[Federal Register Volume 60, Number 50 (Wednesday, March 15, 1995)]
[Rules and Regulations]
[Pages 13914-13915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-6416]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4F4373/R2113; FRL-4940-9]
RIN 2070-AB78
Pesticide Tolerance for Avermectin B1 and Its Delta-8,9-
Isomer
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes tolerances for residues of the
insecticide avermectin B1 and its delta-8,9-isomer in or on the
raw agricultural commodity head lettuce. Merck Research Laboratories
requested this regulation to establish maximum permissible levels for
residues of the insecticide.
EFFECTIVE DATE: This regulation becomes effective March 15, 1995.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 4F4373/R2113], 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.
FOR FURTHER INFORMATION CONTACT: By mail: George T. 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 May 29, 1991 (56 FR 24189), which announced that
Merck Sharp & Dohme Research Laboratories, Division of Merck & Co.,
Inc., Hillsborough Rd., Three Bridges, NJ 08887, had submitted a
pesticide petition (PP 1F3973) 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 tolerances for
residues of the pesticide abamectin (same as avermectin B1) and
its delta-8, 9-isomer in or on the raw agricultural commodities (RAC)
lettuce at 0.05 part per million (ppm) and almonds and walnuts at 0.005
ppm.
In a letter dated June 9, 1994, Merck Research Laboratories
requested a separation of PP 1F3973 into two distinct petitions.
Almonds and walnuts were to be processed under PP 1F3973, and head
lettuce was assigned a new petition number, PP 4F4373. No comments were
received on the notice of filing (56 FR 24189, May 29, 1991).
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
these tolerances are discussed in detail in related documents published
in the Federal Registers of May 31, 1989 (54 FR 23209) for cottonseed
and August 2, 1989 (54 FR 31836) for 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 extreme seriousness of 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 0f 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
abamectin 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 tolerance-level residues. The ARC from established tolerances and
the current action is estimated at 0.000022 mg/kg bwt/day and utilizes
5.4 percent of the RfD for the U.S. population. The ARC for children,
aged 1 to 6 years old, and nonnursing infants (subgroups most highly
exposed) utilizes 13 and 18 percent of the RfD, respectively. 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 age. The MOE is
calculated as the ratio of the NOEL to the exposure. For this analysis,
the Agency calculated the MOE for high-end exposures for women ages 13
and above. The MOE for the high-end exposure is 200. Generally
speaking, MOEs greater than 100 for data derived from animal studies
are acceptable to the Agency.
The metabolism of the chemical in plants and livestock for this use
is adequately understood. Any secondary residues occurring in meat,
meat byproducts, or milk will be covered by existing tolerances for
those commodities. There is no reasonable expectation of finite
residues in poultry and swine commodities; 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 Reponse 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)-304-5232.
The tolerances established by amending 40 CFR part 180 will be
adequate to cover residues in or on lettuce. 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 tolerances established by amending 40 CFR part 180 will
protect the public health. Therefore, the tolerance is established as
set forth below. [[Page 13915]]
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).
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: March 3, 1995.
Stephen L. Johnson,
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 revising paragraph (b), to read as follows:
Sec. 180.449 Avermectin B1 and its delta-8,9-isomer; tolerances
for residues.
* * * * *
(b) Tolerances are established for the combined residues of the
insecticide avermectin B1 and its delta-8,9-isomer [a mixture of
avermectin containing greater than 80 percent avermectin B1a (5-O-
demethyl avermectin A1a) and less than 20 percent avermectin
B1b (5-O-demethyl-25-di(1-methylpropyl)-25-(1-methylethyl)
avermectin A1a)] in or on the following commodities:
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Parts per
Commodity million
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Celery..................................................... 0.05
Lettuce, head.............................................. 0.05
Strawberry................................................. 0.02
Tomatoes, fresh............................................ 0.01
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[FR Doc. 95-6416 Filed 3-14-95; 8:45 am]
BILLING CODE 6560-50-F
