[Federal Register Volume 72, Number 35 (Thursday, February 22, 2007)]
[Notices]
[Pages 7979-7983]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3008]


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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.

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SUMMARY: EPA is seeking information to determine how insect repellent-
sunscreen 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 repellent-sunscreen 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:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> 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 e-
mail. 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 e-mail address will be automatically

[[Page 7980]]

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: 
<a href="/cdn-cgi/l/email-protection#3c5b595e575952124e555f545d4e587c594c5d125b534a"><span class="__cf_email__" data-cfemail="e18684838a848fcf93888289809385a1849180cf868e97">[email protected]</span></a>.

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 repellent-sunscreen 
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-meta-toluamide 
(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):
    <bullet> Read and follow all directions and precautions on the 
product label.
    <bullet> Do not apply over cuts, wounds, or irritated skin.
    <bullet> Do not apply to hands or near eyes and mouth of young 
children.
    <bullet> Do not allow young children to apply repellent products.
    <bullet> Use just enough repellent to cover exposed skin and/or 
clothing.
    <bullet> Do not use under clothing.
    <bullet> Avoid over-application.
    <bullet> After returning indoors, wash treated skin with soap and 
water.
    <bullet> Wash treated clothing before wearing it again.
    <bullet> Use may cause skin reactions in rare cases.

[[Page 7981]]

    The following additional statements should appear on the labels of 
aerosol and pump spray formulation labels:
    <bullet> Do not spray in enclosed areas.
    <bullet> 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-meta-toluamide 
(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 p-methane-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. p-
methane-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-the-counter (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 Sec.  352.10, provides for 
combinations of sunscreen active ingredients in Sec.  353.20, specifies 
required labeling in Sec. Sec.  352.50, 352.52 and 352.60, and sets 
forth required testing procedures in Sec. Sec.  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

[[Page 7982]]

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 Repellent-Sunscreen 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 over-application of this product''. 
The directions for sunscreen drug products in Sec.  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?

[[Page 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


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