[Federal Register Volume 64, Number 213 (Thursday, November 4, 1999)]
[Rules and Regulations]
[Pages 60112-60121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28887]


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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.

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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: 
[email protected].

 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 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: 
[email protected].

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 
[email protected], 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-
[email protected]. 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
------------------------------------------------------------------------

    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

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