Document wZY2rDBeEBYYY2xMjoOR9owd

MAR 2 2 1973 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE, N.W. WASHINGTON, D. C. 20009 (202) 483-6126 March 20, 1973 To: FOOD, DRUG, AND COSMETIC CHEMICALS COMMITTEE Subject: Environmental Impact Statements Members: Attached is the notice on the above subject from the March 15 FEDERAL REGISTER. Note that the FDA proposal of July 12, with changes, has been made effective as of March 15. Although we claimed FDA has no authority to require that a food additive petition contain an environmental impact analysis report and no authority to refuse to file or deny it because it does not contain such a report, the attached notice says: "The Commissioner concludes that the National Environmental Policy Act, as interpreted by the courts, amends the Federal Food, Drug, and Cosmetic Act to the extent that it requires consideration of environmental issues in the review by FDA of these applications and petitions, and that the FDA there fore has the authority to require submission of adequate en vironmental data as a criterion for accepting, filing, and approving them." Also: "The Commissioner concludes that en vironmental impact analysis reports are necessary for all applications and petitions submitted to FDA ... to provide sufficient environmental data and information to enable the agency to determine whether an environmental impact statement must be issued on the action involved. The amount and detail of the information provided in the environmental impact analy sis report will be expected to vary depending upon the nature of the action involved." We also urged language recognizing the obligation of the agency, in the preparation of environmental impact statements, to maintain as confidential trade secret information which it has received from regulated companies. The attached notice says: "The Commissioner concludes that data and information which constitute trade secrets or confidential information under 21 CFR Part 4 should not be submitted in an environmental impact ASI 00003372 2- - analysis report, although they are submitted as part of an application or petition itself. A new paragraph (h) is therefore added to Section 6.1 to this effect. The FDA is not precluded from considering trade secrets or confidential information submitted by an applicant or petitioner in its environmental assessment of an application or petition. However, no trade secrets or confidential information sub mitted in the application or petition will be disclosed in an environmental impact statement circulated outside the Department." Sincerely yours MMHigr Attachment Distribution "B" M. M. nuuvci, DcuieLary Food, Drug, and Cosmetic Chemicals committee AST O0O03373 COPIED BY MCA RULES AND REGULATIONS 7001 No. so--Pt. I- Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINIS TRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE ENVIRONMENTAL IMPACT STATEMENTS Procedures for Preparation In the Federal Register of July 12, 1972 (37 FR 13636), the Commissioner of 'Food and Drags published proposed pro cedures for consideration of environ mental impact factors pursuant to the National Environmental Policy Act of 1969 (Public Law 91-190; 83 Stat. 852 et seq.; 42 UJ3.C. 4321-4347). During the 60-day comment period, 15 comments were received on the pro posal; from the Environmental Protec tion Agency, one college of agriculture, three trade associations, and regulated Industries. The principal points raised and the Commissioner's conclusions are as follows: A. Applicability. Seven comments ques tioned whether routine actions of the Food and Drug Administration, such as approval of new drag applications, new animal drug applications, antibiotic drug monographs, food additive petitions and color additive petitions constitute major actions significantly affecting the quality of the human environment which would require issuance of environmental Impact statements. Two comments doubted that destruction of condemned, enjoined, de tained, or recalled articles would ever amount to a major agency action requir ing an environmental impact statement. Five comments proposed establishing categories of animal drags which would be excluded from environmental impact consideration. The Commissioner con cludes that the National Environmental Policy Act applies to the categories of agency action in ; 6.1(b) and that FDA shall therefore consider the need for preparing environmental impact state ments for them. No environmental im pact statement will be issued if the agency action is not major or it does not significantly affect the quality of the hu man environment. B. Environmental impact analysis re ports. Frye comments stated that the FDA has no authority to require new drug applications, new animal drug ap plications. new antibiotic drag applica tions, food additive petitions and color additive petitions to include environ- FEDERAL REGISTER, VOL. 38, NO. 50--THURSDAY, MARCH 15, 1973 ASI 00003374 7002 RULES AND REGULATIONS mental impact analysis reports, or to Seven comments proposed that appli lutants in the manufacture of any drug, refuse to accept or file such an appli cants and petitioners have the oppor food additive or color additive it reviews cation or petition for failure to Include tunity to review environmental impact for marketing and in the destruction of ^ such a report, or to reject such an ap statements before they are made avail all articles removed from the market plication or petition for failure to include able to the public to prevent disclosure a result of legal action it initiates. Oncl^ an adequate environmental impact of trade secrets and confidential infor a description of the pollutants expectet^^ analysis report. Seven comments ob mation by the statements. The Commis to be discharged is included, a statement jected that the filing of environmental sioner concludes that data and informa of other applicable Federal, State, and impact analysis reports would cause tion which constitute trade secrets or local requirements, and information lengthy delays in the processing of such confidential information under 21 CFR showing that they are satisfied, will ordi applications and petitions. The Commis Part 4 should not be submitted in an narily be sufficient for this aspect of the sioner concludes that the National En environmental impact analysis report, environmental impact analysis report. vironmental Policy Act, as interpreted although they are submitted as part of F. Destruction of perishable articles. by the courts, amends the Federal Food, an application or petition itself. A new One comment expressed concern that Drug, and Cosmetic Act to the extent paragraph (h) is therefore added to f 6.1 perishable articles condemned, enjoined, that it requires consideration of environ to this effect. The FDA is not precluded detained, or recalled might create an en mental issues in the review by the FDA from considering trade secrets or con vironmental and health hazard while of these applications and petitions, and fidential information submitted by an awaiting environmental Impact consid that the FDA therefore has the authority applicant or petitioner in its environ eration prior to destruction. Section 6.3 to require submission of adequate en mental assessment of an application or (c) of the regulation permits immediate vironmental data as a criterion for ac petition. However, no trade secrets or destruction of such articles without en cepting, filing, and approving them. confidential Information submitted in vironmental Impact statement considera Five comments proposed that an ap the application or petition will be dis tion in order to protect the public health. plicant or a petitioner be required to closed in an environmental impact state G. Direct solicitation of comments file an environmental Impact analysis ment circulated outside the Department, from Federal agencies. The Environ report only when the FDA determines D. Time for consideration of environ mental Protection Agency proposed that that a specific application or petition mental impact statements. Nine com comments on draft environmental im constitutes a major agency action sig ments proposed time limitations for the pact statements be directly solicited from nificantly affecting the quality of the preparation and review of environmental those Federal agencies concerned with human environment. One comment sug impact statements for food additive peti the substance of the statements by rea gested that submission of an environ tions, new drug applications and new son of Jurisdiction by law or special ex mental impact analysis report be re animal drug applications on the grounds pertise to insure maximum input to the quired for destruction of condemned, that sections 409(c), 505(c), and 512(c) agency's environmental statement re enjoined, detained, or recalled articles of the Federal Food, Drug, and Cosmetic view process pursuant to the NEPA only when the agency determines that Act require the agency to act on such guidelines of the Council on Environ destruction of an article constitutes a applications and petitions within 180 mental Quality. The Commissioner con major FDA action significantly affect days after filing. The Commissioner con curs with this proposal, and provision for ing the quality of the human environ cludes that the National Environmental direct solicitation is therefore included ment, The Commissioner concludes that Policy Act, as interpreted by the courts, in 5 6.3(a)(3). environmental impact analysis reports amends the Federal Food, Drug, and H. Investigational new drugs. The are necessary for all applications and Cosmetic Act to the extent that it re Environmental Protection Agency ques petitions submitted to FDA and for all quires the FDA to give full consideration tioned the exemption afforded investig^i destructions of condemned, enjoined, de without restrictions of time to all en tional new drugs from environment^^ tained, and recalled articles in order to vironmental Issues relevant to FDA ap impact statement consideration in provide sufficient environmental data proval of food additive petitions, new (d) (5) of the proposal. Since an invest and information to enable the agency drugs and new animal drugs. Every tigational new drug is not permitted to to determine whether an environmental effort will be made to stay within the be commercially marketed, the Commis impact statement must be issued on the statutory time periods and the regula sioner concludes that allowing limited in action involved. The amount, and detail tions so provide. vestigation in most instances is not a of the information provided in the en E. Alleged regulatory duplication. major action and does not significantly vironmental impact analysis report will Seven comments contended that the re affect the quality of the human environ be expected to vary depending upon the quirement to include a description of ment. In those instances where an en nature of the action involved. manufacturing processes in environ vironmental impact statement may be Three comments proposed prompt notification to an applicant if its en vironmental impact analysis report is inadequate. Three comments also rec mental impact analysis reports unneces sarily duplicates regulatory activity since the Environmental Protection Agency and various State and local au required, the applicant will be so noti fied and 6.1(d) (5) is amended to so provide. I. Additional changes. In addition to ommended that notice be afforded an thorities already administer air and the amendments adopted on the basis of applicant when the FDA deems the water quality standards controlling the comments received, the Commissioner amendment to an existing regulation or emission of pollutants. Two comments concludes that additional amendments the supplement to an existing approval is substantial enough to require submis sion of an environmental Impact analy sis report. Notice in both these instances will be given in accordance with existing regulations of the FDA providing that an applicant will be notified if its ap plication is incomplete for filing. C. Trade secrets and confidential in formation. Twelve comments expressed concern that submission of an environ mental impact analysis report by an ap plicant or petitioner would necessitate disclosure of trade secrets and confiden tial information, particularly with re spect to a description of the manufac turing, process required in the report. made an identical contention with re spect to the requirement of environ mental impact analysis reports for destruction of condemned, enjoined, de tained, or recalled articles. The Commis sioner finds that existing Federal, State, and local regulation of air and water pollution does not eliminate the inde pendent statutory obligation of the FDA under NEPA to consider all relevant en vironmental factors in performing its regulatory activities. The Commissioner concludes that, to fulfill its responsibili ties under the National Environmental Policy Act, the FDA must require the submission of environmental data and information on the discharge of pol be made to the regulation, as follows: 1. All provisions of the proposal gov erning hazardous substances are deleted since jurisdiction for such substances is being transferred from FDA to the Con sumer Product Safety Commission. 2. Sections 6.1(e) and 6.1(g) are amended to delete the provision requir ing that an applicant in its environ mental impact analysis report analyze whether the proposed action is a major Federal action significantly affecting tire quality of the human environment. The National Environmental Policy Act re quires the FDA to make this determina tion, and in any event an applicant may comment on this issue in an environ- ASI 00003375 FEDERAL REGISTER, VOL. 38, NO. SO--THURSDAY, MARCH 15, 1973 RULES AND REGULATIONS 7003 mental impact analysis report if be (1) Recommendations or reports made the environmental impact of the dispo wishes to do so. to Congress on proposals for legislation sition of such articles, 3. Section 6.3(b) of the proposal is In instances where the agency has pri (g) An environmental impact analysis amended to reflect the Commissioner's mary responsibility for the subject mat report shall be submitted to the agency conclusion that environmental consid ter involved; in the following format: eration of condemned, enjoined, or recalled articles and disposition of lab oratory waste materials should be under taken on a case-by-case basis and that the disposal methods considered be con sistent with Federal, State, and local (2) Destruction of articles condemned after seizure or enjoined; (3) Destruction of articles following detention or recall at agency request; (4) Disposition of Food and Drug Ad ministration laboratory waste materials; Environmental Impact Analysis Repost Date: Name or applicant; Address: ------------------------------------------------ 1. Describe the proposed action: regulations to safeguard the human en vironment and the public health. 4. The provision for public hearings on final environmental impact state (5) Issuance of licenses for biological products; (6) Establishment by regulation of labeling or other requirements for mar 2. Discuss the probable Impact of the ac tion on the environment (Including primary and secondary consequences):______ ments in S 6.3(a) (6) is deleted from the final order since they are not required by NEPA or by the Council on Environ keting articles; (7) Establishment by regulation of standards for articles (except food 3. Discuss the probable adverse environ mental effects which cannot be avoided; mental Quality. Therefore, having considered the com ments received and other relevant ma standards); (8) Approval of new drug and abbrev iated new drug applications and old drug 4. Evaluate alternatives to the proposed action: terial, the Commissioner concludes that the proposal, with changes, should be adopted as set forth below. Accordingly, pursuant to the National Environmental Policy Act of 1969 (sec. 102(2)(C), 83 Stat. 853; 42 U.S.C. 4332), and pursuant monographs; (9) Approval of new animal drug and abbreviated new animal drug apllcations and old animal drug monographs; (10) Approval of antibiotic drug monographs; 5. Describe the relationship between local short-term uses or the environment with respect to the proposed action and the maintenance and enhancement or long-term productivity: to the provisions of the Federal Food, Drug, and Cosmetic Act (secs. 409, 505, 507, 512, 701, 706, 52 Stat. 1052 as amended, 1055-1056 as amended by 70 Stat. 919 and 72 Stat. 948, 59 Stat. 468 as (11) Approval of food additive petitions; (12) Approval of color additive peti tions; and (13) Policy, regulations, and procedure 6. Describe any irreversible and Irretrieva ble commitment or resources which would be involved In the proposed action should It be Implemented: amended, 72 Stat. 1785-1788 as amended, making which significantly affect the 74 Stat. 399-404 as amended, 82 Stat. quality of the human environment. 343-351; 21 U.S.C. 348,355,357, 360b, 371, (c) An environmental Impact state 376), and under authority delegated to ment will not be required for amend 7. Discuss the objections raised by other agencies, organizations, or individuals which are known to the applicant: the Commissioner (21 CFR 2.120), title 21, Chapter 1 Is amended; 1. By adding a new Part 6 as follows: PART 6--ENVIRONMENTAL IMPACT CONSIDERATIONS ments to existing regulations and ap provals of supplements to existing ap provals unless the change Is substantial. (d) The agency has carefully consid ered the environmental effects of the fol lowing types of actions and has con 8. IT proposed action should be taken prior to 90 days from the circulation of a draft environmental Impact statement or 30 days from the filing of a final environmental Im pact statement, explain why: Sec. 8.1 Applicability. 6.2 Content and format of environmental Impact statements. 6.3 Preparation and review procedures. 6.4 Responsible agency officials. cluded that since they are not major agency actions significantly affecting the quality of the human environment, en vironmental Impact statements are not required for them: 9. Analyze whether the benefit to the publlo of the proposed action will outweigh the action's potential risks to the environment: 6.5 Submission of comments to other (1) Recommendations for court action agencies. concerning foods, drugs, devices, cos 6.6 Public availability of environmental im metics, and electronic products; pact statements. (2) Factory inspections; (Date) (Signature of responsible official) (h) Data and information which con :Authority Sec. 701, 52 Stat. 1055-56 as (3) seafood inspections; stitute trade secrets or confidential in amended by 70 Stat. 919 and 72 Stat. 948, 21 (4) Issuance or amendment of food formation under Part 4 of this chapter U.S.C. 371; sec. 10. 74 Stat. 378, 15 U.S.C. standards; and shall not be submitted In an environ 1369; sec. 102(2) (C), 83 Stat. 353, 43 TJ.S.C. 4332; the Guidelines Issued by the Council on Environmental Quality (36 PR 7724); Ex ecutive Order 11514 Of March 4, 1970 (35 FR 4247), f 6.1 Applicability. (a) (1) An environmental impact statement shall be prepared, circulated, and filed pursuant to section 102(2) (C) of the National Environmental Policy Act of 1969 for every major agency action that significantly affects the quality of the human environment. (2) Agency decisions shall include a careful consideration of all environ mental effects of proposed actions. (b) The need for preparing an envi ronmental impact statement shall be considered for the following agency ac tions pursuant to environmental criteria established by the agency and the department; (5) Investigational new drug applica tions and investigational new animal drug applications, unless the agency no tifies the applicant that one Is required. (e) Whenever a person submits any application or petition requesting action by the agency (except action specified in paragraph (d) of this section), he shall include an environmental impact anal ysis report on the requested action. Failure to include an adequate environ mental impact analysis report in an ap plication or petition shall be sufficient grounds to refuse to accept or file the application or petition. (f) Whenever a manufacturer, distrib utor, or dealer proposes to destroy a food, drug, cosmetic, device, or electronic prod uct which has been condemned, enjoined, detained, or banned by regulation, he shall submit to the agency an environ mental impact analysis report analyzing mental impact analysis report. (i) Upon receipt of an environmental Impact analysis report, the responsible agency official shall make an Independ ent assessment as to whether an en vironmental impact statement shall be prepared for the proposed action. 6.2 Content and format of environ mental impact statements. (a) When it is determined that an environmental impact statement is re quired, draft and final environmental Impact statements shall cover the fol lowing points: (1) There shall be a description of the proposed action including adequate in formation and technical data to permit a careful assessment of the environmen tal impact. Where relevant, exhibits should be provided. (2) The probable impact that the pro posed action will have on the environ- <- ffderal register, voi. 38, no. so--Thursday, march is, 1973 ASI 00003376 7004 RULES AND REGULATIONS ment shall be analyzed and shall include the impact on ecological systems such as wildlife, fish, and other marine life. Both primary and secondary significant con sequences for the environment should be Included in the analysis. (31 There shall be a description of any probable adverse environmental effects which cannot be avoided (such as water or air pollution, undesirable land use pat terns, damage to life systems, threats to health, or other consequences adverse to the environmental goals set forth in sec tion 101(b) of the National Environmen tal Policy Act), (4) Alternatives to the proposed ac tion must be described, in accordance with section 102(2) (D) of the National Environmental Policy Act, which requires the responsible agency to "study, de velop, and describe appropriate alterna tives to recommended courses of action in any proposal which involves unre solved conflicts concerning alternative uses of available resources." A rigorous exploration and objective assessment of alternative actions that might avoid some or all of the adverse environmental effects is essential. Sufficient analysis of alternatives and their costs and impact on the environment should accompany the proposed action through the agency review process in order to avoid elimi nating prematurely options which might have fewer adverse environmental effects. (5) The relationship between local short-term uses of man's environment and the maintenance and enhancement of long-term productivity must be dis cussed. Thus, realizing that each gener ation is trustee of the environment for succeeding generations, the agency must assess the action for cumulative and long-term effects. (6) There must be a statement con cerning any irreversible and irretriev able commitments of resources which would be involved in the proposed action should it be implemented. This requires the agency to identify the extent to which the action curtails the range of beneficial uses of the environment. (7) Where appropriate, there must be a discussion of the problems and ob jections raised by other Federal, State, and local agencies and by private or ganizations and individuals, and a dis position of the issues raised by these problems and objections. This section may be added at the end of the review process in the final text of the environ mental statement. __ (b> When it is determined that an environmental impact statement is re quired, draft and final environmental impact statements shall be prepared in the following format: ("Draft" or "Final") Environmental Im pact Statement, Food and Druo Adminis tration (Responsible Operating Divi sion) 1. Indicate administrative action or legis lative action. Z. Describe the action, indicating any States or counties particularly affected. 3, Analyze the environmental impact of the proposed action. 4. Describe any unavoidable adverse en vironmental effects of the action. 5. Describe and assess alternative courses of action considered. 8, Describe any irreversible and irretriev able commitments of resources involved in implementing the action. 1. Where appropriate, evaluate any objec tions to the action raised by interested persons. 8. (a) For draft statements, state the date and form of Federal Register publication by which comments have been requested from all interested persons and attach a copy of the notice. (b) For final statements, list all persons from which written comments have been re ceived and attach a copy of each. 9. Give the date that the draft or final statement was made available to the Council on Environmental QuaUty and to the public. 6.3 Preparation and review procedures. (a) When it is determined that an environmental Impact statement is re quired, the statement shall be prepared as follows: (1) Preparation of draft environ mental impact statement. A draft en vironmental impact statement shall be prepared by the responsible agency offi cial as designated in 5 6.4. When appro priate during the preparation of a draft environmental impact statement, the re sponsible agency official shall consult with Federal, State, and local officials and other interested persons. (2) Distribution of draft environ mental impact statements. After the responsible agency official has prepared a draft environmental impact statement, he shall forward 20 copies of the draft statement to the Office of the Secretary which shall thereupon forward 10 copies to the Council on Environmental Quality. At the same time the draft statement will be made available for public inspec tion by the Office of the Assistant Com missioner for Public Affairs and the Hearing Clerk. (3) Solicitation of comments, (i) After the preparation and distribution of a draft environmental Impact statement, comments will be solicited from all in terested persons. Sixty days are allowed for reply, after which it is presumed that no comments will be made unless a specified extension of time is requested. (ii) Where the subject of a draft en vironmental impact statement is also the subject of a notice of proposed rule making or a notice of filing published in the Federal Register, the Federal Register notice shall state that the en vironmental impact analysis report and the draft environmental impact state ment are available upon request and shall solicit comments by all interested persons. (iii) Where the subject of a draft en vironmental impact statement is not also the subject of a notice published in the Federal Register, a notice will be pub lished in the Federal Register de scribing the proposed action, stating that the environmental impact analysis re port and the draft environmental im pact statement are available upon re quest, and soliciting comments by all interested persons. This notice may be published by the agency or the depart ment, or the agency or the department may request that the Council on En vironmental Quality publish it. (iv) Comments shall be solicited f^H Federal agencies having jurisdiction^^ law or special expertise with respect to the environmental impact of a proposed action by sending them a copy of a draft environmental impact statement. (v) All comments on draft environ mental impact statements shall be sub mitted in quintuplicate to the Hearing Clerk, Food and Drug Administration. Department of Health, Education, and Welfare, Room 6--88, 5600 Fishers Lane, Rockville, MD 20852, where they shall be available for public inspection during working hours, Monday through Friday. (vi) When the responsible agency offi cial concludes that no environmental impact statement is necessary and the proposed action is the subject of a notice of proposed rule making or a notice of filing published in the Federal Register, the Federal Register notice shall state that no environmental impact statement is necessary and, where applicable, that the environmental impact analysis re port is available upon request. (4) Time for consideration prior to de cision. Draft environmental Impact state ments shall be prepared, forwarded to the Council on Environmental Quality, and made available to the public early enough in the consideration of the pro posed action to permit meaningful re view . of the environmental issues in volved. To the maximum extent practi cable, no final action shall be taken on the proposal earlier than 90 days after e draft environmental impact stateme; has been prepared, forwarded to Council, and made available to public. (5) Final environmental impact state ments. The final text of an environ mental Impact statement shall be pre pared by the responsible agency official after comments on the draft statement have been reviewed and shall include an evaluation of all comments. The final statement shall receive full considera tion in the agency's decisionmaking process. The responsible agency official shall forward 20 copies of the final state ment to the Office of the Secretary which shall thereupon forward 10 copies to the Council on Environmental Quality, and copies of the final statement shall be made available for public Inspection by the Office of the Assistant Commissioner for Public Affairs and the Hearing Clerk. To the maximum extent practicable, no agency action shall take place earlier than 30 days after the final statement has been forwarded to the Council on Environmental Quality and made avail able to the public. (6) Where the subject of an environ mental impact statement is an agency action governed by specific time require ments under statute or regulation, every effort shall be made to comply with the provisions of this part within the time specified, and those time requirements hall be extended only as long as 1-, ab solutely necessary to permit the agency FEDERAL REGISTER, VOL. 38, NO. 50--THURSDAY, MARCH 15, 19/3 ASI 00003377 :L '?SdLW RULES AND REGULATIONS 7005 to consider or issue an environmental impact statement of the action. (b) When the proposed action involves destruction of condemned, enjoined, de tained or recalled articles or disposition of Food and Drug Administration labo ratory waste materials, the agency shall adhere to disposal guidelines consistent with Federal, State, and local regulations applicable on a case-by-case basis. This shall be reflected in environmental im pact statements when they are issued on such actions. (c) There are certain regulatory ac tions which, because of their immediate importance to the public health, make adherence to the requirements of para graph (a) (1) through (5) cf this section impracticable. Compliance with the re quirements for environmental analysis under the National Environmental Policy Act is impossible in instances which re quire Immediate regulatory action to safeguard the public health. The respon sible agency official shall give written notice to the Council on Environmental Quality of those actions having poten tially significant individual environ mental impact as to which no environ mental impact statement Is filed because public health considerations require im mediate action. 6.4 Responsible agency officials. (a) When environmental impact state ments are required, the following agency officials are responsible for preparing the statements as Indicated: (1) The office of the Commissioner is responsible for'preparing a draft or final environmental Impact statement on ac tions not delegated by the Commissioner. (2) The director of each bureau is re sponsible for preparing a draft or final environmental impact statement on ac tions delegated to that bureau by the Commissioner under 2.121 of this chapter. (3) The Executive Director for Re gional Operations is responsible for pre paring a draft or final environmental Impact statement on the destruction of articles condemned after seizure, en joined, under import detention, or under detention or recalled at agency request. (b) Every action memorandum propos ing an agency action Included under 6.1(b) shall contain an evaluation of the environmental impact of the pro posed action and shall be accompanied by a draft or final environmental impact statement if one is required. 6,6 Public availability of environmen. t;il Impact statements. (a) All draft and final environmental impact statements and all environmental impact analysis reports shall be available for public inspection through the office of the Assistant commissioner for Public Affairs and the Hearing Clerk. (b) Draft and final environmental im pact statements will be available immedi ately after preparation. An environ mental impact analysis report will be available at the time a draft environ mental impact statement is circulated or, if no environmental Impact statement is necessary, at the time of publication of the Federal Register notice announcing the availability of the report. PART ft--COLOR ADDITIVES 2. In Part 8, by adding a new item J to the form in 8.4(c), as follows: 8.4 Petitions proposing regulations for color additives. * * (c) * * * J. The petitioner is required to submit an environmental impact analysis report analyz ing the manufacturing process and the ulti mate use or consumption of the color addi tive pursuant to f 6.1 of this chapter, ***** PART 121--FOOD ADDITIVES 3. In Part 121: a. By adding a new item H to the form in 121.51(c), as follows: 121.51 Petitions proposing regulations for food additives. - (c) * * * H. The petitioner Is required to submit an environmental Impact analysis report analyz ing the environmental Impact of the manu facturing process and the ultimate use or consumption of the food additive pursuant to ! e.l of this chapter. ** b. By adding the following sentence to 121.53: 121.53 Substantive amendments to petitions. * * * Where the substantive amendment proposes a substantial'Change to the petition which may affect the quality of the human environment, the peti tioner is required to submit an environ mental impact analysis report pursuant to 6.1 of this chapter. b. Section 130.4 is amended by adding a new item 15 to the form in paragraph (c) (2). and by redesignating paragraph (f) (6) as paragraph (f)(7) and adding a new paragraph (f) (6) as follows: 130.4 Applications. ***** (c) * * * (2) * * * 16. The applicant is required to submit an environmental Impact analysis report analyz ing the environmental Impact of the manu facturing process and the ultimate use or consumption of the drug pursuant to t 6.1 of this chapter, ***** Cf) Abbreviated new drug applications. m* (6) An environmental impact analysis report analyzing the environmental im pact of the manufacturing process and ultimate use or consumption of the drug pursuant to 5 6.1 of this chapter. * ** c. By adding a new subparagraph (8) to 5 130.5(d), as follows: 130.5 Reasons for refusing to file ap plications. (d) * * * (8) The applicant falls to submit an environmental impact analysis report analyzing the environmental impact of the manufacturing process and the ulti mate use- or consumption of the drug pursuant to 8 6.1 of this chapter. ***** d. By adding the following sentence to the end of ! 130.9(a) (1): 130.9 Supplemental applications. (a) (1) * * * A supplemental applica tion proposing substantial changes which may affect the quality of the human en vironment shall be accompanied by an environmental impact analysis report pursuant to 8 6.1 of this chapter. **** e. By adding a new subparagraph (7) to 1130.12(a), as follows: 130.12 Refusal to approve the appli cation. (a) * (7) The applicant fails to submit an environmental Impact analysis report analyzing the environmental impact of the manufacturing process and the ulti mate use or consumption of the drug pursuant to 5 6.1 of this chapter. ***** 6.5 Submission of comments to other agencies. When the Food and Drug Administra tion is requested by the Office of the Sec retary to comment on environmental im pact statements prepared by other agen cies. the Commissioner shall prepare such comments as he deems appropriate and shall submit them to the Office of the Secretary, which shall prepare an ap propriate response for submission to the requesting agency and the Council on En vironmental Quality. PART 130--NEW DRUGS 4. In Part 130: a. By adding a new item 15 to the form in 130.3(a) (2), as follows: 130.3 New drugs for investigational use in human beings; exemptions from section 505(a), (a) * * * (2) * * * 15. When requested by the agency, an environmental Impact analysis report pur suant to 6.1 of this chapter. - * * * PART 135--NEW ANIMAL DRUGS 5. In Part 135; a. By adding a new subparagraph (10) to 5 135.3(b), as follows: 135.3 New animal drugs for investiga tional use; exemptions from section 512(a) of the Act. * * * * (b) * * * (10) When requested by the agency, the sponsor shall submit an environmen tal Impact analysis report pursuant to 8 6.1 of this chapter. * * ,FIDERAL REGISTER, VOL. 38, NO. 50--THURSDAY, MARCH 15 1973 ASI 00003378 7006 RULES AND REGULATIONS b. In S 135.4aOj> , by redesignating subparagraph (13) Assembling and binding the application as subparagraph (15) and adding a new subparagraph (14) as fol lows (a new subparagraph (13) has re cently been proposed): 133.4a New animal drug applications. ***** (b) * * (14) Environmental impact analysis report. The applicant is required to sub mit an environmental Impact analysis report analyzing the environmental im pact of the manufacturing process and the ultimate use or consumption of the new animal drug pursuant to 6.1 of this chapter. ***** c. By adding a new subparagraph (9) to 135.12(a), as follows: antibiotic drug pursuant to 5 6.1 of this chapter. Effective date. This order shall be come effective on March 15, 1973. (Sec. 102(a)(2)(C), 83 Stat. 853; 42 U.S.C. 4332: secs. 409, 505, 507, 512, 701, 706, 52 6tat. 1052 as amended, 1055-1056 as amended by 70 8tat. 910 and 72 Stat, 648, 59 Stat. 488 as amended. 72 Stat. 1785-1788 as amended, 74 Stat. 399-404 as amended, 82 Stat. 343-351; 21 U.S.C. 348, 355, 360b, 371, 375) Dated: March 12, 1973. Sherwin Gardner, Deputy Commissioner of Food and Drugs. [PR Doc.73-5008 Piled 3-14-73;8:45 am] 133.12 Refusal to approve an applira- tion. (a) * * * (9) The applicant fails to submit an environmental impact analysis report analyzing the environmental impact of the manufacturing process and the ulti mate use or consumption of the new animal drug pursuant to S 6.1 of this chapter. ***** d. By adding the following sentence to 5 135.13a(a) (1): 135.13a Supplemental new animal drug applications. (a)(1) * * * A supplemental appli cation proposing substantial changes which may affect the quality of the human environment shall be accom panied by an environmental impact analysis report pursuant to 6.1 of this chapter. ***** e. By adding a new paragraph (d) to 135.13b, as follows: 135.13b Supplemental applications for animal feeds bearing or containing new animal dings. ***** (d) A supplemental application pro posing substantial changes which may affect the quality of the human envi ronment shall be accompanied by an environmental impact analysis report pursuant to 6.1 of this chapter. PART 146--ANTIBIOTIC DRUGS; PROCE DURAL AND INTERPRETATIVE REGU LATIONS 6. In Part 146, by adding a new para graph (i) to 146.10, as follows: 146.10 New antibiotic and antibiotiecontaining products* ***** (i) An environmental impact analysis report analyzing the environmental im pact of the manufacturing process and the ultimate use or consumption of the FEDERAL REGISTER, VQt. 30, NO. 50--THURSDAY, MARCH 15, 1973 ASI 00003379