
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Rules and Regulations]
[Pages 71934-71936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29340]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 11, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 
211

[Docket No. FDA-2011-N-0920]
RIN 0910-AG36


Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food; Clarification of Compliance 
Date for Certain Food Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; clarification of compliance date for certain food 
establishments.

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SUMMARY: The Food and Drug Administration (FDA or we) is clarifying the 
compliance date that we provided for certain food establishments 
subject to a final rule that published in the Federal Register of 
September 17, 2015. Among other things, that final rule amended our 
regulation for current good manufacturing practice in manufacturing, 
packing, or holding human food to modernize it, and to add requirements 
for domestic and foreign facilities that are required to register under 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish 
and implement hazard analysis and risk-based preventive controls for 
human food. We are taking this action in response to requests for 
clarification of the compliance date for facilities that manufacture, 
process, pack, or hold grade ``A'' milk or milk products and that are 
regulated under the National Conference on Interstate Milk Shipments 
(NCIMS) system.

DATES: The compliance date under the Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human 
Food rule (published on September 17, 2015 at 80 FR 55908) for grade 
``A'' milk and milk products covered by NCIMS under the PMO is 
September 17, 2018.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of September 17, 2015 (80 FR 55908), we 
published a final rule entitled ``Current Good Manufacturing Practice, 
Hazard Analysis, and Risk-Based Preventive Controls for Human Food'' 
(the final human preventive controls rule). Among other things, the 
final human preventive controls rule amended our regulation for current 
good manufacturing practice in manufacturing, packing, or holding human 
food to modernize it, and to add requirements for domestic and foreign 
facilities that are required to register under section 415 of the FD&C 
Act (21 U.S.C. 350d) to establish and implement hazard analysis and 
risk-based preventive controls for human food. In the preamble to the 
final human preventive controls rule (80 FR 55908), we stated that the 
rule is effective November 16, 2015, and provided for compliance dates 
of 1 to 3 years in most cases.

[[Page 71935]]

    In Comment 214 in the final human preventive controls final rule 
(80 FR 55908 at 55986 to 55987), we described comments that discuss 
facilities that comply with the Grade ``A'' PMO and are regulated under 
the NCIMS system, and we used the term ``PMO facilities'' as an 
abbreviation for these facilities. As previously discussed (78 FR 3646 
at 3662; January 16, 2013), the PMO is a model regulation published and 
recommended by the U.S. Public Health Service/FDA for voluntary 
adoption by State dairy regulatory agencies to regulate the production, 
processing, storage and distribution of Grade ``A'' milk and milk 
products to help prevent milk-borne disease. Some comments recommended 
that we make full use of the existing milk safety system of State 
regulatory oversight for Grade ``A'' milk and milk products provided 
through the NCIMS and the food safety requirements of the PMO. Some 
comments asked us to exempt PMO-regulated facilities (or the PMO-
regulated part of a PMO facility that also produces food products not 
covered by the PMO) from the requirements of the rule for hazard 
analysis and risk-based preventive controls, or to otherwise determine 
that facilities operating in compliance with the PMO are also in 
compliance with those requirements. These comments suggested we could, 
as an interim step if we find it necessary, stay the application of 
these requirements to PMO-regulated facilities and work with the NCIMS 
cooperative program to enact any modifications to the PMO as may be 
needed to warrant an exemption or comparability determination. In 
response to these comments, we established a compliance date of 
September 17, 2018, for ``PMO facilities'' (see Response 214, 80 FR 
55908 at 55987 to 55988).

II. Clarification of the Compliance Date for Facilities Regulated Under 
the NCIMS System

    On September 10, 2015, the Office of the Federal Register made a 
pre-publication copy of the final human preventive controls rule 
available to the public through its procedures for advance display 
(Ref. 1). Since September 10, 2015, we have provided opportunities for 
stakeholders to ask questions about the rule, through webinars and 
through a Web portal for submission of questions (Refs. 2 and 3). Some 
PMO facilities, in addition to manufacturing, processing, packing, or 
holding grade ``A'' milk or milk products, manufacture, process, pack, 
or hold other food subject to the final human preventive controls rule. 
Some of these facilities have asked us to clarify whether the extended 
compliance date for ``PMO facilities'' applies only to grade ``A'' milk 
and milk products covered by NCIMS under the PMO, or whether the 
extended compliance date applies broadly to all activities conducted by 
the facility (e.g., activities related to other food produced at the 
facility).
    In this document, we are clarifying that the extended compliance 
date of September 17, 2018, for ``PMO facilities'' applies only to 
grade ``A'' milk and milk products covered by NCIMS under the PMO, and 
not to the manufacturing, processing, packing, or holding of other 
food. As we discussed in Response 214 (80 FR 55908 at 55987 to 55988), 
we agreed that we should make use of the existing system of State 
regulatory oversight for Grade ``A'' milk and milk products provided 
through the NCIMS and the food safety requirements of the PMO. We 
described our reasons for deciding to extend the compliance date for 
``PMO-regulated facilities'' to comply with the requirements of 
subparts C and G to September 17, 2018. Those reasons related to the 
current provisions of the PMO, the work already begun by NCIMS to 
modify the PMO to include all of the requirements established in the 
final human preventive controls rule, and complex implementation issues 
concerning the interstate movement of milk and milk products and 
imported milk. We explained that in establishing a compliance date of 
September 17, 2018, for PMO facilities, we considered: (1) The extent 
of revisions that must be made to incorporate the requirements of this 
rule for hazard analysis and risk-based preventive controls into the 
PMO; (2) the process to revise the PMO; and (3) the date at which the 
necessary revisions to the PMO could begin to be made. All of these 
discussions in the human preventive controls final rule related to the 
activities regulated by NCIMS under the PMO.

III. Economic Analysis of Impacts

    We have examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of this final rule (Ref. 4). We believe that this 
final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this final rule is making no change to the compliance 
date announced for facilities regulated under the NCIMS system in the 
human preventive controls rule published on September 17, 2105, we have 
determined that this final rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This final rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

IV. Environmental Impact, No Significant Impact

    We have determined under 21 CFR 25.30(j) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.


[[Page 71936]]


    1. Office of the Federal Register, ``Current Good Manufacturing 
Practice, Hazard Analysis, and Risk-Based Preventive Controls for 
Human Food,'' September 10, 2015. Available at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-21920.pdf.
    2. FDA, ``FSMA Webinar Series: Preventive Controls for Human and 
Animal Food Final Rules,'' 2015. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461512.htm.
    3. FDA, ``Contact FDA About FSMA,'' 2015. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.
    4. FDA, ``Current Good Manufacturing Practice, Hazard Analysis, 
and Risk-Based Preventive Controls for Human Food; Clarification of 
Compliance Date for Certain Food Establishments,'' 2015. Available 
at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

    Dated: November 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-29340 Filed 11-17-15; 8:45 am]
 BILLING CODE 4164-01-P


