101. SUPPLEMENTARY INFORMATION: Regulations implementing Amendment 2 to the FMP are found at 50 CFR part 625, the final rule being published on December 4, 1992 (57 FR 57358). The regulations require annual specification of a commercial quota that is apportioned among the states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state is described in §625.20. The commercial summer flounder quota for the 1994 calendar year, adopted to ensure achievement of the appropriate fishing mortality rate of 0.53 for 1994, is set to equal 16,005,560 lb (7.3 million kg) (59 FR 10586, March 7, 1994). Section 625.20(d)(2) provides that all landings for sale in a state shall be applied against that state's annual commercial quota. Any landings in excess of the state's quota will be deducted from that state's annual quota for the following year. Based on dealer reports and other available information, the following states were determined to have exceeded their 1993 quotas: Maine, Massachusetts, New Jersey, Delaware, Maryland, Virginia, and North Carolina. The remaining states of New Hampshire, Rhode Island, Connecticut, and New York did not exceed their 1993 quotas and, therefore, no adjustments are necessary for these states. Table 1 shows the 1993 quotas adjusted for authorized transfers made between states during the year, 1993 landings, 1993 overage amounts, 1994 quotas, and the adjusted 1994 quotas taking into account 1993 overage amounts, by state. Table 1. Adjusted 1994 Commercial Quota for the Summer Flounder Fishery [Parentheses Indicate a Negative Amount] 1␣ 11993 quota (lb) 11993 landings (lb) 11993 overage (lb) 1Initial 1994 quota (lb) 1Adjusted 1994 quota 2(lb) 2(kg) ME 5,874 6,023 149 7,612 7,463 3,385