[Federal Register Volume 68, Number 45 (Friday, March 7, 2003)]
[Rules and Regulations]
[Pages 10983-10987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5479]



[[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: [email protected].

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 
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.
    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 
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 [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-
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: [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).

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
                                * * * * *
------------------------------------------------------------------------

[FR Doc. 03-5479 Filed 3-6-03; 8:45 am]
BILLING CODE 6560-50-S