[Federal Register Volume 65, Number 88 (Friday, May 5, 2000)]
[Notices]
[Pages 26215-26216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11331]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1262]


Improving Premarket Review and Approval of Food and Color 
Additives in the Center for Food Safety and Applied Nutrition; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting public 
comment on ways to improve the process of premarket review and approval 
of food and color additive petitions by FDA's Center for Food Safety 
and Applied Nutrition (CFSAN). CFSAN received substantial new resources 
for fiscal year 2000 targeted to the premarket review of petitions for 
approval of new uses of food and color additives. This document is 
being

[[Page 26216]]

published to give all interested parties an opportunity to comment on 
how these new resources may best be applied to address public health 
issues related to the timely approval and safe use of food and color 
additives. CFSAN will consider administrative and procedural 
enhancements to ensure that program goals are met while maintaining 
high standards of safety and scientific credibility.

DATES: Submit written comments by July 19, 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: Alan M. Rulis, Center for Food Safety 
and Applied Nutrition (HFS-200), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3100, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: The Office of Premarket Approval (OPA) in 
CFSAN manages the following programs: Petitions for new uses of food 
and color additives, consultations on foods developed using new methods 
of biotechnology, generally recognized as safe (GRAS) notices, 
threshold of regulation (TOR) exemption requests, and premarket 
notifications for food contact substances (PMN). In addition to these 
programs, OPA is the lead technical authority for food additives for 
the U.S. Government. OPA provides expertise and leadership in the 
international forums of the Joint Food Agricultural Organization (FAO)/
World Health Organization (WHO) Expert Committee on Food Additives, the 
North American Free Trade Agreement, and the Codex Alimentarius 
Commission to define international standards, promote harmonization, 
and evaluate equivalency agreements for food additives and other food 
ingredients. OPA also has laboratory research and sample analysis 
components that provide technical support for the enforcement of the 
food additive regulations.
    The current process of reviewing food and color additive petitions 
has evolved over 40 years since the passage of the 1958 Food Additives 
Amendment to the Federal Food, Drug, and Cosmetic Act (the act). 
Approvals of food and color additives have been based on a critical 
scientific evaluation of safety information submitted by petitioners. 
The primary components of this evaluation are the review of chemical, 
toxicological, and environmental scientific data and information and an 
estimation of the probable human dietary exposure to additives. During 
its review of safety of new food additive uses, OPA develops an 
administrative record that relies on scientific data and information to 
support the agency's safety conclusions. Although this framework has a 
high level of scientific credibility, CFSAN recognizes that 
improvements could be made to ensure that the process is more efficient 
while maintaining the current high scientific standards. With this 
notice, CFSAN is soliciting comments on ways to improve the timeliness, 
transparency, and predictability of its review of food and color 
additive petitions, and its monitoring of the safety of food and color 
additives over time.
    To help focus comments, FDA requests that comments regarding food 
and color additive review address the following:
    1. The act requires that the agency base its safety decisions for 
the premarket review of additives on ``a fair evaluation of the data'' 
and requires that new uses of food additives be consistent with the 
agency safety standard of ``reasonable certainty of no harm.'' What 
specific changes can be made to the current review process to make that 
process more efficient, i.e., transparent, timely, responsive, and 
predictable, while preserving these high standards of data review and 
of safety?
    2. On January 5, 1999 (64 FR 517), CFSAN made available a guidance 
describing a policy to expedite the review of petitions for food 
additives that are intended to significantly decrease human pathogens 
or their toxins in/on food. Should the Center consider broadening the 
criteria for eligibility for such expedited petition review? If so, 
petitions for what types of uses should be added?
    3. How should the increased appropriation to CFSAN that is targeted 
for the safety review of food and color additives be allocated? For 
example, to what extent should new resources be allocated to: (1) 
Performing prefiling consultations with prospective applicants for new 
uses of food ingredients, (2) adding personnel resources to the review 
process, (3) enhancing electronic data management systems such as 
automated workflow management or data warehousing, and (4) acquiring or 
monitoring new safety information on already approved additives?
    4. What specific program enhancements should be given the highest 
priority?
    Interested persons may, on or before July 19, 2000, submit to the 
Dockets Management Branch (address above) written comments regarding 
this document. 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.

    Dated: April 28, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-11331 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-F