Document ID: EPA-HQ-OPP-2007-0546-0001
Agency: epa
Document Type: Proposed Rule
Title: Thiabendazole; Threshold of Regulation Determination
Posted Date: 2007-10-03T04:00Z

[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]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]]

----------------------------------------------------------------------------------------------------------------
          Pesticide Chemical               CAS Reg. No.             Use/Limits             Analytical Method
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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]

BILLING CODE 6560-50-S