Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7979 

that are available electronically. Once in 

the system, select ‘‘docket search,’’ then 

key in the docket ID number identified 

above. Please note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing at http://www.regulations.gov, 

as EPA receives them and without 

change, unless the comment contains 

copyrighted material, Confidential 

Business Information (CBI), or other 

information whose public disclosure is 

restricted by statute. For further 

information about the electronic docket, 

go to http://www.regulations.gov. 

Title: NSPS for Automobile and Light 

Duty Truck Surface Coating Operations 

(Renewal). 

ICR Numbers: EPA ICR Number 

1064.15, OMB Control Number 2060–

0034. 

ICR Status: This ICR is scheduled to 

expire on February 28, 2007. Under 

OMB regulations, the Agency may 

continue to conduct or sponsor the 

collection of information while this 

submission is pending at OMB. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. The OMB control numbers for 

EPA’s regulations in title 40 of the CFR, 

after appearing in the Federal Register 

when approved, are listed in 40 CFR 

part 9, and displayed either by 

publication in the Federal Register or 

by other appropriate means, such as on 

the related collection instrument or 

form, if applicable. The display of OMB 

control numbers in certain EPA 

regulations is consolidated in 40 CFR 

part 9. 

Abstract: This Information Collection 

Request (ICR) renewal is being 

submitted for the NSPS for Automobile 

and Light Duty Truck Surface Coating 

Operations (40 CFR part 60, subpart 

MM), which were promulgated on 

December 24, 1980 (45 FR 85415). These 

standards apply to the following 

automobile and light duty truck 

assembly plant lines: each prime coat 

operation, guide coat operation, and top 

coat operation commencing 

construction, modification or 

reconstruction after the date of proposal. 

The affected entities are subject to the 

General Provisions of the NSPS at 40 

CFR part 60 subpart A and any changes, 

or additions to the General Provisions 

specified at 40 CFR part 60, subpart 

MM. 

Burden Statement: The annual public 

reporting and recordkeeping burden for 

this collection of information is 

estimated to average 745 hours per 

response. Burden means the total time, 

effort, or financial resources expended 

by persons to generate, maintain, retain, 

or disclose or provide information to or 

for a Federal agency. This includes the 

time needed to review instructions; 

develop, acquire, install, and utilize 

technology and systems for the purposes 

of collecting, validating, and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; adjust the 

existing ways to comply with any 

previously applicable instructions and 

requirements which have subsequently 

changed; train personnel to be able to 

respond to a collection of information; 

search data sources; complete and 

review the collection of information; 

and transmit or otherwise disclose the 

information. 

Respondents/Affected Entities: 

Automobile and light duty truck surface 

coating operations. 

Estimated Number of Respondents: 

54. 

Frequency of Response: Initially, 

semi-annually, and quarterly. 

Estimated Total Annual Hour Burden: 

156,362. 

Estimated Total Annual Cost: 

$9,733,981, which includes $1,700 

annualized capital startup costs, 

$91,000 annualized operating and 

maintenance (O&M) costs, and 

$9,641,281 annualized labor costs. 

Changes in the Estimates: There is no 

change in the total estimated burden 

currently identified in the OMB 

Inventory of Approved ICR Burdens. 

Dated: February 14, 2007. 

Richard T. Westlund, 

Acting Director, Collection Strategies 

Division. 

[FR Doc. E7–3018 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2007–0087; FRL–8114–6] 

Insect Repellent-Sunscreen 

Combination Products; Request for 

Information and Comments 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice; request for comment. 

SUMMARY: EPA is seeking information to 

determine how insect repellentsunscreen combination products should 

be regulated in order to complete the 

reregistration review which was 

described in the Reregistration 

Eligibility Decision (RED) document for 

the insect repellent DEET. This action 

would consider issues such as labeling, 

product performance and applicable 

safety standards for all currently (and 

any future) registered insect repellentsunscreen combination products. The 

sunscreen components of these products 

are regulated by the Food and Drug 

Administration (FDA). Elsewhere in this 

issue of the Federal Register is a 

companion notice in which the FDA is 

also requesting information and 

comments on these products and for 

which the FDA will be considering 

rulemaking. The decision on what if any 

change in the way these products are 

regulated will consider information and 

comments submitted in response to this 

Notice. 

DATES: Comments must be received on 

or before May 23, 2007. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2007–0087, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305- 

5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2007–

0087. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line 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 information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The Federal regulations.gov 

website 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 regulations.gov, your email address will be automatically 


rwilkins on PROD1PC63 with NOTICES
7980 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 

captured and included as part of the 

comment that is placed in the 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. 

Docket: All documents in the docket 

are listed in the docket index. Although 

listed in the index, some information is 

not publicly available, e.g., 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 in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, 

One Potomac Yard (South Building), 

2777 S. Crystal Drive, Arlington, VA. 

The hours of operation of this Docket 

Facility are from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305-5805. 

FOR FURTHER INFORMATION CONTACT: 

Richard Gebken, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305-6701; fax number: (703) 308- 

0029; e-mail address: 

gebken.richard@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. This action may, however, be 

of interest to those who currently have 

registered products or intend in the 

future to register any insect repellentsunscreen combination products, as 

well as those individuals who use these 

products. Since other entities may also 

be interested, the Agency has not 

attempted to describe all the specific 

entities that may be affected by this 

action. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD ROM that 

you mail to EPA, mark the outside of the 

disk or CD ROM as CBI and then 

identify electronically within the disk or 

CD ROM the specific information that is 

claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date, and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What Action is the Agency Taking? 

Currently, there are approximately 20 

combination insect repellent/sunscreen 

products available for consumers. Each 

of these products contains an insect 

repellent component (N,N-diethyl-metatoluamide (DEET), oil of citronella or 

IR3535)) and a sunscreen component. 

Combination products are available in 

lotion, cream, and spray-on 

formulations. These products are 

currently marketed for use by the entire 

family. These products provide 

consumers with the convenience of 

using one product as opposed to the use 

of multiple products. In addition, it has 

been suggested that these products, 

containing both insect repellent and 

sunscreen components in one 

formulation, preserve the efficacy of 

both components better than if a 

consumer were to apply the insect 

repellent product and the sunscreen 

product sequentially. 

EPA is responsible for reevaluating 

previously registered pesticide products 

through a program called 

‘‘reregistration.’’ In order to reregister a 

pesticide, EPA determines whether the 

product meets current scientific and 

statutory standards. Due to concerns 

about the potential conflict in labeling 

for the insect repellent and the 

sunscreen portions of the product, EPA 

postponed a reregistration eligibility 

decision (RED) on whether to reregister 

the combination DEET/sunscreen 

products until additional information 

could be obtained. This document 

solicits opinion and comment from the 

public to assist in determining how best 

to regulate these products. 

These combination products are 

regulated by both EPA and FDA. EPA 

has regulatory authority over these 

products because of the insect repellent 

component and the sunscreen 

component is regulated by FDA. Both 

agencies are seeking comments to 

determine how these products should 

be regulated. (FDA’s notice is located 

elsewhere in this issue of the Federal 

Register.) EPA and FDA will work 

together to develop a coordinated 

approach to the regulation of 

combination products. 

1. Regulatory status of the insect 

repellent ingredients. EPA provides 

information to the public regarding the 

use of insect repellent products at the 

following web site: http://www.epa.gov/ 

pesticides/factsheets/chemicals/deet.

htm . Information detailed at that site 

provides the EPA-recommended 

precautions when using insect 

repellents, including (in part): 

• Read and follow all directions and 

precautions on the product label. 

• Do not apply over cuts, wounds, or 

irritated skin. 

• Do not apply to hands or near eyes 

and mouth of young children. 

• Do not allow young children to 

apply repellent products. 

• Use just enough repellent to cover 

exposed skin and/or clothing. 

• Do not use under clothing. 

• Avoid over-application. 

• After returning indoors, wash 

treated skin with soap and water. 

• Wash treated clothing before 

wearing it again. 

• Use may cause skin reactions in rare 

cases. 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7981 

The following additional statements 

should appear on the labels of aerosol 

and pump spray formulation labels: 

• Do not spray in enclosed areas. 

• To apply to face, spray on hands 

first and then rub on face. Do not spray 

directly onto face. 

There are currently three (3) insect 

repellent active ingredients used in 

combination with sunscreen (amounting 

to 20 currently registered combination 

products). These are: N,N-diethyl-metatoluamide (DEET), oil of citronella and 

IR3535. Two other active ingredients are 

approved for use in insect repellent 

products, p-methane-3,8-diol and KBR 

3023 (picaridin). Neither chemical, 

however, is currently available in a 

combination sunscreen formulation. 

Both DEET and oil of citronella have 

undergone reregistration which entailed 

an evaluation and analysis of the 

complete database for both chemicals. 

IR3535, picaridin, and p-methane-3,8- 

diol are newly registered chemicals 

which were evaluated during the 

registration process to ensure they met 

the statutory standard. 

In December 1998, EPA completed 

reregistration and issued a 

Reregistration Eligibility Decision (RED) 

document for the pesticide DEET. DEET 

products, which are applied directly to 

skin and/or clothing, are available in 

numerous formulation types (e.g., 

aerosol sprays, non-aerosol sprays, 

creams, lotions, sticks, foams, and 

towelettes) and concentrations 

(products range from 4% active 

ingredient (a.i.) to 100% a.i.. DEET is an 

insect and mite repellent used in 

households/domestic dwellings, on the 

human body and on clothing, on cats, 

dogs and horses and in the living and 

sleeping quarters of pets. 

Based on pesticide usage information 

mainly for 1990 (DEET RED), an average 

annual estimate of the domestic usage of 

DEET is 4 million pounds (active 

ingredient). About 30% of the U.S. 

population uses DEET as an insect 

repellent at least once a year (about 27% 

of adult males, 31% of adult females 

and 34% of children). Approximately 

21% of U.S. households use DEET 

annually. About 19% of households use 

DEET on household members, and 

about 4% of households that have cats 

and/or dogs use DEET on those pets 

(DEET RED). 

As EPA indicated in the DEET RED: 

‘‘The Agency is concerned about 

consumer use of products that combine 

sunscreen and DEET, since the 

directions to reapply sunscreens 

generously and frequently may promote 

greater use of DEET than needed for 

pesticidal efficacy, and thus pose 

unnecessary exposure to DEET’’. DEET 

labels currently recommend that 

products be used sparingly and not be 

reapplied too often. Sunscreen products, 

however, recommend frequent 

reapplication. No benefits attach to use 

of DEET more frequently than necessary 

to achieve its purpose. The Agency did 

not make a regulatory decision about 

whether to reregister these combination 

products at the time of the DEET RED 

because EPA believed that adequate 

information was not available. 

In February 1997, the EPA completed 

its Reregistration Eligibility Decision 

(RED) document for oil of citronella. 

This decision includes a comprehensive 

reassessment of the required target data 

and the use patterns of currently 

registered products. Oil of citronella is 

a biochemical pesticide. It is registered 

as an animal repellent and as an insect 

repellent/feeding depressant. Oil of 

citronella is the volatile oil obtained 

from the steam distillation of freshly cut 

or partially dried grasses (Cymbopogon 

nardus (Rendal) and Cymbopogon 

winterianus (Jowitt). Two varieties of the 

citronella oil exist commercially –

‘‘Ceylon type’’ (derived from C. nardus) 

and ‘‘Java type’’ (derived from C. 

winterianus). (Oil of Citronella RED, 02/ 

97) 

Based on pesticide survey usage 

information for the years 1991 through 

1992, annual citronella domestic usage 

ranged approximately from 33,000 to 

48,000 pounds active ingredient for four 

sites (domestic dwelling; ornamentals; 

human face, skin, and clothing; and 

manufacturing). Oil of citronella is an 

insect repellent with its largest markets, 

in terms of total pounds active 

ingredient, allocated to human face, 

skin, and clothing (56% to 74%); 

domestic dwelling outdoor (22% to 

41%); and ornamentals (1.5% to 2.0%). 

The balance is for manufacturing use. 

(Oil of Citronella RED) 

The third currently registered insect 

repellent used in combination with 

sunscreen is IR3535. In 1997, the 

Agency classified IR3535 as a 

biochemical, based on facts that: 

i. It is functionally identical to 

naturally occurring beta alanine; 

ii. Both repel insects; 

iii. The basic molecular structure is 

identical; 

iv. The end groups are not likely to 

contribute to toxicity; and 

v. It acts to control the target pest via 

a non-toxic mode of action. 

The active ingredient, IR3535 is a liquid 

synthetic biochemical pesticide which 

contains 98% 3 [N Butyl N acetyl] 

aminopropionic acid, ethyl ester as 

active ingredient and 2.00% inert 

ingredients. (Biopesticide Registration 

Eligibility Document) 

Two insect repellent active 

ingredients in registered pesticides are 

not currently utilized in a combination 

product. However, for the purposes of 

completeness, all currently registered 

insect repellents are discussed within 

this Notice. The first chemical is pmethane-3,8-diol, a biochemical 

pesticide which is chemically 

synthesized, although a natural oil 

comparable to p-methane-3,8-diol can 

be extracted from lemon eucalyptus 

leaves and twigs. It can be used in three 

types of consumer pesticide products: A 

spray, a lotion, and a towellette. pmethane-3,8-diol can be used to make 

products that are used for the purpose 

of repelling insects such as mosquitoes. 

(Biopesticide Registration Eligibility 

Document). The other insect repellent is 

KBR 3023, containing the active 

ingredient, picaridin. This chemical is 

currently formulated for use as a human 

skin applied insect repellent. Currently 

EPA-registered picaridin products 

include 15% pump spray, 10% aerosol 

spray, 7% cream, 7% pump spray, 5% 

cream, and 5% pump spray. 

2. Regulatory Status of the Sunscreen 

Ingredients. In the Federal Register of 

May 21, 1999 (64 FR 27666), FDA 

issued a final monograph for over-thecounter (OTC) sunscreen drug products 

in 21 CFR part 352, establishing 

conditions under which these products 

are generally recognized as safe and 

effective and not misbranded. The 

monograph includes 16 sunscreen 

active ingredients in § 352.10, provides 

for combinations of sunscreen active 

ingredients in § 353.20, specifies 

required labeling in §§ 352.50, 352.52 

and 352.60, and sets forth required 

testing procedures in §§ 352.70 through 

352.77. 

Historically, FDA has used its 

enforcement discretion to allow the 

marketing of appropriate insect 

repellent-sunscreen combination 

products. These types of products were 

marketed before the OTC drug review 

began in 1972, and FDA has not 

explicitly addressed them at any time in 

the rulemaking for OTC sunscreen drug 

products. Because they have always 

contained a pesticide, the combination 

insect repellent-sunscreen products 

have also historically been registered 

with and regulated by EPA. FDA has not 

objected to the marketing of the 

combination products pending the 

issuance of the final sunscreen 

monograph so long as the products 

contained sunscreen ingredients 

included in the FDA rulemaking and 

were registered with EPA. FDA is 

interested in determining whether it 

should amend that monograph to 

address these combination products 


rwilkins on PROD1PC63 with NOTICES
7982 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 

before the monograph becomes 

effective. Any combination product 

containing an active drug ingredient 

that is not included in the final 

monograph after the effective date will 

be considered a new drug and need a 

new drug approval (NDA) approval to 

be legally marketed, even if the product 

is also registered with EPA. 

III. Issues Related to Insect RepellentSunscreen Drug Products 

EPA and FDA have identified three 

broad issues areas in connection with 

the regulation of these combination 

products: 

A. Possible Manufacturing Conflicts 

Any insect repellent/sunscreen 

combination product would have to 

comply with EPA’s data requirements in 

40 CFR part 158 and with FDA’s current 

good manufacturing practice for 

finished pharmaceuticals requirements 

in 21 CFR part 211. The Agencies are 

not aware of any specific manufacturing 

requirements that conflict and invite 

specific comment and information on 

this subject. 

B. Possible Formulation Conflicts 

The EPA has solicited information 

from registrants of combination insect 

repellent/sunscreen products regarding 

the possibility of formulation conflicts. 

The Agency is aware of some limited, 

conflicting information, which raises 

the question of whether combining a 

sunscreen and an insect repellent 

component in a single product 

diminishes the efficacy of either the 

sunscreen or the insect repellent. 

Specific comments and information are 

invited on this subject. 

C. Possible Labeling Conflicts 

Insect repellent/sunscreen products 

can have labeling requirements for their 

individual components that could 

theoretically conflict. The insect 

repellent component of the product 

must be labeled in accordance with 40 

CFR part 156 and should comply with 

directions set out in its registration 

notice or the RED for the appropriate 

active ingredient. For each registered 

insect repellent, these requirements are 

listed in the registration or reregistration 

documents. The sunscreen component 

of the product must be labeled in accord 

with 21 CFR 201.66, 352.50, 352.52, and 

352.60. The labeling format and some of 

the content requirements could vary 

between the EPA and FDA 

requirements. The Agency is looking at 

whether it is possible for products to 

comply with both sets of requirements 

and recommendations without 

confusing or misleading users. 

IV. Specific Topics for Comment 

The EPA is particularly interested in 

receiving comments on the following 

topics: 

A. Safety Issues 

1. Application frequency. The EPA is 

concerned that the combination 

products could contain conflicting use 

instructions on product labels which 

compromise safe use of these products. 

For example, the directions for some 

DEET products require a 6–hour interval 

between applications and state ‘‘use just 

enough repellent to cover exposed skin 

and/or clothing’’ and ‘‘avoid overapplication of this product’’. The 

directions for sunscreen drug products 

in § 352.52(d)(1) and (d)(2) state to 

‘‘apply (select ‘liberally’, ‘generously’, 

‘smoothly’, or ‘evenly’), before sun 

exposure and as needed,’’ and ‘‘reapply 

as needed or after towel drying, 

swimming, or (select ‘sweating’ or 

‘perspiring’)’’. EPA is soliciting 

suggestions on how this potential 

concern can be alleviated. 

2. Application location. The EPA has 

directed that insect repellents not be 

used for certain areas of the body (e.g., 

over cuts, applied by spray directly to 

the face, etc.), and apply sparingly 

around ears. Sunscreen use directions, 

however, encourage consumers to apply 

the products, on the face and ears, 

‘‘liberally, generously, smoothly, or 

evenly’’ ‘‘before sun exposure and as 

needed,’’ and ‘‘reapply as needed or 

after towel drying, swimming, or (select 

‘sweating’ or ‘perspiring’).’’ EPA is 

soliciting comment on how the safety 

concern of a potential misapplication of 

the insect repellent can be reconciled 

with the need to provide complete 

coverage of exposed skin for the 

sunscreen component. 

3. Federal Fungicide and Rodentide 

Act (FIFRA) registration. Given the 

aforementioned safety concerns and 

potential conflicts, the Agency would 

like to solicit comments on whether 

these insect repellent-sunscreen 

combination products should be 

registered at all. 

B. Effectiveness Issues 

For some products, there are 

effectiveness concerns because of the 

interval of time required between 

applications of the product. EPA 

identifies reapplication times on 

product labels so consumers maintain 

protection against insect bites, while 

avoiding over-exposure. This 

reapplication time relates to the 

effectiveness of the insect repellent 

portion of the product, not to the 

sunscreen protection. The sunscreen 

reapplication time is under the purview 

of the FDA. For some of the insect 

repellent products currently registered, 

the recommended reapplication time to 

maintain the effectiveness of the insect 

repellent could potentially be longer 

than that recommended to ensure the 

protectiveness of the sunscreen portion 

of the product. EPA is soliciting 

comment on the following questions: 

1. Is it possible to formulate these 

products such that the insect repellent 

protection time coincides with the 

sunscreen protection time? 

2. Are there effective concentrations 

of the insect repellent ingredients that 

could be used to allow for liberal 

application and frequent reapplication 

of the insect repellent-sunscreen 

combination products, as directed by 

the sunscreen instructions, without 

causing unnecessary exposure of the 

consumer to the insect repellent 

component of the product? 

3. Is information available to 

demonstrate that there are any chemical 

or physical incompatibilities between 

insect repellents and sunscreen active 

ingredients when used separately? If so, 

how does this vary by the insect 

repellent component or by the 

sunscreen component? Please submit 

and/or summarize any information that 

you reference. 

4. Are there some product 

performance benefits derived from the 

purposeful combination of the insect 

repellent and the sunscreen ingredients 

(as opposed to the sequential 

application of these products 

separately). What information is 

available which would help frame the 

advantages or disadvantages of these 

formulation combinations? How does 

this vary by insect repellent? Please 

submit and/or summarize any 

information that you reference. 

C. Manufacturing, Registration and 

Testing Issues 

1. Are manufacturers of the insect 

repellent/sunscreen combination 

products aware of any conflicts in the 

EPA and FDA manufacturing 

requirements? If yes, please identify and 

propose a way to resolve the conflict. 

2. As it relates to potential future 

regulatory action taken with regard to 

these products, how should currently 

registered products be addressed? 

Should these products have to meet all 

of the requirements that result from the 

current EPA-FDA joint regulatory effort 

to retain their registrations? If not, what 

requirements should be retained, 

revised or eliminated? 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7983 

D. Labeling Issues 

1. There are many differences 

between the labeling requirements 

required by FDA’s OTC drug labeling 

requirements and EPA’s pesticide 

labeling requirements. For example, the 

formats and the order in which 

information is presented are quite 

different. FDA allows the use of the 

word ‘‘warning’’ on labels; however it is 

only allowed as an indicator of toxicity 

level on pesticide labels. Various 

required section headings are different. 

Please comment on how such labeling 

differences can be reconciled. 

2. FDA ingredient statements list the 

‘‘inactive or inert’’ ingredients more 

often and in greater detail than do EPA 

approved labels. The Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) does not require the listing 

of the identities of inert ingredients on 

the label. Are there ways to provide the 

insect repellent inert ingredients 

information in the product’s labeling to 

satisfy the drug requirements of the 

FFDCA? 

3. Is it desirable for users of these 

products to have a single integrated 

label, or would an insect repellent (EPA) 

and a sunscreen (FDA) section in the 

product’s labeling be preferable? 

4. Should the insect repellent/ 

sunscreen combination products be 

required to have a statement on the front 

panel of the label specifically 

identifying the product as containing an 

insect repellent (such as, This Product 

Contains An Insect Repellent)? Would 

this be useful to help consumers 

distinguish between sunscreen products 

that contain pesticides from the typical 

sunscreen drug products that contain no 

pesticides? 

List of Subjects 

Environmental protection, 

Administrative practice and procedure, 

Intergovernmental relations, Pesticides, 

Pests. 

Dated: February 13, 2007. 

James B. Gulliford, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. E7–3008 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[Docket# EPA–RO4–SFUND–2007–0129; 

FRL–8279–3] 

Starmet CMI; Barnwell, Barnwell 

County, SC; Notice of Settlement 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of settlement. 

SUMMARY: Under Section 122(g) of the 

Comprehensive Environmental 

Response, Compensation and Liability 

Act (CERCLA), the United States 

Environmental Protection Agency has 

entered into a settlement for 

reimbursement of past response costs 

with the Alaron Corporation concerning 

the Starmet CMI Superfund Site located 

in Barnwell, Barnwell County, South 

Carolina. 

DATES: The Agency will consider public 

comments on the settlement until March 

26, 2007. The Agency will consider all 

comments received and may modify or 

withdraw its consent to the settlement 

if comments received disclose facts or 

considerations which indicate that the 

settlement is inappropriate, improper, 

or inadequate. 

ADDRESSES: Copies of the settlement are 

available from Ms. Paula V. Batchelor. 

Submit your comments, identified by 

Docket ID No. EPA–RO4–SFUND–2007–

0129 or Site name Starmet CMI 

Superfund Site by one of the following 

methods: 

• www.regulations.gov: Follow the 

online instructions for submitting 

comments. 

• E-mail: Batchelor.Paula@epa.gov 

• Fax: 404/562–8842/Attn Paula V. 

Batchelor 

Mail: Ms. Paula V. Batchelor, U.S. 

EPA Region 4, WMD–SEIMB, 61 Forsyth 

Street, SW., Atlanta, Georgia 30303. ‘‘In 

addition, please mail a copy of your 

comments on the information collection 

provisions to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: 

Desk Officer for EPA, 725 17th St., NW., 

Washington, DC 20503.’’

Instructions: Direct your comments to 

Docket ID No. EPA–R04–SFUND–2007–

0129. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

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 information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or e-mail. The 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 www.regulations.gov your email 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 docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the U.S. EPA Region 4 office located at 

61 Forsyth Street, SW., Atlanta, Georgia 

30303. Regional office is open from 7 

a.m. until 6:30 p.m.. Monday through 

Friday, excluding legal holidays. 

Written comments may be submitted 

to Ms. Batchelor within 30 calendar 

days of the date of this publication. 

FOR FURTHER INFORMATION CONTACT: 

Paula V. Batchelor at 404/562–8887. 

Dated: February 7, 2007. 

Rosalind H. Brown, 

Chief, Superfund Enforcement & Information 

Management Branch, Superfund Division. 

[FR Doc. E7–3014 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OW–2003–0079; FRL–OW–8280–

2] 

Aquatic Life Ambient Freshwater 

Quality Criteria—Copper 2007 Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of Availability. 

SUMMARY: The Environmental Protection 

Agency (EPA) announces the 

availability of the 2007 revised 

recommended aquatic life ambient 

freshwater quality criteria for copper. 

The Clean Water Act (CWA) requires 


rwilkins on PROD1PC63 with NOTICES