[Federal Register Volume 61, Number 82 (Friday, April 26, 1996)]
[Proposed Rules]
[Pages 18533-18536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10251]
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[[Page 18534]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4434/P-651; FRL-5363-3]
RIN 2070-AB18
Aluminum Tris (O-ethylphosphonate); Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA proposes to establish a time-limited tolerance for
residues of the fungicide aluminum tris (O-ethylphosphonate) (also
referred to in this document as fosetyl-Al) in or on the raw
agricultural commodity blueberry. The proposed regulation to establish
a maximum permissible level for residues of the fungicide was requested
in a petition submitted by the Interregional Research Project No. 4
(IR-4). The time-limited tolerance for blueberry would expire on
December 31, 1998.
DATES: Comments, identified by the document control number [PP 5E4434/
P-651], must be received on or before May 28, 1996.
ADDRESSES: By mail, submit written comments 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 comments to: Rm. 1132 CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202. Comments and data
may also be submitted to OPP by sending electronic mail (e-mail) to:
opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect 5.1 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket number [PP 5E4434/P-651]. Electronic comments
on this proposed rule may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in the ``SUPPLEMENTARY INFORMATION'' section of this document.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information''. CBI should not be submitted
through e-mail. Information marked as CBI 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 Virginia address
given above, from 8 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Sixth Floor, Crystal Station #1,
2800 Jefferson Davis Highway, Arlington, VA 22202, (703) 308-8783; e-
mail:jamerson.hoyt@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 5E4434 to EPA on behalf of the Agricultural Experiment
Stations of Maine, Michigan, New Jersey, North Carolina, and Oregon.
This petition requests that the Administrator, pursuant to section
408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(e), amend 40 CFR 180.415 by establishing a time-limited tolerance
for residues of the fungicide fosetyl-Al [aluminum tris (O-
ethylphosphonate)], in or on the raw agricultural commodity blueberry
at 40 parts per million (ppm). The petitioner requested that the
tolerance expire on December 31, 1998, to allow IR-4 sufficient time to
develop additional magnitude of residue data in support of a permanent
tolerance for blueberries.
The scientific data submitted in the petition and other relevant
material have been evaluated. The toxicological data considered in
support of the proposed tolerance include:
(1) A 2-year feeding study in dogs fed diets containing 0, 10,000,
20,000, or 40,000 ppm with a no-observed-effect level (NOEL) of 10,000
ppm (250 milligrams (mg)/kilogram (kg)/day). The lowest-observed-effect
level (LOEL) was 20,000 ppm (500 mg/kg/day) based on a slight
degeneration of the testes.
(2) A 2-year feeding/carcinogenicity study in rat fed diets
containing 0, 2,000, 8,000, or 40,000/30,000 ppm with a systemic NOEL
of 8,000 ppm (400 mg/kg/day). The 40,000 ppm dose was reduced to 30,000
ppm after the first two weeks of the study due to the occurrence of red
urine and staining of the abdominal fur in male and female rats dosed
at 40,000 ppm. Systemic effects (urinary tract stone formation and
epithelial irritation) were observed at the high dose level. The study
also demonstrated a significantly elevated incidence of urinary bladder
tumors (adenomas and carcinomas combined) at the highest dose tested.
The tumors were mainly seen in surviving males at the time of terminal
sacrifice.
The registrant submitted additional information regarding the
relationship between the induction of urinary bladder tumors and the
presence of urinary bladder stones in rats, which indicates that the
extremely high dose level (40,0000/30,000 ppm) fed to rats produces
urinary tract toxicity that precedes and seems to lead to the
carcinogenic response in rats.
(3) A 2-year feeding/carcinogenicity study in mice fed diets
containing 0, 2,500, 10,000, or 20,000/30,000 ppm. The 20,000 ppm dose
was increased to 30,000 ppm during week 19 of the study. The NOEL for
systemic effects is established at 20,000/30,000 ppm (3,000/4,500 mg/
kg/day) based on hematological effects. There were no carcinogenic
effects observed under the conditions of this study.
(4) A three-generation reproduction study in rats fed diets
containing 0, 6,000, 12,000 or 24,000 ppm with a NOEL for reproductive
effects of 6,000 ppm (300 mg/kg/day). The LOEL is established at 12,000
ppm (600 mg/kg/day) based on decreased pup litter and pup weight.
(5) A developmental toxicity study in rats fed doses of 500, 1,000
or 4,000 mg/kg/day with a NOEL for developmental toxicity of 1,000 mg/
kg/day based on a significant reduction in litter and fetal weight, a
slight increase in malformations, and increased skeletal variations at
the 4,000 mg/kg/day dose level.
(6) A developmental toxicity study in rabbits fed doses of 125,
250, or 500 mg/kg/day with no developmental toxicity observed under the
conditions of the study.
(7) Fosetyl-Al was tested and found be negative for mutagenic
effects in a battery of studies designed to detect gene mutation,
chromosomal aberrations, and other genotoxic effects.
(8) A metabolism study in rats indicates that fosetyl-Al is
hydrolyzed to ethanol, which is excreted in expired air as carbon
dioxide, and to phosphite, which is excreted in the urine. In addition,
some of the compound is also excreted unchanged in the urine.
The Office of Pesticide Programs', Health Effects Division,
Carcinogenicity Peer Review Committee (CPRC)
[[Page 18535]]
determined that fosetyl-Al was not amenable to classification using
current Agency cancer guidelines. Additionally it was concluded that
based on a mechanistic evaluation of the only tumor which occurred at
exceptionally high doses (40,000/30,0000 ppm) in the bladder of male
rats and possibly in the bladder and renal pelvis of female rats, it
appears that humans are not likely to be exposed to doses of fosetyl-Al
that produce urinary tract toxicity which precedes and leads to the
carcinogenic response observed in rats. Based on the available
information, the CPRC concludes that the pesticidal use of fosetyl-al
is unlikely to pose a carcinogenic hazard to humans. EPA has,
therefore, chosen to use the Reference Dose (RfD) to quantify dietary
risk to humans.
The Reference Dose (RfD) is calculated at 3.0 mg/kg of body weight/
day. The RfD is based on a NOEL of 250 mg/kg/day from the 2-year dog
feeding study and an uncertainty factor of 100. The theoretical maximum
residue contribution (TMRC) from existing tolerances and the proposed
tolerance for blueberry utilizes 2.3 percent of the RfD for the U.S.
population, while the TMRC for non-nursing infants utilizes 4.6 percent
of the RfD. EPA generally has no concern for exposures below 100
percent of the RfD.
There is no reasonable expectation that secondary residues will
occur in milk, eggs, or meat of livestock and poultry since there are
no livestock feed items associated with this action. The nature of the
residue in plants is adequately understood. An adequate analytical
method, is available for enforcement purposes. Prior to its publication
in the Pesticide Analytical Manual, Volume II (PAM II), the enforcement
method is being made available in the interim to anyone who is
interested in pesticide residue enforcement from: By mail, Calvin
Furlow, Public Response and Program Resources Branch, Field Operations
Division (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Crystal Mall #2, Rm 1128, 1921 Jefferson
Davis Hwy., Arlington, VA 22202, telephone: 703-305-5805.
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
would protect the public health. Therefore, it is proposed that the
tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
A record has been established for this rulemaking under docket
number [PP 5E4434/P-651] (including comments and data submitted
electronically as described below). 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.
Electronic comments can be sent directly to EPA at:
opp-Docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
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 all comments 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 address in ``ADDRESSES'' at the
beginning of this document.
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.
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
(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: April 11, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR Part 180 be 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. 180.415, by adding a new paragraph (c), to read as
follows:
[[Page 18536]]
Sec. 180.415 Aluminum tris (O-ethylphosphonate); tolerances for
residues.
* * * * *
(c) Time-limited tolerances are established for residues of the
fungicide aluminum tris (O-ethylphosphonate) in or on the following raw
agricultural commodities:
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Parts per
Commodity million Expiration date
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Blueberry.......................... 40 Dec. 31, 1998
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[FR Doc. 96-10251 Filed 4-25-96; 8:45 am]
BILLING CODE 6560-50-F
