Federal Register / Vol. 79, No. 210 / Thursday, October 30, 2014 / Notices 64603 

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. 

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: ctreece@planning

professionals.com. 

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: jeremiah.fasano@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The guidance titled ‘‘Toxicological 

Principles for the Safety Assessment of 

Food Ingredients,’’ or ‘‘Redbook,’’ 

(http://www.fda.gov/Food/

GuidanceRegulation/

GuidanceDocumentsRegulatory

Information/IngredientsAdditivesGRAS

Packaging/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/Guidance

DocumentsRegulatoryInformation/

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? 


tkelley on DSK3SPTVN1PROD with NOTICES
64604 Federal Register / Vol. 79, No. 210 / Thursday, October 30, 2014 / Notices 

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: ctreece@

planningprofessionals.com. 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: Jeremiah.Fasano@fda.hhs.gov. 

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: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING AND ON SUBMITTING COMMENTS TO THE RULEMAKING

DOCKETS

Date Electronic address Address 

Public meeting ............. December 9, 2014 ..... http://www.fda.gov/Food/NewsEvents/

WorkshopsMeetingsConferences/default.htm.

Wiley Building, 5100 Paint Branch Pkwy., 

College Park, MD 20740. 

Advance registration .... By December 2, 2014 Individuals who wish to participate in person 

are asked to preregister at http://

www.fda.gov/Food/NewsEvents/

WorkshopsMeetingsConferences/default.htm.

We encourage you to use electronic registration if possible.1

Request to make an 

oral presentation.

By November 21, 

2014.

http://www.fda.gov/Food/NewsEvents/

WorkshopsMeetingsConferences/default.htm 2.

Request special accommodations due 

to a disability.

By November 21, 

2014.

Jeremiah Fasano, email: Jeremiah.Fasano@

fda.hhs.gov.

See FOR FURTHER INFORMATION CONTACT. 

Submit electronic or 

written comments.

By February 9, 2015 .. Docket FDA–2014–N–1497 ............................ Division of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 

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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