Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; Availability, 12483-12485 [2018-05843]

Download as PDF 12483 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Rules and Regulations Country License requirement Nyakek and Sons, Jubatown District near the Ivory Bank, Juba, South Sudan. Oranto Petroleum, Referendum Road, Juba, South Sudan. Safinat Group. South Sudan. SIPET Engineering and Consultancy Services, a.k.a., the following one alias: —SPECS. Tomping District opposite Arkel Restaurant, two blocks north of Airport Road, Juba, South Sudan. South Sudan Ministry of Mining, Nimra Talata, P.O. Box 376, Juba, South Sudan. South Sudan Ministry of Petroleum, Ministries Road, Opposite the Presidential Palace, P.O. Box 376, Juba, South Sudan. Sudd Petroleum Operating Co., a.k.a., the following one alias: —SPOC. Tharjath, Unity State, South Sudan. * * [FR Doc. 2018–05789 Filed 3–21–18; 8:45 am] BILLING CODE 3510–33–P 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 Food and Drug Administration, HHS. ACTION: Notification of availability. 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 daltland on DSKBBV9HB2PROD with RULES SUMMARY: VerDate Sep<11>2014 For all items subject to the EAR. (See § 744.11 of the EAR.) For all items subject to the EAR. (See § 744.11 of the EAR.) For all items subject to the EAR. (See § 744.11 of the EAR.) For all items subject to the EAR. (See § 744.11 of the EAR.) Presumption of denial ...... For all items subject to the EAR. (See § 744.11 of the EAR.) For all items subject to the EAR. (See § 744.11 of the EAR.) Presumption of denial ...... For all items subject to the EAR. (See § 744.11 of the EAR.) Presumption of denial ...... * Dated: March 16, 2018. Richard E. Ashooh, Assistant Secretary for Export Administration. AGENCY: License review policy Entity 17:42 Mar 21, 2018 Jkt 244001 * Presumption of denial ...... Presumption of denial ...... Presumption of denial ...... Presumption of denial ...... * 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, PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 Federal Register citation 83 FR [INSERT FR NUMBER AND 3/22/18]. 83 FR [INSERT FR NUMBER AND 3/22/18]. 83 FR [INSERT FR NUMBER AND 3/22/18]. 83 FR [INSERT FR NUMBER AND 3/22/18]. PAGE PAGE PAGE PAGE 83 FR [INSERT FR PAGE NUMBER AND 3/22/18]. 83 FR [INSERT FR PAGE NUMBER AND 3/22/18]. 83 FR [INSERT FR PAGE NUMBER AND 3/22/18]. * * 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 E:\FR\FM\22MRR1.SGM 22MRR1 daltland on DSKBBV9HB2PROD with RULES 12484 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Rules and Regulations 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 selfaddressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section VerDate Sep<11>2014 17:42 Mar 21, 2018 Jkt 244001 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 (§ 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 USDAadministered 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 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 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 USDAadministered 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 USDAinspected 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 E:\FR\FM\22MRR1.SGM 22MRR1 Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Rules and Regulations https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. FOR FURTHER INFORMATION CONTACT: Carrie Mann Lavigne, Chief Counsel, Saint Lawrence Seaway Development Corporation, 180 Andrews Street, Massena, New York 13662; 315/764– 3200. Dated: March 19, 2018. Leslie Kux, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF TRANSPORTATION Saint Lawrence Seaway Development Corporation 33 CFR Part 401 [Docket No. SLSDC–2016–0006] RIN 2135–AA43 Seaway Regulations and Rules: Periodic Update, Various Categories Saint Lawrence Seaway Development Corporation, DOT. ACTION: Final rule. AGENCY: The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Seaway Regulations and Rules in various categories. The changes update the following sections of the Regulations and Rules: Condition of Vessels; and, Dangerous Cargo. These amendments are merely editorial or for clarification of existing requirements. The joint regulations will become effective in Canada on March 29, 2018. For consistency, because these are joint regulations under international agreement, and to avoid confusion among users of the Seaway, the SLSDC finds that there is good cause to make the U.S. version of the amendments effective on the same date. DATES: This rule is effective on March 29, 2018. ADDRESSES: Docket: For access to the docket to read background documents or comments received, go to https:// www.Regulations.gov; or in person at the Docket Management Facility; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12–140, Washington, DC 20590–001, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. daltland on DSKBBV9HB2PROD with RULES SUMMARY: VerDate Sep<11>2014 17:42 Mar 21, 2018 Jkt 244001 The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Regulations and Rules (Practices and Procedures in Canada) in their respective jurisdictions. Under agreement with the SLSMC, the SLSDC is amending the joint regulations by updating the Regulations and Rules in various categories. The changes update the following sections of the Regulations and Rules: Condition of Vessels; and, Dangerous Cargo. These changes are to clarify existing requirements in the regulations. Regulatory Notices: Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT’s complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477–78) or you may visit https:// www.Regulations.gov. The joint regulations will become effective in Canada on March 29, 2018. SUPPLEMENTARY INFORMATION: [FR Doc. 2018–05843 Filed 3–21–18; 8:45 am] Regulatory Evaluation This regulation involves a foreign affairs function of the United States and therefore, Executive Order 12866 does not apply and evaluation under the Department of Transportation’s Regulatory Policies and Procedures is not required. 12485 affecting the quality of the human environment. Federalism The Corporation has analyzed this rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and have determined that this rule does not have sufficient federalism implications to warrant a Federalism Assessment. Unfunded Mandates The Corporation has analyzed this rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives. Paperwork Reduction Act This regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review. List of Subjects in 33 CFR Part 401 Hazardous materials transportation, Navigation (water), Penalties, Radio, Reporting and recordkeeping requirements, Vessels, Waterways. Accordingly, the Saint Lawrence Seaway Development Corporation amends 33 CFR part 401 as follows: PART 401—SEAWAY REGULATIONS AND RULES Subpart A—Regulations 1. The authority citation for subpart A of part 401 is revised to read as follows: ■ Authority: 33 U.S.C. 983(a) and 984(a)(4), as amended; 49 CFR 1.52, unless otherwise noted. 2. In § 401.12, revise paragraph (a)(3)(iii) to read as follows: Regulatory Flexibility Act Determination ■ I certify that this regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Regulations and Rules primarily relate to commercial users of the Seaway, the vast majority of who are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels. § 401.12 Minimum requirements—mooring lines and fairleads. Environmental Impact This regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, et seq.) because it is not a major federal action significantly PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 (a) * * * (3) * * * (iii) All lines shall be led through closed chocks or fairleads acceptable to the Manager and the Corporation. * * * * * ■ 3. In § 401.66, revise paragraph (a) to read as follows: § 401.66 Applicable laws. (a) Where a vessel on the seaway is involved in an accident or a dangerous occurrence, the master of the vessel shall report the accident or occurrence, E:\FR\FM\22MRR1.SGM 22MRR1

Agencies

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


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.gpo.gov/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
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