Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Proposed Rules 49707 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket Nos. FDA–2011–C–0344 and FDA– 

2011–C–0463] 

CooperVision, Inc.; Filing of Color 

Additive Petitions 

Correction 

In proposed rule document 2011– 

16089 appearing on page 37690 in the 

issue of Tuesday, June 28, 2011, make 

the following correction: 

On page 37690, in the first column, in 

the twelfth line from the bottom of the 

page, 

‘‘methacryloxyethyl)phenstyamino]’’ 

should read 

‘‘methacryloxyethyl)phenlyamino]’’. 

[FR Doc. C1–2011–16089 Filed 8–10–11; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket Nos. FDA–2000–P–0102, FDA– 

2000–P–0133, and FDA–2006–P–0033] 

Food Labeling; Health Claim; 

Phytosterols and Risk of Coronary 

Heart Disease; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening the 

comment period for the proposed rule 

published in the Federal Register of 

December 8, 2010, proposing to amend 

regulations on plant sterol/stanol esters 

and risk of coronary heart disease 

(CHD). FDA is reopening the comment 

period because the Agency received a 

request for additional time to comment 

on the proposed rule. 

DATES: The comment period for the 

proposed rule published December 8, 

2010 (75 FR 76526), is reopened. Submit 

either electronic or written comments 

by October 25, 2011. 

ADDRESSES: Submit electronic 

comments http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Blakeley Fitzpatrick, Center for Food 

Safety and Applied Nutrition (HFS– 

830), 5100 Paint Branch Pkwy., College 

Park, MD 20740, 240–402–2176. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of December 8, 

2010 (75 FR 76526), FDA proposed to 

amend its regulations in § 101.83 (21 

CFR 101.83) on plant sterol/stanol esters 

and risk of CHD (the phytosterols 

proposed rule). Among other revisions, 

the Agency proposed to: (1) Adopt the 

term ‘‘phytosterols’’ as inclusive of both 

plant sterols and stanols; (2) permit 

claims on products with phytosterols, 

derived from either vegetable oils or tall 

oils, containing at least 80 percent of 

beta-sitosterol, campesterol, 

stigmasterol, sitostanol, and/or 

campestanol (combined weight); (3) 

replace the analytical methods FDA 

uses to determine the amount and 

nature of the substance with the 

Sorenson and Sullivan method for 

evaluation of campesterol, stigmasterol, 

and beta-sitosterol in those foods for 

which the method has been validated; 

(4) revise the daily dietary intake of 

phytosterols necessary to justify the 

CHD risk reduction claim (2 grams (g) 

per day) and the minimum amount of 

phytosterols (non-esterified weight) 

required to be in a serving of the food 

(0.5 g per reference amount customarily 

consumed (RACC)); (5) for conventional 

food, limit the use of the claim to the 

food uses of phytosterols that have been 

submitted to FDA in a generally 

recognized as safe notification to which 

the Agency had no further questions 

and where the conditions of use are 

consistent with the eligibility 

requirements for the health claim; (6) 

remove the requirement that the health 

claim include a recommendation that 

phytosterols be consumed in two 

servings eaten at different times of the 

day, but require that the substance be 

taken with meals or snacks; (7) 

eliminate the enumeration of specific 

conventional foods eligible to bear the 

claim; (8) allow for the use of the health 

claim on phytosterol ester-containing 

dietary supplements (esterified with 

food-grade fatty acids) but not on 

nonesterified phytosterol-containing 

dietary supplements; (9) clarify that the 

limited exemption from the total fat 

disqualifying level of more than 13 g 

total fat per 50 g of food when the RACC 

is 30 g or less or 2 tablespoons or less 

applies to vegetable oil spreads 

resembling margarine; (10) permit liquid 

vegetable oils to be exempt from the 

total fat disqualifying level on a per 

RACC, per labeled serving size, and per 

50 g basis; and (11) permit liquid 

vegetable oils to be exempt from the 

minimum nutrient requirement and 

vegetable oil spreads resembling 

margarine to meet the 10 percent 

minimum nutrient requirement by the 

addition of Vitamin A consistent with 

FDA’s fortification policy. 

Interested persons were originally 

given until February 22, 2011, to 

comment on the proposed rule. 

II. Request for Comments 

After publication of the phytosterols 

proposed rule, the Agency received two 

petitions for an administrative stay of 

action and two letters requesting that 

FDA extend its enforcement discretion 

based on FDA’s February 14, 2003, letter 

of enforcement discretion to Cargill 

Health and Food Technologies. Based 

on concerns that 75 days was not 

enough time for industry to come into 

compliance with § 101.83 or to make the 

claim consistent with the proposed 

requirements in the phytosterols 

proposed rule, the Agency issued, in the 

Federal Register of February 18, 2011, 

an extension of its enforcement 

discretion based on the February 14, 

2003, letter (76 FR 9525). 

On February 10, 2011, the Agency 

received a comment on the phytosterols 

proposed rule by Venable LLP 

requesting an extension of the comment 

period until April 23, 2011, because the 

period of time allowed for comment did 

not provide enough time for them to 

collect, assess, and comment on the 

relevant data regarding the cholesterollowering efficacy of nonesterified 

phytosterols in dietary supplements. 

FDA did not respond to Venable LLP’s 

request within the comment period and 

cannot extend a closed comment period. 

However, the Agency is reopening the 

comment period for this rule in 

response to Venable LLP’s request. The 

Agency recognizes that additional time 

to review and comment on the data 

related to the relationship between 

nonesterified phytosterols and reduced 

risk of CHD would be helpful and 

consistent with sound public policy, 

therefore FDA is reopening the 

comment period for all interested 

persons on the phytosterols proposed 

rule to allow for comments to be 

submitted to the docket. 

Following receipt of comments on 

this document, FDA intends to publish 

a final rule, which will amend § 101.83. 

The reopening of the comment period 

may result in the submission of 

additional information that may cause 

the Agency to reconsider its proposed 

amendments to the phytosterols and 

risk of coronary heart disease health 


emcdonald on DSK2BSOYB1PROD with PROPOSALS
49708 Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Proposed Rules 

claim. The Agency notes that a final rule 

may vary from the proposal. To the 

extent that manufacturers have labeled 

their products consistent with the 

proposed requirements, and the final 

requirements differ from what the 

Agency proposed, manufacturers will be 

required to change their labels to 

conform to the final rule. 

III. How To Submit 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. 

Dated: August 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20406 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R07–OAR–2011–0470, FRL–9450–8] 

Approval and Promulgation of 

Implementation Plans; Iowa: 

Prevention of Significant Deterioration; 

Greenhouse Gas Permitting Authority 

and Tailoring Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to approve 

a revision to the Iowa State 

Implementation Plan (SIP) relating to 

regulation of Greenhouse Gases (GHGs) 

under Iowa’s Prevention of Significant 

Deterioration (PSD) program. This 

revision was submitted by the Iowa 

Department of Natural Resources (IDNR) 

to EPA on December 22, 2010. It is 

intended to align Iowa’s regulations 

with the ‘‘PSD and Title V Greenhouse 

Gas Tailoring Final Rule.’’ EPA is 

proposing to approve the revision 

because the Agency has made the 

preliminary determination that the SIP 

revision, already adopted by Iowa as a 

final effective rule, is in accordance 

with the Clean Air Act (CAA or Act) and 

EPA regulations regarding PSD 

permitting for GHGs. 

DATES: Comments must be received on 

or before September 12, 2011. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R07– 

OAR–2011–0470, by one of the 

following methods: 

1. http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

2. E-mail: gonzalez.larry@epa.gov. 

3. Fax: (913) 551–7844. 

4. Mail: Air Planning and 

Development Branch, Air and Waste 

Management Division, U.S. 

Environmental Protection Agency, 

Region 7, 901 North 5th Street, Kansas 

City, Kansas 66101. 

5. Hand Delivery or Courier: Mr. Larry 

Gonzalez, Air Planning and 

Development Branch, Air and Waste 

Management Division, U.S. 

Environmental Protection Agency, 

Region 7, 901 North 5th Street, Kansas 

City, Kansas 66101. Such deliveries are 

only accepted during the Regional 

Office’s normal hours of operation. The 

Regional Office’s official hours of 

business are Monday through Friday, 

8 a.m. to 4:30 p.m., excluding Federal 

holidays. 

Instructions: Direct your comments to 

Docket ID No. EPA–R07–OAR–2011– 

0470. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit through http:// 

www.regulations.gov or e-mail, 

information that you consider to be CBI 

or otherwise protected. The http:// 

www.regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD–ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the 

electronic docket are listed in the http: 

//www.regulations.gov index. Although 

listed in the index, some information is 

not publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either 

electronically in http:// 

www.regulations.gov or in hard copy at 

the Air Planning and Development 

Branch, Air and Waste Management 

Division, U.S. Environmental Protection 

Agency, Region 7, 901 North 5th Street, 

Kansas City, Kansas 66101. EPA 

requests that if at all possible, you 

contact the person listed in the FOR

FURTHER INFORMATION CONTACT section to 

schedule your inspection. The Regional 

Office’s official hours of business are 

Monday through Friday, 8:30 a.m. to 

4:30 p.m., excluding Federal holidays. 

FOR FURTHER INFORMATION CONTACT: For 

information regarding the Iowa SIP, 

contact Mr. Larry Gonzalez, Air 

Planning and Development Branch, Air 

and Waste Management Division, U.S. 

Environmental Protection Agency, 

Region 7, 901 North 5th Street, Kansas 

City, Kansas 66101. Mr. Gonzalez’s 

telephone number is (913) 551–7047; email address: gonzalez.larry@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. What action is EPA proposing in today’s 

notice? 

II. What is the background for the PSD SIP 

approval proposed by EPA in today’s 

notice? 

III. What is EPA’s analysis of Iowa’s proposed 

SIP revision? 

IV. Proposed Action 

V. Statutory and Executive Order Reviews 

I. What action is EPA proposing in 

today’s notice? 

On December 22, 2010, IDNR 

submitted a request to EPA to approve 

revisions to the State’s SIP and Title V 

program to incorporate recent rule 

amendments adopted by the Iowa 

Environmental Protection Commission. 

These adopted rules became effective in 

the Iowa Administrative Code on that 

date. These amendments establish 

thresholds for GHG emissions in Iowa’s 

PSD and Title V regulations at the same 

emissions thresholds and in the same 


emcdonald on DSK2BSOYB1PROD with PROPOSALS