0541 Categorical Exclusions under NEPA SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the
Center for Food Safety and Applied Nutrition (CFSAN)
OMB Control No. 0910-0541
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
As an integral part of its decision-making process, the Food and Drug Administration
(“FDA” or “we”) is obligated under the National Environmental Policy Act of 1969 (NEPA)
to consider the environmental impact of its actions, including allowing notifications for food
contact substances to become effective and approving food additive petitions, color additive
petitions, generally recognized as safe (GRAS) affirmation petitions, requests for exemption
from regulation as a food additive, and actions on certain food labeling citizen petitions,
nutrient content claims petitions, and health claims petitions. We have provided guidance
that contains sample formats to help industry submit a claim of categorical exclusion or an
Environmental Assessment (EA) to the Center for Food Safety and Applied Nutrition
(CFSAN). The guidance document entitled, “Preparing a Claim of Categorical Exclusion
or an Environmental Assessment for Submission to the Center for Food Safety and Applied
Nutrition” identifies, interprets, and clarifies existing requirements imposed by statute and
regulation, consistent with the Council on Environmental Quality regulations (40 CFR
1507.3). It consists of recommendations that do not themselves create requirements; rather,
they are explanatory guidance for FDA’s own procedures in order to ensure full compliance
with the purposes and provisions of NEPA.
We are requesting OMB approval of the voluntary information collection provisions
contained in the guidance document entitled, “Preparing a Claim of Categorical Exclusion
or an Environmental Assessment for Submission to the Center for Food Safety and Applied
Nutrition” found at https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-industry-preparing-claim-categorical-exclusion-or-environmentalassessment-submission-cfsan.
2. Purpose and Use of the Information Collection
The guidance provides information to assist in the preparation of claims of categorical
exclusion and EAs for submission to CFSAN. The following questions are covered in this
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? and (6) What suggestions does CFSAN have for
preparing an EA? Although CFSAN encourages industry to use the EA formats described in
the guidance because standardized documentation submitted by industry increases the

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efficiency of the review process, alternative approaches may be used if these approaches
satisfy the requirements of the applicable statutes and regulations.
An FDA-regulated firm submitting a notification, petition, or other form of request for
agency action may choose to submit a claim of categorical exclusion or an EA. In doing so,
the firm will collect the information about their product as recommended by the guidance.
We will review the information collected to determine that the firm’s requested action is in
compliance with the purposes and provisions of NEPA.
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. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
We have developed an option for electronic submission via the CFSAN Online Submission
Module (COSM). COSM is part of FDA’s Electronic Submission Gateway (ESG), which is
an electronic system that also accepts information for other information collections. We
also accept information supporting claims of categorical exclusion or an EA by e-mail. The
agency estimates that about ninety-five percent (95%) are submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
Two of the three categorical exclusions that require collection of information to support the
exclusion (21 CFR 25.32(o) and 25.32(q)) are based upon environmental reviews performed
by other federal agencies. Accordingly, the guidance suggests that submitters provide FDA
copies of certain information that has been provided to, or has been generated by, the other
federal agencies. The duplicative information is necessary to support the claimed exclusion
based on the other agency’s environmental review. With regard to the third categorical
exclusion (21 CFR 25.32(i)), we are the only federal agency that collects information and
data to support this exclusion. Because we have issued guidance for respondents with
regard to submission under 21 CFR 25.32, we wish to retain the instant information
collection and capture the associated burden here. Otherwise, we are not aware of
duplicative information collection.
At the same time, burden relating to other information collection provisions required for an
Environmental Assessment is approved under OMB control number 0910-0322,
“Environmental Impact Consideration – 21 CFR part 25.” Upon approval of this collection
of information, we intend to revise 0910-0322 to remove the annual reporting burden for
categorical exclusions and environmental assessment requests related to food additive
petitions, color additive petitions, request from exemption from regulation as a food
additive, and submission of a food contact notification for a food contact substance. The
future burden for categorical exclusion or environmental assessments for these requests will
be captured under this instant collection of information (0910-0541).

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5. Impact on Small Businesses or Other Small Entities
We estimate that ten percent (10%) of respondents are small businesses. There is no known
way to minimize the burdens on a small business wishing to submit a request for action to
the agency. We aid small businesses in complying with FDA requirements through the
agency’s Regional Small Business Representatives and through the scientific and
administrative staffs within the agency. We have provided a Small Business Guide on the
agency’s website at https://www.fda.gov/industry/small-business-assistance.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. 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. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
The recommended information collection contained in the guidance does not involve more
than quarterly submission of information to the agency, written responses to the agency in
less than 30 days, submission of more than an original and 2 copies, retention of records for
more than three years, or the use of statistical methods. However, a firm’s submission of a
claim of categorical exclusion or an EA may contain trade secret and commercial
confidential information. This information is protected by FDA as set out below in the
response to item 10 of this supporting statement.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice for public comment in
the Federal Register of June 25, 2019 (84 FR 29864). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
We do not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Information submitted to FDA in a claim of categorical exclusion or an EA may contain
trade secret and commercial confidential information. As a result, all files are maintained in
a secured area. The guidance provides instructions for assisting FDA with protecting
confidential information. It states, “Data and information that are protected from disclosure
under 18 U.S.C. 1905, 21 U.S.C. 331(j) or 360j(c) shall be submitted separately in a
confidential section of the submission and shall be summarized, to the extent possible, in the
EA (21 CFR 25.51).” Only information that is releasable under the agency’s regulations in

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21 CFR part 20 would be released to the public. This information is also safeguarded by
section 301(j) of the Federal Food, Drug, and Cosmetic Act and would be protected from
disclosure under the Freedom of Information Act (FOIA) under sections 552(a) and (b) (5
U.S.C. 552(a) and (b)).
Privacy Act
This information collection request (ICR) is collecting personally identifiable information
(PII) or other data of a personal nature. Information is collected via Form FDA 3480 (Food
Contact Substance: Notification for New Use Pre-Notification Consultation Food Master
File). PII collected is name, address, country, telephone number, fax number, and email
address. FDA Form 3480A (Amendment to an Existing Food Contact Notification PreNotification Consultation Food Master File) is used to make amendments to the original
submission. PII collected via Form FDA 3480A is name, address, country, telephone
number, fax number, and email address. (Both forms are covered under OMB control
number 0910-0495.) PII is collected in the context of the individual’s professional capacity.
This ICR is guidance for industry for preparing a claim of categorical exclusion or
environmental assessment for submission to the Center for Food Safety and Applied
Nutrition. The guidance identifies, interprets, and clarifies existing requirements imposed
by statute and regulation, consistent with the Council on Environmental Quality regulations
(40 CFR 1507.3). It consists of recommendations that do not themselves create
requirements; rather, they are explanatory guidance for FDA’s own procedures in order to
ensure full compliance with the purposes and provisions of NEPA.
We determined that, although PII is collected, the collection is not subject to the Privacy Act
of 1974 and the particular notice and other requirements of the Act do not apply.
Specifically, we do not use name or any other personal identifier to routinely retrieve
records from the information collected.
In preparing this supporting statement, FDA staff consulted with the FDA Privacy Office to
ensure appropriate handling of information collected.
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:

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Table 1. – Estimated Annual Reporting Burden
21 CFR/
Environmental
Impact
Considerations
25.15(a) & (d)
(to cover CE’s
under 25.32(i))
25.15(a) & (d)
(to cover CE’s
under 25.32(o))
25.15(a) & (d)
(to cover CE’s
under
25.32 (q))
25.40 (a) & (c)
EA’s
TOTAL

No. of
Respondents

No. of
Responses per
Respondent

Total Annual
Responses

Average
Burden per
Response

Total Hours

47

1

47

8

376

1

1

1

8

8

3

1

3

8

24

57

1

57

180

10,260
10,668

The above estimates for respondents and numbers of responses are based on the annualized
numbers of petitions and notifications qualifying for categorical exclusions (CE) listed under
§ 25.32(i) and (q) that we have received in the past 3 years. Please note that, in the past 3
years, 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 burden for submitting a CE is captured
under section 25.15(a) and (d).
To calculate the estimate for the values for Average Burden per Response, we assumed that
the information requested in the guidance for each of these three categorical exclusions is
readily available to the submitter. For the information requested for the exclusion described
in § 25.32(i), we expect that the 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 8
hours per submission. For the information requested for the exclusions described in §
25.32(o) and (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 8 hours per submission.
For the information requested for the environmental assessments in § 25.40(a) and (c), we
believe that submitters will submit an average of 57 environmental assessments annually.
We estimate that each submitter will prepare an EA within 3 weeks (120 hours) and revise
the EA based on Agency comments (between 40 and 60 hours), for a total preparation time
of 180 hours.

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12 b. Annualized Cost Burden Estimate
Gathering the information discussed here and providing it to the agency may be done by a
professional employee such as an environmental scientist. We estimate that the average
hourly wage for this employee would be equivalent to a GS-11/Step-1 level in the locality
pay area of Washington-Baltimore in 2019, approximately $33.34/hour. Doubling this wage
to account for overhead costs, we estimate the average hourly cost to respondents to be
$66.68/hour. The overall estimated cost incurred by the respondents is $711,342.24 (10,668
burden hours x $66.68/hr.).
Gathering
information for
Categorical
Exclusion or
Environmental
Assessment and
submitting to FDA
Categorical
Exclusion
Environmental
Assessments
Total

Total Burden
Hours

Hourly Wage Rate

Total Respondent
Costs

408

$66.68

$27,205.44

10,260

$66.68

$684,136.80
$711,342.24

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection.
14. Annualized Cost to the Federal Government
At the agency, a professional employee reviews the submissions, which requires about one
hour. We estimate the hourly cost for review and evaluation of the submissions to be $53.85
per hour, the GS-13/Step-5 rate for the Washington-Baltimore locality pay area for the year
2019. To account for overhead, this cost is increased by 100 percent, making the total cost
$107.70 per hour. Thus, we estimate the cost to the Federal Government for the review of
submissions to be $11,631.60 ($107.70/hour x 1 hour per submission x 108 submissions =
$11,631.60).
15. Explanation for Program Changes or Adjustments
This collection is an extension and renewal without changes. Burden has not changed from
the burden shown in the current inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
The agency has no plans for publication of information from this information collection.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
We will display the OMB expiration date as required by 5 CFR 1320.5. There are no
reasons why display of the expiration date for OMB approval of the information collection
would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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