[Federal Register: August 13, 2004 (Volume 69, Number 156)]
[Rules and Regulations]
[Page 50074-50077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au04-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0204; FRL-7368-3]
Isodecyl Alcohol Ethoxylated (2-8 moles) Polymer with
Chloromethyl Oxirane; 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 isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane; when used as an inert ingredient in
a pesticide chemical formulation. Cognis Corporation 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 isodecyl alcohol ethoxylated (2-8 moles) polymer with
chloromethyl oxirane.
DATES: This regulation is effective August 13, 2004. Objections and
requests for hearings must be received on or before October 12, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit XI of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
Identification number OPP-2004-0204. All documents in the docket are
listed in the EDOCKET index at http://www.epa.gov/edocket. Although
listed in the index, some information is not publicly available, i.e.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, is not placed on
the Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available either electronically
in EDOCKET or in hard copy at the Public Information and Records
Integrity Branch (PIRIB), Rm. 119, Crystal Mall2, 1801 S. Bell
St., 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.
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, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 32532)
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 Access Electronic Copies of this Document and Other
Related Information
In addition to using EDOCKET http://www.epa.gov/edocket/ youmay
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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of May 12, 2004 (69 FR 26386) (FRL-7357-7),
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a, as amended by the FQPA (Pub. L. 104-170), announcing the filing
of a pesticide petition (PP 4E6820) by Cognis Corporation, 4900 Este
Avenue, Cincinnati, OH 45232.
The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of isodecyl alcohol ethoxylated (2-8 moles) polymer with
chloromethyl oxirane; (CAS Registry No. is not available). That notice
included a summary of the petition prepared by the petitioner. There
was one comment received from the public in response to the notice of
filing. See Unit IX.
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.
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
[[Page 50075]]
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 shown 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 majoridentifiable 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, isodecyl alcohol ethoxylated (2-8 moles) polymer
with chloromethyl oxirane, 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 composition
the atomic elements carbon, hydrogen, and oxygen.
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, isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane, also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW of 2,500 daltons 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, isodecyl alcohol ethoxylated (2-8 moles) polymer with
chloromethyl oxirane meets 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 isodecyl alcohol ethoxylated (2-8
moles) polymer with chloromethyl oxirane.
V. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane could be present in all raw and
processed agricultural commodities and drinking water, and that non-
occupational non-dietary exposure was possible. The number average MW
of isodecyl alcohol ethoxylated (2-8 moles) polymer with chloromethyl
oxirane is 2,500 daltons. Generally, a polymer of this size would be
poorly absorbed through the intact gastrointestinal tract or through
intact human skin. Since isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane conforms 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 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.'' Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane and any other substances and isodecyl
alcohol ethoxylated (2-8 moles) polymer with chloromethyl oxirane 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 isodecyl alcohol ethoxylated (2-8 moles) polymerwith
chloromethyl oxirane 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 policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative/
.
VII. Additional Safety Factor for the Protection of Infants and
Children
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 isodecyl alcohol
ethoxylated (2-8 moles) polymer with chloromethyl oxirane, EPA has not
used a safety factor analysis to assess the risk. For the same reasons
the additional tenfold safety factor is unnecessary.
VIII. Determination of Safety
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, including infants and children, from
aggregate exposure to
[[Page 50076]]
residues of isodecyl alcohol ethoxylated (2-8 moles) polymer with
chloromethyl oxirane.
IX. Other Considerations
A. Endocrine Disruptors
There is no available evidence that isodecyl alcohol ethoxylated
(2-8 moles) polymer with chloromethyl oxirane is an endocrine
disruptor.
B. Existing Exemptions from a Tolerance
There are no existing tolerance exemptions for this polymer.
C. 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.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance for
isodecyl alcohol ethoxylated (2-8 moles) polymer with chloromethyl
oxirane nor have any CODEX Maximum Residue Levels been established for
any food crops at this time.
E. Public Comment
One comment was received from a private citizen opposing the
``production or selling'' of isodecyl alcohol ethoxylated (2-8 moles)
polymer with chloromethyl oxirane. The commentor further stated that it
was their wish that no exemptions be issued and that no tolerances
should be approved. The Agency understands the commentor's concerns and
recognizes that some individuals believe that pesticides should be
banned completely. However, under the existing legal framework provided
by section 408 of the FFDCA, EPA is required to establish pesticide
tolerances or exemptions where persons seeking such exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. The commentor has not provided the Agency with a specific
rationale or additional information pertaining to the legal standards
in FFDCA Section 408 for opposing the establishment of a tolerance
exemption for isodecyl alcohol ethoxylated (2-8 moles) polymer with
chloromethyl oxirane. In the absence of any additional information of a
factual nature, the Agency can not effectively respond to the
commentor's disagreement with the Agency's decision.
X. Conclusion
Accordingly, EPA finds that exempting residues of isodecyl alcohol
ethoxylated (2-8 moles) polymer with chloromethyl oxirane 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 EPAunder 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-2004-0204 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 October
12, 2004.
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 Suite 350, 1099 14th St., NW.,
Washington, DC. 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) 564-6255.
2. 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 ADDRESSES. Mail your
copies, identified by docket ID number OPP-2004-0204, 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-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. 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 Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
[[Page 50077]]
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 TitleII 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: July 29, 2004.
Betty Shackleford,
Acting Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.960 the table is amended by adding alphabetically the
following inert ingredient.
Sec. 180.960 Polymer exemptions from the requirement of a tolerance.
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Polymer CAS NO.
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Isodecyl alcohol ethoxylated (2-8 moles) None
polymer with chloromethyl oxirane,
minimum number average molecular weight
(in amu) 2,500.
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[FR Doc. 04-18574 Filed 8-12-04; 8:45 am]
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