FR Doc E7-19542

[Federal Register: October 3, 2007 (Volume 72, Number 191)]
[Proposed Rules]
[Page 56325-56330]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc07-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0546; FRL-8151-6]

Thiabendazole; Threshold of Regulation Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to establish by rule that there is no need
for a tolerance or tolerance exemption under the Federal Food Drug and
Cosmetic Act (FFDCA) for the use of the fungicide thiabendazole as a
seed treatment on dry peas. This determination is based on EPA's
finding that any residues that remain in food from this use will be
both non-detectable and below the level of regulatory concern.

DATES: Comments must be received on or before December 3, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0546, 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), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0546. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line 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 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.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
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, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at 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 hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5218; fax number: (703) 305-0599; e-mail address:
stanton.susan@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), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
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. 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. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0546. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard

copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.

[[Page 56326]]

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.

II. Background

A. What Action is the Agency Taking?

EPA is proposing that the use of the fungicide thiabendazole, 2-(4-
thiazolyl) benzimidazole, as a seed treatment on dry peas does not need
an FFDCA tolerance or tolerance exemption based on EPA's finding that
any residues that remain in food from this use will be both non-
detectable and below the level of regulatory concern.
In the Federal Register of October 27, 1999 (64 FR 57881),
available at http://www.epa.gov/fedrgstr/EPA-PEST/1999/October/Day-27/p28047.htm
, EPA announced the availability of a policy document titled

``Threshold of Regulation (TOR) Policy - Deciding Whether a Pesticide
with a Food Use Pattern Requires a Tolerance.'' This policy document
describes:
(a) EPA's authority for determining whether a tolerance or
tolerance exemption is, or is not, required for a pesticide use.
(b) Relevant criteria that EPA would consider in determining
whether a tolerance is required for a pesticide use in, on, or near
food that produces no detected residues in the food.
(c) Data, including toxicology and residue chemistry studies, that
EPA would generally consider when deciding whether a tolerance is
required.
(d) The procedures that would guide EPA in evaluating whether new
or existing pesticide uses fall below the level of regulatory concern.
(e) The procedures that EPA would follow to establish a regulation
in title 40 of the Code of Federal Regulations (CFR) for each use found
to be below the level of regulatory concern.
You may obtain electronic copies of the TOR policy document from
the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/.
On the Office of Pesticide Programs' Home Page, select

``Science and Policy,'' then select ``Policy and Guidance''and look up
the TOR entry under ``TRAC Science Policy Issues and Documents.''
Designation of a pesticide use as below the level of regulatory
concern means EPA has determined that no tolerance or exemption is
required under section 408. Accordingly, for the purposes of
registration of the pesticide use under the Federal Insecticide,
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq., a
tolerance or exemption from tolerance would not be deemed necessary
under 40 CFR 152.112(g). Designation of a pesticide use as below the
level of regulatory concern does not legalize any detectable residues
of that pesticide on food.
This proposed decision applies only to the use of the fungicide
thiabendazole as a seed treatment on dry peas when applications are
made according to the following label directions:

A single application of thiabendazole may be made as a seed
treatment at the rate of 0.075 pounds of active ingredient per 100
pounds of seed (dry pea (including field pea), pigeon pea, chickpea
or lentil). Applications will be made as a spray mist or slurry
treatment maintained under constant agitation. Vines and hay grown
from treated seed may not be fed to livestock.

EPA proposes that there is no need for a tolerance or tolerance
exemption for this use under the FFDCA since (a) using a reliable and
appropriately sensitive analytical method to measure residues in dry
peas, no residues were detected in the commodity under the expected
conditions of use; and (b) using reasonably protective criteria, the
estimated potential risk of any theoretically possible residues in food
is not of concern. The information EPA relied on in proposing this
decision is summarized below.
1. Toxicology considerations--i. Toxicological profile. EPA has
evaluated the available toxicity data for thiabendazole and considered
its validity, completeness, and reliability as well as the relationship
of the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. EPA has concluded that there are sufficient data to
characterize the hazard posed by any potential exposures to
thiabendazole. Specific information on the toxicity of thiabendazole is
available in the Reregistration Eligibility Decision (RED) document,
issued by the Agency in October 2002, and available electronically on
the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/.
On the Office of Pesticide Programs' Home Page, under

``Featured Sites'' select ``REDs & Pesticide Reregistration Status;''
then look up the RED for Thiabendazole and its salts in the
alphabetical listing.
ii. Toxicological endpoints. For hazards that have a threshold
below which there is no appreciable risk, the toxicological level of
concern (LOC) is derived from the highest dose at which no adverse
effects are observed (the NOAEL) in the toxicology study identified as
appropriate for use in risk assessment. However, if a NOAEL cannot be
determined, the lowest dose at which adverse effects of concern are
identified (the LOAEL) is sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are used in conjunction with the LOC
to take into account uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns. Safety
is assessed for acute and chronic risks by comparing exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the LOC by all applicable UFs.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm
.

The toxicological endpoints used in making the TOR determination
for the proposed use of thiabendazole as a seed treatment on dry peas
are discussed below and summarized in Table 1 of this unit.
a. Acute dietary endpoint. At the time of the thiabendazole RED,
EPA had selected acute dietary endpoints for the

[[Page 56327]]

general population and females, 13 years and older, based on reduced
fetal weights and decreased maternal body weights seen in the rat
developmental toxicity study. EPA has reconsidered these endpoints and
concluded that reduced fetal weights and decreased maternal body
weights are not effects that are likely to occur after a single dose of
a pesticide and are, therefore, not appropriate for use in assessing
acute risks. EPA has reviewed the toxicology database to determine if
there are other endpoints that would be appropriate for acute
assessment, giving careful consideration to the reproductive and
developmental effects noted in the database and in literature
citations. Since those effects were only observed at very high doses,
they were determined to be inappropriate for risk assessment at the
exposures expected for thiabendazole. EPA has concluded that there is
no appropriate endpoint in the toxicology database that is attributable
to a single dose of thiabendazole and that an acute risk assessment is
not required for this chemical.
b. Chronic dietary endpoint. The chronic dietary endpoint (NOAEL of
10 mg/kg/day) is based on decreased body weight gains and liver
hypertrophy seen at the LOAEL of 30 mg/kg/day in the 2-year chronic
feeding/carcinogenicity study in the rat.
c. Cancer. The Agency has classified thiabendazole as ``likely to
be carcinogenic at doses high enough to cause a disturbance of the
thyroid hormone balance. It is not likely to be carcinogenic at doses
lower than those which could cause a disturbance of this hormonal
balance.'' A mode of action was established in which these tumors were
attributed to interference with thyroid-pituitary homeostasis. EPA is
currently regulating chronic dietary risk using a cPAD that reflects a
dose level below levels at which thyroid hormone balance is impacted;
therefore, the chronic risk assessment is protective of potential
carcinogenic effects. A separate risk assessment for cancer is not
required.

Table 1.--Summary of Toxicological Doses and Endpoints for Thiabendazole Used in the TOR Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, FQPA SF and Level of
Exposure/Scenario Interspecies and Concern for Risk Study and Toxicological
Intraspecies and any Assessment Effects
Traditional FQPA, SF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of Not Applicable (N/A) N/A No effect attributable
age) to a single dose
identified in the
database.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population N/A N/A No effect attributable
including infants and children) to a single dose
identified in the
database.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL= 10 mg/kg/day FQPA SF = 1 2-Year Feeding/Chronic
SF = 100............... cPAD = chronic RfD / Carcinogenicity Study
Chronic RfD = 0.1 mg/kg/ FQPA SF = 0.1 mg/kg/ in the Rat. LOAEL = 30
day. day. mg/kg/day based on
decreased body weight
gains and liver
hypertrophy.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) NA NA Classified as ``not
likely to be
carcinogenic to humans
at doses that do not
alter rat thyroid
hormone homeostasis.
----------------------------------------------------------------------------------------------------------------

2. Safety Factor for Infants and Children. Section 408 of FFDCA
provides that EPA shall apply an additional (``10X'') tenfold margin of
safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and the completeness of the
database on toxicity and exposure unless EPA determines based on
reliable data that a different margin of safety will be safe for
infants and children. This additional margin of safety is commonly
referred to as the FQPA safety factor. In applying this provision, EPA
either retains the default value of 10X when reliable data do not
support the choice of a different factor, or, if reliable data are
available, EPA uses a different additional FQPA safety factor value
based on the use of traditional uncertainty (UFs) and/or considerations
specifically raised in the FQPA, as appropriate.
EPA has determined that reliable data show that it would be safe
for infants and children to reduce the FQPA safety factor for
thiabendazole to 1X. That decision is based on the following findings:
i. The toxicity database for thiabendazole is complete.
ii. There is no indication that thiabendazole is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that thiabendazole results in increased
susceptibility in in utero rats, rabbits or mice in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study. In the prenatal developmental toxicity studies in rats, rabbits,
and mice and in the 2-generation reproduction study in rats,
developmental effects in the fetuses or neonates occurred at or above
doses that caused maternal or parental toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure assessment of the TOR use, discussed
below in Unit II.A.3., was performed assuming 100% crop treated and a
conservative residue estimate. The assessment will not underestimate
the exposure and risks posed by the use of thiabendazole as a seed
treatment on dry peas.
3. Residue data and analytical method considerations. For a use to
be below the level of regulatory concern it is important for it not to
result in detectable residues under a reasonably sensitive analytical
method and for any theoretical residues that are present to pose
essentially a zero risk. Considering the range of sensitivities of
tolerance analytical methods, EPA believes that a reasonably sensitive
method should have a limit of quantitation (LOQ) in the range of 0.01
parts per million (ppm). However, the sensitivity of the method is not
chosen in a vacuum and consideration should be given to how the
sensitivity of the method affects any

[[Page 56328]]

estimation of risk. Accordingly, on a case-specific basis, EPA may
accept a higher or lower LOQ if an appropriate rationale, including a
consideration of risks estimated based on exposure as measured by that
LOQ, supports such a decision.
Interregional Research Project No. 4 (IR-4), 500 College Road East,
Suite 201 W, Princeton, NJ 08540, submitted field trial data for
thiabendazole on dry pea. A total of five field trials were conducted
in Zone 11 (2 trials in Idaho and 3 trials in Washington) during the
1996 growing season. Thiabendazole (30% flowable concentrate
formulation) was formulated with water and seed dye and applied to dry
pea seed at a seed treatment facility, at a nominal rate of 0.075
pounds of active ingredient per 100 pounds of seed. Treated seed was
planted within 10 days of seed treatment, and samples of dry pea were
collected from the field trial sites at maturity, 83-90 days after
planting.
Samples of dry pea were analyzed for residues of thiabendazole per
se using a High Pressure Liquid Chromatography/Fluorescence Detector
(HPLC/FLD) method with a lower limit of the method validation (LLMV) of
0.05 ppm. The method (MRID 45428201) is a modification of the
method Ion-Pairing Liquid Chromatographic Determination of
Benzimidazole Fungicides in Foods, Gilvydis and Walters, JAOAC, vol.
73, no. 5, 1990. The mobile phase hold times were increased to obtain
adequate separations. Duplicate samples were analyzed for residues of
thiabendazole at each of the five field trial locations. Residues of
thiabendazole were less than the method limit of detection (LOD) of
0.02 ppm in all 10 field trial samples.
No data were provided on residues of benzimidazole, a regulated
metabolite of thiabendazole in or on dry pea grown from treated seed.
However, based on residue studies in three diverse crops (wheat,
soybean and sugar beets) in which residues of benzimidazole were
consistently lower than residues of the parent compound, thiabendazole,
EPA does not expect detectable residues of benzamidazole in dried peas
grown from thiabendazole treated seed.
The analytical method used to measure thiabendazole residues
appeared in the JAOAC, The Journal of the Association of Official
Analytical Chemists, a peer reviewed publication. Further, adequate
method validation data were provided in both the journal article and in
conjunction with the submitted residue data. EPA concludes that the
method would be suitable for enforcement purposes. The analytical
method's reported LLMV of 0.05 ppm is higher than the 0.01 ppm value
that has been identified as a target LOQ by the policy document on
identifying uses below the threshold of regulatory concern.
Nevertheless, EPA has concluded that the analytical method used to
generate the residue data is sufficiently sensitive to support the
threshold of regulation determination based on the following supporting
information.
i. The LLMV is an artifact of the concentrations chosen for the
study validation, and the actual analytical limits of quantitation
(LOQ) and limits of detection (LOD) may be significantly below that
value. EPA carefully examined the method chromatograms. Based on peak
heights relative to concentration, peak shape and signal to noise
ratio, the method's LOD was determined to be no greater than 0.02 ppm.
ii. EPA also considered data on the nature of the residue in
soybeans submitted by Gustafson, Inc. The study was entitled ``Total
¹⁴C Thiabendazole Residues in Soybeans from Treated Seed
Grown Under Field Conditions'' (1998, MRID 45200301). In this study,
soybean seeds were treated with 38 ppm ¹⁴C Thiabendazole
(0.00382 lb. a.i./100 lbs. seed). The treated seeds were then planted
in the field and samples were taken of mature dry bean (82 days after
treatment). Samples were assayed by combustion and analysis of
¹⁴CO2 by liquid scintillation spectrometry. The
total radioactive residue (TRR) in soybean seed was < 0.001 ppm (< 1
ppb). EPA considers soybeans to be an appropriate surrogate for dry
pea. Taking into account the higher application rate currently
requested for dry peas, the study supports the conclusion reached in
the field trial data that residues will not exceed the estimated LOD of
0.02 ppm in dry pea grown from treated seed at the currently requested
use rate, and may be lower than 0.02 ppm.
iii. Statistical data on the thiabendazole analytical method
submitted by IR-4 further support the conclusion that the actual LOD is
likely below the conservatively estimated value of 0.02 pm and
indicates that the statistical LOD is much closer to 0.01 ppm.
iv. Finally, EPA's risk assessment of the proposed use assumed
theoretical residues in dry peas equal to one-half the estimated LOD,
which is 0.01 ppm. The resulting risk estimates were essentially zero,
indicating that the method is sensitive enough to demonstrate that any
potential residues in food are not of concern. The risk assessment is
discussed in detail in the next section.
Taking all of these factors into consideration, EPA concludes that
the analytical method used to generate the residue data is sufficiently
sensitive to support a conclusion that the use will not result in
detectable residues in food using a reasonably sensitive method. The
method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.

4. Dietary risk assessment. For a use to be below the level of
regulatory concern, any theoretical residues present from the use
should pose essentially zero dietary risk. As a starting point for
analysis of this question, EPA's policy document has recommended that
essentially zero dietary risk is evidenced by a showing that
incremental risk from exposure to potential residues in food resulting
from use of a pesticide should generally be less than 1/1000 of the
acceptable risk. For a pesticide such as thiabendazole that exerts
``threshold'' effects, this means that incremental acute or chronic
potential exposure from the use should occupy less than 0.1% of the
acute or chronic population-adjusted dose (aPAD or cPAD) for the
pesticide. EPA assessed dietary exposure to thiabendazole from its use
as a seed treatment on dry peas as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for thiabendazole; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). EPA
assumed residues of thiabendazole would be present in dry peas at one-
half the LOD, equal to 0.01 ppm. Only dry peas were included in the
dietary assessment, and 100% of dry peas were assumed to be treated
with thiabendazole.
Using these assumptions, EPA has concluded that chronic dietary
exposure to thiabendazole from residues theoretically present in dry
peas will not exceed 0.01% of the cPAD for the U.S. population or any
population subgroup, including infants and children. The estimated
chronic risk for

[[Page 56329]]

the U.S. population and all subpopulations of concern is significantly
below the level recommended in EPA's policy as showing essentially zero
risk (0.1% of the cPAD).
iii. Cancer. Thiabendazole has been classified as ``not likely to
be carcinogenic to humans at doses that do not alter rat thyroid
hormone homeostasis.'' The Office of Pesticide Programs' Health Effects
Division is currently regulating chronic dietary risk with a chronic
cPAD that reflects a dose level below dose levels at which thyroid
hormone balance is impacted and, consequently, is also being protective
of potential carcinogenic effects. Therefore, a cancer dietary
assessment is unnecessary. Based on the results of the chronic dietary
assessment, the use of thiabendazole on dry peas is not expected to
pose a cancer risk.
5. Threshold of regulation determination. Based on the information
discussed above, EPA has concluded that:
i. Reliable residue data developed using an analytical method with
appropriate sensitivity show that no thiabendazole residues resulting
from the use of the pesticide as a seed treatment on dry peas are
detected in dry peas grown from treated seed when they enter interstate
commerce.
ii. There are sufficient data to characterize the hazard posed by
any potential exposures to thiabendazole.
iii. Risk estimates show that any thiabendazole residues
theoretically present in dry peas as a result of this use pose an
``essentially zero'' dietary risk.
Therefore, EPA proposes to designate the use of thiabendazole as a
seed treatment on dry peas as below the threshold of regulatory concern
and thus as not requiring a tolerance or a tolerance exemption under
FFDCA. EPA proposes to identify the use as such under 40 CFR part
180.2010 (Threshold of regulation determinations).

B. What is the Agency's Authority for Taking this Action?

The Federal Food, Drug and Cosmetic Act (FFDCA) section
408(e)(1)(C) authorizes the Agency to establish general procedures and
requirements to implement FFDCA section 408. FFDCA section 701(a)
authorizes the Agency to establish rules implementing the various
provisions of FFDCA, as follows: ``The authority to promulgate
regulations for the efficient enforcement of this Act, except as
otherwise provided in this section, is hereby vested in the
Secretary.'' The term ``Secretary'' means ``Administrator'' with
respect to those provisions of FFDCA for which the Administrator of
EPA, rather than the Secretary of Health and Human Services, has
responsibility. These provisions grant EPA the authority to identify by
regulation pesticide uses that do not need tolerances or exemptions
from tolerances under section 408 of FFDCA.

III. Statutory and Executive Order Reviews

The Office of Management and Budget (OMB) has exempted these types
of actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993, as amended by
Executive Order 13422, 72 FR 2763, January 18, 2007). Because this
action has been exempted from review under Executive Order 12866, this
action is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution or
Use (66 FR 28355), May 22, 2001 or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks or Safety Risks
(62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
In addition, pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that this action will not have a significant adverse economic
impact on a substantial number of small entities because this action
does not have any adverse economic impacts.
This action directly regulates growers, food processors, food
handlers and food retailers, not States or tribes, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency has determined that this action
will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, the Agency has determined
that Executive Order 13132, entitled Federalism (64 FR 43255, August
10, 1999) and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000) do not apply to this action. In addition, this action does not
impose an enforceable duty or contain any unfunded mandate as described
under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: September 26, 2007.
Debra Edwards,
Director, 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 180.2010 is amended by adding text to read as follows:

Sec. 180.2010 Threshold of regulation determinations.

The following pesticide chemical uses do not need a tolerance or
exemption from the requirement of a tolerance based on EPA's
determination that the uses are below the threshold of regulation.

[[Page 56330]]

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Pesticide Chemical CAS Reg. No. Use/Limits Analytical Method
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Thiabendazole 148-79-8 As a seed treatment for High Performance Liquid
dry pea (including field Chromatography/
pea), pigeon pea, Florescence Detector
chickpea or lentil, method\1\; Modification
using a maximum of Ion-Pairing Liquid
application rate of Chromatographic
0.075 pounds of active Determination of
ingredient per 100 Benzimidazole Fungicides
pounds of seed. Vines or in Foods, Gilvydis and
hay grown from treated Walters, JAOAC, vol. 73,
seed may not be fed to no. 5, 1990.
livestock.
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\1\ Available from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade,
MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov.

[FR Doc. E7-19542 Filed 10-2-07; 8:45 am]

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