Uniform Compliance Date for Food Labeling Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. 96N-0094]

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, 2000, as the uniform compliance date for food labeling regulations

that are issued between January 1, 1997, and December 31, 1998. FDA has

periodically announced uniform compliance dates for new food labeling

requirements to minimize the economic impact of label changes. In 1992,

FDA suspended this practice pending the issuance of regulations

implementing the Nutrition Labeling and Education Act of 1990 (the 1990

amendments). FDA recently reinstated this practice of with the

establishment of a uniform compliance date of January 1, 1998.

DATES: Effective December 27, 1996; written comments by March 13, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Center for Food

Safety and Applied Nutrition (HFS-150), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-4561.

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) and

December 24, 1996 (61 FR 67710). 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.

During the 1980's and into the early 1990's, FDA periodically

issued final rules announcing new uniform compliance dates for food

labeling regulations. The agency suspended the issuance of uniform

compliance date final rules in 1992 because of the pending issuance of

a number of new final regulations implementing the 1990 amendments.

Most of these regulations are now in place and effective.

In the Federal Register of April 15, 1996 (61 FR 16422), FDA issued

a proposal entitled ``Uniform Compliance Date for Food Labeling

Regulations.'' In that document, FDA, among other things, proposed to

reinstate its practice of periodically issuing uniform compliance dates

as final rules. The comments to the proposal fully supported the

agency's doing so. With the publication of this final rule, FDA is

reinstating this practice.

The agency has determined under 21 CFR 25.24(a)(11) 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.

FDA has examined the economic implications of this final rule under

Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-

612). Executive Order 12866 directs agencies to assess all costs and

benefits of available regulatory alternatives and, when regulation is

necessary, to select the regulatory approach that maximizes net

benefits (including potential economic, environmental, public health

and safety effects; distributive impacts; and equity). 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, or if it raises novel

legal or policy issues. If a rule has a significant impact on a

substantial number of small entities, the Regulatory Flexibility Act

requires agencies to analyze options that would minimize the economic

impact of that rule on small entities.

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 options of setting alternative dates, especially with regard to the

impact on small entities. Therefore, the agency finds that the final

rule is not a significant rule as defined by Executive Order 12866.

Similarly, the agency certifies that the final rule will not have a

significant economic impact on a substantial number of small entities.

It has also determined that the rule is not a major rule for the

purpose of congressional review (Pub. L. 104-121).

This action is not intended to change existing requirements for

compliance dates contained in final rules published before publication

of this final rule. Therefore, all final FDA regulations published in

the Federal Register before December 27, 1996 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.

Because FDA has already provided notice and an opportunity for

comment on the practice of establishing uniform compliance dates by

issuance of a final rule announcing the date, it finds any further

rulemaking unnecessary. 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, on or before March 13, 1997 submit to the

Dockets Management Branch (address above) written comments regarding

this final rule. 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 office above between 9

a.m. and 4 p.m., Monday though Friday. After its review of any comments

received to this final rule, FDA will either publish a notice 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, 1997, and before January 1,

1999. Those regulations will specifically identify January 1, 2000, as

their compliance date. All food products subject to the January 1,

2000, compliance date must comply with the

[[Page 68146]]

appropriate regulations when initially introduced into interstate

commerce on or after January 1, 2000. If any food labeling regulation

involves special circumstances that justify a compliance date other

than January 1, 2000, the agency will determine for that regulation an

appropriate compliance date, which will be specified when the final

regulation is published.

Dated: December 20, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-32884 Filed 12-26-96; 8:45 am]

BILLING CODE 4160-01-F