§ 25.31a - Environmental assessment for proposed approvals of FDA-regulated products—Format 1.

(a) For proposed actions to approve food or color additives, drugs, biological products, animal drugs, and class III medical devices, for proposed actions to affirm food substances as generally recognized as safe (GRAS), and for proposed actions to grant requests for exemption from regulation as a food additive, the applicant or petitioner shall prepare an environmental assessment in the following format:

(b) FDA has determined that, for the following actions, certain requirements of the environmental assessment format in paragraph (a) of this section may be abbreviated as specified in this paragraph. All other format items in paragraph (a) of this section are required to be addressed in full. After FDA evaluates environmental information submitted in an EA in which one or more format items are abbreviated, FDA may require the submission of additional information on the subject in question.

(1) For actions (either to approve food additive petitions or to grant requests for exemption from regulation as a food additive) concerning components of food-contact articles present in the finished food-packaging material at a level not greater than 5-percent-by-weight, the following information is required for the format items specified:

(i) Format item 6. For the site(s) of production of the food additive, list the substances expected to be emitted; state the controls exercised; include a citation of, and statement of compliance with, applicable emissions requirements (including occupational) at the Federal, State, and local level; and discuss the effect the approval will have upon compliance with current emissions requirements at the production site(s). For food additives that are present as functional components of finished food-packaging material, estimate the maximum yearly market volume of the additive for the proposed use and the percent of that amount that will be a component of the finished food-packaging material. This information may be used to determine whether the proposed additive has potential for significant environmental introductions at the sites of production and disposal of the food-packaging material. For food additives that are used in the production of and that become nonfunctional components of finished food-packaging material, estimate the maximum yearly market volume of the additive for the proposed use, the percent of that amount that will be a component of the finished food-packaging material, and the concentrations of the proposed food additive expected to enter the environment at the site of production of the food-packaging material. This information may be used to determine whether the proposed additive has potential for significant environmental introductions at the sites of production and disposal of the food-packaging material.

(ii) Format item 7. For food additives that become nonfunctional components of finished food-packaging material, report or incorporate by reference physical/chemical and other data relating to the environmental fate of the additive developed for other purposes in the petition and where pertinent data in the scientific literature are known. Examples of such physical/chemical parameters include water solubility, n-octanol/water partition coefficient, vapor pressure, etc. These data may be used to make a rough estimate of environmental concentration and mobility of the food additive at the site of production of the food-packaging material. Documentation of environmental fate is normally not required for food additives that are present as functional components of finished food-packaging material at not greater than 5-percent-by-weight.

(iii) Format item 8. For food additives that become nonfunctional components of food-packaging material, report or incorporate by reference existing data relating to the environmental effects of the proposed food additive. Toxicity of the proposed food additive to laboratory animals (submitted to satisfy human safety requirements) and information on the toxicity of the product to organisms that may be exposed in the environment, e.g., fish, invertebrates, plants, fungi, and bacteria, known from the scientific literature should be reported. The expected environmental concentrations of the proposed food additive should be compared with the concentrations that caused adverse toxicological effects. Documentation of environmental effects is normally not required for additives that are present as functional components of finished food-packaging material at not greater than 5-percent-by-weight.

(iv) Format item 9. Documentation for this item is ordinarily not required if the proposed food additive is intended for the same use as another additive already in use and will not materially change the potential uses of the packaging material to which it is added.

(v) Format items 10 and 11. For food additives that are present as functional components of finished food-packaging material at not greater than 5-percent-by-weight, documentation for these items is normally not required. For food additives that become nonfunctional components of finished food-packaging material at not greater than 5-percent-by-weight, these format items are addressed in full.

(2) For actions (either to approve food additive petitions or to grant requests for exemption from regulation as a food additive) concerning components of food-contact articles to be used in surfaces of permanent or semipermanent equipment or of other food-contact articles intended for repeated use, the following information is required for the items specified:

(i) Format item 6. For the site(s) of production: list the substances expected to be emitted; state the controls exercised; include a citation of, and statement of compliance with, applicable emissions requirements (including occupational) at the Federal, State, and local level; and discuss the effect the approval of the proposed food additive will have upon compliance with current emissions requirements at the production site(s). To determine whether approval of the proposed food additive will result in potentially significant introductions of substances into the environment due to the disposal of food-contact articles containing the proposed food additives, estimate the maximum yearly market volume of the proposed food additive.

(ii) Format items 7 through 11 and 15. Documentation for these items is ordinarily not required.

(3) For approval of NDA's for human drugs and approval of licenses for biological products, when the drugs or biological products are intended for the prevention, treatment, or diagnosis of a rare disease or for a similarly infrequent use; for ophthalmic or topical application; or for local or general anesthesia; the following information is required for the items specified:

(i) Format item 6. For the site(s) of production: list the substances expected to be emitted; state the controls exercised; include a citation of, and statement of compliance with, applicable emissions requirements (including occupational) at the Federal, State, and local level; and discuss the effect the approval will have upon compliance with current emissions requirements at the production site(s). Estimate the maximum yearly market volume of the drug product to aid in determining whether approval of the application could result in potentially significant environmental introductions from use of the product.

(ii) Format items 7 through 11 and 15. Documentation for these items is ordinarily not required.

(4) For approval of NADA's and supplements and amendments to NADA's for animal drugs intended for use under prescription or veterinarian's order; for treatment of a disease occurring in minor species animals, as defined in § 514.1(d); for use in nonfood animals; for ophthalmic or topical application; or for local or general anesthesia; the following information is required for the format items specified:

(i) Format item 6. For the site(s) of production: list the substances expected to be emitted; state the controls exercised; include a citation of, and statement of compliance with, applicable emissions requirements (including occupational) at the Federal, State, and local level; and discuss the effect the approval will have upon compliance with current emissions requirements at the production site(s). Estimate the maximum yearly market volume of the drug product to aid in determining whether approval of the application will result in potentially significant environmental introductions from use of the product.

(ii) Format items 7 through 11 and 15. Documentation for these items is ordinarily not required.

(5) When the agency approves or issues, for a substance that occurs naturally in the environment, a food or color additive petition, GRAS affirmation petition, NDA, supplemental NDA, biological product license, NADA, supplemental NADA, or class III medical device, the following information is required for the format items specified:

(i) Format item 6. For the site(s) of production: list the substances expected to be emitted; state the controls exercised; and include a citation of, and statement of compliance with, applicable emissions requirements at the Federal, State, and local level; and discuss the effect the approval will have upon compliance with current emissions requirements at the production site(s).

(ii) Format item 7. Discuss whether the use of the product can reasonably be expected on the basis of all available evidence to alter significantly the concentration and distribution of the product, its metabolites, degradation products, or its constituent parts in the environment.

(iii) Format item 8. Report existing data relating to the environmental effects of substances expected to be emitted into the environment as a consequence of use of the product. Report information obtained from the scientific literature on the toxicity of the product to laboratory animals, e.g., that information which is submitted to satisfy human safety requirements, and to organisms in the environment, e.g., fish, invertebrates, plants, fungi, and bacteria, that may be exposed to the product.

(6) For approval or issuance by the agency of a food or color additive petition, NDA, supplemental NDA, biological product license, NADA, or supplemental NADA for a product that has been approved by the Environmental Protection Agency (EPA) under section 4 or 5 of the Toxic Substances Control Act (TSCA) or under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the following information is required:

(i) Format items 7 and 8. To address these items, rely on environmental information in studies submitted to EPA, in the application/petition submitted for FDA approval, and in the scientific literature. Describe any potential adverse environmental impacts determined by EPA.

(ii) Format item 15(b). For studies submitted to EPA or for relevant studies submitted in the application/petition to meet the requirements of the Federal Food, Drug, and Cosmetic Act, test reports may include only a brief description and summary of results of each study in lieu of attaching complete test reports.

(Approved by the Office of Management and Budget under control number 0910-0190)