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Tetrahydrofurfuryl Alcohol (THFA); Proposed Action on Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: April 12, 2006 (Volume 71, Number 70)]
[Proposed Rules]
[Page 18689-18693]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ap06-24]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HO-OPP-2006-0251; FRL-7771-3]
Tetrahydrofurfuryl Alcohol (THFA); Proposed Action on Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes under the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(e)(1) to revoke the existing exemption
from the requirement of a tolerance for residues of the inert
ingredient tetrahydrofurfuryl alcohol (THFA) (CAS Reg. No. 97-99-4)
under 40 CFR 180.910 because it does not meet the safety requirements
of FFDCA section 408(b)(2). While EPA has determined that dietary risks
from use of THFA exceed the Agency's level of concern, limited uses of
THFA may be permitted. Therefore, EPA is also proposing to establish
for THFA an exemption from the requirement of a tolerance under 40 CFR
180.1263 that includes use limitations. The regulatory action proposed
in this document contributes toward the Agency's tolerance reassessment
requirements under FFDCA section 408(q), as amended by the Food Quality
Protection Act (FQPA)
[[Page 18690]]
of 1996. By law, EPA is required by August 2006 to reassess the
tolerances that were in existence on August 2, 1996. The regulatory
action proposed in this document pertains to the proposed revocation of
one tolerance which would be counted as tolerance reassessment toward
the August 2006 review deadline.
DATES: Comments must be received on or before June 12, 2006.
ADDRESSES: Submit your comments, identified by Docket identification
number (ID) No. EPA-HQ-OPP-2006-0251, by one of the following methods:
? http://www.regulations.gov. 
Follow the on-line
instructions for submitting comments.
? Mail. Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
? Hand Delivery. Public Information and Records Integrity
Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801
S. Bell St., Arlington, VA, Attention: Docket ID number EPA-HQ-OPP-
2006-0251. The docket facility is open from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
docket facility is (703) 305-5805. Such deliveries are only accepted
during the Docket's normal hours of operation, and special arrangements
should be made for deliveries of boxed information.
Instructions. Direct your comments to Docket ID No. EPA-HQ- OPP-
2006-0251. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov/, including any personal
information provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage athttp://www.epa.gov/epahome/dockets.htm.
Docket. All documents in the docket are listed in the
regulations.gov index. Although listed in the index, some information
is not publicly available, e.g., CBI or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov/ or in hard copy at the
Public Information and Records Integrity Branch (PIRIB) (7502C), Office of
Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Karen Angulo, Registration Division
(7505C), 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. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all
of the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading Federal Register date and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived
at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
[[Page 18691]]
II. Background and Statutory Findings
A. What Action is the Agency Taking?
EPA is now in the process of reassessing all inert ingredient
exemptions from the requirement of a tolerance (``tolerance
exemptions'') established prior to August 2, 1996, as required by the
FFDCA section 408(q), as amended by the FQPA. Inert ingredient
chemicals must meet a high safety standard in order to merit an exemption
from the numerical residue limitations that are imposed in a tolerance.
1. In evaluating the inert ingredient THFA, the Agency has
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.
Consistent systemic effects from repeated dermal and oral exposure to
THFA include decreased body weight and body weight gain. Effects were
consistent over species and routes of exposure. While no neurotoxicity
studies were performed, whole body spasms were reported in the
subchronic inhalation study.
Developmental and reproductive effects of concern have been
identified. Alterations in the male reproductive system from subchronic
exposure to THFA also indicates a concern for alterations in the
developing male reproductive system. 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 screening level dietary exposure assessment showed that the
risks were above the Agency's level of concern for the general
population and the most highly exposed sub-population (children 1 to 2
years old). Because of these risk levels, the unlimited exemption from
a tolerance as is currently granted to THFA under 40 CFR 180.910 does
not meet the safety requirements of FFDCA section 408(b)(2). Therefore,
EPA is proposing to revoke the existing THFA tolerance exemption,
revocation to be effective 18 months after publication of the final rule.
The assessment documents for THFA are available electronically
under EPA-HQ-OPP-2006-0251 at http://www.regulations.gov.
2. EPA has identified uses of THFA that do not pose risks of
concern. EPA is proposing to establish a tolerance exemption under
Sec. 180.1263 that permits:
(1) Use as a seed treatment,
(2) Application at the time of planting,
(3) Application to cotton, and,
(4) Use in herbicides with one application to wheat and barley
prior to the pre-boot stage.
These limitations 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. Contributions to surface/drinking water are
not anticipated from the use of THFA-containing pesticide products
under the proposed use limitations considering THFA's physical-chemical
properties and biodegradation potential in the environment. No
residential risks of concern are anticipated at this time for the new
tolerance exemption.
i. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to THFA and any other
substances and THFA 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 THFA 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 http://www.epa.gov/pesticides/cumulative/.
ii. Determination of safety for U.S. population, infants and
children. Considering that dietary (food and drinking water) and
residential risks are not of concern under the use limitations of the
new exemption, EPA finds that exempting THFA with the limitations in
Sec. 180.1263 will be safe for the general population including
infants and children.
iii. Analytical enforcement methodology. An analytical method is
not required for the new tolerance exemption for enforcement purposes
because the Agency is establishing an exemption from the requirement of
a tolerance.
B. 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 the 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 the 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.
C. When do these Actions Become Effective?
EPA is proposing to revoke THFA's current tolerance exemption in 40
CFR 180.910, effective 18 months after the date of publication of the
final rule in the Federal Register. Any commodities listed in this
proposal treated with pesticide products containing the inert
ingredient THFA, and in the channels of trade following the tolerance
revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticide chemicals 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 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
[[Page 18692]]
the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates when the pesticide was applied to such food.
EPA is proposing that the establishment of a new tolerance
exemption under Sec. 180.1263 for use of THFA will become effective on
the date of publication of the final rule in the Federal Register.
Applications for new pesticide products that include THFA will be
subject to the limitations of the new tolerance exemption as of the
date of publication of the final rule in the Federal Register.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006 to reassess the
tolerancesand exemptions from tolerances that were in existence on
August 2, 1996. This document proposes to place an 18 month expiration
date on one inert ingredient tolerance exemption, which will be counted
in a final rule as a tolerance reassessment toward the August 2006
review deadline under FFDCA section 408(q), as amended by FQPA in 1996.
III. Are the Proposed Actions Consistent with International Obligations?
The tolerance revocation in this proposal is not discriminatory and
is designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported foods.
EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov/. On the
Home Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr/.
IV. Statutory and Executive Order Reviews
This proposed rule establishes a tolerance under section 408(d) of
the FFDCA in response to a petition submitted to the Agency. The Office
of Management and Budget (0MB) 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed 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 proposed
rule does not contain any information collections subject to 0MB
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 0MB 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 establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations 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. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020), respectively, and were provided to the chief Counsel for
Advocacy of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed
action will not have a significant negative economic impact on a
substantial number of small entities. Specifically, the Agency has
concluded in a memorandum dated May 25, 2001 that for import tolerance
revocation there is a negligible joint probability of certain defined
conditions holding simultaneously which would indicate an RFA/SBREFA
concern and require more analysis. (This Agency document is available
in the docket of this proposed rule). Furthermore, for the pesticide
named in this proposed rule, the Agency knows of no extraordinary
circumstances that exist as to the present proposal that would change
the EPA's previous analysis. Any comments about the Agency's
determination should be submitted to the EPA along with comments on the
proposal, and will be addressed prior to issuing a final rule.
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 proposed 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
[[Page 18693]]
provisions of section 408(n)(4) of the FFDCA. For these same reasons,
the Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (59 FR 22951,
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 proposed 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 proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: April 6, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.910 is amended by revising the entry for
Tetrahydrofurfuryl alcohol in the table to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions
from the requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Tetrahydrofurfuryl alcohol Expires [insert Solvent/cosolvent
(THFA) (CAS Reg. No 97-99-4) date 18 months
after date of
publication of
the Final rule in
the Federal
Register]
* * * * * * *
------------------------------------------------------------------------
* * * * *
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 application 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.
[FR Doc. E6-5399 Filed 4-11-06; 8:45 am]
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