2-Propenoic acid, polymer with α-[4-(ethenyloxy) butyl]-ω-hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt; Tolerance Exemption, 10501-10504 [E9-5264]
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rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it 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 FFDCA, such as
the tolerance 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes, or otherwise have any unique
impacts or local governments. Thus, the
Agency has determined that Executive
Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
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).
Although this action does not 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), EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. As such, to the
extent that information is publicly
available or was submitted in comments
to EPA, the Agency considered whether
groups or segments of the population, as
VerDate Nov<24>2008
16:30 Mar 10, 2009
Jkt 217001
10501
a result of their location, cultural
practices, or other factors, may have
atypical or disproportionately high and
adverse human health impacts or
environmental effects from exposure to
the pesticide discussed in this
document, compared to the general
population.
[FR Doc. E9–5245 Filed 3–10–09; 8:45 am]
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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).
[EPA–HQ–OPP–2008–0619; FRL–8396–8]
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 12, 2009.
Lois Rossi,
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), 346a and 371.
2. In §180.960, the table is amended
by alphabetically adding the following
polymer to read:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
*
*
*
Polymer
CAS No.
*
*
*
2-Propenoic acid,
polymer with a-[4(ethenyloxy) butyl]w-hydroxypoly (oxy1,2-ethanediyl) and
1,2-propanediol
mono-2propenoate, potassium sodium salt,
minimum number
average molecular
weight (in amu),
16,000.
*
*
*
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Frm 00047
Fmt 4700
*
*
518026–64–7
*
Sfmt 4700
*
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
2-Propenoic acid, polymer with α-[4(ethenyloxy) butyl]-w-hydroxypoly
(oxy-1,2-ethanediyl) and 2,5furandione, sodium salt; Tolerance
Exemption
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance under 40 CFR 180.960 for
residues of 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt; (CAS Reg.
No. 251479–97–7); when used as an
inert ingredient in a pesticide chemical
formulation. BASF Corporation,
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of 2-Propenoic acid,
polymer with a-[4-(ethenyloxy) butyl]w-hydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt on food or
feed commodities.
DATES: This regulation is effective
March 11, 2009. Objections and requests
for hearings must be received on or
before May 11, 2009, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0619. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(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 in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
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Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
Regulatory Public Docket in Rm. S–
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
Docket Facility is open from 8:30 a.m.
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Facility telephone number is (703) 305–
5805.
FOR FURTHER INFORMATION CONTACT:
Alganesh Debesai, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8353; e-mail address:
debesai.alganesh@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
rwilkins on PROD1PC63 with RULES
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 code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 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?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
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16:30 Mar 10, 2009
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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.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0619. 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 11, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0619, by one of
the following methods.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of November
5, 2008 (73 FR 65852) (FRL–8385–1),
EPA issued a notice pursuant to section
408 of FFDCA, 21 U.S.C. 346a,
announcing the receipt of a pesticide
petition (PP 8E7378) filed by BASF
Corporation, 100 Campus Drive,
Florham Park, NJ 07932. The petition
requested that 40 CFR 180.960 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt (CAS Reg.
No. 251479–97–7). That notice included
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a summary of the petition prepared by
the petitioner and solicited comments
on the petitioner’s request. The Agency
did not receive any comments.
Section 408(c)(2)(A)(i) of 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 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
use in residential settings, but does not
include occupational exposure. Section
408(b)(2)(C) of 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. 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 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
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Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
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 expected to
present minimal or no risk. The
definition of a polymer is given in 40
CFR 723.250(b) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt conforms to
the definition of a polymer given in 40
CFR 723.250(b) and meets the following
criteria that are used to identify low-risk
polymers.
1. The polymer 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 also meets
as required the following exemption
criteria specified in 40 CFR 723.250(e).
7. The polymer’s number average MW
of 25,000 is greater than or equal to
10,000 daltons. The polymer contains
less than 2% oligomeric material below
MW 500 and less than 5% oligomeric
material below MW 1,000.
Thus, 2-Propenoic acid, polymer with
a-[4-(ethenyloxy) butyl]-w-hydroxypoly
(oxy-1,2-ethanediyl) and 2,5-furandione,
sodium salt meets the criteria for a
polymer to be considered low risk under
40 CFR 723.250. Based on its
conformance to the criteria in this unit,
no mammalian toxicity is anticipated
from dietary, inhalation, or dermal
exposure to 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt.
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Jkt 217001
IV. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption,EPA considered that 2Propenoic acid, polymer with a-[4(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 2,5-furandione,
sodium salt could be present in all raw
and processed agricultural commodities
and drinking water, and that nonoccupational non-dietary exposure was
possible. The number average MW of 2Propenoic acid, polymer with a-[4(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 2,5-furandione,
sodium salt is 25,000 daltons. Generally,
a polymer of this size would be poorly
absorbed through the intact
gastrointestinal tract or through intact
human skin. Since 2-Propenoic acid,
polymer with a-[4-(ethenyloxy) butyl]w-hydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt 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.
V. 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.’’
For the purposes of this tolerance
action, EPA has not assumed that 2Propenoic acid, polymer with a-[4(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 2,5-furandione,
sodium salt has a common mechanism
of toxicity with other substances, based
on the anticipated absence of
mammalian toxicity. 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 website at https://
www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the
Protection of Infants and Children
Section 408(b)(2)(C) of FFDCA
provides that EPA shall apply an
additional tenfold margin of safety for
PO 00000
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Fmt 4700
Sfmt 4700
10503
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 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt, EPA has
not used a safety factor analysis to
assess the risk. For the same reasons the
additional tenfold safety factor is
unnecessary.
VII. 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
residues of 2-Propenoic acid, polymer
with a-[4-(ethenyloxy) butyl]-whydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt.
VIII. Other Considerations
A. 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.
B. International Tolerances
The Agency is not aware of any
country requiring a tolerance for 2Propenoic acid, polymer with a-[4(ethenyloxy) butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 2,5-furandione,
sodium salt nor have any CODEX
Maximum Residue Levels (MRLs) been
established for any food crops at this
time.
IX. Conclusion
Accordingly, EPA finds that
exempting residues of 2-Propenoic acid,
polymer with a-[4-(ethenyloxy) butyl]w-hydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt from the
requirement of a tolerance will be safe.
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these rules
from review under Executive Order
12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this final rule has been
exempted from review under Executive
Order 12866, this final rule is not
subject to Executive Order 13211,
E:\FR\FM\11MRR1.SGM
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rwilkins on PROD1PC63 with RULES
10504
Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Rules and Regulations
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
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., nor does it 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 FFDCA, such as
the tolerance 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.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes, or otherwise have any unique
impacts or local governments. Thus, the
Agency has determined that Executive
Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
9, 2000) do not apply to this final rule.
In addition, this final rule does not
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).
Although this action does not 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), EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
VerDate Nov<24>2008
16:30 Mar 10, 2009
Jkt 217001
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. As such, to the
extent that information is publicly
available or was submitted in comments
to EPA, the Agency considered whether
groups or segments of the population, as
a result of their location, cultural
practices, or other factors, may have
atypical or disproportionately high and
adverse human health impacts or
environmental effects from exposure to
the pesticide discussed in this
document, compared to the general
population.
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report 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: February 12, 2009.
Lois Rossi,
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), 346a and 371
2. In §180.960, the table is amended
by adding alphabetically the following
polymer to read:
■
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
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*
*
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*
Fmt 4700
*
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Polymer
*
*
CAS No.
*
*
2-Propenoic acid, polymer
with a-[4-(ethenyloxy)
butyl]-w-hydroxypoly (oxy1,2-ethanediyl) and 2,5furandione, sodium salt,
minimum number average
molecular weight (in amu),
25,000.
*
*
*
*
*
251479–97–7
*
[FR Doc. E9–5264 Filed 3–10–09; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0618; FRL–8396–7]
2-Propenoic acid, 2-hydroxyethyl ester,
polymer with α-[4-(ethenyloxy)butyl]-whydroxypoly (oxy-1,2-ethanediyl);
Tolerance Exemption
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of 2-Propenoic
acid, 2-hydroxyethyl ester, polymer
with a-[4-(ethenyloxy)butyl]-w-hydroxy
poly (oxy-1,2-ethanediyl); (CAS Reg. No.
1007234–89–0); when used as an inert
ingredient in a pesticide chemical
formulation. BASF Corporation
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of 2-Propenoic acid, 2hydroxyethyl ester, polymer with a-[4(ethenyloxy)butyl]-w-hydroxypoly (oxy1,2-ethanediyl) on food or feed
commodities.
DATES: This regulation is effective
March 11, 2009. Objections and requests
for hearings must be received on or
before May 11, 2009, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2008–0618. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
E:\FR\FM\11MRR1.SGM
11MRR1
]]>Agencies
[Federal Register Volume 74, Number 46 (Wednesday, March 11, 2009)]
[Rules and Regulations]
[Pages 10501-10504]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5264]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0619; FRL-8396-8]
2-Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-
[omega]-hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium
salt; Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance under 40 CFR 180.960 for residues of 2-Propenoic acid,
polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-
1,2-ethanediyl) and 2,5-furandione, sodium salt; (CAS Reg. No. 251479-
97-7); when used as an inert ingredient in a pesticide chemical
formulation. BASF Corporation, submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of 2-
Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-
hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt on
food or feed commodities.
DATES: This regulation is effective March 11, 2009. Objections and
requests for hearings must be received on or before May 11, 2009, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0619. All documents in the
docket are listed in the docket index available at https://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (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 in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the OPP
[[Page 10502]]
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Alganesh Debesai, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-8353; e-mail address:
debesai.alganesh@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 code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 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?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at https://www.epa.gov/fedrgstr. You may also access
a frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2008-0619. 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 11, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0619, by one of the following methods.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of November 5, 2008 (73 FR 65852) (FRL-
8385-1), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the receipt of a pesticide petition (PP 8E7378)
filed by BASF Corporation, 100 Campus Drive, Florham Park, NJ 07932.
The petition requested that 40 CFR 180.960 be amended by establishing
an exemption from the requirement of a tolerance for residues of 2-
Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-
hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt (CAS
Reg. No. 251479-97-7). That notice included a summary of the petition
prepared by the petitioner and solicited comments on the petitioner's
request. The Agency did not receive any comments.
Section 408(c)(2)(A)(i) of 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 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 use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of 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. 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 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
[[Page 10503]]
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 expected to present minimal or no risk. The definition of a
polymer is given in 40 CFR 723.250(b) and the exclusion criteria for
identifying these low-risk polymers are described in 40 CFR 723.250(d).
2-Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-
hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt
conforms to the definition of a polymer given in 40 CFR 723.250(b) and
meets the following criteria that are used to identify low-risk
polymers.
1. The polymer 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 also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
7. The polymer's number average MW of 25,000 is greater than or
equal to 10,000 daltons. The polymer contains less than 2% oligomeric
material below MW 500 and less than 5% oligomeric material below MW
1,000.
Thus, 2-Propenoic acid, polymer with [alpha]-[4-(ethenyloxy)
butyl]-[omega]-hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione,
sodium salt meets the criteria for a polymer to be considered low risk
under 40 CFR 723.250. Based on its conformance to the criteria in this
unit, no mammalian toxicity is anticipated from dietary, inhalation, or
dermal exposure to 2-Propenoic acid, polymer with [alpha]-[4-
(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-1,2-ethanediyl) and 2,5-
furandione, sodium salt.
IV. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption,EPA considered that 2-Propenoic acid, polymer with [alpha]-
[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-1,2-ethanediyl) and
2,5-furandione, sodium salt 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 2-Propenoic
acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly
(oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt is 25,000 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since 2-
Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-
hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt
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.
V. 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.'' For the purposes
of this tolerance action, EPA has not assumed that 2-Propenoic acid,
polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-
1,2-ethanediyl) and 2,5-furandione, sodium salt has a common mechanism
of toxicity with other substances, based on the anticipated absence of
mammalian toxicity. 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 website at
https://www.epa.gov/pesticides/cumulative.
VI. Additional Safety Factor for the Protection of Infants and Children
Section 408(b)(2)(C) of 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 2-Propenoic acid, polymer
with [alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-1,2-
ethanediyl) and 2,5-furandione, sodium salt, EPA has not used a safety
factor analysis to assess the risk. For the same reasons the additional
tenfold safety factor is unnecessary.
VII. 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 residues of 2-Propenoic acid, polymer with
[alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-1,2-ethanediyl)
and 2,5-furandione, sodium salt.
VIII. Other Considerations
A. 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.
B. International Tolerances
The Agency is not aware of any country requiring a tolerance for 2-
Propenoic acid, polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-
hydroxypoly (oxy-1,2-ethanediyl) and 2,5-furandione, sodium salt nor
have any CODEX Maximum Residue Levels (MRLs) been established for any
food crops at this time.
IX. Conclusion
Accordingly, EPA finds that exempting residues of 2-Propenoic acid,
polymer with [alpha]-[4-(ethenyloxy) butyl]-[omega]-hydroxypoly (oxy-
1,2-ethanediyl) and 2,5-furandione, sodium salt from the requirement of
a tolerance will be safe.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these rules from review under
Executive Order 12866, entitled Regulatory Planning and Review (58 FR
51735, October 4, 1993). Because this final rule has been exempted from
review under Executive Order 12866, this final rule is not subject to
Executive Order 13211,
[[Page 10504]]
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). 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., nor does it 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 FFDCA, such as the tolerance 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes, or otherwise have any unique
impacts or local governments. Thus, the Agency has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled Consultation and Coordination
with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not
apply to this final rule. In addition, this final rule does not 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).
Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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: February 12, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
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 polymer to read:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * * * *
------------------------------------------------------------------------
Polymer CAS No.
------------------------------------------------------------------------
* * * * *
2-Propenoic acid, polymer with [alpha]-[4- 251479-97-7
(ethenyloxy) butyl]-[omega]-hydroxypoly
(oxy-1,2-ethanediyl) and 2,5-furandione,
sodium salt, minimum number average
molecular weight (in amu), 25,000.
* * * * *
------------------------------------------------------------------------
[FR Doc. E9-5264 Filed 3-10-09; 8:45 am]
BILLING CODE 6560-50-S
