[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