[Federal Register: June 3, 2002 (Volume 67, Number 106)]
[Notices]               
[Page 38276-38279]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jn02-51]                         

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0078; FRL-7179-2]

 
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

[[Page 38277]]

pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number OPP-2002-0078, 
must be received on or before July 3, 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 
control number OPP-2002-0078 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: By mail: Shaja Brothers, Registration 
Support Branch, Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-3194 and e-mail 
address: brothers.shaja@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 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 control number OPP-2002-0078 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., 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 OPP-2002-0078 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: 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 OPP-2002-0078. 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

[[Page 38278]]

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.

    Dated: May 17,2002.
Robert Forrest,
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, 
and represents the view of the Interreional Research Project. 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.

PP 1E6322

     EPA has received a pesticide petition (1E6322) from the 
Interregional Research Project Number 4, 681 U.S. Highway 1 South, 
North Brunswick, New Jersey 08902-3390] proposing, pursuant to section 
408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.479 by 
establishing a tolerance for residues of the herbicide [halosulfuron, 
methyl 5-[(4,6-dimethoxy-2-pyrimidinyl) amino]carbonylaminosulfonyl-3-
chloro-1-methyl-1H-pyrazole-4-carboxylate] in or on the raw 
agricultural commodities (RAC) dry bean and succulent snap bean at 0.05 
parts per million (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 
support granting of the petition. Additional data may be needed before 
EPA rules on the petition. This notice includes a summary of the 
petition prepared by Gowan Company, Yuma, Arizona 85366.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of halosulfuron-methyl as well 
as the nature of the residues in plants is adequately understood for 
purposes of this tolerance.
    2. Analytical method. A practical analytical method, gas 
chromatography with a nitrogen specific detector (TSD) which detects 
and measures residues of halosulfuron-methyl, 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. 
This enforcement method has been submitted to the Food and Drug 
Administration for publication in the Pesticide Analytical Manual (PAM 
II). It has undergone independent laboratory validation and validation 
at the Beltsville laboratory.
    3. Magnitude of residues. In snap and dry bean residue studies, 
there were no quantifiable residues found in the RAC using an 
analytical method with limit of quantitation (LOQ) of 0.05 ppm.

B. Toxicological Profile

    The nature of the toxic effects caused by halosulfuron-methyl is 
discussed in unit II.B of the Federal Register on April 31, 2001 (66 FR 
45993) (FRL-6796-1).

C. Aggregate Exposure

    1. Dietary exposure. Tolerances have been established (40 CFR 
180.479) for residues of halosulfuron-methyl in or on a variety of 
plant and animal RACs.
    i. Food-- a. Acute exposure. For purposes of assessing the 
potential dietary exposure from food under existing and proposed 
tolerances, the aggregate exposure is based on the Theoretical Maximum 
Residue Contribution (TMRC) which is an estimate of the level of 
residues consumed daily if each food item contained pesticide residues 
equal to the tolerance.
    The calculated TMRC value using the 99.9th percentile 
consumption data was 0.006 milligrams/kilograms bodyweight day (mg/kg 
bwt day) or 1.2% acute Reference Dose (aRfD) for the general U.S. 
population. TMRC is obtained by multiplying the tolerance levels for 
each commodity by the daily consumption of the food forms of that 
commodity eaten by the U.S. population and various population 
subgroups.
    In conducting this exposure assessment, conservative assumptions 
were made resulting in a large overestimate of human exposure. Thus, 
the dietary exposures to halosulfuron-methyl are less 3.0% aRfD for all 
sub-populations. Food consumption data from DEEM software were used in 
the calculation.
    b. Chronic exposure. The chronic Reference Dose (cRfD) is 0.1 mg/
kg/day. For all established and proposed tolerances of halosulfuron-
methyl, the calculated TMRC value for the U.S. population is 0.00049 
mg/kg/day or 0.5% RfD.
    ii. Drinking water. The estimated environmental concentrations 
(EECs) in ground water (acute and chronic) is 0.008 [mu]g/L. The 
estimated EECs (acute and chronic) for surface water are 4.3 [mu]g/L 
and 1.1 [mu]g/L, respectively. These estimates are based on a maximum 
application rate of 0.063 lbs. active per acre, which may be applied 
twice per season. There is no Maximum Contaminant Level (MCL) 
established for residues of halosulfuron-methyl.
    2. Non-dietary exposure. The non-dietary exposure assessment for 
halosulfuron-methyl is discussed in unit II.C of the Federal Register 
on April 31, 2001 (66 FR 45993) (FRL-6796-1).

D. Cumulative Effects

    The potential for cumulative effects for halosulfuron-methyl is 
discussed in unit II.D of the Federal Register on April 31, 2001 (66 FR 
45993) (FRL-6796-1).

E. Safety Determination

    1. U.S. population. Aggregate chronic exposure to halosulfuron-
methyl from ``food only'' utilizes less than 1% of the chronic 
populated adjusted dose (cPAD) for the most sensitive subgroup, 
children (1-6 years). The lowest drinking water level of concern 
(DWLOC) calculated was 1,000 [mu]g/L for infants and children which is 
significantly higher than the EEC for chronic ground water (0.008 
[mu]g/L) and surface water (1.1 [mu]g/L). As a result, the aggregate 
risk from chronic exposure to halosulfuron-methyl residues from all 
anticipated dietary exposures does not pose appreciable risks to human 
health.
     Short-term risk--short-term aggregate exposure takes into account 
chronic dietary food and water plus short-term residential exposure. 
For halosulfuron-methyl, the EPA has determined that it is appropriate 
to aggregate exposure via

[[Page 38279]]

oral exposure route (food and water) with those via oral and dermal 
exposure routes from residential uses. The MOEs for ``food only'' and 
residential exposure routes are 113, 600, and 330 for females 13+ 
years. Short-term DWLOC for females 13+ is 10,000 [mu]g/L which is 
substantially higher than the EECs for acute surface water (4.3 [mu]g/
L). The food only and residential (oral and dermal) MOEs are well above 
the acceptable short-term aggregate MOE of 100. Therefore, exposure to 
halosulfuron-methyl residues resulting from current and proposed uses 
does not pose a short-term aggregate risk.
     Intermediate-term risk--intermediate-term aggregate exposure takes 
into account chronic dietary food and water plus intermediate-term 
residential exposure. The MOEs for ``food only'' and residential 
exposure routes are 22,800 and 120 for adult males, and 23,000 and 100 
for females 13+ years. The intermediate-term DWLOCs are 590 [mu]g/L and 
57 [mu]g/L, respectively, for adult males and females 13+. 
Intermediate-term DWLOCs are substantially higher than the EEC for 
chronic surface water (1.1 [mu]g/L). The food only and residential 
(dermal) MOEs are above the acceptable short-term aggregate MOE of 100. 
Therefore, exposure to halosulfuron-methyl residues resulting from 
current and proposed uses does not pose a intermediate-term aggregate 
risk.
     Halosulfuron-methyl has been classified as a Group E chemical 
based upon the lack of evidence of carcinogenicity in mice and rats, 
and has been classified as not likely to be a human carcinogen.
    Therefore based upon this risk assessment, there is reasonable 
certainty that no harm will result from aggregate exposure to 
halosulfuron-methyl residues resulting from current and proposed uses.
    2. Infants and children. 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-natal and post-
natal toxicity and the completeness of the data base. Except for the 
pending request for a developmental neurotoxicity study, the toxicity 
data base is complete for halosulfuron-methyl.
     The chronic RfD was determined to be 0.1 mg/kg/day based upon the 
chronic dog study. The percent of RfD occupied is 0.9% for the most 
sensitive population subgroup, children (1-6 years old). The DWLOC for 
chronic exposure for infants and children is 1,000 [mu]g/L and is 
significantly greater than the maximum concentration of halosulfuron-
methyl in drinking water (0.008 [mu]g/L in ground water and 1.1 [mu]g/L 
in surface water).
     Based upon reliable toxicity data, the use of an additional 10X 
safety factor is not warranted. Dietary assessments do not indicate a 
level of concern for potential risks to infants and children based upon 
the low use rates of halosulfuron-methyl, and the results of field and 
animal RAC studies conclude that detectable residues are not expected 
in human foods.
     Therefore, based on complete and reliable toxicity data and the 
conservative exposure assessment, it is concluded that there is 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to halosulfuron-methyl residues with respect to 
the proposed new uses on dry and succulent snap beans.

F. International Tolerances

     Maximum residue levels have not been established for residues of 
halosulfuron-methyl on any food or feed crop by the Codex Alimentarius 
Commission.
[FR Doc. 02-13814 Filed 5-31-02 8:45 am]
BILLING CODE 6560-50-S