Inert Ingredient; Revocation of the Tetrahydrofurfuryl Alcohol (THFA) Tolerance Exemption, 45411-45415 [E6-12591]
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.920, the table is amended
by revising the following inert
ingredient to read as follows:
I
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
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Inert ingredients
Limits
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Mono- and bis-(1H, 1H, 2H, 2H-perfluoroalkyl) phosphates where
the alkyl group is even numbered and in the C6-C12 range.
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Not more than 0.5% of pesticide
formulation. Expires February 9,
2008.
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[FR Doc. E6–12541 Filed 8–8–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0251; FRL–8082–2]
Inert Ingredient; Revocation of the
Tetrahydrofurfuryl Alcohol (THFA)
Tolerance Exemption
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
SUMMARY: EPA is revoking, under the
Federal Food, Drug, and Cosmetic Act
(FFDCA) section 408(e)(1), the existing
exemption from the requirement of a
tolerance for residues of the inert
ingredient ‘‘Tetrahydrofurfuryl alcohol’’
(THFA) under 40 CFR 180.910, and
establishes a limited tolerance for THFA
under 40 CFR 180.1263. The regulatory
action contributes toward the Agency’s
tolerance reassessment requirements
under FFDCA section 408(q), as
amended by the Food Quality Protection
Act (FQPA) of 1996. By law, EPA is
required by August 2006 to reassess the
tolerances that were in existence on
August 2, 1996. This regulatory action
counts as a tolerance reassessment
toward the August 2006 review
deadline.
DATES: This rule is effective February 9,
2008.
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0251. All documents in the
docket are listed in the index for the
docket. 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
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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
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 306–0404; e-mail address:
angulo.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.
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Uses
Surfactant, related
surfactants
adjvants
of
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 the FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
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–2006–0251 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before October 10, 2006.
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–2006–0251, 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),
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
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 Drive, 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 telephone number is (703) 305–
5805.
tolerance exemption is revoked in this
final rule. The revocation will take
effect 18 months after the publication
date of this final rule in the Federal
Register.
EPA has evaluated the scope of the
new limited THFA tolerance exemption
under 40 CFR 180.1263 and has added
limited uses on canola, soybeans, and
field corn, and has clarified that
applications will now be permitted
prior to planting. EPA finds that
exempting THFA with the limitations in
40 CFR 180.1263 will be safe for the
general population including infants
and children.
B. EPA’s Responses to Comments
1. Applications at the time of
A. What Action is the Agency Taking?
planting. Several commentors requested
On April 12, 2006, EPA published in
the proposed use of THFA ‘‘at-plant’’ be
the Federal Register (71 FR 18689; FRL– expanded to include all applications
7771–3) proposed actions for the inert
prior to planting. EPA agrees. The
ingredient tetrahydrofurfuryl alcohol
proposed limitation ‘‘For application at
(THFA). This final rule revokes the
the time of planting.’’ under 40 CFR
exemption from the requirement of a
180.1263 is replaced with ‘‘For
tolerance for THFA under 40 CFR
applications prior to planting and at the
180.910 and establishes a limited
time of planting.’’ This includes uses
tolerance exemption for THFA under 40 such as applications made in
CFR 180.1263. In evaluating THFA, EPA preparation for the planting of the crop,
determined that dietary risks of concern in the furrow during planting of seeds
may result from the use of THFA under
and transplants, and to the soil surface
the current tolerance exemption in 40
at the time of planting. This small
CFR 180.910, which allows an
expansion of the proposed limitation is
unlimited amount of THFA to be
in keeping with the uses of currently
applied to growing crops and raw
registered pesticide products containing
agricultural commodities after harvest.
THFA. Considering THFA’s physicalThe hazard characterization of THFA
chemical properties and biodegradation
shows effects of concern, including
potential in the environment, the new
significant developmental and
limitation does not change EPA’s safety
reproductive effects from repeated oral
finding for the new 40 CFR 180.1263.
exposures. The available data show
2. Requests to expand uses, and
there is evidence of increased
establish application rates and presusceptibility (both quantitative and
harvest intervals. One commentor stated
qualitative) of the offspring after in utero that EPA does not have to restrict the
exposure to THFA, including decreased crops that THFA can be applied to if the
fetal body weights. The Agency
Agency would set either a maximum
concluded that THFA’s unlimited
THFA percentage limit in pesticide
tolerance exemption under 40 CFR
concentrates, or a maximum THFA
180.910 does not meet the safety
percentage limit for dilute product rates
requirements of FFDCA section
applied to food crops. In addition,
408(b)(2), and proposed the revocation
several commentors suggested the
of the tolerance exemption 18 months
establishment of pre-harvest intervals as
after the publication of the final rule in
a way to limit or eliminate the potential
the Federal Register. In the same
for residues of THFA on harvested
document, EPA proposed to establish a
commodities.
In determining whether uses of THFA
new exemption under 40 CFR 180.1263
could be maintained, the Agency
for applications to cotton, use with
evaluated the uses of all currently
herbicides with one application to
registered pesticide products that
wheat and barley prior to the pre-boot
contained THFA. The products were
stage, for use as a seed treatment, and
registered for applications to a very
applications at the time of planting.
large number of crops and most
EPA’s responses to comments
permitted multiple applications (e.g.,
received on the proposed rule are given
six) including on the day of harvest. For
in Unit II.B. EPA maintains its
many pesticide products, the quantity of
conclusion that THFA’s tolerance
THFA in formulation was unusually
exemption under 40 CFR 180.910 does
high, with more than half containing 75
not meet the safety standard of FFDCA
- 98 % THFA. The Agency discussed its
section 408(b)(2), therefore, this
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II. Background and Statutory Findings
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toxicity concerns for THFA with the
registrants of these pesticide products,
and the large majority elected to
reformulate their products with another
solvent. Of the pesticide products that
continued to contain THFA, EPA
determined that the safety finding could
be made for their uses and crafted the
limitations of the new tolerance
exemption under 40 CFR 180.1263 to
include only those uses. The available
reliable information on THFA’s
physical-chemical properties and
biodegradation potential in soil was
considered in making the safety finding
for the uses described in the new
exemption. The uses in the new
exemption significantly reduce the
number of times that THFA may be
applied per season - often to one
application only — and, therefore,
reduce the potential for dietary
exposures below the Agency’s level of
concern.
EPA believes that defining the scope
of a tolerance exemption for THFA
requires a cautious approach
considering the significant toxicity
concerns. THFA’s toxicity profile is
more similar to pesticide active
ingredients or safeners than to minimal
risk inert ingredients. Therefore, certain
supporting data typically required for
active ingredients and safeners may also
be necessary for petitions requesting
applications of THFA to most growing
food crops (especially applications to
edible parts). Considering THFA’s
significant reproductive and
developmental toxicity and lack of
neurotoxicity data (a sub-chronic study
reported whole body spasms), EPA does
not believe it can pick a safe maximum
application rate or pre-harvest interval
in the absence of the appropriate
acceptable guideline studies (such as
crop residue data) normally used by
EPA to set these use limitations.
Unfortunately, the Agency does not
have acceptable, reliable crop residue
data that could assist in setting THFA
application rates and pre-harvest
intervals.
Several commentors requested that 40
CFR 180.1263 permit the application of
THFA to many crops, such as all cereal
grains in crop group 15. Considering the
chemical’s toxicity profile, EPA does
not believe it has the necessary data to
broadly grant more uses of THFA now
without knowing exact application
scenarios. EPA needs to evaluate the
uses of a pesticide product in order to
estimate the potential for residues of
THFA and determine whether residue
data may be necessary. In the future, 40
CFR 180.1263 will be amended if the
Agency receives a petition that is
supported by data and information
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sufficient for the request, and the
Agency determines that the safety
finding can be made for these new and/
or expanded uses. EPA suggests that
parties interested in petitioning for new
and/or expanded uses of THFA first
consult with the Agency to determine
data needs.
Several commentors requested 40 CFR
180.1263 include two early season (prebloom) applications in herbicides on
soybeans, canola, and field corn. The
Agency evaluated the requested
application scenarios for these crops
and determined that the FQPA safety
finding could be made for these limited
early season uses.
3. Availability of acceptable crop
residue data for THFA. All commenters
asserted that a residue study (MRID
56444) provides sufficient data to
demonstrate the rapid rate of decline of
THFA residues from treated crops, and
that the results of this study support the
use of THFA on all crops. EPA disagrees
that any reliable data have been
submitted to the Agency concerning
residues on food resulting from
applications of pesticide products
containing THFA. The study identified
by the commentors, MRID 56444, was
developed by Chemagro in 1972 and
submitted to EPA in 1973 by Quaker
Oats Company. The three crops used
(alfalfa, Roma variety tomato, and
soybeans in pod) do not represent the
broad range of crops requested by the
commentors. It is not an acceptable
study for a number of reasons. MRID
56444 is an unpublished summary of
data (one page per crop) that lacks
documentation about how the study was
conducted or method validation, and
does not include a discussion of the
study results. The data are considered to
be of low reliability because of the low
rates of recoveries. It appears that
sampling was done at 0, 4, and 24 hours
after application of THFA. The results
on Roma variety tomato between the 4
and 24 hour sampling times were
contradictory and no discussion was
provided. No results for the 24th hour
sample were included in the comments
submitted by Penn Specialty Chemicals,
Inc. The study MRID 56444 is
considered unacceptable and cannot be
used to support a tolerance or tolerance
exemption for THFA.
The Agency disagrees with the
commentors who asserted that THFA is
naturally occurring, and is sufficiently
volatile that it will not be available for
uptake into plants and treated crops. An
acceptable plant metabolism study that
would describe the potential for plant
uptake of THFA is not available to the
Agency. In addition, EPA cannot locate
any reliable information that THFA is a
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naturally occurring substance and is
ubiquitous in the environment, as the
commentor inferred. On the contrary,
Quaker Oats stated that THFA is
produced commercially by catalytic
hydrogenation of furfural or furfuryl
alcohol.
4. Use of DEEM in the THFA
assessment. All commentors objected to
Agency’s use of the inert ingredient
screening level DEEM as a basis for its
decision to limit the uses of THFA, and
they proposed refinements that support
their THFA use proposals. The Agency’s
regulatory decision that the current
unlimited THFA tolerance exemption
under 40 CFR 180.910 does not meet the
safety requirements of FFDCA section
408(b)(2) was based on a consideration
of the significant hazard profile of
THFA rather than the result of the inert
ingredient screening level DEEM. The
results of the screening level DEEM was
provided in the Public Docket for
informational purposes in order to
provide some information regarding the
potential for exposure from the use of
THFA on food crops under the
unlimited 40 CFR 180.910 tolerance
exemption. It should be noted that
while the inert ingredient DEEM
screening model is designed to be
conservative, it is not conservative
enough to cover the registered uses of
THFA under the 40 CFR 180.910
tolerance exemption because the
quantity of THFA in the formulations of
many pesticide products was quite high,
with more than half containing 75 - 98
% THFA.
EPA disagrees with the commentors
who asserted that the Agency must
refine the inert ingredient DEEM with
the dissipation and decline data they
calculated from MRID 56444. The inert
ingredient DEEM is used as a screening
level model only, and refinements to the
screening model are inappropriate and
do not meet the standards of sound
science. Residue decline data are used
in refined exposure modeling and
assessments, which were not performed
for THFA because the remaining
supported registered uses included in
40 CFR 180.1263 did not need a refined
exposure assessment. Also, EPA will not
consider the results of MRID 56444 in
any future refined exposure modeling
because the study is unacceptable (see
above).
C. What is the Agency’s Authority for
Taking this Action?
A ‘‘tolerance’’ represents the
maximum level for residues of pesticide
chemicals legally allowed in or on raw
agricultural commodities and processed
foods. Section 408 of FFDCA, 21 U.S.C.
346a, as amended by the FQPA of 1996,
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45413
Public Law 104-170, authorizes the
establishment of tolerances, exemptions
from tolerance requirements,
modifications in tolerances, and
revocation of tolerances for residues of
pesticide chemicals in or on raw
agricultural commodities and processed
foods. Without a tolerance or
exemption, food containing pesticide
residues is considered to be unsafe and
therefore ‘‘adulterated’’ under section
402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate
commerce (21 U.S.C. 331(a)). For a fooduse pesticide to be sold and distributed,
the pesticide must not only have
appropriate tolerances under FFDCA,
but also must be registered under FIFRA
(7 U.S.C. 136 et seq.). Food-use
pesticides not registered in the United
States must have tolerances in order for
commodities treated with those
pesticides to be imported into the
United States.
D. When do These Actions Become
Effective?
The revocation of the tolerance
exemption for THFA under 40 CFR
180.910 becomes effective 18 months
after the publication date of this final
rule in the Federal Register. Any
commodities listed in the regulatory text
of this document that are treated with
the pesticide chemical subject to this
final rule, and that are in the channels
of trade following the tolerance
exemption revocations, shall be subject
to FFDCA section 408(1)(5), as
established by the FQPA. Under this
section, any residue of the pesticide
chemical in or on such food shall not
render the food adulterated so long as it
is shown to the satisfaction of the Food
and Drug Administration that:
1. The residue is present as the result
of an application or use of the pesticide
chemical at a time and in a manner that
was lawful under FIFRA, and
2. The residue does not exceed the
level that was authorized at the time of
the application or use to be present on
the food under an exemption from
tolerance. Evidence to show that food
was lawfully treated may include
records that verify the dates that the
pesticide chemical was applied to such
food.
The establishment of the new
tolerance exemption for THFA under 40
CFR 180.1263 becomes effective on the
publication date of this final rule in the
Federal Register.
E. What Is the Contribution to Tolerance
Reassessment?
By law, EPA is required by August
2006, to reassess the tolerances and
exemptions from tolerances that were in
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations
existence on August 2, 1996. This
document revokes one inert ingredient
tolerance exemption which is counted
as a tolerance reassessment toward the
August 2006, review deadline under
FFDCA section 408(q), as amended by
FQPA in 1996.
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VI. Statutory and Executive Order
Reviews
In this final rule, EPA is establishing
and revoking specific tolerance
exemptions established under section
408(d) of FFDCA. The Office of
Management and Budget (OMB) has
exempted this type of action from
review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted
from review under Executive Order
12866 due to its lack of significance,
this final rule is not subject to Executive
Order 13211, Actions Concerning
Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66
FR 28355, May 22, 2001). This final rule
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
special considerations under Executive
Order 12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or OMB review or any Agency
action under Executive Order 13045,
entitled Protection of Children from
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note). Pursuant to
the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency
previously assessed whether revocations
of tolerances might significantly impact
a substantial number of small entities
and concluded that, as a general matter,
these actions do not impose a significant
economic impact on a substantial
number of small entities. This analysis
was published on December 17, 1997
(62 FR 66020), and was provided to the
Chief Counsel for Advocacy of the Small
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Business Administration. Taking into
account this analysis, and available
information concerning the pesticide
listed in this rule, the Agency hereby
certifies that this final action will not
have a significant economic impact on
a substantial number of small entities.
Specifically, as per the 1997 notice, EPA
has reviewed its available data on
imports and foreign pesticide usage and
concludes that there is a reasonable
international supply of food not treated
with pesticides containing the
ingredients being revoked in this notice.
Furthermore, for the pesticide named in
this final rule, the Agency knows of no
extraordinary circumstances that exist
as to the present revocations that would
change the EPA’s previous analysis. In
addition, the Agency has determined
that this action will not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this final
rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive order to include
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regulations that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
final rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this final rule.
IV. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
Agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and 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 the 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: Juky 26, 2006.
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
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.910, the table is amended
by revising the entry for
Tetrahydrofurfuryl alcohol to read as
follows:
I
§ 180.910 Inert ingredients used pre- and
post-harvest; exemptions from the
requirement of a tolerance.
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Inert ingredients
Limits
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Tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No 97–99–4)
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3. Section 180.1263 is added to
subpart D to read as follows:
I
§ 180.1263 Tetrahydrofurfuryl alcohol;
exemption from the requirement of a
tolerance.
Tetrahydrofurfuryl alcohol (THFA,
CAS Reg. No. 97–99–4) is exempt from
the requirement of a tolerance in or on
all raw agricultural commodities when
used in accordance with good
agricultural practices as an inert
ingredient applied only:
(a) For use as a seed treatment.
(b) For applications prior to planting
and at the time of planting.
(c) For use on cotton.
(d) For use in herbicides with one
application to wheat and barley prior to
the pre-boot stage, and two applications
to canola and soybeans pre-bloom.
(e) For use in herbicides with two
applications to field corn up to 24
inches tall (V 5 stage).
[FR Doc. E6–12591 Filed 8–8–06; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0230; FRL–8084–1]
Inert Ingredients; Revocation of
Tolerance Exemptions with Insufficient
Data for Reassessment
Environmental Protection
Agency (EPA).
ACTION: Final rule.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This final rule revokes under
section 408(e)(1) of the Federal Food,
Drug, and Cosmetic Act (FFDCA) the
existing exemptions from the
requirement of a tolerance for residues
of certain inert ingredients because
there are insufficient data to make the
determination of safety required by
FFDCA section 408(b)(2), or because
they are redundant and, therefore, are
not necessary. In addition, EPA has
identified substances within certain of
these tolerance exemptions that meet
the definition of low-risk polymers and
is establishing new tolerance
exemptions for them. The revocation
actions in this document contribute
towards the Agency’s tolerance
reassessment requirements under
FFDCA section 408(q), as amended by
16:38 Aug 08, 2006
Jkt 208001
*
*
*
*
Uses
*
Expires February 9, 2008
*
Solvent/cosolvent
the Food Quality Protection Act (FQPA)
of 1996. By law, EPA is required by
August 2006 to reassess the tolerances
that were in existence on August 2,
1996. The regulatory actions in this
document pertain to the revocation of
130 tolerance exemptions which are
counted as tolerance reassessment
toward the August 2006 review
deadline.
This rule is effective August 9,
2008, except amendatory instructions
dd for § 180.910; jj and pp for § 180.920;
m, q, bb, and kk for § 180.930; and §
180.960 which are effective August 9,
2006. Objections and requests for
hearings must be received on or before
October 10, 2006, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
DATES:
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0230. All documents in the
docket are listed in the index for the
docket. 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) 3055805.
ADDRESSES:
BILLING CODE 6560–50–S
VerDate Aug<31>2005
45415
FOR FURTHER INFORMATION CONTACT:
Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001; telephone number:
(703) 308-8811; e-mail address:
leifer.kerry@epa.gov.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00053
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\09AUR1.SGM
09AUR1
Agencies
[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Rules and Regulations]
[Pages 45411-45415]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12591]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0251; FRL-8082-2]
Inert Ingredient; Revocation of the Tetrahydrofurfuryl Alcohol
(THFA) Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is revoking, under the Federal Food, Drug, and Cosmetic
Act (FFDCA) section 408(e)(1), the existing exemption from the
requirement of a tolerance for residues of the inert ingredient
``Tetrahydrofurfuryl alcohol'' (THFA) under 40 CFR 180.910, and
establishes a limited tolerance for THFA under 40 CFR 180.1263. The
regulatory action contributes toward the Agency's tolerance
reassessment requirements under FFDCA section 408(q), as amended by the
Food Quality Protection Act (FQPA) of 1996. By law, EPA is required by
August 2006 to reassess the tolerances that were in existence on August
2, 1996. This regulatory action counts as a tolerance reassessment
toward the August 2006 review deadline.
DATES: This rule is effective February 9, 2008.
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0251. All documents in the
docket are listed in the index for the docket. 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 telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.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 the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2006-0251 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 10, 2006.
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-2006-0251, 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),
[[Page 45412]]
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 Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
A. What Action is the Agency Taking?
On April 12, 2006, EPA published in the Federal Register (71 FR
18689; FRL-7771-3) proposed actions for the inert ingredient
tetrahydrofurfuryl alcohol (THFA). This final rule revokes the
exemption from the requirement of a tolerance for THFA under 40 CFR
180.910 and establishes a limited tolerance exemption for THFA under 40
CFR 180.1263. In evaluating THFA, EPA determined that dietary risks of
concern may result from the use of THFA under the current tolerance
exemption in 40 CFR 180.910, which allows an unlimited amount of THFA
to be applied to growing crops and raw agricultural commodities after
harvest. The hazard characterization of THFA shows effects of concern,
including significant developmental and reproductive effects from
repeated oral exposures. The available data show there is evidence of
increased susceptibility (both quantitative and qualitative) of the
offspring after in utero exposure to THFA, including decreased fetal
body weights. The Agency concluded that THFA's unlimited tolerance
exemption under 40 CFR 180.910 does not meet the safety requirements of
FFDCA section 408(b)(2), and proposed the revocation of the tolerance
exemption 18 months after the publication of the final rule in the
Federal Register. In the same document, EPA proposed to establish a new
exemption under 40 CFR 180.1263 for applications to cotton, use with
herbicides with one application to wheat and barley prior to the pre-
boot stage, for use as a seed treatment, and applications at the time
of planting.
EPA's responses to comments received on the proposed rule are given
in Unit II.B. EPA maintains its conclusion that THFA's tolerance
exemption under 40 CFR 180.910 does not meet the safety standard of
FFDCA section 408(b)(2), therefore, this tolerance exemption is revoked
in this final rule. The revocation will take effect 18 months after the
publication date of this final rule in the Federal Register.
EPA has evaluated the scope of the new limited THFA tolerance
exemption under 40 CFR 180.1263 and has added limited uses on canola,
soybeans, and field corn, and has clarified that applications will now
be permitted prior to planting. EPA finds that exempting THFA with the
limitations in 40 CFR 180.1263 will be safe for the general population
including infants and children.
B. EPA's Responses to Comments
1. Applications at the time of planting. Several commentors
requested the proposed use of THFA ``at-plant'' be expanded to include
all applications prior to planting. EPA agrees. The proposed limitation
``For application at the time of planting.'' under 40 CFR 180.1263 is
replaced with ``For applications prior to planting and at the time of
planting.'' This includes uses such as applications made in preparation
for the planting of the crop, in the furrow during planting of seeds
and transplants, and to the soil surface at the time of planting. This
small expansion of the proposed limitation is in keeping with the uses
of currently registered pesticide products containing THFA. Considering
THFA's physical-chemical properties and biodegradation potential in the
environment, the new limitation does not change EPA's safety finding
for the new 40 CFR 180.1263.
2. Requests to expand uses, and establish application rates and
pre-harvest intervals. One commentor stated that EPA does not have to
restrict the crops that THFA can be applied to if the Agency would set
either a maximum THFA percentage limit in pesticide concentrates, or a
maximum THFA percentage limit for dilute product rates applied to food
crops. In addition, several commentors suggested the establishment of
pre-harvest intervals as a way to limit or eliminate the potential for
residues of THFA on harvested commodities.
In determining whether uses of THFA could be maintained, the Agency
evaluated the uses of all currently registered pesticide products that
contained THFA. The products were registered for applications to a very
large number of crops and most permitted multiple applications (e.g.,
six) including on the day of harvest. For many pesticide products, the
quantity of THFA in formulation was unusually high, with more than half
containing 75 - 98 % THFA. The Agency discussed its toxicity concerns
for THFA with the registrants of these pesticide products, and the
large majority elected to reformulate their products with another
solvent. Of the pesticide products that continued to contain THFA, EPA
determined that the safety finding could be made for their uses and
crafted the limitations of the new tolerance exemption under 40 CFR
180.1263 to include only those uses. The available reliable information
on THFA's physical-chemical properties and biodegradation potential in
soil was considered in making the safety finding for the uses described
in the new exemption. The uses in the new exemption significantly
reduce the number of times that THFA may be applied per season - often
to one application only -- and, therefore, reduce the potential for
dietary exposures below the Agency's level of concern.
EPA believes that defining the scope of a tolerance exemption for
THFA requires a cautious approach considering the significant toxicity
concerns. THFA's toxicity profile is more similar to pesticide active
ingredients or safeners than to minimal risk inert ingredients.
Therefore, certain supporting data typically required for active
ingredients and safeners may also be necessary for petitions requesting
applications of THFA to most growing food crops (especially
applications to edible parts). Considering THFA's significant
reproductive and developmental toxicity and lack of neurotoxicity data
(a sub-chronic study reported whole body spasms), EPA does not believe
it can pick a safe maximum application rate or pre-harvest interval in
the absence of the appropriate acceptable guideline studies (such as
crop residue data) normally used by EPA to set these use limitations.
Unfortunately, the Agency does not have acceptable, reliable crop
residue data that could assist in setting THFA application rates and
pre-harvest intervals.
Several commentors requested that 40 CFR 180.1263 permit the
application of THFA to many crops, such as all cereal grains in crop
group 15. Considering the chemical's toxicity profile, EPA does not
believe it has the necessary data to broadly grant more uses of THFA
now without knowing exact application scenarios. EPA needs to evaluate
the uses of a pesticide product in order to estimate the potential for
residues of THFA and determine whether residue data may be necessary.
In the future, 40 CFR 180.1263 will be amended if the Agency receives a
petition that is supported by data and information
[[Page 45413]]
sufficient for the request, and the Agency determines that the safety
finding can be made for these new and/or expanded uses. EPA suggests
that parties interested in petitioning for new and/or expanded uses of
THFA first consult with the Agency to determine data needs.
Several commentors requested 40 CFR 180.1263 include two early
season (pre-bloom) applications in herbicides on soybeans, canola, and
field corn. The Agency evaluated the requested application scenarios
for these crops and determined that the FQPA safety finding could be
made for these limited early season uses.
3. Availability of acceptable crop residue data for THFA. All
commenters asserted that a residue study (MRID 56444) provides
sufficient data to demonstrate the rapid rate of decline of THFA
residues from treated crops, and that the results of this study support
the use of THFA on all crops. EPA disagrees that any reliable data have
been submitted to the Agency concerning residues on food resulting from
applications of pesticide products containing THFA. The study
identified by the commentors, MRID 56444, was developed by Chemagro in
1972 and submitted to EPA in 1973 by Quaker Oats Company. The three
crops used (alfalfa, Roma variety tomato, and soybeans in pod) do not
represent the broad range of crops requested by the commentors. It is
not an acceptable study for a number of reasons. MRID 56444 is an
unpublished summary of data (one page per crop) that lacks
documentation about how the study was conducted or method validation,
and does not include a discussion of the study results. The data are
considered to be of low reliability because of the low rates of
recoveries. It appears that sampling was done at 0, 4, and 24 hours
after application of THFA. The results on Roma variety tomato between
the 4 and 24 hour sampling times were contradictory and no discussion
was provided. No results for the 24th hour sample were included in the
comments submitted by Penn Specialty Chemicals, Inc. The study MRID
56444 is considered unacceptable and cannot be used to support a
tolerance or tolerance exemption for THFA.
The Agency disagrees with the commentors who asserted that THFA is
naturally occurring, and is sufficiently volatile that it will not be
available for uptake into plants and treated crops. An acceptable plant
metabolism study that would describe the potential for plant uptake of
THFA is not available to the Agency. In addition, EPA cannot locate any
reliable information that THFA is a naturally occurring substance and
is ubiquitous in the environment, as the commentor inferred. On the
contrary, Quaker Oats stated that THFA is produced commercially by
catalytic hydrogenation of furfural or furfuryl alcohol.
4. Use of DEEM in the THFA assessment. All commentors objected to
Agency's use of the inert ingredient screening level DEEM as a basis
for its decision to limit the uses of THFA, and they proposed
refinements that support their THFA use proposals. The Agency's
regulatory decision that the current unlimited THFA tolerance exemption
under 40 CFR 180.910 does not meet the safety requirements of FFDCA
section 408(b)(2) was based on a consideration of the significant
hazard profile of THFA rather than the result of the inert ingredient
screening level DEEM. The results of the screening level DEEM was
provided in the Public Docket for informational purposes in order to
provide some information regarding the potential for exposure from the
use of THFA on food crops under the unlimited 40 CFR 180.910 tolerance
exemption. It should be noted that while the inert ingredient DEEM
screening model is designed to be conservative, it is not conservative
enough to cover the registered uses of THFA under the 40 CFR 180.910
tolerance exemption because the quantity of THFA in the formulations of
many pesticide products was quite high, with more than half containing
75 - 98 % THFA.
EPA disagrees with the commentors who asserted that the Agency must
refine the inert ingredient DEEM with the dissipation and decline data
they calculated from MRID 56444. The inert ingredient DEEM is used as a
screening level model only, and refinements to the screening model are
inappropriate and do not meet the standards of sound science. Residue
decline data are used in refined exposure modeling and assessments,
which were not performed for THFA because the remaining supported
registered uses included in 40 CFR 180.1263 did not need a refined
exposure assessment. Also, EPA will not consider the results of MRID
56444 in any future refined exposure modeling because the study is
unacceptable (see above).
C. What is the Agency's Authority for Taking this Action?
A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate commerce (21 U.S.C. 331(a)).
For a food-use pesticide to be sold and distributed, the pesticide must
not only have appropriate tolerances under FFDCA, but also must be
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not
registered in the United States must have tolerances in order for
commodities treated with those pesticides to be imported into the
United States.
D. When do These Actions Become Effective?
The revocation of the tolerance exemption for THFA under 40 CFR
180.910 becomes effective 18 months after the publication date of this
final rule in the Federal Register. Any commodities listed in the
regulatory text of this document that are treated with the pesticide
chemical subject to this final rule, and that are in the channels of
trade following the tolerance exemption revocations, shall be subject
to FFDCA section 408(1)(5), as established by the FQPA. Under this
section, any residue of the pesticide chemical in or on such food shall
not render the food adulterated so long as it is shown to the
satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of
the pesticide chemical at a time and in a manner that was lawful under
FIFRA, and
2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under an
exemption from tolerance. Evidence to show that food was lawfully
treated may include records that verify the dates that the pesticide
chemical was applied to such food.
The establishment of the new tolerance exemption for THFA under 40
CFR 180.1263 becomes effective on the publication date of this final
rule in the Federal Register.
E. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006, to reassess the tolerances
and exemptions from tolerances that were in
[[Page 45414]]
existence on August 2, 1996. This document revokes one inert ingredient
tolerance exemption which is counted as a tolerance reassessment toward
the August 2006, review deadline under FFDCA section 408(q), as amended
by FQPA in 1996.
VI. Statutory and Executive Order Reviews
In this final rule, EPA is establishing and revoking specific
tolerance exemptions established under section 408(d) of FFDCA. The
Office of Management and Budget (OMB) has exempted this type of action
from review under Executive Order 12866, entitled Regulatory Planning
and Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this final rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether revocations of tolerances
might significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
This analysis was published on December 17, 1997 (62 FR 66020), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration. Taking into account this analysis, and available
information concerning the pesticide listed in this rule, the Agency
hereby certifies that this final action will not have a significant
economic impact on a substantial number of small entities.
Specifically, as per the 1997 notice, EPA has reviewed its available
data on imports and foreign pesticide usage and concludes that there is
a reasonable international supply of food not treated with pesticides
containing the ingredients being revoked in this notice. Furthermore,
for the pesticide named in this final rule, the Agency knows of no
extraordinary circumstances that exist as to the present revocations
that would change the EPA's previous analysis. In addition, the Agency
has determined that this action will not have a substantial direct
effect on States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive
Order 13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of FFDCA.
For these same reasons, the Agency has determined that this final rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This final rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this final rule.
IV. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the Agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and 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 the 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: Juky 26, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
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Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.910, the table is amended by revising the entry for
Tetrahydrofurfuryl alcohol to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
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[[Page 45415]]
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Inert ingredients Limits Uses
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Tetrahydrofurfuryl alcohol (THFA) (CAS Expires February 9, 2008 Solvent/cosolvent
Reg. No 97-99-4)
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3. Section 180.1263 is added to subpart D to read as follows:
Sec. 180.1263 Tetrahydrofurfuryl alcohol; exemption from the
requirement of a tolerance.
Tetrahydrofurfuryl alcohol (THFA, CAS Reg. No. 97-99-4) is exempt
from the requirement of a tolerance in or on all raw agricultural
commodities when used in accordance with good agricultural practices as
an inert ingredient applied only:
(a) For use as a seed treatment.
(b) For applications prior to planting and at the time of planting.
(c) For use on cotton.
(d) For use in herbicides with one application to wheat and barley
prior to the pre-boot stage, and two applications to canola and
soybeans pre-bloom.
(e) For use in herbicides with two applications to field corn up to
24 inches tall (V 5 stage).
[FR Doc. E6-12591 Filed 8-8-06; 8:45 am]
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