[Federal Register Volume 65, Number 32 (Wednesday, February 16, 2000)]
[Proposed Rules]
[Pages 7806-7807]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 94P-0036]
RIN 0910-AB66


Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient 
Content Claims, and Health Claims; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening for 60 
days the comment period for the submission of comments and other 
related information regarding the proposed rule on trans fatty acids in 
nutrition labeling, nutrient content claims, and health claims. This 
proposed rule was announced in the Federal Register of November 17, 
1999 (64 FR 62746). This action is being taken in response to requests 
for more time to submit comments to FDA.

DATES: Submit written comments on the proposal by April 17, 2000.

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: Susan Thompson, Center for Food Safety 
and Applied Nutrition (HFS-165), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-5587.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 1999 
(64 FR 62746), FDA proposed to amend its regulations on nutrition 
labeling to require that the amount of trans fatty acids present in a 
food, including dietary supplements, be included in the amount and 
percent Daily Value declared for saturated fatty acids. FDA proposed 
that when trans fatty acids are present, the declaration of saturated 
fatty acids shall bear a symbol that refers to a footnote at the bottom 
of the nutrition label that states the number of grams (g) of trans 
fatty acids present in a serving of the product. FDA also proposed 
that, wherever saturated fat limits are placed on nutrient content 
claims, health claims, or disclosure and disqualifying levels, the 
amount of trans fatty acids be limited as well. In addition, the agency 
proposed to define the nutrient content claim ``trans fat free.'' The 
proposal responded, in part, to a citizen petition on trans fatty acids 
in food labeling from the Center for Science in the Public Interest. 
This action was taken to prevent misleading claims and to provide 
information to assist consumers in maintaining healthy dietary 
practices. Interested persons were given until February 15, 2000, to 
comment on the proposed rule.
    The agency has received requests to reopen the comment period for 
the November 17, 1999, proposal to allow additional time for interested 
persons to comment.
    National trade associations representing manufacturers, processors, 
retailers, and other industry groups assert that the complexity of the 
issue requires a thorough and thoughtful analysis to prepare meaningful 
comments. They believe that the comment deadline of February 15, 2000, 
does not provide the time necessary to accomplish this task. Also, 
industry reported that the comment period covered several major 
holidays and the critical Y2K period, in which many people had limited 
time or simply were not available to work on this important issue. The 
trade associations indicate they are currently gathering comments and 
surveying their members on the effect of the proposal and that many 
members are small businesses that do not have the resources to respond 
quickly. The trade associations assert that they and their members need 
time to: (1) Test their products to determine whether they contain 0.5 
g trans fat per serving; (2) investigate appropriate analytical 
methods; (3) evaluate options such as product reformulation with 
alternative fat and oil sources; (4) review data bases and food product 
formulations; (5) review scientific evidence included and omitted from 
the proposal; (6) review labeling options and the costs of label 
changes; (7) establish economic models and evaluate them; and (8) 
assess the implementation costs relative to the length of the 
implementation period.
    Additionally, the trade associations believe that they need to 
determine the number of food products affected because they think that 
FDA's estimate is low. Also, they note that the agency's estimate of 
zero for discarding label and package inventory is based on a 2-year 
compliance period. They point out the compliance period could be closer 
to 1 year. Also, they state that trade associations must have time to 
resolve member differences to present a consensus position for the 
industry.
    In its proposal, FDA tentatively concluded that the proposed 
action, if finalized, will have a significant impact on consumers 
ability to use the food label to maintain healthy dietary practices. 
The agency also acknowledged that the proposed rule is economically 
significant under Executive Order 12866 and would have a major economic 
impact under the Small Business Regulatory Enforcement and Fairness Act 
(Public Law 104-121). In addition, the Administrator of the Office of 
Information and Regulatory Affairs of the Office of Management and 
Budget has determined that the proposed rule would be a major rule for 
the purpose of congressional review. It is therefore important that 
adequate time be allowed to appropriately address the many issues 
involved in this proposed rulemaking. Accordingly, the agency has 
decided to reopen the comment period on the November 17, 1999, proposal 
for 60 days in response to the requests.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this proposal by April 17, 
2000. 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

[[Page 7807]]

document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: February 11, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-3787 Filed 2-14-00; 12:00 pm]
BILLING CODE 4160-01-F