[Federal Register Volume 65, Number 197 (Wednesday, October 11, 2000)]
[Rules and Regulations]
[Page 60359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-26022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 25

[Docket No. 00N-0085]


National Environmental Policy Act; Food Contact Substance 
Notification System; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of August 24, 2000, for the direct final rule (DFR) that 
appeared in the Federal Register of May 11, 2000 (65 FR 30352). The DFR 
amended FDA's regulations on environmental impact considerations. This 
document confirms the effective date of the DFR.

DATES: Effective date confirmed: August 24, 2000.

FOR FURTHER INFORMATION CONTACT: Mitchell A. Cheeseman, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3083.

SUPPLEMENTARY INFORMATION: In a DFR published in the Federal Register 
of May 11, 2000 (65 FR 30352), FDA amended its regulations on 
environmental impact considerations as part of the agency's 
implementation of the FDA Modernization Act (FDAMA) of 1997. FDAMA 
amended the Federal Food, Drug, and Cosmetic Act (the act) by 
establishing a notification process for authorizing new uses of food 
additives that are food contact substances. The DFR amended the 
regulations in 21 CFR 25.20 to add to the list of those actions that 
require an environmental assessment allowing a notification submitted 
under section 409(h) of the act (21 U.S.C. 348(h)) to become effective 
and in 21 CFR 25.32(i), (j), (k), (q), and (r) to expand the existing 
categorical exclusions from the requirement of an environmental 
assessment to include allowing a notification submitted under section 
409(h) of the act to become effective.
    FDA solicited comments concerning the DFR for a 75-day period 
ending July 25, 2000. FDA stated that the effective date of the DFR 
would be on August 24, 2000, 30 days after the end of the comment 
period, unless any significant adverse comment was submitted to FDA 
during the comment period.
    FDA received only one comment (from a trade association) on the 
DFR, which reiterated the association's views presented in response to 
an agency public meeting held prior to the initiation of this 
rulemaking. FDA has determined that the received comment is not a 
significant adverse comment for several reasons. First, in the preamble 
to the DFR, FDA referenced the association's prior submission and 
addressed its substance. Second, the comment does not dispute (or even 
directly address) the analysis presented in the DFR. It raises no new 
arguments and provides no new information for the agency's 
consideration. Finally, the association expressly characterizes the 
comment as not a ``significant adverse comment'' and supports the rule 
becoming effective as drafted.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, the 
amendments issued thereby became effective August 24, 2000.

    Dated: October 3, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-26022 Filed 10-10-00; 8:45 am]
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