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avermectin (Agri-Mek, Affirm) Proposed Pesticide Tolerance 7/96


ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5F4508/P673; FRL-5385-2]
RIN 2070-AC18

 
Avermectin B1 and Its Delta-8,9-Isomer; Proposed Pesticide 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed Rule.

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SUMMARY: EPA proposes to establish a tolerance for combined residues of 
the insecticide Avermectin B<INF>1 and its delta-8,9-isomer in or on 
the raw agricultural commodity potatoes. The proposed regulation to 
establish a maximum permissible level for residues of the insecticide 
was requested in a petition submitted by the Merck Research 
Laboratories, Division of Merck Co., Inc.

DATES: Comments, identified by the docket number [PP 5F4508/P673], must 
be received on or before August 23, 1996.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202. Information 
submitted as a comment concerning this notice 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 address given above, from 8 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to opp-docket@epamail.epa.gov. 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 disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PP 5F4508/P673]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at 
many Federal Depository Libraries. Additional information on electronic 
submissions can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By mail: George 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. 204, CM #2, 1921 
Jefferson Davis Highway, Arlington, VA 22202. (703) 305-6100, e-mail: 
larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On April 19, 1995, Merck Research 
Laboratories, Inc. submitted a pesticide petition (PP 5F4508) 
requesting that the Administrator, pursuant to section 408(d) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), 
establish a tolerance for combined residues of the insecticide 
avermectin B<INF>1 and its delta-8,9-isomers in or on the raw 
agricultural commodity (RAC) potatoes at 0.002 parts per million (ppm). 
On February 20, 1996, at the request of EPA, Merck amended the 
pesticide petition proposing an increase in the tolerance from 0.002 
ppm to 0.005 ppm based on the limits of the analytical methodology 
testing.
    The data submitted in support of this tolerance and other relevant 
material have been reviewed. The toxicological and metabolism data and 
analytical methods for enforcement purposes considered in support of 
this tolerance are discussed in detail in related documents published 
in the Federal Register of May 31, 1989 (54 FR 23209) (for cottonseed) 
and August 2, 1989 (54 FR 31836) (for citrus).
    The Agency used a two-generation rat reproduction study with an 
uncertainty factor of 300 to establish a Reference Dose (RfD). The 300-
fold uncertainty factor was utilized for (1) inter- and intra-species 
differences, (2) the extremely serious nature (pup death) observed in 
the reproduction study, (3) maternal toxicity (lethality) no-
observable-effect level (NOEL) (0.05 mg/kg/day), and (4) cleft palate 
in the mouse developmental toxicity study with isomer (NOEL = 0.06 mg/
kg/day). Thus, based on a NOEL of 0.12 mg/kg/day from the two-
generation rat reproduction study and an uncertainty factor of 300, the 
RfD is 0.0004 mg/kg/body weight(bwt)/day.
    A chronic dietary exposure/risk assessment has been performed for 
avermectin B<INF>1 using the above RfD. Available information on 
anticipated residues and 100% crop treated was incorporated into the 
analysis to estimate the Anticipated Residue Contribution (ARC). The 
ARC is generally considered a more realistic estimate than an estimate 
based on the tolerance-level residues. The ARC for established 
tolerances and the current action is estimated at 0.000017 mg/kg/bwt/
day and utilizes 4.2 percent of the RfD for the U.S. population. For 
non-nursing infants less than 1 year old (the sub-group population with 
the highest exposure level) the ARC for established tolerances and the 
current action is estimated at 0.000040 mg/kg bwt/day and utilizes 
10.0% of the RfD. Generally speaking, the Agency has no cause for 
concern if anticipated residues contribution for all published and 
proposed tolerances is less than the RfD.
    Because of the developmental effects seen in animal studies, the 
Agency used the mouse teratology study (with a NOEL of 0.06 mg/kg/day 
for developmental toxicity for the delta-8,9 isomer) to assess acute 
dietary exposure and determine a margin of exposure (MOE) for the 
overall U.S. population and certain subgroups. Since the toxicological 
end point pertains to developmental toxicity, the population group of 
interest for this analysis is women aged 13 and above, the subgroup 
which most closely approximates women of child bearing ages. The MOE is 
calculated as the ratio of the NOEL to the exposure. For this analysis, 
the Agency calculated the MOE for the high-end exposures for women ages 
13 and above. The MOE is 120. Generally speaking, MOEs greater than 100 
for developmental toxicity do not raise concerns.
    The metabolism of the chemical in plants and animals for the use is 
adequately understood. The established tolerances for cattle meat, meat 
byproducts, milk and fat are adequate to cover the increased dietary 
burden from the addition of the feed items potato culls and processed 
potato waste. There is no reasonable expectation of finite residues in 
poultry and swine, therefore no tolerances are necessary at this time. 
Adequate analytical methodology (HPLC-Fluorescence Methods) is 
available for enforcement purposes. Prior to publication in the 
Pesticide Analytical Manual, Vol II, the enforcement methodology is 
being made available in the interim to anyone who is interested in 
pesticide enforcement when requested from Calvin Furlow, Public 
Response and Program Resource Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, U.S. Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460. Office location and 
telephone number: Rm. 1132, CM #2, 1921 Jefferson-Davis Hwy., 
Arlington, VA 22202, (703) 305-5232.
    The tolerances established by amending 40 CFR part 180 will be 
adequate to cover residues in or on potatoes. There are presently no 
actions pending against the continued registration of this chemical. 
Based on the information and data considered, the Agency has determined 
that the tolerance established by amending 40 CFR part 180 would 
protect the public health. Therefore, it is proposed that the tolerance 
be established as set forth below.
    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 notice in the Federal Register that this rulemaking proposal be 
referred to an Advisory Committee in accordance with section 408(e) of 
the FFDCA.
    Interested persons are invited to submit written comments on the 
proposed regulation. Comments must bear a notation indicating the 
docket number, [PP 5F4508/P673].
    A record has been established for this rulemaking under docket 
number [PP 5F4508/P673](including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper versions of electronic comments, which does 
not include any information claimed as CBI, is available for inspection 
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
The public record is located in Room 1132 of the Public Response and Program Resources 
Branch, Field Operations Division (7506C), Office of Pesticide 
Programs, Environmental Protection Agency, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA 22202.
    Electronic comments can be sent directly to EPA at:

    opp-docket@epamail.epa.gov

    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record of this rulemaking, as well as the public 
version, as described above, will be kept in paper form. Accordingly, 
EPA will transfer all comments received electronically into printed 
paper form as they are received and will place the paper copies in the 
official rulemaking record which will also include all comments 
submitted directly in writing. The official rulemaking record is the 
paper record maintained at the address in ADDRESSEES at the beginning 
of this document.
    Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency 
must determine whether the regulatory action is ``significant'' and 
therefore subject to all the requirements of the Executive Order (i.e., 
Regulatory Impact Analysis, review by the Office of Management and 
Budget (OMB)). Under section 3(f), the order defines ``significant'' as 
those actions likely to lead to a rule (1) having an annual effect on 
the economy of $100 million or more, or adversely and materially 
affecting a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments or communities (also known as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs; or (4) raising novel legal or policy issues 
arising out of legal mandates, the President's priorities, or the 
principles set forth in this Executive Order.
    Pursuant to the terms of this Executive Order, EPA has determined 
that this rule is not ``significant'' and is therefore not subject to 
OMB review.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Pursuant to the requirements of the Regulatory Flexibility Act 
(U.S.C. 601-612), the Administrator has determined that regulations 
establishing new tolerances or raising tolerance levels or establishing 
exemptions from tolerance requirements do not have a significant 
economic impact on a substantial number of small entities. A 
certification statement explaining the factual basis for this 
determinations was published in the Federal Register of May 4, 1981 (46 
FR 24950).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and record 
keeping requirements.

    Dated: July 10, 1996.

Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation of part 180 continues to read as follows:

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

    2. In Sec. 180.449 the table in paragraph (b) is amended by adding 
alphabetically an entry for the commodity ``potatoes,'' to read as 
follows:


Sec. 180.449   Avermectin B<INF>1 and its delta-8,9-isomer; tolerances 
for residues.

*      *      *      *      *
    (b) *      *      *

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Potatoes...................................................        0.005
                                                                        
                  *        *        *        *        *                 
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[FR Doc. 96-18392 Filed 7-23-96; 8:45 am]
BILLING CODE 6560-50-F