Proposed Test Guidelines; Notice of Availability and Request for Comments

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: December 15, 1999 (Volume 64, Number 240)]
[Notices]
[Page 70023-70025]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15de99-60]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00633; FRL-6395-8]


Proposed Test Guidelines; Notice of Availability and Request for
Comments

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability and request for comments.

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SUMMARY: EPA has established a unified library for test guidelines
issued by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS) for use in testing chemical substances to develop data for
submission to EPA under the Toxic Substances Control Act (TSCA), the
Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). These test
guidelines represent an Agency effort that began in 1991 to harmonize
the test guidelines within OPPTS, as well as to harmonize the OPPTS
test guidelines with those of the Organization for Economic Cooperation
and Development (OECD). The process for developing and amending these
test guidelines includes public participation and the extensive
involvement of the scientific community, including peer review by the
Scientific Advisory Panel (SAP) and the Scientific Advisory Board (SAB)
and other expert scientific organizations. With this notice, EPA is
announcing the availability of the proposed tests for the Series 810-
Product Performance Testing Guidelines titled ``OPPTS 810.3700 Insect
Repellents For Human Skin and Outdoor Premises'' and a Pesticide
Registration (PR) Notice titled ``Insect Repellants: Labeling, Data
Citations, and Testing Criteria'' explaining specific areas of the
guideline and recommended label language.

DATES: Comments, identified by docket control number OPP-00633, must be
received by EPA on or before January 14, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit III. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-00633 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: For general information contact:
    Toxic Substances Control Act (TSCA) information contact: TSCA
Hotline at TAIS/7408, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460; telephone number: (202) 554-1404; fax number:
(202) 554-5603; e-mail address: TSCA-Hotline@epa.gov.
    Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
information contact: Communications Services Branch (7506C), Field and
External Affairs Division, Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone
number: (703) 305-5017; fax number: (703) 305-5558.
     For technical information contact: Robyn Rose, Office of Pesticide
Programs, Biopesticides and Pollution Prevention Division (7511C),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 308-9581; e-mail address: rose.robyn@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

     This action is directed to the public in general. Although this
action may be

[[Page 70024]]

of particular interest to those persons who are or may be required to
conduct testing of chemical substances under the Toxic Substances
Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA),
or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under ``FOR FURTHER INFORMATION CONTACT.''

II. How Can I Get Additional Information, Including Copies of this
Document or Other Related Documents?

     A. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register  listings at http://www.epa.gov/fedrgstr/.
     You may also obtain copies of test guidelines from the EPA
Internet Home Page by selecting ``Researchers and Scientists/Test
Methods and Guidelines/OPPTS Harmonized Test Guidelines'' at http://
www.epa.gov/epahome/research.htm.
     B. Fax on demand. You may request a faxed copy of the PR Notice
titled ``Insect Repellants: Labeling, Data Citations, and Testing
Criteria'' by using a faxphone to call (202) 401-0527 and selecting
item 6122. You may also follow the automated menu.
     C. In person. The Agency has established an official record for
this proposed guideline under docket control number OPP-00633. The
official record consists of the documents specifically referenced in
this action, any public comments received during an applicable comment
period, and other information related to this action, including any
information claimed as Confidential Business Information (CBI). This
official record includes the documents that are physically located in
the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available
for inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number OPP-00633 in the subject line on the
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
     2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
     3. Electronically. Submit your comments electronically by e-mail
to: ``opp-docket@epa.gov,'' or mail your computer disk to the address
identified above. Do not submit any information electronically that you
consider to be CBI. Electronic comments must be submitted as an ASCII
file avoiding the use of special characters and any form of encryption.
Comments and data will also be accepted on standard computer disks in
Wordperfect 6.1/8.0 or ASCII file format. All comments in electronic
form must be identified by the docket control number OPP-00633.
Electronic comments may also be filed online at many Federal Depository
Libraries.

B. How Should I Handle CBI that I Want to Submit to the Agency?

     Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI by marking any part or all of that information as
CBI. Information so marked will not be disclosed except in accordance
with procedures set forth in 40 CFR part 2. In addition to one complete
version of the comment that includes any 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 version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the technical person identified under ``FOR FURTHER
INFORMATION CONTACT.''

C. What Should I Consider as I Prepare My Comments for EPA?

     You may find the following suggestions helpful for preparing your
comments:
     1. Explain your views as clearly as possible.
     2. Describe any assumptions that you used.
     3. Provide copies of any technical information and/or data you
used that support your views.
     4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
     5. Provide specific examples to illustrate your concerns.
     6. Offer alternative ways to improve the notice or collection
activity.
     7. Make sure to submit your comments by the deadline in this
document.
     8. To ensure proper receipt by EPA, be sure to identify the docket
control number OPP-00633 in the subject line on the first page of your
response. You may also provide the name, date, and Federal Register
citation.

IV. What Action is EPA Taking?

     EPA is announcing the availability of a proposed test guideline
for the Series 810 guidelines titled ``OPPTS 810.3700 Insect Repellents
For Human Skin and Outdoor Premises Product Performance Testing
Guidelines'' and a PR notice titled ``Insect Repellants: Labeling, Data
Citations, and Testing Criteria'' explaining specific areas of the
guideline and recommended label language.

V. How Were these Test Guidelines Developed?

 A. Product Performance Testing Guidelines for Insect Repellents

     These product performance testing guidelines are intended to
update EPA, Pesticide Assessment Guidelines, Subdivision G: OPP
guidelines 95-9 Treatments to control pests of humans and pets and 95-
10 Mosquito, black fly,

[[Page 70025]]

non-biting midge, and biting midge. These guidelines are concerned with
product performance testing for evaluation of pesticides used to repel
biting flies, fleas, chiggers and ticks from human skin and outdoor
premises. Commercial pesticide formulations used to repel mosquitoes,
fleas, chiggers and ticks from human skin include, but are not limited
to, liquid or pressurized spray products, impregnated material or
articles with the repellent, lotions, coils, candles, or vaporizing
mats.
     The recommendations contained within these guidelines address the
conduct of product performance testing of insect repellents. Because
they are guidelines, mandatory requirements are not imposed. However,
they do reflect the considered judgment of the Agency and recognized
experts as to what minimum steps are necessary to produce reliable data
on product performance. Accordingly, EPA advises that any deviations
from final guidelines be fully explained and justified.

 B. Pesticide Regulation Notice

     Inconsistencies have developed in product performance testing and
labeling of insect repellents. In order to minimize this variance, EPA
is developing product performance testing guidelines and recommended
label language. The label language proposed by the Agency is intended
to standardize and improve the information provided to the consumer.
     EPA intends to use the data from the guideline studies to help
determine the adequacy of the labeling of insect repellent products.
EPA will review label statements as products are initially registered
as well as for previously registered products.

 VI. Specific Areas For Comment

     Please comment on all aspects of the guidelines and PR Notice. The
Agency is particularly looking for comments to the following questions:
     1. Do you agree with the Agency's proposed decision to recommend
that data be evaluated based upon the mean time to the first bite or a
95% reduction in bites rather than relying on the first confirmed bite
test?
     2. Is the Agency's recommended biting pressure adequate to verify
the insect is being repelled by the pesticide?
     3. Are 5 treated test subjects for a label claim of 4 hours of
repellency and 10 treated test subjects for a label claim of 5 or more
hours of repellency enough test subjects for statistically credible
results? (For more information reference: Rutledge, L.C., and R.K.
Gupta. 1999. Variation in the protection periods of repellents on
individual human subjects: an analytical review. J. Am. Mosq. Cont.
Ass. 15(3) 348-355.)
     4. Although it is preferred, the Agency did not think it was
feasible to expect an equal number of male and female test subjects. Do
you agree?
     5. Do the proposed application rates correlate to typical consumer
use?
     6. The Agency did not believe it was feasible to recommend all
treated test subjects leave an untreated limb exposed to bites. Is it
acceptable to allow one untreated test subject? Why or why not?
     7. Is a 50% reduction in bites an acceptable level of efficacy for
candles, coils, and vaporizing mats? Can this be justified
statistically?
     8. The Agency acquired several different methods to test
repellency of fleas and ticks. Due to the high incidence of Lyme
disease in the U.S., EPA did not recommend field tests for deer ticks.
Due to the difficulty to find an area with adequate biting pressure,
the Agency did not recommend field tests for fleas. Will the proposed
laboratory tests provide adequate data to determine deer tick and flea
repellency?
    9. Are positive and negative controls under replicate test
conditions adequate to provide a foundation against which efficacy can
be assessed?

VII. Are there Any Applicable Voluntary Consensus Standards that
EPA Should Consider?

     This notice of availability does not involve a proposed regulatory
action that would require the Agency to consider voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by voluntary consensus
standards bodies. The NTTAA requires EPA to provide an explanation to
Congress, through OMB, when the Agency decides not to use available and
applicable voluntary consensus standards when the NTTAA directs the
Agency to do so.
    These test guidelines represent an Agency effort to harmonize the
test guidelines within OPPTS, as well as to harmonize the OPPTS test
guidelines with those of the OECD. The process for developing and
amending these test guidelines, which began in 1991, includes public
participation and the extensive involvement of the scientific
community, including peer review by the SAP and the SAB and other
expert scientific organizations.
     In the future, these test guidelines could be incorporated into
regulatory actions taken by EPA under TSCA, i.e., with regard to the
section 4 testing program. Although the NTTAA requirements do not
specifically apply to the issuance of these particular test guidelines
today, EPA invites your comment on whether or not there are any
voluntary consensus standards that should be considered during the
development of the final test guidelines or any future regulatory
action that may be taken under TSCA. Future regulatory actions under
TSCA section 4 may involve notice and comment rulemaking or negotiated
voluntary testing enforcement consent agreements/orders/decrees.
Nevertheless, the Agency is interested in whether or not there are any
voluntary consensus standards that EPA should consider either as part
of the development of the test guidelines themselves or in lieu of
these test guidelines when the Agency develops any future regulatory
action that incorporates these test guidelines. Any comments provided
will assist the Agency in complying with the NTTAA by facilitating the
Agency's identification of voluntary consensus standards that should be
addressed in the test guideline or considered during the development of
a proposed regulatory action that incorporates any standards included
in the final test guidelines. Please submit your comments as directed
in Unit III. of the ``SUPPLEMENTARY INFORMATION.''

List of Subjects

     Environmental protection, Administrative practice and procedure,
Agricultural commodities, Chemical testing, Pesticides and pests, Test
guideline.

    Dated: December 7, 1999.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 99-32385 Filed 12-14-99; 8:45 am]
BILLING CODE 6560-50-F
Proposed Test Guidelines; Notice of Availability and Request for Comments

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