83 FR 3445 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 17 (January 25, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 17 (January 25, 2018)
| Page Range | 3445-3446 | |
| FR Document | 2018-01297 |
[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)] [Proposed Rules] [Pages 3445-3446] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01297] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2017-D-5225] Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.'' The draft guidance, once finalized, will provide our thinking on how importers of human or animal food can comply with the regulation on foreign supplier verification programs (FSVPs) issued on November 27, 2015. DATES: Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, ADDRESSES: You may submit comments on any guidance at any time as follows.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-5225 for ``Foreign Supplier Verification Programs for Importers of Food for Humans and 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 [[Page 3446]] 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 draft guidance to the Outreach and Information Center (HFS-009), Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Office of Compliance (HFS-600), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, 240-701-5986. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of November 27, 2015 (80 FR 74226), we issued a final rule adopting a regulation on foreign supplier verification programs (FSVPs) for importers of food for humans and animals (FSVP final rule). The FSVP final rule implements section 301 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), which enables the Agency to better protect public health by helping to ensure the safety and security of the food supply. Section 301 of FSMA added section 805 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) to require persons who import food into the United States to perform risk-based foreign supplier verification activities. In addition to directing FDA to issue regulations on the content of FSVPs, section 805 directs FDA to issue guidance to assist importers in developing FSVPs. In accordance with section 805 of the FD&C Act, we are announcing the availability of a draft guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.'' The draft guidance, once finalized, will provide our thinking on how to comply with the FSVP regulation, including, but not limited to, requirements to analyze the hazards in food, evaluate a potential foreign supplier's performance and the risk posed by a food, and determine and conduct appropriate foreign supplier verification activities. The draft guidance also addresses how importers can meet the modified FSVP requirements for importers of dietary supplements, very small importers, importers of food from certain small foreign suppliers, and importers of food from countries whose food safety systems we have officially recognized as comparable or determined to be equivalent to that of the United States. The draft guidance reflects interpretations regarding two matters addressed in the preamble to the FSVP final rule that differ from the interpretations expressed there. First, the draft guidance reflects an interpretation that is different from our statement in the preamble to the FSVP final rule that waxing and cooling raw agricultural commodities, when done by a packing operation for purposes of storage or transport, may be considered a packing activity (see 80 FR 74226 at 74236 (Comment/Response 14)). Instead, the draft guidance states that such activities may be packing activities and/or holding activities, depending on the circumstances. This change reflects our revised thinking regarding the classification of waxing, which we now consider may be incidental to holding (not packing) under certain circumstances (see ``Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: Draft Guidance for Industry'' (81 FR 58421, August 25, 2016) available at: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM517575.pdf). Second, the draft guidance reflects an interpretation that differs from our statement in the preamble to the FSVP final rule that there may be circumstances in which hazards that may be intentionally introduced by acts of terrorism may present a known or reasonably foreseeable hazard, such that importers may need to address these hazards as part of their supplier verification activities (see 80 FR 74226 at 74281 (Comment/ Response 174)). That statement assumed that importers would consider such hazards in their hazard analyses. In the draft guidance, we clarify that importers are not required under the FSVP regulation to consider in their hazard analysis hazards that are intentionally introduced to cause wide scale public health harm. Instead, importers should consider warning letters or other enforcement action taken by FDA against foreign suppliers for violation of FDA's regulation on intentional adulteration (in 21 CFR part 121) as part of their evaluation of potential suppliers under 21 CFR 1.505 in the FSVP regulation. Our prior statements were incorrect and we hereby withdraw them. We further explain our thinking on these matters in the FSVP draft guidance. II. Significance of Guidance This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent 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 may use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866. III. Paperwork Reduction Act of 1995 This draft 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 21 CFR part 1, subpart L, have been approved under OMB control number 0910-0752. IV. Electronic Access Persons with access to the internet may obtain the draft 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 draft guidance. Dated: January 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01297 Filed 1-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules 3445
FSMA also includes provisions III. Electronic Access such as medical information, your or
requiring certain food facilities to Persons with access to the internet anyone else’s Social Security number, or
implement preventive controls to, may obtain the guidance at either confidential business information, such
among other things, provide assurances https://www.fda.gov/FoodGuidances or as a manufacturing process. Please note
that hazards identified in a hazard https://www.regulations.gov. Use the that if you include your name, contact
analysis will be significantly minimized FDA website listed in the previous information, or other information that
or prevented. FDA’s final rules on sentence to find the most current identifies you in the body of your
current good manufacturing practice, version of the guidance. comments, that information will be
hazard analysis, and risk-based posted on https://www.regulations.gov.
preventive controls for human food (80 Dated: January 18, 2018. • If you want to submit a comment
FR 55908, September 17, 2015) and for Leslie Kux, with confidential information that you
animal food (80 FR 56170, September Associate Commissioner for Policy. do not wish to be made available to the
17, 2015) include provisions requiring [FR Doc. 2018–01298 Filed 1–24–18; 8:45 am] public, submit the comment as a
receiving facilities to conduct a hazard BILLING CODE 4164–01–P written/paper submission and in the
analysis and to establish and implement manner detailed (see ‘‘Written/Paper
supply-chain programs for domestic and Submissions’’ and ‘‘Instructions’’).
imported raw materials and other DEPARTMENT OF HEALTH AND Written/Paper Submissions
ingredients for which the facility has HUMAN SERVICES
identified a hazard requiring a supply- Submit written/paper submissions as
chain applied control. Food and Drug Administration follows:
• Mail/Hand delivery/Courier (for
The preventive controls requirements, written/paper submissions): Dockets
including the supply-chain program 21 CFR Part 1
Management Staff (HFA–305), Food and
provisions, do not apply to facilities that [Docket No. FDA–2017–D–5225] Drug Administration, 5630 Fishers
are solely engaged in the storage of non- Lane, Rm. 1061, Rockville, MD 20852.
produce RACs (including grain RACs) Foreign Supplier Verification Programs
• For written/paper comments
intended for further distribution or for Importers of Food for Humans and
submitted to the Dockets Management
processing. However, the FSVP Animals; Draft Guidance for Industry;
Staff, FDA will post your comment, as
regulation applies to all importers of Availability
well as any attachments, except for
non-produce RACs, including importers AGENCY: Food and Drug Administration, information submitted, marked and
that are solely engaged in the storage of HHS. identified, as confidential, if submitted
these RACs intended for further ACTION: Notification of availability. as detailed in ‘‘Instructions.’’
processing. Instructions: All submissions received
The guidance describes FDA’s current SUMMARY: The Food and Drug must include the Docket No. FDA–
thinking on the application of the FSVP Administration (FDA, the Agency, or 2017–D–5225 for ‘‘Foreign Supplier
regulation to importers of grain RACs. we) is announcing the availability of a Verification Programs for Importers of
To better align the FSVP regulation with draft guidance for industry entitled Food for Humans and Animals:
the exemption from preventive controls ‘‘Foreign Supplier Verification Programs Guidance for Industry.’’ Received
requirements for facilities solely for Importers of Food for Humans and comments will be placed in the docket
engaged in the storage of non-produce Animals.’’ The draft guidance, once and, except for those submitted as
RACs, and because of the nature of the finalized, will provide our thinking on ‘‘Confidential Submissions,’’ publicly
hazards associated with grain RACs and how importers of human or animal food viewable at https://www.regulations.gov
how they are generally addressed in the can comply with the regulation on or at the Dockets Management Staff
distribution chain, we intend to exercise foreign supplier verification programs between 9 a.m. and 4 p.m., Monday
enforcement discretion for importers of (FSVPs) issued on November 27, 2015. through Friday.
grain RACs that are solely engaged in DATES: Submit either electronic or • Confidential Submissions—To
the storage of grain intended for further written comments on the draft guidance submit a comment with confidential
distribution or processing with respect by May 25, 2018 to ensure that the information that you do not wish to be
to the FSVP regulation. This intent to Agency considers your comments on made publicly available, submit your
exercise enforcement discretion with this draft guidance before it completes comments only as a written/paper
respect to FSVP also applies to grain a final version of the guidance, submission. You should submit two
importers that do not take physical ADDRESSES: You may submit comments copies total. One copy will include the
possession of the grain they import but on any guidance at any time as follows. information you claim to be confidential
instead arrange for the delivery of the with a heading or cover note that states
grain to others for storage, packing or Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
manufacturing/processing. Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
following way: Agency will review this copy, including
II. Paperwork Reduction Act of 1995
• Federal eRulemaking Portal: the claimed confidential information, in
This guidance refers to previously https://www.regulations.gov. Follow the its consideration of comments. The
approved collections of information instructions for submitting comments. second copy, which will have the
found in FDA regulations. These Comments submitted electronically, claimed confidential information
sradovich on DSK3GMQ082PROD with PROPOSALS
collections of information are subject to including attachments, to https:// redacted/blacked out, will be available
review by the Office of Management and www.regulations.gov will be posted to for public viewing and posted on
Budget (OMB) under the Paperwork the docket unchanged. Because your https://www.regulations.gov. Submit
Reduction Act of 1995 (44 U.S.C. 3501– comment will be made public, you are both copies to the Dockets Management
3520). The collections of information in solely responsible for ensuring that your Staff. If you do not wish your name and
21 CFR part 1, subpart L have been comment does not include any contact information to be made publicly
approved under OMB control number confidential information that you or a available, you can provide this
0910–0752. third party may not wish to be posted, information on the cover sheet and not
VerDate Sep<11>2014 16:54 Jan 24, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 E:\FR\FM\25JAP1.SGM 25JAP1](https://thefederalregister.org/doc/83_FR_3462/page/1.svg)
![3446 Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules
in the body of your comments and you FSVPs, section 805 directs FDA to issue verification activities (see 80 FR 74226
must identify this information as guidance to assist importers in at 74281 (Comment/Response 174)).
‘‘confidential.’’ Any information marked developing FSVPs. That statement assumed that importers
as ‘‘confidential’’ will not be disclosed In accordance with section 805 of the would consider such hazards in their
except in accordance with 21 CFR 10.20 FD&C Act, we are announcing the hazard analyses. In the draft guidance,
and other applicable disclosure law. For availability of a draft guidance for we clarify that importers are not
more information about FDA’s posting industry entitled ‘‘Foreign Supplier required under the FSVP regulation to
of comments to public dockets, see 80 Verification Programs for Importers of consider in their hazard analysis
FR 56469, September 18, 2015, or access Food for Humans and Animals.’’ The hazards that are intentionally
the information at: https://www.gpo.gov/ draft guidance, once finalized, will introduced to cause wide scale public
fdsys/pkg/FR-2015-09-18/pdf/2015- provide our thinking on how to comply
health harm. Instead, importers should
23389.pdf. with the FSVP regulation, including, but
consider warning letters or other
Docket: For access to the docket to not limited to, requirements to analyze
the hazards in food, evaluate a potential enforcement action taken by FDA
read background documents or the against foreign suppliers for violation of
electronic and written/paper comments foreign supplier’s performance and the
risk posed by a food, and determine and FDA’s regulation on intentional
received, go to https://
conduct appropriate foreign supplier adulteration (in 21 CFR part 121) as part
www.regulations.gov and insert the
verification activities. The draft of their evaluation of potential suppliers
docket number, found in brackets in the
guidance also addresses how importers under 21 CFR 1.505 in the FSVP
heading of this document, into the
‘‘Search’’ box and follow the prompts can meet the modified FSVP regulation. Our prior statements were
and/or go to the Dockets Management requirements for importers of dietary incorrect and we hereby withdraw
Staff, 5630 Fishers Lane, Rm. 1061, supplements, very small importers, them. We further explain our thinking
Rockville, MD 20852. importers of food from certain small on these matters in the FSVP draft
You may submit comments on any foreign suppliers, and importers of food guidance.
guidance at any time (see 21 CFR from countries whose food safety
systems we have officially recognized as II. Significance of Guidance
10.115(g)(5)).
Submit written requests for single comparable or determined to be This level 1 draft guidance is being
copies of the draft guidance to the equivalent to that of the United States. issued consistent with FDA’s good
Outreach and Information Center (HFS– The draft guidance reflects guidance practices regulation (21 CFR
009), Center for Food Safety and interpretations regarding two matters
10.115). The draft guidance, when
Applied Nutrition (HFS–317), Food and addressed in the preamble to the FSVP
finalized, will represent the current
Drug Administration, 5001 Campus Dr., final rule that differ from the
interpretations expressed there. First, thinking of FDA on this topic. It does
College Park, MD 20740. Send one self- not establish any rights for any person
addressed adhesive label to assist that the draft guidance reflects an
interpretation that is different from our and is not binding on FDA or the public.
office in processing your requests. See You may use an alternative approach if
the SUPPLEMENTARY INFORMATION section statement in the preamble to the FSVP
final rule that waxing and cooling raw it satisfies the requirements of the
for electronic access to the draft applicable statutes and regulations. This
agricultural commodities, when done by
guidance document. draft guidance is not subject to
a packing operation for purposes of
FOR FURTHER INFORMATION CONTACT: storage or transport, may be considered Executive Order 12866.
Mischelle B. Ledet, Office of a packing activity (see 80 FR 74226 at
Compliance (HFS–600), Center for Food III. Paperwork Reduction Act of 1995
74236 (Comment/Response 14)).
Safety and Applied Nutrition, 5001 Instead, the draft guidance states that This draft guidance refers to
Campus Dr., College Park, MD 20740, such activities may be packing activities previously approved collections of
240–701–5986. and/or holding activities, depending on information found in FDA regulations.
SUPPLEMENTARY INFORMATION: the circumstances. This change reflects These collections of information are
I. Background our revised thinking regarding the subject to review by the Office of
classification of waxing, which we now Management and Budget (OMB) under
In the Federal Register of November consider may be incidental to holding the Paperwork Reduction Act of 1995
27, 2015 (80 FR 74226), we issued a (not packing) under certain (44 U.S.C. 3501–3520). The collections
final rule adopting a regulation on circumstances (see ‘‘Classification of of information in 21 CFR part 1, subpart
foreign supplier verification programs Activities as Harvesting, Packing, L, have been approved under OMB
(FSVPs) for importers of food for Holding, or Manufacturing/Processing control number 0910–0752.
humans and animals (FSVP final rule). for Farms and Facilities: Draft Guidance
The FSVP final rule implements section for Industry’’ (81 FR 58421, August 25, IV. Electronic Access
301 of the FDA Food Safety 2016) available at: https://www.fda.gov/
Modernization Act (FSMA) (Pub. L. downloads/Food/GuidanceRegulation/ Persons with access to the internet
111–353), which enables the Agency to GuidanceDocumentsRegulatory may obtain the draft guidance at either
better protect public health by helping Information/UCM517575.pdf). Second, https://www.fda.gov/FoodGuidances or
to ensure the safety and security of the the draft guidance reflects an https://www.regulations.gov. Use the
food supply. interpretation that differs from our FDA website listed in the previous
sradovich on DSK3GMQ082PROD with PROPOSALS
Section 301 of FSMA added section statement in the preamble to the FSVP sentence to find the most current
805 to the Federal Food, Drug, and final rule that there may be version of the draft guidance.
Cosmetic Act (FD&C Act) (21 U.S.C. circumstances in which hazards that Dated: January 18, 2018.
384a) to require persons who import may be intentionally introduced by acts
Leslie Kux,
food into the United States to perform of terrorism may present a known or
risk-based foreign supplier verification reasonably foreseeable hazard, such that Associate Commissioner for Policy.
activities. In addition to directing FDA importers may need to address these [FR Doc. 2018–01297 Filed 1–24–18; 8:45 am]
to issue regulations on the content of hazards as part of their supplier BILLING CODE 4164–01–P
VerDate Sep<11>2014 16:54 Jan 24, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4702 Sfmt 9990 E:\FR\FM\25JAP1.SGM 25JAP1](https://thefederalregister.org/doc/83_FR_3462/page/2.svg)
Document Created: 2018-01-25 08:50:29
Document Modified: 2018-01-25 08:50:29
| 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 | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comments on this draft guidance before it completes a final version of the guidance, | |
| Contact | Mischelle B. Ledet, Office of Compliance (HFS-600), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, 240-701-5986. | |
| FR Citation | 83 FR 3445 |
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