83 FR 3442 - Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; 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 | 3442-3443 | |
| FR Document | 2018-01300 |
[Federal Register Volume 83, Number 17 (Thursday, January 25, 2018)] [Proposed Rules] [Pages 3442-3443] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01300] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2011-N-0143] Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; 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 guidance for industry entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.'' 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 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 [[Page 3443]] 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-2011-N-0143 for ``What You Need to Know About the FDA Regulation: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals--Small Entity Compliance Guide.'' 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)). See the SUPPLEMENTARY INFORMATION section for electronic access to the SECG. 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 In the Federal Register of November 27, 2015 (80 FR 74225), we issued a final rule entitled ``Foreign Supplier Verification Programs for Importers of Food for Humans and Animals'' (the final rule) that requires importers to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. The final rule, which is codified at 21 CFR part 1, subpart L, became effective January 26, 2016, but has compliance dates starting May 30, 2017. We examined the economic implications of the final rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and determined that the final rule will have a significant economic impact on a substantial number of small entities. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104- 121, as amended by Pub. L. 110-28), we are making available the SECG to reduce the burden of determining how to comply by further explaining and clarifying the actions that a small entity must take to comply with the rule. We are issuing the SECG consistent with our good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 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. 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 SECG 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 19, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-01300 Filed 1-24-18; 8:45 am] BILLING CODE 4164-01-P
![3442 Federal Register / Vol. 83, No. 17 / Thursday, January 25, 2018 / Proposed Rules
Commission’s Online Support at (202) not the same as it was in July 2016. I DEPARTMENT OF HEALTH AND
502–6652 (toll free at 1–866–208–3676) acknowledge that a significant amount of HUMAN SERVICES
or e-mail at ferconlinesupport@ferc.gov, time and effort have been committed to the
or the Public Reference Room at (202) development of these standards in response Food and Drug Administration
502–8371, TTY (202) 502–8659. E-mail to a duly voted Commission order. Most
the Public Reference Room at importantly, I agree that they are an 21 CFR Part 1
public.referenceroom@ferc.gov. improvement over the status quo. I do not
[Docket No. FDA–2011–N–0143]
believe that remanding these standards or the
By direction of the Commission.
Commissioner LaFleur is concurring with a larger supply chain issue to the NERC Foreign Supplier Verification Programs
separate statement attached. standards process would be a prudent step at for Importers of Food for Humans and
Issued: January 18, 2018. this point. Rather, I believe the better course Animals: What You Need To Know
of action at this time is to move forward with About the Food and Drug
Nathaniel J. Davis, Sr.,
these standards and, assuming the Administration Regulation; Small
Deputy Secretary.
Commission ultimately proceeds to Final
Entity Compliance Guide; Availability
Attachment Rule, improve them over time as needed.
In that regard, I believe the Commission is AGENCY: Food and Drug Administration,
LaFLEUR, Commissioner concurring:
appropriately proposing to direct a HHS.
In today’s order, the Commission proposes modification to the proposed standards to ACTION: Notification of availability.
to approve the supply chain risk management address an identified reliability gap regarding
standards filed by the North American SUMMARY: The Food and Drug
Electric Reliability Corporation (NERC), and Electronic Access Control and Monitoring
Systems. I also support the proposal to Administration (FDA, the Agency, or
direct certain modifications to those
standards. I write separately to explain my require NERC to include Physical Access we) is announcing the availability of a
vote in support of today’s order, given my Controls and Protected Cyber Assets within guidance for industry entitled ‘‘Foreign
dissent on the Commission order that its ongoing assessment of the supply chain Supplier Verification Programs for
directed the development of these risks posed by low-impact Bulk Electric Importers of Food for Humans and
standards.1 System Cyber Systems, which will help the Animals: What You Need to Know
As I stated in my dissent, I shared the Commission and NERC determine whether About the FDA Regulation; Small Entity
Commission’s concern about supply chain Compliance Guide.’’ The small entity
further revisions to the standards are needed.
threats and supported continued Commission
attention to those threats. Indeed, I remain More so than with most standards, I compliance guide (SECG) is intended to
concerned that the supply chain is a believe that whether these standards are help small entities comply with the
significant cyber vulnerability for the bulk effective will only reveal itself over time as final rule entitled ‘‘Foreign Supplier
power system. However, I believed that the we gain additional experience with them. I Verification Programs for Importers of
Commission was proceeding too quickly to am therefore particularly interested in Food for Humans and Animals.’’
require a supply chain standard, without feedback from commenters on how the DATES: The announcement of the
having sufficiently worked with NERC, Commission, NERC, and industry should
industry, and other stakeholders on how to
guidance is published in the Federal
assess these standards, including any Register on January 25, 2018.
design an effective, auditable, and
reporting obligations that might be ADDRESSES: You may submit either
enforceable standard. In my view, the
directive that resulted was insufficiently appropriate.3 In addition, given the very electronic or written comments on
developed and created a risk that needed general process-oriented nature of the
Agency guidances at any time as
protections against supply threats would be standard, I also support the proposal to
follows:
delayed, due in large part to the nature of the shorten the implementation date for the new
NERC standards process. standards. If ultimately adopted, the revised Electronic Submissions
Given the limited guidance and timeline deadline will allow industry, NERC, and the
provided by the Commission in Order No.
Submit electronic comments in the
Commission to put the standards in place following way:
829, the proposed standards are,
unsurprisingly, quite general, focusing
sooner while continuing to evaluate how best • Federal eRulemaking Portal:
to protect the bulk power system against https://www.regulations.gov. Follow the
primarily ‘‘on the processes Responsible
Entities implement to consider and address supply chain threats. instructions for submitting comments.
cyber security risks from vendor products or For these reasons, I respectfully concur. Comments submitted electronically,
services during BES Cyber System planning Cheryl A. LaFleur, including attachments, to https://
and procurement, not on the outcome of Commissioner. www.regulations.gov will be posted to
those processes . . .’’ 2 The proposed
standards would provide significant [FR Doc. 2018–01247 Filed 1–24–18; 8:45 am] the docket unchanged. Because your
flexibility to registered entities to determine BILLING CODE 6717–01–P
comment will be made public, you are
how best to comply with their requirements. solely responsible for ensuring that your
In my view, that flexibility presents both comment does not include any
potential risks and benefits. It could allow confidential information that you or a
effective, adaptable approaches to flourish, or third party may not wish to be posted,
allow compliance plans that meet the letter such as medical information, your or
of the standards but do not effectively
anyone else’s Social Security number, or
address supply chain threats. I hope that we
will see more of the former, but I believe the confidential business information, such
Commission, NERC, and the Regional as a manufacturing process. Please note
that if you include your name, contact
sradovich on DSK3GMQ082PROD with PROPOSALS
Entities should closely monitor
implementation if the standards are information, or other information that
3 I note that NERC has also developed draft
ultimately approved. identifies you in the body of your
In voting for today’s order, I recognize that implementation guidance that provides additional
comments, that information will be
the choice before the Commission today is detail regarding possible compliance approaches.
As NERC and the Regional Entities gain additional
posted on https://www.regulations.gov.
1 Revised Critical Infrastructure Protection experience with assessing compliance under these
• If you want to submit a comment
Reliability Standards, Order No. 829, 156 FERC ¶ standards, updating this implementation guidance with confidential information that you
61,050 (2016) (LaFleur, Comm’r, dissenting). could be an effective approach for quickly do not wish to be made available to the
2 NERC Petition at 27. disseminating best practices and lessons learned. public, submit the comment as a
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![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.
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Document Created: 2018-01-25 08:50:37
Document Modified: 2018-01-25 08:50:37
| 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 3442 |
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