[Federal Register Volume 68, Number 180 (Wednesday, September 17, 2003)]
[Notices]
[Pages 54462-54464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23623]


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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Draft Guidance for Industry on Preparing a Claim of Categorical 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.

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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availability of a draft guidance document entitled ``Guidance for 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and Applied Nutrition'' (the draft guidance). The draft guidance 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DATES: Submit written or electronic comments on the draft guidance and 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry: Preparing a Claim of 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, [email protected]. 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SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance.
    Submit written comments on the draft guidance and the collection of 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: [email protected].

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
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25.32(i)       137           0.5          68          4          272
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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