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avermectin (Agri-Mek, Affirm) Renewal of Tolerances 7/94

40 CFR Parts 180, 185, and 186



[PP 7F3500, 8F3592, FAP 8H5650/P586; FRL-4898-6]



RIN 2070-AC18



Pesticide Tolerances for Avermectin B1 and its Delta-8,9-Isomer; 

Renewal of Tolerances 



AGENCY: Environmental Protection Agency (EPA). 



ACTION: Proposed rule.

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SUMMARY: This document proposes to renew tolerances for the 

residues of the insecticide avermectin B1 and its delta-8,9-

isomer in or on certain raw agricultural commodities and food 

and feed commodities. Merck & Co., Inc., requested this proposal 

to renew the effective date for tolerances for maximum permissible 

levels of residues of this insecticide in or on these commodities.



DATES: Written comments, identified by the document control 

number [PP 7F3500, 8F3592, FAP 8H5650/P586) must be received 

on or before September 2, 1994. 



ADDRESSES: Written comments, identified by the document control 

number, [PP 7F3500, 8F3592, FAP 8H5650/P586], may be submitted 

to: Public Response Section, Field Operations Division (7506C), 

Office of Pesticide Programs, Environmental Protection Agency, 

Rm. M3708, 401 M St., SW., Washington, DC 20460. In person, 

bring comments to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., 

Arlington, VA. Information submitted as a comment concerning 

this document may be claimed confidential by marking any part 

or all of that information as ``Confidential Business Information'' 

(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 may be 

disclosed publicly by EPA without prior notice. All written 

comments will be available for public inspection in Rm. 1132 

at the Virginia address given above, from 9 a.m. to 4 p.m., 

Monday through Friday, excluding legal holidays. 



FOR FURTHER INFORMATION CONTACT: By mail: George T. LaRocca, 

Product Manager (PM) 13, Registration Division (7505C), Office 

of Pesticide Programs, Environmental Protection Agency, 401 

M St., SW., Washington, DC 20460. Office location and telephone 

number: Rm. 202, CM #2, 1921 Jefferson Davis Hwy., Arlington, 

VA 22202, 703-305-6100. 



SUPPLEMENTARY INFORMATION: The Agency issued a conditional registration 

for avermectin B1 for use on cotton on May 22, 1989, with an 

expiration date of March 31, 1992 (see the Federal Register 

of August 23, 1989 (54 FR 35059)). This conditional registration 

was amended on July 25, 1989, to include citrus (see the Federal 

Register of August 2, 1989 (54 FR 31836)). On April 1, 1992, 

this expiration date was subsequently extended to April 30, 

1995, to allow the Agency sufficient time to review the data. 

The registrations were made conditional since certain data were 

lacking and required by the Agency to allow it to evaluate the 

effects of avermectin B1 on fish and aquatic organisms. See 

the Federal Register of August 23, 1989 (54 FR 35059), for specific 

data requirements. Because of the lack of these data the tolerances 

on cotton and citrus were established with an expiration date 

of March 31, 1993. 



   On November 20, 1992, Merck & Co. requested a waiver of the 

aquatic field study (mesocosm study) due to a change in Agency 

policy regarding the need for higher tiered fate and ecological 

effects data. In addition, Merck & Co. agreed to implement interim 

risk reduction measures designed to reduce the potential for 

aquatic exposure from application of avermectin B1 to cotton 

and citrus. The interim risk reduction measures included label 

changes aimed at reducing exposure to aquatic organisms such 

as (1) reduction in the number of applications and total seasonal 

applications; (2) increase in retreatment intervals; (3) geographic 

limitations; and (4) inclusion of aquatic buffer zones.

   The Agency reexamined the existing ecological effects data 

base and concluded that it had sufficient baseline data to characterize 

aquatic hazard for this pesticide. Thus, on January 10, 1993, 

the Agency waived the requirement for a mesocosm study. However, 

the Agency still concluded that this pesticide may pose aquatic 

risk from use on cotton and citrus and that the registration 

must remain conditional until the Agency had evaluated the effectiveness 

of the risk reduction measures and completed its aquatic risk 

assessment. By April 30, 1995, or sooner, the Agency intends 

to complete review of all data and other information submitted 

and to make FIFRA section 3(c)(5) or other appropriate regulatory 

decisions for the cotton and citrus use of avermectin B1.

   To be consistent with the extensions issued for the conditional 

registrations, the Agency is proposing to renew the tolerances 

on cotton, citrus and other affected commodities. The Agency 

has determined that renewing the tolerances will protect the 

human health. Therefore, renewals for the tolerances on cotton, 

citrus, and other affected crops are proposed as set forth below.

   The data submitted in support of these tolerances and other 

relevant material have been reviewed. The toxicological and 

metabolism data and analytical methods for enforcement purposes 

considered in support of these tolerances are discussed in detail 

in related documents published in the Federal Registers of May 

31, 1989 (54 FR 23209) for cottonseed and August 2, 1989 (54 

FR 31836) for citrus.

   Residues remaining in or on the above raw agricultural commodity 

after expiration of these tolerances will not be considered 

actionable if the pesticide is legally applied during the term 

of and in accordance with the provisions of the conditional 

registrations.

   Any person who has registered or submitted an application 

for registration of a pesticide under the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) as amended, which contains 

any of the ingredients listed herein, may request within 30 

days after publication of this document in the Federal Register 

that this rulemaking proposal be referred to an Advisory Committee 

in accordance with section 408(e) of FIFRA.

   Interested persons are invited to submit written comments 

on the proposed regulation. Comments must bear a notation indicating 

the document control number (PP 7F3500, 8F3592, FAP 8H5650/P586). 

All written comments filed in response to this petition will 

be available to the Public Response Section, at the address 

given above from 9 a.m. to 4 p.m., Monday through Friday, except 

legal holidays.

   The Office of Management and Budget has exempted this rule 

from the requirements of Executive Order 12866.

   Pursuant to the requirements of the Regulatory Flexibility 

Act (Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator 

has determined that regulations establishing new tolerances 

or food/feed additive regulations or raising tolerance or food/feed 

additive regulation levels or establishing exemptions from tolerance 

requirements do not have a significant economic impact on a 

substantial number of small entities. A certification statement 

to this effect was published in the Federal Register of May 

4, 1981 (46 FR 24950).



List of Subjects in 40 CFR Parts 180, 185, and 186



   Environmental protection, Administrative practice and procedure, 

Agricultural commodities, Food additives, Feed additives, Pesticides 

and pests, Reporting and recordkeeping requirements. 



Dated: July 19, 1994.





Lois Rossi,

Acting Deputy Director, Registration Division, Office of Pesticide 

Programs.

   Therefore, it is proposed that chapter I of title 40 of the 

Code of Federal Regulations be amended as follows: 



PART 180-[AMENDED]



   1. In part 180:



   a. The authority citation for part 180 continues to read 

as follows:



   Authority: 21 U.S.C. 346 and 371.



   b. In sec 180.449, by revising paragraph (a), to read as follows:



sec 180.449   Avermectin B1 and its delta-8,9-isomer; tolerances 

for residues.



   (a) Tolerances, to expire on April 30, 1996, are established 

for the combined residues of the insecticide avermectin B1 and 

its delta-8,9-isomer (a mixture of avermectins containing > 

80 percent avermectin B1A (5-O-demthyl avermectin B1A) and < 

20 percent avermectin B1B (5-O-demethyl-25-di (1-methylpropyl)-

25-1 (1-methylelthyl) avermectin A1A) in or on the following 

commodities:





                                                                              

                                                                              

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        Commodity                              Parts per   

                                              million    

-------------------------------------------------------------

                                                                              

Citrus, whole fruit............................  0.02  

Cattle, meat ....................................0.02  

Cattle, mbyp ....................................0.02  

Cottonseed .....................................0.005  

Milk .......................................... 0.005  

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PART 185-[AMENDED]



   2. In part 185:

   a. The authority citation for part 185 continues to read 

as follows:



   Authority: 21 U.S.C. 346a and 348.



   b. By revising sec 185.300, to read as follows:



sec 185.300   Avermectin B1 and its delta-8,9 isomer; tolerances 

for residues.



   Tolerances to expire on April 30, 1996, are established for 

the combined residues of the insecticide avermectin B1 and its 

delta 8,9-isomer (a mixture of avermectins containing >= 80 percent 

avermectin B1A (5-O-demethyl avermectin A1A) and less than or 

equal to 20 percent avermectin B1B (5-o-demethyl-25-di (1-methylpropyl) 

-25-(1-methylethyl) avermectin A1A)) in or on the following 

commodity:





                                                                              

                                                                              

----------------------------------------------------------------

           Commodity                              Parts per   

                                                  million    

----------------------------------------------------------------

                                                                              

Citrus oil ........................................0.10  

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PART 186-[AMENDED]



   3. In part 186:

   a. The authority citation for part 186 continues to read 

as follows:



   Authority: 21 U.S.C. 348.



   b. In sec 186.300, by revising paragraph (a) to read as follows:



sec 186.300   Avermectin B1 and its delta-8,9-isomer; tolerances 

for residues.



   (a) Tolerances to expire on April 30, 1996, are established 

for the combined residues of the insecticide avermectin B1 and 

its delta 8,9-isomer (a mixture of avermectins containing >= 

80 percent avermectin B1A (5-O-demethyl avermectin A1A) and 

less than or equal to 20 percent avermectin B1B (5-O-demethyl-

25-di (1-methylpropyl) -25-(1-methylethyl) avermectin A1A)) 

in or on the following commodity:





                                                                              

                                                                              

--------------------------------------------------------------

    Commodity                              Parts per   

                                           million    

--------------------------------------------------------------

                                                                              

Dried citrus pulp ..........................0.10  

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[FR Doc. 94-18759 Filed 8-2-94; 8:45 am]