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avermectin (Agri-Mek, Affirm) Pesticide Tolerance 3/96

[Federal Register: March 8, 1996 (Volume 61, Number 47)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4354/R2196; FRL-4993-5]
RIN 2070-AB78
Pesticide Tolerance; Avermectin B1 and Its Delta-8,9-Isomer
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for combined residues of the 
insecticide avermectin B1 and its delta-8,9-isomer in or on the 
raw agricultural commodities cucurbit vegetables group (cucumbers, 
melons, and squashes). The regulation to establish a maximum 
permissible level for residues of the insecticide was requested in a 
petition submitted by the Merck Research Laboratories.

 EFFECTIVE DATE: This regulation becomes effective March 8, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
document control number, [PP 4F4354/R2196], 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 
docket 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. 
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.
    An electronic copy of objections and hearing requests filed with 
the Hearing Clerk may be submitted to OPP by sending electronic mail 
(e-mail) to:
                      opp-docket@epamail.epa.gov


    Copies of electronic objections and hearing requests must be 
submitted as an ASCII file avoiding the use of special characters and 
any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 5.1 file format 
or ASCII file format. All copies of electronic objections and hearing 
requests must be identified by the docket number [PP 4F4354/R2196]. No 
Confidential Business Information (CBI) should be submitted through e-mail. 
Copies of electronic 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, telephone number, and e-mail address: Rm. 204, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703)-305-6100; e-mail:
              larocca.george@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice published in the Federal 
Register of November 2, 1994 (59 FR 54911), and September 28, 1994 (59 
FR 49392), which announced that Merck Research Laboratories had 
submitted pesticide petition (PP) 4F4354 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 commodities (RACs) cucurbit 
vegetables group (cucumbers, melons, and squashes) at 0.005 part per 
million (ppm). No comments were received in response to the notice of 
filing.
    The scientific data submitted in the petition and other relevant 
material have been evaluated. The toxicological 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 intraspecies 
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 body weight(bwt) /day), and 
(4) cleft palate in the mouse developmental toxicity study with isomer 
(NOEL = 0.06 mg/kg bwt/day). Thus, based on a NOEL of 0.12 mg/kg bwt/
day from the two-generation rat reproduction and an uncertainty factor 
of 300, the RfD is 0.0004 mg/kg/ 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 3.2% 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 0.000018 mg/kg bwt/day and utilizes 4.5% 
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 years 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 years and above. The MOE is 150. 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 cucurbits. An adequate analytical method (HPLC-
Fluorescence Method) 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 required 
from Calvin Furlow, Public Response and Program Resources 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 cucurbits (cucumbers, melons, and 
squashes). There are currently no actions pending against the continued 
registration of this chemical. The pesticide is considered useful for 
the purpose for which it is intended.
    Based on the information and data considered, the Agency has 
determined that the tolerance established by amending 40 CFR part 180 
will protect the public health. Therefore, the tolerance is 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 to the regulation and may also request a hearing on 
those objections. Objections and hearing requests must be filed 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 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 of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issue(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 the docket 
number [PP 4F4354/R2196] (including any comments and data submitted 
electronically). 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 22202.
    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 any copies of objections and hearing requests 
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, October 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: February 23, 1996.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.449, by amending the table in paragraph (b) by 
adding alphabetically an entry for cucurbits, to read as follows:


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

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    (b)  *  *  *

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                                                              Parts per 
                         Commodity                             million  
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                          *    *    *    *    *                         
Cucurbits (cucumbers, mellons, and squashes)...............     0.005
                                                                        
                          *    *    *    *    *                         
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