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avermectin (Agri-Mek, Affirm) Pesticide Tolerance 4/96

[Federal Register: April 10, 1996 (Volume 61, Number 70)]
[Rules and Regulations]
[Page 15896-15900]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 186
[PP 1F3973, PP 4F4345, FAP 1H5611 and 4H5693/R2227; FRL-5361-9]
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 rule establishes tolerances for combined residues of the 
insecticide Avermectin B1 and its delta-8,9-isomer in or on the raw 
agricultural commodities (RACs) almonds, apples, and walnuts; and in or on 
processed feed items apples, wet pomace and almonds, hulls. The 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.

EFFECTIVE DATE: This regulation becomes effective April 10, 1996.

ADDRESSES: Written objections and hearing requests, identified by the docket 
number, [PP 1F3973, PP 4F4345, FAP 1H5611 and 4H5693/R], 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 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. 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 
a 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 disk 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 1F3973, PP 4F4345, FAP 1H5611 and 4H5693/R]. 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 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: EPA issued notices published in the Federal 
Register of May 29, 1991 (56 FR 24189) and July 13, 1994 (59 FR 35720), which 
announced that Merck Research Laboratories had submitted pesticide petitions 
(PPs) 1F3973 and 4F4345 to EPA requesting the that Administrator, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), amend 40 CFR 180.449 by establishing tolerances for the combined 
residues of the insecticide avermectin B1 and its delta-8,9-isomer, in or on 
the RACs almonds at 0.005 parts per million (ppm); apples at 0.02 ppm; and 
walnuts at 0.005 ppm. In the same notices, Merck Research Laboratories 
submitted feed additive petitions (FAPs) 1H5611 and 4H5693 requesting that the 
Administrator, pursuant to section 409(e) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 348(b), amend 40 CFR 186.300 by establishing a 
feed additive regulations for the combined residues of the insecticide 
avermectin B1 and its delta-8,9-isomer, in or on processed feed commodities 
apples, wet pomace at 0.10 ppm and almonds, hulls at 0.10 ppm.
    There were no comments received in response to the notice of filing.
    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) on cottonseed, and August 2, 
1989 (54 FR 31836) on 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 actions are 
estimated at 0.000017 mg/kg bwt/day and utilizes 4.3% 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 actions are 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 500. Generally speaking, 
MOEs greater than 100 for developmental toxicity do not raise concerns.
    The metabolism of the chemical in plants and animals for these uses are 
adequately understood. Any secondary residues occurring in meat, meat-
byproducts of cattle or milk will be covered by existing tolerances for those 
commodities. 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 parts 180 and 186 will be 
adequate to cover residues in or on almonds, apples and walnuts. There are 
presently no actions pending against the continued registration of this 
chemical.
    The pesticide is considered useful for the purpose for which the 
tolerances are sought and capable of achieving its physical or technical 
effect.
    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, and that the establishment of a feed additive regulation by 
amending 40 CFR part 186 would be safe. Therefore, the tolerances are 
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 requester'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 requester would, if 
established, resolve one or more of such issues in favor of the requester, 
taking into account uncontested claims or facts to the contrary; and 
resolution of the factual issue(s) in the manner sought by the requester 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 1F3973, PP 4F4345, FAP 1H5611 and 4H5693/R] (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 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.
    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 rule-making record which will also include all comments submitted 
directly in writing. The official rulemaking record is the paper record 
maintained at the Virginia 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

40 CFR Part 180

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

40 CFR Part 186

    Animal feeds, Pesticides and pests.

    Dated: March 29, 1996.

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

    Therefore, chapter I of title 40 Code of Federal Regulations is amended as 
follows:

    1. In part 180:

PART 180--[AMENDED]

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

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

        b. In Sec. 180.449, the table in paragraph (b) is amended by adding 
alphabetically entries for the commodities almonds, apples and walnuts to read 
as follows:


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

* * * * *    (b) * * *

------------------------------------------------------------------------
                                     Parts per 
Commodity                             million  
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Almonds...............................0.005
Apples................................0.020
                                                                        
                  *        *        *        *        *                 
Walnuts...............................0.005
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    2. In part 186:

PART 186--[AMENDED]

       a. The authority citation of part 186 continues to read as follows:

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

       b. In Sec. 186.300 the table in paragraph (b) is amended by adding 
alphabetically entries for the commodities almonds, hulls; and apples, wet 
pomace to read as follows:

Sec. 186.300   Avermectin B1 and its delta-8,9-isomer; tolerances for 
residues.

* * * * *    (b) * * *

------------------------------------------------------------------------
                                     Parts per 
Commodity                             million  
------------------------------------------------------------------------
                                                                      
Almonds, hulls...................      0.10
 Apples, wet pomace..............      0.10
                                                                        
                  *        *        *        *        *                 
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