[Federal Register Volume 65, Number 224 (Monday, November 20, 2000)]
[Rules and Regulations]
[Pages 69666-69667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29538]


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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, 2004, as the uniform compliance date for food labeling regulations 
that are issued between January 1, 2001, and December 31, 2002. FDA 
periodically announces uniform compliance dates for new food labeling 
requirements to minimize the economic impact of label changes. On 
December 23, 1998, FDA established January 1, 2002, as the uniform 
compliance date for food labeling regulations that issued between 
January 1, 1999, and December 31, 2000.

DATES: This rule is effective November 20, 2000. Submit written 
comments by February 5, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 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, 200 C St. 
SW., Washington, DC 20204, 202-205-4273.

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

[[Page 69667]]

Federal Registers of October 19, 1984 (49 FR 41019), December 24, 1996 
(61 FR 67710), December 27, 1996 (61 FR 68145), and December 23, 1998 
(63 FR 71015)). 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 (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, safety, distributive, and equity 
effects). Executive Order 12866 classifies a rule as ``economically 
significant'' if it meets any one of a number of specified conditions 
including having an annual effect on the economy of $100 million, 
adversely affecting some sector of the economy in a material way, or 
adversely affecting jobs or competition. A regulation 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 
neither an economically significant rule nor a significant regulatory 
action as defined by Executive Order 12866. In addition, in accordance 
with the Small Business Regulatory Enforcement Fairness Act of 1996, 
the administration of 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 requirements, 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.
    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 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, 
2001. Therefore, all final FDA regulations published in the Federal 
Register before January 1, 2001, 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 (61 FR 67710), 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 
(address above) written comments regarding this final rule by February 
5, 2001. Two copies of any comments are to be submitted, except that 
individuals may submit one 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, 2001, and before December 
31, 2002. Those regulations will specifically identify January 1, 2004, 
as their compliance date. All food products subject to the January 1, 
2004, compliance date must comply with the appropriate regulations when 
initially introduced into interstate commerce on or after January 1, 
2004. If any food labeling regulation involves special circumstances 
that justify a compliance date other than January 1, 2004, the agency 
will determine for that regulation an appropriate compliance date, 
which will be specified when the final regulation is published.

    Dated: November 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-29538 Filed 11-17-00; 8:45 am]
BILLING CODE 4160-01-F