[Federal Register: December 31, 2002 (Volume 67, Number 251)]
[Rules and Regulations]               
[Page 79851-79852]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de02-7]                         


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


21 CFR Part 101


[Docket No. 00N-1596]


 
Uniform Compliance Date for Food Labeling Regulations


AGENCY: Food and Drug Administration, HHS.


ACTION: Final rule.


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SUMMARY: The Food and Drug Administration (FDA) is establishing January 
1, 2006, as the uniform compliance date for food labeling regulations 
that are issued between January 1, 2003, and December 31, 2004. FDA 
periodically announces uniform compliance dates for new food labeling 
requirements to minimize the economic impact of label changes. On 
November 20, 2000, FDA established January 1, 2004, as the uniform 
compliance date for food labeling regulations that issued between 
January 1, 2001, and December 31, 2002.


DATES: This rule is effective December 31, 2002. Submit written or 
electronic comments by March 17, 2003.


ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.


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 Registers 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), and November 20, 2000 (65 FR 69666)). 
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


[[Page 79852]]


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 (OMB) under the 
Paperwork Reduction Act of 1995 is not required.
    FDA has examined the economic implications of this final rule as 
required by Executive Order 12866. 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 effects). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions including having an annual effect on the economy 
of $100 million or adversely affecting in a material way a sector of 
the economy, competition, or jobs. A regulation also is considered a 
significant regulatory action under Executive Order 12866 if it raises 
novel legal or policy issues. FDA finds that this final rule is not a 
significant regulatory action as defined by Executive Order 12866. In 
addition, in accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, OMB has determined that this final rule is not a 
major rule for purposes of congressional review. The establishment of a 
uniform compliance date does not impose either costs or benefits. For 
future labeling regulations, FDA will assess the costs and benefits of 
the uniform compliance date as well as the option of setting other 
dates.
    Because FDA has issued this final rule without first publishing a 
general notice of proposed rulemaking, a final regulatory analysis is 
not required by the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Nonetheless, the uniform compliance date does not impose any burden on 
small entities. The agency will assess the costs and benefits of 
setting alternative dates as part of the regulatory flexibility 
analyses of future labeling regulations.
    Title II of the Unfunded Mandates Reform Act of 1995 (Public Law 
104-4) requires cost-benefit and other analyses before any rulemaking 
if the rule would include a ``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 1 year.'' The current inflation-adjusted 
statutory threshold is $112 million. FDA has determined that this final 
rule does not constitute a significant rule under the Unfunded Mandates 
Reform Act.
    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, 
2003. Therefore, all final FDA regulations published in the Federal 
Register before January 1, 2003, 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 proposal 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 Dockets Management Branch (see 
ADDRESSES), written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
 or two hard copies of any written comments, except 
that individuals may submit one hard copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday. After its 
review of any comments received to this final rule, FDA will either 
publish a document providing its conclusions concerning the comments or 
will initiate notice and comment rulemaking to modify or revoke the 
uniform compliance date established by this final rule.
    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, 2003, and before December 
31, 2004. Those regulations will specifically identify January 1, 2006, 
as their compliance date. All food products subject to the January 1, 
2006, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2006. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2006, the agency 
will determine for that regulation an appropriate compliance date, 
which will be specified when the final regulation is published.


    Dated: December 24, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32978 Filed 12-30-02; 8:45 am]

BILLING CODE 4160-01-S