0342 SS for FR Revision 2016

Substances Generally Recognized as Safe (GRAS) Notification Procedures

OMB Control No. 0910-0342
RIN 0910-AH15

Terms of Clearance: In accordance with the terms of 5 CFR 1320, this ICR is approved for a
period of three years. OMB notes that the Supporting Statement claims that the new form will
be more efficient than the existing form, but it does not calculate a reduction in the burden on
the public or a reduction in Agency processing time. Please examine this as the form is in use
and consider updating these figures, as appropriate, when resubmitting to OMB.

Response: Consistent with the rulemaking, Form FDA 3667 provides a standardized format for
information being submitted to the agency. While we do not calculate a reduction in burden to
respondents, we believe the standardized format will facilitate agency review of information
being submitted so that a GRAS determination can be made.

A. Justification

1. Circumstances Making the Collection of Information Necessary

Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348)
establishes a premarket approval requirement for “food additives.” Section 201(s) of the FD&C
Act (21 U.S.C. 321) provides an exclusion to the definition of “food additive,” and thus from the
premarket approval requirement, for uses of substances that are GRAS by qualified experts.
The Food and Drug Administration (FDA, the agency, or we) has issued a final rule
implementing regulations that clarify the criteria for when the use of a substance in food for
humans or animals is not subject to the premarket approval requirements of the FD&C Act
because the substance is GRAS under the conditions of its intended use. The regulations also
replace the voluntary GRAS affirmation petition process with a voluntary notification procedure
under which any person may notify us of a conclusion that a substance is GRAS under the
conditions of its intended use. Food additives that are not GRAS must obtain premarket
approval. The clarified criteria for GRAS status should help stakeholders draw more informed
conclusions about whether the intended conditions of use of a substance in food for humans or
animals complies with the FD&C Act, and the notification procedure will enable stakeholders to
be aware of whether we have questioned the basis of a conclusion of GRAS status.
As explained in the regulations, a GRAS notice must include the following:
PART
NO.
1
2
3
4

INFORMATION TO BE INCLUDED
Signed statements and a certification
The identity, method of manufacture, specifications, and physical or technical effect of the notified
substance
Dietary exposure to the notified substance
Self-limiting levels of use in circumstances where the amount of the notified substance that can be
added to human food or animal food is limited because the food containing levels of the notified
substance above a particular level would become unpalatable or technologically impractical

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PART
NO.
5

6

7

INFORMATION TO BE INCLUDED
The history of consumption of the substance for food use by a significant number of consumers (or
animals in the case of animal food) prior to January 1, 1958, if a conclusion of GRAS status is based
on common use of the substance in food prior to 1958
A narrative that provides the basis for the notifier’s conclusion of GRAS status, including why the
scientific data, information, methods, and principles described in the notice provide a basis for the
conclusion that the notified substance is generally recognized, among qualified experts, to be safe
under the conditions of its intended use
A list of the generally available data, information, and methods the notifier cites in the GRAS notice

Accordingly, FDA is requesting OMB approval of the information collection provisions
associated with applicable regulations in parts 170 and 570 as revised by our final rule of August
17, 2016 (81 FR 54960) regarding the notification procedures for GRAS substances. These
regulations implement the GRAS provision of section 201(s) of the FD&C Act in part 170 and
part 570 for human food and animal food, respectively. We are also requesting approval of Form
FDA 3667 entitled, “Generally Recognized As Safe (GRAS) Notice.”
2. Purpose and Use of the Information Collection

The information submitted to us in a GRAS notice is necessary to allow us to administer
efficiently the FD&C Act’s various provisions that apply to the use of substances added to
food, specifically with regard to whether a substance is GRAS under the conditions of its
intended use or is a food additive subject to premarket review. We will use the information
collected through the GRAS notification procedure to complete our evaluation within the
timelines specified in the final rule.

Description of Respondents: Respondents to the collection of information are manufacturers of
substances used in human food and animal food. As estimated in the Final Regulatory Impact
Analysis (FRIA), we estimate there are 480 such respondents: approximately 340 to 460
notifiers for human food and approximately 10 to 20 notifiers for animal food.

3. Use of Improved Information Technology and Burden Reduction

We acknowledge that technology may not be available to every notifier and, thus, the
regulations do not require the submission of an electronic copy. Instead, the regulations
final provide that a notifier may submit a GRAS notice either in an electronic format that
is accessible for our evaluation or on paper (see § 170.210(b)). Based on our review, we
estimate 70% of submissions will be made electronically, while 30% will continue to be
submitted in letter format.
4. Efforts to Identify Duplication and Use of Similar Information

We are unaware of duplicative information collection. Under the Meat and Poultry Inspection
Acts, the United States Department of Agriculture’s Food Safety and Inspection Service
(USDA/FSIS) has regulatory authority for meat and poultry. FDA and USDA have signed a
Memorandum of Understanding that provides for a coordinated evaluation process with FSIS
when the intended conditions of use of a notified substance include use in a product or

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products subject to regulation by USDA under statutes that it administers (75 FR 81536 at
81541-81542).

5. Impact on Small Businesses or Other Small Entities

We estimate ten percent (10%) of respondents are small businesses; however the regulations are
applicable to all respondents. 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 also provides a Small Business Guide on the
Agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently

GRAS notifications are submitted only once.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

The information collection requirements are consistent with 5 CFR §1320.5, excepting extended
retention of GRAS notification records. We believe this extended retention period is necessary
because, under the regulations, notifiers submit a summary of information that provides the
basis for a conclusion of GRAS status rather than the information itself. Although the rule does
not specify any timeframe to retain the data and information that support the conclusion of
GRAS status, preservation of the data and information that are the basis for the conclusion of
GRAS status represents prudent practice for those who claim an exclusion from a statutory
requirement regardless of whether the person subsequently notifies FDA.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(B)), FDA
solicited public comment on the information collection provisions in its proposed rule of April
17, 1997 (62 FR 18938). In 2010, we reopened the comment period for the proposed rule to
update comments and to solicit comment on specific issues (75 FR 81536, December 28, 2010).
While some comments were received suggesting specific modifications and different approaches
and questioning the utility of the information, no comments suggested that we modify burden
estimates. All comments received in response to the rulemaking may be found in the Agency
docket, FDA-1997-N-0020 (formerly 97N-0103), and are addressed in the agency’s final rule
that published August 17, 2016 (81 FR 54960).

9. Explanation of Any Payment or Gift to Respondents

FDA does not provide any payments or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents

In accordance with our public information regulations in § 20.85 (Disclosure to other Federal
government departments and agencies), we can share confidential commercial information
with another Federal agency pursuant to a written agreement that the record will not be further
disclosed. The amended MOU between FDA and USDA’s FSIS now provides for FDA to
share with FSIS confidential commercial information in a submission such as a GRAS notice.
We generally cannot share trade secret information with other Federal agencies under section
301(j) of the FD&C Act (21 U.S.C. 331(j)), and therefore we would need the notifier’s
authorization to share this information with FSIS. For efficiency in administering the
coordinated evaluation of a GRAS notice with FSIS, we have added a requirement for a
notifier who submits a GRAS notice that we would send to FSIS to include in part 1 of the
GRAS notice a statement as to whether the notifier: (1) Authorizes us to send any trade secrets
to FSIS; or (2) asks us to exclude any trade secrets from the copy of the GRAS notice that we
will send to FSIS (see § 170.225(c)(11)). Under the provisions that make the coordinated
evaluation of a GRAS notice with FSIS explicit, we will exclude any trade secrets unless the
notifier has authorized us to send trade secret information to FSIS (see § 170.270). These
provisions will enable us, with the notifier’s authorization, to share a GRAS notice that
includes trade secret information with FSIS without first redacting the GRAS notice to remove
the trade secret information and, thus, will reduce the time it takes for us to provide FSIS with
a copy of the GRAS notice. These provisions also will clarify the notifier’s expectations
regarding whether we should share trade secret information with FSIS and, thus, require us to
redact the trade secret information from the copy we send to FSIS when consistent with the
notifier’s express wishes.

Information submitted to FDA in a GRAS notice may contain trade secret and commercial
confidential information. As a result, all files are maintained in a secured area. Form FDA
3667, its instructions, and related guidance, provide instructions for assisting FDA with
protecting confidential information. A notifier may choose to provide a redacted copy of the
GRAS notice, identifying that information that the submitter views as trade secret or as
confidential commercial or financial information.
Only information that is releasable under the agency’s regulations in 21 CFR part 20 would be
released to the public. This information is also safeguarded by Section 301(j) of the FD&C Act
and would be protected from disclosure under FOIA under sections 552(a) and (b) (5 U.S.C.
552(a) and (b)).

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
FDA estimates the burden of this information collection as follows:

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12 a. Annualized Hour Burden Estimate
One-Time Reporting Burden
Table 1 shows the estimated one-time reporting burden associated with the final rule. We expect
that all respondents to the information collection will spend time reading and understanding the
requirements of the final rule and revising standard operating procedures for preparing and
submitting GRAS notices. As noted, we estimate that approximately 340 to 460 notifiers (for
human food) and approximately 10 to 20 notifiers (for animal food) will be affected by the final
rule. We use the upper-bound estimates of 460 and 20 respondents as shown in rows 1 and 2.
We estimate that it will take from 20 to 80 hours for respondents to perform this action. We use
the upper-bound estimate of 80 hours as shown in rows 1 and 2. Of the 480 affected
respondents, some will have outstanding GRAS petitions. Firms with outstanding GRAS
petitions regarding substances intended for use in human food may choose to submit GRAS
notices and incorporate the information included in their petition. As estimated in the Final
Regulatory Impact Analysis, up to 45 petitions (for human food) will be submitted as GRAS
notices and incorporated. We use the upper-bound estimate of 45 as shown in row 3. To account
for the additional effort by these firms, we include the one-time burden to prepare and submit a
GRAS notice for all outstanding petitions. Because there are no outstanding GRAS petitions
regarding substances intended for use in animal food, we do not account for any burden for the
submission of a GRAS notice that incorporates a GRAS petition regarding a substance intended
for use in animal food. We estimate that respondents will spend between 170 and 190 hours to
submit GRAS notices for each outstanding petition and have used, therefore, an average estimate
of 185 hours as shown in row 3.
Table 1 – Estimated One-time Reporting Burden1
Activity; 21 CFR Section

Notifier’s review of final rule and revision
of procedures for preparing and submitting
GRAS notices for human food;
170.210 through 170.270
Notifier’s review of final rule and revision
of procedures for preparing and submitting
GRAS notices for animal food;
570.210 through 570.270
Prepare and submit GRAS notice for an
outstanding GRAS petition;
170.285
TOTAL
1

No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden
per
Response

Total
Hours

460

1

460

80

36,800

20

1

20

80

1,600

45

1

45

185

8,325

525

46,725

There are no capital costs or operating and maintenance costs associated with this collection of information.

Recurring Reporting Burden
Table 2 shows the estimated recurring annual reporting burden associated with the information
collection. As previously discussed, the rulemaking replaces the petition process with a GRAS
notification procedure. The level of effort required by a firm to reach a conclusion that a

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substance is GRAS for its intended use remains unchanged by the final rule. However, the
regulations require that firms submit some additional information to support the conclusions
found within their notices. The additional information might include an amendment (§§ 170.260
and 570.260); a supplement (§§ 170.280 and 570.280); a request for FDA to cease to evaluate a
GRAS notice (§§ 170.260 and 570.260); an incorporation into a GRAS notice (§§ 170.215 and
570.215); and, information required when the intended conditions of use of a notified substance
includes use in a product subject to regulation by FSIS, including authorization to us to share any
trade secrets with FSIS (§ 170.270). Because the amount of additional information may vary, we
estimate that respondents will spend between 155 and 170 hours to prepare and submit each
notice. Using the upper-bound figure of 170 hours, we therefore estimate that the 50 notifiers for
human food and 25 notifiers for animal food will expend 12,750 hours annually as shown,
respectively, in rows 1 and 2.
Table 2 – Estimated Annual Reporting Burden1
Activity;
21 CFR Section
GRAS notification
procedure for human
food;170.210 through
170.270
GRAS notification
procedure for animal food;
570.210 through 570.270
TOTAL
1

No. of
Respondents

Total Annual
Responses

50

No. of
Responses per
Respondent
1

Total Hours

50

Average
Burden per
Response
170

25

1

25

170

4,250

75

8,500

12,750

There are no capital costs or operating and maintenance costs associated with this collection of information.

Recordkeeping
The rulemaking does contain recordkeeping requirements. We believe that documentation used
by respondents in support of a conclusion of GRAS status is information that is collected and
retained as a part of usual and customary business practices for a firm engaged in the
manufacture of substances used in human food and animal food. While the regulations do not
specify a timeframe to retain the data and information that support the conclusion of GRAS
status, preservation of the data and information that are the basis for the conclusion of GRAS
status represents prudent practice for those who claim an exclusion from a statutory requirement
regardless of whether the person subsequently notifies FDA. Accordingly, no estimated burden
is provided for these activities (5 CFR 1320.3(b)(2)).

This final rule also refers to other currently approved collections of information found in FDA
regulations. These collections of information are subject to review by OMB under the PRA. The
collections of information in 21 CFR 25.32(i) are approved under OMB control number 09100541. The collections of information in 21 CFR 10.33 are approved under OMB control number
0910-0191.

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12 b. Annualized Cost Burden Estimate

As estimated in the Final Regulatory Impact Analysis, the total annualized cost burden is
$9,953.49 to $14,965.90, as calculated below.

Activity
Cost to Read and Understand the Final Rule
Cost to Revise SOPs
Cost to Prepare a GRAS Notice for an outstanding
petition
Incremental costs for additional information
Total

Lower Bound
Estimate
$720.24
$580.15

Upper bound
Estimate
$1,350.45
$3,480.90

$8,403.10
$250.00
$9,953.49

$9,144.55
$990.00
$14,965.90

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 information
collection.

14. Annualized Cost to Federal Government

FDA estimates it will direct approximately 4 full time equivalent positions (FTE’s) to the
GRAS notification procedure for human foods. Due to the smaller number of notices
anticipated for animal food, only 3 FTE are expected to be devoted to processing the notices
submitted to CVM. Based on an average cost of $172,000 per fully supported position
($86,000 increased by 100 percent to account for overhead), the cost of processing GRAS
notifications would be $1,204,000 per year ($172,000 x 7).

15. Explanation for Program Changes or Adjustments

The information collection includes a one-time burden of 525 responses and 46,725 hours to
reflect current rulemaking. Upon its next request for renewal of the information collection the
agency expects this burden to have been realized. Meanwhile, the annual reporting burden
reflects an adjustment of 15 additional responses and 2,850 additional hours. We attribute the
increase to an increase in the number of respondents to the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The final rule specifies that we will make the following readily accessible to the public: (1) A list
of filed GRAS notices, including the information described in certain of the signed statements
that are included in Part 1 of a GRAS notice (i.e., § 170.225(c)(2) through (c)(5)); and (2) The
text of any letter that we issue under § 170.265(b)(1) (our response to a GRAS notice based on
our evaluation of the notice), § 170.265(b)(3) (a letter if we grant a request that we cease to
evaluate a GRAS notice), or § 170.265(c) (a subsequent letter that we send about a GRAS
notice). (See § 170.275(b).) We are not specifying that the mechanism for us to do so is through
an “Inventory” because the procedure we used to make this information readily accessible to the

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public evolved over time during the Interim Pilot program, and may continue to evolve.
17. Reason(s) Display of OMB Expiration Date is Inappropriate

Display of OMB expiration date is appropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification.