Preparing a Claim of Categorical Exclusion or an Environmental Assessment
for Submission to the Center for Food Safety and Applied Nutrition
SUPPORTING STATEMENT
1.
Circumstances Making the Collection of Information Necessary
As
an integral part of its decision-making process, the Food and Drug
Administration (FDA) 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, 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. 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 (62
FR 40570; July 29, 1997). As a result of that rulemaking, FDA no
longer routinely requires submission of information about the
manufacturing and production of FDA-regulated articles. FDA also has
eliminated the previously required Environmental
Assessment (EA) and
abbreviated EA formats from the amended regulations. Instead, FDA
has provided guidance that contains sample formats to help industry
submit a claim of categorical exclusion or an 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.
FDA is 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 http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm081049.htm on the internet.
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 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. FDA 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
CFSAN
currently accepts information supporting claims of categorical
exclusion or an EA by e-mail. The
agency estimates that about twenty-five percent (25%) 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)), FDA is the only federal agency that collects information
and data to support this exclusions. There is no similar information
or data that can be used or modified for this purpose.
5.
Impact on Small Businesses or Other Small Entities
FDA
estimates 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. FDA aids small businesses in
complying with its requirements through the agency’s Regional
Small Business Representatives and through the scientific and
administrative staffs within the agency. FDA has provided a Small
Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
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 question 10.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In
accordance with 5 CFR 1320.8(d), in the Federal Register of
October
28, 2013 (78 FR 64218),
FDA published a
60-day notice requesting public comment on the collection of
information.
The agency received one comment that was not responsive to the
comment request on the information collection provisions.
12.
Estimates of
Annualized Burden Hours and Costs
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).
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Reporting Burden1 |
|||||
21 CFR Part 25/ Environmental Impact Considerations |
No. of Respondents |
No. of Responses per Respondent |
Total Annual Responses |
Average Burden per Response |
Total Hours |
25.32(i) |
42 |
1 |
42 |
1 |
42 |
25.32(o) |
1 |
1 |
1 |
1 |
1 |
25.32(q) |
2 |
1 |
2 |
1 |
2 |
Total |
45 |
||||
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 (q) that the agency has 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, FDA has estimated the burden for this categorical exclusion at one respondent making one submission a year for a total of one annual submission.
To calculate the estimate for the values for Average Burden per Response, we assumed that the information requested in this guidance for each of these three categorical exclusions is readily available to the submitter. For the 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 information requested for the exclusions 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 1 hour per submission.
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. FDA estimates 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 2013, approximately $29.93/hour. Doubling this wage to account for overhead costs, FDA estimates the average hourly cost to respondents to be $59.86/hour. The overall estimated cost incurred by the respondents is $2,693.70 (45 burden hours x $59.86/hr = $2,693.70).
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. FDA estimates the
hourly cost for review and evaluation of the submissions to be $48.35
per hour, the GS-13/Step-5 rate for the Washington-Baltimore locality
pay area for the year 2013. To account for overhead, this cost is
increased by 100 percent, making the total cost $96.70 per hour.
Thus, FDA estimates the cost to the Federal Government for the review
of submissions to be $4,351.50 ($96.70/hour x 1 hour per submission x
45 submissions = $4,351.50).
15.
Explanation for Program Changes or Adjustments
This
collection of information has increased by 8 respondents, resulting
in an increase of 8 burden hours. Thus, FDA has
increased its annual burden estimate from 37 hours to 45 hours.
16. Plans for Tabulation and Publication and Project Time Schedule
The
agency has no plans for publication of information from this
information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
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.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Bean, Domini |
| File Modified | 2013-12-19 |
| File Created | 2013-12-19 |