Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments, 71934-71936 [2015-29340]
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71934
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations
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Hazardous waste, Indians,
Intergovernmental relations, Manpower
training programs, Nuclear energy,
Nuclear materials, Occupational safety
and health, Penalties, Radiation
protection, Reporting and recordkeeping
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For the reasons set out in the
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Atomic Energy Act of 1954, as amended;
the Energy Reorganization Act of 1974,
as amended; the Nuclear Waste Policy
Act of 1982, as amended; and 5 U.S.C.
552 and 553; the NRC is adopting the
following amendments to 10 CFR part
72:
PART 72—LICENSING
REQUIREMENTS FOR THE
INDEPENDENT STORAGE OF SPENT
NUCLEAR FUEL, HIGH–LEVEL
RADIOACTIVE WASTE, AND
REACTOR–RELATED GREATER THAN
CLASS C WASTE
Initial Certificate Effective Date:
February 4, 2009, superseded by Initial
Certificate, Revision 1, on February 1,
2016.
Initial Certificate, Revision 1,
Effective Date: February 1, 2016.
Amendment Number 1 Effective Date:
August 30, 2010, superseded by
Amendment Number 1, Revision 1, on
February 1, 2016.
Amendment Number 1, Revision 1,
Effective Date: February 1, 2016.
Amendment Number 2 Effective Date:
January 30, 2012, superseded by
Amendment Number 2, Revision 1, on
February 1, 2016.
Amendment Number 2, Revision 1,
Effective Date: February 1, 2016.
Amendment Number 3 Effective Date:
July 25, 2013, superseded by
Amendment Number 3, Revision 1, on
February 1, 2016.
Amendment Number 3 Revision 1,
Effective Date: February 1, 2016.
Amendment Number 4 Effective Date:
April 14, 2015.
Amendment Number 5 Effective Date:
June 29, 2015.
SAR Submitted by: NAC
International, Inc.
SAR Title: Final Safety Analysis
Report for the MAGNASTOR® System.
Docket Number: 72–1031.
Certificate Expiration Date: February
4, 2029.
Model Number: MAGNASTOR®.
*
*
*
*
*
Dated at Rockville, Maryland, this 5th day
of November, 2015.
For the Nuclear Regulatory Commission.
Glenn M. Tracy,
Acting, Executive Director for Operations.
[FR Doc. 2015–29424 Filed 11–17–15; 8:45 am]
■
1. The authority citation for part 72
continues to read as follows:
BILLING CODE 7590–01–P
Authority: Atomic Energy Act of 1954,
secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182,
183, 184, 186, 187, 189, 223, 234, 274 (42
U.S.C. 2071, 2073, 2077, 2092, 2093, 2095,
2099, 2111, 2201, 2210e, 2232, 2233, 2234,
2236, 2237, 2238, 2273, 2282, 2021); Energy
Reorganization Act of 1974, secs. 201, 202,
206, 211 (42 U.S.C. 5841, 5842, 5846, 5851);
National Environmental Policy Act of 1969
(42 U.S.C. 4332); Nuclear Waste Policy Act
of 1982, secs. 117(a), 132, 133, 134, 135, 137,
141, 145(g), 148, 218(a) (42 U.S.C. 10137(a),
10152, 10153, 10154, 10155, 10157, 10161,
10165(g), 10168, 10198(a)); 44 U.S.C. 3504
note.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
2. In § 72.214, Certificate of
Compliance No. 1031 is revised to read
as follows:
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■
§ 72.214 List of approved spent fuel
storage casks.
*
*
*
*
*
Certificate Number: 1031.
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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.
Final rule; clarification of
compliance date for certain food
establishments.
ACTION:
PO 00000
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Fmt 4700
Sfmt 4700
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.
SUMMARY:
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.
DATES:
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.
E:\FR\FM\18NOR1.SGM
18NOR1
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations
wgreen on DSK2VPTVN1PROD with RULES
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 prepublication 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
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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 riskbased 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
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71935
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 https://
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.
E:\FR\FM\18NOR1.SGM
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71936
Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations
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/201521920.pdf.
2. FDA, ‘‘FSMA Webinar Series: Preventive
Controls for Human and Animal Food Final
Rules,’’ 2015. Available at https://
www.fda.gov/Food/GuidanceRegulation/
FSMA/ucm461512.htm.
3. FDA, ‘‘Contact FDA About FSMA,’’
2015. Available at https://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:
https://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
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket Nos. FR 5797–I–01 and FR 5797–
C–02]
RIN 2506–AC39
Changes to Accounting Requirements
for the Community Development Block
Grants (CDBG) Program; Correction
Office of the General Counsel,
HUD.
ACTION:
Correction
In interim final rule FR Doc. 2015–
28700, published on November 12, 2015
(80 FR 69864), make the following
correction:
On page 69872, in the first column, in
§ 570.489, correct paragraph (a)(3)(ii) to
read as follows:
§ 570.489 Program administrative
requirements.
24 CFR Part 570
AGENCY:
requirements for the CDBG program,
including 24 CFR 570.489. The
amendments included clarification of
how HUD determines compliance with
planning and administration cost limits.
In the preamble to the rule, at page
69867, first column, HUD stated that the
regulations revised by rule modify the
limits on administrative and planning
expenses by adding to the existing
compliance test a new test for grants
with an origin year of 2015and
subsequent years, which would
continue to remain in place for all
grants. However, language was
inadvertently included in the regulatory
text that limited the existing test to
CDBG grants with an origin year prior
to 2015. This document corrects that
limiting language.
Interim final rule; correction.
This document corrects a
technical error in HUD’s interim final
rule on CDBG accounting requirements,
published November 12, 2015.
DATES: Effective date: December 14,
2015.
SUMMARY:
(a) * * *
(3) * * *
(ii) The combined expenditures by the
State and its funded units of general
local government for planning,
management, and administrative costs
shall not exceed 20 percent of the
aggregate amount of the origin year
grant, any origin year grant funds
reallocated by HUD to the State, and the
amount of any program income received
during the program year.
*
*
*
*
*
Dated: November 13, 2015.
Camille Acevedo,
Associate General Counsel for Legislation and
Regulations.
[FR Doc. 2015–29478 Filed 11–17–15; 8:45 am]
BILLING CODE 4210–67–P
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FOR FURTHER INFORMATION CONTACT:
Stanley Gimont, Director, Office of
Block Grant Assistance, Department of
Housing and Urban Development, Office
of Community Planning and
Development, 451 7th Street SW., Suite
7286, Washington, DC 20410 at 202–
708–3587, (this is not a toll-free
number). Individuals with speech or
hearing impairments may access this
number via TTY by calling the Federal
Relay Service, toll-free, at 800–877–
8339.
HUD
published a document in the Federal
Register on November 12, 2015, at 80
FR 69864, amending the accounting
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
14:36 Nov 17, 2015
Jkt 238001
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
29 CFR Part 2509
RIN 1210–AB74
Interpretive Bulletin Relating to State
Savings Programs That Sponsor or
Facilitate Plans Covered by the
Employee Retirement Income Security
Act of 1974
Employee Benefits Security
Administration, Labor.
AGENCY:
PO 00000
Frm 00008
Fmt 4700
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ACTION:
Interpretive bulletin.
This document sets forth the
views of the Department of Labor
(Department) concerning the application
of the Employee Retirement Income
Security Act of 1974 (ERISA) to certain
state laws designed to expand the
retirement savings options available to
private sector workers through ERISAcovered retirement plans. Concern over
adverse social and economic
consequences of inadequate retirement
savings levels has prompted several
states to adopt or consider legislation to
address this problem. The Department
separately released a proposed
regulation describing safe-harbor
conditions for states and employers to
avoid creation of ERISA-covered plans
as a result of state laws that require
private sector employers to implement
in their workplaces state-administered
payroll deduction IRA programs (autoIRA laws). This Interpretive Bulletin
does not address such state auto-IRA
laws.
DATES: This interpretive bulletin is
effective on November 18, 2015.
FOR FURTHER INFORMATION CONTACT:
Office of Regulations and
Interpretations, Employee Benefits
Security Administration, (202) 693–
8500. This is not a toll-free number.
SUPPLEMENTARY INFORMATION: In order to
provide a concise and ready reference to
its interpretations of ERISA, the
Department publishes its interpretive
bulletins in the Rules and Regulations
section of the Federal Register. The
Department is publishing in this issue of
the Federal Register, ERISA Interpretive
Bulletin 2015–02, which interprets
ERISA section 3(2)(A), 29 U.S.C.
1002(2)(A), section 3(5), 29 U.S.C.
1002(5), and section 514, 29 U.S.C.
1144, as they apply to state laws
designed to expand workers’ access to
retirement savings programs. Some
states have adopted laws or are
exploring approaches designed to
expand the retirement savings options
available to their private sector workers
through ERISA-covered retirement
plans. One of the challenges the states
face in expanding retirement savings
opportunities for private sector
employees is uncertainty about ERISA
preemption of such efforts. ERISA
generally would preempt a state law
that required employers to establish and
maintain ERISA-covered employee
benefit pension plans. The Department
also has a strong interest in promoting
retirement savings by employees. The
Department recognizes that some
employers currently do not provide
pension plans for their employees. The
SUMMARY:
E:\FR\FM\18NOR1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461512.htm.
3. FDA, ``Contact FDA About FSMA,'' 2015. Available at https://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: https://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
