[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Rules and Regulations]
[Pages 63960-63962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30117]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8F3607/R2184; FRL-4985-3]
RIN 2070-AB78
Glufosinate Ammonium; Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This document establishes time-limited tolerances for residues
of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, in or on various raw agricultural
commodities (RAC's). AgrEvo USA Co. submitted a petition to EPA under
the Federal Food, Drug and Cosmetic Act (FFDCA) requesting the
tolerances. The document also conforms the chemical expression for the
herbicide to Chemical Abstract nomenclature.
EFFECTIVE DATE: This regulation becomes effective December 13, 1995.
The tolerances will expire on July 13, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
document control number, [PP 8F3607/R2184], may be submitted to:
Hearing Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M
St., SW., Washington, DC 20460. Fees accompanying objections and
hearing requests shall be labeled ``Tolerance Petition Fees'' and
forwarded to: EPA Headquarters Accounting Operations Branch, OPP
(Tolerance Fees), P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any
objections and hearing requests filed with the Hearing Clerk should be
identified by the document control 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.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect in 5.1
file format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket number [PP
8F3607/R2184]. No Confidential Business Information (CBI) should be
submitted through e-mail. Electronic copies of 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: Joanne I. Miller, Product
Manager (PM) 23, Registration Division (7505C), Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis
Hwy., Arlington, VA 22202, (703)-305-6224; e-mail:
miller.joanne@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of July 26, 1995 (60
FR 38334), EPA issued a notice announcing that AgrEvo USA Co., Little
Falls One, 2711 Centerville Rd., Wilmington, DE 19808, had submitted an
amendment to PP 8F3607 (published at 53 FR 18897, May 25, 1988)
proposing to amend 40 CFR 180.473 by adding tolerances for residues of
glufosinate ammonium and its metabolite, 3-methylphosphinico-propionic
acid, in or on the following raw agricultural commodities: Tree nuts
group at 0.10 ppm, almond hulls at 0.50 ppm, cattle fat at 0.05 ppm,
cattle meat at 0.05 ppm, cattle meat byproducts (mbyp) at 0.10 ppm,
eggs at 0.05 ppm,
[[Page 63961]]
goat fat at 0.05 ppm, goat meat at 0.05 ppm, goat mbyp at 0.10 ppm, hog
fat at 0.05 ppm, hog meat at 0.05 ppm, hog mbyp at 0.10 ppm, horse fat
at 0.05 ppm, horse meat at 0.05 ppm, horse mbyp at 0.10 ppm, milk at
0.02 ppm, poultry fat at 0.05 ppm, poultry meat at 0.05 ppm, poultry
mbyp at 0.10 ppm, sheep fat at 0.05 ppm, sheep meat at 0.05 ppm, and
sheep mbyp at 0.10 ppm. Almonds are not considered a poultry feed
commodity under present EPA Guidelines, and AgrEvo USA Co. has
requested that the proposed tolerances for secondary residues in eggs,
poultry fat, meat, and meat byproducts be deleted from the tolerances
requested. This document also amends 40 CFR 180.473 to change the
chemical expression for the herbicide to that given above in conformity
with Chemical Abstract nomenclature.
The chemical expression for glufosinate ammonium has been changed
to follow that given by the Chemical Abstracts Index Name for this
chemical. This action is taken in concert with the final rule for
Premanufacture Notification; Revisions of Premanufacture Notification
Regulations, published in the Federal Register of March 29, 1995 (60 FR
16298-16310). The proposed analytical method for determining residues
is high-pressure liquid chromatography.
There were no comments or requests for referral to an advisory
committee received in response to the notice of filing.
The data submitted in the petition and other relevant material have
been evaluated. The toxicology data listed below were considered in
support of these tolerances.
1. A battery of acute toxicity studies placing technical
glufosinate-ammonium in Toxicity Categories II and III.
2. A 90-day feeding study in rats at dietary intakes of 0, 0.52,
4.1, 32, or 263 mg/kg/day with a no-observed-effect level (NOEL) of 4.1
mg/kg/day. The lowest-observed-effect level (LOEL) was established at
32 mg/kg/day based on increased absolute and relative kidney weights.
3. A 90-day feeding study in mice at dietary intakes of 0, 16.6,
67.1, or 278 mg/kg/day with a NOEL of 16.6 mg/kg/day and an LOEL of
67.1 mg/kg/day based on increased absolute and relative liver weights
(both sexes) and an increase in serum potassium levels (males).
4. Three teratology studies in rats at doses from 0.5 to 250 mg/kg/
day with no teratogenic effects occurring up to and including 250 mg/
kg/day. A NOEL for developmental toxicity was 2.24 mg/kg/day, based
upon an increase in the incidence of dilated renal pelvis with
hydroureter in the fetuses at 10 mg/kg/day. The maternal NOEL was also
2.24 mg/kg/day.
5. A teratology study in rabbits at doses of 0, 2, 6.3, or 20 mg/
kg/day with no teratogenic effects occurring up to and including 20 mg/
kg/day, and a maternal NOEL of 6.3 mg/kg/day and a developmental NOEL
of 20 mg/kg/day, the highest dose tested.
6. A two-generation reproduction study in rats at dietary
concentrations of 0, 40, 120, or 360 ppm with an NOEL for reproductive
effects at 120 ppm (equivalent to 12 mg/kg/day) based upon reduced
number of pups in the high-dose group. The NOEL for parental toxicity
was also 120 ppm based upon increased kidney weights in the high-dose
group.
7. A 12-month feeding study in dogs at doses of 0, 2, 5, or 8.5 mg/
kg/day. The NOEL was 5.0 mg/kg/day based upon the death of one male and
one female dog at 8.5 mg/kg/day with no other treatment-related
toxicity.
8. A mouse carcinogenicity study at doses of 0, 2.8, 10.8, or 22.7
mg/kg/day in males and 0, 4.2, 16.2, or 64.0 mg/kg/day in females for
104 weeks with no carcinogenic effects observed under the conditions of
the study up to and including 64 mg/kg/day and a systemic NOEL of 10.8
and 16.2 for males and females, respectively, based on the dose-related
increase in mortality.
9. A chronic feeding/carcinogenicity study in rats at dietary doses
of 0, 2.5, 8.8, or 31.5 mg/kg/day (males) and 0, 2.4, 8.2, or 28.7 mg/
kg/day (females) with an NOEL of 2.1 mg/kg/day for systemic effects
based on an increase in mortality rate in females at the two higher
doses. There were no treatment-related carcinogenic effects at any dose
level.
10. Acceptable studies on gene mutation (Salmonella, E coli., and
mouse lymphoma assays), structural chromosomal aberration (in vivo
micronucleus assay in mice), and other genotoxic effects (unscheduled
DNA synthesis assay with rat hepatocytes) yielded negative results.
11. Pharmacokinetic and metabolism studies in rats indicated that
approximately 80 to 90 percent of the orally administered dose of
glufosinate ammonium remained unabsorbed and was eliminated in the
feces. Approximately 10 to 15 percent was eliminated in the urine. The
major metabolic pathway is oxidative deamination yielding the
metabolite, 3-methyl-phospinico propionic acid.
The chronic analysis used a Reference Dose (RfD) of 0.02 mg/kg/
body weight day, based on an NOEL of 2.1 mg/kg/day and an uncertainty
factor of 100. The NOEL is based on a 2-year rat feeding study that
demonstrated increased absolute and relative kidney weight in males as
an endpoint effect.
Using tolerance-level residues and assumptions that 100 percent of
every crop for which glufosinate-ammonium has a proposed use is
treated, the total Theoretical Maximum Residue Contribution (TMRC) for
the general population and the highest exposed subgroup in DRES are as
follows (as percents of RFD): General population, 0.627 percent;
nonnursing infants less than 1-year-old, 3.7 percent.
A data gap currently exists for a rat carcinogenicity study. All
tolerances are time-limited because of this gap. The time limitation
allows for development and review of the data.
The analysis for glufosinate-ammonium using tolerance level
residues suggests that the proposed uses on apples, grapes, and tree
nut group will not cause exposure to exceed the levels at which the
Agency believes there is an appreciable risk. All DRES subgroups are
below 100 of the RfD for chronic effects.
The pesticide is useful for the purposes for which these tolerances
are sought. The nature of the residues is adequately understood for the
purpose of establishing these tolerances. Adequate analytical
methodology (gas chromatography with flame photometric detection of
phosphorus) is available for enforcement purposes. Because of the long
lead time from establishing these tolerances to publication, the
enforcement methodology is being made available in the interim to
anyone interested in pesticide enforcement when requested by mail from:
Calvin Furlow, Public Response Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. Office location and telephone
number: Rm. 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA
22202, (703)-305-5937.
Based on the information cited above, the Agency has determined
that the establishment of the time-limited tolerances by amending 40
CFR 180.473 will protect the public health; therefore, the time-limited
tolerances are 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 and/or request a hearing with the Hearing Clerk, at
the address given above (40 CFR 178.20). A copy of the objections and/
or hearing requests filed
[[Page 63962]]
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 a 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 docket
number [PP 8F3607/R2184] (including any objections and hearing requests
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.
Written objections and hearing requests, identified by the document
control number [PP 8F3607/R2184], may be submitted to the Hearing Clerk
(1900), Environmental Protection Agency, Rm. 3708, 401 M St., SW.,
Washington, DC 20460.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk can be sent directly to EPA at:
opp-Docket@epamail.epa.gov.
A copy of electronic objections and hearing requests filed with the
Hearing Clerk 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 any 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 objections and hearing requests 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 review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action that
is likely to result in 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 referred to 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 the rights and obligations of recipients
thereof; 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 the 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. 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: November 30, 1995.
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. 180.473, by revising paragraph (a), to read as follows:
Sec. 180.473 Glufosinate ammonium; tolerances for residues.
(a)(1) Time-limited tolerances are established for residues of the
herbicide glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per Expiration
Commodity million date
------------------------------------------------------------------------
Almond hulls.................................. 0.50 July 13,
1999
Apples........................................ 0.05 Do.
Cattle, fat................................... 0.05 Do.
Cattle, meat.................................. 0.05 Do.
Cattle, mbyp.................................. 0.10 Do.
Goats, fat.................................... 0.05 Do.
Goats, meat................................... 0.05 Do.
Goats, mbyp................................... 0.10 Do.
Grapes........................................ 0.05 Do.
Hogs, fat..................................... 0.05 Do.
Hogs, meat.................................... 0.05 Do.
Hogs, mbyp.................................... 0.10 Do.
Horses, fat................................... 0.05 Do.
Horses, meat.................................. 0.05 Do.
Horses, mbyp.................................. 0.10 Do.
Milk.......................................... 0.02 Do.
Sheep, fat.................................... 0.05 Do.
Sheep, meat................................... 0.05 Do.
Sheep, mbyp................................... 0.10 Do.
Tree nuts group............................... 0.1 Do.
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(2) Residues in these commodities not in excess of the established
tolerances resulting from the uses described in paragraph (a)(1) of
this section remaining after expiration of the time-limited tolerance
will not be considered to be actionable if the herbicide is applied
during the term of and in accordance with the provisions of paragraph
(a)(1) of this section.
* * * * *
[FR Doc. 95-30117 Filed 12-12-95; 8:45 am]
BILLING CODE 6560-50-F
