[Federal Register Volume 62, Number 24 (Wednesday, February 5, 1997)]
[Rules and Regulations]
[Pages 5333-5338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2838]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[PP-5F4578/R-2277; FRL-5585-8]
RIN 2070-AB78


Glufosinate Ammonium; Tolerances for Residues

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes time-limited tolerances for residues 
of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites: 2-
acetamino-4-methylphosphinico-butanoic acid and 3-methylphosphinico-
propionic acid, in or on various raw agricultural commodities (RACs), 
derived from transgenic field corn and transgenic soybeans. AgrEvo USA 
Co. submitted a petition to EPA under the Federal Food, Drug and 
Cosmetic Act (FFDCA) as amended by the Food Quality Protection Act of 
l996 (FQPA) requesting the tolerances.

EFFECTIVE DATE: This regulation becomes effective February 5, 1997. The 
tolerances expire and are revoked automatically without further action 
by EPA on July 13, l999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [PP-5F4578/R-2277], may be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk should be identified by 
the docket control number and submitted 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 copy of objections and hearing 
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically to the OPP by sending 
electronic mail (e-mail) to: <a href="/cdn-cgi/l/email-protection#076877772a6368646c6273476277666a666e6b2962776629606871"><span class="__cf_email__" data-cfemail="d5baa5a5f8b1bab6beb0a195b0a5b4b8b4bcb9fbb0a5b4fbb2baa3">[email protected]</span></a>. Copies of 
objections and hearing requests must be submitted as an ASCII file 
avoiding the use of special characters and any form of encryption. 
Copies of objections and hearing requests will also be accepted on 
disks in WordPerfect in 5.1 file format or ASCII file format. All 
copies of objections and hearing requests in electronic form must be 
identified by the docket control number [PP-5F4578/R-2277]. No 
Confidential Business Information (CBI) should be submitted through e-
mail. Electronic copies of objections and hearing requests on this rule 
may be filed online at many Federal Depository Libraries. Additional 
information on electronic submissions can be found in Unit IX. of this 
preamble.

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, telephone number, and e-mail address: Rm. 237, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA, (703)-305-6224; e-mail: 
<a href="/cdn-cgi/l/email-protection#402d292c2c25326e2a2f212e2e25002530212d21292c6e2530216e272f36"><span class="__cf_email__" data-cfemail="8fe2e6e3e3eafda1e5e0eee1e1eacfeaffeee2eee6e3a1eaffeea1e8e0f9">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 25, 1995 
(60 FR 54689)(FRL-4982-4), EPA issued a notice pursuant to section 
408(d) of FFDCA, 21 U.S.C. 346a(d), announcing the filing of a 
pesticide tolerance petition by AgrEvo USA Co., Little Falls One, 2711 
Centerville Rd., Wilmington, DE 19808. The petition requested that 40 
CFR 180.473 be amended by adding tolerances for residues of glufosinate 
ammonium and its metabolites 2-acetamido-4-methylphosphinico-butanoic 
acid and 3-methylphosphinico-propionic acid, in or on the following 
RACs: corn, field, grain at 0.2 part per million (ppm); corn, field, 
forage at 4.0 ppm; corn, field, silage at 3.5 ppm; corn, field, fodder 
at 5.5 ppm; soybean seed at 2.0 ppm; and soybean hulls at 6.0 ppm. In 
the Federal Register of July 31, l996 (61 FR 39964)(FRL-5384-7), EPA 
issued a notice of an amendment to the petition. The tolerances 
requested were changed to residues of glufosinate-ammonium and its 
metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-
methylphosphico-propionic acid expressed as glufosinate free acid 
equivalents, in or on the following RACs: corn, field, grain, at 0.2 
ppm; corn, field, forage, at 4.0 ppm; corn, field, fodder, at 6.0 ppm; 
soybeans, at 2.0 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, meat by-products (mbyp) at 0.10 ppm. The revised petition also 
requested that a maximum residue level be established for the same 
residues in or on the processed commodity under section 701 of FFDCA: 
soybean hulls at 5.0 ppm.
    In the Federal Register of November 18, l996 (61 FR 58684) (FRL-
5572-7), EPA issued a third Notice of Filing to amend the petition to 
bring the petition in conformity with FQPA (Pub. L. 104-170). The 
notice contained a summary of the petition prepared by the petitioner 
and this summary contained conclusions and arguments to support its 
conclusion that the petition complied with FQPA. In this instance the 
petitioner proposed to amend 40 CFR 180.473 by establishing tolerances 
for residues of glufosinate ammonium in or on the following RACs: corn, 
field, grain, at 0.2 ppm; corn, field, forage, at 4.0 ppm; corn, field, 
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 at 0.10 
ppm. The residues of glufosinate-ammonium were defined as 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.
    There were no comments or requests for referral to an advisory 
committee received in response to the notices of filing. The Notice of 
Filings were incorrectly stated for eggs and the poultry commodities 
because the residue chemistry data showed only the parent chemical and 
one metabolite, 3-methylphosphinico-propionic acid. The subject 
regulation is therefore amended accordingly. The data submitted in the

[[Page 5334]]

petition and other relevant material have been evaluated. The 
toxicology data listed below were considered in support of these 
tolerances.

I. Toxicological Profile

    1. A battery of acute toxicity studies placing technical 
glufosinate-ammonium in Toxicity Categories II and III.
    2. A 90-day feeding study in rats at dietary intakes of 0, 0.52, 
4.1, 32, or 263 mg/kg/day with a no-observed-effect level (NOEL) of 4.1 
mg/kg/day. The lowest-observed-effect level (LOEL) was established at 
32 mg/kg/day based on increased absolute and relative kidney weights.
    3. A 90-day feeding study in mice at dietary intakes of 0, 16.6, 
67.1, or 278 mg/kg/day with a NOEL of 16.6 mg/kg/day and an LOEL of 
67.1 mg/kg/day based on increased absolute and relative liver weights 
(both sexes) and an increase in serum potassium levels (males).
    4. Three teratology studies in rats at doses from 0.5 to 250 mg/kg/
day with no teratogenic effects occurring up to and including 250 mg/
kg/day. A NOEL for developmental toxicity was 50 mg/kg/day, based upon 
an increase in the incidence of dilated renal pelvis and hydroureter in 
fetuses at 250 mg/kg/day. The maternal NOEL was 10 mg/kg/day, based on 
the finding of hyperactivity and vaginal bleeding of dams at 50 mg/kg/
day.
    5. A teratology study in rabbits at doses of 0, 2, 6.3, or 20 mg/
kg/day with no teratogenic effects occurring up to and including 20 mg/
kg/day, and a maternal NOEL of 6.3 mg/kg/day and a developmental NOEL 
of 20 mg/kg/day, the highest dose tested.
    6. A two-generation reproduction study in rats at dietary 
concentrations of 0, 40, 120, or 360 ppm with an NOEL for reproductive 
effects at 120 ppm (equivalent to 12 mg/kg/day) based upon reduced 
number of pups in the high-dose group. The NOEL for parental toxicity 
was 40 ppm (4 mg/kg/day) based upon increased kidney weights in the 
high-dose group.
    7. A 12-month feeding study in dogs at doses of 0, 2, 5, or 8.5 mg/
kg/day. The NOEL was 5.0 mg/kg/day based upon the death of one male and 
one female dog at 8.5 mg/kg/day with no other treatment-related 
toxicity.
    8. A mouse carcinogenicity study at doses of 0, 2.8, 10.8, or 22.7 
mg/kg/day in males and 0, 4.2, 16.2, or 64.0 mg/kg/day in females for 
104 weeks with no carcinogenic effects observed under the conditions of 
the study up to and including 64 mg/kg/day and a systemic NOEL of 10.8 
and 16.2 for males and females, respectively, based on the dose-related 
increase in mortality.
    9. A chronic feeding/carcinogenicity study in rats at dietary doses 
of 0, 2.5, 8.8, or 31.5 mg/kg/day (males) and 0, 2.4, 8.2, or 28.7 mg/
kg/day (females) with an NOEL of 2.1 mg/kg/day for systemic effects 
based on an increase in kidney weights in females at the two higher 
doses. There were no treatment-related carcinogenic effects at any dose 
level. The study was determined to be unacceptable because a high 
enough dose was not tested.
    10. Acceptable studies on gene mutation (Salmonella, E coli., and 
mouse lymphoma assays), structural chromosomal aberration (in vivo 
micronucleus assay in mice), and other genotoxic effects (unscheduled 
DNA synthesis assay with rat hepatocytes) yielded negative results.
    11. Pharmacokinetic and metabolism studies in rats indicated that 
approximately 80 to 90 percent of the orally administered dose of 
glufosinate ammonium remained unabsorbed and was eliminated in the 
feces. Approximately 10 to 15 percent was eliminated in the urine. The 
major metabolic pathway is oxidative deamination yielding the 
metabolite, 3-methyl-phospinico propionic acid.

II. Method of Determining Risks

    1. Human dietary exposure. Residues in the agricultural commodities 
harvested from the crop cultured with the aid of the pesticide are 
determined by chemical analysis. To account for the diversity of 
growing conditions, culture practices, soil types, climatic conditions, 
crop varieties and methods of use of the pesticide, data from studies 
that represent the resulting commodities are collected and evaluated to 
determine an appropriate level of residue that would not be exceeded if 
the pesticide is used as represented in the studies. The conduct of the 
field trial and guidelines for determining the residues are given in 
EPA ``OPPTS Test Guidelines, Series 860, Residue Chemistry, August 
l996''(see 61 FR 44308, August 28, 1996, for availability of 
document)(FRL-5390-7).
    The method of chemical analysis proposed for determining the 
residues in the various commodities is evaluated by a method ``try-
out'' in EPA laboratories. If the method is found to be acceptable the 
Agency accepts the claim that a method of analysis is available for 
determining residues. The method must be appropriate for enforcement 
purposes. The presence of the pesticide or degradates of the pesticide 
in potable water may also be a source of dietary exposure that must be 
considered in establishing a tolerance level for a agricultural 
commodity.
    The Reference Dose (RfD) is assumed to be the exposure at or below 
which daily aggregate exposure over a lifetime will not pose an 
appreciable risk to human health. To assure the adequacy of the RfD, 
the Agency uses an uncertainty factor in deriving it. The factor is 
usually 100, based on the assumption that certain segments of the human 
population could be as much as 100 times more sensitive than the 
species represented by the toxicology data.
    If the pesticide is determined to be a human carcinogen, the 
toxicological end-point must be determined based on the nature of the 
carcinogenic response and a knowledge of its mode of action. The Agency 
uses a weight of evidence in classifying the potential of the pesticide 
as a human carcinogen. Glufosinate-ammonium has not been determined to 
be a human carcinogen, therefore a derived RfD was used as the 
toxicological end-point in the dietary risk assessments and the subject 
action. Available data show no indication that it is carcinogenic, 
however this Agency is requiring a repeat rat carcinogenicity study.
    2. Non-dietary exposure. Margins of Exposures (MOEs) are determined 
for non-dietary exposures based on toxicological end-points and 
measured or estimated exposures. Dermal absorption studies are required 
for pesticidal chemicals that have serious toxic effects as identified 
by oral or inhalation studies, for which a significant route of human 
exposure is dermal and for which the assumption of 100% absorption does 
not produce an adequate margin of safety. Glufosinate ammonium has not 
been identified as having a serious toxic effects by either oral or 
inhalation routes of exposure. A rat glufosinate ammonium dermal 
absorption study at doses of 0.1, 1.0 and 10 mg/rat on 6 square 
centimeters of skin showed maximum levels of absorption between 4 to 10 
hours. The absorption at 0.1 was 42.5 to 50.8% of the applied 
radioactivity, whereas at 10.0, 26% of the dose was absorbed.
    The petitioner has informed EPA that a dermal absorption study was 
submitted to the State of California for the formulated product, that 
is to be registered for use in the culture of transgenic corn and 
soybeans. The petitioner stated that the data indicated that the dermal 
absorption by rats following 0.5- to 24-hour dermal exposures at dose 
levels of 12 to 1,218 micrograms per square centimeter averaged 
approximately 6%, with an upper limit of 19%. The only values

[[Page 5335]]

greater than 10% were following 24-hour exposures at dose level of 
1,218 micrograms per square centimeter. The petitioner also stated that 
in vitro data with the same formulation suggest that the rate of 
penetration in rats is about 3 to 29 times higher than in humans, 
depending on the dose level.
    An acceptable rat oncogenicity study is required and is one of the 
reasons for designating these tolerances ``time-limited'' with an 
expiration date. Without an acceptable rat oncogenicity study the risk 
from the many non-dietary uses can not be determined precisely. Also, 
without appropriate dermal absorption data EPA cannot determine the 
risks from the non-dietary use exposures. As an interim policy in 
safety decisions, EPA is using a default assumption based on the 
information available from similar pesticides. A maximum of 20% of the 
RfD is being assigned for all non-dietary uses of glufosinate ammonium 
in the risk analysis associated with this final rule.

III. Aggregate Exposures

    1. Food and feed uses. The primary source for human exposure to 
glufosinate ammonium will be from ingestion of both raw and processed 
agricultural commodities as proposed in the November 18, 1996 Notice 
for Filing cited above and as established already by 40 CFR 180.473.
    2. Potable water. There is presently no EPA Lifetime Health 
Advisory level for glufosinate ammonium and its degradates as drinking 
water contaminates. At the dosage of proposed uses and existing uses, 
the level of contamination of drinking water is not expected to be 
significant in the analysis of risk from the proposed and existing uses 
of this pesticide. At the maximum application rate of 0.75 lb per acre, 
the Agency does not expect residues to reach ground water.
    3. Non-dietary uses. Glufosinate ammonium is registered for use as 
a post-emergent herbicide for non-food use-sites, such as 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 nonfood crop areas. The 
exposure from these uses are expected to be dermal in nature. Results 
of an acute dermal toxicity study indicate that there is dermal 
absorption of glufosinate ammonium. This Agency has no quantitative 
data on dermal absorption for the formulation of this chemical. Without 
these data the Agency cannot determine the risk from exposure to 
children and adults, nor determine the aggregate risk to the public 
exposed by these non-food uses of this pesticide. For this reason, the 
Agency is using a maximum default assumption of 20% of the RfD (0.004 
mg/kg bwt/day) as the exposure from these uses.
    The petitioner has argued in their Notice of Filing that these non-
food use exposures are not expected to pose any acute toxicity concerns 
and that the average homeowner would not expect to use pesticide 
products containing glufosinate ammonium more than four times per year, 
therefore such exposure would not ``normally be factored into a chronic 
exposure assessment.'' They did not address the matter of aggregate 
risk from the chronic effects of all such exposures, nor the need for 
such exposure data for determining the aggregate exposure.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. The mechanism of toxicity is believed to be caused by an 
interference with neurotransmitter function of glutamate, to which it 
is a close structural analog. No other substance with this mechanism of 
toxicity has been identified; for this reason, only exposures to 
glufosinate ammonium and its metabolites and degradates have been 
identified for quantitation in the risk assessment for the proposed 
tolerances.

IV. Determination of Safety for U.S. Population and Non-Nursing 
Infants

A. The U.S. Population

    Based on a NOEL of 2.1 mg/kg bwt/day from a 2-year rat chronic 
toxicity study that demonstrated increased absolute and relative kidney 
weights in males as an endpoint effect, and using an uncertainty factor 
of 100 the Agency has determined a RfD of 0.02 mg/kg bwt/day for this 
assessment of risk. Based on the available toxicity data and the 
available exposure data identified above, the proposed tolerances will 
utilize 3.7% of the RfD. Existing tolerances utilize 2.07% of the RfD; 
therefore, the subject proposed tolerances for use of glufosinate 
ammonium in the culture of transgenic corn and soybeans will result in 
a cumulative total use of 25.77% of the RfD, when the 20% default 
assumption for the non-food use exposures is included.

B. Non-Nursing Infants

    Exposure to non-nursing infants as a result of the use of 
glufosinate ammonium in the culture of transgenic corn and soybeans 
will result in the use of 17.2% of the RfD. Existing exposures from 
established tolerances utilize 10.6% of the RfD. The cumulative 
exposure will be 47.8% of the RfD, when the 20% default assumption for 
the non-food uses are included.

C. Nonfood Uses

    Exposure from nonfood uses of glufosinate ammonium and from 
contaminated potable water sources have not been precisely addressed in 
this assessment. However, EPA does not foresee that these exposures 
will result in a cumulative level that exceeds the RfD. EPA concludes 
that there is reasonable certainty that no harm will result from the 
aggregate exposures to residues and degradates of glufosinate ammonium.

V. Determination of Safety for Infants and Children

    Risk to infants and children was determined by use of three 
teratology studies in rats that had a NOEL for developmental toxicity 
of 2.24 mg/kg/day, based on an increase in the incidence of dilated 
renal pelvis with dyroureter in the fetuses at 10 mg/kg/day and a 
maternal NOEL also 2.24 mg/kg/day and a teratology study in rabbits 
that had a NOEL of 20 mg/kg/day for developmental effects and a 
maternal NOEL of 6.3 mg/kg/day, and a two-generation reproduction study 
in rats that had a NOEL of 12 mg/kg/day for reproductive effects. The 
effect was reduced number of pups in the high-dose group. The NOEL for 
parental toxicity was also 12 mg/kg/day based upon increased kidney 
weights in the high-dose group.
    FFDCA section 408 provides that EPA shall 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 
data base unless EPA determines that such additional factor is not 
necessary to protect the safety of infants and children. Based on 
current data requirements, the data base relative to pre- and post-
natal toxicity is complete. The NOEL of 2.1 mg/kg bwt/day from a 2-year 
rat chronic toxicity study is lower than the NOELs from the 
developmental studies in rats and rabbits. In the reproduction study, 
the NOEL was about 6 times greater than the NOEL used for establishing 
the RfD. Effect of

[[Page 5336]]

pups in the reproduction study did not indicate a greater sensitivity 
for infants and children. Therefore, EPA concludes that an additional 
uncertainty factor is not necessary to protect the safety of infants 
and children and that the RfD at 0.02 mg/kg/day is appropriate for 
assessing aggregate risk to infants and children. The percent of the 
RfD that will be utilized by the aggregate exposure to glufosinate 
ammonium will range from 29.098 for children 7-12 years old, up to 
48.303 for non-nursing infants. Therefore, EPA concludes that there is 
a reasonable certainty that no harm will result to infants and children 
from aggregate exposure.

VI. Other Considerations

A. Endocrine Effects

    An evaluation of the potential effects on the endocrine systems of 
mammals has not been determined; however, no evidence of such effects 
were reported in the chronic toxicology studies described in Unit I. in 
this document. There were no observed pathology of the endocrine organs 
in these studies. There is no evidence at this time that glufosinate 
ammonium causes endocrine effects.

B. Metabolism in Plants and Animals

    The metabolism of glufosinate ammonium in plants and animals is 
adequately understood for the purposes of these tolerances. The only 
crop residue found after the preemergence use is the metabolite 3-
methylphosphinico-propionic acid, which is found in only trace 
quantities. With the exception of corn grain, the principal residue 
identified in the metabolism studies after post-emergence use of 
glufosinate ammonium was 2-acetamido-4-methylphosphinico-butanoic acid, 
with lesser quantities of glufosinate and 3-methylphosphinico-propionic 
acid. In corn grain, which exhibits much lower total radio-labeled 
residues than the other commodities, the principal residue identified 
was 3-methylphospinico-propionic acid, with lesser amounts of 2-
acetamido-4-methylphosphinico-butanoic acid.

C. Analytical Method

    There is a practical analytical method for detecting and measuring 
levels of glufosinate ammonium and its metabolites in or on food with a 
limit of detection that allows monitoring of food with residues at or 
above the levels set in these tolerances. The proposed analytical 
method for determining residues is high-pressure liquid chromatography. 
EPA has provided information on this method to the Food and Drug 
Administration. Because of the long lead time from establishing these 
tolerances to publication, the enforcement methodology is being made 
available in the interim to anyone interested in pesticide enforcement 
when requested by mail from: Calvin Furlow, Public Response Branch, 
Field Operations Division (7506C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location and telephone umber: Rm. 1130A, CM #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703)-305-5937.

D. International Tolerances

    The following Codex Alimentarius Commission (Codex) Maximum Residue 
Levels (MRLs) for glufosinate ammonium 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 use-patterns for no-till systems of culture of 
non-transgenic corn and soybeans. AgrEvo USA Co. states that a petition 
for the same tolerances as proposed in the November 18, l996 EPA Notice 
of Filing is pending with 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 to establish Codex MRLs for use of glufosinate ammonium in the 
culture of transgenic corn and soybeans. The proposed tolerances for 
corn and soybean commodities are greater than the MRLs established by 
the Codex Alimentarius Commission because glufosinate ammonium is 
applied as a post-emergence herbicide in the culture of transgenic corn 
and soybeans; whereas the Codex MRLs are for preemergence applications 
of this herbicide in the culture of these crops. Studies showed the 
level of residues from the post-emergence use was greater.

E. Data Gaps

    A data gap currently exists for a rat carcinogenicity study. All 
tolerances are time-limited because of this data gap. The time 
limitation allows for development and review of the data. A repeat rat 
carcinogenicity study has been required and is expected to be submitted 
and reviewed prior to the expiration date of these tolerances. A mouse 
carcinogenicity and a rat carcinogenicity study have been reviewed and 
showed no evidence of carcinogenicity. However, the EPA Peer Review 
Committee determined that the rat study was flawed in that the study 
was not conducted at the maximum tolerated dose. Based on the 
toxicological data and the levels of exposure, EPA has determined that 
the existing tolerances and the proposed tolerances will be safe.

VII. Summary of Findings

    The analysis for glufosinate ammonium using tolerance level 
residues shows that the existing uses on apples, grapes, and tree nut 
group and the proposed uses on transgenic corn and soybeans will not 
cause exposure to exceed the levels at which the Agency believes there 
is an appreciable risk. All population subgroups examined by EPA are 
exposed to glufosinate ammonium residues at levels below 100% of the 
RfD for chronic effects. Based on the information cited above, the 
Agency has determined that the establishment of the time-limited 
tolerances by amending 40 CFR 180.473 will be safe; therefore, the 
time-limited tolerances are established as set forth below.

VIII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (1)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which governs the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by April 7, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) and may also request a hearing on those objections. 
Objections and hearing requests must be filed with the Hearing Clerk, 
at the address given under the ADDRESSES section (40 CFR 178.20). A 
copy of the objections and/or hearing requests filed with the Hearing 
Clerk should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issue(s) on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the objector (40 CFR 178.27). A

[[Page 5337]]

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

IX. Public Docket

    A record has been established for this rulemaking under docket 
control number [PP-5F4578/R-2277]. A public version of this record, 
which does not include any information claimed as CBI, is available for 
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operation Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the address in ADDRESSES at 
the beginning of this document.

X. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and since this action 
does not impose any information collection requirements subject to 
approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it 
is not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, l993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, l994).
    Because tolerances established on the basis of a petition under 
section 408(d) of FFDCA do not require issuance of a proposed rule, the 
regulatory flexibility analysis requirements of the Regulatory 
Flexibility Act (RFA), 5 U.S.C. 604(a), do not apply. Prior to the 
recent amendment of the FFDCA, EPA had treated such rulemakings as 
subject to the RFA; however, the amendments to the FFDCA clarify that 
no proposal is required for such rulemakings and hence that the RFA is 
inapplicable.
    Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted 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 
General Accounting Office prior to publication of the rule in today's 
Federal Register. This rule is not a major rule as defined by 5 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.
    Dated: January 17, 1997.
Peter Caulkins,

Acting 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. 346a and 371.

    2. In Sec. 180.473, by adding alphabetically the following 
commodities and tolerances to paragraph (a) and adding paragraph (c) to 
read as follows:


Sec. 180.473  Glufosinate ammonium; tolerances for residues.

    (a) *    *    *   

                                                                        
------------------------------------------------------------------------
                                     Parts per                          
             Commodity                million        Expiration date    
------------------------------------------------------------------------
              *        *        *        *        *                     
Eggs..............................      0.05          July 13, 1999.    
              *        *        *        *        *                     
Poultry, fat......................      0.05          July 13, 1999.    
Poultry, mbyp.....................      0.10          July 13, 1999.    
Poultry, meat.....................      0.05          July 13, 1999.    
              *        *        *        *        *                     
------------------------------------------------------------------------

*    *    *    *    *
    (c) Time-limited tolerances are established 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 in or on the following raw agricultural commodities 
derived from transgenic corn and soybeans that are tolerant to the 
herbicide glufosinate ammonium, as provided below. These tolerances 
shall expire and be automatically revoked on July 13, l999.

[[Page 5338]]



                                                                        
------------------------------------------------------------------------
                                     Parts per                          
             Commodity                million        Expiration date    
------------------------------------------------------------------------
Aspirated Grain Fractions.........      25.0          July 13, 1999.    
Corn, field, forage...............      0.4           July 13, 1999.    
Corn, field, grain................      0.2           July 13, 1999.    
Corn, field, stover...............      6.0           July 13, 1999.    
Soybean, hulls....................      5.0           July 13, 1999.    
Soybeans..........................      2.0           July 13, 1999.    
------------------------------------------------------------------------

[FR Doc. 97-2838 Filed 2-4-97; 8:45 am]
BILLING CODE 6560-50-F


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