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avermectin (Agri-Mek, Affirm) Pesticide Tolerance 12/95

[Federal Register: December 20, 1995 (Volume 60, Number 244)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 9F3787/R2194; FRL-4991-1]
RIN 2070-AB78
Avermectin B1 and Its Delta-8,9-Isomer; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes a tolerance for combined residues of 
the insecticide avermectin B1 and its delta-8,9-isomer in or on 
the raw agricultural commodity pears. Merck Research Laboratories 
requested this regulation to establish a maximum permissible level for 
residues of the insecticide pursuant to the Federal Food, Drug and 
Cosmetic Act (FFDCA).

EFFECTIVE DATE: This regulation becomes effective December 20, 1995.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number [PP 9F3787/R2194], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
document control number and submitted 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 copy of objections and hearing 
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 
22202. Fees accompanying objections shall be labeled "Tolerance 
Petition Fees" and forwarded to EPA Headquarters Accounting Operations 
Branch, OPP (Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket number [PP 
9F3787/R2194]. No Confidential Business Information (CBI) should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this 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: EPA issued a notice, published in the 
Federal Register of November 1, 1989 (54 FR 46118), which announced 
that Merck Research Laboratories, Inc., Hillsborough Rd., Three 
Bridges, NJ 98887, had submitted a pesticide petition (PP 9F3787) to 
EPA 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) pears at 0.035 part per million (ppm). In 
a letter dated September 22, 1993, Merck requested that the pesticide 
petition be amended by proposing a lower tolerance on pears at 0.02 
ppm. No comments were received in response to the notice of filing (See 
58 FR 64583; Dec. 8, 1993).
    The data submitted in support of this tolerance and other relevant 
material have been reviewed. The toxicological and metabolism data 
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, 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 0.000013 mg/kg/bwt/
day and utilizes 3.4 percent of the RfD for the U.S. population. For 
nonnursing 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 0.000030 mg/kg bwt/day and utilizes 7.5% 
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 1,000. 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 by-products are not expected since there are no known animal feed 
stock uses for pears. Adequate analytical methodology (HPLC-Fluorescence 
Methods) is available for enforcement purposes. The enforcement methodology 
has been submitted to the Food and Drug Administration for publication in the 
Pesticide Analytical Manual, Vol. II (PAM II). Because of the long lead time 
for publication of the method in PAM II, the analytical methodology is being 
made available in the interim to anyone 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 pears. 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 adversely affected by this regulation may, within 30 
days after publication of this document in the Federal Register, file 
written objections and/or request a hearing with the Hearing Clerk, at 
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed with the Hearing Clerk should be submitted to 
the OPP docket for this rulemaking. The objections submitted must 
specify the provisions of the regulation deemed objectionable and the 
grounds for the objections (40 CFR 178.25). Each objection must be 
accompanied by the fee prescribed by 40 CFR 180.33(i). If a hearing is 
requested, the objections must include a statement of the factual 
issue(s) on which a hearing is requested, the requestor's contentions 
on such issues, and a summary of any evidence relied upon by the 
objector (40 CFR 178.27). A request for a hearing will be granted if 
the Administrator determines that the material submitted shows the 
following: There is a genuine and substantial issue of fact; there is a 
reasonable possibility that available evidence identified by the 
requestor would, if established, resolve one or more of such issues in 
favor or the requestor, taking into account uncontested claims or facts 
to the contrary; and resolution of the factual issues(s) in the manner 
sought by the requestor would be adequate to justify the action 
requested (40 CFR 178.32).
    A record has been established for this rulemaking under docket 
number [PP 9F3787/R2194] (including comments and data submitted 
electronically as described below). A public version of this record, 
including printed, paper version 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, 
Crystall Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
                        oop-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: December 7, 1995.

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

    Therefore, 40 CFR part 180 continues to read 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(b) in the table therein by adding and 
alphabetically inserting an entry for pears, 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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                  *        *        *        *        *                 
Pears.................... .............         0.02
                                                                        
                  *        *        *        *        *                 
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