82 FR 41364 - Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 168 (August 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 168 (August 31, 2017)
| Page Range | 41364-41365 | |
| FR Document | 2017-18464 |
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)] [Proposed Rules] [Pages 41364-41365] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18464] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA-2016-D-2343] Hazard Analysis and Risk-Based Preventive Controls for Human Food: 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 another draft chapter of a multichapter guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.'' This multichapter draft guidance is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk- based preventive controls under our rule entitled ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.'' The newly available draft chapter is entitled ``Chapter Six--Use of Heat Treatments as a Process Control.'' DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments by February 27, 2018. You may submit comments 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-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive Controls for Human Food: 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 office 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. Submit written requests for single copies of the draft 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 [[Page 41365]] to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166. SUPPLEMENTARY INFORMATION: I. Background 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 enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117). In the Federal Register of August 24, 2016 (81 FR 57816), we announced the availability of several chapters of a multichapter draft guidance for industry entitled ``Hazard Analysis and Risk-Based Preventive Controls for Human Food.'' We now are announcing the availability of an additional draft chapter of this multichapter guidance for industry. We are issuing the draft guidance consistent with our 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 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 multichapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapter that we are announcing in this document is entitled ``Chapter Six--Use of Heat Treatments as a Process Control.'' We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them. II. 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 part 117 have been approved under OMB control number 0910-0751. III. 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 Web site listed in the previous sentence to find the most current version of the guidance. Dated: August 22, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-18464 Filed 8-30-17; 8:45 am] BILLING CODE 4164-01-P
![41364 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules
List of Subjects in 18 CFR Part 11 and Risk-Based Preventive Controls for identified, as confidential, if submitted
Dams, Electric power, Indians-lands, Human Food: Guidance for Industry.’’ as detailed in ‘‘Instructions.’’
Public lands, Reporting and This multichapter draft guidance is Instructions: All submissions received
recordkeeping requirements. intended to explain our current thinking must include the Docket No. FDA–
on how to comply with the 2016–D–2343 for ‘‘Hazard Analysis and
By direction of the Commission. requirements for hazard analysis and Risk-Based Preventive Controls for
Issued: August 17, 2017. risk-based preventive controls under our Human Food: Guidance for Industry.’’
Nathaniel J. Davis, Sr., rule entitled ‘‘Current Good Received comments will be placed in
Deputy Secretary. Manufacturing Practice, Hazard the docket and, except for those
Analysis, and Risk-Based Preventive submitted as ‘‘Confidential
In consideration of the foregoing, the Submissions,’’ publicly viewable at
Controls for Human Food.’’ The newly
Federal Energy Regulatory Commission https://www.regulations.gov or at the
available draft chapter is entitled
proposes to amend Part 11, Chapter I, Dockets Management Staff office
‘‘Chapter Six—Use of Heat Treatments
Title 18, Code of Federal Regulations, as between 9 a.m. and 4 p.m., Monday
as a Process Control.’’
follows: through Friday.
DATES: Although you can comment on
any guidance at any time (see 21 CFR • Confidential Submissions—To
PART 11—ANNUAL CHARGES UNDER
10.115(g)(5)), to ensure that we consider submit a comment with confidential
PART I OF THE FEDERAL POWER ACT
your comment on this draft guidance information that you do not wish to be
■ 1. The authority citation for part 11 before we issue the final version of the made publicly available, submit your
continues to read as follows: guidance, submit either electronic or comments only as a written/paper
written comments by February 27, 2018. submission. You should submit two
Authority: 16 U.S.C. 792–828c; 42 U.S.C.
You may submit comments as copies total. One copy will include the
7101–7352.
follows: information you claim to be confidential
■ 2. In § 11.2, add paragraph (c)(1)(iv) to with a heading or cover note that states
read as follows: Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
* * * * * Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
(c) * * * following way: Agency will review this copy, including
(1) * * * • Federal eRulemaking Portal: the claimed confidential information, in
(iv) For all geographic areas in Alaska https://www.regulations.gov. Follow the its consideration of comments. The
except for the Aleutian Islands Area, the instructions for submitting comments. second copy, which will have the
Commission will calculate a statewide Comments submitted electronically, claimed confidential information
average per-acre land value based on the including attachments, to https:// redacted/blacked out, will be available
average per-acre land and building www.regulations.gov will be posted to for public viewing and posted on
values published in the NASS Census the docket unchanged. Because your https://www.regulations.gov. Submit
for the Kenai Peninsula and the comment will be made public, you are both copies to the Dockets Management
Fairbanks Areas. This statewide average solely responsible for ensuring that your Staff. If you do not wish your name and
per-acre value will be reduced by the comment does not include any contact information to be made publicly
sum of the state-specific modifier and confidential information that you or a available, you can provide this
seven percent. The resulting adjusted third party may not wish to be posted, information on the cover sheet and not
statewide average per-acre value will be such as medical information, your or in the body of your comments and you
applied to all projects located in Alaska, anyone else’s Social Security number, or must identify this information as
except for those projects located in the confidential business information, such ‘‘confidential.’’ Any information marked
Aleutian Island Area. as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
* * * * * that if you include your name, contact except in accordance with 21 CFR 10.20
[FR Doc. 2017–17846 Filed 8–30–17; 8:45 am] information, or other information that and other applicable disclosure law. For
BILLING CODE 6717–01–P identifies you in the body of your more information about FDA’s posting
comments, that information will be of comments to public dockets, see 80
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
written/paper submission and in the read background documents or the
21 CFR Part 117 manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Submissions’’ and ‘‘Instructions’’). received, go to https://
[Docket No. FDA–2016–D–2343] www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
Hazard Analysis and Risk-Based
Submit written/paper submissions as heading of this document, into the
Preventive Controls for Human Food:
follows: ‘‘Search’’ box and follow the prompts
Guidance for Industry; Availability
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management
AGENCY: Food and Drug Administration, written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
nlaroche on DSKBBV9HB2PROD with PROPOSALS
HHS. Management Staff (HFA–305), Food and Rockville, MD 20852.
ACTION: Notification of availability. Drug Administration, 5630 Fishers Submit written requests for single
Lane, Rm. 1061, Rockville, MD 20852. copies of the draft guidance to Office of
SUMMARY: The Food and Drug • For written/paper comments Food Safety, Center for Food Safety and
Administration (FDA, we, or Agency) is submitted to the Dockets Management Applied Nutrition, Food and Drug
announcing the availability of another Staff, FDA will post your comment, as Administration (HFS–300), 5001
draft chapter of a multichapter guidance well as any attachments, except for Campus Dr., College Park, MD 20740.
for industry entitled ‘‘Hazard Analysis information submitted, marked and Send two self-addressed adhesive labels
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![Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Proposed Rules 41365
to assist that office in processing your announcing in this document is entitled SUMMARY: This document proposes to
request. See the SUPPLEMENTARY ‘‘Chapter Six—Use of Heat Treatments extend the special transition period
INFORMATION section for electronic as a Process Control.’’ under sections II and IX of the Best
access to the draft guidance. We intend to announce the Interest Contract Exemption and section
FOR FURTHER INFORMATION CONTACT: availability for public comment of VII of the Class Exemption for Principal
Jenny Scott, Center for Food Safety and additional chapters of the draft guidance Transactions in Certain Assets Between
Applied Nutrition (HFS–300), Food and as we complete them. Investment Advice Fiduciaries and
Drug Administration, 5001 Campus Dr., Employee Benefit Plans and IRAs. This
II. Paperwork Reduction Act of 1995
College Park, MD 20740, 240–402–2166. document also proposes to delay the
This draft guidance refers to applicability of certain amendments to
SUPPLEMENTARY INFORMATION:
previously approved collections of Prohibited Transaction Exemption 84–
I. Background information found in FDA regulations. 24 for the same period. The primary
The FDA Food Safety Modernization These collections of information are purpose of the proposed amendments is
Act (FSMA) (Pub. L. 111–353) enables subject to review by the Office of to give the Department of Labor the time
FDA to better protect public health by Management and Budget (OMB) under necessary to consider possible changes
helping to ensure the safety and security the Paperwork Reduction Act of 1995 and alternatives to these exemptions.
of the food supply. It enables FDA to (44 U.S.C. 3501–3520). The collections The Department is particularly
focus more on preventing food safety of information in part 117 have been concerned that, without a delay in the
problems rather than relying primarily approved under OMB control number applicability dates, regulated parties
on reacting to problems after they occur. 0910–0751. may incur undue expense to comply
FSMA recognizes the important role III. Electronic Access with conditions or requirements that it
industry plays in ensuring the safety of ultimately determines to revise or
the food supply, including the adoption Persons with access to the Internet repeal. The present transition period is
of modern systems of preventive may obtain the draft guidance at either from June 9, 2017, to January 1, 2018.
controls in food production. https://www.fda.gov/FoodGuidances or The new transition period would end on
Section 103 of FSMA amended the https://www.regulations.gov. Use the July 1, 2019. The proposed amendments
Federal Food, Drug, and Cosmetic Act FDA Web site listed in the previous to these exemptions would affect
(FD&C Act), in section 418 of the FD&C sentence to find the most current participants and beneficiaries of plans,
Act (21 U.S.C. 350g), by adding version of the guidance. IRA owners and fiduciaries with respect
requirements for hazard analysis and Dated: August 22, 2017. to such plans and IRAs.
risk-based preventive controls for Anna K. Abram, DATES: Comments must be submitted on
establishments that are required to Deputy Commissioner for Policy, Planning, or before September 15, 2017.
register as food facilities under our Legislation, and Analysis. ADDRESSES: All written comments
regulations, in 21 CFR part 1, subpart H, [FR Doc. 2017–18464 Filed 8–30–17; 8:45 am] should be sent to the Office of
in accordance with section 415 of the BILLING CODE 4164–01–P Exemption Determinations by any of the
FD&C Act (21 U.S.C. 350d). We have following methods, identified by RIN
established regulations to implement 1210–AB82:
these requirements within part 117 (21 DEPARTMENT OF LABOR Federal eRulemaking Portal: http://
CFR part 117). www.regulations.gov at Docket ID
In the Federal Register of August 24, Employee Benefits Security number: EBSA–2017–0004. Follow the
2016 (81 FR 57816), we announced the Administration instructions for submitting comments.
availability of several chapters of a Email to:
multichapter draft guidance for industry 29 CFR Part 2550 EBSA.FiduciaryRuleExamination@
entitled ‘‘Hazard Analysis and Risk- dol.gov.
[Application Number D–11712; D–11713;
Based Preventive Controls for Human D–11850] Mail: Office of Exemption
Food.’’ We now are announcing the Determinations, EBSA, (Attention: D–
availability of an additional draft ZRIN 1210–ZA27 11712, 11713, 11850), U.S. Department
chapter of this multichapter guidance of Labor, 200 Constitution Avenue NW.,
for industry. We are issuing the draft Extension of Transition Period and Suite 400, Washington, DC 20210.
guidance consistent with our good Delay of Applicability Dates; Best Hand Delivery/Courier: OED, EBSA
guidance practices regulation (21 CFR Interest Contract Exemption (PTE (Attention: D–11712, 11713, 11850),
10.115). The draft guidance, when 2016–01); Class Exemption for U.S. Department of Labor, 122 C St.
finalized, will represent the current Principal Transactions in Certain NW., Suite 400, Washington, DC 20001.
thinking of FDA on this topic. It does Assets Between Investment Advice Comments will be available for public
not establish any rights for any person Fiduciaries and Employee Benefit inspection in the Public Disclosure
and is not binding on FDA or the public. Plans and IRAs (PTE 2016–02); Room, EBSA, U.S. Department of Labor,
You can use an alternate approach if it Prohibited Transaction Exemption 84– Room N–1513, 200 Constitution Avenue
satisfies the requirements of the 24 for Certain Transactions Involving NW., Washington, DC 20210. Comments
applicable statutes and regulations. This Insurance Agents and Brokers, will also be available online at
guidance is not subject to Executive Pension Consultants, Insurance www.regulations.gov, at Docket ID
nlaroche on DSKBBV9HB2PROD with PROPOSALS
Order 12866. Companies, and Investment Company number: EBSA–2017–0004 and
The multichapter draft guidance for Principal Underwriters (PTE 84–24) www.dol.gov/ebsa, at no charge. Do not
industry is intended to explain our AGENCY: Employee Benefits Security include personally identifiable
current thinking on how to comply with Administration, Labor. information or confidential business
the requirements for hazard analysis information that you do not want
ACTION: Notice of proposed amendments
and risk-based preventive controls publicly disclosed. Comments online
to PTE 2016–01, PTE 2016–02, and PTE
under part 117, principally in subparts can be retrieved by most Internet search
84–24.
C and G. The chapter that we are engines.
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Document Created: 2017-09-23 10:08:16
Document Modified: 2017-09-23 10:08:16
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments by February 27, 2018. | |
| Contact | Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166. | |
| FR Citation | 82 FR 41364 |
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