Foramsulfuron; Exemption from the Requirement of a Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 29, 2002 (Volume 67, Number 61)]
[Rules and Regulations]
[Page 15120-15125]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr02-11]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-301227; FRL-6829-8]
RIN 2070-AB78

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:
miller.joanne@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

[[Page 15122]]

870.3800 Reproduction and fertility Parental/Systemic, Reproductive and
effects Offspring NOAEL = 1,082 mg/kg/day, HDT
----------------------------------------------------------------------------------------------------------------
870.4100/870.4200 Chronic toxicity and NOAEL = 849 mg/kg/day, HDT
Carcinogenicity rodents No evidence of carcinogenicity
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
870.5100 Gene Mutation Negative
----------------------------------------------------------------------------------------------------------------
870.5375 Cytogenetics Negative
----------------------------------------------------------------------------------------------------------------
870.5385 Other Effects Negative
----------------------------------------------------------------------------------------------------------------
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 tompkins.jim@epa.gov,
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: opp-docket@epa.gov. 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

Foramsulfuron; Exemption from the Requirement of a Tolerance

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