[Federal Register: March 7, 2003 (Volume 68, Number 45)]
[Rules and Regulations]
[Page 10983-10987]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr03-11]
[[Page 10983]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0037; FRL-7290-9]
1,3 Benzene Dicarboxylic Acid, 5-Sulfo-, 1,3-Dimethyl Ester,
Sodium Salt, Polymer with 1,3-Benzene Dicarboxylic Acid, 1,4-Benzene
Dicarboxylic Acid, Dimethyl 1,4-Benzene Dicarboxylate and 1,2-
Ethanediol; Tolerance Exemption
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 1,3 benzene dicarboxylic acid, 5-sulfo-,
1,3-dimethyl ester, sodium salt, polymer with 1,3-benzene dicarboxylic
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate
and 1,2-ethanediol; when used as an inert ingredient. Rhodia Inc.,
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA) requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of 1,3 benzene dicarboxylic acid, 5-sulfo-, 1,3-
dimethyl ester, sodium salt, polymer with 1,3-benzene dicarboxylic
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate
and 1,2-ethanediol.
DATES: This regulation is effective March 7, 2003. Objections and
requests for hearings, identified by docket ID number OPP-2003-0037,
must be received on or before May 6, 2003.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit XI. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703-308-8380; e-mail address: gandhi.bipin@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, pesticide manufacturer, or
antimicrobial pesticide manufacturer. Potentially affected entities may
include, but are not limited to:-
[sbull] Industry (NAICS 111), e.g., Crop Production.
[sbull] Industry (NAICS 112), e.g., Animal Production.
[sbull] Industry (NAICS 311), e.g., Food manufacturing.
[sbull] Industry (NAICS 32532), e.g., Pesticide Manufacturing.
[sbull] Industry (NAICS 32561), e.g., Antimicrobial Pesticide.--
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of This Document and Other Related Information?
-1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0037. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.A frequently updated
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
www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a
beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number. -
II. Background and Statutory Findings-
In the Federal Register of November 15, 2002 (67 FR 69217) (FRL-
7280-1), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA (Public Law 104 -170), announcing
the filing of a pesticide petition (PP 2E6515) by Rhodia, Inc., CN
7500, Prospect Plains Rd., Cranbury, NJ 08512-7500. That notice
included a summary of the petition prepared by the petitioner. There
were no comments received in response to the notice of filing. -
The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of 1,3 benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl
ester, sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-
benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2-
ethanediol; CAS Reg. No. 212842-88-1.-
Section 408(c)(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(c)(2)(A)(ii) of the FFDCA
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) of the FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing an exemption
from the requirement of 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...'' and
specifies factors EPA is to consider in establishing an exemption.
[[Page 10984]]
III. Inert Ingredient Definition -
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Risk Assessment and Statutory Findings-
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
Consistent with section 408(b)(2)(D) of the 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. In the case of certain chemical
substances that are defined as polymers, the Agency has established a
set of criteria to identify categories of polymers that should present
minimal or no risk. The definition of a polymer is given in 40 CFR
723.250(b). The following exclusion criteria for identifying these low
risk polymers are described in 40 CFR 723.250(d).
1. The polymer, 1,3 benzene dicarboxylic acid, 5-sulfo-, 1,3-
dimethyl ester, sodium salt, polymer with 1,3-benzene dicarboxylic
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate
and 1,2-ethanediol, is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
2. The polymer does contain as an integral part of its compostion
the atomic elements carbon, hydrogen, oxygen and sulfur.
3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
Additionally, the polymer, 1,3 benzene dicarboxylic acid, 5-sulfo-,
1,3-dimethyl ester, sodium salt, polymer with 1,3-benzene dicarboxylic
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate
and 1,2-ethanediol, also meets, as required, the following exemption
criteria specified in 40 CFR 723.250(e).
7. The polymer's minimum number average molecular weight (NAMW) of
2,580 is greater than 1,000 and less than 10,000 daltons. The polymer
contains less than 10% oligomeric material below MW 500 and less than
25% oligomeric material below MW 1,000, and the polymer does not
contain any reactive functional groups.
Thus, 1,3 benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester,
sodium salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2-
ethanediol meet all the criteria for a polymer to be considered low
risk under 40 CFR 723.250. Based on its conformance to the above
criteria, no mammalian toxicity is anticipated from dietary,
inhalation, or dermal exposure to 1,3 benzene dicarboxylic acid, 5-
sulfo-, 1,3-dimethyl ester, sodium salt, polymer with 1,3-benzene
dicarboxylic acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene
dicarboxylate and 1,2-ethanediol.
V. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that 1,3 benzene dicarboxylic acid, 5-sulfo-,
1,3-dimethyl ester, sodium salt, polymer with 1,3-benzene dicarboxylic
acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate
and 1,2-ethanediol could be present in all raw and processed
agricultural commodities and drinking water, and that non-occupational,
non-dietary exposure was possible. The minimum NAMW of 1,3 benzene
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer
with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid,
dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol is 2,580 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since 1,3
benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt,
polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic
acid, dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol conform to
the criteria that identify a low risk polymer, there are no concerns
for risks associated with any potential exposure scenarios that are
reasonably foreseeable. The Agency has determined that a tolerance is
not necessary to protect the public health.
VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance or
tolerance exemption, the Agency consider ``available information''
concerning the cumulative effects of a particular chemical's residues
and ``other substances that have a common mechanism of toxicity.'' The
Agency has not made any conclusions as to whether or not 1,3 benzene
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer
with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid,
dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol share a common
mechanism of toxicity with any other chemicals. However, 1,3 benzene
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer
with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid,
dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol conform to the
criteria that identify a low risk polymer. Due to the expected lack of
toxicity based on the above conformance, the Agency has
[[Page 10985]]
determined that a cumulative risk assessment is not necessary.
VII. Determination of Safety for U.S. Population
Based on the conformance to the criteria used to identify a low
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population from aggregate exposure to residues of 1,3
benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt,
polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic
acid, dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol.
VIII. Determination of Safety for Infants and Children
FFDCA section 408 of the FFDCA 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 unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of 1,3 benzene dicarboxylic
acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer with 1,3-
benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-
benzene dicarboxylate and 1,2-ethanediol, EPA has not used a safety
factor analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.
IX. Other Considerations
A. Endocrine Disruptors
There is no available evidence that 1,3 benzene dicarboxylic acid,
5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer with 1,3-benzene
dicarboxylic acid, 1,4-benzene dicarboxylic acid, dimethyl 1,4-benzene
dicarboxylate and 1,2-ethanediol is an endocrine disruptor.
B. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
1,3 benzene dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium
salt, polymer with 1,3-benzene dicarboxylic acid, 1,4-benzene
dicarboxylic acid, dimethyl 1,4-benzene dicarboxylate and 1,2-
ethanediol nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.
X. Conclusion
Accordingly, EPA finds that exempting residues of 1,3 benzene
dicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt, polymer
with 1,3-benzene dicarboxylic acid, 1,4-benzene dicarboxylic acid,
dimethyl 1,4-benzene dicarboxylate and 1,2-ethanediol from the
requirement of a tolerance will be safe.
XI. 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, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA 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)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. 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 ID number -OPP-2003-0037 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 6,
2003.
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 confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
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-
0001.
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 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit XI.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.1. Mail your
copies, identified by docket ID number-OPP-2003-0037, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,
[[Page 10986]]
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in Unit I.B.1. 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).
XII. Statutory and Executive Order Review
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA 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 section 408(d) of the FFDCA, 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, entitled Federalism
(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 section 408(n)(4) of the FFDCA. 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 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.
XIII. Congressional Review Act
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 rule in the Federal Register. This 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: January 30, 2003.
Debra Edwards,
Acting Director, Registration Division, 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 371.-
2. In Sec. 180.960 the table is amended by adding alphabetically
the following inert ingredient to read as follows:-
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
[[Page 10987]]
------------------------------------------------------------------------
Polymers CAS No.
------------------------------------------------------------------------
* * * * *
1,3 Benzene dicarboxylic acid, 5-sulfo-, 1,3- 212842-88-1
dimethyl ester, sodium salt, polymer with 1,3-
benzene dicarboxylic acid, 1,4-benzene dicarboxylic
acid, dimethyl 1,4-benzene dicarboxylate and 1,2-
ethanediol, minimum number average molecular weight
(in amu), 2,580
* * * * *
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[FR Doc. 03-5479 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S