Pesticide registration, cancellation, etc.: Isomeric active ingredients,

[Federal Register: April 28, 1999 (Volume 64, Number 81)]

[Notices]

[Page 22863-22865]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr28ap99-49]

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.

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:

1. 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.

2. 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.

3. How Can I Get Additional Information or Copies of this Document or Other Documents?

   1. 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/.

   2. 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.

4. 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.

   1. 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.

   2. 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.

   3. Electronically

      Submit your comments and/or data electronically by e-mail to: opp- 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 filedonline at many Federal Depository Libraries.

5. 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.

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

   1. 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:

      ‹bullet› Explain your views as clearly as possible.

      ‹bullet› Describe any assumptions that you used.

      ‹bullet› Provide solid technical information and/or data to support your views.

      ‹bullet› If you estimate potential burden or costs, explain how you arrived at the estimate.

      ‹bullet› Tell us what you support, as well as what you disagree with.

      ‹bullet› Provide specific examples to illustrate your concerns.

      ‹bullet› Offer alternative ways to improve the rule or collection activity.

      ‹bullet› Make sure to submit your comments by the deadline in this notice.

      ‹bullet› 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.

   2. 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:

      ‹bullet› Isomers present and their percentages.

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      ‹bullet› Relative activity of each isomer.

      ‹bullet› Relative toxicology of each isomer (human health and environmental effects).

      ‹bullet› Relative environmental fate of each isomer.

   3. 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. 99-10522Filed04-27-99; 8:45 am]

      BILLING CODE 6560-50-F