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avermectin (Agri-Mek, Affirm) Proposed Pesticide Tolerance 9/95

[Federal Register: September 20, 1995 (Volume 60, Number 182)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 3F4258/P630; FRL-4973-8]
RIN 2070-AC18
Avermectin B1 and Its Delta-8,9-Isomer; 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 B1 and its delta-8,9-isomer in or on the raw 
agricultural commodity bell peppers. Merck Research Laboratories requested the 
proposed regulation to establish a maximum permissible level for residues of 
the insecticide pursuant to the Federal Food, Drug and Cosmetic Act (FFDCA).

DATES: Comments, identified by the document control number [PP 3F4258/P630], 
must be received on or before October 20, 1995.

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 
Hwy., Arlington, VA 22202. 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 
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 in 5.1 file format or ASCII file format. All comments and data in 
electronic form must be identified by the docket number [PP 3F4258/P630]. No 
Confidential Business Information (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 Hwy., Arlington, VA 
22202, (703)-305-6100; e-mail: larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: On August 17, 1993, Merck Research Laboratories, 
Inc., submitted a pesticide petition (PP 3F4258) 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 B1 and its delta-8,9-isomer in or on 
the raw agricultural commodity (RAC) group, fruiting vegetables (tomatoes, 
peppers, and eggplants) at 0.01 part per million (ppm). On August 9, 1994, 
Merck requested that the pesticide petition be amended by withdrawing group 
tolerances and proposing tolerances for bell peppers only at 0.01 ppm., since 
EPA had concluded there was insufficient data to establish the crop group 
tolerance and insufficient data to establish a tolerance on all varieties of 
peppers except for bell peppers.
    The data submitted in support of the tolerance and other relevant material 
have been reviewed. The toxicological and metabolism data and analytical 
methods for enforcement purposes considered in support of the tolerance are 
discussed in detail in related documents published in the Federal Registers of 
May 31, 1989 (54 FR 23209, cottonseed) and August 2, 1989 (54 FR 31836, 
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 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 B1 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 0.000022 mg/kg/bwt/day and utilizes 5.4 percent of the RfD for 
the U.S. population. For nonnursing infants less than 1-year-old (the subgroup 
population with the highest exposure level) the ARC for established tolerances 
and the current action is estimated at 0.000072 mg/kg bwt/day and utilizes 
17.9% of the RfD. Generally speaking, the Agency has no cause for concern if 
the anticipated residue 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 age. 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. Secondary residues occurring in livestock and their 
byproducts are not expected since there are no known animal feed stock uses 
for bell peppers. 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 bell peppers. There are currently 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 document 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 document control 
number, [PP 3F4258/P630]. All written comments filed in response to this 
petition will be available in the Public Response and Program Resources 
Branch, at the address given above from 8 a.m. to 4 p.m., Monday through 
Friday, except legal holidays.
     A record has been established for this rulemaking under docket number [PP 
3F4258/P630] (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, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    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 for 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 "ADDRESSES" 
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.
    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 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 to this effect 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 recordkeeping 
requirements.

    Dated: August 28, 1995.

Stephen L. Johnson, Director, Registration Division, Office of Pesticide 
Programs.

    Therefore, 40 CFR part 180 is 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. By amending Sec. 180.449 in paragraph (b) in the table therein, by 
adding and alphabetically inserting an entry for bell pepper, to read as 
follows:


Sec. 180.449   Avermectin B1 and its delta-8,9-isomer; tolerances for 
residues.

*        *        *        *      *    (b) *  *  *

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                                                              Parts per 
                         Commodity                             million  
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                  *        *        *        *        *                 
                       Peppers, bell                             0.01   
                                                                        
                  *        *        *        *        *                 
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