96-29576. Pesticide Tolerance Petition: Notice of Filing  

  • [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: opp-docket@epamail.epa.gov. 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: 
    miller.joanne@epamail.epa.gov.
    
    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
    
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    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
    
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    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.
    
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    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:
        opp-docket@epamail.epa.gov
    
    
        Electronic comments must be submitted as an ASCII file avoiding the
    
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    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
    
    
    

Document Information

Published:
11/18/1996
Department:
Environmental Protection Agency
Entry Type:
Notice
Action:
Notice.
Document Number:
96-29576
Dates:
Comments, identified by the docket number [PF-671], must be received on or before December 18, 1996.
Pages:
58684-58688 (5 pages)
Docket Numbers:
PF-671, FRL-5572-7
PDF File:
96-29576.pdf