[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Notices]
[Pages 8291-8292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4858]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0409]
Alternative and Traditional Models for Safety Evaluation of Food
Ingredients; Announcement of Study; Request for Scientific Data and
Information; Announcement of Open Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
Life Sciences Research Office (LSRO) of the Federation of American
Societies for Experimental Biology (FASEB) will undertake a
comprehensive discussion of the scientific criteria and principles
generally agreed upon by scientists in the food safety community as
necessary for demonstrating that a food ingredient is safe. This
discussion will include both a description of the data needed to ensure
safety or to achieve a reasonable certainty that the ingredient will
not cause harm and alternative approaches for achieving that assurance
when traditional approaches do not definitively resolve safety
questions.
To assist in the preparation of a scientific report, LSRO/FASEB is
inviting the submission of scientific data and information regarding
this topic. LSRO/FASEB will provide an opportunity for oral
presentations at an open meeting.
DATES: LSRO/FASEB has scheduled a 1-day public meeting on this topic
for May 15, 1996. Requests to make oral presentations at the open
meeting must be submitted in writing and received by April 24, 1996.
Submit written presentations of scientific data, information, and views
on or before May 10, 1996.
ADDRESSES: Submit written requests to make oral presentations at the
open meeting to both the Life Sciences Research Office, Federation of
American Societies for Experimental Biology, 9650 Rockville Pike,
Bethesda, MD 20814-3998 and to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville,
MD 20857. Two copies of the scientific data, information, and views for
presentation should be submitted to each office. The meeting will be
held in the Chen Auditorium, Lee Bldg., FASEB (address above).
FOR FURTHER INFORMATION CONTACT: Daniel J. Raiten or Sue Ann Anderson,
Life Sciences Research Office, Federation of American Societies for
Experimental Biology, 9650 Rockville Pike, Bethesda, MD 20814-3998,
301-530-7030, on the scheduling of presentations at the public meeting
and related matters. Other information may be obtained from Victor
Frattali, Center for Food Safety and Applied Nutrition (HFS-2), Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-
1730.
SUPPLEMENTARY INFORMATION: FDA has a contract (223-92-2185) with LSRO/
FASEB concerning the analysis of scientific issues that bear on the
safety of foods and cosmetics. The objectives of this contract are to
provide information to FDA on general and specific issues of scientific
fact associated with the analysis of human nutrition.
As one task under the contract, FDA has requested information on
matters related to the adequacy of data needed to support decisions on
the safety of food ingredients. Currently, FDA provides safety testing
guidelines for food ingredients through a publication entitled
``Toxicological Principles for the Safety Assessment of Direct Food
Additives and Color Additives Used in Food'' (also known as the
``Redbook''). This document gives guidance to petitioners primarily for
those situations in which a traditional approach to safety testing is
appropriate (i.e., those in which food additives to be used in low
concentrations are tested for safety).
However, traditional studies involving administration of
substances constituting a large part of an animal's diet may produce
adverse effects simply as a result of the unusual diet rather than the
inherent toxicity of the test substance. Further, FDA recognizes that
the advent of new technologies such as genetic engineering of
traditional foods and novel uses of plant products, as well as
development of macroingredients, present new situations for which an
alternative approach to safety assessment may be needed. While FDA has
successfully reached decisions on food ingredients produced with such
new technologies on a case-by-case basis, it has become clear that a
need exists for information on the criteria that the scientific
community believes are appropriate so that both a requirement for new
types of safety studies and any elimination or limitation of the role
of traditional studies can be justified. Types of food ingredients for
which an alternative model may be appropriate include, for example,
macroingredient substitutes such as psyllium, ingredients derived from
botanicals such as Stevia rebaudiana Bertoni, restructured fats such as
caprenin, and ingredients derived using biotechnology.
Based on an evolving need to be responsive to the development of
food ingredients resulting from new technologies, FDA wishes to have
LSRO/FASEB prepare a comprehensive report on the principles and
criteria generally agreed upon by the community of food safety experts
for determining when the traditional safety model is appropriate. The
agency is also interested in a discussion identifying the principles
and criteria to be used to determine the safety of a food ingredient
when the traditional safety model is not appropriate. FDA is especially
interested in a discussion of how different principles and criteria
should be ranked and weighted, interrelationships that should be
considered, and any situation where a principle or criterion might be
considered determinative without regard to other considerations. It
would also be desirable to have a discussion about how the new testing
approaches may substitute for more traditional testing.
In framing this discussion, FDA has suggested that the following
questions be considered. These questions are not intended as a
statement of specific tasks. They are intended to be illustrative and
to be used as a basis for stimulating thinking regarding the
determination of the safe use of food ingredients.
1. In what cases, if any, are animal feeding studies not necessary
to ensure safety? For example: Do such studies need to be conducted for
ingredients that also occur naturally in foods at similar or higher
concentrations? Is it reasonable and necessary to test food-like
substances for toxicity and nutritional influences recognizing the
potential for confounding results? If so, how?
2. To what extent can chemical and structural similarity to food
ingredients known to be safe obviate the need for animal or human
testing?
3. What criteria should be used to determine when a treatment-
related effect (including effects from nutritional imbalance or
interference) is an adverse effect?
4. Are there criteria that can be used to determine whether an
adverse effect observed in a study is relevant to human safety as
opposed to an effect that is dependent on study design and has no
[[Page 8292]]
relevance to safety under actual use conditions?
5. Under what circumstances should clinical studies in humans
supplement or replace studies in laboratory animals? How will use of
human data affect the need for safety factors? Which parameters should
be measured and what study duration is necessary?
6. Is there an agreed-upon basis for determining the maximum level
of an additive to be administered in a test diet above which a study
should be presumed unacceptable?
7. Can postmarketing surveillance (such as monitoring of use or
monitoring of adverse reaction reports by consumers and physicians) be
used to ensure safety? For example, can such surveillance be used
without compromising safety to verify exposure estimates or to
eliminate the need for specific data prior to marketing, thus reducing
the need to use worst-case assumptions in a safety evaluation? If so,
how could this be accomplished?
The objective of this review is to make recommendations on the set
of circumstances under which the scientific community believes that the
use of a safety model that is an alternative to the traditional safety
model is justified and will ensure the safety of food ingredients. Such
discussions would include: (1) Circumstances prompting the need for new
types of studies, (2) circumstances in which traditional studies should
not be required or should be modified or their use limited, and (3) the
appropriate use of safety factors. FDA also requests a description of
the principles and criteria that would be used in the nontraditional or
alternative situations and a ranking/weighting of these criteria and
principles.
The project is divided into two phases. In the first phase, LSRO/
FASEB will solicit input from 40 to 60 members of the food safety
community. The nature of this input from each individual will be in the
form of a 3- to 5-page ``white paper'' which will contain expert
opinion on issues related to food ingredient safety evaluations.
Individuals will be asked to furnish sufficient background material
with their white papers to provide a basis for comment on the issues
being addressed by LSRO/FASEB in this contract.
A Phase I Expert Panel composed of five members will be convened by
LSRO/FASEB. LSRO/FASEB staff will assemble a background document for
the Phase I Expert Panel that consists of a compilation of the
previously obtained comments from the scientific community. This
background document is intended to provide a perspective for the Phase
I Expert Panel in its deliberations; it will not be a preliminary draft
of the report to be delivered to FDA in fulfillment of the scope of
work for the contract task. Upon approval by the Phase I Expert Panel,
the background document will be available on or before April 12, 1996,
from LSRO/FASEB (address above). The background document will be on
display at LSRO/FASEB and the Dockets Management Branch (addresses
above).
In Phase II, the Expert Panel will be expanded to eight members.
The Phase II Expert Panel will conduct a comprehensive discussion of
the principles and criteria generally agreed upon by the community of
food safety experts for determining when the traditional safety model
is appropriate. More specifically, based on the deliberations of the
Phase II Expert Panel, LSRO/FASEB will organize the scientific concepts
of food ingredient safety to yield a set of criteria in a report that
the agency could then consider in evaluating the safety of food
ingredients. Additionally, based on the discussions of the Phase II
Expert Panel, the report will identify a ranking and weighting of such
considerations that the scientific community would agree could be used
to evaluate whether a new or modified food ingredient should be
considered safe.
FDA and LSRO/FASEB are announcing that LSRO/FASEB will hold a
public meeting on this topic on May 15, 1996. It is anticipated that
the meeting will last 1 day, depending on the number of requests to
make oral presentations. Requests to make oral presentations at the
open meeting must be submitted in writing and received by April 24,
1996. Participants will be required to submit two copies of the written
text of oral presentations of scientific data, information, and views
on or before May 10, 1996, to LSRO/FASEB (address above) and two copies
to the Dockets Management Branch (address above). The meeting will be
held in the Chen Auditorium, Lee Bldg., FASEB (address above).
For individuals not wishing to make an oral presentation, FDA and
LSRO/FASEB are also inviting submission in writing of scientific data,
information, and views. Two copies of these materials must be submitted
on or before May 10, 1996, to both LSRO/FASEB and the Dockets
Management Branch (addresses above).
Pursuant to its contract with FDA, LSRO/FASEB will provide the
agency with a scientific report on the Phase II review and discussions
on or about July 31, 1997.
Dated: February 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy.
[FR Doc. 96-4858 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F
