[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Rules and Regulations]
[Pages 77983-77985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27714]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 170 and 570

[Docket No. FDA-2017-D-0085]


Best Practices for Convening a GRAS Panel; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Best Practices 
for Convening a GRAS Panel.'' This guidance document is intended for 
any person who is responsible for a conclusion that a substance may be 
used in food on the basis of the generally recognized as safe (GRAS) 
provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when 
that person convenes a panel of experts (``GRAS panel'') to 
independently evaluate whether the available scientific data, 
information, and methods establish that the substance is safe under the 
conditions of its intended use in human food or animal food. This 
guidance provides our current thinking on best practices to identify 
GRAS panel

[[Page 77984]]

members who have appropriate and balanced expertise; to take steps to 
reduce the risk that bias (or the appearance of bias) will affect the 
credibility of the GRAS panel's output (often called a ``GRAS panel 
report''), including the assessment of potential GRAS panel members for 
conflict of interest and the appearance of conflict of interest; and to 
limit the data and information provided to a GRAS panel to public 
information (e.g., by not providing the GRAS panel with information 
such as trade secret information).

DATES: The announcement of the guidance is published in the Federal 
Register on December 21, 2022.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-0085 for ``Best Practices for Convening a GRAS Panel.'' 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to Office 
of Food Additive Safety, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration (HFS-200), 5001 Campus Dr., College Park, 
MD 20740, or to the Office of Surveillance and Compliance (HFV-200), 
Center for Veterinary Medicine, 12225 Wilkins Ave., Rockville, MD 
20855. Send two self-addressed adhesive labels to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Regarding substances that would be 
used in human food: Paulette M. Gaynor, Office of Food Additive Safety 
(HFS-255), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1192. 
Regarding substances that would be used in animal food: Geoffrey K. 
Wong, Office of Surveillance and Compliance (HFV-225), Center for 
Veterinary Medicine, Food and Drug Administration, 12225 Wilkins Ave., 
Rockville, MD 20855, 240-402-5838. Regarding other questions about this 
document: Alexandra Jurewitz, Office of Regulations and Policy (HFS-
024), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 201(s) of the FD&C Act (21 U.S.C. 321(s)) defines a ``food 
additive'' as any substance the intended use of which results or may 
reasonably be expected to result, directly or indirectly, in its 
becoming a component or otherwise affecting the characteristics of any 
food if such substance is not generally recognized, among experts 
qualified by scientific training and experience to evaluate its safety, 
as having been adequately shown through scientific procedures (or, in 
the case of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use in food) 
to be safe under the conditions of its intended use. Under this 
definition, a substance that is GRAS under the conditions of its 
intended use is not a ``food additive'' and is therefore not subject to 
mandatory premarket review by FDA under section 409 of the FD&C Act (21 
U.S.C. 348). In this document, we refer to a person who is responsible 
for a conclusion that a substance may be used in human food or animal 
food on the basis of the GRAS provision of the FD&C Act, without 
premarket review by FDA under section 409 of the FD&C Act, as the 
``proponent'' of that substance.
    We have established regulations implementing the GRAS provision of 
section 201(s) of the FD&C Act in part 170 (21 CFR part 170) for human 
food

[[Page 77985]]

and in part 570 (21 CFR part 570) for animal food. Those regulations 
include a voluntary procedure (``GRAS notification procedure'') through 
which a proponent may notify us of a conclusion that a substance is 
GRAS under the conditions of its intended use in human food (part 170, 
subpart E) or animal food (part 570, subpart E).
    In some cases, the process whereby the proponent evaluates whether 
the available data and information support a conclusion that a 
substance is GRAS under the conditions of its intended use includes 
considering the opinion of a ``GRAS panel'' of qualified experts who 
independently evaluate whether the available scientific data, 
information, and methods establish that a substance is safe under the 
conditions of its intended use in human food or animal food. Depending 
on the outcome of the GRAS panel's analysis, the proponent could either 
reach a conclusion regarding the safety of the substance under the 
conditions of its intended use or be advised of one or more issues 
(such as gaps in the data and information or alternative 
interpretations of the available data and information) that warrant 
investigation before a conclusion can be drawn about whether the 
substance is safe under the conditions of its intended use. When the 
outcome of the GRAS panel's analysis supports the proponent's 
conclusion that a substance is safe under the conditions of its 
intended use, in essence the proponent then relies on the members of 
the GRAS panel to act as a proxy for the larger scientific community 
knowledgeable about the safety of substances directly or indirectly 
added to food and, in so doing, relies on the outcome of the GRAS 
panel's analysis to support the proponent's conclusion that the safety 
of the intended use is ``generally recognized'' by qualified experts. 
Whether a GRAS panel is a sufficient proxy for the larger scientific 
community depends on a number of factors, such as the subject matter 
expertise of the members of the GRAS panel and whether the members of 
the GRAS panel would be considered representative of experts qualified 
by scientific training and experience to evaluate the safety of the 
substance under the conditions of its intended use.
    A GRAS panel is one mechanism that proponents have used to 
demonstrate that the safety of a substance under the conditions of its 
intended use is generally recognized by qualified experts. However, the 
use of a GRAS panel is not the only mechanism for doing so, and the use 
of a GRAS panel does not necessarily mean that the GRAS criteria have 
been met (81 FR 54960 at 54974 through 54975, August 17, 2016).
    We are announcing the availability of a guidance for industry 
entitled ``Best Practices for Convening a GRAS Panel.'' We are issuing 
this guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance represents the current thinking of FDA on 
this topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations.
    In the Federal Register of November 16, 2017 (82 FR 53433), we made 
available a draft guidance for industry entitled ``Best Practices for 
Convening a GRAS Panel'' (``draft guidance''), which was intended for 
any proponent who convenes a GRAS panel and provided our current 
thinking on best practices to identify GRAS panel members who have 
appropriate and balanced expertise; to take steps to reduce the risk 
that bias (or the appearance of bias) will affect the credibility of a 
GRAS panel report, including the assessment of potential GRAS panel 
members for conflict of interest and the appearance of conflict of 
interest; and to limit the data and information provided to a GRAS 
panel to public information (e.g., by not providing the GRAS panel with 
information such as trade secret information). We gave interested 
parties until May 15, 2018, to submit comments for us to consider 
before beginning work on the final version of the guidance.
    We received 13 comments on the draft guidance. Most comments 
supported the draft guidance and offered ideas on how to improve the 
guidance. One comment discussed FDA's analysis of the proposed 
collection of information, and another comment involved issues not 
related to the draft guidance. We have modified the final guidance 
where appropriate. Changes to the guidance include:
     Emphasizing that, in many cases, a GRAS panel is not 
necessary, in response to comments suggesting the GRAS notification 
process may become too burdensome;
     Providing additional background information regarding the 
value of a GRAS panel in providing evidence to support the ``general 
acceptance'' aspect of the criteria for eligibility for GRAS status 
through scientific procedures;
     Clarifying the GRAS panel policy discussions around 
evaluating and managing conflicts of interest and appearance issues, as 
well as honoraria;
     Removing one reference, as it has been withdrawn since 
publication of the draft guidance; and
     Removing a mistaken reference to a section V.J.
    The guidance announced in this notice finalizes the draft guidance 
dated November 2017.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The 
collections of information in this guidance have been approved under 
OMB control number 0910-0911.
    This guidance also refers to previously approved FDA collections of 
information. The collections of information in 21 CFR parts 170 and 570 
have been approved under OMB control number 0910-0342.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA websites listed in the previous 
sentence to find the most current version of the guidance.

    Dated: December 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27714 Filed 12-20-22; 8:45 am]
BILLING CODE 4164-01-P


