[Federal Register Volume 64, Number 81 (Wednesday, April 28, 1999)]
[Notices]
[Pages 22863-22865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10522]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00580; FRL-6055-1]
Pesticides; Request for Comment on Pesticide Registration
Proposal for Isomeric Active Ingredients
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This Federal Register notice solicits comments on how the
Agency should handle the registration of pesticide active ingredients
(AI's) that are composed of chemical isomers. In particular the Agency
intends to clarify its approach on how it will determine whether a
particular isomeric pesticide is a new active ingredient or not. This
Federal Register notice describes issues associated with the
registration of pesticide active ingredients that are composed of
chemical isomers and how you can submit your comments to the Agency.
DATES: Written comments, identified by the docket control number ``OPP-
00580'', must be received on or before June 28, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit IV. of the ``SUPPLEMENTARY INFORMATION'' section of
this notice.
FOR FURTHER INFORMATION CONTACT: Alan Dixon, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460, Telephone: 703-305-7237, Fax:
703-305-6920, e-mail: dixon.alan@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Notice Apply to Me?
You may be potentially affected by this notice if you are applying
for a registration or amended registration of a pesticide product that
contains isomeric active ingredients and in particular a product
purified for one or more (usually more chemically active) isomers. If
you have any questions regarding the applicability of this action to a
particular entity, consult the technical person listed in the ``FOR
FURTHER INFORMATION CONTACT'' section.
II. Why is EPA Issuing this Notice?
The Office of Pesticide Program (OPP) is soliciting comments on how
the Agency should handle the registration of pesticide active
ingredients that are composed of chemical isomers. In particular, OPP
is interested in learning the various opinions on the question of
whether an AI originally registered at a particular proportion of
isomers should be subsequently registered as a new AI when purified for
one or more (usually more chemically active) isomers.
In the past the Agency has treated some purified isomeric compounds
as new formulations and some purified isomeric compounds as new AI's.
Examples of purified isomeric compounds treated as new formulations
are: Fluazifop butyl and fluazifop-p-butyl, fenoxaprop-ethyl and
fenoxaprop-p-ethyl, 2,4-DP and 2,4-DP-p, and MCPP to MCPP-p. Examples
of purified isomeric compounds treated as new AI's are: Metolachlor and
alpha-metolachlor, and metalaxyl and mefenoxam. Some recent regulatory
decisions caused the Agency to re-evaluate its policy on isomeric
active ingredients.
The Agency is considering three options:
1. To continue determining case by case whether an isomeric
compound is a new AI.
2. To consider all purified isomeric compounds not as new AI's but
as new formulations.
3. To consider all purified isomeric compounds as new active
ingredients.
III. How Can I Get Additional Information or Copies of this
Document or Other Documents?
A. Electronic Availability
You may obtain electronic copies of this document from the EPA
internet Home Page at http://www.epa.gov/. 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/.
B. In Person or By Phone
If you have any questions or need additional information about this
action, you may contact the technical person identified in the ``FOR
FURTHER INFORMATION CONTACT'' section. In addition, the official record
for this notice, including the public version, has been established
under docket control number ``OPP-00580''. A public version of this
record, including printed, paper versions of any electronic comments,
which does not include any information claimed as Confidential Business
Information (CBI), is available for inspection in 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
[[Page 22864]]
holidays. The Public Information and Records Integrity Branch telephone
number is 703-305-5805.
IV. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. Be sure to identify the appropriate docket control
number, ``OPP-00580'', in your correspondence.
A. By Mail
Submit written comments to: Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C),
Office of Pesticide Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460.
B. In Person or By Courier
Deliver written comments to: Public Information and Records
Integrity Branch, Information Resources and Services Division, Rm. 119,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
C. Electronically
Submit your comments and/or data electronically by e-mail to: docket@epa.gov. Do not submit any information electronically that you
consider to be CBI. Submit electronic comments 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 5.1/6.1 or ASCII file format. All comments and data in
electronic form must be identified by the docket control number ``OPP-
00580''. Electronic comments on this notice may also be filed online at
many Federal Depository Libraries.
V. How Should I Handle CBI Information that I Want to Submit to the
Agency?
You may claim information that you submit 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. A copy of the comment that does
not contain CBI must be submitted for inclusion in the public record.
Information not marked confidential will be included in the public
docket by EPA without prior notice. If you have any questions about CBI
or the procedures for claiming CBI, please consult with the technical
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
VI. What Should I Consider as I Prepare My Comments for EPA?
A. General Tips for Preparing Your Comments
We invite you to provide your views on the various options we
propose, new approaches we haven't considered, the potential impacts of
the various options (including possible unintended consequences), and
any data or information that you would like the Agency to consider
during the development of the final action. You may find the following
suggestions helpful for preparing your comments:
Explain your views as clearly as possible.
Describe any assumptions that you used.
Provide solid technical information and/or data to support
your views.
If you estimate potential burden or costs, explain how you
arrived at the estimate.
Tell us what you support, as well as what you disagree
with.
Provide specific examples to illustrate your concerns.
Offer alternative ways to improve the rule or collection
activity.
Make sure to submit your comments by the deadline in this
notice.
At the beginning of your comments (e.g., as part of the
``Subject'' heading), be sure to properly identify the document you are
commenting on. You can do this by providing the docket control number
assigned to the notice, along with the name, date, and Federal Register
citation.
B. Specific Issues for Your Consideration
In answering the specific questions in Unit VI.C., you might
consider the following:
1. There are substantial benefits for the registration holder of a
new active ingredient. With a new active ingredient the registrant has
10 years exclusive use of the data used to support the chemical. In
practice this likely amounts to several more years of exclusive
distribution or sale of the pesticide given the time it may take
subsequent applicants to develop their own data. If potential follow-on
applicants do not generate their own data this exclusive period is
obviously much longer.
2. One of Congress's intentions on giving preferential status to
data submitted on new AI's was to reward innovation that provides
significant benefits to agriculture, the environment, and the public.
There may be cases where a modified isomeric mixture may truly be
innovative and provide substantial benefits to agriculture, the
environment, and the public. On the other hand, if new AI status was
granted to purified isomers, economic competition might be reduced by
creating a regulatory barrier to other companies wishing to enter the
market by registering competing products.
3. The public, growers, and environment stand to benefit from new
active ingredients if the pesticide is effective against pests that no
other pesticide controls, and/or substantially outperforms alternative
pesticides, and/or is safer for human health and the environment than
alternative pesticides, and/or is substantially less expensive than
alternative pesticides. Some purified isomeric mixtures may have these
benefits.
4. In some instances a purified isomeric mixture may reduce
environmental burden by reducing the total pesticide application rate.
Take for example the case of a 50-50 racemic mixture purified to 95
percent of the active isomer and 5 percent of the less active isomer
and then applied at one-half the rate. If both isomers present some
risk concerns, the new formulation would reduce the risk associated
with the product since there is half the total pounds of product
applied. On the other hand, if there is little risk concern for the
less active isomer, only the environmental burden (pounds product
applied) will be reduced since there is half the total pounds of
product applied.
5. The reduction in risk in for purified isomeric compounds may be
negligible if there is little concern for the less active isomer. In
this case there is no change in the amount of the active isomer (isomer
of risk concern) applied. For this instance, the risk of using the
purified isomeric mixture remains the essentially the same as the
original unpurified isomeric mixture.
6. There are other environmental benefits from a significant
reduction in the total use of pesticides. The environmental burden from
transportation is reduced as is the environmental burden associated
with packaging and disposal.
7. Some companies have requested and been granted reduced risk
status for their purified isomeric compounds citing arguments similar
to items 4. and 6.
8. The Agency may determine that additional types of information on
the isomeric composition of active ingredients is necessary prior to
registration of the product. Information that might be necessary could
include:
Isomers present and their percentages.
[[Page 22865]]
Relative activity of each isomer.
Relative toxicology of each isomer (human health and
environmental effects).
Relative environmental fate of each isomer.
C. Specific Questions for Commenters
1. Under what circumstances should the Agency register an isomeric
AI purified for one or more (usually more chemically active isomers) as
a new AI?
2. Under what circumstances should the Agency not register an
isomeric AI purified for one or more (usually more chemically active
isomers) as a new AI?
3. What would be the advantages or disadvantages to the regulated
community, the Agency, growers, the environment, the general public,
and other interest groups from your answer to questions 1. and 2.?
4. If isomerically purified AI's were not treated as new AI's but
as new formulations, what incentives could the Agency create to promote
these innovations?
5. What information might the Agency need for initial and
subsequent registrations of isomeric AI's?
6. Under what circumstances should the Agency grant reduced risk
pesticide status to an isomeric AI purified for one or more (usually
more chemically active isomers)?
List of Subjects
Environmental protection, Pesticides.
Dated: April 19, 1999.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 99-10522 Filed 04-27-99; 8:45 am]
BILLING CODE 6560-50-F
