[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: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
[[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) * * *
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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) * * *
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Parts per
Commodity million
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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
