[Title 21 CFR 25.31a]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES]
[Subchapter A - GENERAL]
[Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS]
[Subpart C - Preparation of Environmental Documents]
[Sec. 25.31a - Environmental assessment for proposed approvals of FDA-regulated products--Format 1.]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
1
1996-04-01
1996-04-01
false
Environmental assessment for proposed approvals of FDA-regulated products--Format 1.
25.31a
Sec. 25.31a
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
GENERAL
ENVIRONMENTAL IMPACT CONSIDERATIONS
Preparation of Environmental Documents
Sec. 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:
Environmental Assessment
1. Date:
2. Name of applicant/petitioner:
3. Address:
4. Description of the proposed action: Briefly describe the
requested approval; need for the action; the locations where the
products will be produced; to the extent possible, the locations where
the products will be used and disposed of; and the types of environments
present at and adjacent to those locations.
5. Identification of chemical substances that are the subject of the
proposed action: Provide complete nomenclature, CAS Reg. No. (if
available), molecular weight, structural formulae, physical description,
additives, and impurities. This information is required to be adequate
to allow accurate location of data about chemicals in the scientific
literature and to allow identification of closely related chemicals.
6. Introduction of substances into the environment: 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 action will have upon compliance with current emissions
requirements at the production site(s). Through use of calculations and/
or direct measures, estimate to the extent possible the quantities and
concentrations of substances expected to enter the environment as a
result of use and/or disposal of products affected by the action.
7. Fate of emitted substances in the environment: Predict
environmental concentrations of and exposures to substances entering the
environment as a consequence (direct or indirect) of the use and/or
disposal of the products affected by the action for the following
environmental compartments, including consideration of the major
environmental transport and transformation processes involved:
(a) Air--taking into account, to the extent possible, factors such
as volatilization, photochemical and chemical degradation, rainout, and
dispersion;
(b) Freshwater, estuarine, and marine ecosystems--taking into
account, to the extent possible, factors such as chemical and biological
degradation, exchange between the water column and sediments via
sorption/desorption and biological processes, accumulation in animals,
plants, and other organisms, introductions due to rainfall and losses
due to volatilization;
(c) Terrestrial ecosystems--taking into account, to the extent
possible, factors such as chemical and biological degradation, sorption/
desorption and leaching in soils, accumulation in animals and plants,
introductions due to rainfall, losses due to volatilization, and entry
into groundwater.
8. Environmental effects of released substances: Given the
information developed on the introduction (item 6) and fate (item 7) of
substances which would be released as a consequence of the use and/or
disposal of the products affected by the action, use any relevant
toxicological data or other appropriate measures to predict, to the
extent applicable, effects on animals, plants, humans, other organisms,
and effects at the ecosystem-level in each of the environmental
compartments listed in item 7.
9. Use of resources and energy: Specify the natural resources,
including land use, minerals, and energy, required to produce,
transport, use, and/or dispose of a given amount of any product which is
the subject of the action, including the resources and energy required
to dispose of wastes generated from
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production, use, and/or disposal. Effects, if any, upon endangered or
threatened species and upon property listed in or eligible for listing
in the National Register of Historic Places must be discussed.
10. Mitigation measures: Describe measures taken to avoid or
mitigate potential adverse environmental impacts associated with the
proposed action.
11. Alternatives to the proposed action: If potential adverse
environmental impacts have been identified for the proposed action,
describe in detail the environmental impact of all 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 applicant/petitioner would undertake). Describe
particularly those alternatives that will enhance the quality of the
environment and avoid some or all of the adverse environmental impacts
of the proposed action. Discuss the environmental benefits and risks of
the proposed action. Discuss the environmental benefits and risks of
each alternative.
12. List of preparers: Those persons preparing the assessment
together with their qualifications (expertise, experience, professional
disciplines) shall be listed. Persons and agencies consulted shall also
be listed.
13. Certification: The undersigned official certifies that the
information presented is true, accurate, and complete to the best of the
knowledge of the firm or agency responsible for preparation of the
environmental assessment.
(Date)__________________________________________________________________
_______________________________________________________________________
(Signature of responsible official)
(Title)_________________________________________________________________
14. References: List complete citations for all referenced material.
Copies of referenced articles not generally available should be
attached.
15. Appendices: (a) Data summary charts (e.g., structural formula,
vapor pressure, water solubility, n-octanol/water partition coefficient,
biodegradation half-life, LC50 for each species tested, etc.).
(b) Test reports (for each experiment: research objective,
experimental design and procedure, all data relevant to interpretation
of the test result given in item 15(a), sample calculations and
statistical analyses).
(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.
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(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
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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 Sec. 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
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each study in lieu of attaching complete test reports.
(Approved by the Office of Management and Budget under control number
0910-0190)
[50 FR 16656, Apr. 26, 1985, as amended at 50 FR 30267, July 25, 1985;
60 FR 36594, July 17, 1995]