![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: May 19, 2000 (Volume 65, Number 98)]
[Notices]
[Page 31904-31908]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my00-57]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[PF-943; FRL-6558-2]
Notice of Filing a Pesticide Petition to Establish a Tolerance
for Certain Pesticide Chemicals in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.
DATES: Comments, identified by docket control number PF-943, must be
received on or before June 19, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-943 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Joanne I. Miller,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania
Ave., NW., Washington, DC 20460; telephone number: (703) 305-6224; e-
mail address: miller.joanne@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you are an agricultural
producer, food manufacturer or pesticide manufacturer. Potentially
affected categories and entities may include, but are not limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of this
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations'' and then look up the entry for this document under the
``Federal Register--Environmental Documents.'' You can also go directly
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number PF-943. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, and other
information related to this action, including any information claimed
as confidential business information (CBI). This official record
includes the documents that are physically located in the docket, as
well as the documents that are referenced in those documents. The
public version of the official record does not include any
[[Page 31905]]
information claimed as CBI. The public version of the official record,
which includes printed, paper versions of any electronic comments
submitted during an applicable comment period, is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
C. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-943 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC
20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3.Electronically. You may submit your comments electronically by e-
mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-943. Electronic comments may
also be filed online at many Federal Depository Libraries.
D. How Should I Handle CBI That I Want to Submit to the Agency?
Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified under FOR FURTHER INFORMATION
CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used
that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.
II. What Action is the Agency Taking?
EPA has received a pesticide petition as follows proposing the
amendment of the regulation for residues of glufosinate-ammonium, a
pesticide chemical, in or on food commodities derived from cotton under
section 408 of the Federal Food, Drug, and Comestic Act (FFDCA), 21
U.S.C. 346a. EPA has determined that this request contains data or
information regarding the elements set forth in section 408(d)(2);
however, EPA has not evaluated the submitted data at this time or
whether the data supports granting of the petition. Additional data may
be needed before EPA rules on the petition.
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: May 9, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the view of the
petitioners. EPA is publishing the petition summary verbatim without
editing it in any way. The summary identifies an analytical method
available to EPA for the detection and measurement of the residues of
glufosinate-ammonium in or on cotton commodities.
Aventis CropScience USA
PP 0F6140
EPA has received a pesticide petition (PP 0F6140) from Aventis
CropScience USA, PO Box 12014, 2 T. W. Alexander Drive, Research
Triangle Park, NC 27709, proposing, pursuant to section 408(d) of the
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to
amend 40 CFR part 180.473(a)(1) by establishing tolerances for residues
of the herbicide glufosinate-ammonium (butanoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxymethylphosphinyl)butanoic acid equivalents in or on the raw
agricultural commodities derived from cotton: undelinted seed at 3.5
parts per million (ppm) and gin byproducts at 12.0 ppm. Aventis
CropScience also proposes to amend 40 CFR part 180.473(c) by
establishing tolerances for residues of the herbicide glufosinate-
ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-,
monoammonium salt) and its metabolites, 3-methylphosphinico-propionic
acid, and 2-acetamido-4-methylphosphinico-butanoic acid expressed as 2-
amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on the
raw agricultural commodities derived from transgenic cotton tolerant to
glufosinate-ammonium: Undelinted seed at 3.5 ppm and gin byproducts at
12.0 ppm. EPA has determined that the petition contains data or
information regarding the elements set forth in section 408(d)(2) of
the FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of
[[Page 31906]]
the petition. Additional data may be needed before EPA rules on the
petition.
A. Residue Chemistry
1. Plant metabolism. The metabolism of glufosinate-ammonium in
plants has been investigated and is understood. The crop residue
profile following selective use of glufosinate-ammonium on transgenic
crops is different from that found in conventional crops. The crop
residue observed after non-selective use is the metabolite 3-
methylphosphinico-propionic acid which is found only in trace amounts.
The principal residue identified in the metabolism studies after
selective use of glufosinate-ammonium on transgenic crops is the
acetylated derivative of parent material, 2-acetamido-4-
methylphosphinico-butanoic acid with lesser amounts of 3-
methylphosphinico-propionic acid observed.
2. Analytical method. The enforcement analytical method utilizes
gas chromatography for detecting and measuring levels of glufosinate-
ammonium and metabolites with a general limit of quantification of 0.05
ppm. This method allows detection of residues at or above the proposed
tolerances.
3. Magnitude of residues. Field residue trials were conducted
across the five major regions of cotton production in the U.S. Two
different treatment regimes were examined to represent use patterns
which are the most likely to result in the highest residues.
Glufosinate-ammonium derived residues did not exceed 3.4 ppm in
undelinted cotton seed and 11.6 ppm in cotton gin byproducts (trash)
when sampled at 70 days or more after the last treatment. No
significant concentration of the residues occurred in the processed
cotton commodities meal and hull and in refined oil the residues were
less than the limit of quantitation (LOQ) of the analytical method.
Thus, tolerances are not being proposed for the processed commodities
from cotton.
B. Toxicological Profile
1. Acute toxicity. Glufosinate-ammonium has been classified as
toxicity category III for acute oral, dermal and inhalation toxicity.
It is toxicity category III for eye irritation. It is not a dermal
irritant (toxicity category IV) nor is it a dermal sensitizer. The oral
LD50 is 2 gram/kilogram (g/kg) in male rats and 1.62 g/kg in
female rats.
2. Genotoxicity. Based on results of a complete genotoxicity
database, there is no evidence of mutagenic activity in a battery of
studies, including: Salmonella spp., E. coli, in vitro mammalian cell
gene mutation assays, mammalian cell chromosome aberration assays, in
vivo mouse bone marrow micronucleus assays, and unscheduled DNA
synthesis assays.
3. Reproductive and developmental toxicity. In a developmental
toxicity study, groups of 20 pregnant female Wistar rats were
administered glufosinate-ammonium by gavage at doses of 0, 0.5, 2.24
10, 50 and 250 mg/kg/day from days 7 to 16 of pregnancy. The no
observed adverse effect level (NOAEL) for maternal toxicity is 10 mg/
kg/day; the lowest observed adverse effect level (LOAEL) is 50 mg/kg/
day based on vaginal bleeding and hyperactivity in dams. In the fetus,
the NOAEL is 50 mg/kg/day, based on dilated renal pelvis observations
at the LOAEL of 250 mg/kg/day.
In a developmental toxicity study, groups of 15 pregnant female
Himalayan rabbits were administered glufosinate-ammonium by gavage at
doses of 0, 2.0, 6.3 or 20.0 millgrams/kilogram/day (mg/kg/day) from
days 7 to 19 of pregnancy. In maternal animals, decreases in food
consumption and body weight gain were observed at the 20 mg/kg/day dose
level. The NOAEL for both maternal and developmental toxicity was 6.3
mg/kg/day.
In a multi-generation reproduction study, glufosinate-ammonium was
administered to groups of 30 male and 30 female Wistar/Han rats in the
diet at concentrations of 0, 40, 120 or 360 ppm. The LOAEL for systemic
toxicity is 120 ppm based on increased kidney weights in both sexes and
generations. The systemic toxicity NOAEL is 40 ppm. The LOAEL for
reproductive/developmental toxicity is 360 ppm based on decreased
numbers of viable pups in all generations. The NOAEL is 120 ppm.
4. Subchronic toxicity. In a sub-chronic oral toxicity study,
glufosinate-ammonium was administered to 10 NMRI mice/sex/ dose in the
diet at levels of 0, 80, 320 or 1,280 ppm (equivalent to 0, 12, 48, or
192 mg/kg/day) for 13 weeks. Significant (p< 0.05) increases were
observed in serum aspartate aminotransferase and in alkaline
phosphatase in high-dose (192 mg/kg/day) males. Also observed were
increases in absolute and relative liver weights in mid-(48 mg/kg/day)
and high-dose males. The NOAEL is 12 mg/kg/day, the LOAEL is 48 mg/kg/
day based on the changes in clinical biochemistry and liver weights.
5. Chronic toxicity. In a combined chronic toxicity/oncogenicity
study, glufosinate-ammonium was administered to 50 Wistar rats/sex/dose
in the diet for 130 weeks at dose levels of 0, 40, 140, or 500 ppm
(mean compound intake in males was 0, 1.9, 6.8, and 24.4 mg/kg/day and
for females was 0, 2.4, 8.2 and 28.7 mg/kg/day, respectively). A dose-
related increase in mortality was noted in females at 140 and 500 ppm,
whereas in males increased absolute and relative kidney weights were
noted at 140 ppm and 500 ppm. The NOAEL was considered to be 40 ppm. No
treatment-related oncogenic response was noted.
In an oncogenicity study, glufosinate-ammonium was administered to
50 NMRI mice/sex/dose in the diet at dose levels of 0, 80, 160 (males
only) or 320 (females only) ppm for 104 weeks. The NOAEL for systemic
toxicity is 80 ppm (10.82/16.19 mg/kg/day in males/females (M/F)), and
the LOAEL is 160/320 ppm (22.60/63.96 mg/kg/day in M/F), based on
increased mortality in males, increased glucose levels in males and
females, and changes in glutathione levels in males. No increase in
tumor incidence was found in any treatment group.
In a chronic feeding study, glufosinate-ammonium technical was fed
to male and female beagle dogs for 12 months in the diet at levels of
2.0, 5.0 or 8.5 mg/kg/day. The NOAEL is 5.0 mg/kg/day based on clinical
signs of toxicity, reduced weight gain and mortality 8.5 mg/kg/day.
In a rat oncogenicity study, glufosinate-ammonium was administered
to Wistar rats (60/sex/group) for up to 24 months at 0, 1,000, 5,000,
or 10,000 ppm (equivalent to 0, 45.4, 228.9, or 466.3 mg/kg/day in
males and 0, 57.1, 281.5, or 579.3 mg/kg/day in females). The LOAEL for
chronic toxicity is 5,000 ppm (equivalent to 228.9 mg/kg/day for male
rats and 281.5 mg/kg/day for females), based on increased incidences of
retinal atrophy. The chronic NOAEL is 1,000 ppm. Under the conditions
of this study, there was no evidence of carcinogenic potential. Dosing
was considered adequate based on the increased incidence of retinal
atrophy.
6. Animal metabolism. Studies conducted in rats using
14C-glufosinate-ammonium have shown that the compound is
poorly absorbed (5-10%) after oral administration and is rapidly
eliminated primarily as the parent compound. The highest residue levels
were found in liver and kidney tissues.
The metabolic profile and the quantitative distribution of
metabolites was very similar in both goat and hen. The vast majority of
the dose was excreted, primarily as parent compound. The very limited
residues found in edible tissues, milk and eggs were comprised
principally of glufosinate and 3-methylphosphinico-
[[Page 31907]]
propionic acid (Hoe 061517), with lesser amounts of N-acetyl-L-
glufosinate (Hoe 099730) and 2-methylohosphinico-acetic acid (Hoe
064619).
7. Metabolite toxicology. Additional testing has been conducted
with the major metabolites, Hoe 061517 and Hoe 099730, as well as the
L-isomer of glufosinate-ammonium, identified as Hoe 058192. Based on
sub-chronic and developmental toxicity study results, a profile of
similar or less toxicity compared to the parent compound, glufosinate-
ammonium, was observed.
8. Endocrine disruption. No special studies have been conducted to
investigate the potential of glufosinate-ammonium to induce estrogenic
or other endocrine effects. However, no evidence of estrogenic or other
endocrine effects have been noted in any of the toxicology studies that
have been conducted with this product and there is no reason to suspect
that any such effects would be likely.
C. Aggregate Exposure
1. Dietary exposure. Tolerances have been established (40 CFR part
180.473) for the combined residues of glufosinate-ammonium and
metabolites in or on a variety of raw agricultural commodities. No
appropriate toxicological endpoint attributable to a single exposure
was identified in the available toxicity studies. EPA, therefore, has
no, established an acute reference dose (RfD) for the general
population including infants and children. An acute RfD of 0.063 mg/kg/
day was established, however, for the females 13+ subgroup. An acute
analysis was conducted for the sub-population of females 13+. Chronic
dietary analysis was conducted for the usual populations.
i. Food. An acute dietary analysis was conducted using the Dietary
Exposure Evaluation Model (DEEM) software and the 1994-1996 CSFII
consumption data base. The analysis assumed tolerance level residues
for all commodities and 100% of crop treated. This Tier One analysis
resulted in an exposure of 0.007432 mg/kg bw/day (95th percentile) for
the female 13+ sub-population (the only population of concern)
representing 35% utilization of the acute reference dose (RfD).
Chronic dietary analysis was conducted to estimate exposure to
potential glufosinate-ammonium residues in or on registered and
proposed commodities. The DEEM software and the 1994-1996 USDA food
consumption data were used. Tolerance level residues were assumed for
all commodities and conservative percent crop treated values were
incorporated for major crops (25% corn, 15% soybean, 10% potatoes, 20%
cotton), whereas 100% of the crop was assumed to be treated for all
other registered or pending uses. Chronic dietary exposure estimates
from residues of glufosinate-ammonium for the US Population utilized
approximately 25% of the chronic RfD. The sub-population with the
highest exposure was children 1-6 utilizing approximately 67% of the
chronic RfD. This analysis was based on highly conservative
assumptions. The Agency has no concerns with RfD utilization up to
100%.
ii. Drinking water. US EPA's Standard Operating Procedure (SOP) for
Drinking Water Exposure and Risk Assessments was used to perform the
drinking water assessment. The models screening concentrations in
ground water (SCI-GROW) and EPA's Pesticide Root Zone Model (PRZM)-
EXAMS were used to estimate the concentration of glufosinate-ammonium
which might occur in water. The acute drinking water level of
comparison (DWLOC) for females 13+ is 408 parts per billion (ppb). In
comparison, the acute drinking water estimated concentrations (DWEC)
calculated by Generic expected environmental concentration (GENEEC) is
45 ppb, nearly an order of magnitude below the DWLOC.
The chronic DWLOC calculated for adults is 184 ppb and that for
children/toddlers is 24 ppb. The chronic DWEC calculated using a worst
case scenario is 11 ppb (GENEEC). Thus, the drinking water estimated
concentration represents only 11% of the DWLOC for adults and 46% of
that for children/toddlers. The DWLOC are based on highly conservative
dietary (food) exposures and are expected to be much higher in real
world situations reducing further the percent utilization of the DWLOC
even more favorable.
2. Non-dietary exposure. Glufosinate-ammonium is currently
registered for use on the following non-food sites: areas around
ornamentals, shade trees, Christmas trees, shrubs, walks, driveways,
flower beds, farmstead buildings, in shelter belts, and along fences.
It is also registered for use as a post-emergent herbicide on
farmsteads, areas associated with airports, commercial plants, storage
and lumber yards, highways, educational facilities, fence lines, ditch
banks, dry ditches, schools, parking lots, tank farms, pumping
stations, parks, utility rights-of-way, roadsides, railroads, and other
public areas and similar industrial and non-food crop areas. It is also
registered for lawn renovation uses.
The EPA has determined that there are no acute or chronic non-
dietary exposure scenarios. Further, the Agency has determined that it
is not appropriate to aggregate short- and intermediate-term non-
dietary exposure with dietary exposures in risk assessments because the
end-points are different.
D. Cumulative Effects
Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
``available information'' concerning the cumulative effects of a
particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.'' EPA has indicated that, at this time,
the Agency does not have available data to determine whether
glufosinate-ammonium has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
glufosinate-ammonium does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
petition, therefore, it has not been assumed that glufosinate-ammonium
has a common mechanism of toxicity with other substances.
E. Safety Determination
1. U.S. population. Using the conservative assumptions described
above, based on the completeness and reliability of the toxicity data,
it is concluded that chronic dietary exposure to the registered and
proposed uses of glufosinate-ammonium will utilize at most 25% of the
chronic RfD for the US Population. The actual exposure is likely to be
much less as more realistic data and models are developed. Exposures
below 100% of the RfD are generally assumed to be of no concern because
the RfD represents the level at or below which daily aggregate exposure
over a lifetime will not pose appreciable risk to human health.
The acute population of concern, female 13+ utilizes 35% of the
acute RfD. This is a Tier One highly conservative assessment and actual
exposure is likely to be far less. DWLOC based on dietary exposures are
greater than highly conservative estimated levels, and would be
expected to be well below the 100% level of the RfD, if they occur at
all.
EPA has concluded that it is not appropriate to aggregate non-
dietary exposures with dietary exposures in a risk assessment because
the toxicity end-points are different.
Therefore, there is a reasonable certainty that no harm will occur
to the
[[Page 31908]]
US Population from aggregate exposure (food, drinking water and
nonresidential) to residues of glufosinate-ammonium and metabolites.
2. Infants and children. The toxicological data base is sufficient
for evaluating prenatal and postnatal toxicity for glufosinate-
ammonium. There are no prenatal or postnatal susceptibility concerns
for infants and children, based on the results of the rat and rabbit
developmental toxicity studies and the 2-generation reproduction study.
Based on clinical signs of neurological toxicity in short and
intermediate dermal toxicity studies with rats, EPA has determined that
an added FQPA safety factor of 3x is appropriate of assessing the risk
of glufosinate-ammonium derived residues in crop commodities.
Using the conservative assumptions described in the exposure
section above, the percent of the chronic reference dose that will be
used for exposure to residues of glufosinate-ammonium in food for
children 1-6 (the most highly exposed sub group) is 67%. Infants
utilize 43% of the chronic RfD. As in the adult situation, DWLOC are
higher than the worst case drinking water estimated concentrations and
are expected to use well below 100% of the RfD, if they occur at all.
Therefore, there is a reasonable certainty that no harm will occur
to infants and children from aggregate exposure to residues of
glufosinate-ammonium.
F. International Tolerances
Maximum residue limits (Codex MRLs) for glufosinate-ammonium and
metabolites in or on cotton commodities have not been established by
the Codex Alimentarius Commission.
[FR Doc. 00-12651 Filed 5-18-00; 8:45 am]
BILLING CODE 6560-50-F