[Federal Register Volume 59, Number 187 (Wednesday, September 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23760]
[Federal Register: September 28, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8F3649, 9F3703, 0F3880/P590; FRL-4913-2]
RIN 2070-AC18
Pesticide Tolerances for Abamectin B1 and Its Delta-8,9-
Isomer
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish tolerances for residues of the
insecticide abamectin B1 and its delta-8,9-isomer in or on the raw
agricultural commodities celery, tomatoes, and strawberries. The
proposed regulation to establish maximum permissible levels for
residues of the insecticide was requested in petitions submitted by the
Merck Sharp & Dohme, Division of Merck & Co.
DATES: Comments, identified by document control number [PP 8F3649,
9F3703, 0F3880/P590], must be received on or before October 28, 1994.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. In person, bring objections and hearing
requests to Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202.
Information submitted as comments concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business'' (CBI). Information marked so will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 1132 at the
address given above, from 8 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
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: Second Floor, Crystall
Mall #2, Rm. 204, 1921 Jefferson Davis Hwy., Arlington, VA 22202,
(703)-305-6100.
SUPPLEMENTARY INFORMATION: EPA issued a notice, published in the
Federal Registers of October 12, 1988 (53 FR 39783), February 22, 1989
(54 FR 7596), and January 16, 1991 (56 FR 1631), which announced that
Merck Sharp & Dohme, Division of Merck & Co., Hillsborough Rd., Three
Bridges, NJ 08887, had submitted pesticide petitions (PP 8F3649 for
celery, PP 9F3703 for tomatoes, and PP 0F3880 for strawberries) 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 B1
and its delta-8,9-isomer (a mixture of abamectin containing greater
than or equal to 80 percent abamectin B1b (5-0-demethyl abamectin
A1a) and less than or equal to 20 percent abamectin B1a (5-0-
demethyl-25-di(1-methylpropyl)-25-(1-methylethyl) abamectin A1a))
in or on the raw agricultural commodities (RACs) celery at 0.035 part
per million (ppm); tomatoes at 0.005 ppm; and strawberries at 0.02 ppm
and a feed additive petition (FAP 9H5570) proposing to amend 40 CFR
186.300 by establishing a feed additive regulation under section 409 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.348) for abamectin
B1 and its delta-8,9-isomer in or on tomato wet pomace at 0.01 ppm
and tomato dry pomace at 0.07 ppm.
On January 31, 1990, Merck Sharp & Dohme, Division of Merck & Co.
requested that the pesticide petitions be amended by increasing the
proposed tolerances for the RACs tomatoes (PP 9F3703) and celery (PP
8F3649) to 0.01 and 0.05 ppm, respectively, and by deleting the
proposed tolerance on wet tomato pomace (9H5570) since there is no
distinction between wet and dry pomace, and the higher proposed feed
additive tolerance of 0.07 ppm for tomato pomace is adequate.
Subsequent to the initial notices of filing, EPA established import
tolerances for residues of abamectin B1 and its delta-8,9 isomer
on the RAC fresh tomatoes at 0.01 ppm and established a feed additive
regulation for tomato pomace at 0.07 ppm for tomatoes imported from
Mexico. (See the Federal Register of December 13, 1991 (56 FR 6503)).
Although the tolerance level proposed for tomatoes is the same as that
established in December 13, 1991, that tolerance was limited to fresh
tomatoes only. The current proposed tolerance is for all tomatoes.
Since the tolerance level proposed for tomato pomace is the same as
that established in December 13, 1991, FAP 9H5570 is being
administratively withdrawn.
The data submitted in support of these tolerances 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, 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 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
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 0.000106 mg/kg bwt/day and utilizes
26.5 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 64.2 and 95.1 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 167. Generally
speaking, MOEs greater than 100 for developmental toxicity 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 celery, strawberries, and tomatoes.
There are presently 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,
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).
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: September 16, 1994.
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 amending paragraph (b) by revising the table
therein, to read as follows:
Sec. 180.449 Abamectin B1 and its delta-8,9-isomer; tolerances
for residues.
* * * * *
(b) * * *
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Parts per
Commodity million
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Celery..................................................... 0.05
Strawberry................................................. 0.02
Tomatoes................................................... 0.01
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[FR Doc. 94-23760 Filed 9-27-94; 8:45 am]
BILLING CODE 6560-50-F
