[Federal Register Volume 85, Number 59 (Thursday, March 26, 2020)]
[Rules and Regulations]
[Pages 17008-17009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 117, and 507

[Docket No. FDA-2020-D-1108]


Temporary Policy Regarding Preventive Controls and Foreign 
Supplier Verification Programs Food Supplier Verification Onsite Audit 
Requirements During the COVID-19 Public Health Emergency: 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, Agency, or we) is 
announcing the availability of a final guidance for industry entitled 
``Temporary Policy Regarding Preventive Controls and FSVP Food Supplier 
Verification Onsite Audit Requirements During the COVID-19 Public 
Health Emergency.'' The guidance communicates the Agency's intention 
not to enforce certain onsite audit requirements in three of our food 
safety regulations in certain circumstances related to the impact of 
the coronavirus if other supplier verification methods that are 
designed to provide sufficient assurance that hazards have been 
significantly minimized or prevented are used instead during the period 
of onsite audit delay.

DATES: The announcement of the guidance is published in the Federal 
Register on March 26, 2020.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: 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-2020-D-1108 for ``Temporary Policy Regarding Preventive Controls 
and FSVP Food Supplier Verification Onsite Audit Requirements During 
the COVID-19 Public Health Emergency.'' 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.
     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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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

[[Page 17009]]

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.
    You may submit comments on any guidance at any time (see Sec.  
10.115(g)(5) (21 CFR 10.115(g)(5))).
    Submit written requests for single copies of the guidance to the 
Office of Food Safety, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park, 
MD 20740. 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: 
    For questions relating to Current Good Manufacturing Practices 
(CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-
300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 
20740, 240-402-2166.
    For questions relating to CGMP, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals: Jeanette Murphy, Center for 
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-6246.
    For questions relating to Foreign Supplier Verification Programs 
(FSVP) for Importers of Food for Humans and Animals: Charlotte 
Christin, Office of Food Policy and Response, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-7526.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Temporary Policy Regarding Preventive Controls and FSVP Food 
Supplier Verification Onsite Audit Requirements During the COVID-19 
Public Health Emergency.'' We are issuing this guidance consistent with 
our good guidance practices regulation (Sec.  10.115). In accordance 
with Sec.  10.115(g)(2), we are implementing the guidance immediately 
because we have determined that prior public participation is not 
feasible or appropriate. Although the guidance document is immediately 
in effect, FDA will accept comments at any time. 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.
    This guidance document concerns certain supplier verification 
requirements contained in three of the seven foundational regulations 
that we have established in Title 21 of the Code of Federal Regulations 
(CFR) as part of our implementation of the FDA Food Safety 
Modernization Act (Pub. L. 111-353). The three final regulations are 
entitled ``Current Good Manufacturing Practice, Hazard Analysis, and 
Risk-Based Preventive Controls for Human Food'' (part 117 (21 CFR part 
117)) (https://www.fda.gov/food/guidanceregulation/fsma/ucm334115.htm); 
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals'' (part 507 (21 CFR part 507)) 
(https://www.fda.gov/food/guidanceregulation/fsma/ucm366510.htm); and 
``Foreign Supplier Verification Programs for Importers of Food for 
Humans and Animals'' (part 1, subpart L (21 CFR part 1, subpart L)) 
(https://www.fda.gov/food/guidanceregulation/fsma/ucm361902.htm). In 
brief, each of these regulations requires a supply-chain or supplier 
verification program in certain circumstances when a supplier is 
controlling a hazard. In addition, each of these regulations provides 
for onsite audits of suppliers under certain circumstances to verify 
that the hazard is being controlled.
    The purpose of the guidance is to state the current intent of FDA, 
in certain circumstances related to the impact of the coronavirus, not 
to enforce requirements in the three regulations to conduct onsite 
audits of food suppliers when other supplier verification methods are 
used to provide sufficient assurance that hazards have been 
significantly minimized or prevented, during the period of onsite audit 
delay.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of 
information. These collections of information 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 
part 117 have been approved under OMB control number 0910-0751. The 
collections of information in part 507 have been approved under OMB 
control number 0910-0789. The collections of information in part 1, 
subpart L have been approved under OMB control number 0910-0752.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: March 17, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05897 Filed 3-25-20; 8:45 am]
BILLING CODE 4164-01-P


