[Federal Register: September 17, 2003 (Volume 68, Number 180)]
[Notices]
[Page 54462-54464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se03-74]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0379]
Draft Guidance for Industry on Preparing a Claim of Categorical
Exclusion or an Environmental Assessment for Submission to the Center
for Food Safety and Applied Nutrition; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance document entitled ``Guidance for
Industry: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition'' (the draft guidance). The draft guidance
provides information to industry on how to prepare a claim of
categorical exclusion or an environmental assessment (EA) for
submission to the Center for Food Safety and Applied Nutrition (CFSAN)
in notifications for food contact substances, food additive petitions,
color additive petitions, requests for exemption from regulation as a
food additive, generally recognized as safe (GRAS) petitions, and
petitions for certain food labeling regulations.
DATES: Submit written or electronic comments on the draft guidance and
the collection of information by November 17, 2003, to ensure their
adequate consideration in preparation of a revised guidance, if
warranted. However, you may submit comments at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry: Preparing a Claim of
Categorical Exclusion or an Environmental Assessment for Submission to
the Center for Food Safety and Applied Nutrition'' to the Office of
Food Additive Safety (HFS-200), Center for Food Safety and Applied
Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-
418-3100, premarkt@cfsan.fda.gov. Send two self-addressed adhesive
labels to assist that office in processing your requests. See
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance.
Submit written comments on the draft guidance and the collection of
information provisions to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Layla I. Batarseh, Center for Food
Safety and Applied Nutrition (HFS-246), 5100 Paint Branch Pkwy.,
College Park, MD 20740-3835, 202-418-3016 or 202-
[[Page 54463]]
418-3005, FAX 202-418-3030, Internet: Layla.Batarseh@cfsan.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The National Environmental Policy Act of 1969 (NEPA) requires each
Federal agency to assess, as an integral part of its decisionmaking
process, the environmental impacts of its actions and requires that the
interested and affected public be informed of environmental analyses.
As an integral part of its regulatory procedures, FDA is obligated
under NEPA to consider the environmental impact of agency actions,
including allowing notifications for food contact substances to become
effective and approving food additive petitions, color additive
petitions, GRAS affirmation petitions, requests for exemption from
regulation as a food additive, certain food labeling citizen petitions,
nutrient content claims petitions, and health claims petitions. In
1997, FDA amended its regulations in part 25 (21 CFR part 25) to
provide for categorical exclusions for additional classes of actions
that do not individually or cumulatively have a significant effect on
the human environment and for which, therefore, neither an
environmental impact statement nor an EA is required (62 FR 40570, July
29, 1997) (the 1997 rule). As a result of the 1997 rule, FDA no longer
routinely requires submission of information about the manufacturing
and production of FDA-regulated articles, which information includes a
certification of compliance with Federal, State, and local
environmental laws. As FDA stated in the 1997 rule (62 FR 40570 at
40585-40586), after reviewing hundreds of EA's, the agency found that
articles produced in compliance with applicable emission and
occupational safety requirements do not have significant environmental
effects, provided that no extraordinary circumstances apply to the
production site. FDA also has eliminated the previously required EA and
abbreviated EA formats from the amended regulations. Instead,
appropriate EA formats are to be presented in guidance documents. FDA
believes that guidance documents provide the agency with greater
flexibility to interpret requirements under its NEPA procedures in a
manner that responds to the evolving nature of environmental science
and the needs of industry and interested parties. Such guidance
documents, which interpret and clarify existing requirements imposed by
statute and regulation and do not themselves create requirements, are
not subject to the notice and comment rulemaking provisions of the
Administrative Procedure Act (5 U.S.C. 553) and are consistent with the
Council on Environmental Quality regulations (40 CFR 1507.3) that
encourage agencies to publish explanatory guidance for their own
procedures and to revise them as necessary to ensure full compliance
with the purposes and provisions of NEPA.
This draft guidance provides information on how to prepare claims
of categorical exclusion and EAs for submission to CFSAN. The following
topics are covered in this draft guidance: (1) What types of industry-
initiated actions are subject to a claim of categorical exclusion? (2)
What must a claim of categorical exclusion include by regulation? (3)
What is an EA? (4) When is an EA required by regulation and what format
should be used? (5) What are extraordinary circumstances? (6) What
suggestions does CFSAN have for preparing an EA? Although CFSAN
encourages industry to use the EA formats described in this draft
guidance because standardized documentation submitted by industry
increases the efficiency of the review process, alternative approaches
may be used if these approaches satisfy the requirements of the
applicable statutes and regulations.
This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulations (21 CFR 10.115). The draft
guidance, when finalized, will represent FDA's current thinking on the
preparation of a claim of categorical exclusion or an environmental
assessment for submission to CFSAN. It does not create or confer any
rights, for or on any person, and does not operate to bind FDA or the
public. You can use an alternative approach if the approach satisfies
the requirements of the applicable statutes and regulations. If you
want to discuss an alternative approach, contact the FDA staff
responsible for implementing the guidance. If you cannot identify the
appropriate FDA staff, call the appropriate number listed in the title
page of the guidance.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Preparing a Claim of Categorical Exclusion or an
Environmental Assessment for Submission to the Center for Food Safety
and Applied Nutrition
Description: FDA's regulation in Sec. 25.20 specifies the types of
actions related to food additive petitions, color additive petitions,
requests for exemption from regulation as a food additive under Sec.
170.39 (21 CFR 170.39), notifications for food contact substances under
section 409(h) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 348(h)), GRAS affirmation petitions, and citizen petitions
for certain food labeling regulations that require at least the
preparation of an EA, unless the action qualifies for a categorical
exclusion under Sec. 25.30 or Sec. 25.32. FDA's regulations in part
25 are based upon the requirements of NEPA (42 U.S.C. 4321 et seq.).
The agency's collection of information on food additives and food-
contact substances is based upon the requirements in section 409 of the
act. Likewise, section 721 of the act (21 U.S.C. 379(e)) provides for
the collection of information on color additives. The submission to FDA
by interested parties of a GRAS affirmation petition is voluntary. The
information to be submitted with a GRAS affirmation petition is listed
in Sec. 170.35 (21 CFR 170.35), including, in Sec.
170.35(c)(1)(viii), the environmental
[[Page 54464]]
information to be submitted. The environmental information to be
submitted with petitions for certain food labeling regulations is
listed in 21 CFR 101.12(h)(12), 101.69(h), and 101.70(f)F.
Thus, FDA collects information on the potential for environmental
impacts of its actions in the form of environmental assessments and
claims for categorical exclusions from interested parties who request
agency action by submitting to the agency any of the above listed
petitions, requests for exemption, or food contact substance
notifications. After this information has been collected, the agency
will use it to determine whether its action may significantly affect
the quality of the human environment.
FDA has collected information from interested parties requesting
agency action for many years. Over the years, this collected
information has taken several different forms. The agency amended its
environmental regulations in the 1997 rule to reduce the number of NEPA
evaluations by providing for categorical exclusions for additional
classes of actions that do not individually or cumulatively have a
significant affect on the quality of the human environment. In the 1997
rule, FDA also removed the formats for EAs from its regulations and,
instead, now directs interested parties to the agency's Centers for
information on what is needed in EAs. This draft guidance is FDA's
current thinking on what information is needed for the environmental
documentation of the actions that are most often requested. The draft
guidance contains requests for certain information that has not been
requested routinely in the past. FDA is now requesting that submitters
provide certain information to support their claims that the
categorical exclusions listed in Sec. 25.32(i), (o), and (q) will be
applicable to their requested actions. Since these informational
requests are new, FDA is requesting approval from OMB for this
collection of information. The remainder of the environmental
information requests are covered by the information collection
approvals for the underlying actions, i.e., the OMB control number for
food additive petitions is 0910-0016; for color additive petitions,
0910-0185; for requests for exemption from regulation as a food
additive under Sec. 170.39, 0910-0298; for notifications for food
contact substances, 0910-0480; for GRAS affirmation petitions, 0910-
0132; and for petitions for food labeling regulations, 0910-0183.
Description of Respondents: The likely respondents include
businesses engaged in the manufacture or sale of food, food
ingredients, and substances used in materials that come into contact
with food.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
------------------------------------------------------------------------
Annual
21 CFR No. of Frequency Total Hours per Total
Section Respondents per Annual Response Hours
Respondent Responses
------------------------------------------------------------------------
25.32(i) 137 0.5 68 4 272
------------------------------------------------------------------------
25.32(o) 1 1 1 1 1
------------------------------------------------------------------------
25.32(q) 10 0.5 5 1 5
------------------------------------------------------------------------
Total 148 ........... 74 ......... 278
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
associated with this collection of information.
The above estimates for respondents and numbers of responses are
based on the annualized numbers of petitions and notifications
qualifying for Sec. 25.32(i) and (q) that the agency has received
since its environmental regulations were amended to include additional
categorical exclusions. Please note that, since the agency revised its
environmental regulations, there have been no submissions that
requested an action that would have been subject to the categorical
exclusion in Sec. 25.32(o). To avoid counting this burden as zero, FDA
has estimated the burden for this categorical exclusion at one
respondent making one submission a year for a total of one annual
submission. The hours per response were estimated as follows: First,
FDA assumed that the new information it suggest be submitted in this
guidance for each of these three categorical exclusions is readily
available to the submitter. For the new information suggested for the
exclusion in Sec. 25.32(i), FDA expects that the submitter would
gather information from appropriate persons in the submitter's company
and to prepare this information for attachment to the claim for
categorical exclusion. FDA believes that this effort should take about
4 hours per submission. For the new information suggested for the
exclusions in Sec. 25.32(o) and (q), the submitters almost always
would only copy existing documentation and attach it to the claim for
categorical exclusion. FDA believes that this should take no longer
than about 1 hour per submission.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at http://www.cfsan.fda.gov/guidance.html.
Dated: September 8, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23623 Filed 9-16-03; 8:45 am]
BILLING CODE 4160-01-S