Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Rules and Regulations 78155 

15 CFR Part 742 

Exports, Terrorism. 

15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

15 CFR Part 745 

Administrative practice and 

procedure, Chemicals, Exports, Foreign 

trade, Reporting and recordkeeping 

requirements. 

■ Accordingly, the EAR (15 CFR parts 

730–774) is amended as follows: 

PART 730—[AMENDED] 

■ 1. The authority citation for 15 CFR 

part 730 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 22 U.S.C. 287c; 22 U.S.C. 2151 note; 

22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 30 

U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 

U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 

50 U.S.C. app. 5; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; E.O. 11912, 41 FR 15825, 3 CFR, 

1976 Comp., p. 114; E.O. 12002, 42 FR 35623, 

CFR, 1977 Comp., p. 133; E.O. 12058, 43 FR 

20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12214, 45 FR 29783, 3 CFR, 1980 Comp., p. 

256; E.O. 12851, 58 FR 33181, 3 CFR, 1993 

Comp., p. 608; E.O. 12854, 58 FR 36587, 3 

CFR, 1993 Comp., p. 179; E.O. 12918, 59 FR 

28205, 3 CFR, 1994 Comp., p. 899; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; E.O. 12947, 60 FR 5079, 3 CFR, 1995 

Comp., p. 356; E.O. 12981, 60 FR 62981, 3 

CFR, 1995 Comp., p. 419; E.O. 13020, 61 FR 

54079, 3 CFR, 1996 Comp., p. 219; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 

Comp., p. 208; E.O. 13222, 66 FR 44025, 3 

CFR, 2001 Comp., p. 783; E.O. 13224, 66 FR 

49079, 3 CFR, 2001 Comp., p. 786; E.O. 

13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 

168; Notice of August 12, 2010, 75 FR 50681 

(August 16, 2010); Notice of November 4, 

2010, 75 FR 68673 (November 8, 2010). 

PART 734—[AMENDED] 

■ 2. The authority citation for 15 CFR 

part 734 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 

3 CFR, 1994 Comp., p. 950; E.O. 13020, 61 

FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 12, 2010, 75 

FR 50681 (August 16, 2010); Notice of 

November 4, 2010, 75 FR 68673 (November 

8, 2010). 

PART 736—[AMENDED] 

■ 3. The authority citation for 15 CFR 

part 736 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 2151 note; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 

Comp., p. 219; E.O. 13026, 61 FR 58767, 3 

CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; E.O. 

13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 

168; Notice of August 12, 2010, 75 FR 50681 

(August 16, 2010); Notice of November 4, 

2010, 75 FR 68673 (November 8, 2010). 

PART 742—[AMENDED] 

■ 4. The authority citation for 15 CFR 

part 742 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; Sec. 1503, Pub. L. 108–11, 117 

Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 

1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 

3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 

FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Presidential Determination 

2003–23 of May 7, 2003, 68 FR 26459, May 

16, 2003; Notice of August 12, 2010, 75 FR 

50681 (August 16, 2010); Notice of November 

4, 2010, 75 FR 68673 (November 8, 2010). 

PART 744—[AMENDED] 

■ 5. The authority citation for 15 CFR 

part 744 is revised to read as follows: 

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; E.O. 12058, 43 FR 20947, 3 CFR, 

1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 

3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 

FR 59099, 3 CFR, 1994 Comp., p. 950; E.O. 

12947, 60 FR 5079, 3 CFR, 1995 Comp., p. 

356; E.O. 13026, 61 FR 58767, 3 CFR, 1996 

Comp., p. 228; E.O. 13099, 63 FR 45167, 3 

CFR, 1998 Comp., p. 208; E.O. 13222, 66 FR 

44025, 3 CFR, 2001 Comp., p. 783; E.O. 

13224, 66 FR 49079, 3 CFR, 2001 Comp., p. 

786; Notice of August 12, 2010, 75 FR 50681 

(August 16, 2010); Notice of November 4, 

2010, 75 FR 68673 (November 8, 2010). 

PART 745—[AMENDED] 

■ 6. The authority citation for 15 CFR 

part 745 is revised to read as follows: 

Authority: 50 U.S.C. 1701 et seq.; E.O. 

12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 

950; Notice of November 4, 2010, 75 FR 

68673 (November 8, 2010). 

Dated: December 10, 2010. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2010–31488 Filed 12–14–10; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2000–N–0011] 

Uniform Compliance Date for Food 

Labeling Regulations 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is establishing 

January 1, 2014, as the uniform 

compliance date for food labeling 

regulations that are issued between 

January 1, 2011, and December 31, 2012. 

FDA periodically announces uniform 

compliance dates for new food labeling 

requirements to minimize the economic 

impact of label changes. On December 8, 

2008, FDA established January 2, 2012, 

as the uniform compliance date for food 

labeling regulations issued between 

January 1, 2009, and December 31, 2010 

(January 1, 2012 fell on a Sunday; 

therefore the uniform compliance date 

was January 2, 2012). 

DATES: This rule is effective December 

15, 2010. Submit either electronic or 

written comments by February 14, 2011. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2000–N– 

0011, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM 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 Agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ 

paragraph of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read background documents or 


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78156 Federal Register / Vol. 75, No. 240 / Wednesday, December 15, 2010 / Rules and Regulations 

comments received, go to http:// 

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: 

Louis B. Brock, Center for Food Safety 

and Applied Nutrition (HFS–24), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2378. 

SUPPLEMENTARY INFORMATION: FDA 

periodically issues 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 separately to each 

change would be substantial. Therefore, 

the Agency periodically has 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), and December 8, 2008 (73 FR 

74349). 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. 

This policy serves consumers’ interests 

as well because the cost of multiple 

short-term label revisions that would 

otherwise occur would likely be passed 

on to consumers in the form of higher 

prices. 

The Agency has 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. 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Pub. L. 

104–4). Executive Order 12866 directs 

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). The 

Agency believes that this final rule is 

not a significant regulatory action under 

the Executive order. 

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, the Agency certifies 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 $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

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, the 

Agency has 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, 2011. Therefore, all 

final FDA regulations published in the 

Federal Register before January 1, 2011, 

will still go into effect on the date stated 

in the respective final rule. 

The Agency generally encourages 

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, FDA 

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 

rulemaking unnecessary for 

establishment of the uniform 

compliance date. Nonetheless, under 21 

CFR 10.40(e)(1), FDA is providing an 

opportunity for comment on whether 

this uniform compliance date should be 

modified or revoked. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

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, 2011, and before 

December 31, 2012. Those regulations 

will specifically identify January 1, 

2014, as their compliance date. All food 

products subject to the January 1, 2014, 

compliance date must comply with the 

appropriate regulations when initially 

introduced into interstate commerce on 

or after January 1, 2014. If any food 

labeling regulation involves special 

circumstances that justify a compliance 

date other than January 1, 2014, the 

Agency will determine for that 

regulation an appropriate compliance 

date, which will be specified when the 

final regulation is published. 

Dated: December 9, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31382 Filed 12–14–10; 8:45 am] 

BILLING CODE 4160–01–P 


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