Environmental impact considerations (21 CFR 25.01-25.60)

297 Food and Drug Administration, HHS Pt. 25 continuing dialogue between two agen cies over a prolonged period, such as discussion of an enforcement action be tween the Food and Drug Administra tion and the Department of Justice. In such cases, a general notation may be made that, as of a certain date, con tract was initiated, to continue until resolution of the matter. [42 FR 15626, Mar. 22, 1977, as amended at 50 FR 52278, Dec. 23, 1985; 54 FR 9038, Mar. 3, 1989] § 21.72 Individual consent to disclo sure of records to other persons. (a) Individuals may consent to disclo sure of records about themselves to other persons in several ways, for ex ample: (1) An individual may give consent at the time that the information is col lected for disclosure for specific pur poses or to specific persons. (2) An individual may give consent for disclosure of his records to a spe cific person. (3) An individual may request the Food and Drug Administration to tran scribe a specific record for submission to another person. (b) In each case the consent shall be in writing and shall specify the indi vidual, organizational unit, or class of individuals or organizational units to whom the record may be disclosed, which record may be disclosed, and, if applicable, for what time period. A blanket consent to release all of an in dividual’s records to unspecified indi viduals or organizational units will not be honored. Verification of the identity of the individual and, where applicable, of the person to whom the record is to be disclosed shall be made in accord ance with § 21.44. Consent documents shall be retained for a period of at least 2 years. If such documents are used as a means of accounting for the disclo sure, they shall be retained as provided in § 21.71(e)(2). § 21.73 Accuracy, completeness, timeli ness, and relevance of records dis closed from Privacy Act Record Systems. (a) The Food and Drug Administra tion shall make reasonable efforts to assure that a record about an indi vidual in a Privacy Act Record System is accurate, relevant to a Food and Drug Administration purpose, timely, and complete before such record is dis closed under § 21.71. (b) Paragraph (a) of this section shall not apply to disclosures that are re quired under part 20 of this chapter (the public information regulations) or made to other Federal Government de partments and agencies. Where appro priate, the letter disclosing the infor mation shall indicate that the Food and Drug Administration has not re viewed the record to assure that it is accurate, relevant, timely, and com plete. § 21.74 Providing notice that a record is disputed. Whenever an individual has filed a statement of disagreement with the Food and Drug Administration con cerning a refusal to amend a record under § 21.51(a)(2) or with another agen cy that provides the record to the Food and Drug Administration, the Food and Drug Administration shall in any sub sequent disclosure under this subpart provide a copy of the statement of dis agreement and a concise statement by the agency, if one has been prepared, of the reasons for not making the amend ment(s) requested. § 21.75 Rights of legal guardians. For the purposes of this part, the par ent of any individual who is a minor or the legal guardian of any individual who has been declared to be incom petent due to physical or mental inca pacity or age by a court of competent jurisdiction may act on behalf of the individual. PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS Subpart A—General Provisions Sec. 25.1 Purpose. 25.5 Terminology. 25.10 Policies and NEPA planning. Subpart B—Agency Actions Requiring Environmental Consideration 25.15 General procedures. 25.16 Public health and safety emergencies. 25.20 Actions requiring preparation of an environmental assessment. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00307 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 298 21 CFR Ch. I (4–1–16 Edition) § 25.1 25.21 Extraordinary circumstances. 25.22 Actions requiring the preparation of an environmental impact statement. Subpart C—Categorical Exclusions 25.30 General. 25.31 Human drugs and biologics. 25.32 Foods, food additives, and color addi tives. 25.33 Animal drugs. 25.34 Devices and electronic products. 25.35 Tobacco product applications. Subpart D—Preparation of Environmental Documents 25.40 Environmental assessments. 25.41 Findings of no significant impact. 25.42 Environmental impact statements. 25.43 Records of decision. 25.44 Lead and cooperating agencies. 25.45 Responsible agency official. Subpart E—Public Participation and Notification of Environmental Documents 25.50 General information. 25.51 Environmental assessments and find ings of no significant impact. 25.52 Environmental impact statements. Subpart F—Other Requirements 25.60 Environmental effects abroad of major agency actions. AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262, 263b–264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500–1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531–533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123–124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356–360. SOURCE: 62 FR 40592, July 29, 1997, unless otherwise noted. Subpart A—General Provisions § 25.1 Purpose. The National Environmental Policy Act of 1969 (NEPA), as amended, directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA. All agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements. The reg ulations in this part implement section 102(2) of NEPA in a manner that is con sistent with FDA’s authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This part also supplements the regula tions for implementing the procedural provisions of NEPA that were pub lished by the Council on Environ mental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures in cluded in the ‘‘HHS General Adminis tration Manual, part 30: Environmental Protection’’ (45 FR 76519 to 76534, No vember 19, 1980). § 25.5 Terminology. (a) Definitions that apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508. The terms and the sections of 40 CFR part 1508 in which they are defined follow: (1) Categorical exclusion (40 CFR 1508.4). (2) Cooperating agency (40 CFR 1508.5). (3) Cumulative impact (40 CFR 1508.7). (4) Effects (40 CFR 1508.8). (5) Environmental assessment (EA) (40 CFR 1508.9). (6) Environmental document (40 CFR 1508.10). (7) Environmental impact statement (EIS) (40 CFR 1508.11). (8) Federal agency (40 CFR 1508.12). (9) Finding of no significant impact (40 CFR 1508.13). (10) Human environment (40 CFR 1508.14). (11) Lead agency (40 CFR 1508.16). (12) Legislation (40 CFR 1508.17). (13) Major Federal action (40 CFR 1508.18). (14) Mitigation (40 CFR 1508.20). (15) NEPA process (40 CFR 1508.21). (16) Notice of intent (40 CFR 1508.22). (17) Proposal (40 CFR 1508.23). (18) Scope (40 CFR 1508.25). (19) Significantly (40 CFR 1508.27). (b) The following terms are defined solely for the purpose of implementing the supplemental procedures provided by this part and are not necessarily ap plicable to any other statutory or regu latory requirements: (1) Abbreviated application applies to an abbreviated new drug application and an abbreviated new animal drug application. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00308 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 299 Food and Drug Administration, HHS § 25.10 (2) Active moiety means the molecule or ion, excluding those appended por tions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex chelate or clath rate) of the molecule responsible for the physiological or pharmacological action of the drug substance. (3) Agency means the Food and Drug Administration (FDA). (4) Increased use of a drug or biologic product may occur if the drug will be administered at higher dosage levels, for longer duration or for different in dications than were previously in ef fect, or if the drug is a new molecular entity. The term ‘‘use’’ also encom passes disposal of FDA-regulated arti cles by consumers. (5) Responsible agency official means the agency decisionmaker designated in the delegated authority for the un derlying actions. (c) The following acronyms are used in this part: (1) CEQ—Council on Environmental Quality. (2) CGMP—Current good manufac turing practice. (3) EA—Environmental assessment. (4) EIS—Environmental impact state ment. (5) The act—Federal Food, Drug, and Cosmetic Act. (6) FIFRA—Federal Insecticide, Fun gicide, and Rodenticide Act. (7) FONSI—Finding of no significant impact. (8) GLP—Good laboratory practice. (9) GRAS—Generally recognized as safe. (10) HACCP—Hazard analysis critical control point. (11) IDE—Investigational device ex emption. (12) IND—Investigational new drug application. (13) INAD—Investigational new ani mal drug application. (14) NADA—New animal drug applica tion. (15) NDA—New drug application. (16) NEPA—National Environmental Policy Act of 1969. (17) OTC—Over-the-counter. (18) PDP—Product development pro tocol. (19) PMA—Premarket approval appli cation. [62 FR 40592, July 29, 1997, as amended at 64 FR 399, Jan. 5, 1999; 69 FR 17291, Apr. 2, 2004] § 25.10 Policies and NEPA planning. (a) All FDA’s policies and programs will be planned, developed, and imple mented to achieve the policies declared by NEPA and required by CEQ’s regula tions to ensure responsible stewardship of the environment for present and fu ture generations. (b) Assessment of environmental fac tors continues throughout planning and is integrated with other program planning at the earliest possible time to ensure that planning and decisions reflect environmental values, to avoid delays later in the process, and to avoid potential conflicts. (c) For actions initiated by the agen cy, the NEPA process will begin when the agency action under consideration is first identified. For actions initiated by applicants or petitioners, NEPA planning begins when FDA receives from an applicant or petitioner an EA or a claim that a categorical exclusion applies, or when FDA personnel consult with applicants or petitioners on the NEPA-related aspects of their re quested actions. FDA may issue a pub lic call for environmental data or oth erwise consult with affected individ uals or groups when a contemplated ac tion in which it is or may be involved poses potential significant environ mental effects. (d) Environmental documents shall concentrate on timely and significant issues, not amass needless detail. (e) If a proposed action for which an EIS will be prepared involves possible environmental effects that are required to be considered under statutes or Ex ecutive Orders other than those re ferred to under ‘‘Authority’’ in this part, these effects shall be considered in the NEPA review, consistent with 40 CFR 1502.25 and the HHS General Ad ministration Manual, part 30: Environ mental Protection. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00309 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 300 21 CFR Ch. I (4–1–16 Edition) § 25.15 Subpart B—Agency Actions Re quiring Environmental Consid eration § 25.15 General procedures. (a) All applications or petitions re questing agency action require the sub mission of an EA or a claim of categor ical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclu sion criteria and shall state that to the applicant’s knowledge, no extraor dinary circumstances exist. Failure to submit an adequate EA for an applica tion or petition requesting action by the agency of a type specified in § 25.20, unless the agency can determine that the action qualifies for exclusion under §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35 is sufficient grounds for FDA to refuse to file or approve the application or pe tition. An EA adequate for filing is one that addresses the relevant environ mental issues. An EA adequate for ap proval is one that contains sufficient information to enable the agency to de termine whether the proposed action may significantly affect the quality of the human environment. (b) The responsible agency officials will evaluate the information con tained in the EA to determine whether it is accurate and objective, whether the proposed action may significantly affect the quality of the human envi ronment, and whether an EIS will be prepared. If significant effects requir ing the preparation of an EIS are iden tified, FDA will prepare an EIS for the action in accordance with the proce dures in subparts D and E of this part. If significant effects requiring the preparation of an EIS are not identi fied, resulting in a decision not to pre pare an EIS, the responsible agency of ficial will prepare a FONSI in accord ance with § 25.41. (c) Classes of actions that individ ually or cumulatively do not signifi cantly affect the quality of the human environment ordinarily are excluded from the requirement to prepare an EA or an EIS. The classes of actions that qualify as categorical exclusions are set forth in §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35. (d) A person submitting an applica tion or petition of a type subject to categorical exclusion under §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35, or pro posing to dispose of an article as pro vided in § 25.30(d) or 25.32(h), is not re quired to submit an EA if the person states that the action requested quali fies for a categorical exclusion, citing the particular categorical exclusion that is claimed, and states that to the applicant’s knowledge, no extraor dinary circumstances exist. [62 FR 40592, July 29, 1997, as amended at 80 FR 57535, Sept. 24, 2015] § 25.16 Public health and safety emer gencies. There are certain regulatory actions that, because of their immediate im portance to the public health or safety, may make full adherence to the proce dural provisions of NEPA and CEQ’s regulations impossible. For such ac tions, the responsible agency official shall consult with CEQ about alter native arrangements before the action is taken, or after the action is taken, if time does not permit prior consulta tion with CEQ. § 25.20 Actions requiring preparation of an environmental assessment. Any proposed action of a type speci fied in this section normally requires at least the preparation of an EA, un less it is an action in a specific class that qualifies for exclusion under §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35: (a) Major recommendations or re ports made to Congress on proposals for legislation in instances where the agency has primary responsibility for the subject matter involved. (b) Destruction or other disposition of articles condemned after seizure or whose distribution or use has been en joined, unless categorically excluded in §§ 25.30(d) or 25.32(h). (c) Destruction or other disposition of articles following detention or recall at agency request, unless categorically excluded in §§ 25.30(d) or 25.32(h). (d) Disposition of FDA laboratory waste materials, unless categorically excluded in § 25.30(m). (e) Intramural and extramural re search supported in whole or in part through contracts, other agreements, or grants, unless categorically ex cluded in § 25.30 (e) or (f). VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00310 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 301 Food and Drug Administration, HHS § 25.22 (f) Establishment by regulation of la beling requirements, a standard, or a monograph, unless categorically ex cluded in §§ 25.30(k) or 25.31 (a), (b), (c), (h), (i), or (j), or 25.32 (a) or (p). (g) Issuance, amendment, and en forcement of FDA regulations, or an exemption or variance from FDA regu lations, unless categorically excluded in § 25.30 (h), (i), or (j), or § 25.32 (e), (g), (n), or (p). (h) Withdrawal of existing approvals of FDA-approved articles, unless cat egorically excluded in §§ 25.31 (d) or (k), 25.32(m), or 25.33 (g) or (h). (i) Approval of food additive petitions and color additive petitions, approval of requests for exemptions for inves tigational use of food additives, the granting of requests for exemption from regulation as a food additive under § 170.39 of this chapter, and al lowing notifications submitted under 21 U.S.C. 348(h) to become effective, un less categorically excluded in § 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r). (j) Establishment of a tolerance for unavoidable poisonous or deleterious substances in food or in packaging ma terials to be used for food. (k) Affirmation of a food substance as GRAS for humans or animals, on FDA’s initiative or in response to a pe tition, under parts 182, 184, 186, or 582 of this chapter and establishment or amendment of a regulation for a prior sanctioned food ingredient, as defined in §§ 170.3(l) and 181.5(a) of this chapter, unless categorically excluded in § 25.32 (f), (k), or (r). (l) Approval of NDA’s, abbreviated applications, applications for mar keting approval of a biologic product, supplements to such applications, and actions on IND’s, unless categorically excluded in § 25.31 (a), (b), (c), (e), or (l). (m) Approval of NADA’s, abbreviated applications, supplements, actions on INAD’s, and granting of requests for determination of eligibility for index ing, unless categorically excluded under § 25.33 (a), (c), (d), or (e). (n) Approval of PMA’s for medical de vices, notices of completion of PDP’s for medical devices, authorizations to commence clinical investigation under an approved PDP, or applications for an IDE, unless categorically excluded in § 25.34. (o) Issuance of an order finding a to bacco product substantially equivalent under the Federal Food, Drug, and Cos metic Act, or granting of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, unless cat egorically excluded under § 25.35. (p) Issuance of an order authorizing marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act or an order au thorizing marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act, unless categorically excluded under § 25.35. [62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 72 FR 69118, Dec. 6, 2007; 80 FR 57535, Sept. 24, 2015] § 25.21 Extraordinary circumstances. As required under 40 CFR 1508.4, FDA will require at least an EA for any spe cific action that ordinarily would be excluded if extraordinary cir cumstances indicate that the specific proposed action may significantly af fect the quality of the human environ ment (see 40 CFR 1508.27 for examples of significant impacts). Examples of such extraordinary circumstances in clude: (a) Actions for which available data establish that, at the expected level of exposure, there is the potential for se rious harm to the environment; and (b) Actions that adversely affect a species or the critical habitat of a spe cies determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law. § 25.22 Actions requiring the prepara tion of an environmental impact statement. (a) There are no categories of agency actions that routinely significantly af fect the quality of the human environ ment and that therefore ordinarily re quire the preparation of an EIS. (b) EIS’s are prepared for agency ac tions when evaluation of data or infor mation in an EA or otherwise available VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00311 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 302 21 CFR Ch. I (4–1–16 Edition) § 25.30 to the agency leads to a finding by the responsible agency official that a pro posed action may significantly affect the quality of the human environment. Subpart C—Categorical Exclusions § 25.30 General. The classes of actions listed in this section and §§ 25.31 through 25.35 are categorically excluded and, therefore, ordinarily do not require the prepara tion of an EA or an EIS: (a) Routine administrative and man agement activities, including inspec tions, and issuance of field compliance programs, program circulars, or field investigative assignments. (b) Recommendation for an enforce ment action to be initiated in a Fed eral court. (c) Agency requests for initiation of recalls. (d) Destruction or disposition of any FDA-regulated article condemned after seizure or the distribution or use of which has been enjoined or following detention or recall at agency request if the method of destruction or disposi tion of the article, including packaging material, is in compliance with all Federal, State, and local requirements. (e) Extramural contracts, other agreements, or grants for statistical and epidemiological studies, surveys and inventories, literature searches, and report and manual preparation, or any other studies that will not result in the production or distribution of any substance and, therefore, will not re sult in the introduction of any sub stance into the environment. (f) Extramural contracts, other agreements, and grants for research for such purposes as to develop analytical methods or other test methodologies. (g) Activities of voluntary Federal State cooperative programs, including issuance of model regulations proposed for State adoption. (h) Issuance, amendment, or revoca tion of procedural or administrative regulations and guidance documents, including procedures for submission of applications for product development, testing and investigational use, and ap proval. (i) Corrections and technical changes in regulations. (j) Issuance of CGMP regulations, HACCP regulations, establishment standards, emergency permit control regulations, GLP regulations, and issuance or denial of permits, exemp tions, variances, or stays under these regulations. (k) Establishment or repeal by regu lation of labeling requirements for marketed articles if there will be no in crease in the existing levels of use or change in the intended uses of the product or its substitutes. (l) Routine maintenance and minor construction activities such as: (1) Repair to or replacement of equip ment or structural components (e.g., door, roof, or window) of facilities con trolled by FDA; (2) Lease extensions, renewals, or succeeding leases; (3) Construction or lease construc tion of 10,000 square feet or less of oc cupiable space; (4) Relocation of employees into ex isting owned or currently leased space; (5) Acquisition of 20,000 square feet or less of occupiable space in a structure that was substantially completed be fore the issuance of solicitation for of fers; and (6) Acquisition of between 20,000 square feet and 40,000 square feet of oc cupiable space if it constitutes less than 40 percent of the occupiable space in a structure that was substantially completed before the solicitation for offers. (m) Disposal of low-level radioactive waste materials (as defined in the Nu clear Regulatory Commission regula tions at 10 CFR 61.2) and chemical waste materials generated in the lab oratories serviced by the contracts ad ministered by FDA, if the waste is dis posed of in compliance with all applica ble Federal, State, and local require ments. [62 FR 40592, July 29, 1997, as amended at 65 FR 56479, Sept. 19, 2000; 80 FR 57535, Sept. 24, 2015] § 25.31 Human drugs and biologics. The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00312 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 303 Food and Drug Administration, HHS § 25.32 (a) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or ac tion on an OTC monograph, if the ac tion does not increase the use of the active moiety. (b) Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the esti mated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion. (c) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or ac tion on an OTC monograph, for sub stances that occur naturally in the en vironment when the action does not alter significantly the concentration or distribution of the substance, its me tabolites, or degradation products in the environment. (d) Withdrawal of approval of an NDA or an abbreviated application. (e) Action on an IND. (f) Testing and release by the Food and Drug Administration of lots or batches of a licensed biologic product. (g) Establishment of bioequivalence requirements for a human drug or a comparability determination for a bio logic product subject to licensing. (h) Issuance, revocation, or amend ment of a standard for a biologic prod uct. (i) Revocation of a license for a bio logic product. (j) Action on an application for mar keting approval for marketing of a bio logic product for transfusable human blood or blood components and plasma. [62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 70 FR 14980, Mar. 24, 2005] § 25.32 Foods, food additives, and color additives. The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Issuance, amendment, or repeal of a food standard. (b) Action on a request for exemption for investigational use of a food addi tive if the food additive to be shipped under the request is intended to be used for clinical studies or research. (c) Approval of a color additive peti tion to change a provisionally listed color additive to permanent listing for use in food, drugs, devices, or cos metics. (d) Testing and certification of batches of a color additive. (e) Issuance of an interim food addi tive regulation. (f) Affirmation of a food substance as GRAS for humans or animals on FDA’s initiative or in response to a petition, under parts 182, 184, 186, or 582 of this chapter, and establishment or amend ment of a regulation for a prior-sanc tioned food ingredient, as defined in §§ 170.3(l) and 181.5(a) of this chapter, if the substance or food ingredient is al ready marketed in the United States for the proposed use. (g) Issuance and enforcement of regu lations relating to the control of com municable diseases or to interstate conveyance sanitation under parts 1240 and 1250 of this chapter. (h) Approval of a request for diver sion of adulterated or misbranded food for humans or animals to use as animal feeds. (i) Approval of a food additive peti tion or GRAS affirmation petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allow ing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is present in finished food-packaging material at not greater than 5 percent-by-weight and is ex pected to remain with finished food packaging material through use by consumers or when the substance is a component of a coating of a finished food-packaging material. (j) Approval of a food additive peti tion or GRAS affirmation petition, the granting of a request for exemption from regulation as a food additive under § 170.39 of this chapter, or allow ing a notification submitted under 21 U.S.C. 348(h) to become effective, when the substance is to be used as a compo nent of a food-contact surface of per manent or semipermanent equipment VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00313 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 304 21 CFR Ch. I (4–1–16 Edition) § 25.33 or of another food-contact article in tended for repeated use. (k) Approval of a food additive peti tion, color additive petition, or GRAS affirmation petition, or allowing a no tification submitted under 21 U.S.C. 348(h) to become effective, for sub stances added directly to food that are intended to remain in food through in gestion by consumers and that are not intended to replace macronutrients in food. (l) Approval of a petition for color ad ditives used in contact lenses, sutures, filaments used as supporting haptics in intraocular lenses, bone cement, and in other FDA-regulated products having similarly low levels of use. (m) Action to prohibit or otherwise restrict or reduce the use of a sub stance in food, food packaging, or cos metics. (n) Issuance, amendment, or revoca tion of a regulation pertaining to in fant formulas. (o) Approval of a food additive peti tion for the intended expression prod uct(s) present in food derived from new plant varieties. (p) Issuance, amendment, or revoca tion of a regulation in response to a reference amount petition as described in § 101.12(h) of this chapter, a nutrient content claim petition as described in § 101.69 of this chapter, a health claim petition as described in § 101.70 of this chapter, or a petition pertaining to the label declaration of ingredients as de scribed in § 10.30 of this chapter. (q) Approval of a food additive peti tion, the granting of a request for ex emption from regulation as a food ad ditive under § 170.39 of this chapter, or allowing a notification submitted under 21 U.S.C. 348(h) to become effec tive for a substance registered by the Environmental Protection Agency under FIFRA for the same use re quested in the petition, request for ex emption, or notification. (r) Approval of a food additive peti tion, color additive, GRAS affirmation petition, or allowing a notification sub mitted under 21 U.S.C. 348(h) to become effective for a substance that occurs naturally in the environment, when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or deg radation products in the environment. [62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 76 FR 59248, Sept. 26, 2011] § 25.33 Animal drugs. The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supple ment to such applications, or a modi fication of an index listing, if the ac tion does not increase the use of the drug. Actions to which this categorical exclusion applies may include: (1) An animal drug to be marketed under the same conditions of approval as a previously approved animal drug; (2) A combination of previously ap proved animal drugs; (3) A new premix or other formula tion of a previously approved animal drug; (4) Changes specified in § 514.8(b)(3), (b)(4), or (c)(3) of this chapter; (5) A change of sponsor; (6) A previously approved animal drug to be contained in medicated feed blocks under § 510.455 of this chapter or as a liquid feed supplement under § 558.5 of this chapter; or (7) Approval of a drug for use in ani mal feeds if such drug has been ap proved under § 514.2 or 514.9 of this chapter for other uses. (b) [Reserved] (c) Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supple ment to such applications, or a modi fication of an index listing, for sub stances that occur naturally in the en vironment when the action does not alter significantly the concentration or distribution of the substance, its me tabolites, or degradation products in the environment. (d) Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supple ment to such applications, or a modi fication of an index listing, for: (1) Drugs intended for use in nonfood animals; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00314 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 305 Food and Drug Administration, HHS § 25.35 (2) Anesthetics, both local and gen eral, that are individually adminis tered; (3) Nonsystemic topical and oph thalmic animal drugs; (4) Drugs for minor species, including wildlife and endangered species, when the drug has been previously approved for use in another or the same species where similar animal management practices are used; and (5) Drugs intended for use under pre scription or veterinarian’s order for therapeutic use in terrestrial species. (e) Action on an INAD. (f) Action on an application sub mitted under section 512(m) of the act. (g) Withdrawal of approval of an NADA or an abbreviated NADA or re moval of a new animal drug from the index. (h) Withdrawal of approval of a food additive petition that reduces or elimi nates animal feed uses of a food addi tive. [62 FR 40592, July 29, 1997, as amended at 71 FR 74782, Dec. 13, 2006; 72 FR 69119, Dec. 6, 2007] § 25.34 Devices and electronic prod ucts. The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS: (a) Action on a device premarket no tification submission under subpart E of part 807 of this chapter. (b) Classification or reclassification of a device under part 860 of this chap ter, including the establishment of spe cial controls, if the action will not re sult in increases in the existing levels of use of the device or changes in the intended use of the device or its sub stitutes. (c) Issuance, amendment, or repeal of a standard for a class II medical device or an electronic product, and issuance of exemptions or variances from such a standard. (d) Approval of a PMA or a notice of completion of a PDP or amended or supplemental applications or notices for a class III medical device if the de vice is of the same type and for the same use as a previously approved de vice. (e) Changes in the PMA or a notice of completion of a PDP for a class III medical device that do not require sub mission of an amended or supplemental application or notice. (f) Issuance of a restricted device reg ulation if it will not result in increases in the existing levels of use or changes in the intended uses of the product or its substitutes. (g) Action on an application for an IDE or an authorization to commence a clinical investigation under an ap proved PDP. (h) Issuance of a regulation exempt ing from preemption a requirement of a State or political subdivision con cerning a device, or a denial of an ap plication for such exemption. (i) Approval of humanitarian device exemption under subpart H of part 814 of this chapter. [62 FR 40592, July 29, 1997, as amended at 70 FR 69277, Nov. 15, 2005] § 25.35 Tobacco product applications. The classes of actions listed in this section are categorically excluded and, therefore, normally do not require the preparation of an EA or an EIS: (a) Issuance of an order finding a to bacco product substantially equivalent under section 910(a)(2)(B) of the Fed eral Food, Drug, and Cosmetic Act; (b) Issuance of an order finding a to bacco product not substantially equiv alent under section 910(a) of the Fed eral Food, Drug, and Cosmetic Act, de nial of a request for an exemption under 21 CFR part 1107 from the re quirement of demonstrating substan tial equivalence, issuance of an order under section 910(c) of the Federal Food, Drug, and Cosmetic Act that a new tobacco product may not be intro duced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the Federal Food, Drug, and Cosmetic Act that a modified risk tobacco product may not be introduced or delivered for introduc tion into interstate commerce; (c) Rescission or temporary suspen sion of an order authorizing the mar keting of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00315 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 306 21 CFR Ch. I (4–1–16 Edition) § 25.40 (d) Rescission of an order authorizing the marketing of a modified risk to bacco product under section 911 of the Federal Food, Drug, and Cosmetic Act; and (e) Rescission of an order granting an exemption request under § 1107.1 of this chapter. [80 FR 57535, Sept. 24, 2015] Subpart D—Preparation of Environmental Documents § 25.40 Environmental assessments. (a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public docu ment that serves to provide sufficient evidence and analysis for an agency to determine whether to prepare an EIS or a FONSI. The EA shall include brief discussions of the need for the pro posal, of alternatives as required by section 102(2)(E) of NEPA, of the envi ronmental impacts of the proposed ac tion and alternatives, and a listing of agencies and persons consulted. An EA shall be prepared for each action not categorically excluded in § 25.30, § 25.31, § 25.32, § 25.33, or § 25.34, or § 25.35. The EA shall focus on relevant environ mental issues relating to the use and disposal from use of FDA-regulated ar ticles and shall be a concise, objective, and well-balanced document that al lows the public to understand the agen cy’s decision. If potentially adverse en vironmental impacts are identified for an action or a group of related actions, the EA shall discuss any reasonable al ternative course of action that offers less environmental risk or that is envi ronmentally preferable to the proposed action. The use of a scientifically justi fied tiered testing approach, in which testing may be stopped when the re sults suggest that no significant im pact will occur, is an acceptable ap proach. (b) Generally, FDA requires an appli cant to prepare an EA and make nec essary corrections to it. Ultimately, FDA is responsible for the scope and content of EA’s and may include addi tional information in environmental documents when warranted. (c) Information concerning the na ture and scope of information that an applicant or petitioner shall submit in an EA may be obtained from the center or other office of the agency having re sponsibility for the action that is the subject of the environmental evalua tion. Applicants and petitioners are en couraged to submit proposed protocols for environmental studies for technical review by agency staff. Applicants and petitioners also are encouraged to con sult applicable FDA EA guidance docu ments, which provide additional advice on how to comply with FDA regula tions. (d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA’s may incorporate by reference information presented in other documents that are available to FDA and to the public. (e) The agency evaluates the infor mation contained in an EA and any public input to determine whether it is accurate and objective, whether the proposed action may significantly af fect the quality of the human environ ment, and whether an EIS or a FONSI will be prepared. The responsible agen cy official examines the environmental risks of the proposed action and the al ternative courses of action, selects a course of action, and ensures that any necessary mitigating measures are im plemented as a condition for approving the selected course of action. [62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004; 80 FR 57535, Sept. 24, 2015] § 25.41 Findings of no significant im pact. (a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is a document prepared by a Federal agency stating briefly why an action, not otherwise excluded, will not significantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a sum mary of it and a reference to any other related environmental documents. (b) The agency official(s) responsible for approving the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusion not to prepare an EIS for the action under consideration. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00316 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 307 Food and Drug Administration, HHS § 25.50 § 25.42 Environmental impact state ments. (a) As defined by CEQ regulations (40 CFR 1508.11) and section 102(2)(C) of NEPA, an EIS should be a clear, con cise, and detailed written statement describing: (1) The environmental impacts of a proposed action; (2) Any adverse effects that cannot be avoided if the action is implemented; (3) Alternatives to the action; (4) The relationship between local short-term uses of the environment and the maintenance and enhancement of long-term productivity; and (5) Any irreversible and irretrievable commitments of resources that would be involved in the proposed action should it be implemented. (b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the proc ess for determining the scope of an EIS and provide detailed requirements for the preparation of draft and final EIS’s. CEQ format and procedures for preparing EIS shall be followed. (c) Under the conditions prescribed in 40 CFR 1502.9, the agency will prepare a supplement for a draft or final EIS and introduce the supplement into the ad ministrative record. § 25.43 Records of decision. (a) In cases requiring environmental impact statements, at the time of its decision, the agency shall prepare a concise public record of decision. (b) The record of decision shall: (1) State what the decision was; (2) Identify and discuss alternatives considered by the agency in reaching its decision; (3) State whether all practicable means to avoid or minimize environ mental harm have been adopted, and if not, why not; and (4) Summarize the program for moni toring and enforcing the practicable means adopted to avoid or minimize the environmental harm. § 25.44 Lead and cooperating agencies. For actions requiring the preparation of an EIS, FDA and other affected Fed eral agencies will agree which will be the lead agency and which will be the cooperating agencies. The responsibil ities of lead agencies and cooperating agencies are described in the CEQ regu lations (40 CFR 1501.5 and 1501.6, respec tively). If an action affects more than one center within FDA, the Commis sioner of Food and Drugs will designate one of these units to be responsible for coordinating the preparation of any re quired environmental documentation. § 25.45 Responsible agency official. (a) The responsible agency official prepares the environmental documents or ensures that they are prepared. (b) The responsible agency official will weigh any environmental impacts of each alternative course of action, in cluding possible mitigation measures, and will balance environmental im pacts with the agency’s objectives in choosing an appropriate course of ac tion. The weighing of any environ mental impacts of alternatives in se lecting a final course of action will be reflected in the agency’s record of for mal decisionmaking as required by 40 CFR 1505.2. [62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004] Subpart E—Public Participation and Notification of Environ mental Documents § 25.50 General information. (a) To the extent actions are not pro tected from disclosure by existing law applicable to the agency’s operation, FDA will involve the public in pre paring and implementing its NEPA procedures and will provide public no tice of NEPA-related hearings, public meetings, and the availability of envi ronmental documents. (b) Many FDA actions involving in vestigations, review, and approval or market authorization of applications, and premarket notifications for human drugs, animal drugs, biologic products, devices, and tobacco products are pro tected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic Act. These actions are also protected from disclosure under FDA’s regulations including part 20, §§ 312.130(a), 314.430(b), 514.11(b), 514.12(a), 601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this chapter. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00317 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 308 21 CFR Ch. I (4–1–16 Edition) § 25.51 Even the existence of applications for human drugs, animal drugs, biologic products, devices, and tobacco products is protected from disclosure under these regulations. Therefore, unless the existence of applications for human drugs, animal drugs, biologic products, tobacco products, or premarket notifi cation for devices has been made pub licly available, the release of the envi ronmental document before approval or authorization of human drugs, ani mal drugs, biologic products, devices and tobacco products is inconsistent with statutory requirements imposed on FDA. Appropriate environmental documents, comments, and responses will be included in the administrative record to the extent allowed by appli cable laws. [62 FR 40592, July 29, 1997, as amended at 80 FR 57535, Sept. 24, 2015] § 25.51 Environmental assessments and findings of no significant im pact. (a) Data and information that are protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c) shall not be included in the portion of envi ronmental documents that is made public. When such data and informa tion are pertinent to the environ mental review of a proposed action, an applicant or petitioner shall submit such data and information separately in a confidential section and shall sum marize the confidential data and infor mation in the EA to the extent pos sible. (b) FONSI’s and EA’s will be avail able to the public in accordance with 40 CFR 1506.6 as follows: (1) When the proposed action is the subject of a notice of proposed rule making or a notice of filing published in the FEDERAL REGISTER, the notice shall state that no EIS is necessary and that the FONSI and the EA are available for public inspection at FDA’s Division of Dockets Manage ment. If the responsible agency official is unable to complete environmental consideration of the proposed action before a notice of filing of a food or color additive petition is required to be published under the act, and if the sub sequent environmental analysis leads to the conclusion that no EIS is nec essary, the final regulation rather than the notice of filing shall state that no EIS is necessary and that the FONSI and the EA are available upon request and filed in FDA’s Division of Dockets Management. (2) For actions for which notice is not published in the FEDERAL REGISTER, the FONSI and the EA shall be made available to the public upon request ac cording to the procedures in 40 CFR 1506.6. (3) For a limited number of actions, the agency may make the FONSI and EA available for public review (includ ing review by State and areawide infor mation clearinghouses) for 30 days be fore the agency makes its final deter mination whether to prepare an EIS and before the action may begin, as de scribed in 40 CFR 1501.4(e). This proce dure will be followed when the pro posed action is, or is closely similar to, one that normally requires an EIS or when the proposed action is one with out precedent. § 25.52 Environmental impact state ments. (a) If FDA determines that an EIS is necessary for an action involving in vestigations, approvals, or market au thorizations for drugs, animal drugs, biologic products, devices, or tobacco products, an EIS will be prepared but will become available only at the time of the approval or market authoriza tion of the product. The EIS will in all other respects conform to the require ments for EIS’s as specified in 40 CFR part 1502 and 1506.6(f). (b) Comments on the EIS may be sub mitted after the approval or market authorization of the drug, animal drug, biologic product, device, or tobacco product. Those comments can form the basis for the Agency to consider begin ning an action to withdraw the ap proval or market authorization of ap plications for a drug, animal drug, bio logic product, or tobacco product, or to withdraw premarket notifications or premarket approval applications for devices. (c) In those cases where the existence of applications and premarket notifica tions for drugs, animal drugs, biologic products, devices, or tobacco products has already been disclosed before the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00318 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 309 Food and Drug Administration, HHS Pt. 26 Agency approves the action, the Agen cy will ensure appropriate public in volvement consistent with 40 CFR 1506.6 and part 1503 in preparing and implementing the NEPA procedures re lated to preparing EISs while following its own disclosure requirements includ ing those listed in part 20 and §§ 312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter. (d) Draft and final EIS’s, comments, and responses will be included in the administrative record and will be available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. [62 FR 40592, July 29, 1997, as amended at 68 FR 24879, May 9, 2003; 80 FR 57535, Sept. 24, 2015] Subpart F—Other Requirements § 25.60 Environmental effects abroad of major agency actions. (a) In accordance with Executive Order 12114, ‘‘Environmental Effects Abroad of Major Federal Actions’’ of January 4, 1979 (44 FR 1957, January 9, 1979), the responsible agency official, in analyzing actions under his or her pro gram, shall consider the environmental effects abroad, including whether the actions involve: (1) Potential environmental effects on the global commons and areas out side the jurisdiction of any nation, e.g., oceans and the upper atmosphere. (2) Potential environmental effects on a foreign nation not participating with or otherwise involved in an FDA activity. (3) The export of products (or emis sions) that in the United States are prohibited or strictly regulated be cause their effects on the environment create a serious public health risk. (4) Potential environmental effects on natural and ecological resources of global importance designated under the Executive Order. (b) Before deciding on any action falling into the categories specified in paragraph (a) of this section, the re sponsible agency official shall deter mine, in accordance with section 2–3 of the Executive Order, whether such ac tions may have a significant environ mental effect abroad. (c) If the responsible agency official determines that an action may have a significant environmental effect abroad, the responsible agency official shall determine, in accordance with section 2–4 (a) and (b) of the Executive Order, whether the subject action calls for: (1) An EIS; (2) A bilateral or multilateral envi ronmental study; or (3) A concise environmental review. (d) In preparing environmental docu ments under this subpart, the respon sible official shall: (1) Determine, as provided in section 2–5 of the Executive Order, whether proposed actions are subject to the ex emptions, exclusions, and modification in contents, timing, and availability of documents. (2) Coordinate all communications with foreign governments concerning environmental agreements and other arrangements in implementing the Ex ecutive Order. PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE RE PORTS, MEDICAL DEVICE QUAL ITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EURO PEAN COMMUNITY Sec. 26.0 General. Subpart A—Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices 26.1 Definitions. 26.2 Purpose. 26.3 Scope. 26.4 Product coverage. 26.5 Length of transition period. 26.6 Equivalence assessment. 26.7 Participation in the equivalence assess ment and determination. 26.8 Other transition activities. 26.9 Equivalence determination. 26.10 Regulatory authorities not listed as currently equivalent. 26.11 Start of operational period. 26.12 Nature of recognition of inspection re ports. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00319 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B