[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Notices]
[Pages 58684-58688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29576]


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ENVIRONMENTAL PROTECTION AGENCY
[PF-671; FRL-5572-7]


Pesticide Tolerance Petition: Notice of Filing

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice is a summary of a pesticide petition proposing the 
establishment of a regulation for residues of glufosinate-ammonium in 
or on corn and soybeans. This summary was prepared by the petitioner.

DATES: Comments, identified by the docket number [PF-671], must be 
received on or before December 18, 1996.

ADDRESSES: By mail, submit written comments to: Public Response and 
Program Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW, 
Washington, DC 20460. In person, bring comments to: Rm. 1132 CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect 5.1 file format or ASCII file format. 
All comments and data in electronic form must be identified by the 
docket number [PF-671]. Electronic comments on this notice may be filed 
online at many Federal Depository Libraries. Additional information on 
electronic submissions can be found below in this document.
    Information submitted as comments concerning this notice may be 
claimed confidential by marking any part or all of that information as 
``Confidential Business Information'' (CBI). CBI should not be 
submitted through e-mail. Information marked as CBI will not be 
disclosed except in accordance with procedures set forth in 40 CFR part 
2. A copy of the comment 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. All written 
comments will be available for public inspection in Rm. 1132 at the 
address given above, from 8 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller, Product 
Manager (PM) 23, Registration Division (7505C), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location and telephone number: Rm. 237, CM #2, 1921 Jefferson Davis 
Hwy., Arlington, VA 22202, (703)-305-6224; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition (PP) 
5F4578 pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, as amended, 21 U.S.C. Section 346a(d), by the Food 
Quality Protection Act of 1996 (Pub. L. 104-170, 110 Stat. 1489) from 
AgrEvo USA Company (AgrEvo), Little Falls Centre One, 2711 Centerville 
Rd., Wilmington, DE 19808 proposing to amend 40 CFR 180.473 by 
establishing tolerances for residues of the herbicide, glufosinate-
ammonium: butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, 
monoammonium salt and its metabolites: 2-acetamido-4-methylphosphinico-
butanoic acid and 3-methylphosphinico-propionic acid expressed as 
glufosinate free acid equivalents. The new tolerances would be for 
residues of the herbicide in or on the following raw agricultural 
commodities: field corn grain, at 0.2 parts per million (ppm); field 
corn forage, at 4.0 ppm, field corn fodder, at 6.0 ppm, soybeans, at 
2.0 ppm, soybean hulls, at 5.0 ppm, aspirated grain fractions, at 25.0 
ppm, eggs, at 0.05 ppm, poultry, meat at 0.05 ppm, poultry, fat at 0.05 
ppm, and poultry, mbyp (meat byproducts) at 0.10 ppm. The proposed 
analytical method for determining residues is gas chromatography.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
AgrEvo has submitted the following summary of information, data and 
arguments in support of its pesticide petition. This summary was 
proposed by AgrEvo and EPA has not yet fully evaluated the merits of 
the petition. The conclusions and arguments presented are those of the 
petitioner and not of the EPA although the EPA has edited the summary 
for clarification as necessary. Glufosinate-ammonium is a non-selective 
herbicide which will be used for post-emergence weed control in corn 
and soybeans which have been genetically modified to be resistant to 
the herbicide.

I. AgrEvo Petition Summary:

A. Plant Metabolism and Analytical Method

    1. Plant Metabolism: The metabolism of glufosinate-ammonium in 
plants is adequately understood for the purposes of these tolerances. 
The crop residue profile following selective use of glufosinate-
ammonium on transgenic crops is different than that found in 
conventional crops. The only crop residue found after non-selective use 
is the metabolite 3-methylphosphinico-propionic acid, which is found in 
only trace amounts. With the exception of corn grain, the principal 
residue identified in the metabolism studies after selective use of 
glufosinate-ammonium was 2-acetamido-4-methylphosphinico-butanoic acid, 
with lesser amounts of glufosinate and 3-methylphosphinico-propionic 
acid. In corn grain, which exhibited much lower total radiolabelled 
residues than the other commodities, the principal residue identified 
was 3-methylphosphinico-propionic acid, with lesser amounts of 2-
acetamido-4-methylphosphinico-butanoic acid.
    2. Analytical Method: There is a practical analytical method 
utilizing gas chromatography for detecting and measuring levels of 
glufosinate-ammonium and its metabolites in or on food with a general 
limit of quantification of 0.05 ppm that allows monitoring of food with 
residues at or above the levels proposed in these tolerances. This 
method has been validated by an independent laboratory and the 
petitioner has been advised that the EPA concluded its own successful 
method try out.

B. Magnitude of the Residue

    1. Magnitude of the Residue in Plants: Field residue trials with 
glufosinate-ammonium resistant corn and soybean have been conducted in 
1993 and 1994 at several different use rates and timing intervals to 
represent the use patterns which would most likely result in the 
highest residue. In these trials, the primary residue in all samples 
was 2-acetamido-4-methylphosphinico-butanoic acid, which was found at 
levels at least 2-7 times that of glufosinate or 3-methylphosphinico-
propionic acid. In field corn grain, only 15 out of 301 samples 
analyzed exhibited residues  0.05 ppm (the limit of 
quantification). The tolerance value has been proposed at 0.2 ppm. In 
soybean seed, the total mean glufosinate-ammonium derived residues 
range from 0.32 ppm to 1.89 ppm (mean = 0.92 ppm) and the tolerance has 
been proposed at 2 ppm. For both corn and

[[Page 58685]]

soybean, the tolerances levels have been proposed assuming the 
following: (1) a maximum of two applications of glufosinate-ammonium to 
each crop per season, (2) a seasonal maximum rate of 0.8 pound of 
active ingredient per acre for each crop, (3) the last application made 
to corn no later than the 24 inch stage of growth and (4) the final 
soybean application made no later than early bloom.
    2. Magnitude of the Residue in Processed Commodities:Studies have 
been conducted to determine the level of glufosinate derived residues 
found in or on the processed commodities from glufosinate resistant 
corn and soybean grain. The studies utilized treatments at 
significantly exaggerated rates to provide the necessary test 
sensitivity. No concentration of glufosinate derived residue was found 
in field corn processed commodities which are relevant food or feed 
items, i.e., flour, starch, grits, meal or oil. No processed food 
tolerance is indicated for the use of glufosinate-ammonium on 
glufosinate-ammonium resistant corn.
    In the soybean processing studies, no residues of parent or 
metabolites were found in the crude or refined soybean oil. Measurable 
levels of residue were found in the soybean hulls and in the meal. Only 
the soybean hulls are to be considered a relevant animal feed item and 
a tolerance of 5 ppm for soybean hulls has been proposed.
    3. Magnitude of the Residue in Animals: Ruminant and poultry 
feeding studies were conducted to determine the magnitude of 
glufosinate-derived residues in the tissues and milk of cows and the 
tissues and eggs of chicken hens which were dosed for 28 consecutive 
days with a mixture of parent (glufosinate-ammonium) and metabolite (2-
acetamido-4-methylphosphinico-butanoic acid) in a ratio which 
represents the terminal residue in animal feed. No residues were 
detected in meat, milk or eggs at the dose calculated to represent the 
highest residue legally allowed in livestock feed.
    As a consequence of the ruminant and poultry feeding studies, no 
secondary tolerances in animal commodities above the limit of 
quantification are necessitated as a result of the proposed use of 
glufosinate-ammonium on transgenic corn and soybean.

C. Toxicological Profile of Glufosinate-Ammonium

    1. Acute Toxicity: The acute oral LD50 values for glufosinate-
ammonium technical ranged from 1510 to 2000 mg/kg in rats and from 200 
to 464 mg/kg in mice and dogs. The acute dermal LD50 was 2000 mg/kg in 
rabbits and was 4000 mg/kg in rats. The 4-hour rat inhalation LC50 was 
1.26 mg/L in males and 2.6 mg/L in females. Glufosinate-ammonium was 
not irritating to rabbit skin but was slightly irritating to the eyes. 
Glufosinate-ammonium did not cause skin sensitization in guinea pigs. 
Glufosinate-ammonium should be classified as Tox Category II for oral 
toxicity, Tox Category III for inhalation and dermal toxicity and Tox 
Category IV for skin irritation and eye irritation.
    2. Genotoxicity: No evidence of genotoxicity was noted in an 
extensive battery of in vitro and in vivo studies. The petitioner has 
been advised by the EPA that negative studies determined acceptable 
included Salmonella, E. coli and mouse lymphoma gene mutation assays, a 
mouse micronucleus assay, and an in vitro UDS assay.
    3. Reproductive And Developmental Toxicity: Three developmental 
toxicity studies were conducted with rats, at dose levels ranging from 
0.5 to 250 mg/kg/day. The no observable effect levels (NOELs) for 
maternal and developmental effects were determined to be 10 mg/kg/day 
for maternal toxicity and 50 mg/kg/day for developmental toxicity, 
based on the findings of hyperactivity and vaginal bleeding in dams at 
50 mg/kg/day and increased incidence of arrested renal and ureter 
development in fetuses at 250 mg/kg/day.
    A developmental toxicity study was conducted in rabbits at dose 
levels of 0, 2, 6.3 and 20 mg/kg/day. The maternal NOEL for this study 
was determined to be 6.3 mg/kg/day, based on increases in abortion and 
premature delivery, and decreases in food consumption and weight gain 
at 20 mg/kg/day. No evidence of developmental toxicity was noted at any 
dose level; thus the developmental NOEL was determined to be 20 mg/kg/
day.
    A 2-generation rat reproduction study was conducted at dietary 
concentrations of 0, 40, 120 and 360 ppm. The parental NOEL was 
determined to be 40 ppm (4 mg/kg/day) based on increased kidney weights 
at 120 ppm. The NOEL for reproductive effects was determined to be 120 
ppm (12 mg/kg/day) based on reduced numbers of pups at 360 ppm.
    4. Subchronic Toxicity: A 90-day feeding study was conducted in 
Fisher 344 rats at dietary concentrations of 0, 8, 64, 500 and 4000 
ppm. Although slight evidence of toxicity was observed, there were no 
treatment-related histopathological findings at any dose level. The 
NOEL for this study was determined to be 8 ppm, based on increased 
kidney weights at 64 ppm.
    A 90-day feeding study was conducted in NMRI mice at dietary 
concentrations of 0, 80, 320 and 1280 ppm. There were no treatment-
related pathological findings at any dose level but increases in 
absolute and relative liver weights, serum AST, and serum potassium 
levels were noted at 320 and/or 1280 ppm. Based on these findings, the 
NOEL for this study was determined to be 80 ppm (16.6 mg/kg/day).
    A 90-day feeding study was conducted in beagle dogs at dietary 
concentrations of 0, 4, 8, 16, 64 and 256 ppm. There were no treatment-
related histopathological findings at any dose level. However, because 
of reduced weight gain and decreased thyroid weights at 64 and/or 256 
ppm, the NOEL was determined to be 16 ppm (0.53 mg/kg/day).
    5. Chronic Toxicity/Oncogenicity: A 12-month feeding study was 
conducted in beagle dogs at dose levels of 0, 2, 5 and 8.5 mg/kg/day. 
The NOEL was 5 mg/kg/day based on clinical signs of toxicity, reduced 
weight gain and mortality at 8.5 mg/kg/day.
    A 2-year mouse oncogenicity study was conducted in NMRI mice at 
dietary concentrations of 0, 20, 80 and 160 (males) or 320 (females) 
ppm. The NOEL was determined to be 80 ppm (10.8 and 16.2 mg/kg/day for 
males and females, respectively) based on increased blood glucose, 
decreased glutathione levels and increased mortality in the high-dose 
males and/or females. No evidence of oncogenicity was noted at any dose 
level.
    A combined chronic toxicity/oncogenicity study was conducted in 
Wistar rats for up to 130 weeks at dietary concentrations of 0, 40, 140 
and 500 ppm. A dose-related increase in mortality was noted in females 
at 140 and 500 ppm, while increased absolute and relative kidney 
weights were noted in 140 and 500 ppm males. Thus, the NOEL for this 
study was determined to be 40 ppm (2.1 mg/kg/day). No treatment-related 
oncogenic response was noted. However, the high-dose level in this 
study did not satisfy the EPA criteria for a Maximum Tolerated Dose and 
thus a data gap currently exists for a rat carcinogenicity study. All 
glufosinate-ammonium tolerances previously established by the EPA are 
time-limited because of this gap. A new rat oncogenicity study is 
currently being conducted and is due to the EPA by July 1, 1998.
    6. Animal Metabolism: Numerous studies have been conducted to 
evaluate the absorption, distribution, metabolism and/or excretion of 
glufosinate-ammonium in rats. These studies indicate that glufosinate-
ammonium is

[[Page 58686]]

poorly absorbed (5-10%) after oral administration and is rapidly 
eliminated, primarily as parent compound. Small amounts of the 
metabolites 3-methylphosphinico-propionic acid and 2-acetamido-4-
methylphosphinico-butanoic acid were found in the excreta, although the 
latter is believed to be a result of a reversible acetylation and 
deacetylation process by intestinal bacteria.
    7. Metabolite Toxicology: The primary residue resulting from the 
use of glufosinate-ammonium in genetically transformed corn and soybean 
consists of the metabolites 2-acetamido-4-methylphosphinico-butanoic 
acid and 3-methylphosphinico-propionic acid. A considerable number of 
toxicity studies have been conducted with these metabolites, including 
developmental toxicity studies in rats and rabbits with both 
metabolites and a 2-generation rat reproduction study with 2-acetamido-
4-methylphosphinico-butanoic acid. Neither metabolite presents an acute 
toxicity hazard and both were determined to be non-genotoxic in an 
extensive battery of in vitro and in vivo genotoxicity studies. Neither 
metabolite demonstrated significant developmental toxicity to either 
rats or rabbits. Subchronic studies in rats, mice and dogs were 
conducted with both metabolites with no clear evidence for any specific 
target organ toxicity and with NOEL's or No Observed Adverse Effects 
Levels (NOAEL's) substantially higher than those seen with glufosinate-
ammonium. Thus, these studies indicate that both metabolites are less 
toxic than the parent compound and do not pose any reproductive or 
developmental concerns.
    8. Endocrine Effects: No special studies investigating potential 
estrogenic or endocrine effects of glufosinate-ammonium have been 
conducted. However, the standard battery of required studies has been 
completed. These studies include an evaluation of the potential effects 
on reproduction and development, and an evaluation of the pathology of 
the endocrine organs following repeated or long-term exposure. These 
studies are generally considered to be sufficient to detect any 
endocrine effects but no such effects were noted in any of the studies 
with either glufosinate-ammonium or its metabolites.

D. Aggregate Exposure

    Glufosinate-ammonium is a non-selective, post-emergent herbicide 
with both food and non-food uses. As such, aggregate non-occupational 
exposure would include exposures resulting from consumption of 
potential residues in food and water, as well as from residue exposure 
resulting from non-crop use around trees, shrubs, lawns, walks, 
driveways, etc. Thus, the possible human exposure from food, drinking 
water and residential uses has been assessed below.
    1. Dietary (Food) Exposure: For purposes of assessing the potential 
dietary exposure from food under the proposed tolerances, the 
petitioner has been advised that the EPA has estimated exposure based 
on the Theoretical Maximum Residue Contribution (TMRC) derived from the 
previously established tolerances for glufosinate-ammonium on apples, 
grapes, tree nuts, bananas, milk and the fat, meat and meat-by-products 
of cattle, goats, hogs, horses and sheep as well as the proposed 
tolerances for glufosinate-ammonium on field corn grain, at 0.2 ppm, 
field corn forage, at 4.0 ppm, field corn fodder, at 6.0 ppm, soybeans, 
at 2.0 ppm, soybean hulls, at 5.0 ppm, aspirated grain fractions, at 
25.0 ppm, eggs, at 0.05 ppm, poultry, meat at 0.05 ppm, poultry, fat at 
0.05 ppm, and poultry, mbyp (meat byproducts) at 0.10 ppm. The TMRC is 
obtained by using a model which multiplies the tolerance level residue 
for each commodity by consumption data which estimate the amount of 
each commodity and products derived from the commodity that are eaten 
by the U.S. population and various population subgroups. In conducting 
this exposure assessment, the EPA has made very conservative 
assumptions--100% of all commodities will contain glufosinate-ammonium 
residues and those residues would be at the level of the tolerance--
which result in a large overestimate of human exposure. Thus, in making 
a safety determination for these tolerances, the Agency took into 
account this very conservative exposure assessment.
    2. Dietary (Drinking Water) Exposure: There is no Maximum 
Contaminant Level established for residues of glufosinate-ammonium. The 
petitioner has been advised by the EPA that all environmental fate data 
requirements for glufosinate-ammonium have been satisfied. The 
potential for glufosinate-ammonium to leach into groundwater has been 
assessed in a total of nine terrestrial field dissipation studies 
conducted in several states and in varying soil types. The degradation 
of glufosinate-ammonium in these studies was rapid, with half-lives 
ranging from a low of 6 to a high of 23 days. Despite the relatively 
high water solubility of glufosinate-ammonium, this compound did not 
appear to leach under typical test conditions. This is a result of the 
combination of its rapid degradation and its tendency to bind to 
certain soil elements such as clay or organic matter. Based on these 
studies and the expected conditions of use, the potential for finding 
significant glufosinate-ammonium residues in water is minimal and the 
contribution of any such residues to the total dietary intake of 
glufosinate-ammonium will be negligible.
    3. Non-Dietary Exposure: As a non-selective, post-emergent 
herbicide, homeowner use of glufosinate-ammonium will consist primarily 
of spot spraying of weeds around trees, shrubs, walks, driveways, 
flower beds, etc. There will be minimal opportunity for post-
application exposure since contact with the treated weeds will rarely 
occur. Thus, any exposures to glufosinate-ammonium resulting from 
homeowner use will result from dermal exposure during the application 
and will be limited to adults, not to infants or children. These 
exposures are not expected to pose any acute toxicity concerns. 
Furthermore, based on the US EPA National Home and Garden Pesticide Use 
Survey (RTI/5100/17-01F, March 1992), the average homeowner is expected 
to use non-selective herbicides only about four times a year. Thus, 
these exposures would not normally be factored into a chronic exposure 
assessment.

E. Cumulative Effects

    The potential for cumulative effects of glufosinate-ammonium and 
other substances that have a common mechanism of toxicity must also be 
considered. The precise mechanism of action for the toxic effects of 
glufosinate-ammonium in animals is not known but is believed to result, 
at least in part, from interference with the neurotransmitter function 
of glutamate, to which it is a close structural analog. No other 
registered active ingredients are known to have a similar mechanism of 
action. Thus, no cumulative effects with other substances are 
anticipated. Furthermore, the residues on transgenic crops will consist 
primarily of the metabolites of glufosinate-ammonium, not glufosinate-
ammonium itself. These metabolites are less toxic than glufosinate-
ammonium and, since they are not structural analogs of glutamate, they 
should not cause the same effects. Thus, consideration of a common 
mechanism of toxicity is not appropriate at this time and only the 
potential risks of glufosinate-ammonium need to be considered in its 
aggregate exposure assessment.

[[Page 58687]]

F. Safety Determinations

    1. U.S. Population in General: Based on a complete and reliable 
toxicity database, the EPA has adopted an RfD value of 0.02 mg/kg/day 
using the NOEL of 2.1 mg/kg/day from the chronic rat toxicity study and 
a 100-fold safety factor. Using the conservative exposure assumptions 
described above, the petitioner has been advised that the EPA has 
concluded that aggregate exposure to glufosinate-ammonium from the 
previously established and the proposed tolerances will utilize 6.1 
percent of the RfD for the U.S. population. There is generally no 
concern for exposures below 100 percent of the RfD because the RfD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks to human health. 
Therefore, there is a reasonable certainty that no harm will result 
from aggregate exposure to glufosinate-ammonium residues to the U.S. 
population in general.
    2. Infants and Children: In assessing the potential for additional 
sensitivity of infants and children to residues of glufosinate-
ammonium, one should consider 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 pesticide exposure 
during pre- natal development. Reproduction studies provide information 
relating to reproductive and other effects on adults and offspring from 
pre-natal and post-natal exposure to the pesticide.
    Three developmental toxicity studies in rats (including pre- and 
post-natal phases), a developmental toxicity study in rabbits, and a 2-
generation rat reproduction study have been conducted with glufosinate-
ammonium. No evidence of developmental toxicity was noted in rabbits, 
even at the maternally toxic dose level of 20 mg/kg/day. No 
developmental or reproductive effects were noted in rats except at 
parentally toxic dose levels. The NOEL's for maternal and developmental 
toxicity in the rat developmental toxicity studies were determined to 
be 10 mg/kg/day and 50 mg/kg/day, respectively, based on findings of 
hyperactivity and vaginal bleeding in dams at 50 mg/kg/day and 
increased incidence of arrested renal and ureter development in fetuses 
at 250 mg/kg/day. The parental and reproductive NOEL's in the 2-
generation rat reproduction study were determined to be 40 ppm (4 mg/
kg/day) and 120 ppm (12 mg/kg/day), respectively, based on increased 
parental kidney weights at 120 ppm and decreased numbers of pups at 360 
ppm. In all cases, the reproductive and developmental NOEL's were 
greater than or equal to the parental NOEL's, thus indicating that 
glufosinate-ammonium does not pose any increased risk to infants or 
children.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor for infants and children in the case of threshold effects to 
account for pre- and post-natal toxicity and the completeness of the 
database. Based on the current toxicological data requirements, the 
database relative to pre- and post-natal effects for children is 
complete. Further, the NOEL at 2.1 mg/kg/day from the chronic rat study 
with glufosinate-ammonium, which was used to calculate the RfD 
(discussed above), is already lower than the NOEL's from the 
reproductive and developmental studies with glufosinate-ammonium by a 
factor of at least 6-fold. Therefore, an additional safety factor is 
not warranted and an RfD of 0.02 mg/kg/day is appropriate for assessing 
aggregate risk to infants and children.
    Using the highly conservative exposure assumptions described above, 
the petitioner has been advised that EPA has concluded that the percent 
of the RfD that will be utilized by aggregate exposure to residues of 
glufosinate-ammonium ranges from 13.6 percent for children 1 to 6 years 
old, up to 28.3 percent for non-nursing infants (1 year 
old). Using more realistic assumptions concerning anticipated residues 
and percent crop treated, the percent of RfD utilized would be no more 
than 5% for infants or children. Therefore, based on the completeness 
and reliability of the toxicity data and a comprehensive exposure 
assessment, it may be concluded that there is a reasonable certainty 
that no harm will result to infants and children from aggregate 
exposure to glufosinate-ammonium residues.

G. International Tolerances

    Glufosinate-ammonium as a non-selective herbicide is currently 
registered in more than 60 countries worldwide for both non-crop use as 
well as for weed control and desiccation in numerous conventional 
crops, including corn and soybeans. The following Codex Alimentarius 
Commission (Codex) Maximum Residue Levels (MRLs) for glufosinate-
ammonium on conventional corn and soybeans have been established: 
maize, at 0.1 ppm, maize forage, at 0.2 ppm and soya bean (dry) at 0.1 
ppm. These tolerances are for non-selective uses such as no-till 
systems or post-directed applications on non-transgenic crops.
    The U.S. tolerances for corn and soybean commodities are being 
proposed at higher levels based on residue trial data submitted by the 
petitioner. The residue trials were conducted in the U.S. on transgenic 
corn and soybeans according to the proposed U.S. label parameters for 
these crops. These use parameters (application rate, application 
timing, crop growth stage, pre-harvest interval etc.) differ for direct 
application use on transgenic crops than for non-selective use on 
conventional crops. Based on the U.S. data, the petitioner's parent 
company, AgrEvo GmbH of Berlin, Germany has petitioned the Joint 
Meeting of the Food and Agriculture Organization Panel of Experts on 
Pesticide Residues in Food and the Environment and the World Health 
Organization Expert Group on Pesticide Residues (JMPR) to establish 
Codex MRLs for use on transgenic corn and soybeans that are identical 
to the tolerances proposed for these commodities in the U.S. It is 
anticipated that the JMPR will consider and establish the MRLs for 
glufosinate-ammonium on transgenic crops during 1997-1998.

II. Administrative Matters

    Interested persons are invited to submit comments on the this 
notice of filing. Comments must bear a notation indicating the document 
control number, [PF-671]. All written comments filed in response to 
this petition will be available in the Public Response and Program 
Resources Branch, at the address given above from 8 a.m. to 4 p.m., 
Monday through Friday,except legal holidays.
    A record has been established for this notice under docket number 
[PF-671] (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8 a.m. to 
4:30 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the

[[Page 58688]]

use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
notice record which will also include all comments submitted directly 
in writing. The official notice record is the paper record maintained 
at the address in ``ADDRESSES'' at the beginning of this document.

List of Subjects in 40 CFR Part 180

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

    Dated: November 7, 1996.

Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 96-29576 Filed 11-15-96; 8:45 am]
BILLING CODE 6560-50-F