Glufosinate Ammonium; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: November 4, 1999 (Volume 64, Number 213)]
[Rules and Regulations]
[Page 60112-60121]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no99-9]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300945; FRL-6391-5]
RIN 2070-AB78

Glufosinate Ammonium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for combined residues
of glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-mono ammonium salt) and metabolite(s) (3-
methylphosphinico-propionic acid and 2-acetamido-4-methylphosphinico-
butanoic acid), expressed as 2-amino-4-(hydroxymethylphosphinyl)
butanoic acid equivalents in or on almond hulls; apples; bananas;
cattle fat, meat and meat-byproducts; eggs; goat fat, meat, and meat-
by-products; grapes, hog fat, meat, and meat-by-products; horse fat,
meat, and meat-by-products; milk; potatoes, potato chips and granules/
flakes; poultry fat, meat, and meat-by-products; sheep fat, meat, and
meat-by-products; transgenic aspirated grain fractions, transgenic
corn, field, forage; transgenic corn, field, grain; transgenic corn,
field, stover; transgenic soybean hulls, transgenic soybeans, and tree
nuts group. AgrEvo USA Company requested these tolerances under the
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality
Protection Act of 1996. This regulation also corrects the existing
regulation for time-limited tolerances for transgenic canola and sweet
corn commodities.
DATES: This regulation is effective November 4, 1999. Objections and
requests for hearings, identified by docket control number OPP-300945,
must be received by EPA on or before January 3, 2000.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VI. of the ``SUPPLEMENTARY
INFORMATION'' section. To ensure proper receipt by EPA, your objections
and hearing requests must identify docket control number OPP-300945 in
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-6224 and e-mail address:
miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you are an agricultural
producer, food manufacturer, or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
Examples of Potentially
Categories NAICS Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide manufacturing
------------------------------------------------------------------------

This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the ``FOR FURTHER INFORMATION
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?

1. Electronically.You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-300945. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall <greek-i>2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

In the Federal Register of October 8, l997, (62 FR 52544) (FRL-
5746-9) and July 14, l999 (64 FR 37973) (FRL-6085-5), EPA issued
notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDCA), 21 U.S.C. 346a(d) as amended by the Food Quality
Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the
filing of a pesticide petition (PP) for tolerance by AgrEvo USA
Company, Little Falls

[[Page 60113]]

Centre One, 2711 Centerville Road, Wilmington, DE 19808. These notices
included a summary of the petition prepared by AgrEvo USA Company, the
registrant. There were no comments received in response to the notices
of filing.
These petitions requested that 40 CFR 180.473 be amended by
establishing permanent tolerances for combined residues of the
herbicide glufosinate ammonium and its metabolite(s) expressed as 2-
amino-4-(hydroxymethylphosphinyl) butanoic acid in or on almond hulls
at 0.50 part per million (ppm), apples at 0.05 ppm, bananas at 0.3 ppm
(not more than 0.2 ppm shall be present in the pulp after peel is
removed), cattle, fat and meat at 0.05 ppm; cattle, meat-by-products at
0.10 ppm; eggs at 0.05 ppm, goats, fat and meat at 0.05 ppm; goats,
meat-by-products at 0.10 ppm; grapes at 0.05 ppm; hogs, fat and meat at
0.05 ppm; hogs, meat-by-product at 0.10 ppm; horses, fat and meat at
0.05 ppm; horses, meat-by-products at 0.10 ppm; milk at 0.02 ppm,
potatoes at 0.8 ppm, potato chips at 1.6 ppm, potato granules/flakes at
2.0 ppm, poultry, fat and meat at 0.05 ppm; poultry, meat-by-products
at 0.10 ppm; sheep, fat and meat at 0.05 ppm; sheep, meat-by-products
at 0.10 ppm; transgenic aspirated grain fractions at 25.0 ppm,
transgenic corn, field, forage at 4.0 ppm; trangenic corn, field, grain
at 0.2 ppm; transgenic corn, field stover at 6.0 ppm; transgenic
soybeans hulls at 5.0 ppm, transgenic soybeans at 2.0 ppm and tree nut
group at 0.1 ppm.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. Aggregate Risk Assessment and Determination of Safety

Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2), for permanent tolerances for combined residues of
glufosinate ammonium and its metabolite(s) in or on almond hulls at
0.50 ppm, apples at 0.05 ppm, bananas at 0.3 ppm (not more that 0.2 ppm
shall be present in the pulp after peel is removed), cattle, fat and
meat at 0.05 ppm; cattle, meat-by-products at 0.10 ppm, eggs at 0.05
ppm, goats, fat and meat at 0.05 ppm; goats, meat-by-products at 0.10
ppm; grapes at 0.05 ppm, hogs, fat and meat at 0.05 ppm; hogs, meat-by-
product at 0.10 ppm; horses, fat and meat at 0.05 ppm; horses, meat-by-
products at 0.10 ppm; milk at 0.02 ppm; potatoes at 0.8 ppm; potato
chips at 1.6 ppm; potato granule/flakes at 2.0 ppm; poultry, fat and
meat at 0.05 ppm; poultry, meat-by-products at 0.10 ppm; sheep, fat and
meat at 0.05 ppm; sheep, meat-by-products at 0.10 ppm; transgenic
aspirated grain fractions at 25.0 ppm, transgenic corn, field, forage
at 4.0 ppm; transgenic corn, field, grain at 0.2 ppm; transgenic corn,
field, stover at 6.0 ppm; transgenic soybeans, hulls at 5.0 ppm;
transgenic soybeans at 2.0 ppm and tree nuts group at 0.1 ppm. The
addition (a corrective action on the Administrator's own initiative
under section 408(e)(A)(C) of a second metabolite (2-acetamido-4-
methylphosphinico-butamoic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents) to the residues of
glufosinate ammonium found in transgenic canola and sweet corn
commodities is consistent with section 408(b)(2)(D) and is appropriate
because the second metabolite consistently occurs in commodities
derived from transgenic plants. The risk assessment included the second
metabolite found in canola and sweet corn commodities. EPA's assessment
of the dietary exposures and risks associated with establishing these
tolerances follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by are discussed in
this unit.
1. Glufosinate ammonium (also referred to as DL-glufosinate
ammonium or HOE 039866 ) is toxicity category III for acute oral,
dermal, and eye irritation toxicities. It is toxicity category III for
inhalation toxicity. It is not a dermal irritant (toxicity category IV)
nor is it a dermal sensitizer.
2. In a sub-chronic oral toxicity study, glufosinate-ammonium
(95.3% active ingredient (a.i.)) was administered to 10 NMRI mice/sex/
dose in the diet at levels of 0, 80, 320 or 1,280 ppm (equivalent to 0,
12, 48 or 192 millgrams/kilogram/day (mg/kg/day)) for 13 weeks.
Significant (p< 0.05) increases were observed in serum aspartate
aminotransferase and in alkaline phosphatase in high-dose (192 mg/kg/
day) males. Also observed were increases in absolute and relative liver
weights in mid-(48 mg/kg/day) and high-dose males. The no observed
adverse effect level (NOAEL) is 12 mg/kg/day, the lowest observed
adverse effect level (LOAEL) is 48 mg/kg/day based on the changes in
clinical biochemistry and liver weights.
3. In a 21-day repeated dose dermal toxicity study, groups of 6
male and 6 female Wistar rats were treated with HOE 039866 (95.3%) in
deionized water by dermal occlusion at doses of 0, 100, 300 or 1,000
mg/kg/day, 6 hours/day, 5 days/week for 21 applications in 30 days. An
additional five males and five females/dose group were dose and
observed for 44 days in a ``recovery study''. Two of 6 LDT males at 300
mg/kg/day, and 4 of 11 males and two of 11 females at 1,000 mg/kg/day
displayed aggressive behavior, piloerection and a high startle
response. There were no effects of toxicological importance on body
weights, food consumption, hematology, clinical chemistry, urinalysis,
organ weights, or gross or microscopic pathology. Based on clinical
observations, the LOAEL is 300 mg/kg/day and the NOAEL is 100 mg/kg/
day.
4. In an oncogenicity study, HOE 039866 (glufosinate ammonium) was
administered to 50 NMRI mice/sex/dose in the diet at dose levels of 0,
80, 160 (males only) or 320 (females only) ppm for 104 weeks. Dose
levels corresponded to 0, 2.83, 10.82, 22.60 mg/kg/day in males and 0,
4.23, 16.19, 66.96 mg/kg/

[[Page 60114]]

day in females. The NOAEL for systemic toxicity is 80 ppm (10.82/16.19
mg/kg/day in males/females (M/F)), and the LOAEL is 160/320 ppm (22.60/
63.96 mg/kg/day in M/F), based on increased mortality in males,
increased glucose levels in males and females, and consistent changes
in glutathione levels in males. No increase in tumor incidence was
found in any treatment group.
5. In a chronic feeding study, HOE 039866 technical was fed to
male and female beagle dogs for 12 months in the diet at levels of 2.0,
5.0 or 8.5 mg/kg/day. There were no overt signs of toxicity or dose-
related effects on body weight, food consumption, ophthalmology,
hematology, clinical chemistry, urinalyses or organ weights. Two dogs
receiving 8.5 mg/kg/day died during the study as a result of heart and
circulatory system failure from rapid diet consumption and necrotizing
aspiration pneumonia. Electrocardiogram results of dosed males and
females indicated a dose-related decrease in heart rate at 6 months;
heart rates of dosed animals at 12 months were considered to be normal.
The NOAEL is 5.0 mg/kg/day, the LOAEL is 8.5 mg/kg/day based on
mortality.
6. In a rat oncogenicity study, glufosinate-ammonium (95.2-96.0%
a.i.) was administered to Wistar rats (60/sex/group) for up to 24
months at 0, 1,000, 5,000, or 10,000 ppm (equivalent to 0, 45.4, 228.9,
or 466.3 mg/kg/day in males and 0, 57.1, 281.5, or 579.3 mg/kg/day in
females). The LOAEL for chronic toxicity is 5,000 ppm (equivalent to
228.9 mg/kg/day for male rats and 281.5 mg/kg/day for females), based
on increased incidences of retinal atrophy. The chronic NOAEL is 1,000
ppm. Under the conditions of this study, there was no evidence of
carcinogenic potential. Dosing was considered adequate based on
increased incidences of retinal atrophy.
7. In a combined chronic toxicity/oncogenicity study, glufosinate
ammonium was administered to 50 Wistar rats/sex/dose in the diet for 24
months at dose levels of 0, 40, 140, or 500 ppm (mean compound intake
in males was 0, 1.9, 6.8, and 24.4 mg/kg/day and for females was 0,
2.4, 8.2 and 28.7 mg/kg/day, respectively). The LOAEL is 2.4 mg/kg/day
(LDT) based on the increase in kidney glutamine synthetase activity and
increased kidney weights in females. A NOAEL was not established. There
was no clear demonstration of increased tumor incidence following
exposure to glufosinate ammonium. Dosing was considered adequate based
on the increase in kidney glutamine synthetase activity and increased
kidney weights in females.
8. In a developmental toxicity study, groups of 20 pregnant female
Wistar rats were administered by gavage HOE 039866 (glufosinate
ammonium, 96.9 a.i.) at doses of 0, 0.5, 2.24 10, 50 and 250 mg/kg/day
from days 7 to 16 of pregnancy. The NOAEL for maternal toxicity is 10
mg/kg/day; the LOAEL is 50 mg/kg/day based on vaginal bleeding and
hyperactivity in dams. In the fetus, the NOAEL is 50 mg/kg/day, based
on dilated renal pelvis at the LOAEL of 250 mg/kg/day.
9. In a developmental toxicity study, groups of 15 pregnant female
Himalayan rabbits were administered by gavage HOE 039866 at doses of 0,
2.0, 6.3 or 20.0 mg/kg/day from days 7 to 19 of pregnancy. The NOAEL
for both maternal toxicity and developmental toxicity was 2.0 mg/kg/
day. The LOAEL is 6.3 mg/kg/day based on reduced food consumption, body
weight and weight gains and increased kidney weights in dams, and
incomplete ossification in fetuses with fetal death at 20 mg/kg/day.
10. In a multigeneration reproduction study, glufosinate ammonium
was administered to groups of 30 male and 30 female Wistar/Han rats in
the diet at concentrations of 0, 40, 120 or 360 ppm (approximately 2.0,
6.0, 18.0 mg/kg). The LOAEL for systemic toxicity is 120 ppm (6 mg/kg/
day) based on increased kidney weights in both sexes and generations.
The systemic toxicity NOAEL is 40 ppm (2 mg/kg/day). The LOAEL for
reproductive/developmental toxicity is 360 ppm (18 mg/kg/day) based on
decreased number of viable pups in all generations. The NOAEL is 120
ppm.
11. There is no concern for mutagenic activity in several studies,
including: Salmonella spp., E. coli, in vitro mammalian cell gene
mutation assays, mammalian cell chromosome aberration assays, in vivo
mouse bone marrow micronucleus assays, and unscheduled DNA synthesis
assays.
12. A rat metabolism study with dermal application showed that
about 50% of the given radioactivity is absorbed 48 hours after a
single dose application. In other metabolism studies, it was shown that
over 80% of administered radioactivity is excreted within 24 to 48
hours as the parent compound in the feces and kidneys. Highest tissue
levels were found in liver, kidney and gonads.
A consistent pattern of neurotoxicity was seen in several studies,
including the subchronic, developmental and chronic studies in rats,
mice and dogs. In addition to the clinical signs such as hyperactivity,
aggressive behavior, piloerection, high startle response, retinal
atrophy was observed. Changes in glutamine synthetase levels were
observed in liver, kidney and brain in rats. These occurrences raise
concern for the mechanism of neurotoxicity in these studies, an area
where there are data gaps. It is expected that the requested
neurotoxicity studies will provide the information needed for further
characterization of these effects.
Additional testing was conducted with the major metabolites, HOE
061517 and HOE 099730, as well as the L-isomer, identified as HOE
058192. These compounds, tested in subchronic rat, mouse and dog
studies, and in developmental toxicity studies in rat and rabbit showed
a similar profile of toxicity as the parent compound (HOE 039866).

B. Toxicological Endpoints

1. Acute toxicity. An acute Reference dose (RfD) was not
established for the general population. No appropriate toxicological
endpoint attributable to a single exposure was identified in the
available toxicity studies. However, an acute RfD of 0.063 mg/kg/day
was established for the females 13+ subgroup, based on a developmental
NOAEL of 6.3 mg/kg/day in the rabbit and a 100x uncertainty factor (10x
inter- 10x intra-species extrapolation). The developmental LOAEL (20
mg/kg/day) was based on reduced fetal body weight and increased fetal
death. The FQPA safety factor of 10x was reduced to 3x because there
was no qualitative or quantitative indication of increased
susceptibility in the prenatal developmental toxicities in rats and
rabbits or in the 2-generation reproductive study in rats with parent
compound, the isomer or metabolites of concern. Toxicological studies
showed neurological effects in short term studies described as
aggressive behavior, piloerection and a high startle response at
dosages of 300 mg/kg/day. Based on these effects, EPA determined that a
3x FQPA safety factor was appropriate for the risk assessment for the
food and feed used of glufosinate ammonium. Using the 3x FQPA safety
factor, the acute population adjusted dose (aPAD) for glufosinate
ammonium is 0.021 mg/kg/day.
2. Short-, intermediate-, and long-term toxicity.--i. Dermal.
Short- and intermediate-term dermal toxicity risk assessments were
recommended based on neurological clinical signs (hyperactivity,
aggressive behavior, pilo erection) observed in the 21-day dermal study
at 300 mg/kg/day (LOAEL). The NOAEL was 100 mg/kg/day. A long-

[[Page 60115]]

term dermal risk assessment was recommended based on the NOAEL of 2.1
mg/kg/day established in the 2-year chronic study in rats (see chronic
dietary; 50% dermal absorption).
ii. Inhalation. With the exception of an acute inhalation study,
no other inhalation studies were available. Therefore, oral NOAELs were
selected for inhalation risk assessments. Because an oral dose was
used, the exposure assessments was conducted by converting the
application rate to oral equivalents and assuming 100% absorption.
Short-term inhalation risk assessments were recommended based on
the developmental NOAEL of 6.3 mg/kg/day in the rabbit (see acute
dietary endpoint). Intermediate-term inhalation risk assessments were
recommended based on the NOAEL of 2.1 mg/kg/day from the 2-year chronic
rat study (see chronic dietary endpoint below).
3. Chronic toxicity. EPA has established the RfD for glufosinate
ammonium at 0.021 mg/kg/day based on the NOAEL of 2.1 mg/kg/day in the
2-year chronic study in rats and a 100x uncertainty factor (10x inter-
10x intra-species extrapolation). The LOAEL in the study was based on
increased kidney weight and kidney/brain weight in males at 52 weeks
(6.8 mg/kg/day) and decreased survival in females at 130 weeks (8.2 mg/
kg/day). Using the 3x FQPA safety factor, the chronic population
adjusted dose (cPAD) for glufosinate ammonium is 0.007 mg/kg/day.
4. Carcinogenicity. Based on a lack of mutagenic potential as
assessed in a battery of mutagenicity assays and the absence of
treatment-related tumors in rats and mice at dose levels adequate for
assessment, the EPA has determined that glufosinate ammonium is not
likely a carcinogen; and has classified it as a ``Group E -- Evidence
of Non-Carcinogenicity for Humans'' chemical.

C. Exposures and Risks

1. From food and feed uses. Tolerances have been established (40
CFR 180.473 for the combined residues of glufosinate ammonium and its
metabolites, in or on a variety of raw agricultural commodities. All
tolerances listed under Unit III of this Rule except those for potatoes
at 0.8 ppm, potato chips at 1.6 ppm, potato granules/flakes at 2.0 ppm,
were previously established as time-limited tolerances with expiration
dates. This rule addresses a pending petition for these tolerances and
the establishment of the time-limited tolerances as permanent
tolerances for this pesticide. Risk assessments were conducted by EPA
to assess dietary exposures from tolerance levels of residue as
follows:
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of crop treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: that the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant sub-population group; and that if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F), EPA may require registrants
to submit data on PCT.
The Agency used PCT information as follows:
The chronic dietary exposure analysis assumed tolerance level
residues for all registered and proposed commodities. The weighted
average percent crop treated was incorporated for all registered
commodities. Sweet corn and proposed commodities were maintained at
100% crop treated.
The Agency believes that the three conditions listed above have
been met. The percent of crop treated estimates are derived from
Federal and private market survey data, which are reliable and have a
valid basis. EPA uses a weighted average percent crop treated for
chronic dietary exposure estimates. This weighted average percent crop
treated figure is derived by averaging state-level data for a period of
up to 10 years, and weighting for the more robust and recent data. A
weighted average of the percent crop treated reasonably represents a
person's dietary exposure over a lifetime, and is unlikely to
underestimate exposure to an individual because of the fact that
pesticide use patterns (both regionally and nationally) tend to change
continuously over time, such that an individual is unlikely to be
exposed to more than the average percent crop treated over a lifetime.
For acute dietary exposure estimates, EPA uses an estimated maximum
percent crop treated. The exposure estimates resulting from this
approach reasonably represent the highest levels to which an individual
could be exposed,and are unlikely to underestimate an individual's
acute dietary exposure. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
The regional consumption information and consumption information for
significant subpopulations is taken into account through EPA's
computer-based model for evaluating the exposure of significant
subpopulations including several regional groups. Use of this
consumption information in EPA's risk assessment process ensures that
EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which pesticide
glufosinate ammonium may be applied in a particular area.
i. Acute exposure and risk. The acute dietary exposure analysis for
females 13+ (no acute dietary endpoint was identified for the general
U.S. population including infants and children) assumed tolerance level
residues and 100% crop treated for all registered and proposed
commodities (Tier 1 analysis). The most highly exposed population was
females 13+/nursing at 58% of the aPAD (95th percentile). Acute dietary
food exposure to glufosinate ammonium is below EPA's level of concern.
ii. Chronic exposure and risk. The chronic dietary exposure
analysis assumed tolerance level residues for all registered and
proposed commodities. The weighted average percent crop treated was
incorporated for all registered commodities. Sweet corn and proposed
commodities were maintained at 100% crop treated. The most highly
exposed population was children 1-6 years old at 71% of the cPAD
(0.004974 mg/kg/day). Chronic dietary food exposure to glufosinate
ammonium is below EPA's level of concern.
2. From drinking water. Aggregate exposures are generally
calculated by summing dietary (food and water) and residential
exposures. If the aggregate exposure is less than the specified PAD,
the exposure is not expected to be a concern. Because EPA does not have
ground and surface water monitoring data to calculate a quantitative
aggregate exposure, a drinking water level of concentration (DWLOC) was
calculated. The DWLOC is the upper limit of a chemical's concentration
in drinking water that will result in an acceptable aggregate exposure.
The DWLOC is used as a point of comparison against model estimates of a
pesticide's concentration

[[Page 60116]]

in water. DWLOC values are not regulatory standards for drinking water.
They do have indirect regulatory impact through aggregate exposure and
risk assessments.
To calculate the acceptable acute and chronic exposure to
glufosinate ammonium in drinking water, the dietary food exposure
estimate was subtracted from the appropriate PAD (only short-term
residential exposure). A DWLOC was then calculated by using default
body weights and drinking water consumption figures (70kg/2L (adult
male), 60kg/2L (adult female) and 10kg/1L (infant/child)).
The estimated maximum and average concentration of glufosinate
ammonium in ground and surface water are less than EPA's DWLOC for
glufosinate ammonium as a contribution to acute and chronic aggregate
exposure (for all population subgroups).
i. Acute exposure and risk. The Agency's analysis based on the
information available is presented in the following table 1:

Table 1.-- Acute DWLOCs
----------------------------------------------------------------------------------------------------------------
Food Maximum
aPAD Exposure Water DWLOC\3\ SCI- PRZM-
Population Subgroup\1\ mg/kg/ mg/kg/ Exposure\2\ ppb GROW EXAMS
day day mg/kg/day ppb ppb
----------------------------------------------------------------------------------------------------------------
Females (13+, nursing).................................. 0.021 0.012131 0.008869 270 1.16 34.1
----------------------------------------------------------------------------------------------------------------
\1\ Highest exposed subgroup among females 13+
\2\ Maximum water exposure (mg/kg/day) = 0.021 mg/kg/day - acute food exposure (mg/kg/day)
\3\ DWLOC = [(maximum water exposure mg/kg/day)(body weight kg)/(water consumption liters)] * 1,000.

ii. Chronic exposure and risk. The Agency's analysis based on the
information available is presented in the following table.

Table 2.-- Chronic (non-cancer) DWLOC
----------------------------------------------------------------------------------------------------------------
Food Maximum
cPAD Exposure Water DWLOC\3\ SCI- PRZM-
Population Subgroup\1\ mg/kg/ mg/kg/ Exposure\2\ ppb GROW EXAMS
day day mg/kg/day ppb ppb
----------------------------------------------------------------------------------------------------------------
U.S. Population........................................... 0.007 0.002120 0.004880 170 1.16 0.79
Non-Hispanic blacks....................................... 0.007 0.002246 0.004754 170 1.16 0.79
Non-Hispanic/non-.white/non-black......................... 0.007 0.002256 0.004744 170 1.16 0.79
Non-Hispanic whites....................................... 0.007 0.002132 0.004868 170 1.16 0.79
Children 1-6 yrs.......................................... 0.007 0.004974 0.002026 20 1.16 0.79
Females 13+ nursing....................................... 0.007 0.002035 0.004965 150 1.16 0.79
Males 13-19 yrs........................................... 0.007 0.002449 0.004551 160 1.16 0.79
----------------------------------------------------------------------------------------------------------------
\1\ The subgroups listed above are the following: (1) U.S. Population, (2) the other general subgroups for which
the %cPAD is greater than that of the U.S. Population and (3) the most highly exposed population among infants
and children, females, and males.
\2\ Maximum water exposure (mg/kg/day) = (0.007 mg/kg/day - acute food exposure, (mg/kg/day)); no residential
exposure.
\3\ DWLOC = [(maximum water exposure mg/kg/day)(body weight kg)/(water consumption liters)]* 1,000.

3. From non-dietary exposure. Glufosinate ammonium is currently
registered for use on the following non-food sites: areas around
ornamentals, shade trees, Christmas trees, shrubs, walks, driveways,
flower beds, farmstead buildings, in shelter belts, and along fences.
It is also registered for use as a post-emergent herbicide on
farmsteads, areas associated with airports, commercial plants, storage
and lumber yards, highways, educational facilities, fence lines, ditch
banks, dry ditches, schools, parking lots, tank farms, pumping
stations, parks, utility rights-of -way, roadsides, railroads, and
other public areas and similar industrial and non-food crop areas. It
is also registered for lawn renovation uses.
In a pharmacokinetics study with dermal application in rats
radioactive glufosinate ammonium at levels of 0.1, 1.0, or 10.0 mg/rat
on 6 cm square of shaved skin and exposed for 0.5, 1, 2, 4, 10, 24, or
168 hrs. At the low dose (0.1 mg) 42.5 to 50.8% of the applied
radioactivity was absorbed whereas at the high dose (10.0 mg) 26% was
absorbed. After removal and washing of the treated skin a substantial
amount of the radioactivity still remained in the skin. and it was
gradually absorbed and eliminated. Radioactivity was found in both
fecies and urine samples, but the majority of glufosinate ammonium was
eliminated in the urine. In all organs/tissues examined, radioactivity
was found to reach a maximum level either at 4 or 10 hours after
exposure. Subsequently, the radioactivity dropped rapidly. The amount
of radioactivity found in the brain was minimal relative to that of
kidneys and liver. Based on this study, a 50% dermal absorption factor
was determined based on the range of 42.5% to 50.8% of radioactivity
absorbed at 0.10 mg/kg.
i. Acute exposure and risk. There are no acute non-dietary
exposure scenarios.
ii. Chronic exposure and risk. There are no chronic non-dietary
exposure scenarios.
iii. Short- and intermediate-term exposure and risk. It is not
appropriate to aggregate short- and intermediate-term non-dietary
exposure with dietary exposures in this risk assessment because the
end-points are different.
iv. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether

[[Page 60117]]

glufosinate ammonium has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
glufosinate ammonium does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that glufosinate ammonium has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62
FR 62961, November 26, 1997).

D. Aggregate Risks and Determination of Safety for U.S. Population

1. Acute risk. The acute dietary exposure analysis assumed
tolerance level residues and 100% crop treated for all commodities
derived from glufosinate ammonium treated crops. For the most highly
exposed subgroup among females 13+ (nursing females), 58% of the aPAD
is occupied by dietary (food) exposure, an acute RfD was not
established for the general population including infants and children.
The estimated glufosinate ammonium concentration in surface and ground
water are less than EPA's DWLOC (for all population subgroups). Acute
aggregate exposure to glufosinate ammonium and related metabolites, as
a result of all registered and proposed uses, is below EPA's level of
concern.
2. Chronic risk. There are no chronic non-dietary exposure
scenarios. Therefore, only food and water are included in the chronic
aggregate risk. The chronic dietary exposure analysis assumed tolerance
level residues for all commodities derived from the crop use of
glufosinate ammonium and incorporated the weighted average percent crop
treated for all commodities derived from glufosinate ammonium treated
crops, except for sweet corn, registered under section 18 of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended.
For the most highly exposed subgroup (children, 1-6 years), 71% of the
cPAD is occupied by dietary (food) exposure. The estimated glufosinate
ammonium concentrations in surface and ground water are less than EPA's
DWLOC for all population subgroups. Chronic aggregate exposure to
glufosinate ammonium as a result of all registered and proposed uses is
below EPA's level of concern. EPA generally has no concern for
exposures below 100% of the cPAD because the cPAD represents the level
at or below which daily aggregate dietary exposure over a life time
will not pose appreciable risks to human health. Despite the potential
for chronic exposure to glufosinate ammonium in drinking water, after
calculating a DWLOC (236 parts per billion (ppb)) for the U.S.
population and comparing it to conservative model estimates of
concentrations of glufosinate ammonium surface and ground water (59.43
ppb and 1.16 ppb, respectively), EPA does not expect the aggregate
exposure to exceed 100% of the cPAD.
3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(consider to be a background exposure level) plus indoor and outdoor
residential exposure. There are registered residential uses for
glufosinate ammonium. The potential dermal exposures were not
aggregated because the toxic effects for short- and intermediate-term
exposure (neurological clinical signs) and chronic exposure (increases
in absolute and relative kidney weights) are different.
4. Aggregate cancer risk for U.S. population. There is no cancer
concern based on negative results observed in three guideline studies
available for the carcinogenicity screen: a chronic feeding study in
rats, a carcinogenicity study in rats and a carcinogenicity study in
mice, each described under the ``Toxicology Profile'' of this Rule.
Glufosinate ammonium has been classified as a ``not likely'' carcinogen
according to the EPA Proposed Guidelines for Carcinogn Risk Assessment.
Therefore, a cancer risk assessment was not necessary.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to glufosinate ammonium residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of glufosinate ammonium, EPA considered data from
developmental toxicity studies in the rat and rabbit and a 2-generation
reproduction study in the rat. The developmental toxicity studies are
designed to evaluate adverse effects on the developing organism
resulting from maternal pesticide exposure during gestation.
Reproduction studies provide information relating to effects from
exposure to the pesticide on the reproductive capability of mating
animals, and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the data base unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard uncertainty factor (usually 100 for combined inter-
and intra-species variability) and not the additional tenfold MOE/
uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.
ii. Developmental toxicity studies. Two studies were described in
the Toxicology Profile section (See Unit III.A.8. and 9. of this
Rule.).
iii. Reproductive toxicity study. A reproductive toxicity study was
described in the Toxicology Profile (See Unit III.A.10. of this Rule.).
iv. Pre- and post-natal sensitivity. The toxicological data base
for evaluating prenatal and postnatal toxicity for glufosinate ammonium
is complete with respect to current data requirements. There are no
prenatal or postnatal susceptibility concerns for infants and children,
based on the results of the rat and rabbit developmental toxicity
studies and the 2-generation reproduction study.
v. Other studies. Based on clinical signs of neurological toxicity
in short and intermediate dermal toxicity studies with rats, EPA has
determined that an added FQPA safety factor of 3x is appropriate for
the risk assessment for the tolerances in the commodities listed in
this Final Rule. The FQPA safety factor of 10x was reduced to 3x
because there were no qualitative or quantitative indications of
increased susceptibility in the prenatal developmental toxicities in
rats and rabbits, or in the 2-generation reproductive studies in rats
with the parent compound, the isomer or metabolites of concern.
vi. Conclusion. There is a complete toxicity database for
glufosinate

[[Page 60118]]

ammonium, and exposure data is complete or is estimated based on data
that reasonably accounts for potential exposures.
2. Acute risk. The acute dietary exposure analysis assumed
tolerance level residues and 100% crop treated for all registered and
proposed commodities. For the most highly exposed subgroup among
females 13 - 50 (nursing females), 58% of the aPAD is occupied by
dietary (food) exposure (no acute RfD was established for the general
population including infants and children). The estimated glufosinate
ammonium concentration in surface and ground water are less than EPA's
DWLOC (for all population subgroups). Acute aggregate exposure to
glufosinate ammonium and related metabolites, as a result of all
registered and proposed uses, is below EPA's level of concern.
3. Chronic risk. Based on exposure assumptions described above, EPA
has concluded that aggregate exposure to glufosinate ammonium from food
will utilize 71% of the cPAD for children 1-6 years of age, the most
highly exposed subgroup. EPA generally has no concern for exposures
below 100% of the cPAD because the cPAD represents the level at or
below which daily aggregate dietary exposure over a lifetime will not
pose appreciable risks to human health. Despite the potential for
chronic exposure to glufosinate ammonium in drinking water, after
calculating a DWLOC (64 ppb) for non-nursing infants and comparing it
to conservative model estimates of concentrations of glufosinate
ammonium in surface and ground water (59.43 ppb and 11.16 ppb,
respectively), EPA does not expect the aggregate exposure to exceed
100% of the cPAD.
4. Short- or intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account chronic dietary food and water
(considered to be a background exposure level) plus indoor and outdoor
residential uses. There are registered residential uses for glufosinate
ammonium, however, the potential dermal exposures were not aggregated
because the toxic effects for short- and intermediate-term exposure
(neurological clinical signs) and chronic exposure (increases in
absolute and relative kidney weights) are different.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to residues of
glufosinate ammonium residues.

IV. Other Considerations

A. Metabolism in Plants and Animals

1. Plants. The nature of the residues of glufosinate ammonium is
considered to be understood. The Agency has concluded that the residues
of concern are glufosinate ammonium and its metabolites 2-acetamido-4-
methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid
expressed as glufosinate ammonium free acid equivalents.
2. Animals A rat metabolism study with dermal application indicated
that about 50% of the given radioactivity was absorbed 48 hours after a
single dose application. In other metabolism studies, it was shown that
over 80% of administered radioactivity is excreted within 24 to 48
hours as the parent compound in the feces and kidneys. Highest tissue
levels were found in liver, kidney and gonads. The nature of
glufosinate ammonium residues in lactating goats and hens is considered
to be understood. Glufosinate ammonium and its metabolite (3-
methylphosphinico propionic acid) are largely excreted and do not
accumulate too any great degree in animal tissues. The only
identifiable compounds in feces, urine, milk, eggs and tissues were the
parent and 3-methylphosphinico propionic acid. EPA has concluded that
the residues of concern in commodities derived from ruminants and
poultry are glufosinate ammonium and its metabolite 3-methylphospinico
propionic acid, expressed as glufosinate ammonium free acid
equivalents.

B. Analytical Enforcement Methodology

In Pesticide Analytical Manual II (PAM II), method HRAV-5A
describes an adequate analytical method for determining residues of
glufosinate ammonium and its metabolite 3-methylphosphinico propionic
acid in or on apples, bananas, grape, potatoes and tree nuts. In PAM
II, method HRAV-12, is an adequate method for determining residues of
glufosinate ammonium and its metabolite 3-methylphosphinico-propionic
acid in or on milk, eggs and tissues of ruminants and poultry. Method
XAM-24A, which is a modification of method HRAV-5A is an adequate
method for determining residues of glufosinate ammonium and its
metabolites in or on transgenic field corn, and transgenic soybeans.
The method describes an additional post-extraction cation exchange
procedure to allow for separate detection and measurement of each
residue component. Final determination is made by gas chromatography
with flame photometric detection operating in the phosphorus selective
mode (p-mode). Residues are expressed as glufosinate ammonium free acid
equivalents.
Adequate enforcement methodology (gas chromatography with mass
spectrophotometry) is available to enforce the tolerances for
commodities derived from potatoes. The method may be requested from:
Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

C. Magnitude of Residues

The residues established by this regulation are qualified and
quantified in Unit V of this Rule.

D. International Residue Limits

The Codex Alimentarius Commission has established maximum residue
limits (CODEX MRLs) for the combined residues of glufosinate ammonium
and 3-methylphosphinico propionic acid, expressed as glufosinate free
acid equivalents, in or on potatoes at 0.5 ppm. Because the appropriate
U.S. tolerance for potatoes (0.8 ppm) is greater than the CODEX MRL of
0.5 ppm and CODEX MRLs for residues in or on potato chips and potato
granules and flakes do not exist, harmonization is not possible. The
Codex Alimentarius Commission did not establish MRLs for glufosinate
ammonium in processed potato commodities because earlier processing
studies in cooked potatoes did not show any concentration of residues
after cooking in water. The difference in residues represented by the
CODEX MRL of 0.5 ppm and the 0.8 ppm tolerance for residues in or on
potatoes established by this Rule was apparently due to differences in
the methods used by the two Agencies in determining the level of
residues that would be appropriate. The EPA sets tolerances based on
the residue level from the highest average field trial where as the
CODEX and European authorities use statistical calculations derived
from all residue data covering one worst case label for the calculation
of MRL proposals.

E. Rotational Crop Restrictions

A 120 day plant-back interval is required for all crops with the
exceptions of buckwheat, barley, millet oats, rye, sorghum, triticale
and wheat that requires a 70-day plant-back interval. Field corn and
soybeans may be planted back any time.

[[Page 60119]]

V. Conclusion

Therefore, permanent tolerances are established for combined
residues of glufosinate ammonium and its metabolite(s) in or on almond
hulls at 0.50 ppm, apples at 0.05 ppm, bananas at 0.3 (not more than
0.2 ppm shall be present in the pulp after peel is removed), cattle,
fat and meat at 0.05 ppm; cattle, meat by-products at 0.10 ppm; eggs at
0.05 ppm; goats, fat and meat at 0.05 ppm; goats, meat-by-products at
0.10 ppm; grapes at 0.05 ppm; hogs, fat and meat at 0.05 ppm; hogs,
meat-by-products at 0.10 ppm; horses, fat and meat at 0.05 ppm; horses,
meat-by-products at 0.10 ppm; milk at 0.02 ppm; potatoes at 0.8 ppm;
potato chips at 1.6 ppm; potato granule/flakes at 2.0 ppm; poultry, fat
and meat at 0.05 ppm; poultry, meat-by-products at 0.10 ppm; sheep, fat
and meat at 0.05 ppm; sheep, meat-by-products at 0.10 pm; transgenic
aspirated grain fractions at 25.0 ppm; transgenic corn, field, forage
at 4.0 ppm; transgenic corn, field, grain at 0.2 ppm; transgenic corn,
field, stover at 6.0 ppm; transgenic soybeans, hulls at 5.0 ppm;
transgenic soybeans at 2.0 ppm and tree nuts group at 0.1 ppm.
The time-limited tolerances for residues in transgenic canola and
transgenic sweet corn commodities under Section 18 emergency exemptions
(64 FR 44829-44836, August 18, l999)) are not replaced, These time-
limited tolerances will expire December 1, l999.

VI. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-300945 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before January
3, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(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).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information 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.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
You may also deliver your request to the Office of the Hearing Clerk in
Room M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission be labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ''when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' (cite). For
additional information regarding the waiver of these fees, you may
contact James Tompkins by phone at (703) 305-5697, by e-mail at
tompkins.jim@epa.gov, or by mailing a request for information to Mr.
Tompkins at Registration Division (7505C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A. of
this preamble, you should also send a copy of your request to the PIRB
for its inclusion in the official record that is described in Unit
I.B.2. of this preamble. Mail your copies, identified by docket number
OPP-300945, to: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person or by courier, bring a copy to the
location of the PRIB described in Unit I.B.2. of this preamble. You may
also send an electronic copy of your request via e-mail to: opp-
docket@epa.gov. Please use an ASCII file format and avoid 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 5.1/6.1 file format or ASCII file format. Do not include
any CBI in your electronic copy. You may also submit an electronic copy
of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

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 issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VII. Regulatory Assessment Requirements

This final rule establishes tolerances under section 408(d) of the
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735,

[[Page 60120]]

October 4, 1993). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require prior consultation with State, local, and tribal
government officials as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993) and Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), or special
consideration of environmental justice related issues under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994) or require OMB review in accordance with Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, l997). The Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 12612,
entitled Federalism (52 FR 41685, October 30, l987). This action
directly regulates growers, food processors, food handlers and food
retailers, not States. This action does not alter the relationships or
distribution of power and responsibilities established by Congress in
the preemption provisions of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 346a(b)(4). This action does not involve any technical
standards that would require Agency consideration of voluntary
consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law
104-113, section 12(d) (15 U.S.C. 272 note). In addition, since
tolerances and exemptions that are established on the basis of a
petition under FFDCA section 408(d), such as the tolerances in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.

VIII. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by
the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule and other required information to the U.S. Senate, the U.S. House
of Representatives, and the Comptroller General of the United States
prior to publication of this rule in the Federal Register. This rule
is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements

Dated: October 26, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 321(q), (346a), and 371.

2. By revising Sec. 180.473 to read as follows:

Sec. 180. 473 Glufosinate ammonium; tolerances for residues.

(a) General. (1) Tolerances are established for residues of the
herbicide glufosinate ammonium (butonoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxmethylphosphinyl) butanoic acid equivalents, in or on the
following food commodities:

------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
Almond hulls................................................... 0.50
Apples......................................................... 0.05
Bananas........................................................ 0.30
Bananas, pulp.................................................. 0.20
Cattle, fat.................................................... 0.05
Cattle, meat................................................... 0.05
Cattle, mbyp................................................... 0.10
Eggs........................................................... 0.05
Goats, fat..................................................... 0.05
Goats, meat.................................................... 0.05
Goats, mbyp.................................................... 0.10
Grapes......................................................... 0.05
Hogs, fat...................................................... 0.05
Hogs, meat..................................................... 0.05
Hogs, mbyp..................................................... 0.10
Horses, fat.................................................... 0.05
Horses, meat................................................... 0.05
Horses, mbyp................................................... 0.10
Milk........................................................... 0.02
Potatoes....................................................... 0.80
Potato chips................................................... 1.60
Potato granules and flakes..................................... 2.00
Poultry, fat................................................... 0.05
Poultry, meat.................................................. 0.05
Poultry, mbyp.................................................. 0.10
Sheep, fat..................................................... 0.05
Sheep, meat.................................................... 0.05
Sheep, mbyp.................................................... 0.10
Tree nuts group................................................ 0.10
------------------------------------------------------------------------

(2) Tolerances are established for the combined residues of
glufosinate ammonium (butanoic acid, 2-ammino-4-
(hydroxymethylphosphinyl)- monoammonium salt) and its metabolites, 2-
acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)
butanoic acid equivalents, in or on the following raw agricultural
commodities derived from transgenic field corn and transgenic soybeans
and that are tolerant to the herbicide glufosinate ammonium as follows:

------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Aspirated Grain Fractions.................................. 25.0
Corn, field, forage........................................ 4.0
Corn, field, grain......................................... 0.2
Corn, field, stover........................................ 6.0
Soybean hulls.............................................. 5.0
Soybeans................................................... 2.0
------------------------------------------------------------------------

(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of the herbicide (butanoic acid, 2-
amino-4-(hydroxymethylphosphinyl) -monoamonium salt and its metabolites
, 2-acetamido-4-methylphosphinico-butamoic acid and 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents in or on the
following raw agricultural commodities derived from transgenic canola
and transgenic sweet corn in connection with use of section 18
emergency exemptions granted by EPA. The tolerances will expire and are
revoked on the date specified in the following table:

[[Page 60121]]

------------------------------------------------------------------------
Parts Expiration/
Commodity per Revocation
million Date
------------------------------------------------------------------------
Canola meal.................................... 1.1 12/1/99
Canola Seed.................................... 0.4 12/1/99
Corn, sweet, forage............................ 4.0 12/1/99
Corn, sweet, kernels and cobs with husks 4.0 12/1/99
removed.......................................
Corn, sweet, stover............................ 6.0 12/1/99
------------------------------------------------------------------------

[FR Doc. 99-28887 Filed 11-3-99; 8:45 am]
BILLING CODE 6560-50-F

Glufosinate Ammonium; Pesticide Tolerance

Local Navigation