Supporting Statement for New Requests for Information

in the

*Guidance for Industry:*

*Preparing a Claim of Categorical Exclusion or an Environmental
Assessment*

*for Submission to the Center for Food Safety and Applied Nutrition*

*0910-0518*

A.  **JUSTIFICATION**

1\. [Circumstances Necessitating Information Collection]{.underline}

FDA\'s regulations in 21 *CFR* 25.20 specify that environmental
assessments must be submitted as part of food additive petitions, color
additive petitions, requests for exemption from regulation as a food
additive under 21 *CFR* 170.39, notifications for food contact
substances under 21 USC 348(h), GRAS affirmation petitions, and
petitions for certain food labeling regulations, unless the submission
qualifies for a categorical exclusion under 21 *CFR* 25.30 or 25.32.
FDA's regulations in 21 *CFR* part 25 are based upon the requirements of
the National Environmental Policy Act of 1969 (NEPA) (Title 42 of the
United States Code). The agencys collection of information on food
additives and food-contact substances is based upon the requirements in
Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 348). Likewise, Section 721 of the FD&C 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 21 *CFR* 170.35, including, in 170.35(c)(1)(viii),
the environmental information to be submitted. The environmental
information to be submitted with petitions for certain food labeling
regulations is listed in sections 101.12(h)(12), 101.69(h), and
101.70(f)F of 21 *CFR*. The authority for part 101 of 21 *CFR* is 15
U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371.

FDA has collected information from interested parties requesting agency
action for many years. Over the years, this collected information has
taken several different forms. In 1997, the agency amended its
environmental regulations (62 *FR* 40570; on July 29, 1997) to reduce
the number of NEPA evaluations by providing for categorical exclusions
for additional classes of agency actions that do not individually or
cumulatively have a significant effect on the human environment. At that
time, FDA also removed the formats for environmental assessments (EAs)
from its regulations and, instead, now directs interested parties to the
agency's Centers for information on what is needed in EAs. The guidance
that is the subject of this supporting statement is the current thinking
in the Center for Food Safety and Applied Nutrition (CFSAN) on what
information is needed for the environmental documentation of the actions
that are most often requested of CFSAN. In this guidance, certain
information has not been routinely requested before now. Specifically,
we now recommend that submitters provide certain information to support
their claims that the categorical exclusions listed in  25.32(i),
25.32(o), and  25.32(q) will be applicable to their requested actions.
Since these requests for additional information are new, we are
requesting approval from the Office of Management and Budget (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 number for food additive
petitions is 0910-0016; for color additive petitions is 0910-0185; for
requests for exemption from regulation as a food additive under 21 *CFR*
170.39 is 0910-0298; for notifications for food contact substances is
0910-0444; for GRAS affirmation petitions is 0910-0132; and for
petitions for food labeling regulations is 0910-0381.

2\. [How, By Whom, Purpose of Collection]{.underline}

Interested parties request agency action by submitting to the agency any
of the petitions, requests for exemption, or notifications listed above
in Section A.1. As a part of these submissions, FDA collects information
on the potential for environmental impacts in the form of environmental
assessments or claims for categorical exclusions. The agency uses this
information to reach a conclusion on the potential for significant
environmental impacts to result from the action requested in the
submission.

3\. [Consideration Given to Information Technology]{.underline}

On 7/31/01 (66 *FR* 39517), the Food and Drug Administration (FDA)
announced the availability of two draft guidances for industry entitled
\`\`Providing Regulatory Submissions to Office of Food Additive Safety
in Electronic Format‑‑General Considerations\'\' and \`\`Providing
Regulatory Submissions to Office of Food Additive Safety in Electronic
Format for Food Additive and Color Additive Petitions.\'\' These
documents are the first in a series of guidance documents intended to
provide guidance for industry regarding the preparation of regulatory
submissions in electronic format to the Office of Food Additive Safety
(OFAS), CFSAN. We expect that the collection of information discussed in
this document will be included along with other requested information in
the electronic submissions discussed in the two above mentioned draft
guidances as the interested parties making submissions to CFSAN become
comfortable with making electronic submissions. The collection of
information discussed in this document will not alter the current
practice of accepting requested information from industry via electronic
mail; such submissions will expedite the review process of claims of
categorical exclusions.

4\. [Identification of Duplicative Information]{.underline}

For two of the three categorical exclusions being discussed in this
document (25 *CFR* 25.32(o) and 25.32(q)), the final guidance suggests
that submitters provide copies of certain information pertaining to the
requested action that has been provided to, or has been generated by,
other Federal agencies and such reviews are not available to us. We are
requesting these pieces of information because these two categorical
exclusions are based upon the environmental reviews performed by other
Federal agencies for the subjects of the submissions. Thus, although we
are requesting duplicative information from these submitters, we believe
that time and effort will be saved for both the submitters and us in the
preparation and review of the submission. The submitters will save time
and effort by adequately supporting the claim of categorical exclusion
before submitting the request to us. Also, the time and effort the
submitter puts in collecting this new information is much less than the
time needed to prepare an EA for an action that does not have supporting
documentation. The agency's review time will be saved because of the
ready availability of the documentation supporting the cited claim. For
the third categorical exclusion being discussed here (25 *CFR*
25.32(i)), we believe that the requested information is not duplicated
anywhere else but is readily available to the submitter.

5\. [Small Businesses]{.underline}

There is no known way to minimize the burdens on a small business
wishing to submit a request for action to the agency. The agency has
established criteria as to the type of data necessary for these
submissions. Where possible, the agency provides assistance to any party
requesting it, including small businesses.

6\. [Less Frequent Information Collection]{.underline}

If the information collection being considered here was not conducted,
the agency might have difficulty determining if the categorical
exclusion being claimed in a submission was, in fact, warranted. This
difficulty could cause the agency to not be in compliance with its NEPA
responsibilities.

7\. [Information Collection Circumstances]{.underline}

The information collections in this document involve no special
circumstances.

8\. [Consultations with Persons Outside FDA]{.underline}

In accordance with 5 *CFR* 1320.8(d), on September 17, 2003 (68 FR
64452), a 60-day notice for public comment was published in the Federal
Register. No comments were received from the public.

9\. [Payment or Gift]{.underline}

No payment or gift is provided to submitters.

10\. [Confidentiality Provisions]{.underline}

Because submissions to the agency often contain trade secret
information, all files are maintained in a secured area. Confidentiality
of data and information in submissions to the agency is regulated in
various sections of 21 *CFR*. The submitted information is also
safeguarded by provisions in the FD&C Act.

11\. [Privacy]{.underline}

There are no questions of a sensitive nature in the requirements the
agency has established for the submissions under consideration here.

12\. [Burden of Information Collection]{.underline}

FDA estimates the burden of this collection of information as follows:

Table 1 - Estimated Annual Reporting Burden^1^

  ---------- ------------- ------------- ------------- ---------- ------------
  21 *CFR*   No. of        Annual        Total Annual  Hours per  Total Burden
  Section    Respondents   Frequency per Responses     Response   Hours
                           Respondent                             

  25.32(i)   68            2             136           1          136

  25.32(o)   1             1             1             1          1

  25.32(q)   5             2             10            1          10

  Total                                  147                      147
  ---------- ------------- ------------- ------------- ---------- ------------

^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
 25.32(i) and 25.32(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  25.32(o).
To avoid counting this burden as zero, we have 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 values
were estimated as follows: First, we assumed that the new information
requested in this guidance for each of these three categorical
exclusions is readily available to the submitter. For the new
information requested for the exclusion in  25.32(i), we expect that
submitter will need to gather information from appropriate persons in
the submitter's company and to prepare this information for attachment
to the claim for categorical exclusion. We believe that this effort
should take no longer than 1 hour per submission. For the new
information requested for the exclusions in  25.32(o) and 25.32(q), the
submitters will almost always merely need to copy existing documentation
and attach it to the claim for categorical exclusion. We believe that
collecting this information should also take no longer than 1 hour per
submission.

13\. [Cost to Respondents]{.underline}

Gathering the information discussed here and providing it to the agency
may be done by a professional employee such as an environmental
scientist. We are assuming that the hourly wage plus overhead for an
environmental scientist is \$50/hour. Based on that and on the burden
hours calculated in Table 1 above (147), the annual cost to respondents
is \$7,350 (147 burden hours x \$50/hour).

14\. [Annual Cost to Government]{.underline}

At the agency, reviewing the information discussed here is done by a
professional employee and required about one hour. Assuming that the
aggregate professional hourly cost, including overhead, is \$90, the
annual cost to FDA is \$ 13,230 (147 responses one hour/response
\$90/hour).

15\. [Reason for Change]{.underline}

This collection of information is new. Thus, there is no current OMB
inventory.

16\. [Statistical Reporting]{.underline}

The information collected for the three categorical exclusions discussed
here will not be published.

17\. [Display of OMB Approval Date]{.underline}

No approval is being sought to not display the expiration date for OMB
approval of the information collection.

18\. [Exceptions to \"Certification for Paperwork Reduction Act
Submissions\", of OMB Form 83-I]{.underline}

There are no exceptions to the certification statement identified in
Item 19, \"Certification for Paperwork Reduction Act Submissions,\" of
OMB Form 83-I.

**B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS**

This collection of information will not employ statistical methods. Nor
would the use of statistical methods with this collection of information
reduce burden or improve accuracy of results.