[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Rules and Regulations]
[Pages 15120-15125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7502]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301227; FRL-6829-8]
RIN 2070-AB78


Foramsulfuron; Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of foramsulfuron on corn when applied/used 
as a herbicide. Aventis CropScience USA LP submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act, as amended by the Food 
Quality Protection Act of 1996, requesting tolerances for foramsulfuron 
on corn commodities. After review of the data submitted in support to 
the petition for tolerances, EPA determined that the toxicological 
profile of foramsulfuron supports a tolerance exemption for this 
chemical as no adverse effects were observed in the submitted 
toxicological studies regardless of the route of exposure. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of foramsulfuron.

DATES: This regulation is effective March 29, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301227, 
must be received on or before May 28, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301227 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, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 305-6224; 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 Potentially
             Categories                 NAICS       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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development. To access the OPPTS Harmonized Guidelines referenced 
in this document, go directly to the guidelines at http://www.gpo.gov/opptsfrs/home/guidelin.htm

[[Page 15121]]

    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301227. The official record 
consists of the documents specifically referenced in this action, 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 Hwy., 
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.

II. Background and Statutory Findings

    In the Federal Register of February 7, 2001 (66 FR 9319-9323) (FRL-
6765-6), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170), announcing the 
filing of a pesticide tolerance petition (PP 0F6161) by Aventis 
CropScience USA LP, P.O. Box 12014, 2 T.W. Alexander Drive, Research 
Triangle Park, NC 27709. This notice included a summary of the petition 
prepared by the petitioner Aventis CropScience USA LP. There were no 
comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of foramsulfuron on corn grain, 
corn forage, and corn stover. After review of the data submitted in 
support of the petition for tolerances, EPA determined that the 
toxicological profile of foramsulfuron supports a tolerance exemption 
for this chemical as no adverse effects were observed in the submitted 
toxicological studies regardless of the route of exposure.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. The nature of the toxic effects caused by 
foramsulfuron are discussed in the following Table 1 as well as the no 
observed adverse effect level (NOAEL). There was no lowest observed 
adverse effect level (LOAEL) in any of the subchronic or chronic 
toxicity studies reviewed.

                                Table 1.--Subchronic, Chronic, and Other Toxicity
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             Guideline No.                       Study Type                            Results
----------------------------------------------------------------------------------------------------------------
870.1100                                 Acute Oral                  LD50>5,000 mg/kg
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870.1200                                 Acute Dermal                LD50>2,000 mg/kg
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870.1300                                 Acute Inhalation            LC50>5.04 mg/L
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870.2400                                 Primary Eye Irritation      Mild eye irritant
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870.2500                                 Primary Skin Irritation     Not a dermal irritant
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870.2600                                 Dermal Sensitization        Not a dermal sensitizer
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870.3100                                 90-Day oral toxicity        NOAEL = 1,002 mg/kg/day, Highest Dose
                                          rodents                     Tested (HDT)
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870.3150                                 90-Day oral toxicity in     NOAEL = 1,000 mg/kg/day, HDT
                                          nonrodents
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870.3200                                 21/28-Day dermal toxicity   NOAEL = 1,000 mg/kg/day, HDT
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870.3700                                 Prenatal developmental in   Maternal and Developmental NOAEL = 1,000 mg/
                                          rodents                     kg/day, HDT
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870.3700                                 Prenatal developmental in   Maternal and Developmental NOAEL = 500 mg/
                                          nonrodents                  kg/day, HDT
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[[Page 15122]]

 
870.3800                                 Reproduction and fertility  Parental/Systemic, Reproductive and
                                          effects                     Offspring NOAEL = 1,082 mg/kg/day, HDT
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870.4100/870.4200                        Chronic toxicity and        NOAEL = 849 mg/kg/day, HDT
                                          Carcinogenicity rodents    No evidence of carcinogenicity
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870.4100                                 Chronic toxicity dogs       NOAEL = 1,000 mg/kg/day, HDT
----------------------------------------------------------------------------------------------------------------
870.4300                                 Carcinogenicity mice        NOAEL = 1,115 mg/kg/day, HDT
                                                                     No evidence of carcinogenicity
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870.5100                                 Gene Mutation               Negative
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870.5375                                 Cytogenetics                Negative
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870.5385                                 Other Effects               Negative
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870.7485                                 Metabolism and              Primarily excreted in feces as parent
                                          pharmacokinetics            compound within 3 days of oral dosing.
----------------------------------------------------------------------------------------------------------------

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non- occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    Due to low toxicity, it was determined that a dietary risk 
assessment of foramsulfuron in food is not needed and, therefore, none 
was conducted.
    1. Food--i. Acute exposure. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a one day or single exposure. Since the acute toxicity is low 
(toxicity categories III and IV) for all tests conducted, the 
occurrence of an effect of concern as a result of a one day or single 
exposure is highly unlikely, and, therefore, an acute dietary risk 
assessment was not conducted.
    ii. Chronic exposure. There were no observed adverse effects at the 
highest dose tested (500 mg/kg/day or higher) in any of the subchronic 
or chronic toxicity tests conducted. The August 1998 OPPTS Series 870 
Harmonized Test Guidelines for health effects recommend for subchronic 
and chronic testing the highest dose tested should not exceed 1,000 mg/
kg/day using the procedures described for these studies, unless 
potential human exposure data indicate the need for higher doses. A 
dose of 1,000 mg/kg/day is equivalent to a diet in which the pesticide 
comprises approximately 7% of dietary consumption. Similarly, the 
lowest high dose tested in the studies, 500 mg/kg/day, is equivalent to 
a diet in which the pesticide comprises approximately 3.5% of the 
dietary consumption. In normal food consumption, humans would be 
exposed to much less foramsulfuron than 3.5% of the dietary 
consumption. Therefore, it was determined that a chronic dietary risk 
assessment of foramsulfuron in food is not needed and, therefore, none 
was conducted.
    2. Drinking water exposure. The Agency uses the First Index 
Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure 
Analysis Modeling System (PRZM/EXAMS), to produce estimates of 
pesticide concentrations in an index reservoir. The screening 
concentration in groundwater (SCI-GROW) model is used to predict 
pesticide concentrations in shallow groundwater. For a screening-level 
assessment for surface water EPA will use FIRST (a tier 1 model) before 
using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the 
PRZM/EXAMS model that uses a specific high-end runoff scenario for 
pesticides. While both FIRST and PRZM/EXAMS incorporate an index 
reservoir environment, the PRZM/EXAMS model includes a percent crop 
area factor as an adjustment to account for the maximum percent crop 
coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Drinking water screening concentrations for humans potentially 
exposed to total residues of foramsulfuron and structurally similar 
transformation products in surface water were estimated by using the 
standard, linked PRZM (version 3.12)/EXAMS (version 2.97.5) tier 2 
models that the Environmental Fate and Effects Division (EFED) has 
adapted for an index reservoir. The EFED SCI-GROW2 tier 1 regression 
model (version 2.1; May 1, 2001) was used for estimating exposure from 
groundwater. These routinely used models and their descriptions are at 
the following EPA internet site: http://www.epa.gov/oppefed1/models/water. Results are tabulated and shown in the following discussion. The 
effect of including structurally similar transformation products and 
the effect of different time intervals between applications are 
evaluated in the following discussion.
    Based on the PRZM/EXAMS and SCI-GROW models, at the use rate of 
0.0365 lb a.i./acre, the estimated environmental concentrations (EECs) 
of foramsulfuron for acute exposures are estimated to be 1.0 parts per 
billion (ppb) for surface water and 0.05 ppb for ground water. The EECs 
for chronic exposures are estimated to be 0.3 ppb for surface water and 
0.05 ppb for ground water. These concentrations were compared to the 
lowest high dose tested in the toxicity studies (500 mg/kg/day) divided 
by an uncertainty factor of 100, i.e. 5 mg/kg/

[[Page 15123]]

day. Using infants as a worst case (1 L water per day, 10 kg body 
weight), chronic exposure from surface water (EEC = 0.3 ppb) would be 3 
 x  10-5 mg/kg/day, which represents 6  x  
10-4 percent of the 5 mg/kg/day. For acute 
exposure in surface water, a similar calculation using the 1.0 ppb EEC 
gives an exposure of 1  x  10-4 mg/kg/day, or 
0.002% of the 5 mg/kg/day. For chronic and acute exposure in ground 
water, the EEC of 0.05 ppb gives an exposure that is 0.0001% of the 5 
mg/kg/day. Because the concentrations of foramsulfuron in drinking 
water result in exposure much less than 5 mg/kg/day, the contribution 
of consumption of foramsulfuron via drinking water to total dietary 
consumption of foramsulfuron (food plus water) is not significant.

B. Other Non-Occupational Exposure

    The term residential exposure is used in this document to refer to 
non-occupational, non-dietary exposure (e.g., for lawn and garden pest 
control, indoor pest control, termiticides, and flea and tick control 
on pets). Foramsulfuron is not registered or proposed for use on any 
sites that would result in residential exposure.

V. 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 does not have, at this time, available data to determine 
whether foramsulfuron 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, 
foramsulfuron does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that foramsulfuron has a common mechanism of 
toxicity with other substances. For information regarding EPA's efforts 
to determine which chemicals have a common mechanism of toxicity and to 
evaluate the cumulative effects of such chemicals, see the final rule 
for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

VI. Determination of Safety for U.S. Population, Infants and 
Children

    1. In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base on toxicity and exposure 
unless EPA determines that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a margin of exposure 
(MOE) analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. 
Since a dietary risk assessment was not conducted for foramsulfuron due 
to its low toxicity, a safety factor for infants and children is not 
applicable to the determination of the risk due to exposure of infants 
and children to foramsulfuron.
    2. Prenatal and postnatal sensitivity. No significant toxicity or 
prenatal or postnatal toxicity was seen in any of the studies conducted 
with foramsulfuron.
    3. Conclusion. There is a complete toxicity data base for 
foramsulfuron. Since a dietary risk assessment was not conducted for 
foramsulfuron due to its low toxicity, a safety factor for infants and 
children is not applicable to the determination of the risk due to 
exposure of infants and children to foramsulfuron. Based on the 
information in this preamble, EPA concludes that there is a reasonable 
certainty of no harm from aggregate exposure to residues. Accordingly, 
EPA finds that exempting from the requirement of a tolerance will be 
safe.

VII. Other Considerations

A. Endocrine Disruptors

    No special studies have been conducted to investigate the potential 
of foramsulfuron to induce estrogenic or other endocrine effects. 
However, no evidence of estrogenic or other endocrine effects have been 
noted in any of the standard toxicology studies that have been 
conducted with this product and there is no reason to suspect that any 
such effects would be likely.

B. Analytical Method(s)

    This action is establishing an exemption from the requirement of a 
tolerance for the reasons described above. For this reason, no 
analytical method for enforcement purposes is required.

C. Existing Tolerances

    There are no existing tolerances for foramsulfuron.

D. International Tolerances

    There are no established or proposed Codex Maximum Residue Limits 
(MRLs) for foramsulfuron.

VIII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301227 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 28, 
2002.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked

[[Page 15124]]

confidential may be disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301227, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). This final rule does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor 
does it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, 
entitledFederalism(64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This final rule directly regulates 
growers, food processors, food handlers and food retailers, not States. 
This action does not alter the relationships or distribution of power 
and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this rule does not have any ``tribal 
implications'' as described in Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 6, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This rule will not have substantial 
direct

[[Page 15125]]

effects on tribal governments, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes, as 
specified in Executive Order 13175. Thus, Executive Order 13175 does 
not apply to this rule.

X. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: March 15, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 374.


    2. Section 180.1219 is added to subpart D to read as follows:


Sec. 180.1219  Foramsulfuron; exemption from the requirement of a 
tolerance.

    The pesticide foramsulfuron is exempted from the requirement of a 
tolerance in corn grain, corn forage, and corn stover when applied as a 
herbicide in accordance with good agricultural practices.

[FR Doc. 02-7502 Filed 3-28-02; 8:45 am]
BILLING CODE 6560-50-S