[Federal Register Volume 62, Number 120 (Monday, June 23, 1997)]
[Notices]
[Pages 33864-33868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16355]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-745; FRL-5722-8]


Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Comments, identified by the docket control number PF-745, must 
be received on or before July 23, 1997.
ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7506C), Office of Pesticides 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.
    Comments and data may also be submitted electronically by following 
the instructions under ``SUPPLEMENTARY INFORMATION.'' No confidential 
business information should be submitted through e-mail.
    Information submitted as a comment concerning this document 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 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays.

FOR FURTHER INFORMATION CONTACT: By mail: Jim Tompkins, Product Manager 
(PM) 25, Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Office location, telephone number, and e-mail address: Rm. 239, CM #2, 
1921 Jefferson Davis Highway, Arlington, VA 22202, 703-305-5697, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: EPA has received pesticide petitions as 
follows proposing the establishment and/or amendment of regulations for 
residues of certain pesticide chemicals in or on various food 
commodities under section 408 of the Federal Food, Drug, and Comestic 
Act (FFDCA), 21 U.S.C. 346a. EPA has determined that these petitions 
contain 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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.
    The official record for this notice of filing, as well as the 
public version, has been established for this notice of filing under 
docket control number PF-745 (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 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The official record is located at the address in 
``ADDRESSES'' at the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment 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 control number PF-745 and appropriate petition 
number. Electronic comments on this notice may be filed online at many 
Federal Depository Libraries.

List of Subjects

    Environmental protection, Agricultural commodities, Food additives, 
Feed additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: June 13, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The summaries of the 
petitions were prepared by the petitioners and represent the views of 
the petitioners. EPA is publishing the petition summaries verbatim 
without editing them 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.

Monsanto Company

PP 6F4620

    EPA has received a pesticide petition (PP 6F4620) from the Monsanto 
Company, 700 14th St., NW., Suite 1100, Washington, DC 20005 pursuant 
to section 408(d) of FFDCA, as amended, 21 U.S.C. 346a(d), by the Food 
Quality Protection Act of 1996 (Pub. L. 104-170, 110 Stat. 1489) 
proposing to amend 40 CFR 180.479 by establishing tolerance for 
residues of the herbicide, halosulfuron-methyl: (methyl 5-[(4,6-
dimethoxy-2-pyrimidinyl)amino] carbon-ylaminosul-fonyl-3-chloro-1-
methyl-1H-pyrazole-4-carbo-xylate), in or on the raw agricultural 
commodity sugarcane, cane at 0.05 ppm. EPA has determined that the 
petition contains data or information regarding the elements set forth 
in section 408(d)(2); however, EPA has not fully evaluated the 
sufficieny of 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.
    The proposed analytical method for determining residues is by gas 
chromatography with an electron-capture detection.
    The following is a summary of the information submitted to EPA to 
support the establishment, under section 408(b)(2)(D) of the amended 
FFDCA, of a tolerance for halosulfuron-methyl in sugarcane. 
Halosulfuron-methyl is a selective herbicide for the control of annual 
broadleaf weeds and nutsedge in field corn, milo, turf,

[[Page 33865]]

sugarcane, sweet corn/popcorn and other crops which is effective at low 
use rates. It may be applied pre-emergent, pre-plant incorporated, or 
postemergent in field corn. Single or sequential postemergence 
application rates are effective in milo, turf, and sugarcane.

A. Plant Metabolism and Analytical Method

    The metabolism of halosulfuron-methyl as well as the nature of the 
residues is adequately understood for purposes of the tolerances. 
Metabolism depends on the mode of application. Preemergent applications 
result in rapid soil degradation of halosulfuron-methyl followed by 
crop uptake of the resulting pyrazole moiety. The pyrimidine ring binds 
tightly to soil and is eventually converted to carbon dioxide by 
microbial degradation. In postemergent applications, little metabolism 
and translocation take place resulting in unmetabolized parent compound 
as the major residue on the directly treated foliar surfaces. Very low 
levels of residues are found in the grain. In the sugarcane residue 
study, no residues at or above the limit of quantitation of 0.05 parts 
per million (ppm) were observed even from samples obtained when the 
exaggerated rate (>10x) was applied.
    An adequate analytical method, gas chromatography with an electron-
capture detector, is available for enforcement purposes with a limit of 
detection that allows monitoring of food with residues at or above the 
levels set in these tolerances. The field corn and grain sorghum (milo) 
enforcement methodology has been submitted to the Food and Drug 
Administration for publication in the Pesticide Analytical Manual, Vol. 
II (PAM II). This method underwent independent laboratory validation 
and validation at the Beltsville laboratory. The Analytical Chemistry 
section of the EPA concluded that the method is adequate for 
enforcement. Analytical method is also available for analyzing meat by-
products which also underwent successful independent laboratory and 
Beltsville laboratory validations.

B. Toxicological Profile of Halosulfuron-methyl

    The toxicological data has been deemed complete by EPA. Data 
considered in support of the tolerance include:
    1. Acute toxicological studies placing the technical-grade 
halosulfuron in Toxicity Category III.
    2. A 90-day feeding study in rats resulted in a lowest-observed-
effect-level (LOEL) of 497 milligrams/kilograms/day (mg/kg/day) in 
males and 640 mg/kg/day in females, and a no-observed-effect-level 
(NOEL) of 116 mg/kg/day in males and 147 mg/kg/day in females.
    3. A 21-day dermal toxicity study in rats resulted in a NOEL of 100 
mg/kg/day in males and greater than 1,000 mg/kg/day in females. The 
only treatment-related effect was a decrease in body weight gain of the 
1,000 mg/kg/day group in males.
     4. A 1-year chronic oral study in dogs resulted in a LOEL of 40 
mg/kg/day based on decreased weight gain and a NOEL of 10 mg/kg/day for 
systemic toxicity.
    5. A 78-week carcinogenicity study was performed on mice. Males in 
the 971.6 mg/kg/day group had decreased body weight gains and an 
increased incidence of microconcretion/mineralization in the testis and 
epididymis. No treatment-related effects were noted in females. Based 
on these results, a LOEL of 971.9 mg/kg/day was established in males 
and NOEL's of 410 mg/kg/day in males and 1,214.6 mg/kg/day in females 
were established. The study showed no evidence of carcinogenicity.
    6. A combined chronic toxicity/carcinogenicity study in rats 
resulted in a LOEL of 225.2 mg/kg/day in males and 138.6 mg/kg/day in 
females based on decreased body weight gains, and a NOEL of 108.3 mg/
kg/day in males and 56.3 mg/kg/day in females. The study showed no 
evidence of carcinogenicity.
    7. A developmental toxicity study in rats resulted in a 
developmental LOEL of 750 mg/kg/day, based on decreases in mean litter 
size and fetal body weight, and increases in resorptions, resorptions/
dam, post-implantation loss and in fetal and litter incidences of soft 
tissue and skeletal variations, and a developmental NOEL of 250 mg/kg/
day. Maternal LOEL was 750 mg/kg/day based on increased incidence of 
clinical observations, reduced body weight gains, and reduced food 
consumption and food efficiency. The maternal NOEL was 250 mg/kg/day.
    8. A developmental toxicity study in rabbits resulted in a 
developmental LOEL of 150 mg/kg/day, based on decreased mean litter 
size and increases in resorptions, resorptions/dam and post-
implantation loss, and a developmental NOEL of 50 mg/kg/day. The 
maternal LOEL was 150 mg/kg/day based on reduced body weight gain and 
reduced food consumption and food efficiency. The maternal NOEL was 50 
mg/kg/day.
    9. A dietary two-generation reproduction study in rats resulted in 
parental toxicity at 223.2 mg/kg/day in males and 261.4 mg/kg/day in 
females in the form of decreased body weights, decreased body weight 
gains, and reduced food consumption during the premating period. Very 
slight effects were noted in body weight of the offspring at this dose. 
This effect was considered to be developmental toxicity (developmental 
delay) rather than a reproductive effect. No effects were noted on 
reproductive or other developmental toxicity parameters. The systemic/
developmental toxicity LOEL was 223.2 mg/kg/day in males and 261.4 mg/
kg/day in females; the systemic/developmental toxicity NOEL was 50.4 
mg/kg/day in males and 58.7 mg/kg/day in females. The reproductive LOEL 
was greater than 223.2 mg/kg/day in males and 261.4 mg/kg/day in 
females; the reproductive NOEL was equal to or greater than 223.2 mg/
kg/day in males and 261.4 mg/kg/day in females.
    10. Bacterial/mammalian microsomal mutagenicity assays were 
performed and found not to be mutagenic.
    11. Two mutagenicity studies were performed to test gene mutation 
and found to produce no chromosomal aberrations or gene mutations in 
cultured Chinese hamster ovary cells.
    12. An in vivo mouse micronucleus assay did not cause a significant 
increase in the frequency of micronucleated polychromatic erythrocytes 
in bone marrow cells.
    13. A mutagenicity study was performed on rats and found not to 
induce unscheduled DNA synthesis in primary rat hepatocytes.
    14. A metabolism study in rats resulted in the administered dose 
being absorbed rapidly and incompletely. Most of the test article was 
eliminated by urine and feces within 72 hours, and appeared to be 
independent of dose and sex.
Threshold Effects
    Chronic effects. Based on the complete and reliable toxicity data 
base, EPA has adopted a Reference Dose (RfD) value of 0.1 mg/kg body 
weight/day based on a NOEL of 10.0 mg/kg body weight/day from a one-
year dog feeding study and an uncertainty factor of 100. EPA has 
concluded that the toxicity of the metabolite is lower compared to the 
parent compound and is not a residue of concern (see metabolite 
toxicity section below).
    Acute effects. EPA has determined that the appropriate NOEL to use 
to assess safety in acute exposure is 50 mg/kg body weight/day from a 
developmental toxicity study in rabbits. EPA has concluded that the 
subpopulation of concern for this endpoint are females older than 13 
years old.
Non-threshold Effects

[[Page 33866]]

    Carcinogenicity. EPA's Office of Pesticide Programs' Health Effects 
Division's Carcinogenicity Peer Review Committee (CPRC) has classified 
halosulfuron-methyl in Group E (evidence of noncarcinogenicity for 
humans) under the Agency's ``Guidelines for Carcinogen Risk 
Assessment'' published in the Federal Register of September 24, 1986 
(51 FR 33992). In its evaluation, CPRC gave consideration to body 
weight gain changes and changes in hematological and blood chemistry 
parameters in the 1-year feeding study in dogs. Hence, there are no 
non-threshold effects associated with the compound and cancer risk 
assessment is not appropriate.
    Metabolite toxicity. The following toxicology studies were 
conducted with the metabolite, 3-chloro-1-methyl-5-sulfamoylpyrazole-4-
carboxylic acid (3-CSA). Based on the toxicological data of the 3-CSA 
metabolite, EPA has concluded that it appears to be of lower toxicity 
compared to the parent compound and that it should not be included in 
the tolerance expression. The residue of concern is the parent compound 
only.
    (1) A 90-day rat feeding study resulted in a LOEL in males of 
>20,000 ppm and a NOEL of 20,000 ppm (1,400 mg/kg/day). In 
females, the LEL is 10,000 ppm (772.8 mg/kg/day) based on decreased 
body weight gains and a NOEL of 1,000 ppm (75.8 mg/kg/day).
    (2) A developmental toxicity resulted in a LOEL for maternal 
toxicity of >1,000 mg/kg/day based on the absence of systemic toxicity, 
a NOEL of 1,000 mg/kg/day. The developmental LOEL is >1,000 
mg/kg/day and the NOEL is 1,000 mg/kg/day.
    (3) The microbial reverse gene mutation did not produce any 
mutagenic effect while the mammalian cell gene mutation/chinese hamster 
ovary cells showed no clear evidence of mutagenic effect in the Chinese 
hamster ovary cells.
    (4) The mouse micronucleus assay did not show any clastogenic or 
aneugenic effect.

C. Aggregate Exposure

    1. Dietary exposure. For purposes of assessing the potential 
dietary exposure from food under the proposed tolerances, Monsanto has 
estimated aggregate exposure based on the Theoretical Maximum Residue 
Contribution (TMRC) from established tolerances, viz.; tolerances in or 
on the following raw agricultural commodities, field corn, grain at 0.1 
ppm; field corn, forage at 0.3 ppm; field corn, fodder at 1.5 ppm; 
grain sorghum (milo) grain at 0.1 ppm; grain sorghum (milo) forage at 
0.1 ppm; grain sorghum (milo) fodder/stover at 0.1 ppm; and meat and 
meat byproducts (cattle, goats, hogs, horses, and sheep) at 0.1 ppm as 
well as proposed tolerances, viz.; on sugarcane and sweet corn/popcorn 
(included in another submission under PP 6F4661). Field corn forage and 
fodder as well as sorghum forage and fodder/stover are fed to animals, 
thus exposure of humans to residues from these commodities might result 
if such residues are transferred to meat, milk, poultry, or eggs. 
However, based on the results of a animal metabolism study and the 
amount of halosulfuron-methyl expected in animal feed, Monsanto has 
concluded that there is no reasonable expectation that residues of 
halosulfuron-methyl will exceed existing tolerances in meat. EPA has 
concluded that regulation of animal commodities and poultry products 
are not required.
    TMRC is obtained by multiplying the tolerance levels for each 
commodity by consumption data which estimates the amount of crops and 
related food stuff consumed by the U.S. population and various 
population subgroups. In conducting this exposure assessment, Monsanto 
has made very conservative assumptions, e.g., 100% of all commodities 
will contain halosulfuron-methyl residues and those residues would be 
at the level of their respective tolerances. This results in a large 
overestimate of human exposure. Even with these conservative 
assumptions, the potential dietary exposure to halosulfuron from 
consumption of products for which it is currently labeled and proposed 
represents only 0.6% of the RfD for the general population.
    2. Dietary (drinking water) exposure. There is no Maximum 
Contaminant Level (MCL) established for residues of halosulfuron-methyl 
nor is it listed for MCL development or monitoring in drinking water 
supplies under the Safe Drinking Water Act. It is not a target of EPA's 
National Survey of Wells for Pesticides. Monsanto is not aware of 
halosulfuron-methyl being detected in any wells, ponds, lakes, streams, 
etc. from its use in the United States. A Lifetime Health Advisory 
Level (HAL) calculated by EPA procedures may be used as a preliminary 
acceptable level in drinking water. The calculated level is 700 ppb 
assuming a 20% relative contribution from water which is high enough to 
provide ample margin of safety. In addition, EPA has concluded that 
potential levels of halosulfuron-methyl in soil and water do not appear 
to have toxicological effects on humans or animals. No effects were 
observed on a variety of animals at concentrations several orders of 
magnitude greater than would likely occur in soil, ground water, or 
surface water.
    Based on the very low level of mammalian toxicity, lack of other 
toxicological concerns coupled with low use rates, Monsanto believes 
that there is reasonable certainty that no harm will result from 
dietary exposure to halosulfuron-methyl since dietary exposure to 
residues on food will use only a small fraction of the RfD and any 
contribution through drinking water is expected to be insignificant.
    3. Non-dietary exposure. Halosulfuron-methyl is labeled for use on 
commercial and residential turf and other non-crop sites which could 
have minimal opportunity for exposure. The other uses which are 
agricultural including the proposed uses (sugarcane and sweet corn/
popcorn) will not increase the non-occupational exposure appreciably, 
if at all. Any exposure to halosulfuron-methyl resulting from turf use 
will result from dermal exposure during application and will be limited 
because of low use rates. In the 21-day dermal study, no treatment 
related adverse effects were observed and the NOAEL was determined to 
be greater than the highest dose level tested, 1000 mg/kg. 
Halosulfuron-methyl is non-volatile with a vapor pressure of <1 x 10-7 
mm Hg, hence, inhalation exposure during and after application will not 
add significantly to aggregate exposure. Based on the physical and 
chemical characteristics, low use rates, low acute toxicity and lack of 
other toxicological concerns, Monsanto believes that the risk posed by 
non-occupational exposure to halosulfuron-methyl is minimal.

D. Cumulative Effect

    Halosulfuron-methyl belongs to the sulfonyl urea class of 
compounds. The mode of action of halosulfuron-methyl is the inhibition 
of the plant enzyme aceto lactase synthetase, which is essential for 
the production of required amino acid in the plant. Although other 
registered sulfonyl ureas may have similar herbicidal mode of action, 
there is no information available to suggest that these compounds 
exhibit a similar toxicity profile in the mammalian system that would 
be cumulative with halosulfuron-methyl. Thus, consideration of a common 
mechanism of toxicity is not appropriate at this time. Monsanto is 
considering only the potential risks of halosulfuron-methyl in its 
aggregate exposure assessment.

[[Page 33867]]

E. Determination of Safety for U.S. Population

    1. Chronic dietary exposure. The Agency has concluded that the 
aggregate exposure to halosulfuron-methyl from the previously 
established tolerances is 0.00051 mg/kg of body weight/day for the 
general population utilizing 0.051% of the RfD. The exposure 
contribution from the proposed uses in sugarcane and sweetcorn/popcorn 
when combined with exposure from established tolerances is calculated 
to be 0.6% of the RfD over all U.S. population and considered to be 
minimal. EPA generally has no concern for exposures below 100 percent 
of the RfD for the U.S. population 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. Toxicology data indicating 
low potential for mammalian toxicity and lack of other toxicity 
concerns plus the conservative assumptions used here support the 
conclusion that there is a ``reasonable certainty of no harm'' from 
aggregate exposure to halosulfuron-methyl residues from all anticipated 
dietary exposures and all other non-occupational exposures.
    2. Acute dietary exposure. The detailed DRES acute exposure 
analysis conducted by EPA evaluates individual food consumption as 
reported by respondents in the USDA 77-78 Nationwide Food Consumption 
Survey (NFCS) and estimates the distribution of single day exposures 
through the diet for the US population and certain subgroups. Since the 
toxicological effect to which high end exposure is compared is 
developmental toxicity, EPA determined that the DRES subgroup of 
concern is females (13+ years) which approximates women of child-
bearing age. The Margin of Exposure (MOE) is a measure of how closely 
the high end exposure comes to the NOEL, and is calculated as the ratio 
of the NOEL to the exposure (NOEL/exposure = MOE). For toxicological 
endpoints established based upon animal studies, the agency is 
generally not concerned unless the MOE is below 100. In this analysis, 
EPA used tolerance level residues to calculate the exposure of the 
highest exposed individual (females, 13+ year subgroup). High end 
exposure for this subgroup resulted in an MOE in excess of 30,000. EPA 
concluded that acute dietary exposure to halosulfuron-methyl does not 
represent a risk concern. Monsanto's calculation of the MOE which 
included proposed tolerances for sugarcane and sweet corn/popcorn was 
24,732.

F. Safety Determination for Infants and Children

    In assessing the potential for additional sensitivity of infants 
and children to residues of halosulfuron-methyl, Monsanto considered 
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 the potential for adverse effects on 
the developing organism resulting from exposure during prenatal 
development to the female parent. Reproduction studies provide 
information relating to effects from exposure to the chemical on the 
reproductive capability of both (mating) parents and on systemic 
toxicity.
    In a developmental toxicity study in the rat, the NOEL for both 
maternal and developmental toxicity was considered to be 250 mg/kg/day. 
In a developmental toxicity study in rabbits, a NOEL for both 
developmental and maternal toxicity was considered to be 50 mg/kg/day. 
A dietary two-generation reproduction study in rats resulted in 
parental toxicity at 223.2 mg/kg/day in males and 261.4 mg/kg/day in 
females in the form of decreased body weights, decreased body weight 
gains, and reduced food consumption during the premating period. Very 
slight effects were noted in body weight of the offspring at this dose. 
This effect was considered to be developmental toxicity (developmental 
delay) rather than a reproductive effect. No effects were noted on 
reproductive or other developmental toxicity parameters. The systemic/
developmental toxicity NOEL was 50.4 mg/kg/day in males and 58.7 mg/kg/
day in females. The reproductive NOEL was equal to or greater than 
223.2 mg/kg/day in males and 261.4 mg/kg/day in females. In all cases, 
the reproductive and developmental NOELs were greater than the NOEL on 
which the RfD was based, thus allowing for an additional margin of 
safety and indicating that halosulfuron-methyl does not pose any 
increased risk to infants or children.
    Chronic analysis. Using the conservative dietary exposure 
assumptions described above, EPA has established that the TMRC for the 
most exposed subgroups is 0.0012 mg/kg body weight/day for nonnursing 
infants (less than 1 year old) and 0.0010 mg/kg body weight/day for 
children (1 to 6 years old), and that this aggregate exposure to 
residues of halosulfuron-methyl utilizes only 1.17 and 1.01 percent of 
the RfD, respectively when existing tolerances are considered. 
Monsanto's analysis included contribution from sugarcane and sweet 
corn/popcorn exposures and the additional amount of the RfD utilized 
was minimal (1.7 and 1.3%), respectively.
    FFDCA section 408 provides that EPA may apply an additional safety 
factor (up to 10) in the case of threshold effects for infants and 
children to account for pre- and post-natal toxicity and the 
completeness of the data base. Based on current toxicological data 
requirements, the data base relative to preand post-natal effects in 
children is complete. Further, the NOEL of 10 mg/kg/day from the 1-year 
feeding study in dogs, which was used to calculate the RfD (discussed 
above), is already lower than the NOELs from the reproductive and 
developmental studies with halosulfuron-methyl by a factor of at least 
25- and 5-fold, respectively. Therefore, an additional safety factor is 
not warranted and an RfD of 0.1 mg/kg/day is appropriate for assessing 
aggregate risk to infants and children.
    Therefore, based on complete and reliable toxicity data and the 
conservative exposure assessment, Monsanto concludes that there is 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to halosulfuron-methyl residues.

G. Estrogenic Effects

    No specific tests have been conducted with halosulfuron-methyl to 
determine whether the chemical may have an effect in humans that is 
similar to an effect produced by a naturally occuring estrogen or other 
endocrine effects. However, there were no significant findings in other 
relevant toxicity tests, i.e., teratology and multi-generation 
reproduction studies, which would suggest that halosulfuron-methyl 
produces effects characteristic of the disruption of the estrogenic 
hormone.

H. International Tolerances

    Maximum residue levels have not been established for residues of 
halosulfuron-methyl on corn, sorghum, sugarcane or sweet corn or any 
other food or feed crop by the Codex Alimentarius Commission.

PP 6F4661

    EPA has received a pesticide petition (PP 6F4661) from the Monsanto 
Company, 700 14th St., NW., Suite 1100, Washington, DC 20005 pursuant 
to section 408(d) of FFDCA, as amended, 21 U.S.C. 346a(d), by FQPA 
(Pub. L. 104-170, 110 Stat. 1489) proposing to amend 40 CFR part 
180.479 by establishing tolerance for residues of the herbicide, 
halosulfuron-

[[Page 33868]]

methyl: (methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbon-
ylaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate), in or on 
the raw agricultural commodity sweet corn, sweet corn (kernel plus cobs 
with husks removed) at 0.1 ppm, sweet corn forage at 0.5 ppm and sweet 
corn fodder/stover at 1.5 ppm and pop corn grain at 0.1 ppm and pop 
corn stover/fodder at 1.5 ppm. EPA has determined that the petition 
contains data or information regarding the elements set forth in 
section 408(d)(2); however, EPA has not fully evaluated the sufficieny 
of 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.
    The proposed analytical method for determining residues is by gas 
chromatography with an electron-capture detection.
    EPA, as mentioned above, is in the process of evaluating the 
petition. With one exception, the summary for PP 6F4661 is identical to 
the summary of PP 6F4620 as outlined above, therefore it is not 
restated. With regards to the exception, the sugarcane residues study 
discussed in the first paragraph, last sentence of Unit A of the PP 
6F4620 summary was not included in the PP 6F4661 summary.

[FR Doc. 97-16355 Filed 6-20-97; 8:45 am]
BILLING CODE 6560-50-F