83 FR 3443 - Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: 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 | 3443-3445 | |
| FR Document | 2018-01298 |
[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)] [Proposed Rules] [Pages 3443-3445] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01298] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2017-D-6592] Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry.'' This guidance is intended to explain our intent to exercise enforcement discretion for importers of grain raw agricultural commodities (RACs) that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing. [[Page 3444]] DATES: The announcement of the guidance is published in the Federal Register on January 25, 2018. ADDRESSES: You may submit either electronic or written comments on FDA 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-2017-D-6592 for ``Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: 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 Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Sharon Mayl, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4719. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ``Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry.'' We are issuing the guidance consistent with our good guidance practices regulation Sec. 10.115 (21 CFR 10.115). In accordance with Sec. 10.115(g)(2), we are implementing the guidance immediately because we have determined that prior public participation is not feasible or appropriate. We made this determination because this guidance document provides information pertaining to regulations with which many importers were required to comply as of May 30, 2017, and it sets out compliance policy that reduces regulatory burdens for importers of certain raw agricultural commodities. Although the guidance document is immediately in effect, we invite comments at any time in accordance with the Agency's good guidance practices (Sec. 10.115(g)(3)). 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add, among other food safety requirements, provisions requiring the verification of the safety of food imported from foreign suppliers of that food. Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA to issue regulations on the content of Foreign Supplier Verification Programs (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 and 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. [[Page 3445]] FSMA also includes provisions requiring certain food facilities to implement preventive controls to, among other things, provide assurances that hazards identified in a hazard analysis will be significantly minimized or prevented. FDA's final rules on current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food (80 FR 55908, September 17, 2015) and for animal food (80 FR 56170, September 17, 2015) include provisions requiring receiving facilities to conduct a hazard analysis and to establish and implement supply-chain programs for domestic and imported raw materials and other ingredients for which the facility has identified a hazard requiring a supply-chain applied control. The preventive controls requirements, including the supply-chain program provisions, do not apply to facilities that are solely engaged in the storage of non-produce RACs (including grain RACs) intended for further distribution or processing. However, the FSVP regulation applies to all importers of non-produce RACs, including importers that are solely engaged in the storage of these RACs intended for further processing. The guidance describes FDA's current thinking on the application of the FSVP regulation to importers of grain RACs. To better align the FSVP regulation with the exemption from preventive controls requirements for facilities solely engaged in the storage of non- produce RACs, and because of the nature of the hazards associated with grain RACs and how they are generally addressed in the distribution chain, we intend to exercise enforcement discretion for importers of grain RACs that are solely engaged in the storage of grain intended for further distribution or processing with respect to the FSVP regulation. This intent to exercise enforcement discretion with respect to FSVP also applies to grain importers that do not take physical possession of the grain they import but instead arrange for the delivery of the grain to others for storage, packing or manufacturing/processing. 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 21 CFR part 1, subpart L have been approved under OMB control number 0910-0752. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: January 18, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01298 Filed 1-24-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules 3443
written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015- statutes and regulations. This guidance
manner detailed (see ‘‘Written/Paper 23389.pdf. is not subject to Executive Order 12866.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
II. Paperwork Reduction Act of 1995
read background documents or the
Written/Paper Submissions This guidance refers to previously
electronic and written/paper comments
Submit written/paper submissions as received, go to https:// approved collections of information
follows: www.regulations.gov and insert the found in FDA regulations. These
• Mail/Hand delivery/Courier (for docket number, found in brackets in the collections of information are subject to
written/paper submissions): Dockets heading of this document, into the review by the Office of Management and
Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts Budget (OMB) under the Paperwork
Drug Administration, 5630 Fishers and/or go to the Dockets Management Reduction Act of 1995 (44 U.S.C. 3501–
Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061, 3520). The collections of information in
• For written/paper comments Rockville, MD 20852. 21 CFR part 1, subpart L, have been
submitted to the Dockets Management You may submit comments on any approved under OMB control number
Staff, FDA will post your comment, as guidance at any time (see 21 CFR 0910–0752.
well as any attachments, except for 10.115(g)(5)). III. Electronic Access
information submitted, marked and See the SUPPLEMENTARY INFORMATION
section for electronic access to the Persons with access to the internet
identified, as confidential, if submitted may obtain the SECG at either https://
as detailed in ‘‘Instructions.’’ SECG.
www.fda.gov/FoodGuidances or https://
Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: www.regulations.gov. Use the FDA
must include the Docket No. FDA– Sharon Mayl, Office of Foods and website listed in the previous sentence
2011–N–0143 for ‘‘What You Need to Veterinary Medicine, Food and Drug to find the most current version of the
Know About the FDA Regulation: Administration, 10903 New Hampshire guidance.
Foreign Supplier Verification Programs Ave., Silver Spring, MD 20993–0002,
for Importers of Food for Humans and Dated: January 19, 2018.
301–796–4719.
Animals—Small Entity Compliance Leslie Kux,
SUPPLEMENTARY INFORMATION:
Guide.’’ Received comments will be Associate Commissioner for Policy.
placed in the docket and, except for I. Background [FR Doc. 2018–01300 Filed 1–24–18; 8:45 am]
those submitted as ‘‘Confidential In the Federal Register of November BILLING CODE 4164–01–P
Submissions,’’ publicly viewable at 27, 2015 (80 FR 74225), we issued a
https://www.regulations.gov or at the final rule entitled ‘‘Foreign Supplier
Dockets Management Staff between Verification Programs for Importers of DEPARTMENT OF HEALTH AND
9 a.m. and 4 p.m., Monday through Food for Humans and Animals’’ (the HUMAN SERVICES
Friday. final rule) that requires importers to
Food and Drug Administration
• Confidential Submissions—To perform certain risk-based activities to
submit a comment with confidential verify that food imported into the
21 CFR Part 1
information that you do not wish to be United States has been produced in a
made publicly available, submit your manner that meets applicable U.S. [Docket No. FDA–2017–D–6592]
comments only as a written/paper safety standards. The final rule, which
submission. You should submit two is codified at 21 CFR part 1, subpart L, Application of the Foreign Supplier
copies total. One copy will include the became effective January 26, 2016, but Verification Program Regulation to
information you claim to be confidential has compliance dates starting May 30, Importers of Grain Raw Agricultural
with a heading or cover note that states 2017. Commodities: Guidance for Industry;
‘‘THIS DOCUMENT CONTAINS We examined the economic Availability
CONFIDENTIAL INFORMATION.’’ The implications of the final rule as required AGENCY: Food and Drug Administration,
Agency will review this copy, including by the Regulatory Flexibility Act (5 HHS.
the claimed confidential information, in U.S.C. 601–612) and determined that ACTION: Notification of availability.
its consideration of comments. The the final rule will have a significant
second copy, which will have the economic impact on a substantial SUMMARY: The Food and Drug
claimed confidential information number of small entities. In compliance Administration (FDA, we, or Agency) is
redacted/blacked out, will be available with section 212 of the Small Business announcing the availability of a
for public viewing and posted on Regulatory Enforcement Fairness Act guidance for industry entitled
https://www.regulations.gov. Submit (Pub. L. 104–121, as amended by Pub. ‘‘Application of the Foreign Supplier
both copies to the Dockets Management L. 110–28), we are making available the Verification Program Regulation to
Staff. If you do not wish your name and SECG to reduce the burden of Importers of Grain Raw Agricultural
contact information to be made publicly determining how to comply by further Commodities: Guidance for Industry.’’
available, you can provide this explaining and clarifying the actions This guidance is intended to explain our
information on the cover sheet and not that a small entity must take to comply intent to exercise enforcement
in the body of your comments and you with the rule. discretion for importers of grain raw
must identify this information as We are issuing the SECG consistent agricultural commodities (RACs) that
sradovich on DSK3GMQ082PROD with PROPOSALS
‘‘confidential.’’ Any information marked with our good guidance practices are solely engaged in the storage of grain
as ‘‘confidential’’ will not be disclosed regulation (21 CFR 10.115(c)(2)). The intended for further distribution or
except in accordance with 21 CFR 10.20 SECG represents the current thinking of processing and grain importers that do
and other applicable disclosure law. For FDA on this topic. It does not establish not take physical possession of the grain
more information about FDA’s posting any rights for any person and is not they import, but instead arrange for the
of comments to public dockets, see 80 binding on FDA or the public. You can delivery of the grain to others for
FR 56469, September 18, 2015, or access use an alternative approach if it satisfies storage, packing, or manufacturing/
the information at: https://www.gpo.gov/ the requirements of the applicable processing.
VerDate Sep<11>2014 16:54 Jan 24, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 E:\FR\FM\25JAP1.SGM 25JAP1](https://thefederalregister.org/doc/83_FR_3460/page/1.svg)
![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_3460/page/3.svg)
Document Created: 2018-01-25 08:50:40
Document Modified: 2018-01-25 08:50:40
| 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 | The announcement of the guidance is published in the Federal Register on January 25, 2018. | |
| Contact | Sharon Mayl, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4719. | |
| FR Citation | 83 FR 3443 |
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