[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Notices]
[Pages 54196-54200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21280]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0170; FRL-7190-9]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0170, must be 
received on or before September 20, 2002.

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 ID 
number OPP-2002-0170 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja R. Brothers, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         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,'' ``Regulations and Proposed Rules,'' 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 ID number OPP-2002-0170. 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 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.,

[[Page 54197]]

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 ID number OPP-2002-0170 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, 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: [email protected], 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 ID number OPP-2002-0170. 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 
ID 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 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support 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.

    August 15, 2002.
Peter Caulkins,
Acting 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 Interregional Research Project Number 4 
(IR-4), and represents the view of IR-4. EPA is publishing the petition 
summary verbatim without editing it in any way. The petition summary 
announces the availability of a description of the analytical methods 
available to EPA for the detection and measurement of the pesticide 
chemical residues or an explanation of why no such method is needed.

Interregional Research Project Number 4 (IR-4)

PP 2E6404

     EPA has received a pesticide petition 2E6404 from Interregional 
Research Project Number 4 (IR-4), 681 US Highway #1 South, North 
Brunswick, NJ 08902-3390 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 180.473 by establishing a tolerance for residues of the 
herbicide glufosinate ammonium (butonoic acid, 2-amino-4-
(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-
methylphosphinico-propionic acid, expressed as 2-amino-4-
(hydroxmethylphosphinyl) butanoic acid in or on the raw agricultural 
commodities blueberry, lingonberry, juneberry, and salal at 0.10 part 
per million (ppm). This notice includes a summary of the petition 
prepared by Aventis CropScience U.S.A., P.O. Box 12014, 2 T.W. 
Alexander Drive, Research Triangle Park, NC 27709. 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 support granting of the petition. Additional data may be 
needed before EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The nature of residues found in plants as a 
result of a treatment of glufosinate-ammonium is well understood.
    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 at 
sites in New Jersey, New Hampshire, North Carolina, and Michigan. The 
treatment regime was selected to represent the use

[[Page 54198]]

pattern that is the most likely to result in the highest residues. 
Glufosinate-ammonium derived residues did not exceed 0.072 ppm in 
blueberries when sampled at 14 days or more after the last treatment.

B. Toxicological Profile

    1. Acute toxicity. Glufosinate-ammonium has been classified as 
toxicity category III for acute oral, dermal, and inhalation toxicity 
and for eye irritation. Glufosinate-ammonium is not a dermal irritant 
(toxicity category IV) nor is it a dermal sensitizer. The oral lethal 
dose (LD)50 is 2 grams/kilogram (g/kg) in male rats and 1.62 
g/kg in female rats.
    2. Genotoxicty. Based on results of a complete genotoxicity data 
base, 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 milligrams/kilogram/day (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 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 lowest 
observed adverse effect level (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 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 maternal 
toxicity was 6.3 mg/kg/day and that for developmental toxicity was 20 
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 a decreased 
number of viable pups at this dose. The NOAEL is 120 ppm.
    4. Subchronic toxicity. In a subchronic 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/carcinogenicity 
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 carcinogenic response was noted.
     In a carcinogenicity 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, technical glufosinate-ammonium 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 at the 
8.5 mg/kg/day dose level. In a rat carcinogenicity 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 were 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-propionic acid (Hoe 
061517), with lesser amounts of N-acetyl-L-glufosinate (Hoe 099730) and 
2-methylphosphinico-acetic acid (Hoe 064619).
    7. Metabolite toxicology. Additional testing has been conducted 
with the major metabolites, 3-methylphosphinico-propionic acid, and N-
acetyl-L-glufosinate. Based on subchronic and developmental toxicity 
study results, a profile of similar or less toxicity was observed for 
the metabolites as compared to the parent compound, glufosinate-
ammonium.
    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 
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 has, therefore, 
not 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. Therefore, 
an acute dietary analysis was conducted for this subpopulation; 
whereas, chronic dietary

[[Page 54199]]

analysis was conducted for the usual populations.
    i. Food. An acute dietary analysis was conducted using the Dietary 
Exposure Evaluation ModelTM (DEEM) software and the 1994-
1996 CSFII consumption data base. The analysis assumed tolerance level 
residues for all commodities and 100% of crop treated for all 
registered or pending uses. This tier one analysis resulted in an 
exposure of 0.007552 mg/kg bwt/day (95th percentile) for the female 13+ 
subpopulation (the only population of concern) representing 36% 
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. Percent crop treated values generated by the agency 
were incorporated as follows: Tree nuts 1%; apples, 1%; field corn, 
2.6%; grapes, 1%; and soybeans, 1%. Aventis CropScience estimates that 
an upper bound value for cotton at market maturity is 20% and that for 
potato is 10%. All other crops are included at 100% of crop treated. 
Chronic dietary exposure estimates from residues of glufosinate-
ammonium for the U.S. population represented approximately 25% of the 
chronic RfD; whereas that for children 1-6, the subpopulation with the 
highest exposure, represented approximately 61% of the chronic RfD. 
This analysis was based on highly conservative assumptions, yet still 
indicates that dietary exposures for all segments of the population are 
well within the chronic RfDs. The Agency has no concerns with RfD 
utilization up to 100%.
    ii. Drinking water. EPA's standard operating procedure for Drinking 
Water Exposure and Risk Assessments was used to perform the drinking 
water assessment. The models Screening Concentration in Ground Water 
(SCI-GROW) and EPA's Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM-EXAMS) were used to estimate the concentration of 
glufosinate-ammonium that might occur in water. The acute drinking 
water level of comparison (DWLOC) for females 13+ is 403 parts per 
billion (ppb). In comparison, the acute drinking water estimated 
concentrations (DWEC) calculated by the Generic Expected Environmental 
Concentration (GENEEC) is 127 ppb.
     The chronic DWLOC calculated for adults is 185 ppb and that for 
children/toddlers is 41 ppb. The chronic DWEC calculated using a worst 
case scenario is 31 ppb (GENEEC). The DWLOCs 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.
    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.
     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 and 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 U.S. population. The actual exposure is likely 
to be significantly less than predicted by this analysis as data and 
models that are more realistic are developed. Exposures below 100% of 
the RfD are generally assumed to be of no concern because the RfD dose 
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 36% of the 
acute RfD. This is a tier one highly conservative assessment and actual 
exposure is likely to be far less. DWLOCs 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. Therefore, there is a reasonable certainty that no harm will occur 
to the U.S. 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 years old 
(the most highly exposed subgroup) is 61%. Infants utilize 37% of the 
chronic RfD. As in the adult situation, DWLOCs 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

     The codex maximum residue limit for glufosinate-ammonium and 
metabolite in or on berries and other small fruits (except for 
currants) has been

[[Page 54200]]

established by the Codex Alimentarius Commission at 0.10 ppm.
[FR Doc. 02-21280 Filed 8-16-02; 4:19 pm]
BILLING CODE 6560-50-S