Fosetyl-Al - Proposed Limited-time Tolerance 4/96
[Federal Register: April 26, 1996 (Volume 61, Number 82)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 5E4434/P-651; FRL-5363-3]
Aluminum Tris (O-ethylphosphonate); Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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: email@example.com.
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:firstname.lastname@example.org.
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
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
(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
(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) 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:
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
Dated: April 11, 1996.
Stephen L. Johnson, Director, Registration Division, Office of Pesticide
Therefore, it is proposed that 40 CFR Part 180 be amended as follows:
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:
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
Commodity million Expiration date
Blueberry.......................... 40 Dec. 31, 1998