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)
Food and Drug Administration
Federal Register Volume 83, Issue 56 (March 22, 2018)
| Page Range | 12483-12485 | |
| FR Document | 2018-05843 |
[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] ======================================================================= ----------------------------------------------------------------------- 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.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
![Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Rules and Regulations 12483
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Nyakek and Sons, Jubatown District For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
near the Ivory Bank, Juba, South the EAR. (See § 744.11 NUMBER AND
Sudan. of the EAR.) 3/22/18].
Oranto Petroleum, Referendum Road, For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
Juba, South Sudan. the EAR. (See § 744.11 NUMBER AND
of the EAR.) 3/22/18].
Safinat Group. For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
South Sudan. the EAR. (See § 744.11 NUMBER AND
of the EAR.) 3/22/18].
SIPET Engineering and Consultancy For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
Services, a.k.a., the following one the EAR. (See § 744.11 NUMBER AND
alias: of the EAR.) 3/22/18].
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Tomping District opposite Arkel Res-
taurant, two blocks north of Airport
Road, Juba, South Sudan.
South Sudan Ministry of Mining, Nimra For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
Talata, P.O. Box 376, Juba, South the EAR. (See § 744.11 NUMBER AND
Sudan. of the EAR.) 3/22/18].
South Sudan Ministry of Petroleum, For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
Ministries Road, Opposite the Presi- the EAR. (See § 744.11 NUMBER AND
dential Palace, P.O. Box 376, Juba, of the EAR.) 3/22/18].
South Sudan.
Sudd Petroleum Operating Co., a.k.a., For all items subject to Presumption of denial ...... 83 FR [INSERT FR PAGE
the following one alias: the EAR. (See § 744.11 NUMBER AND
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Tharjath, Unity State, South Sudan.
* * * * * * *
Dated: March 16, 2018. on foreign supplier verification such as medical information, your or
Richard E. Ashooh, programs (FSVPs) to importers of anyone else’s Social Security number, or
Assistant Secretary for Export certain live animals. The enforcement confidential business information, such
Administration. discretion would apply to importers of as a manufacturing process. Please note
[FR Doc. 2018–05789 Filed 3–21–18; 8:45 am] live animals that are required to be that if you include your name, contact
BILLING CODE 3510–33–P slaughtered and processed at U.S. information, or other information that
Department of Agriculture (USDA) identifies you in the body of your
regulated establishments subject to comments, that information will be
DEPARTMENT OF HEALTH AND USDA-administered Hazard Analysis posted on https://www.regulations.gov.
HUMAN SERVICES and Critical Control Point (HACCP) • If you want to submit a comment
requirements, or at State-inspected with confidential information that you
Food and Drug Administration establishments subject to requirements do not wish to be made available to the
equivalent to the Federal standard. public, submit the comment as a
21 CFR Part 1 DATES: The announcement of the written/paper submission and in the
guidance is published in the Federal manner detailed (see ‘‘Written/Paper
[Docket No. FDA–2018–D–0721] Register on March 22, 2018. Submissions’’ and ‘‘Instructions’’).
Application of the Foreign Supplier ADDRESSES: You may submit either Written/Paper Submissions
Verification Program Regulation to the electronic or written comments on
Agency guidances at any time as Submit written/paper submissions as
Importation of Live Animals: Guidance follows:
for Industry; Availability follows:
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, Electronic Submissions written/paper submissions): Dockets
HHS. Submit electronic comments in the Management Staff (HFA–305), Food and
ACTION: Notification of availability. following way: Drug Administration, 5630 Fishers
• Federal eRulemaking Portal: Lane, Rm. 1061, Rockville, MD 20852.
SUMMARY: The Food and Drug https://www.regulations.gov. Follow the • For written/paper comments
Administration (FDA, Agency, or we) is instructions for submitting comments. submitted to the Dockets Management
announcing the availability of a Comments submitted electronically, Staff, FDA will post your comment, as
guidance for industry entitled including attachments, to https:// well as any attachments, except for
‘‘Application of the Foreign Supplier www.regulations.gov will be posted to information submitted, marked and
daltland on DSKBBV9HB2PROD with RULES
Verification Program Regulations to the the docket unchanged. Because your identified, as confidential, if submitted
Importation of Live Animals: Guidance comment will be made public, you are as detailed in ‘‘Instructions.’’
for Industry.’’ The purpose of this solely responsible for ensuring that your Instructions: All submissions received
document is to state FDA’s intent to comment does not include any must include the Docket No. FDA–
exercise enforcement discretion confidential information that you or a 2018–D–0721 for ‘‘Application of the
regarding application of the regulation third party may not wish to be posted, Foreign Supplier Verification Program
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![Federal Register / Vol. 83, No. 56 / Thursday, March 22, 2018 / Rules and Regulations 12485
https://www.regulations.gov. Use the FOR FURTHER INFORMATION CONTACT: affecting the quality of the human
FDA website listed in the previous Carrie Mann Lavigne, Chief Counsel, environment.
sentence to find the most current Saint Lawrence Seaway Development
Federalism
version of the guidance. Corporation, 180 Andrews Street,
Dated: March 19, 2018. Massena, New York 13662; 315/764– The Corporation has analyzed this
3200. rule under the principles and criteria in
Leslie Kux,
Executive Order 13132, dated August 4,
Associate Commissioner for Policy. SUPPLEMENTARY INFORMATION: The Saint 1999, and have determined that this rule
[FR Doc. 2018–05843 Filed 3–21–18; 8:45 am] Lawrence Seaway Development does not have sufficient federalism
BILLING CODE 4164–01–P Corporation (SLSDC) and the St. implications to warrant a Federalism
Lawrence Seaway Management Assessment.
Corporation (SLSMC) of Canada, under
DEPARTMENT OF TRANSPORTATION international agreement, jointly publish Unfunded Mandates
and presently administer the St. The Corporation has analyzed this
Saint Lawrence Seaway Development Lawrence Seaway Regulations and rule under Title II of the Unfunded
Corporation Rules (Practices and Procedures in Mandates Reform Act of 1995 (Pub. L.
Canada) in their respective jurisdictions. 104–4, 109 Stat. 48) and determined that
33 CFR Part 401 Under agreement with the SLSMC, the it does not impose unfunded mandates
SLSDC is amending the joint regulations on State, local, and tribal governments
[Docket No. SLSDC–2016–0006] by updating the Regulations and Rules and the private sector requiring a
RIN 2135–AA43 in various categories. The changes written statement of economic and
update the following sections of the regulatory alternatives.
Seaway Regulations and Rules: Regulations and Rules: Condition of
Periodic Update, Various Categories Vessels; and, Dangerous Cargo. These Paperwork Reduction Act
changes are to clarify existing This regulation has been analyzed
AGENCY: Saint Lawrence Seaway
requirements in the regulations. under the Paperwork Reduction Act of
Development Corporation, DOT.
Regulatory Notices: Privacy Act: 1995 and does not contain new or
ACTION: Final rule. Anyone is able to search the electronic modified information collection
SUMMARY: The Saint Lawrence Seaway form of all comments received into any requirements subject to the Office of
Development Corporation (SLSDC) and of our dockets by the name of the Management and Budget review.
the St. Lawrence Seaway Management individual submitting the comment (or
signing the comment, if submitted on List of Subjects in 33 CFR Part 401
Corporation (SLSMC) of Canada, under
international agreement, jointly publish behalf of an association, business, labor Hazardous materials transportation,
and presently administer the St. union, etc.). You may review DOT’s Navigation (water), Penalties, Radio,
Lawrence Seaway Regulations and complete Privacy Act Statement in the Reporting and recordkeeping
Rules (Practices and Procedures in Federal Register published on April 11, requirements, Vessels, Waterways.
Canada) in their respective jurisdictions. 2000 (Volume 65, Number 70; Pages Accordingly, the Saint Lawrence
Under agreement with the SLSMC, the 19477–78) or you may visit http:// Seaway Development Corporation
SLSDC is amending the joint regulations www.Regulations.gov. amends 33 CFR part 401 as follows:
by updating the Seaway Regulations and The joint regulations will become
Rules in various categories. The changes effective in Canada on March 29, 2018. PART 401—SEAWAY REGULATIONS
update the following sections of the AND RULES
Regulatory Evaluation
Regulations and Rules: Condition of Subpart A—Regulations
Vessels; and, Dangerous Cargo. These This regulation involves a foreign
amendments are merely editorial or for affairs function of the United States and
therefore, Executive Order 12866 does ■ 1. The authority citation for subpart A
clarification of existing requirements. of part 401 is revised to read as follows:
The joint regulations will become not apply and evaluation under the
Department of Transportation’s Authority: 33 U.S.C. 983(a) and 984(a)(4),
effective in Canada on March 29, 2018. as amended; 49 CFR 1.52, unless otherwise
For consistency, because these are joint Regulatory Policies and Procedures is
not required. noted.
regulations under international
agreement, and to avoid confusion Regulatory Flexibility Act ■ 2. In § 401.12, revise paragraph
among users of the Seaway, the SLSDC Determination (a)(3)(iii) to read as follows:
finds that there is good cause to make § 401.12 Minimum requirements—mooring
I certify that this regulation will not
the U.S. version of the amendments lines and fairleads.
have a significant economic impact on
effective on the same date. (a) * * *
a substantial number of small entities.
DATES: This rule is effective on March The St. Lawrence Seaway Regulations (3) * * *
29, 2018. and Rules primarily relate to (iii) All lines shall be led through
ADDRESSES: Docket: For access to the commercial users of the Seaway, the closed chocks or fairleads acceptable to
docket to read background documents vast majority of who are foreign vessel the Manager and the Corporation.
or comments received, go to http:// operators. Therefore, any resulting costs * * * * *
www.Regulations.gov; or in person at will be borne mostly by foreign vessels. ■ 3. In § 401.66, revise paragraph (a) to
the Docket Management Facility; U.S.
daltland on DSKBBV9HB2PROD with RULES
Environmental Impact read as follows:
Department of Transportation, 1200
New Jersey Avenue SE, West Building This regulation does not require an § 401.66 Applicable laws.
Ground Floor, Room W12–140, environmental impact statement under (a) Where a vessel on the seaway is
Washington, DC 20590–001, between 9 the National Environmental Policy Act involved in an accident or a dangerous
a.m. and 5 p.m., Monday through (49 U.S.C. 4321, et seq.) because it is not occurrence, the master of the vessel
Friday, except Federal Holidays. a major federal action significantly shall report the accident or occurrence,
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Document Created: 2018-03-22 01:25:05
Document Modified: 2018-03-22 01:25:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on March 22, 2018. | |
| Contact | Sharon Mayl, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4716. | |
| FR Citation | 83 FR 12483 |
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