[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: 
<a href="/cdn-cgi/l/email-protection#375443455252545277475b5659595e5950474558515244445e5859565b441954585a"><span class="__cf_email__" data-cfemail="e182959384848284a1918d808f8f888f8691938e87849292888e8f808d92cf828e8c">[email protected]</span></a>.
    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: 
<a href="/cdn-cgi/l/email-protection#1a707f687f77737b72347c7b697b74755a7c7e7b34727269347d756c"><span class="__cf_email__" data-cfemail="8fe5eafdeae2e6eee7a1e9eefceee1e0cfe9ebeea1e7e7fca1e8e0f9">[email protected]</span></a>.

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:
    <bullet> Determining the human exposure that will occur from the 
use of the ingredient in foods;
    <bullet> Determining which toxicity studies are appropriate;
    <bullet> Designing, conducting, and reporting the results of 
toxicity studies; and
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#2546515740404640655549444b4b4c4b4255574a434056564c4a4b4449560b464a48"><span class="__cf_email__" data-cfemail="a0c3d4d2c5c5c3c5e0d0ccc1cecec9cec7d0d2cfc6c5d3d3c9cfcec1ccd38ec3cfcd">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="5f153a2d3a32363e3771193e2c3e31301f393b3e7137372c71383029">[email protected]</a>.

    Table 1--Information on Participation in the Meeting and on Submitting Comments to the Rulemaking Dockets
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                                             Date              Electronic address               Address
----------------------------------------------------------------------------------------------------------------
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.                                           <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="2c66495e4941454d44026a4d5f4d42436c4a484d0244445f024b">[email protected]</a>   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


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