80_FR_72156 80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments

80 FR 71934 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Clarification of Compliance Date for Certain Food Establishments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 222 (November 18, 2015)

Page Range71934-71936
FR Document2015-29340

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.

Federal Register, Volume 80 Issue 222 (Wednesday, November 18, 2015) 
[Federal Register Volume 80, Number 222 (Wednesday, November 18, 2015)]
[Rules and Regulations]
[Pages 71934-71936]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

71934 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations The NRC may post materials related Initial Certificate Effective Date: SUMMARY: The Food and Drug to this document, including public February 4, 2009, superseded by Initial Administration (FDA or we) is clarifying comments, on the Federal Rulemaking Certificate, Revision 1, on February 1, the compliance date that we provided Web site at http://www.regulations.gov 2016. for certain food establishments subject under Docket ID NRC–2015–0186. The Initial Certificate, Revision 1, to a final rule that published in the Federal Rulemaking Web site allows Effective Date: February 1, 2016. Federal Register of September 17, 2015. you to receive alerts when changes or Amendment Number 1 Effective Date: Among other things, that final rule additions occur in a docket folder. To August 30, 2010, superseded by amended our regulation for current good subscribe: (1) navigate to the docket Amendment Number 1, Revision 1, on manufacturing practice in folder (NRC–2015–0186); (2) click the February 1, 2016. manufacturing, packing, or holding ‘‘Sign up for Email Alerts’’ link; and (3) Amendment Number 1, Revision 1, human food to modernize it, and to add enter your email address and select how Effective Date: February 1, 2016. requirements for domestic and foreign frequently you would like to receive Amendment Number 2 Effective Date: facilities that are required to register emails (daily, weekly, or monthly). January 30, 2012, superseded by under the Federal Food, Drug, and Amendment Number 2, Revision 1, on Cosmetic Act (the FD&C Act) to List of Subjects in 10 CFR Part 72 February 1, 2016. establish and implement hazard Administrative practice and Amendment Number 2, Revision 1, analysis and risk-based preventive procedure, Criminal penalties, Effective Date: February 1, 2016. controls for human food. We are taking Hazardous waste, Indians, Amendment Number 3 Effective Date: this action in response to requests for Intergovernmental relations, Manpower July 25, 2013, superseded by clarification of the compliance date for training programs, Nuclear energy, Amendment Number 3, Revision 1, on facilities that manufacture, process, Nuclear materials, Occupational safety February 1, 2016. pack, or hold grade ‘‘A’’ milk or milk and health, Penalties, Radiation Amendment Number 3 Revision 1, products and that are regulated under protection, Reporting and recordkeeping Effective Date: February 1, 2016. the National Conference on Interstate requirements, Security measures, Spent Amendment Number 4 Effective Date: Milk Shipments (NCIMS) system. fuel, Whistleblowing. April 14, 2015. Amendment Number 5 Effective Date: DATES: The compliance date under the For the reasons set out in the June 29, 2015. Current Good Manufacturing Practice, preamble and under the authority of the SAR Submitted by: NAC Hazard Analysis, and Risk-Based Atomic Energy Act of 1954, as amended; International, Inc. Preventive Controls for Human Food the Energy Reorganization Act of 1974, SAR Title: Final Safety Analysis rule (published on September 17, 2015 as amended; the Nuclear Waste Policy Report for the MAGNASTOR® System. at 80 FR 55908) for grade ‘‘A’’ milk and Act of 1982, as amended; and 5 U.S.C. Docket Number: 72–1031. milk products covered by NCIMS under 552 and 553; the NRC is adopting the Certificate Expiration Date: February the PMO is September 17, 2018. following amendments to 10 CFR part 4, 2029. FOR FURTHER INFORMATION CONTACT: 72: Model Number: MAGNASTOR®. Jenny Scott, Center for Food Safety and PART 72—LICENSING * * * * * Applied Nutrition (HFS–300), Food and REQUIREMENTS FOR THE Dated at Rockville, Maryland, this 5th day Drug Administration, 5100 Paint Branch INDEPENDENT STORAGE OF SPENT of November, 2015. Pkwy., College Park, MD 20740, 240– NUCLEAR FUEL, HIGH–LEVEL For the Nuclear Regulatory Commission. 402–2166. RADIOACTIVE WASTE, AND Glenn M. Tracy, SUPPLEMENTARY INFORMATION: REACTOR–RELATED GREATER THAN Acting, Executive Director for Operations. CLASS C WASTE I. Background [FR Doc. 2015–29424 Filed 11–17–15; 8:45 am] BILLING CODE 7590–01–P In the Federal Register of September ■ 1. The authority citation for part 72 17, 2015 (80 FR 55908), we published a continues to read as follows: final rule entitled ‘‘Current Good Authority: Atomic Energy Act of 1954, DEPARTMENT OF HEALTH AND Manufacturing Practice, Hazard secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, HUMAN SERVICES Analysis, and Risk-Based Preventive 183, 184, 186, 187, 189, 223, 234, 274 (42 Controls for Human Food’’ (the final U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, Food and Drug Administration human preventive controls rule). 2099, 2111, 2201, 2210e, 2232, 2233, 2234, Among other things, the final human 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 21 CFR Parts 1, 11, 16, 106, 110, 114, preventive controls rule amended our 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); 117, 120, 123, 129, 179, and 211 regulation for current good National Environmental Policy Act of 1969 manufacturing practice in [Docket No. FDA–2011–N–0920] (42 U.S.C. 4332); Nuclear Waste Policy Act manufacturing, packing, or holding of 1982, secs. 117(a), 132, 133, 134, 135, 137, RIN 0910–AG36 human food to modernize it, and to add 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), requirements for domestic and foreign 10152, 10153, 10154, 10155, 10157, 10161, Current Good Manufacturing Practice, facilities that are required to register 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 Hazard Analysis, and Risk-Based under section 415 of the FD&C Act (21 note. Preventive Controls for Human Food; U.S.C. 350d) to establish and implement Clarification of Compliance Date for hazard analysis and risk-based ■ 2. In § 72.214, Certificate of Certain Food Establishments preventive controls for human food. In wgreen on DSK2VPTVN1PROD with RULES Compliance No. 1031 is revised to read as follows: AGENCY: Food and Drug Administration, the preamble to the final human HHS. preventive controls rule (80 FR 55908), § 72.214 List of approved spent fuel we stated that the rule is effective storage casks. ACTION: Final rule; clarification of November 16, 2015, and provided for compliance date for certain food * * * * * compliance dates of 1 to 3 years in most establishments. Certificate Number: 1031. cases. VerDate Sep<11>2014 14:36 Nov 17, 2015 Jkt 238001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\FR\FM\18NOR1.SGM 18NOR1

Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 71935 In Comment 214 in the final human clarify whether the extended Analysis of Impacts that assesses the preventive controls final rule (80 FR compliance date for ‘‘PMO facilities’’ impacts of this final rule (Ref. 4). We 55908 at 55986 to 55987), we described applies only to grade ‘‘A’’ milk and milk believe that this final rule is not a comments that discuss facilities that products covered by NCIMS under the significant regulatory action as defined comply with the Grade ‘‘A’’ PMO and PMO, or whether the extended by Executive Order 12866. are regulated under the NCIMS system, compliance date applies broadly to all The Regulatory Flexibility Act and we used the term ‘‘PMO facilities’’ activities conducted by the facility (e.g., requires us to analyze regulatory options as an abbreviation for these facilities. As activities related to other food produced that would minimize any significant previously discussed (78 FR 3646 at at the facility). impact of a rule on small entities. 3662; January 16, 2013), the PMO is a In this document, we are clarifying Because this final rule is making no model regulation published and that the extended compliance date of change to the compliance date recommended by the U.S. Public Health September 17, 2018, for ‘‘PMO announced for facilities regulated under Service/FDA for voluntary adoption by facilities’’ applies only to grade ‘‘A’’ the NCIMS system in the human State dairy regulatory agencies to milk and milk products covered by preventive controls rule published on regulate the production, processing, NCIMS under the PMO, and not to the September 17, 2105, we have storage and distribution of Grade ‘‘A’’ manufacturing, processing, packing, or determined that this final rule will not milk and milk products to help prevent holding of other food. As we discussed have a significant economic impact on milk-borne disease. Some comments in Response 214 (80 FR 55908 at 55987 a substantial number of small entities. recommended that we make full use of to 55988), we agreed that we should The Unfunded Mandates Reform Act the existing milk safety system of State make use of the existing system of State of 1995 (section 202(a)) requires us to regulatory oversight for Grade ‘‘A’’ milk regulatory oversight for Grade ‘‘A’’ milk prepare a written statement, which and milk products provided through the and milk products provided through the includes an assessment of anticipated NCIMS and the food safety requirements NCIMS and the food safety requirements costs and benefits, before proposing of the PMO. Some comments asked us of the PMO. We described our reasons ‘‘any rule that includes any Federal to exempt PMO-regulated facilities (or for deciding to extend the compliance mandate that may result in the the PMO-regulated part of a PMO date for ‘‘PMO-regulated facilities’’ to expenditure by State, local, and tribal facility that also produces food products comply with the requirements of governments, in the aggregate, or by the not covered by the PMO) from the subparts C and G to September 17, 2018. private sector, of $100,000,000 or more requirements of the rule for hazard Those reasons related to the current provisions of the PMO, the work already (adjusted annually for inflation) in any analysis and risk-based preventive begun by NCIMS to modify the PMO to one year.’’ The current threshold after controls, or to otherwise determine that include all of the requirements adjustment for inflation is $144 million, facilities operating in compliance with established in the final human using the most current (2014) Implicit the PMO are also in compliance with preventive controls rule, and complex Price Deflator for the Gross Domestic those requirements. These comments implementation issues concerning the Product. This final rule would not result suggested we could, as an interim step interstate movement of milk and milk in an expenditure in any year that meets if we find it necessary, stay the application of these requirements to products and imported milk. We or exceeds this amount. PMO-regulated facilities and work with explained that in establishing a IV. Environmental Impact, No the NCIMS cooperative program to enact compliance date of September 17, 2018, Significant Impact any modifications to the PMO as may be for PMO facilities, we considered: (1) needed to warrant an exemption or The extent of revisions that must be We have determined under 21 CFR comparability determination. In made to incorporate the requirements of 25.30(j) that this action is of a type that response to these comments, we this rule for hazard analysis and risk- does not individually or cumulatively established a compliance date of based preventive controls into the PMO; have a significant effect on the human September 17, 2018, for ‘‘PMO (2) the process to revise the PMO; and environment. Therefore, neither an facilities’’ (see Response 214, 80 FR (3) the date at which the necessary environmental assessment nor an 55908 at 55987 to 55988). revisions to the PMO could begin to be environmental impact statement is made. All of these discussions in the required. II. Clarification of the Compliance Date human preventive controls final rule for Facilities Regulated Under the V. Paperwork Reduction Act of 1995 related to the activities regulated by NCIMS System NCIMS under the PMO. This final rule contains no collection On September 10, 2015, the Office of of information. Therefore, clearance by the Federal Register made a pre- III. Economic Analysis of Impacts the Office of Management and Budget publication copy of the final human We have examined the impacts of this under the Paperwork Reduction Act of preventive controls rule available to the final rule under Executive Order 12866, 1995 is not required. public through its procedures for Executive Order 13563, the Regulatory VI. References advance display (Ref. 1). Since Flexibility Act (5 U.S.C. 601–612), and September 10, 2015, we have provided the Unfunded Mandates Reform Act of The following references are on opportunities for stakeholders to ask 1995 (Pub. L. 104–4). Executive Orders display in the Division of Dockets questions about the rule, through 12866 and 13563 direct us to assess all Management (see ADDRESSES) and are webinars and through a Web portal for costs and benefits of available regulatory available for viewing by interested submission of questions (Refs. 2 and 3). alternatives and, when regulation is persons between 9 a.m. and 4 p.m., Some PMO facilities, in addition to necessary, to select regulatory Monday through Friday; they are also wgreen on DSK2VPTVN1PROD with RULES manufacturing, processing, packing, or approaches that maximize net benefits available electronically at http:// holding grade ‘‘A’’ milk or milk (including potential economic, www.regulations.gov. FDA has verified products, manufacture, process, pack, or environmental, public health and safety, the Web site addresses, as of the date hold other food subject to the final and other advantages; distributive this document publishes in the Federal human preventive controls rule. Some impacts; and equity). We have Register, but Web sites are subject to of these facilities have asked us to developed a comprehensive Economic change over time. VerDate Sep<11>2014 14:36 Nov 17, 2015 Jkt 238001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\FR\FM\18NOR1.SGM 18NOR1

71936 Federal Register / Vol. 80, No. 222 / Wednesday, November 18, 2015 / Rules and Regulations 1. Office of the Federal Register, ‘‘Current requirements for the CDBG program, ACTION: Interpretive bulletin. Good Manufacturing Practice, Hazard including 24 CFR 570.489. The Analysis, and Risk-Based Preventive Controls amendments included clarification of SUMMARY: This document sets forth the for Human Food,’’ September 10, 2015. how HUD determines compliance with views of the Department of Labor Available at https://s3.amazonaws.com/ (Department) concerning the application public-inspection.federalregister.gov/2015- planning and administration cost limits. In the preamble to the rule, at page of the Employee Retirement Income 21920.pdf. Security Act of 1974 (ERISA) to certain 2. FDA, ‘‘FSMA Webinar Series: Preventive 69867, first column, HUD stated that the regulations revised by rule modify the state laws designed to expand the Controls for Human and Animal Food Final Rules,’’ 2015. Available at http:// limits on administrative and planning retirement savings options available to www.fda.gov/Food/GuidanceRegulation/ expenses by adding to the existing private sector workers through ERISA- FSMA/ucm461512.htm. compliance test a new test for grants covered retirement plans. Concern over 3. FDA, ‘‘Contact FDA About FSMA,’’ with an origin year of 2015and adverse social and economic 2015. Available at http://www.fda.gov/Food/ subsequent years, which would consequences of inadequate retirement GuidanceRegulation/FSMA/ucm459719.htm. continue to remain in place for all savings levels has prompted several 4. FDA, ‘‘Current Good Manufacturing states to adopt or consider legislation to Practice, Hazard Analysis, and Risk-Based grants. However, language was inadvertently included in the regulatory address this problem. The Department Preventive Controls for Human Food; text that limited the existing test to separately released a proposed Clarification of Compliance Date for Certain Food Establishments,’’ 2015. Available at: CDBG grants with an origin year prior regulation describing safe-harbor http://www.fda.gov/AboutFDA/ to 2015. This document corrects that conditions for states and employers to ReportsManualsForms/Reports/ limiting language. avoid creation of ERISA-covered plans EconomicAnalyses/default.htm. as a result of state laws that require Correction private sector employers to implement Dated: November 10, 2015. In interim final rule FR Doc. 2015– in their workplaces state-administered Leslie Kux, 28700, published on November 12, 2015 payroll deduction IRA programs (auto- Associate Commissioner for Policy. (80 FR 69864), make the following IRA laws). This Interpretive Bulletin [FR Doc. 2015–29340 Filed 11–17–15; 8:45 am] correction: does not address such state auto-IRA BILLING CODE 4164–01–P On page 69872, in the first column, in laws. § 570.489, correct paragraph (a)(3)(ii) to DATES: This interpretive bulletin is read as follows: effective on November 18, 2015. DEPARTMENT OF HOUSING AND § 570.489 Program administrative FOR FURTHER INFORMATION CONTACT: URBAN DEVELOPMENT requirements. Office of Regulations and 24 CFR Part 570 (a) * * * Interpretations, Employee Benefits (3) * * * Security Administration, (202) 693– [Docket Nos. FR 5797–I–01 and FR 5797– (ii) The combined expenditures by the 8500. This is not a toll-free number. C–02] State and its funded units of general SUPPLEMENTARY INFORMATION: In order to RIN 2506–AC39 local government for planning, provide a concise and ready reference to management, and administrative costs its interpretations of ERISA, the Changes to Accounting Requirements shall not exceed 20 percent of the Department publishes its interpretive for the Community Development Block aggregate amount of the origin year bulletins in the Rules and Regulations Grants (CDBG) Program; Correction grant, any origin year grant funds section of the Federal Register. The reallocated by HUD to the State, and the Department is publishing in this issue of AGENCY: Office of the General Counsel, amount of any program income received the Federal Register, ERISA Interpretive HUD. during the program year. Bulletin 2015–02, which interprets ACTION: Interim final rule; correction. * * * * * ERISA section 3(2)(A), 29 U.S.C. SUMMARY: This document corrects a Dated: November 13, 2015. 1002(2)(A), section 3(5), 29 U.S.C. technical error in HUD’s interim final Camille Acevedo, 1002(5), and section 514, 29 U.S.C. rule on CDBG accounting requirements, Associate General Counsel for Legislation and 1144, as they apply to state laws published November 12, 2015. Regulations. designed to expand workers’ access to DATES: Effective date: December 14, [FR Doc. 2015–29478 Filed 11–17–15; 8:45 am] retirement savings programs. Some 2015. BILLING CODE 4210–67–P states have adopted laws or are exploring approaches designed to FOR FURTHER INFORMATION CONTACT: expand the retirement savings options Stanley Gimont, Director, Office of available to their private sector workers Block Grant Assistance, Department of DEPARTMENT OF LABOR through ERISA-covered retirement Housing and Urban Development, Office plans. One of the challenges the states of Community Planning and Employee Benefits Security Administration face in expanding retirement savings Development, 451 7th Street SW., Suite opportunities for private sector 7286, Washington, DC 20410 at 202– employees is uncertainty about ERISA 708–3587, (this is not a toll-free 29 CFR Part 2509 preemption of such efforts. ERISA number). Individuals with speech or RIN 1210–AB74 generally would preempt a state law hearing impairments may access this that required employers to establish and number via TTY by calling the Federal Interpretive Bulletin Relating to State maintain ERISA-covered employee wgreen on DSK2VPTVN1PROD with RULES Relay Service, toll-free, at 800–877– Savings Programs That Sponsor or benefit pension plans. The Department 8339. Facilitate Plans Covered by the also has a strong interest in promoting Employee Retirement Income Security SUPPLEMENTARY INFORMATION: HUD retirement savings by employees. The Act of 1974 published a document in the Federal Department recognizes that some Register on November 12, 2015, at 80 AGENCY:Employee Benefits Security employers currently do not provide FR 69864, amending the accounting Administration, Labor. pension plans for their employees. The VerDate Sep<11>2014 14:36 Nov 17, 2015 Jkt 238001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\FR\FM\18NOR1.SGM 18NOR1


Document Created: 2018-03-01 11:20:18
Document Modified: 2018-03-01 11:20:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; clarification of compliance date for certain food establishments.
DatesThe 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.
ContactJenny 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.
FR Citation80 FR 71934 
RIN Number0910-AG36
CFR Citation21 CFR 1
21 CFR 106
21 CFR 11
21 CFR 110
21 CFR 114
21 CFR 117
21 CFR 120
21 CFR 123
21 CFR 129
21 CFR 16
21 CFR 179
21 CFR 211
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