[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]
[Page 45411-45415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09au06-20]
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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.
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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 http://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 http://www.regulations.gov
, you may access this ''Federal Register'' document
electronically through the EPA Internet under the ''Federal Register''
listings at http://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 http://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: http://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.
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. 180.910, 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.
* * * * *
[[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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0
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]
BILLING CODE 6560-50-S