[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Rules and Regulations]
[Pages 17170-17179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8000]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300986; FRL-6498-1]

2070-AB78


Glufosinate Ammonium; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

[[Page 17171]]


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 metabolites (3-
methylphosphinico-propionic acid and 2-acetamido-4-methylphosphinico-
butanoic acid), expressed as 2-amino-4-(hydroxymethylphosphinyl) 
butanoic acid equivalents in or on transgenic canola meal and seed and 
trangenic sugar beet molasses, roots and tops. AgrEvo USA Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996. Revoked/
expired tolerances under Sec. 180.473 (b) are deleted from the 
regulation.

DATES: This regulation is effective March 31, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300986, 
must be received by EPA on or before May 30, 2000.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 305-6224 and 
e-mail address: miller. [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
           Categories                    NAICS            potentially
                                                       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 under FOR FURTHER INFORMATION 
CONTACT.

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-300986. 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, 1997, (62 FR 52544) (FRL- 
5746-9) and July 14, 1999 (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 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 metabolites 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.
    This list included transgenic beet, sugar, tops (leaves) at 1.5 
ppm; transgenic beet, sugar, root at 0.9 ppm; transgenic beet, sugar, 
molasses at 5.0 ppm; transgenic canola meal at 1.1 ppm and transgenic 
canola seed at 0.4 ppm. Tolerances were established for the former list 
of commodities on November 4, 1999 (64 FR 60112-60121). As EPA was not 
able to validate the analytical method submitted in support of 
tolerances for the commodities derived from transgenic canola and 
transgenic sugar beets, tolerances were not established at that time. 
AgrEvo USA Company revised the analytical method for determining 
residues in these commodities and the EPA has been able to validate the 
revised method and found it adequate for determining residues in these 
commodities. The level of the residues were also found appropriate.
    The tolerances for canola and sugar beet commodities are listed 
under Sec. 180.473(b) as commodities derived from transgenic canola and 
transgenic sugar beets and with commodities derived from transgenic 
corn and trangenic soybeans because the registered use-sites are for 
tolerant (transgenic) canola and tolerant (transgenic) sugar beets; and 
the metabolite residue 2-acetamido-4-methylphosphinico-butanoic acid is 
common to these tolerant (transgenic) crop plants cultured with the 
used of

[[Page 17172]]

glufosinate ammonium as a post-emergent herbicide.
    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 transgenic canola 
meal at 1.1 ppm, tansgenic canola seed at 0.4 ppm transgenic beet, 
sugar, tops (leaves) at 1.5 ppm; transgenic beet, sugar, root at 0.9 
ppm; transgenic beet, sugar, molasses at 5.0 ppm. 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 glufosinate 
ammonium 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% 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 mg/
kg/day) for 13 weeks. Significant (p0.05) 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-observe-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 2 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/day in females. The NOAEL for systemic 
toxicity is 80 ppm (10.82/16.19 mg/kg/day in 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 HOE 039866 (glufosinate ammonium, 96.9 
a.i.) by gavage at doses of 0, 0.5, 2.24 10, 50 and 250 mg/kg/day from 
days 7 to 16 of

[[Page 17173]]

pregnancy. The no-observed-adverse effect level (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 HOE 039866 by gavage 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 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 two 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, piloerection) observed in the 21- day dermal study at 300 mg/
kg/day (LOAEL). The NOAEL was 100 mg/kg/day. A long-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 preamble, except those for 
canola meal at 1.1 ppm, canola seed at 0.4 ppm, sugar beet, molasses at 
5.0 ppm; sugar beet, roots at 0.9 ppm and sugar beet tops (leaves) at 
1.5 ppm, were established as permanent tolerances on November 4, 1999 
(64 FR 60112-61121). This rule addresses the pending petition for 
establishing permanent tolerances in these commodities. 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

[[Page 17174]]

Agency can make the following findings: Condition 1, 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, Condition 2, that the exposure estimate does not underestimate 
exposure for any significant sub-population group and Condition 3. 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. With respect to (Condition 1), 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. As to Condition 2 and Condition 3, 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 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 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 (70 kg/2L (adult 
male), 60 kg/2L (adult female) and 10 kg/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      ppb    GROW  EXAMS
                                                              day      day     \2\ mg/kg/             ppb   ppb
----------------------------------------------------------------------------------day---------------------------
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


[[Page 17175]]

    ii. Chronic exposure and risk. The Agency's analysis based on the 
information available is presented in the following table 2:

                                      Table 2.--Chronic (non-cancer) DWLOC
----------------------------------------------------------------------------------------------------------------
                                                                      Food      Maximum
                                                              cPAD  Exposure     Water       DWLOC   SCI-  PRZM-
                  Population Subgroup \1\                    mg/kg/  mg/kg/     Exposure    \3\ ppb  GROW  EXAMS
                                                              day      day     \2\ mg/kg/             ppb   ppb
----------------------------------------------------------------------------------day---------------------------
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) US Population, (2) the other general subgroups for which
  the %cPAD is greater than that of the US 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 was used 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 feces 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 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

[[Page 17176]]

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 ppb) for the 
U.S. population and comparing it to conservative model estimates of 
concentrations of glufosinate ammonium in 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 
(considered 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'', Unit III.A. of 
this preamble. 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, Unit III.A.8. and 9. of this preamble.
    iii. Reproductive toxicity study. A reproductive toxicity study was 
described in the Toxicology Profile, Unit III.A.10. of this preamble.
    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 two-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 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 
blow 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.

[[Page 17177]]

F. 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.

G. 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 
BK/01/99 is an adequate method for determining residues of glufosinate 
ammonium and its metabolites in or on commodities derived from 
transgenic canola, transgenic field corn, transgenic soybeans and 
transgenic sugar beets. This method detects and measures total residues 
of parent and metabolites and allows detection and measurement of 
parent compound residues separately from residues of the metabolites. 
Final determination is made by gas chromatography with flame 
photometric detection (GC/FPD) 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 transgenic canola and transgenic sugar beets. 
These methods 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].

H. Magnitude of Residues

    The residues established by this regulation are qualified and 
quantified in Unit IV. of this preamble.

I. International Residue Limits

    The Codex Alimentarius Commission has established maximum residue 
limits (CODEX MRLs) for the combined residues of glufosinate ammonium 
and metabolites 3-methylphosphinico-propionic acid and, when used in 
culture of genetically modified glufosinate ammonium tolerant crops, N-
acetyl glufosinate (2-acetamido-4-methylphosphinico-butanoic acid) 
expressed as glufosinate free acid equivalents. A CODEX MRL is 
established in or on rape seed (canola seed) at 5 ppm. Canada has 
established a maximum residue limit (MRL) for the combined residues of 
glufosinate ammonium and 3-methylphosphinico-propionic acid in/on 
canola seed at 3.0 ppm. Because the CODEX and Canadian MRLs for canola 
seed are significantly greater than the appropriate U.S. tolerance for 
canola seed established by this Final Rule, and because there are no 
MRLs for canola meal harmonization is not possible. CODEX MRLs are 
established in or on sugar beets at 0.05 ppm and sugar beet leaves or 
tops at 0.1 ppm. There is no CODEX MRL for sugar beet molasses and 
there are no Canadian MRLs for sugar beet commodities. Because the 
appropriate tolerances for sugar beet roots and tops (leaves) 
established by this Final Rule are greater than the CODEX MRLs and 
there is no CODEX MRL for molasses, harmonization is also not possible. 
As this Rule establishes tolerances for transgenic canola and 
transgenic sugar beet commodities and includes the metabolite 2-
acetamido-4-methylphosphinico-butanoic acid expressed as 2-amino-4-
(hydroxymethylphosphinyl) butanoic acid equivalents, harmonization is 
also not possible. These differences in residues are due to differences 
in the use-patterns represented in the data bases used in establishing 
these different levels of residues found in the raw agricultural 
commodities derived from transgenic canola and transgenic sugar beets, 
cultured with the use of glufosinate ammonium as a herbicide for weed 
control.

IV. Conclusion

    Therefore, permanent tolerances are established for combined 
residues of glufosinate ammonium and its metabolites in or on 
transgenic canola meal at 1.1 ppm, transgenic canola seed at 0.4 ppm, 
transgenic sugar beet tops (leaves) at 1.5 ppm, transgenic sugar beet 
root at 0.9 ppm and transgenic sugar beet molasses at 5.0 ppm.

V. 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-300986 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 May 30, 
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

[[Page 17178]]

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, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. You may also deliver your request to 
the Office of the Hearing Clerk in Rm. C400, 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 by 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.'' 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
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, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., 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 V.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300986, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to: [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 6.1/8.0 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).

VI. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
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, 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 any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); special considerations as 
required by 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 or 
any Agency action under Executive Order 13045, entitled Protection of 
Children from Environmental Health Risks and Safety Risks (62 FR 19885, 
April 23, 1997). 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). Since tolerances and exemptions that are 
established on the basis of a petition under FFDCA section 408(d), such 
as the tolerance 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. In addition, 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 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the 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.'' This final 
rule 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 FFDCA section 408(n)(4).

VII. 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

[[Page 17179]]

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 final rule in the Federal Register. This final 
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: March 17, 2000
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. In Sec. 180.473 by revising paragraph (a)(2) and by removing and 
reserving paragraph (b) to read as follows:


Sec. 180.473  Glufosinate ammonium; tolerances for residues.

    (a) * * *
    (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 food commodities 
derived from transgenic canola, transgenic field corn, transgenic 
soybeans and transgenic sugar beets that are tolerant to the herbicide 
glufosinate ammonium as follows:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Aspirated grain fractions..................................         25.0
Canola meal................................................          1.1
Canola seed................................................          0.4
Corn, field, forage........................................          4.0
Corn, field, grain.........................................          0.2
Corn, field, stover........................................          6.0
Soybean hulls..............................................          5.0
Soybeans...................................................          2.0
Sugar beet, molasses.......................................          5.0
Sugar beet, roots..........................................          0.9
Sugar beet, tops (leaves)..................................          1.5
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    *    *    *    *    *
[FR Doc. 00-8000 Filed 3-30-00; 8:45 am]
BILLING CODE 6560-50-F