1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-, monosodium salt, polymer with ethenol and ethenyl acetate; Exemption from the Requirement of a Tolerance, 9211-9214 [E8-3126]
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Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
9211
EPA-APPROVED GEORGIA NON-REGULATORY PROVISIONS
Name of nonregulatory SIP
provision
*
27. Atlanta Early Progress
Plan.
Applicable geographic or nonattainment area
*
*
*
*
Barrow, Bartow, Carroll, Cherokee, Clayton, Cobb, Coweta,
DeKalb, Douglas, Fayette, Forsyth, Fulton, Gwinnett, Hall,
Henry, Newton, Paulding, Rockdale, Spalding and Walton
counties.
[FR Doc. E8–2706 Filed 2–19–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0223; FRL–8344–7]
1-Propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]-, monosodium
salt, polymer with ethenol and ethenyl
acetate; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
sroberts on PROD1PC70 with RULES
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]-, monosodium
salt, polymer with ethenol and ethenyl
acetate (CAS Reg. No. 107568–12–7)
when used as an inert ingredient in a
pesticide chemical formulation. Keller
and Heckman, LLP 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-propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propenyl)amino]-,
monosodium salt, polymer with ethenol
and ethenyl acetate.
DATES: This regulation is effective
February 20, 2008. Objections and
requests for hearings must be received
on or before April 21, 2008, 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–2007–0223. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
VerDate Aug<31>2005
15:54 Feb 19, 2008
State submittal
date/effective
date
Jkt 214001
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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
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:
Karen Samek, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 347–8825; e-mail address:
samek.karen@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
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EPA approval date
*
1/12/07
*
2/20/08 [Insert first page of
publication].
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. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
Unit II. 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 an electronic
copy of this Federal Register document
through the electronic docket 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, as
amended by 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.
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–2007–0223 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 April 21, 2008.
E:\FR\FM\20FER1.SGM
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9212
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
sroberts on PROD1PC70 with RULES
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–2007–0223, 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’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 on April 30,
2007 (72 FR 21261) (FRL–8124–5), EPA
issued a notice pursuant to section 408
of FFDCA, 21 U.S.C. 346a, as amended
by FQPA (Public Law 104–170),
announcing the filing of a pesticide
petition (PP 7E7193) by Keller and
Heckman LLP, 1001 G St., NW., Suite
500 West, Washington, DC 20001. The
petition requested that 40 CFR 180.960
be amended by establishing an
exemption from the requirement of a
tolerance for residues of 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate; CAS Reg. No. 107568–12–7.
That notice included a summary of the
petition prepared by the petitioner.
There were no comments in response to
the notice of filing.
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
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Jkt 214001
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 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
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.
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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, 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) and the exclusion
criteria for identifying these low-risk
polymers are described in 40 CFR
723.250(d). 1-Propanesulfonic acid, 2methyl-2-[(1-oxo-2-propenyl)amino]monosodium salt, polymer with ethenol
and ethenyl acetate conforms to the
definition of a polymer given in 40 CFR
723(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 55,000 daltons 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, 1-propanesulfonic acid, 2methyl-2-[(1-oxo-2-propenyl)amino]monosodium salt, polymer with ethenol
and ethenyl acetate meets all the criteria
for a polymer to be considered low risk
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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 1-propanesulfonic acid, 2methyl-2-[(1-oxo-2-propenyl)amino]monosodium salt, polymer with ethenol
and ethenyl acetate.
sroberts on PROD1PC70 with RULES
V. Aggregate Exposures
For the purposes of assessing
potential exposure under this
exemption, EPA considered that 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate 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 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate is 50,000 daltons. Generally, a
polymer of this size would be poorly
absorbed through the intact
gastrointestinal tract or through intact
human skin. Since 1-propanesulfonic
acid, 2-methyl-2-[(1-oxo-2propenyl)amino]- monosodium salt,
polymer with ethenol and ethenyl
acetate 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.’’
EPA does not have, at this time,
available data to determine whether 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate has a common mechanism of
toxicity with other substances. 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 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate and any other substances and 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
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15:54 Feb 19, 2008
Jkt 214001
acetate 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 1-propanesulfonic acid, 2methyl-2-[(1-oxo-2-propenyl)amino]monosodium salt, polymer with ethenol
and ethenyl acetate 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 website at https://www.epa.gov/
pesticides/cumulative.
VII. Additional Safety Factor for the
Protection of Infants and Children
Section 408 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 pre-natal and post-natal
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 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate, 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
residues of 1-propanesulfonic acid, 2methyl-2-[(1-oxo-2-propenyl)amino]monosodium salt, polymer with ethenol
and ethenyl acetate.
IX. 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 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
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Fmt 4700
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9213
acetate 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 1propanesulfonic acid, 2-methyl-2-[(1oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl
acetate from the requirement of a
tolerance will be safe.
XI. 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 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, 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) 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 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).
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
E:\FR\FM\20FER1.SGM
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9214
Federal Register / Vol. 73, No. 34 / Wednesday, February 20, 2008 / Rules and Regulations
the Federal Government and Indian
tribes. 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 6, 2000) do not apply
to this rule. In addition, This 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).
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).
Polymer
CAS Reg. No.
*
*
*
*
1-propanesulfonic
107568-12-7
acid, 2-methyl-2[(1-oxo-2-propenyl)amino]-,
monosodium salt,
polymer with
ethenol and ethenyl
acetate, minimum
number average
molecular weight
(in amu) 50,000.
*
*
*
*
*
*
[FR Doc. E8–3126 Filed 2–19–08; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
XII. Congressional Review Act
[EPA–HQ–OPP–2005–0306; FRL–8347–8]
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).
Vitamin E, d-alpha tocopherol, dl-alpha
tocopherol, d-alpha tocopheryl acetate,
and dl-alpha tocopheryl acetate; Inert
Ingredients; Exemption from the
Requirement of a Tolerance
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 6, 2008.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
sroberts on PROD1PC70 with RULES
Authority: 21 U.S.C. 321(q), 346a and 371.
I 2. In §180.960, the table is amended
by alphabetically adding the following
polymer to read as follows:
§ 180.960 Polymers; exemptions from the
requirement of a tolerance.
*
*
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*
15:54 Feb 19, 2008
Jkt 214001
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance under 40 CFR 180.910 for
residues of vitamin E (CAS Reg. No.
1406–18–4), d-alpha tocopherol (CAS
Reg. No. 9–02–9), dl-alpha tocopherol
(CAS Reg. No.10191–41–0), d–alpha
tocopheryl acetate (CAS Reg. No. 58–
95–7), and dl-alpha tocopheryl acetate
(CAS Reg. No. 7695–91–2) in or on raw
agricultural commodities when applied
or used as inert ingredients in pesticide
formulations. Because these five
substances are chemically-similar, for
the sake of simplicity, discussion of
vitamin E in this rule (unless otherwise
noted) can be considered to be vitamin
E per se and/or one of the two alcohols
(d-alpha tocopherol, dl-alpha
tocopherol) or two acetates (d-alpha
tocopheryl acetate, dl-alpha tocopheryl
acetate). BASF Corporation submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act, as amended by
the Food Quality Protection Act of 1996,
requesting an exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of vitamin E.
DATES: This regulation is effective
February 20, 2008. Objections and
requests for hearings must be received
on or before April 21, 2008, and must
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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–2005–0306. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. All
documents in the docket are listed in
the docket index available in
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 either in the electronic docket
at https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are
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:
Kathleen Martin, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–2857; e-mail address:
martin.kathleen@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
E:\FR\FM\20FER1.SGM
20FER1
]]>Agencies
[Federal Register Volume 73, Number 34 (Wednesday, February 20, 2008)]
[Rules and Regulations]
[Pages 9211-9214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3126]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0223; FRL-8344-7]
1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-,
monosodium salt, polymer with ethenol and ethenyl acetate; Exemption
from the Requirement of a Tolerance
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-propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propenyl)amino]-, monosodium salt, polymer with ethenol and
ethenyl acetate (CAS Reg. No. 107568-12-7) when used as an inert
ingredient in a pesticide chemical formulation. Keller and Heckman, LLP
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-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propenyl)amino]-, monosodium salt, polymer with ethenol and ethenyl
acetate.
DATES: This regulation is effective February 20, 2008. Objections and
requests for hearings must be received on or before April 21, 2008, 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-2007-0223. To access the
electronic docket, go to https://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 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: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8825; e-mail address: samek.karen@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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. 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 an electronic copy of this Federal
Register document through the electronic docket 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, as amended by 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. 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-2007-0223 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 April 21, 2008.
[[Page 9212]]
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-2007-0223, 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'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 on April 30, 2007 (72 FR 21261) (FRL-8124-
5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (PP 7E7193) by Keller and Heckman LLP, 1001 G St.,
NW., Suite 500 West, Washington, DC 20001. The petition requested that
40 CFR 180.960 be amended by establishing an exemption from the
requirement of a tolerance for residues of 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propenyl)amino]- monosodium salt, polymer with
ethenol and ethenyl acetate; CAS Reg. No. 107568-12-7. That notice
included a summary of the petition prepared by the petitioner. There
were no comments in response to the notice of filing.
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 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. 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 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, 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) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 1-Propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propenyl)amino]- monosodium salt, polymer with ethenol and
ethenyl acetate conforms to the definition of a polymer given in 40 CFR
723(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 55,000 daltons 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, 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-
monosodium salt, polymer with ethenol and ethenyl acetate meets all the
criteria for a polymer to be considered low risk
[[Page 9213]]
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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propenyl)amino]- monosodium salt, polymer with ethenol and ethenyl
acetate.
V. Aggregate Exposures
For the purposes of assessing potential exposure under this
exemption, EPA considered that 1-propanesulfonic acid, 2-methyl-2-[(1-
oxo-2-propenyl)amino]- monosodium salt, polymer with ethenol and
ethenyl acetate 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 1-propanesulfonic acid,
2-methyl-2-[(1-oxo-2-propenyl)amino]- monosodium salt, polymer with
ethenol and ethenyl acetate is 50,000 daltons. Generally, a polymer of
this size would be poorly absorbed through the intact gastrointestinal
tract or through intact human skin. Since 1-propanesulfonic acid, 2-
methyl-2-[(1-oxo-2-propenyl)amino]- monosodium salt, polymer with
ethenol and ethenyl acetate 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.'' EPA does not
have, at this time, available data to determine whether 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl acetate has a common mechanism
of toxicity with other substances. 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-
monosodium salt, polymer with ethenol and ethenyl acetate and any other
substances and 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propenyl)amino]- monosodium salt, polymer with ethenol and ethenyl
acetate 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 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propenyl)amino]- monosodium salt, polymer with ethenol and ethenyl
acetate 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 website at https://www.epa.gov/pesticides/
cumulative.
VII. Additional Safety Factor for the Protection of Infants and
Children
Section 408 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 pre-natal and post-natal 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-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-
propenyl)amino]- monosodium salt, polymer with ethenol and ethenyl
acetate, 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 residues of 1-propanesulfonic acid, 2-methyl-2-
[(1-oxo-2-propenyl)amino]- monosodium salt, polymer with ethenol and
ethenyl acetate.
IX. 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 1-
propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]- monosodium
salt, polymer with ethenol and ethenyl acetate 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-propanesulfonic
acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]- monosodium salt, polymer
with ethenol and ethenyl acetate from the requirement of a tolerance
will be safe.
XI. 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 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, 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) 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 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).
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
[[Page 9214]]
the Federal Government and Indian tribes. 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 6, 2000) do not apply to this rule. In addition, This
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).
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).
XII. 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 6, 2008.
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 alphabetically adding the
following polymer to read as follows:
Sec. 180.960 Polymers; exemptions from the requirement of a
tolerance.
* * *
------------------------------------------------------------------------
Polymer CAS Reg. No.
------------------------------------------------------------------------
* * * * *
1-propanesulfonic acid, 2-methyl-2-[(1-oxo- 107568-12-7
2-propenyl)amino]-, monosodium salt,
polymer with ethenol and ethenyl acetate,
minimum number average molecular weight
(in amu) 50,000.
* * * * *
------------------------------------------------------------------------
[FR Doc. E8-3126 Filed 2-19-08; 8:45 am]
BILLING CODE 6560-50-S
