[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]



-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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.G[email protected].

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:

------------------------------------------------------------------------
                                                              Parts per 
                         Commodity                             million  
------------------------------------------------------------------------
Celery.....................................................         0.05
Lettuce, head..............................................         0.05
Strawberry.................................................         0.02
Tomatoes, fresh............................................         0.01
------------------------------------------------------------------------


[FR Doc. 95-6416 Filed 3-14-95; 8:45 am]
BILLING CODE 6560-50-F