Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Appendix B May 2006
September 2003; Revised May 2006
Main Document Table of Contents
Below are recommendations for the suggested format and types of information to submit to the agency in an environmental assessment. An alternative approach may be used if the approach satisfies the requirements of the applicable statutes and regulations.
- Date: The environmental assessment (EA) should provide the date the EA was prepared.
- Name of submitter: The EA should identify the submitter.
- Address: The EA should provide the business address for the submitter.
Description of the proposed action: FDA recommends that the EA describe the proposed action by addressing the following:
- Requested action: The EA should describe the requested action by naming the secondary direct food additive (hereinafter "food additive") or the food contact substance that is the subject of the action, by describing the proposed use of the food additive or food contact substance, including any limitations, and by providing the use level. For food additive petitions, the EA should identify the proposed regulation by providing the section(s) of the Code of Federal Regulations (CFR) to be amended, if known. FDA recommends that the description of the proposed use in the EA is consistent with the use requested and described in other sections of the submission.
- Need for action: The EA must include brief discussions of the need for the proposal (21 CFR 25.40). The description of the proposal, e.g., the intended technical effect of the food additive or food contact substance, should be consistent with other sections of the submission.
- Locations of use/disposal:(1) The EA should describe briefly the locations where the food additive or food contact substance will be used in the processing/manufacturing of food. FDA recommends that you describe these sites in general terms, e.g., potato slicing plant. In addition, the EA should describe, to the extent possible, the types of environments that might be affected such as the workplace, waters receiving liquid production wastes, and areas subject to air emissions.
- Identification of substances that are the subject of the proposed action: FDA recommends that the EA identify fully the food additive or food contact substance by providing sufficient information to accurately locate data about the food additive or food contact substance in the scientific literature, to identify closely related substances, and to use structure-activity relationships (SAR) programs to predict the fate and effects of the food additive or food contact substance. FDA recommends that the information presented elsewhere in the submission be repeated here so that the EA is a complete and independent document. FDA recommends that the EA contain:
- Complete nomenclature
- Chemical Abstracts Service (CAS) registration number (if available)
- Molecular weight
- Molecular formula
- Structural (graphic) formula
- Physical description; for example, white solid, powder.
Introduction of substances into the environment:
- Introduction of substances into the environment as a result of manufacture: FDA routinely does not ask that information about environmental introductions resulting from the production of an FDA-regulated article be included in an EA. (2) However, the preparer of an EA should determine if any extraordinary circumstances pertain to the manufacture of the article. Extraordinary circumstances include situations where 1) unique emission circumstances are not adequately addressed by general or specific emission requirements (including occupational) promulgated by Federal, State or local environmental agencies and the emissions may harm the environment; 2) a proposed action threatens a violation of Federal, State or local environmental laws or requirements (40 CFR 1508.27(b)(10)); and 3) production associated with a proposed action may adversely affect a species or the critical habitat of a species determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Fauna and Flora to be endangered or threatened, or wild fauna or flora that are entitled to special protection under some other Federal law. If extraordinary circumstances apply to the manufacture of the food additive or food contact substance, such as those outlined above, the EA must discuss any reasonable alternative course of action that offers less environmental risk or that is preferable environmentally to the proposed action (21 CFR 25.40(a)). If no extraordinary circumstances apply to the manufacture of the food additive or food contact substance, FDA recommends that the EA include a statement to that effect.
- Introduction of substances into the environment as a result of use/disposal: The EA should discuss any introductions of substances into the environment resulting from the use and disposal of the food additive or food contact substance. Such substances may include the food additive or food contact substance, its degradation products, and/or any other substance resulting from the use and disposal of the food additive or food contact substance. CFSAN believes that, in general, introductions of substances into the environment occur as a result of disposal of the food additive or food contact substance after its use in the production/processing of food. To discuss the introduction of substances into the environment, FDA recommends that the EA should include 1) an estimate of the maximum yearly market volume of the food additive or food contact substance for the proposed use based on total fifth year production estimates; 2) the percent of that amount that will enter the waste stream at the site where the food additive or food contact substance is used to produce/process food; (3) 3) the mode by which the substances are introduced into the environment, e.g., continuous or intermittent (batch) and at what frequency if it is intermittent, e.g., once a week; 4) the expected concentration of substances introduced into the environment at these sites (EIC), (4) e.g., concentrations in air emissions, wastewater effluents, solid waste (including sewage sludge), and the workplace; and 5) the material safety data sheets (MSDSs) for substances to which workers are expected to be exposed. Since food producing/processing plants vary in production capacity, FDA recommends that you calculate the most conservative estimate of the EIC(s). You should state all assumptions, show all calculations, and provide the basis for the calculations. If your calculations and the basis for those calculations are protected from disclosure under 18 U.S.C. 1905, 21 U.S.C. 331(j) or 360j(c), such data and information must be submitted separately in a confidential section of the submission and must be summarized, to the extent possible, in the EA (21 CFR 25.51(a)). FDA recommends that the EIC(s) be used to calculate the expected environmental concentrations (EEC(s)) (5) of the substances under Format Item 7 and, in combination with information provided under Format Item 8, to determine whether the proposed action has potential for significant environmental effects.
- Fate of substances released into the environment: FDA recommends using the EIC(s) calculated above in Format Item 6 and available information regarding the fate parameters for substances introduced into the environment, when estimating the EEC(s) for these substances. (6) Environmental fate parameters may include the following:
- Physical/chemical properties such as water solubility, dissociation constants in water, n-octanol/ water partition coefficient (Kow), and vapor pressure or Henry's Law constant.
- Environmental depletion mechanisms such as adsorption coefficient (Koc), aerobic and anaerobic biodegradation, hydrolysis, and photolysis. (7)
You may want to use FDA's Environmental Assessment Technical Handbook (Table of Contents as Attachment 1) that contains technical assistance documents as guidance for environmental fate testing (Sections 3.01-3.12). You also may want to consider using environmental fate test protocols based on scientifically validated methods issued by other organizations, e.g., the Environmental Protection Agency (EPA; see 40 CFR part 796 for EPA's Chemical Fate Testing Guidelines, or EPA's Office of Pollution Prevention and Toxic Substances (OPPTS) Harmonized Test Guidelines: 835 - Fate, Transport and Transformation Test Guidelines and the Organization for Economic Co-operation and Development (OECD; the OECD's Guidelines for the Testing of Chemicals, Section 1--PHYSICAL-CHEMICAL PROPERTIES and Section 3--DEGRADATION AND ACCUMULATION are available on the Internet.) Actual experimental data regarding physical/chemical properties and environmental depletion mechanisms generally are preferable to computer modeling; however, you may use fate prediction models such as the structure-activity relationships (SAR) programs when data about substances are not available. CFSAN will evaluate your modeling predictions and the applicability of the SAR program you used to the substance(s) in question. If CFSAN determines that a predicted value is not applicable to a substance, it may recommend testing. The estimate(s) of the EEC(s) in various environmental compartments (air, water, soil, workplace) should also consider dilution, e.g., the water in receiving streams will dilute entering effluents; the soil with which sewage sludge is mixed will dilute the sludge. If a substance has a high Kow, it may persist in the environment, therefore, you should consider its potential to bioaccumulate. We suggest that you use a table, such as the Sample Data Summary Table (Attachment 2), to summarize environmental fate data.
Environmental effects of released substances: FDA recommends that the EA compare the EEC(s) of the substances to the relevant toxicity endpoints (e.g., EC50, LC50) so that the potential for adverse environmental effects may be determined. The EA should report, or incorporate by reference, existing data relating to the environmental effects of the substance(s) introduced into the environment as a result of the use and disposal of the food additive or food contact substance in the production/processing of food. The EA should report the toxicity of these substances to laboratory animals (submitted to satisfy human safety requirements) and their toxicity to organisms that may be exposed in the environment, e.g., vertebrates, invertebrates, plants, fungi, and bacteria. FDA recommends that you consider environmental testing if no effects data are available, or if the data are available only for species not representative of those found in environments predicted to have significant concentrations of the substances. Chronic toxicity testing should be considered for substances that persist in the environment and have the potential to bioaccumulate or are continuously introduced into the environment. You may want to use FDA's Environmental Assessment Technical Handbook (Table of Contents as Attachment 1) that contains protocols that may be used for conducting environmental effects tests (Sections 4.01-4.12). You also may want to consider using environmental toxicity test protocols based on scientifically validated methods issued by other organizations, e.g., EPA (see 40 CFR part 797 for EPA's Environmental Effects Testing Guidelines, or EPA's OPPTS Harmonized Test Guidelines: 850 - Ecological Effects Test Guidelines and OECD (the OECD's Guidelines for the Testing of Chemicals, Section 2--EFFECTS ON BIOTIC SYSTEMS are available on the Internet.). Actual experimental data regarding environmental effects are generally preferable to computer modeling; however, you may consider using effects prediction models such as the structure-activity relationships (SAR) programs when data about substances are not available. CFSAN will evaluate your modeling predictions and the applicability of the program you use to the substance(s) in question. If CFSAN determines that a predicted value is not applicable to a substance, it may recommend testing. We suggest that you use a table, such as the Sample Data Summary Table (Attachment 2), to summarize environmental effects data. If your comparison of the EECs with the toxicity endpoints shows that an EEC exceeds a toxicity endpoint, after taking appropriate safety factors into consideration, then adverse environmental effects may occur.
Existing laws and regulations may apply to introductions resulting from use and disposal of the food additive or food contact substance. If this is the case, FDA recommends that the EA cite the specific laws and regulations and discuss how such laws and regulations will control the introduction of substances into the environment and prevent adverse environmental impacts. FDA recommends that this discussion consider, based on the environmental fate and effects information provided under Format Items 7 and 8, whether the proposed use presents unique emissions circumstances that would threaten a violation of such laws and regulations.
If you think that there are uncertainties about the potential for, or significance of, environmental effects, we recommend that you consult CFSAN for specific guidance.
- Use of resources and energy: FDA recommends that the EA state whether the use of the food additive or food contact substance is intended to compete with and replace another substance already used in the production/processing of food such that there is essentially no effect on the use of natural resources and energy. If so, FDA recommends that the EA should contain a brief justification for this conclusion and identify the substance(s) being replaced. Otherwise, FDA recommends that the EA specify the natural resources, including land use, minerals, and energy, required to produce, transport, use, and/or dispose of wastes generated from production, use, and/or disposal of the food additive or food contact substance.
- Mitigation measures: The EA must describe mitigation measures, which are not included in the proposed action or alternatives, for the purpose of avoiding or mitigating potential adverse environmental impacts associated with the proposed action (40 CFR 1502.14(f) and 1502.16(h); 21 CFR 25.40(a)). The EA must include the environmental impacts of the proposed action (21 CFR 25.40(a)). Thus, if, based upon a review of adequate and complete data and information, no adverse environmental effects have been identified, you need to state that in the EA.
- Alternatives to the proposed action: If potential adverse environmental impacts have been identified for the proposed action, the EA must describe the environmental impact of reasonable alternatives to the proposed action (including no action, and including measures that FDA or another government agency could undertake as well as those the submitter could undertake) (40 CFR 1502.14 and 1502.16). The EA must describe any reasonable course of action that offers less environmental risk or that is preferable environmentally to the proposed action (21 CFR 25.40(a)). The EA should discuss the environmental benefits and risks of the proposed action and of each alternative.
- List of preparers: The EA should list the name, job title, and qualifications (e.g., educational background or professional discipline) for each person preparing the EA. The EA must identify any persons or agencies consulted (21 CFR 25.40(a)).
Certification: FDA recommends that the EA provide a signed and dated statement such as the following:
"The undersigned official certifies that the information presented is true, accurate, and complete to the best of the knowledge of (insert company name)."
(Signature of responsible official)
(Name and title of responsible official, printed)
- References: The EA should provide complete citations for all materials referenced in the EA either in footnotes within the EA or as endnotes under this format item.
- Attachments: The EA should provide a list of any materials that are attached to the EA. Confidential materials must not be attached to the EA, but must be provided in a separate section of the submission, as provided in 21 CFR 25.51(a).
(1) The term "locations of use/disposal" refers to the sites of use of the food additive or food contact substance, not the locations where the substance itself is produced or manufactured. If the suggested descriptions of use/disposal sites provided in subsection 4.c. are not applicable for the food additive or food contact substance, FDA recommends that you provide the appropriate descriptions. (Return to text)
(2) After reviewing hundreds of EAs, the agency found that FDA-regulated articles produced in compliance with applicable emission and occupational safety requirements do not affect the environment significantly. Therefore, as provided in 21 CFR 25.40(a), the EA must focus on relevant environmental issues relating to the use and disposal from use of FDA-regulated articles. (Return to text)
(3) For example, assume that 100,000 kilograms (kg) of the food additive or food contact substance is the maximum yearly market volume for the proposed use. If 90,000 kg of this amount enters the waste stream at a food production/processing site and if 10,000 kg stays with food, then the percentage of the market volume of the food additive or food contact substance that enters the environment at the site(s) of production/processing of food will be 90%. (Return to text)
(4) The EIC is the expected introduction concentration as a result of use of the food additive or food contact substance. For substances that do not stay with the food, the EICs would be pertinent to the use sites (e.g., food production/processing plants). Your estimates should consider any emissions control devices (e.g., scrubbers that control air emissions) or pre-release treatment processes (e.g., on-site primary, secondary, or tertiary wastewater treatment), along with any relevant environmental fate processes reported under Format Item 7. Please note that if you claim environmental introductions are limited because of pre-release wastewater treatment processes, FDA recommends that the claim be supported by appropriate biodegradation data under Format Item 7. All calculations used in making your estimates should be included. (Return to text)
(5) The EEC is the expected concentration of a substance that organisms would be exposed to in the environment after consideration of fate parameters. The EEC is usually lower than the EIC. (Return to text)
(6) If the degradation products are persistent in the environment, the EA should identify these products and provide any available fate data about them. (Return to text)
(7) If a depletion mechanism is being used to claim a reduction in the expected introduction and/or environmental concentrations, FDA recommends that you provide an analysis of the depletion mechanism (e.g., according to a standard test method, analysis of expected exposure time in the environment, test protocols and test data). (Return to text)
The above guidance document supercedes the previous version dated September 2003.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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