[Federal Register Volume 79, Number 210 (Thursday, October 30, 2014)]
[Notices]
[Pages 64603-64604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25800]
[[Page 64603]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1497]
Toxicological Principles for the Safety Assessment of Food
Ingredients; Public Meeting on Updates and Safety and Risk Assessment
Considerations; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting to solicit comments on certain topics related to our
guidance titled ``Toxicological Principles for the Safety Assessment of
Food Ingredients,'' known less formally as the ``Redbook.'' The purpose
of our public meeting is to invite public input into possibly expanding
the scope of the Redbook to include chemical safety assessments for all
products over which FDA's Center for Food Safety and Applied Nutrition
(CFSAN) has statutory authority including regulatory contexts such as
food additives, food contact substances, dietary supplement
ingredients, food contaminants, and cosmetics. The Redbook would
describe toxicological principles which apply across regulatory
categories while still providing specific guidance for applying these
principles within each particular context. The safety of foods
containing microbial contaminants will continue to remain outside of
the scope of the Redbook.
DATES: See section III, ``How to Participate in the Public Meeting,''
in the SUPPLEMENTARY INFORMATION section of this document for the date
and time of the public meeting, closing dates for advance registration,
and information on deadlines for submitting either electronic or
written comments to FDA's Division of Dockets Management.
ADDRESSES: See section III, ``How To Participate in the Public
Meeting,'' in the SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT:
For questions about registering for the meeting; to register by
telephone; or to register by mail, FAX, or email: Courtney Treece,
Planning Professionals Ltd., 1210 W. McDermott St., Suite 111, Allen,
TX 75013, 704-258-4983, FAX: 469-854-6992, email:
[email protected].
For general questions about the meeting or for special
accommodations due to a disability: Jeremiah Fasano, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1173, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The guidance titled ``Toxicological Principles for the Safety
Assessment of Food Ingredients,'' or ``Redbook,'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm2006826.htm) provides guidance to
industry and other stakeholders (e.g., academia and other regulatory
groups) regarding the information used by CFSAN to evaluate the safety
of food and color additives. The Federal Food, Drug, and Cosmetic Act
(the FD&C Act) requires our premarket approval of the use of a new food
or color additive, including the new use of an approved additive. With
respect to premarket approval, the safety of food additives and color
additives used in foods must be established by evaluating the probable
exposure to the substance and appropriate toxicological and other
safety information. Thus, approval of any new food additive or color
additive used in foods depends, in part, upon the outcome of toxicity
tests that are performed and evaluated before marketing. The law also
allows a manufacturer to market a substance for a use without premarket
approval, if the substance is generally recognized as safe (GRAS).
However, general recognition of safety based upon scientific procedures
requires the same quantity and quality of evidence as is required to
obtain food additive approval (21 CFR 170.30(b)). The same
toxicological principles apply to other types of cosmetic and food
safety assessments, such as for contaminants and for dietary
ingredients in dietary supplements. However, the kind of information
needed varies depending on the product types based on the requirements
of the FD&C Act.
The Redbook sets out a system of tiered recommendations for
additives in foods. These recommendations provide guidance on how much
toxicity testing should be done depending on the level of estimated
exposure to a substance in foods. The Redbook is a guidance document
that is intended to help interested parties understand FDA's
expectations regarding:
Determining the human exposure that will occur from the
use of the ingredient in foods;
Determining which toxicity studies are appropriate;
Designing, conducting, and reporting the results of
toxicity studies; and
Submitting the information to FDA as part of a safety
assessment.
Subsequent to the Redbook's publication, we provided a related
guidance document titled ``Guidance for Industry: Preparation of Food
Contact Notifications for Food Contact Substances: Toxicology
Recommendations'' (http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm081825.htm) describing the
information we expect in various types of submissions concerning the
safety of substances added to foods, such as food contact substances
(formerly known as indirect food additives), substances generally
recognized as safe for a defined use in foods, and new dietary
ingredients in dietary supplement products. This related guidance
document illustrates how the Redbook, developed for food additive and
color additive premarket reviews, can inform assessments in other
regulatory contexts, including risk assessments of constituent
residues.
II. Purpose and Scope of the Public Meeting:
The purpose of this public meeting is to invite public comment on
what should be included, changed, or even excluded from the updated
Redbook. We are interested in expanding the scope of the Redbook to
emphasize the principles of safety and risk assessment that are shared
across different regulatory contexts for foods and cosmetics, while
still providing specific guidance for applying these principles in
particular contexts such as the requirements for pre-market safety
submissions or for risk assessments conducted on foods and cosmetics
already on the market. We invite comments from interested parties on
the following topics:
1. What components of the Redbook should receive priority for
review and update?
2. What aspects of the safety and risk assessment of food
ingredients or other CFSAN-regulated products are not addressed and
should be considered for incorporation in the Redbook?
3. How can the Redbook be updated to more fully support the
development and submission of safety assessments for substances
introduced into food?
[[Page 64604]]
4. How should we balance the desire for transparency and
consistency in risk assessment as described in the Redbook, with the
goal of flexibility in applying the most appropriate analysis for
specific contexts?
III. How To Participate in the Public Meeting
We are holding the public meeting to invite public comment on what
should be included, changed, or even excluded from the updated Redbook.
Due to limited space and time, we encourage all persons who wish to
attend the meeting to register in advance. There is no fee to register
for the public meeting, and registration will be on a first-come,
first-served basis. Early registration is recommended because seating
is limited. Onsite registration will be accepted, as space permits,
after all preregistered attendees are seated. Live Webcasting of the
event is also being offered through the registration process.
Those requesting an opportunity to make an oral presentation during
the time allotted for public comment at the meeting are asked to submit
a request. When submitting a request to make an oral presentation,
individuals should identify the number of each question they wish to
address (see II. Purpose and Scope of the Public Meeting) in their
presentation to help us organize the presentations. We would like to
maximize the number of individuals who make a presentation at the
meeting. If time permits, individuals or organizations that did not
register in advance may be granted the opportunity to make an oral
presentation.
We encourage persons and groups who have similar interests to
consolidate their information for presentation by a single
representative. After reviewing the presentation requests, we will
notify each participant before the meeting of the approximate time
their presentation is scheduled to begin.
While oral presentations from specific individuals and
organizations will be necessarily limited due to time constraints
during the public meeting, stakeholders may submit electronic or
written comments discussing any issues of concern to the administrative
record (the docket).
Table 1 of this document provides information on participation in
the public meeting:
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\1\ You may also register via telephone, email, mail, or FAX.
Please include your name, title, firm name, address, and phone and
FAX numbers in your registration information and send to: Courtney
Treece, Planning Professionals Ltd., 1210 W. McDermott St., Suite
111, Allen, TX 75013, 704-258-4983, FAX: 469-854-6992, email:
[email protected]. Onsite registration will also be
available.
\2\ You may also request to make an oral presentation at the
public meeting via email. Please include your name, title, firm
name, address, and phone and FAX numbers and send to: Jeremiah
Fasano,, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
240-402-1173, email: [email protected].
Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
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Date Electronic address Address
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Public meeting.................... December 9, 2014..... http://www.fda.gov/Food/ Wiley Building, 5100
NewsEvents/ Paint Branch Pkwy.,
WorkshopsMeetingsConferen College Park, MD 20740.
ces/default.htm.
Advance registration.............. By December 2, 2014.. Individuals who wish to We encourage you to use
participate in person are electronic registration
asked to preregister at if possible.\1\
http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.
Request to make an oral By November 21, 2014. http://www.fda.gov/Food/
presentation. NewsEvents/
WorkshopsMeetingsConferen
ces/default.htm \2\.
Request special accommodations due By November 21, 2014. Jeremiah Fasano, email: See FOR FURTHER
to a disability. [email protected] INFORMATION CONTACT.
ov.
Submit electronic or written By February 9, 2015.. Docket FDA-2014-N-1497.... Division of Dockets
comments. Management (HFA-305),
Food and Drug
Administration, 5630
Fishers Lane, rm. 1061,
Rockville, MD 20852.
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IV. Request for Comments
Regardless of attendance at the public meeting, interested persons
may submit either electronic comments to http://www.regulations.gov or
written comments to the Division of Dockets Management (see ADDRESSES).
It is only necessary to send one set of comments. Identify comments
with the docket number found in brackets in the heading of this
document. To ensure consideration, submit comments by February 9, 2015.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at http://www.regulations.gov.
V. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: October 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25800 Filed 10-29-14; 8:45 am]
BILLING CODE 4164-01-P