[Federal Register Volume 59, Number 133 (Wednesday, July 13, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16857]
[[Page Unknown]]
[Federal Register: July 13, 1994]
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POSTAL SERVICE
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 8F3607/R2071; FRL-4900-3]
RIN 2070-AB78
Pesticide Tolerances for Glufosinate Ammonium
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 [ammonium DL-homoalanine-4-yl-
(methyl phosphinate)] and its metabolite, 3-methylphosphinico-propionic
acid, in or on raw agricultural commodities (RAC's) apples and grapes
at 0.05 part per million (ppm) and tree nuts group (except almonds) at
0.1 ppm. Hoechst Celanese Corp. (now AgrEvo) requested these tolerances
in petitions submitted to EPA.
EFFECTIVE DATES: This regulation becomes effective July 13, 1994. The
tolerances will expire July 13, 1999.
ADDRESSES: Written objections, identified by the document control
number, [PP 8F3607/R2071], may be submitted to: Hearing Clerk (1900),
Environmental Protection Agency, Rm. M3708, 401 M St., SW., Washington,
DC 20460.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Product Manager (PM)
23, (7505C), Registration Division, Environmental Protection Agency,
401 M St., Washington, DC 20460. Office location and telephone number:
Rm 237, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703)-
305-7830.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 25, 1988 (53
FR 18897), EPA issued a notice announcing that Hoechst Celanese Corp.,
Route 202-208 North, Sommerville, NJ 08878, had submitted a pesticide
petition (PP 8F3607) proposing to amend 40 CFR part 180 by establishing
a regulation pursuant to section 408 of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. 346a, to permit the residues of the herbicide
monoammonium 2-amino-4-(hydroxymethylphosphinyl)-butanoate (expressed
as 2-amino-4-(hydroxymethylphosphinyl)-butanoic acid) and 3-
methylphosphinicopropionic acid (expressed as 2-amino-4-
(hydroxymethylphosphinyl)-butanoic acid), in or on soybean seed,
apples, grapes, field corn (grain, forage, silage, and fodder), and
nuts at 0.05 ppm and almond hulls at 0.50 ppm. This petition was
assigned the number 8F3607. The proposed analytical method for
determining residues was high-pressure liquid chromatography.
There were no comments of request for referral to an advisory
committee received in response to the notice of filing.
The petitioner subsequently amended the petition by withdrawing the
tolerance proposal for residues of the active ingredient and its
metabolite in or on soybean seed, field corn grain, field corn forage,
field corn silage, and field corn fodder. Since this revision decreases
the pesticide burden on the environment, it was not published for
comment.
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 a 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 a 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 a 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 which 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 a 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, 0.3 percent;
nonnursing infants less than 1 year old, 2.1 percent.
A data gap currently exists for a rat carcinogenicity study. The
tolerances will be 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 nuts
(excluding almonds) 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 residue 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., Washington, DC 20460. Office location and telephone number:
Rm. 1130A, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA 22202,
(703)-305-5937.
There are currently no actions pending against the registration of
this chemical. There is no reasonable expectation that secondary
residues will occur in meat, fat, and meat byproducts of cattle, goats,
hogs, horses, sheep, or poultry, nor is there any reasonable
expectation that secondary residues will occur in eggs or milk.
Based on the information cited above, the Agency has determined
that the establishment of the tolerances by amending 40 CFR part 180
will protect the public health; therefore, the 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 with the Hearing Clerk, at the address given above.
40 CFR 178.20. 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 each such issue, 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
1798.32
The Office of Management and Budget has exempted this rule from the
requirements of Executive Order 12866.
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 tolerance 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: July 1, 1994.
Daniel M. Barolo,
Director, 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. By adding new Sec. 180.473, to read as follows:
Sec. 180.473 Glufosinate ammonium; tolerances for residues.
(a) Tolerances, to expire on July 13, 1999, are established for
residues of the herbicide glufosinate ammonium [ammonium DL-
homoalanine-4-yl-(methyl phosphinate)] and its metabolite, 3-
methylphosphinico-propionic acid, in or on the following raw
agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
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Apples..................................................... 0.05
Grapes..................................................... 0.05
Tree nuts group (except almonds)........................... 0.1
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(b) Residues in these commodities not in excess of the established
tolerance resulting from the use described in paragraph (a) of this
section remaining after expiration of 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 the above regulation.
[FR Doc. 94-16857 Filed 7-12-94; 8:45 am]
BILLING CODE 6560-50-F