Uniform Compliance Date for Food Labeling Regulations, 73201-73202 [2014-28829]

Download as PDF Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations 73201 Program Statute Section and age distinction Regulation The Children, Youth, and Families At-Risk Sustainable Community Projects (CYFAR SCP). 7 U.S.C. 341, et seq.; 7 U.S.C. 343(d). Section 3(d) of the Smith-Lever Act authorizes the Department to administer the CYFAR SCP. Per Program notices, CYFAR SCP supports community educational programs for at-risk children, youth, and families which are based on locally identified needs, soundly grounded in research, and which lead to the accomplishment of one of four CYFAR National Outcomes; and (2) [t]o integrate CYFAR programming into ongoing Extension programs for children, youth, and families—insuring that at-risk, low income children, youth, and families continue to be part of Extension and/or 4–H programs and have access to resources and educational opportunities. 7 CFR part 3015, 7 CFR part 3019, 7 CFR part 3430. Risk Management Agency Federal Crop Insurance Program. 7 U.S.C. 1501 ............. Dated: November 17, 2014. Thomas J. Vilsack, Secretary. economic impact of label changes. On November 28, 2012, we established January 1, 2016, as the uniform compliance date for food labeling regulations issued between January 1, 2013, and December 31, 2014. DATES: This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015. ADDRESSES: You may submit comments by any of the following methods: [FR Doc. 2014–28452 Filed 12–9–14; 8:45 am] BILLING CODE P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. 21 CFR Part 101 [Docket No. FDA–2000–N–0011 (Formerly Docket No. 2000N–1596)] Uniform Compliance Date for Food Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA or we) is establishing January 1, 2018, as the uniform compliance date for food labeling regulations that are issued between January 1, 2015, and December 31, 2016. We periodically announce uniform compliance dates for new food labeling requirements to minimize the rmajette on DSK2VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 Per the Crop Insurance Handbook, which provides the official FCIC approved underwriting standards for policies administered by Approved Insurance Providers under the Common Crop Insurance Policy Basic Provisions, 7 CFR part 457 including the Catastrophic Risk Protection Endorsement, 7 CFR part 402, and the Actual Production History Regulation 7 CFR part 400 Subpart G for the 2014 and succeeding crop years, to be eligible for crop insurance the applicant must be of ‘‘legal majority.’’ Legal majority is defined as ‘‘where the individual has reached 18 years old or was conferred legal majority by a court. (1) For individuals less than 18 years of age or where legal majority has not been conferred by a court, to be eligible for crop insurance: (a) A minor must provide evidence an insurable share exists; and (b) a court-appointed guardian or parent must co-sign the application. (2) When a court-appointed guardian or parent cosigns the application: (a) An acknowledgement guaranteeing payment of the annual premium must be included with the application; and (b) a written statement describing the farming operation and the insurable share must be provided. (3) For CAT coverage only, a minor who is competent to enter into a binding contract, may insure a crop at CAT level without a cosigner; however, if not competent to enter into a binding contract, a court-appointed guardian or parent must sign the application.’’ Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Docket No. (FDA– 2000–N–0011) for this rulemaking. All comments received may be posted without change to https:// PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 7 CFR parts 400, 402, 457. www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michael Ellison, Center for Food Safety and Applied Nutrition (HFS–24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240–402–2093. SUPPLEMENTARY INFORMATION: I. Background We periodically issue regulations requiring changes in the labeling of food. If the effective dates of these labeling changes were not coordinated, the cumulative economic impact on the food industry of having to respond E:\FR\FM\10DER1.SGM 10DER1 rmajette on DSK2VPTVN1PROD with RULES 73202 Federal Register / Vol. 79, No. 237 / Wednesday, December 10, 2014 / Rules and Regulations separately to each change would be substantial. Therefore, we periodically have announced uniform compliance dates for new food labeling requirements (see, e.g., the Federal Register of October 19, 1984 (49 FR 41019); December 24, 1996 (61 FR 67710); December 27, 1996 (61 FR 68145); December 23, 1998 (63 FR 71015); November 20, 2000 (65 FR 69666); December 31, 2002 (67 FR 79851); December 21, 2006 (71 FR 76599); December 8, 2008 (73 FR 74349); December 15, 2010 (75 FR 78155); and November 28, 2012 (77 FR 70885)). Use of a uniform compliance date provides for an orderly and economical industry adjustment to new labeling requirements by allowing sufficient lead time to plan for the use of existing label inventories and the development of new labeling materials. We have determined under 21 CFR 25.30(k) 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. This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. We have examined the impacts of the 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 (Public Law 104–4). Executive Orders 12866 and 13563 direct Agencies 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 believe that this final rule is not a significant regulatory action under Executive Order 12866. The establishment of a uniform compliance date does not in itself lead to costs or benefits. We will assess the costs and benefits of the uniform compliance date in the regulatory impact analyses of the labeling rules that take effect at that date. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. Because the final rule does not impose compliance costs on small entities, we certify that the final rule will not have a significant VerDate Sep<11>2014 12:45 Dec 09, 2014 Jkt 235001 economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies 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 $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. We do not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount. We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required. This action is not intended to change existing requirements for compliance dates contained in final rules published before January 1, 2015. Therefore, all final rules published by FDA in the Federal Register before January 1, 2015, will still go into effect on the date stated in the respective final rule. We generally encourage industry to comply with new labeling regulations as quickly as feasible, however. Thus, when industry members voluntarily change their labels, it is appropriate that they incorporate any new requirements that have been published as final regulations up to that time. In rulemaking that began with publication of a proposed rule on April 15, 1996 (61 FR 16422), and ended with a final rule on December 24, 1996, we provided notice and an opportunity for comment on the practice of establishing uniform compliance dates by issuance of a final rule announcing the date. Receiving no comments objecting to this practice, FDA finds any further advance notice and opportunity for comment or delayed effective date unnecessary for establishment of the uniform compliance date. We have previously invited comment on the practice of PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 establishing uniform compliance dates by issuing a final rule, and interested parties will have an opportunity to comment on the compliance date for each individual food labeling regulation as part of the rulemaking process for that regulation. Nonetheless, under 21 CFR 10.40(e)(1), we are providing an opportunity for comment on whether the uniform compliance date established by this final rule should be modified or revoked. The new uniform compliance date will apply only to final FDA food labeling regulations that require changes in the labeling of food products and that publish after January 1, 2015, and before December 31, 2016. Those regulations will specifically identify January 1, 2018, as their compliance date. All food products subject to the January 1, 2018, compliance date must comply with the appropriate regulations when initially introduced into interstate commerce on or after January 1, 2018. If any food labeling regulation involves special circumstances that justify a compliance date other than January 1, 2018, we will determine for that regulation an appropriate compliance date, which will be specified when the final regulation is published. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: December 4, 2014. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2014–28829 Filed 12–9–14; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R05–OAR–2014–0123; FRL–9920–13– Region 5] Approval and Promulgation of Air Quality Implementation Plans; Illinois; Withdrawal of Direct Final Rule Environmental Protection Agency (EPA). AGENCY: E:\FR\FM\10DER1.SGM 10DER1

Agencies

[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Rules and Regulations]
[Pages 73201-73202]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-28829]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2000-N-0011 (Formerly Docket No. 2000N-1596)]


Uniform Compliance Date for Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA or we) is establishing 
January 1, 2018, as the uniform compliance date for food labeling 
regulations that are issued between January 1, 2015, and December 31, 
2016. We periodically announce uniform compliance dates for new food 
labeling requirements to minimize the economic impact of label changes. 
On November 28, 2012, we established January 1, 2016, as the uniform 
compliance date for food labeling regulations issued between January 1, 
2013, and December 31, 2014.

DATES: This rule is effective December 10, 2014. Submit electronic or 
written comments by February 9, 2015.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Docket No. 
(FDA-2000-N-0011) for this rulemaking. All comments received may be 
posted without change to https://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
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 Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael Ellison, Center for Food 
Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2093.

SUPPLEMENTARY INFORMATION:

I. Background

    We periodically issue regulations requiring changes in the labeling 
of food. If the effective dates of these labeling changes were not 
coordinated, the cumulative economic impact on the food industry of 
having to respond

[[Page 73202]]

separately to each change would be substantial. Therefore, we 
periodically have announced uniform compliance dates for new food 
labeling requirements (see, e.g., the Federal Register of October 19, 
1984 (49 FR 41019); December 24, 1996 (61 FR 67710); December 27, 1996 
(61 FR 68145); December 23, 1998 (63 FR 71015); November 20, 2000 (65 
FR 69666); December 31, 2002 (67 FR 79851); December 21, 2006 (71 FR 
76599); December 8, 2008 (73 FR 74349); December 15, 2010 (75 FR 
78155); and November 28, 2012 (77 FR 70885)). Use of a uniform 
compliance date provides for an orderly and economical industry 
adjustment to new labeling requirements by allowing sufficient lead 
time to plan for the use of existing label inventories and the 
development of new labeling materials.
    We have determined under 21 CFR 25.30(k) 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.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    We have examined the impacts of the 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 (Public 
Law 104-4). Executive Orders 12866 and 13563 direct Agencies 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 believe that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The establishment of a uniform compliance date does not in itself 
lead to costs or benefits. We will assess the costs and benefits of the 
uniform compliance date in the regulatory impact analyses of the 
labeling rules that take effect at that date.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. Because the final rule does not impose 
compliance costs on small entities, we certify that the final rule will 
not have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies 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 $141 million, using the most current (2013) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we have concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive Order and, consequently, a federalism summary 
impact statement is not required.
    This action is not intended to change existing requirements for 
compliance dates contained in final rules published before January 1, 
2015. Therefore, all final rules published by FDA in the Federal 
Register before January 1, 2015, will still go into effect on the date 
stated in the respective final rule. We generally encourage industry to 
comply with new labeling regulations as quickly as feasible, however. 
Thus, when industry members voluntarily change their labels, it is 
appropriate that they incorporate any new requirements that have been 
published as final regulations up to that time.
    In rulemaking that began with publication of a proposed rule on 
April 15, 1996 (61 FR 16422), and ended with a final rule on December 
24, 1996, we provided notice and an opportunity for comment on the 
practice of establishing uniform compliance dates by issuance of a 
final rule announcing the date. Receiving no comments objecting to this 
practice, FDA finds any further advance notice and opportunity for 
comment or delayed effective date unnecessary for establishment of the 
uniform compliance date. We have previously invited comment on the 
practice of establishing uniform compliance dates by issuing a final 
rule, and interested parties will have an opportunity to comment on the 
compliance date for each individual food labeling regulation as part of 
the rulemaking process for that regulation. Nonetheless, under 21 CFR 
10.40(e)(1), we are providing an opportunity for comment on whether the 
uniform compliance date established by this final rule should be 
modified or revoked.
    The new uniform compliance date will apply only to final FDA food 
labeling regulations that require changes in the labeling of food 
products and that publish after January 1, 2015, and before December 
31, 2016. Those regulations will specifically identify January 1, 2018, 
as their compliance date. All food products subject to the January 1, 
2018, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2018. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2018, we will 
determine for that regulation an appropriate compliance date, which 
will be specified when the final regulation is published.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28829 Filed 12-9-14; 8:45 am]
BILLING CODE 4164-01-P
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