83 FR 12483 - Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 56 (March 22, 2018)

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry.'' The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard.

[Federal Register Volume 83, Number 56 (Thursday, March 22, 2018)]
[Rules and Regulations]
[Pages 12483-12485]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2018-D-0721]


Application of the Foreign Supplier Verification Program 
Regulation to the Importation of Live Animals: 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 guidance for industry entitled 
``Application of the Foreign Supplier Verification Program Regulations 
to the Importation of Live Animals: Guidance for Industry.'' The 
purpose of this document is to state FDA's intent to exercise 
enforcement discretion regarding application of the regulation on 
foreign supplier verification programs (FSVPs) to importers of certain 
live animals. The enforcement discretion would apply to importers of 
live animals that are required to be slaughtered and processed at U.S. 
Department of Agriculture (USDA) regulated establishments subject to 
USDA-administered Hazard Analysis and Critical Control Point (HACCP) 
requirements, or at State-inspected establishments subject to 
requirements equivalent to the Federal standard.

DATES: The announcement of the guidance is published in the Federal 
Register on March 22, 2018.

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. 
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-2018-D-0721 for ``Application of the Foreign Supplier Verification 
Program

[[Page 12484]]

Regulation to the Importation of Live Animals: Guidance for Industry.'' 
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 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.thefederalregister.org/fdsys/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 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, 5001 Campus Dr., College Park, MD 20740. 
Send two self-addressed adhesive labels to assist that office in 
processing your requests. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Sharon Mayl, Office of Foods and 
Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, 301-796-4716.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Application of the Foreign Supplier Verification Program 
Regulation to the Importation of Live Animals: Guidance for Industry.'' 
We are issuing this guidance consistent with our good guidance 
practices (GGP) regulation (21 CFR 10.115). We are implementing this 
guidance without prior public comment because we have determined that 
prior public participation is not feasible or appropriate (Sec.  
10.115(g)(2)). We made this determination because the guidance presents 
a less burdensome policy consistent with the public health. Although 
this guidance is immediately in effect, it remains subject to comment 
in accordance with FDA's GGP regulation. 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 is not subject to Executive 
Order 12866.
    Many live animals are imported into the United States for 
consumption as food. Most imported live animals (e.g., cattle and 
swine) that are for use as food are slaughtered under mandatory 
inspection by USDA's Food Safety and Inspection Service (FSIS) and are 
processed at USDA-regulated establishments subject to USDA-administered 
Hazard Analysis Critical Control Point (HACCP) requirements. The 
slaughter and processing of other live animals (e.g., farmed bison, 
boar, and elk) is under FDA's jurisdiction and is subject to FDA's 
current good manufacturing practice and, unless an exemption applies, 
preventive controls requirements (21 CFR part 117). Some animals under 
FDA jurisdiction (``FDA animals'') are slaughtered under voluntary 
inspection by USDA-FSIS.
    The importation into the United States of live animals for food use 
is subject to certain supplier verification requirements established in 
the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353). FSMA 
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add, 
among other food safety requirements, provisions requiring verification 
of the safety of food imported from foreign suppliers. Section 805(c) 
of the FD&C Act (21 U.S.C. 384(c)) directs FDA to issue regulations on 
the content of FSVPs. We issued the FSVP final rule on November 27, 
2015 (80 FR 74225).
    The FSVP regulation requires food importers to develop, maintain, 
and follow an FSVP that provides adequate assurances that the foreign 
supplier uses processes and procedures that provide the same level of 
public health protection as those required under the preventive 
controls or produce safety provisions of FSMA (if applicable) and 
regulations implementing those provisions, as well as assurances that 
the imported food is not adulterated and that human food is not 
misbranded with respect to allergen labeling (21 CFR 1.502(a)).
    The food resulting from the slaughter and processing of certain 
live animals cannot be consumed without slaughter and processing at 
establishments subject to USDA-administered HACCP requirements (or 
equivalent state programs). In light of the role of another Federal 
agency with regard to these animals, FDA intends to exercise 
enforcement discretion with respect to the FSVP regulation for 
importers of live animals that are imported for slaughter and 
processing at USDA-regulated establishments subject to USDA-
administered HACCP requirements, or imported for slaughter and 
processing under state requirements that are at least equivalent to the 
requirements for USDA-regulated establishments, including designated 
feeder animals. This means that we will not expect FSVP importers of 
live animals that are slaughtered and processed at USDA-inspected 
establishments subject to USDA-administered HACCP requirements (or 
State-inspected establishments subject to equivalent requirements) to 
meet any of the FSVP requirements.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. 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. 3501-3520). 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 document at 
either https://www.fda.gov/FoodGuidances or

[[Page 12485]]

https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: March 19, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05843 Filed 3-21-18; 8:45 am]
 BILLING CODE 4164-01-P