81536 Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Proposed Rules 

1As an error, the authority citation we listed for 

the proposed amendments to part 570 (21 CFR part 

570) did not include an existing authority citation, 

i.e., section 408 of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 346a). 

Nothing in the 1997 proposed rule would alter the 

citation to section 408. Therefore, the authority 

citation for part 570 will continue to include 

section 408. 

(2) Identification of the averaging 

group. An averaging group will consist 

of subject merchandise that is identical 

or virtually identical in all physical 

characteristics and that is sold to the 

United States at the same level of trade. 

In identifying sales to be included in an 

averaging group, the Secretary also will 

take into account, where appropriate, 

the region of the United States in which 

the merchandise is sold, and such other 

factors as the Secretary considers 

relevant. 

(3) Time period over which weighted 

average is calculated. When applying 

the average-to-average method in an 

investigation, the Secretary normally 

will calculate weighted averages for the 

entire period of investigation. However, 

when normal values, export prices, or 

constructed export prices differ 

significantly over the course of the 

period of investigation, the Secretary 

may calculate weighted averages for 

such shorter period as the Secretary 

deems appropriate. When applying the 

average-to-average method in a review, 

the Secretary normally will calculate 

weighted averages on a monthly basis 

and compare the weighted-average 

monthly export price or constructed 

export price to the weighted-average 

normal value for the contemporaneous 

month. 

(e) Application of the average-totransaction method—In applying the 

average-to-transaction method in a 

review, when normal value is based on 

the weighted average of sales of the 

foreign like product, the Secretary will 

limit the averaging of such prices to 

sales incurred during the 

contemporaneous month. 

(f) Contemporaneous Month. 

Normally, the Secretary will select as 

the contemporaneous month the first of 

the following months which applies: (1) 

The month during which the particular 

U.S. sales under consideration were 

made; 

(2) If there are no sales of the foreign 

like product during this month, the 

most recent of the three months prior to 

the month of the U.S. sales in which 

there was a sale of the foreign like 

product. 

(3) If there are no sales of the foreign 

like product during any of these 

months, the earlier of the two months 

following the month of the U.S. sales in 

which there was a sale of the foreign 

like product. 

[FR Doc. 2010–32632 Filed 12–27–10; 8:45 am] 

BILLING CODE 3510–DS–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 170, 184, 186, and 570 

[Docket No. FDA–1997–N–0020; Formerly 

Docket No. 1997N–0103] 

Substances Generally Recognized as 

Safe; Reopening of the Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening the 

comment period for the proposed rule 

published in the Federal Register of 

April 17, 1997 (the 1997 proposed rule). 

The 1997 proposed rule would replace 

the voluntary petition process to affirm 

the generally recognized as safe (GRAS) 

status of a substance intended for use in 

food for humans or animals with a 

voluntary notification procedure. FDA 

is reopening the comment period to 

update comments. The proposed rule 

would also clarify the criteria for 

exempting the use of a substance as 

GRAS. 

DATES: The comment period for the 

proposed rule published April 17, 1997 

(62 FR 18938), is reopened. Submit 

either electronic or written comments 

on the proposed rule by March 28, 2011. 

Submit comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 by February 28, 

2011, (see the ‘‘Paperwork Reduction 

Act of 1995’’ section of this document). 

ADDRESSES: You may submit comments, 

including comments regarding the 

proposed collection of information, 

identified by Docket No. FDA–1997–N– 

0020, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–1997–N–0020, for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

With regard to substances that would be 

used in human food: Paulette M. 

Gaynor, Center for Food Safety and 

Applied Nutrition (HFS–255), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1192. 

With regard to substances that would 

be used in food for animals: Geoffrey K. 

Wong, Center for Veterinary Medicine 

(HFV–224), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6879. 

With regard to the information 

collection: Denver Presley Jr., Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3793. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the 1997 proposed rule, FDA 

proposed to replace the voluntary GRAS 

affirmation petition process in 

§§ 170.35(c) and 570.35(c) (21 CFR 

170.35(c) and 570.35(c)) with a 

voluntary notification procedure 

whereby any person may notify us of a 

determination that a particular use of a 

substance in human food (proposed 

§ 170.36) or in food for animals 

(proposed § 570.36) is GRAS.1 We also 

proposed to clarify the criteria in 

§§ 170.30 (21 CFR 170.30) and 570.30 

(21 CFR 570.30) whereby the use of a 

substance is not subject to the premarket 

approval requirements of the FD&C Act 

because it is GRAS. To simplify the 

discussion in this document, in general, 


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2With regard to GAO’s recommendations, we are 

requesting comment on the recommendations that 

FDA obtain more information about the use of 

engineered nanomaterials (Issue 10(c)), that FDA 

strive to minimize the potential for conflict of 

interest (Issue 15), and that FDA issue guidance on 

how to document GRAS determinations (Issue 16). 

GAO also recommended that FDA develop a 

strategy to finalize the proposal to establish a 

notification program for GRAS ingredients, and this 

notice reopening the comment period is the first 

step of such a strategy. FDA is not seeking comment 

on the remaining GAO recommendations, that FDA 

request that any company conducting a GRAS 

determination provide the Agency with basic 

information about that determination, and that FDA 

develop a strategy to reconsider the safety of certain 

GRAS substances. We consider those 

recommendations, and any comments on them, to 

be beyond the scope of this comment request 

because they raise issues about matters other than 

how a notification program should be run. 

3After we issued the 1997 proposed rule, a 

Presidential Memorandum dated June 1, 1998 (the 

Plain Language Memorandum) (Ref. 3) prescribed a 

government-wide initiative (the Plain Language 

Initiative, or ‘‘PLI’’) to write regulations using ‘‘Plain 

Language.’’ As outlined in that memorandum, 

documents written in plain language use ‘‘you’’ and 

other pronouns. Any final rule based on the 1997 

proposed rule and this document would use such 

pronouns. 

we refer to provisions of the 1997 

proposed rule and issues for further 

comment from the perspective of the 

regulations that would be established in 

part 170 (21 CFR part 170). Unless we 

say otherwise, however, the issues 

discussed also apply to the 

corresponding provisions for part 570. 

Under the proposed notification 

procedure, a GRAS notice would 

include: (1) A ‘‘GRAS exemption claim’’ 

in which a notifier would take 

responsibility for a GRAS 

determination; (2) information about the 

identity of the notified substance, 

including information about the method 

of manufacture (excluding any trade 

secrets); (3) information about any selflimiting levels of use; and (4) a 

comprehensive discussion of the basis 

for the GRAS determination. We would 

evaluate whether the notice provides a 

sufficient basis for a GRAS 

determination and would respond to the 

notifier in writing. We would 

immediately make available to the 

public the notice’s ‘‘GRAS exemption 

claim’’ and our response to the notice, 

and disclose other releasable 

information in a notice in accordance 

with our regulations, in part 20 (21 CFR 

part 20), implementing the Freedom of 

Information Act. 

We invited interested persons who 

determine that a use of a substance is 

GRAS to notify us of those 

determinations, under the framework of 

the 1997 proposed rule, during the 

interim between the proposed and final 

rules (62 FR 18938 at 18954). We said 

that we would determine whether our 

experience in administering such 

notices suggested that modifications to 

the proposed notification procedure 

were necessary (62 FR 18938 at 18954). 

During the period from February 1, 

1999, through December 31, 2009 (the 

interim period), our Center for Food 

Safety and Applied Nutrition (CFSAN) 

received approximately 26 GRAS 

notices per year about substances 

intended for use in human food. The 

Center for Veterinary Medicine (CVM) 

established a pilot notification program 

only recently. (See the Federal Register 

of June 4, 2010; 75 FR 31800.) 

The memorandum in reference 1 of 

this document describes CFSAN’s 

experience (through December 31, 

2009). In the remainder of this 

document, we refer to this 

memorandum as the ‘‘experience 

document.’’ Because CVM’s pilot 

program began relatively recently, the 

experience document does not describe 

any experience under CVM’s pilot 

notification program. 

Also, from 2008 to 2010, the 

Government Accountability Office 

(GAO) conducted a study related to food 

ingredients determined to be GRAS and, 

in 2010, issued a report (Ref. 2, the GAO 

report) that included a number of 

recommendations for FDA’s food 

ingredient program. FDA responded to 

the GAO’s recommendations, and that 

response is also included in the GAO 

report. 

II. Request for Comments 

Because of the length of time that has 

elapsed since publication of the 1997 

proposed rule, we are interested in 

updating comments before issuing a 

final rule. In addition, based on 

CFSAN’s experience with GRAS notices 

during the interim period, comments we 

received on the proposed rule, and 

GAO’s recommendations, we have 

identified a number of issues within the 

scope of the proposed rule that may 

require further clarification. 

Specifically, these issues relate to the 

proposed revisions to § 170.30 (Issue 1), 

the proposed establishment of a 

notification procedure (Issues 2 through 

16), and the effect of the proposed 

notification procedure on existing GRAS 

petitions (Issue 17).2 Accordingly, we 

are requesting comments on the entire 

1997 proposed rule as well as on the 

specific issues identified in this 

document. 

Comments previously submitted to 

the Division of Dockets Management 

(previously the Dockets Management 

Branch), including comments submitted 

to the Division of Dockets Management 

after the comment period closed on July 

16, 1997, but before December 28, 2010, 

do not need to be resubmitted in 

response to this notice because all such 

comments will be considered in any 

final rule based on the 1997 proposed 

rule and this document.3

A. Issue 1. Description of Common 

Knowledge Element and Related 

Definition of ‘‘Scientific Procedures’’ 

In the 1997 proposed rule, we 

proposed to revise § 170.30 to broaden 

the description of the common 

knowledge element to clarify the types 

of technical evidence of safety that 

would form the basis of a GRAS 

determination, and to clarify the role of 

publication in satisfying the common 

knowledge element. Specifically, we 

proposed revising § 170.30(b) from 

‘‘* * * ordinarily be based upon 

published studies which may be 

corroborated by unpublished studies 

and other data and information.’’ to 

‘‘based upon generally available and 

accepted scientific data, information, 

methods, or principles, which 

ordinarily are published and may be 

corroborated by unpublished scientific 

data, information, or methods.’’ We also 

proposed a companion change to the 

definition of scientific procedures 

(§ 170.3(h)) from ‘‘Scientific procedures 

include those human, animal, 

analytical, and other scientific studies, 

whether published or unpublished, 

appropriate to establish the safety of a 

substance.’’ to ‘‘Scientific procedures 

include scientific data (such as human, 

animal, analytical, or other scientific 

studies), information, methods, and 

principles, whether published or 

unpublished, appropriate to establish 

the safety of a substance.’’ 

Most of the comments addressing 

these proposed amendments supported 

the amendments. In general, these 

comments expressed the opinion that 

the proposed amendments would more 

accurately reflect the state of 

contemporary science than the 

provisions they would replace. One 

comment objected to the proposed 

amendment to § 170.30(b). This 

comment asserted that the proposed 

amendment would de-emphasize or 

eliminate the existing criterion for peerreviewed studies. One comment 

objected to the proposed amendment to 

§ 170.3(h) because, under the proposed 

amendment, an ‘‘unpublished principle’’ 

could inappropriately be considered a 

sufficient scientific procedure for 

demonstrating the safety of a food 

substance. 

In light of these comments, we 

reviewed our proposed inclusion of 

scientific ‘‘principles’’ in the proposed 

amendments to §§ 170.3(h) and 

170.30(b). ‘‘Principle’’ can be defined as 


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a fundamental cause or basis of 

something; a primary element, force, or 

law determining a particular result; or a 

fundamental truth or proposition on 

which others depend (Shorter Oxford 

English Dictionary, 5th Edition, 2002). 

Thus, a principle is a different genre 

than data, information, and methods 

and is, by its very nature, generally 

available and accepted. An 

‘‘unpublished principle’’ is a nonsequitur. Therefore, the adjectives 

‘‘published’’ and ‘‘unpublished’’ should 

not modify scientific ‘‘principles.’’ 

We also reviewed our use of the term 

‘‘study’’ in the proposed companion 

change to the definition of scientific 

procedures. A procedure can be defined 

as a particular mode or course of action 

(Shorter Oxford English Dictionary, 5th 

Edition, 2002); a ‘‘study’’ can be defined 

as the devotion of time and attention to 

acquiring information or knowledge or 

as applying the mind to acquiring 

knowledge, especially devoting time 

and effort to this end (Id.). The terms 

‘‘procedure’’ and ‘‘study’’ each carry the 

connotation of an action. However, 

‘‘data and information’’ would be the 

outcome of a study or procedure and do 

not carry the connotation of an action. 

To be a ‘‘procedure,’’ data, information, 

methods or principles would need to be 

acquired or applied. 

We are seeking comment on the use 

of those terms. For example, we are 

considering whether to revise the 

second sentence of § 170.30(b) to require 

that general recognition of safety 

through scientific procedures be based 

upon the application of generally 

available and accepted scientific data, 

information, or methods, which 

ordinarily are published, as well as the 

application of scientific principles, and 

may be corroborated by the application 

of unpublished scientific data, 

information, or methods. We also are 

considering whether to revise the 

definition of scientific procedures to 

include the application of scientific data 

(including, as appropriate, data from 

human, animal, analytical, and other 

scientific studies), information, and 

methods, whether published or 

unpublished, as well as the application 

of scientific principles, appropriate to 

establish the safety of a substance. 

B. Issue 2. Terms 

In the 1997 proposed rule, we used 

the terms ‘‘determine’’ and 

‘‘determination’’ to describe the action of 

a person who informs us that the use of 

a food substance is GRAS under the 

proposed notification procedure. 

However, as discussed in the experience 

document, during the interim period 

CFSAN responded to approximately 5 

percent of submitted GRAS notices with 

a letter informing the notifier that the 

notice did not provide a basis for a 

‘‘GRAS determination’’ (Ref. 1). Clearly, 

in these cases it was CFSAN’s view that 

the notifier had not ‘‘determined’’ GRAS 

status. To clarify that the submission of 

a GRAS notice reflects the view of the 

notifier and may not necessarily provide 

an adequate basis for a GRAS 

determination, we have tentatively 

concluded that the terms ‘‘conclude’’ 

and ‘‘conclusion’’ in lieu of ‘‘determine’’ 

and ‘‘determination’’ would be more 

appropriate, and therefore in this 

document we use the terms ‘‘conclude’’ 

and ‘‘conclusion.’’ We seek comment on 

these terms. 

C. Issue 3. Definitions 

In the 1997 proposed rule, we did not 

propose definitions of terms that would 

be associated with the GRAS 

notification procedure. However, it 

would be consistent with the Plain 

Language Initiative for a final rule to 

include definitions of terms used in the 

rule. While the meanings of some terms 

(such as ‘‘notified substance’’) were 

implicit in the discussion of the 

proposed notification procedure, to 

ensure the opportunity to comment on 

these definitions, we include them here. 

In addition, some terms not used in the 

1997 proposed rule may be useful in 

light of comments already received. We 

seek comment on the definitions 

described in the following paragraphs. 

(Issue 3a). ‘‘Amendment’’ and 

‘‘supplement.’’ Several comments asked 

FDA to allow a notifier to address 

questions FDA had about a GRAS notice 

by submitting an amendment to the 

notice. As discussed in the experience 

document (Ref. 1), during the interim 

period several notifiers submitted one or 

more amendments to their GRAS 

notices. We would define ‘‘amendment’’ 

to mean any data or other information 

that you submit regarding a filed GRAS 

notice before we respond to the notice. 

As discussed in the experience 

document (Ref. 1), during the interim 

period several notifiers submitted 

information to a GRAS notice after 

CFSAN responded to the notice. We 

would define ‘‘supplement’’ to mean any 

data or other information that you 

submit regarding a filed GRAS notice 

after we respond to the notice. 

(Issue 3b) ‘‘Notified substance,’’ 

‘‘notifier,’’ and ‘‘qualified expert.’’ We 

would define ‘‘notified substance’’ to 

mean the substance that is the subject of 

your GRAS notice. We would define 

‘‘notifier’’ to mean the person who is 

responsible for the GRAS notice, even if 

another person (such as an attorney, 

agent, or qualified expert) prepares or 

submits the notice or provides an 

opinion about the basis for a conclusion 

of GRAS status. Consistent with section 

201(s) of the FD&C Act (21 U.S.C. 

321(s)), we would define ‘‘qualified 

expert’’ to mean an individual who is 

qualified by scientific training and 

experience to evaluate the safety of 

substances added to food. 

D. Issue 4. Incorporation by Reference 

One comment requested that a notifier 

be permitted to reference a previously 

submitted GRAS notice to support a 

view that an additional use of the 

applicable substance is GRAS. In the 

comment’s view, this process, known as 

‘‘incorporation by reference,’’ would be 

administratively efficient. As discussed 

in the experience document (Ref. 1), 

during the interim period CFSAN 

encouraged notifiers to use a process 

such as that recommended in the 

comment. 

We are therefore seeking comment on 

whether to include a provision in the 

final rule to expressly permit the 

notifier to incorporate by reference 

either data and information that were 

previously submitted by the notifier, or 

public data and information submitted 

by another party, when such data and 

information remain in our files, such as 

data and information contained in a 

previous GRAS notice, a food additive 

petition, or a food master file. 

While the data and information in a 

previously submitted GRAS notice are 

generally publicly available, other data 

and information that have been 

submitted to us may be confidential. We 

do not anticipate that a notifier would 

have access to another party’s 

confidential data or information. 

We note that, regardless of whether a 

notifier incorporates by reference data 

or information, we may consider taking 

into account other relevant data or 

information that we have from other 

sources. As discussed in the experience 

document (Ref. 1), during the interim 

period CFSAN did review information 

that was available in its files but not 

available to the applicable notifier. 

E. Issue 5. Request That FDA Cease To 

Evaluate a GRAS Notice 

Several comments requested that the 

notification procedure provide for a 

notifier to withdraw a notice in light of 

our questions about the notice. These 

comments considered such a provision 

would provide the notifier with an 

opportunity to resubmit a notice 

addressing our questions. 

Under § 20.29, no person may 

withdraw records submitted to FDA. 

While a notifier cannot withdraw a 

GRAS notice submitted to FDA, when 


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4For example, a notifier may have a question 

about the common or usual name where it is not 

established by regulation. 

we issued the proposed rule, we 

considered a request that FDA cease to 

evaluate a GRAS notice to be an implicit 

prerogative not needing explicit 

authorization in the rule. For GRAS 

notices that FDA has ceased to evaluate 

at the request of the notifier, the GRAS 

notices remain in our files and, thus, are 

available for public disclosure, subject 

to procedures established in part 20. 

As discussed in the experience 

document (Ref. 1), at the request of the 

notifier, CFSAN ceased to evaluate 

approximately 16 percent of GRAS 

notices that came to closure by 

December 31, 2009. Persons who rely 

only on the provisions of proposed 

§ 170.36, without referring to our letters 

responding to GRAS notices, may not be 

aware of the implicit prerogative to 

request that FDA cease to evaluate a 

GRAS notice. 

Therefore, we are seeking comment 

on whether the rule should explicitly 

state that you may request in writing 

that we cease to evaluate your GRAS 

notice at any time during our evaluation 

of your GRAS notice. 

F. Issue 6. Notifier’s Responsibility for a 

GRAS Conclusion 

(Issue 6a) Under proposed 

§ 170.36(c)(1), the GRAS notice would 

be dated and signed by the notifier or by 

the notifier’s attorney or agent or (if the 

notifier is a corporation) by an 

authorized official. As discussed in the 

experience document (Ref. 1), during 

the interim period CFSAN received 

some GRAS notices in which the 

combination of an illegible signature 

and the lack of a typed or printed name 

to accompany the signature made it 

impossible to identify the person who 

was signing the document. Therefore, 

we are seeking comment on how to best 

ensure that the identity and authority of 

the person who is signing the GRAS 

notice is made clear. For example, we 

are considering requiring that the GRAS 

notice state the name and the position 

or title of the person who signs it. 

(Issue 6b) Under the GRAS 

affirmation petition process, a petitioner 

is required to submit a petition for 

GRAS affirmation under 21 CFR part 10 

(§ 170.35(c)(1)(v)). As part of this 

petition, a petitioner is required to 

submit a statement that, ‘‘to the best of 

his knowledge, it [the GRAS affirmation 

petition] is a representative and 

balanced submission that includes 

unfavorable information, as well as 

favorable information, known to him 

and pertinent to the evaluation of the 

safety of the substance.’’ 

(§ 170.35(c)(1)(v)). We implicitly 

proposed this provision under proposed 

§ 170.36(c)(4), which proposed to 

require, among other things, that a 

GRAS notice include a comprehensive 

discussion of any reports of 

investigations or other information that 

may appear to be inconsistent with the 

conclusion of GRAS status. We are 

seeking comment on whether the GRAS 

notification procedure should be as 

explicit on this point as the GRAS 

affirmation petition process it would 

replace. 

We also are seeking comment on 

whether to require a notifier to certify to 

this statement, which would be 

consistent with the certification in item 

E. Certification in § 10.30(b). Such 

certification also would be consistent 

with the procedures established for 

another notification program in CFSAN, 

the premarket notification program for 

food contact substances. (See 

§ 171.101(e) and FDA Form No. 3480 

(Ref. 4).) 

G. Issue 7. Appropriately Descriptive 

Term for the Notified Substance 

In the 1997 proposed rule, we 

proposed to require that the GRAS 

notice include the common or usual 

name of the notified substance 

(proposed § 170.36(c)(1)(ii)). We also 

advised that notifiers with questions 

concerning the common or usual name 

for a substance consult with CFSAN’s 

Office of Food Labeling (now the Office 

of Nutrition, Labeling and Dietary 

Supplements) (for a substance that 

would be used in human food) or with 

CVM’s Division of Animal Feeds (for a 

substance that would be used in animal 

food).4 As discussed in the experience 

document (Ref. 1), in 2004, CFSAN 

began to routinely advise notifiers that 

its use of a particular term to identify 

the notified substance in a letter 

responding to a GRAS notice should not 

be considered an endorsement or 

recommendation of that term as an 

appropriate common or usual name for 

the purpose of complying with the 

labeling provisions of the FD&C Act. 

A GRAS notice addresses sections 

201(s) and 409 of the FD&C Act and 

does not address the labeling provisions 

of the FD&C Act or FDA’s corresponding 

regulations. We are seeking comment on 

whether to revise proposed 

§ 170.36(c)(1)(ii) to make this more 

clear. For example, instead of requiring 

that the GRAS notice include the 

common or usual name of the notified 

substance, we are considering requiring 

that the GRAS notice include the name 

of the notified substance, using an 

appropriately descriptive term. We note 

that this may be the same as the term 

which you may believe would be the 

common or usual name of the substance 

under 21 CFR parts 102 (human food) 

and 502 (animal food). 

H. Issue 8. Public Disclosure 

Under proposed § 170.36(f)(1), the 

elements listed in proposed 

§ 170.36(c)(1)) would be immediately 

available for public disclosure on the 

date the notice is received. As a 

practical consequence of this proposed 

provision, the fact that we had received 

a GRAS notice (i.e., the existence of the 

GRAS notice) would be immediately 

available to the public. As discussed in 

the experience document (Ref. 1), we 

have made this information readily 

accessible to the public. CFSAN 

currently is making a ‘‘GRAS Notice 

Inventory’’ available on its Internet site. 

CFSAN presents notice-specific 

information (such as the name and 

address of the notifier, the name of the 

notified substance, and the intended 

conditions of use) extracted from the 

information submitted under proposed 

§ 170.36(c)(1). CFSAN expects that the 

ways by which we make this 

information readily accessible to the 

public will evolve over time. 

Because, under proposed 

§ 170.36(f)(1), the information submitted 

under proposed § 170.36(c)(1) would be 

immediately available for public 

disclosure, it is implicit in this 

provision that a person submitting 

information under proposed 

§ 170.36(c)(1) should not include in this 

portion any non-public information 

such as trade secret information, 

confidential commercial or financial 

information, and personal privacy 

information. Based on our experience, 

notifiers did not identify any 

information in the information 

submitted under proposed § 170.36(c)(1) 

as being confidential. We are seeking 

comment on whether the final rule 

should explicitly require that the 

information submitted under proposed 

§ 170.36(c)(1) exclude non-public 

information. 

I. Issue 9. Including Confidential 

Information in a GRAS Notice 

We proposed that the method of 

manufacture in a GRAS notice exclude 

any trade secrets (proposed 

§ 170.36(c)(2)). However, we stated that 

a notifier who considers that certain 

information in a submission should not 

be available for public disclosure should 

identify as confidential the relevant 

portions of the submission for our 

consideration (62 FR 18938 at 18952). 

We further stated we would review the 

identified information, determine 


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5 In this document, references to ‘‘consumers’’ for 

the purposes of part 170 are references to ‘‘animals’’ 

for the purposes of part 570. 

whether that information is exempt 

from public disclosure under part 20 

and release or protect the information in 

accordance with our determination. We 

advised that, in most cases, we would 

be likely to determine all information in 

a GRAS notice is available for public 

disclosure, because a conclusion of 

GRAS status must be based on generally 

available data and information. 

We received several comments about 

whether confidential information 

should be included in a GRAS notice. In 

essence, these comments suggested that 

we both provide for the submission of 

trade secrets or other confidential 

information in a GRAS notice and 

protect the trade secrets or other 

confidential information from public 

disclosure, just as we would in the case 

of submissions such as food additive 

petitions. 

As discussed in the experience 

document (Ref. 1), during the interim 

period CFSAN did accept some GRAS 

notices that included information 

identified by the notifier as confidential. 

When a GRAS notice included such 

information, in no case did CFSAN 

disclose the identified information. In 

some cases, including confidential 

information in a GRAS notice did not 

present a problem because it was 

corroborative information. However, in 

other cases CFSAN questioned whether 

there could be a basis for a conclusion 

of GRAS status if qualified experts 

generally did not have access to the 

confidential information. 

In light of both the comments and 

CFSAN’s experience, we are seeking 

comments relevant to including 

confidential information in a GRAS 

notice. We note that, while the decision 

to submit a GRAS notice would be 

voluntary, the provisions governing the 

GRAS notification procedure, including 

the information to be submitted, would 

be mandatory. 

(Issue 9a) We are seeking comment on 

whether proposed § 170.36(c)(2) should 

stipulate that the method of 

manufacture exclude any trade secrets, 

as it was proposed. 

(Issue 9b) We are seeking comment on 

whether to require that a notifier who 

identifies one or more trade secret(s), as 

defined in § 20.61(a), in the GRAS 

notice explain why it is trade secret 

information and how qualified experts 

could conclude that the intended use of 

the notified substance is GRAS without 

access to the trade secret(s). 

(Issue 9c) We are seeking comment on 

whether to require that a notifier who 

identifies confidential commercial or 

financial information, as defined in 

§ 20.61(b), in the GRAS notice explain 

why it is confidential commercial or 

financial information and how qualified 

experts could conclude that the 

intended use of the notified substance is 

GRAS without access to such 

information. 

J. Issue 10. Describing the Identity of a 

Notified Substance 

Under proposed § 170.36(c)(2), a 

GRAS notice would include ‘‘Detailed 

information about the identity of the 

notified substance, including, as 

applicable, its chemical name, Chemical 

Abstracts Service Registry Number, 

Enzyme Commission number, empirical 

formula, structural formula, quantitative 

composition, method of manufacture 

(excluding any trade secrets and 

including, for substances of natural 

biological origin, source information 

such as genus and species), 

characteristic properties, any content of 

potential human toxicants, and 

specifications for food-grade material.’’ 

(Issue 10a) Based on our experience, 

we have found that when the source of 

a notified substance is a biological 

material (e.g., a plant, animal, or 

microorganism), taxonomic information 

about genus and species may be 

insufficient to identify a biological 

source. The experience document (Ref. 

1) provides examples of GRAS notices 

including information such as genus, 

species, variety, strain, part of a plant 

source (such as fruit, seeds or seed 

husks, expressed oil, flowers, roots, 

leaves, pulp, wood, or bark), and part of 

an animal source (such as fluid, muscle 

mass, egg, shells, or extracted oil). We 

note that some GRAS substances are 

derived from animal organs (e.g., the 

enzyme preparation ‘‘catalase’’ is 

manufactured from cow’s liver (21 CFR 

184.1034)) or tissue (e.g., the enzyme 

preparation ‘‘animal lipase’’ is 

manufactured from edible forestomach 

tissue or from animal pancreatic tissue 

(21 CFR 184.1415)). We request 

comment on what scientific information 

would be sufficient to identify the 

biological source. 

(Issue 10b) Based on our experience, 

we have found that information about 

substances known to be toxicants is 

relevant regardless of the state of the 

science regarding the specific toxicity of 

the substance to humans. For example, 

during the interim period CFSAN 

evaluated a GRAS notice about a 

substance derived from a biological 

source that is known to contain 

mutagenic substances (Ref. 1). 

Therefore, we are seeking comment on 

whether to require that information 

about the identity of the notified 

substance specify any known toxicants 

that could be in the source. 

(Issue 10c) Substances that have a 

small particle size often have chemical, 

physical, or biological properties that 

are different from those of their larger 

counterparts (Ref. 5) and, thus, particle 

size and associated chemical and 

physical properties may be relevant to 

the identity of the notified substance. 

GAO’s recent recommendations also 

encouraged us to obtain more 

information about the use of engineered 

nanomaterials (Ref. 2). Therefore, we are 

seeking comment on whether the final 

rule should address, as part of identity, 

particle size and other chemical and 

physical properties that may be used to 

characterize engineered materials. 

K. Issue 11. Dietary Exposure 

We proposed to require that a notice 

regarding a conclusion of GRAS status 

through scientific procedures include a 

comprehensive discussion of, and 

citations to, generally available and 

accepted scientific data, information, 

methods, or principles that the notifier 

relies on to establish safety, including a 

consideration of the ‘‘probable 

consumption of the substance and the 

probable consumption of any substance 

formed in or on food because of its use 

and the cumulative effect of the 

substance in the diet, taking into 

account any chemically or 

pharmacologically related substances in 

such diet’’ (proposed 

§ 170.36(c)(4)(i)(A)). This proposed 

provision restated the statutory language 

of section 409(c)(5) of the FD&C Act 

regarding dietary exposure. 

We proposed to require that a notice 

regarding a conclusion of GRAS status 

through experience based on common 

use in food include a comprehensive 

discussion of, and citations to, generally 

available data and information that the 

notifier relies on to establish safety, 

including evidence of a substantial 

history of consumption of the substance 

by a significant number of consumers 5

(proposed § 170.36(c)(4)(ii)(A)). This 

proposed provision was silent on the 

probable consumption of the substance 

by present-day consumers. 

We are seeking comment on issues 

related to the proposed provisions for 

information about dietary exposure to a 

notified substance. 

(Issue 11a) We are seeking comment 

on whether proposed § 170.36(c)(4)(i)(A) 

should continue to restate the statutory 

language of section 409(c)(5) of the 

FD&C Act or whether this provision 

should be stated more clearly, for 

example, by requiring information about 


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dietary exposure (i.e., the amount of the 

notified substance that consumers are 

likely to eat or drink as part of a total 

diet). 

(Issue 11b) Over 50 years have passed 

since passage of the 1958 Food 

Additives Amendment establishing the 

requirements for food additives and the 

corresponding provisions for GRAS 

substances in food. In evaluating 

whether use of a substance is GRAS 

through experience based on common 

use in food, we rely on information 

documenting that the ‘‘common use in 

food’’ of a substance satisfies the 

definition in § 170.3(f) such that adverse 

health effects, if they occurred, could be 

noted. In other words, a substance is not 

eligible for GRAS status merely because 

it was used in food before January 1, 

1958, if such use were not sufficiently 

widespread (62 FR 18938 at 18949). 

Therefore, we are seeking comment on 

whether a GRAS notice should be 

required to include information about 

dietary exposure to contemporary 

consumers regardless of whether the 

determination of GRAS status is through 

scientific procedures or through 

experience based on common use in 

food. 

(Issue 11c) Some substances are 

administered to certain animal species 

through their drinking water. Section 

201(f) of the FD&C Act defines food as 

‘‘articles used for food or drink for man 

or other animals.’’ In the proposed rule, 

we utilized the terms, ‘‘foods’’ and 

‘‘diet,’’ when addressing the intended 

use and safety evaluation of notified 

substances. We are seeking comment on 

whether it is necessary to clarify that the 

GRAS notification procedure is 

applicable to substances used in both 

food and drinking water of animals and, 

if so, whether it would be necessary to 

clarify this in the provisions of 

proposed § 570.36. 

(Issue 11d) Under proposed 

§ 570.36(c)(1)(iii), notifiers would 

submit information about the applicable 

conditions of use of the notified 

substance, including a description of the 

population expected to consume the 

substance. For substances added to 

animal food, the applicable population 

is the specific animal species intended 

to consume the substance. Animal 

species differ in their physical 

characteristics, digestive physiology, 

and metabolic pathways. Therefore, a 

substance that is safe for use in one 

animal species may not be safe for use 

in other species, and FDA would need 

to know the intended species in order 

to properly evaluate the notifier’s safety 

assessment of the intended use of the 

substance. We are seeking comment on 

whether it is necessary to clarify 

proposed § 570.36(c)(1)(iii) to explicitly 

require submission of information about 

the animal species expected to consume 

the substance. 

(Issue 11e) Proposed § 570.36(c)(2) 

would require that notifiers submit 

detailed information about the notified 

substance, including any content of 

potential human or animal toxicants. 

Additionally, proposed 

§§ 570.36(c)(4)(i)(A) and (c)(4)(ii)(A) 

would require that notifiers submit a 

comprehensive discussion of, and 

citations to, the information that the 

notifier relies on to establish safety. 

Where a substance is intended for use 

in the food of an animal used to produce 

human food, these sections of the 

proposed rule would require that the 

notifier include citations to information 

about both target animal (i.e., the 

specific animal species that are fed the 

notified substance) and human safety. 

The information provided would need 

to be sufficient to show that the use of 

the substance is generally recognized 

among qualified experts to be safe for 

animals consuming food containing the 

substance as well as for humans 

consuming food derived from such 

animals (i.e., under its intended 

conditions of use). A GRAS notice for a 

substance intended for use in the food 

of an animal used to produce human 

food submitted without such 

information would likely receive a 

response from FDA stating that FDA has 

identified questions regarding whether 

the intended use of the substance is 

GRAS. (See the proposed rule (62 FR 

18938 at 18950).) Therefore, we are 

seeking comment on whether it is 

necessary to clarify applicable sections 

of the proposed rule to explicitly 

require, for substances intended for use 

in the food of an animal used to produce 

human food, the submission of 

information about both target animal 

and human safety. 

L. Issue 12. Filing Decision 

Some comments to the 1997 proposed 

rule recommended that we conduct a 

preliminary review of a submission, 

before we file it as a GRAS notice, to 

determine whether it appears, on its 

face, to meet the format requirements. 

Some comments suggested that we 

‘‘decline to file’’ a notice that appears to 

be inadequate, e.g., because it lacks 

critical data or information. These 

comments considered that a preliminary 

review that resulted in a ‘‘filing 

decision’’ would be analogous to the 

current procedure whereby we review a 

GRAS affirmation petition to determine 

whether it appears, on its face, to meet 

the format requirements for the GRAS 

affirmation petition process. 

As discussed in the experience 

document (Ref. 1), CFSAN routinely 

conducted such a preliminary review of 

each submitted GRAS notice. Based on 

our experience, it was the complete 

evaluation process that identified those 

data or information that are critical to 

establish GRAS status. Therefore, a 

decision on our part to file a submission 

as a GRAS notice has not reflected our 

judgment as to whether the notice 

addressed all issues or discussed all 

critical data or information. 

We are seeking comment on whether 

we should make explicit the process by 

which FDA makes such a filing 

decision, including the factors we 

should use to determine whether to file 

a submission as a GRAS notice. Some 

potential factors could be the following: 

• Whether your submission includes 

all required sections; 

• Whether you provided all required 

copies; 

• Where information provided is 

identified as being confidential, whether 

you explain the basis for your 

conclusion of GRAS status; 

• Whether we still retain as a record 

any data or information that you ask us 

to incorporate by reference; and 

• Whether the subject of your 

submission is: (1) Already authorized 

for use under our regulations or (2) a 

mixture of substances that are already 

authorized for use under our 

regulations. For example, if we receive 

a submission about a mixture of 

substances, each of which is affirmed as 

GRAS under 21 CFR part 184 for use as 

an antimicrobial in human food, and the 

intended use of the mixture is as an 

antimicrobial, we may treat the 

submission as general correspondence 

and inform the notifier that we do not 

devote resources to evaluating the use of 

such mixtures under the GRAS 

notification procedure. 

M. Issue 13. Substances Intended for 

Use in Products Subject to Regulation by 

the U.S. Department of Agriculture 

Subsequent to the 1997 proposal, we 

issued a final rule amending the GRAS 

affirmation petition process to provide 

for simultaneous review of a GRAS 

notice by FDA and the U.S. Department 

of Agriculture’s (USDA’s) Food Safety 

and Inspection Service (FSIS) when the 

intended use of the notified substance 

includes use in products subject to 

regulation by FSIS (65 FR 51758, August 

25, 2000). Under § 170.35(c)(3)(i), we 

forward a copy of a GRAS affirmation 

petition to FSIS for simultaneous review 

under the Poultry Products Inspection 

Act (PPIA) (21 U.S.C 451 et seq.) or the 

Federal Meat Inspection Act (FMIA) (21 

U.S.C. 601 et seq.). Under 


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§ 170.35(c)(3)(ii), we ask USDA to 

advise whether the proposed uses 

comply with the FMIA or PPIA or, if 

not, whether use of the substance would 

be permitted in products under USDA 

jurisdiction under specified conditions 

or restrictions. The provisions of this 

review process reflect interagency 

coordination to ease the burden on 

regulated industries and consumers. 

In addition, as discussed in the 

experience document (Ref. 1), during 

the interim period CFSAN developed a 

Memorandum of Understanding (MOU) 

with USDA’s FSIS (65 FR 33330, May 

23, 2000), which provides for the same 

coordinated review process for GRAS 

notices when the intended use of the 

notified substance includes use in 

products subject to regulation by FSIS. 

Under the terms of the MOU, CFSAN 

forwards a copy of an applicable GRAS 

notice to FSIS. CFSAN then 

simultaneously evaluates the basis for 

GRAS status while FSIS evaluates 

whether the intended use of the notified 

substance in meat or poultry products 

complies with the FMIA or PPIA or, if 

not, whether use of the substance would 

be permitted in products under FSIS 

jurisdiction under specified conditions 

or restrictions. In addition, during the 

interim period responsibility to 

administer the Egg Products Inspection 

Act (EPIA) (21 U.S.C. 1031 et seq.) was 

transferred from the Agricultural 

Marketing Service of USDA to FSIS (69 

FR 1647; January 12, 2004). In light of 

this transfer of responsibility, FSIS 

provided its review of the use of a 

notified substance in egg products when 

a GRAS notice that CFSAN sent to 

USDA for its review under the PPIA or 

the FMIA also described a use in egg 

products (Ref. 1). 

As discussed in the experience 

document (Ref. 1), more than 25 percent 

of GRAS notices filed during the interim 

period included the use of the notified 

substance in products subject to 

regulation by FSIS under the FMIA or 

the PPIA, and FDA obtained FSIS 

review for these substances. 

We are seeking comment on whether 

to make our coordinated review process 

with FSIS explicit in the final rule. We 

also are seeking comment on whether 

such a procedure should provide that a 

notifier who submits a GRAS notice for 

the use of a notified substance in 

products subject to regulation by FSIS 

provide an additional paper copy or an 

electronic copy of the GRAS notice that 

we could send to FSIS. This would 

improve the efficiency of a 

simultaneous review process. We note 

that FSIS, under statutes it administers, 

does not review the use of substances 

intended for use in food for animals and 

therefore there would be no need for a 

counterpart provision in proposed 

§ 570.36 for substances intended for use 

in food for animals. 

O. Issue 14. Timeframe for FDA’s 

Evaluation of a GRAS Notice 

Section 170.35 does not specify a 

timeframe for FDA to complete the 

rulemaking associated with a GRAS 

affirmation petition. However, we 

proposed to respond to a GRAS notice 

within 90 days to reflect both a 

commitment to operational efficiency 

and a belief that our evaluation of 

whether a notice provides a sufficient 

basis for a conclusion of GRAS status 

could likely be accomplished in such a 

period. We also considered whether the 

timeframe for our response should be 

longer than 90 days, and specifically 

requested comment on whether the 

proposed 90-day timeframe for an 

Agency response should be lengthened, 

e.g., to 120 days or 150 days. In 

addition, we noted that comments on 

the proposal may justify a longer 

timeframe for notifications concerning 

substances used in animal food. 

Several comments favored a 90-day 

timeframe because a 90-day timeframe 

would provide an incentive for 

manufacturers to submit GRAS notices. 

Other comments questioned whether 

the proposed 90-day timeframe would 

allow sufficient time for us to 

adequately evaluate a GRAS notice and 

urged us to establish a realistic 

timeframe that we would hold ourselves 

accountable to. 

As shown in the experience document 

(Ref. 1), during the interim period 

CFSAN responded to approximately 12 

percent of GRAS notices within 90 days, 

and required more than 180 days to 

respond to more than 31 percent of 

GRAS notices. As discussed in the 

experience document (Ref. 1), the 

scientific challenges associated with the 

safety assessment conducted by the 

notifier were a factor in the time CFSAN 

needed to respond to a GRAS notice. We 

request comment on whether we should 

retain a set timeframe for us to respond 

to a GRAS notice, and, if so, whether it 

should be 90 days or another timeframe. 

O. Issue 15. Conflict of Interest 

In the GAO report (Ref. 2), GAO noted 

that we have not issued any conflict of 

interest guidance that companies can 

use to help ensure that the members of 

their expert panels are independent. 

Further, GAO recommended that FDA 

develop a strategy to minimize the 

potential for conflicts of interest, 

including taking steps such as issuing 

guidance for companies on conflict of 

interest and requiring information in 

GRAS notices regarding expert 

panelists’ independence. As discussed 

in the GAO report (Ref. 2), we consider 

that the use of an expert panel is one 

way to demonstrate consensus (i.e., the 

common knowledge element of safety) 

and we do not consider the view of an 

expert panel alone to be determinative 

for establishing safety. We seek 

comment on whether companies would 

find it useful to have guidance on 

potential conflicts of interest of GRAS 

expert panelists. If such guidance would 

be useful, we seek comment on what 

companies currently do to mitigate such 

a conflict. We also seek comment on 

whether to require that GRAS notices 

include information regarding expert 

panelists’ independence. 

P. Issue 16. Additional Guidance on 

Documenting GRAS Conclusions 

The GAO report recommended that 

FDA issue guidance on how to 

document GRAS conclusions (Ref. 2). In 

our response to GAO, we noted the 

guidance in the preamble to the GRAS 

proposal and the guidance on our Web 

site that answers common questions 

about the food ingredients classified as 

GRAS in the form of frequently asked 

questions (Ref. 6). We seek comment 

whether there is a need to clarify that 

this guidance also applies to a GRAS 

conclusion that is not submitted to FDA 

under the proposed notification 

procedure and whether there is a need 

for FDA to develop further guidance on 

documenting such a GRAS conclusion. 

Q. Issue 17. Pending GRAS Affirmation 

Petitions 

In the 1997 proposed rule, we 

proposed to presumptively convert any 

filed, GRAS affirmation petition that is 

pending on the effective date of the rule 

(hereinafter referred to as a ‘‘pending 

petition’’) to a GRAS notice. The 

conversion would take place on the 

effective date of the final rule. Any 

person (hereinafter referred to as an 

‘‘affected petitioner’’) who had 

submitted a GRAS affirmation petition 

could amend the converted petition by 

submitting the dated and signed 

document that would be required under 

proposed § 170.36(c)(1). In essence, we 

would waive the requirement for an 

affected petitioner who submitted such 

a document to agree to provide us with 

access to applicable data and 

information upon request if the affected 

petitioner informed us that the complete 

record that supports the conclusion of 

GRAS status had been submitted in the 

applicable GRAS petition. The proposed 

procedures for our review and 

administration of a converted petition 

would be similar to those for a newly 


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6Proposed § 170.36(g)(3)(iii) stated that we would 

inform a petitioner who did not submit a 

conversion amendment that the notice was 

inadequate within 90 days of publication of the 

final rule, rather than within 90 days of the effective 

date of the final rule. This was an error. 

submitted GRAS notice. However, by 90 

days after the effective date of the final 

rule,6 we would inform any affected 

petitioner who had not submitted a 

certification that the converted petition 

was inadequate as a notice. 

A few comments stated that the 1997 

proposed rule did not discuss the fate of 

a pending petition if the petitioner 

elected not to submit a conversion 

amendment. These comments did not 

understand the implications of the 

proposed provisions which, in essence, 

would consider that the affected 

petitioner had not provided a basis for 

a conclusion of GRAS status. 

Many comments objected to the 

proposed provisions regarding pending 

petitions. In general, these comments 

expressed the opinion that our proposal 

was fundamentally unfair to an affected 

petitioner because an affected petitioner 

had invested considerable time and 

resources in the petition process. Some 

comments suggested that we 

‘‘grandfather’’ a pending petition (i.e., 

complete the rulemaking that began 

under the petition process), as a matter 

of course, in those circumstances where 

we had completed our scientific review 

and had no outstanding scientific 

questions. Other comments suggested 

that such a ‘‘grandfather’’ provision be 

an option available to an affected 

petitioner rather than a matter of course. 

One comment recommended that the 

final rule provide a petitioner with a 

period of 180, rather than 90, days to 

submit the dated and signed document 

providing information in proposed 

§ 170.36(c)(1). This comment argued 

that many of these petitions had been 

pending for years, that the subjects of 

the petitions had been marketed during 

those years, and that there would 

therefore be no urgency in closing the 

applicable files. 

In light of the view of the comments 

that our proposed disposition of 

pending petitions was unfair, in this 

document we are seeking comments 

regarding pending petitions. 

Specifically, we seek comment on how 

to reduce the impact on affected 

petitioners while retaining the principle 

that we will not devote resources to 

pending petitions. We seek comment on 

whether an outcome of ‘‘withdrawal 

without prejudice’’ instead of 

‘‘insufficient basis’’ would be more 

appropriate when an affected petitioner 

simply chooses not to have the pending 

petition considered under the GRAS 

notification procedure. We are seeking 

comment on whether an affected 

petitioner could request that we 

incorporate by reference a withdrawn 

GRAS affirmation petition into a GRAS 

notice, and if so, if any requirements of 

the GRAS notification procedure should 

be waived. 

We also note that, as discussed in the 

experience document (Ref. 1), during 

the interim period we processed a 

pending petition as a food additive 

petition and issued a food additive 

regulation for the petitioned substance 

(21 CFR 172.780; 70 FR 8032, February 

17, 2005). We note that CVM has no 

pending GRAS petitions and thus, this 

discussion is not applicable to GRAS 

affirmation petitions for food for 

animals. 

III. Costs and Benefits 

FDA requests comments on how the 

issues discussed in this document could 

affect the costs and benefits estimated in 

the 1997 proposed rule, e.g., whether 

these issues would result in costs or 

benefits that would be either greater 

than, or less than, those estimated in the 

1997 proposed rule (62 FR 18938 at 

18958). 

IV. Paperwork Reduction Act of 1995 

The 1997 proposed rule contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). Interested persons 

are requested to send comments 

regarding information collection to FDA 

(see DATES and ADDRESSES). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

VI. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES). 

You may see them between 9 a.m. and 

4 p.m., Monday through Friday. (FDA 

has verified the Web site addresses, but 

FDA is not responsible for any 

subsequent changes to Web sites after 

this document publishes in the Federal 

Register.) 

1. Experience With GRAS Notices 

Under the 1997 Proposed Rule, 

Memorandum Dated November 4, 2010, 

from Linda S. Kahl of FDA to Docket 

No. FDA–1997–N–0020. 

2. United States Government 

Accountability Office, Report to 

Congressional Requestors on Food 

Safety: FDA Should Strengthen Its 

Oversight of Food Ingredients 

Determined To Be Generally Recognized 

as Safe (GRAS), Report No. GAO–10– 

246, February 2010, Accessible at http:// 

www.gao.gov/new.items/d10246.pdf, 

Accessed and printed on May 3, 2010. 

3. Memorandum for the Heads of 

Executive Departments and Agencies, 

Dated June 1, 1998, Signed by President 

William J. Clinton, Accessible at http:// 

www.plainlanguage.gov/whatisPL/gov

mandates/memo.cfm, Accessed and 

printed on July 14, 2008. 

4. FDA Form No. 3480, Notification 

for New Use of a Food Contact 

Substance, Accessible at http:// 

www.fda.gov/downloads/AboutFDA/

ReportsManualsForms/Forms/

ucm076880.pdf, Accessed and printed 

on October 13, 2010. 

5. FDA, 2007, Nanotechnology Task 

Force Report 2007, Accessible at http:// 

www.fda.gov/ScienceResearch/Special

Topics/Nanotechnology/

NanotechnologyTaskForceReport2007/

default.htm, Accessed and printed on 

October 13, 2010. 

6. Guidance for Industry: Frequently 

Asked Questions About GRAS, 

Accessible at http://www.fda.gov/Food/

GuidanceComplianceRegulatory

Information/GuidanceDocuments/Food

IngredientsandPackaging/

ucm061846.htm, Accessed and printed 

on October 13, 2010. 

Dated: December 17, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32344 Filed 12–27–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–132554–08] 

RIN 1545–BI16 

Additional Rules Regarding Hybrid 

Retirement Plans; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to a notice of 

proposed rulemaking. 


emcdonald on DSK2BSOYB1PROD with PROPOSALS