Tetrahydrofurfuryl Alcohol (THFA); Proposed Action on Tolerance Exemption, 18689-18693 [E6-5399]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 70 (Wednesday, April 12, 2006)]
[Proposed Rules]
[Pages 18689-18693]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-5399]


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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 
https://www.regulatioris.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 athttps://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 https://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 
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 https://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 https://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 https://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 https://
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 (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 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 arn]
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