[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:
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 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:
[email protected].
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):
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.
[[Page 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-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