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Benzoic Acid - Pesticide Tolerance 3/96

[Federal Register: March 27, 1996 (Volume 61, Number 60)]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4375/R2219; FRL-5357-6]
RIN 2070-AB78
Pesticide Tolerance for Benzoic Acid
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This rule establishes a tolerance for residues of the
insecticide benzoic acid (3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl) hydrazide), in or on the raw agricultural commodity
apples. The regulation to establish a maximum permissible level for
residues of the insecticide was requested in a petition submitted by
the Rohm and Haas Co.

EFFECTIVE DATE: This regulation becomes effective March 27, 1996.

ADDRESSES: Written objections and hearing requests, identified by the
docket number, [PP 4E4375/R2219], 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 4E4375/R2219] . 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: Richard P. Keigwin, Jr.,
Product Manager (PM) 10, Registration Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: Rm. 210, CM
#2, 1921 Jefferson Davis Highway, Arlington, VA 22202, 703-305-6788; e-
mail: keigwin.rick@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA issued a notice (FRL-4948-2), published
in the Federal Register of April 5, 1995 (60 FR 17357), which announced
that Rohm and Haas Co. had submitted pesticide petition (PP) 4E4375 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 a tolerance for residues of the insecticide benzoic acid
(3,5-dimethyl-1,1-(1,1-dimethylethyl)-2-(4-ethylbenzoyl)hydrazide), in
or on the raw agricultural commodity apples at 1.0 parts per million
(ppm). As of February 29, 1996 there are no U.S. registrations for
apples.
    The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the tolerance include:
    1. A 1-year dog feeding study with a lowest-observable-effect
level (LOEL) of 250 ppm (8.7 mg/kg/day for male and 8.9 mg/kg/day for
female dogs) based on growth retardation in the male and in both sexes
decreases in RBC, HCT, and HGB, increases in Heinz bodies,
methemoglobin, MCV, MCH, reticulites, platelets, plasma total
bilirubin, spleen weight, and spleen/body weight ratio, and liver
weight and liver/body weight ratio. Hematopoiesis and sinusoidal
engorgement occurred in the spleen, and hyperplasia occurred in marrow
of the femur and sternum. The liver showed an increased pigment in the
Kupffer cells. The no-observable-effect level (NOEL) for systemic
toxicity is 50 ppm (1.8mg/kg/day for males and 1.9 mg/kg/day for
females).
    2. An 18-mounth mouse carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 1,000 ppm (males 155 mg/
kg/day; females 186 mg/kg/day).
    3. A 2-year rat carcinogenicity study with no carcinogenicity
observed at dosage levels up to and including 2,000 ppm (97 mg/kg/day
and 125 mg/kg/day for males and females, respectively).
    4. A 2-generation rat reproduction study with a NOEL of 150 ppm
(12.1 mg/kg/day) for reproductive effects compared to a systemic NOEL
of 10 ppm (0.85 mg/kg/day).
    5. A rat developmental study with a NOEL of 1,000 mg/kg/day for
developmental toxicity and a NOEL of 250 mg/kg/day for maternal
toxicity.
    6. A rabbit developmental study with a NOEL of 1,000 mg/kg/day for
developmental toxicity.
    7. Several mutagenicity tests which were all negative. These
include an Ames assay with and without metabolic activation, an in vivo
cytogenetic assay in rat bone marrow cells, an in vitro chromosome
aberration assay in CHO cells, a CHO/HGPRT assay, a reverse mutation
assay with E. coli, and an unscheduled DNA synthesis assay (UDS) in rat
hepatocytes.
    The reference dose (RFD), for chronic toxicity as defined in a 1-
year chronic dog study is 0.018 mg/kg/day based upon a NOEL of 1.8 mg/
kg/day in male dogs and applying an uncertainty factor of 100. Granting
this use of benzoic acid (3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hydrazide) on apples raises the theoretical maximum
residue contribution (TMRC) for the overall U.S. population from
0.000001 mg/kg/day to 0.000792 mg/kg/day and represents 4.4% of the
RFD. The TMRC for the highest exposed subgroup, non-nursing infants is
raised from 0.000001 mg/kg/day to 0.008051 mg/kg/day and represents
44.7% of the RFD for that subgroup.
    The metabolism of benzoic acid, (3,5-dimethyl-1-(1,1-dimethylethyl)-2-(4-
ethylbenzoyl)hyrazide), is adequately understood.
    An adequate analytical method, HPLC separation with UV detection,
is available for enforcement purposes.
    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 tolerance established by amending 40 CFR part 180
will protect the public health. The pesticide is considered useful for
the purposes for which the tolerance is sought. Therefore, the
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 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 4E4375/R2219] (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 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 entitlements,
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. 9-354, 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 15, 1996.

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. 180.482, by adding alphabetically to the table, an entry
for the raw agricultural commodity "apples", to read as follows:

Sec. 180.482  Benzoic acid; tolerances for residues.

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                                      Parts per
Commodities                            million
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Apples.............................      1.0
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