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dihydroazadirachtin Tolerance Requirement Exemption 7/96

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180

[PP 5F4486/R2249; FRL-5381-1]
RIN 2070-AB78

 
Dihydroazadirachtin; Exemption from the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes an exemption from the requirement for a 
tolerance for residues of the biochemical pesticide dihydroazadirachtin 
in or on all raw agricultural commodities when applied as an insect 
growth regulator and/or antifeedant in accordance with good 
agricultural practices. This exemption was requested by AgriDyne 
Technologies, Inc.

EFFECTIVE DATE: This regulation becomes effective July 18, 1996.

ADDRESSES: Written objections and hearing requests, identified by the 
docket number, [PP 5F4486/R2249], 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 an 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 disks 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 5F4486/R2249] . 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: Paul Zubkoff, Registration 
Action Leader (RAL), Biopesticides and Pollution Prevention Division 
(7501W), Environmental Protection Agency, 401 M St., SW., Washington, 
DC 20460. Office location and telephone number: Rm. 5-W54, CS #1, 2800 
Crystal Drive, Arlington, VA 22202. 703-308-8694; e-mail: 
zubkoff.paul@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 1, 1996 
(61 FR 3696), EPA issued a notice (FRL-4994-3) that AgriDyne 
Technologies, Inc., 2401 South Foothill Drive, Salt Lake City, UT 
(represented by E.R. Butts International, Inc. of 26 Sherman Court, 
P.O. Box 764, Fairfield, CT 06430) had submitted pesticide petition 
(PP) 5F4486 to EPA proposing to amend 40 CFR part 180 by establishing a 
regulation pursuant to section 408 of the Federal Food, Drug, and 
Cosmetic Act (FF DCA), 21 U.S.C. 346a(d), to exempt from the 
requirement of a tolerance the residues of the of the biochemical 
pesticide dihydroazadirachtin in or on all raw agricultural commodities 
when applied as an insect growth regulator and/or antifeedant in 
accordance with good agricultural practices.
    There were no adverse comments, or requests for referral to an 
advisory committee received in response to this notice of filing.
    22,23-Dihydroazadirachtin and its related metabolites are extracts 
of the seed kernels of the neem tree, Azadirachtin indica, are 
chemically similar to azadirachtin, the naturally-occurring neem plant 
extract, but differ by a single double bond, and are biologically 
equivalent to azadirachtin in its functionality when tested as a growth 
regulator against the Mexican bean beetle, Epilachna varivestis. 
Additionally, azadirachtin is exempted from the requirement of a 
tolerance when used as a pesticide at 20 grams or less per acre on all 
raw agricultural commodities (40 CFR 180.1119).
    The data submitted in the petition and all other relevant material 
have been evaluated. The toxicological data considered in support of 
the exemption from the requirement of a tolerance include: an acute 
oral toxicity study in rats, an acute dermal study in rabbits, an acute 
inhalation study in rats, a primary eye irritation study in rabbits, a 
primary dermal irritation study in rabbits, a dermal sensitization test 
(Buehler) in guinea pigs, a battery of genotoxicity
studies, an immunotoxicity study with azadirachtin in mice, a 90-day 
oral feeding study with azadirachtin in rats, and a developmental 
toxicity study with azadirachtin in rabbits.
    The results of these studies indicated that dihydroazadirachtin has 
an acute oral LD<INF>50 greater than 5,000 mg/kg body weight in rats 
for both the technical grade active ingredient and an end-use product 
(DAZA 4.5 WDG), an acute dermal LD<INF>50 greater than 2,000 mg/kg body 
weight in rabbits, an acute inhalation LD<INF>50 greater than 2.9 mg/L 
in rats, minimally irritating to the eye based on the primary eye 
irritation study, a non- to slight dermal irritant based on the primary 
dermal irritation study for the technical and end-use product, 
respectively, and a non-dermal sensitizer (Buehler sensitization test) 
in guinea pigs. In a mutagenicity study (Ames assay) the test 
substance, dihydroazadirachtin, was not mutagenic with or without 
activation. In a separate Ames assay and in other genotoxicity studies 
designed to detect structural chromosomal aberrations (i.e., in vivo 
unscheduled DNA synthesis and chromosome aberation/CHO cell culture), 
azadirachtin, the naturally-occurring unmodified counterpart, was not 
found to be mutagenic. Based on these results and due to the known 
composition of dihydroazadirachtin and its reduced metabolites, further 
tests to address structural chromosomal aberrations and forward 
mutations were waived. Results from an immunotoxicity assay, a 90-day 
oral feeding study, and a developmental toxicity assay evaluating 
azadirachtin indicated no significant effects.
    The toxicology data provided are sufficient to demonstrate that 
there are no foreseeable human health hazards likely to arise from the 
use of dihydroazadirachtin. This rule establishes an exemption from the 
requirement of a tolerance; therefore, the Agency has concluded that an 
analytical method is not required for enforcement purposes for 
dihydroazadirachtin.
    Dihydroazadirachtin is considered useful for the purposes for which 
the exemption from tolerance is sought. Based on the information and 
data considered, the Agency concludes that establishment of a tolerance 
is not necessary to protect the public health. Therefore, the exemption 
from tolerance is 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 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 5F4486/R2249] (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 
4:30 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 rulemaking 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 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.
    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.
    This action does not impose any enforceable duty, or contain any 
``unfunded mandates'' as described in Title II of the Unfunded Mandates 
Reform Act of 1995 (Pub. L. 104-4), or require prior consultation as 
specified by Executive Order 12875 (58 FR 58093, October 28, 1993), 
entitled Enhancing the Intergovernmental Partnership, or special 
consideration as required by Executive Order 12898 (59 FR 7629, 
February 16, 1994).
    Pursuant to the requirements of the Regulatory Flexibility Act (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 explaining the factual basis for this 
determination 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: July 8, 1996.

Daniel M. Barolo,
Director, 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. Section 180.1169 is added to subpart C to read as follows:


Sec. 180.1169  Dihydroazadirachtin; exemption from the requirement of a 
tolerance.

    The biochemical pesticide dihydroazadirachtin is exempted from the 
requirement of a tolerance in or on all raw agricultural commodities 
when applied as an insect growth regulator and/or antifeedant at 20 gm 
or less per acre with the maximum number of seven applications per 
growing season on all raw agricultural commodities.

[FR Doc. 96-18159 Filed 7-17-96; 8:45 am]
BILLING CODE 6560-50-F