[Federal Register Volume 61, Number 60 (Wednesday, March 27, 1996)]
[Rules and Regulations]
[Pages 13426-13428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7450]



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[[Page 13427]]



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-
[email protected].
    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: [email protected].

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

[[Page 13428]]
 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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[FR Doc. 96-7450 Filed 3-26-96; 8:45 am]
BILLING CODE 6560-50-F