[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: [email protected].

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: opp-
[email protected]. 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