[Federal Register Volume 61, Number 70 (Wednesday, April 10, 1996)]
[Rules and Regulations]
[Pages 15900-15902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-8944]



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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:[email protected].
    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: 
[email protected].
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

[[Page 15901]]

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 
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 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.


[[Page 15902]]

    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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[FR Doc. 96-8944 Filed 4-9-96; 8:45 am]
BILLING CODE 6560-50-F