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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

 [Federal Register: October 11, 2000 (Volume 65, Number 197)]
[Rules and Regulations]
[Page 60359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc00-8]

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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]
BILLING CODE 4160-01-F

 
 

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