Thiabendazole; Pesticide Tolerances for Emergency Exemptions, 4435-4441 [E7-1234]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 20 (Wednesday, January 31, 2007)]
[Rules and Regulations]
[Pages 4435-4441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-1234]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0962 FRL-8111-1]


Thiabendazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of thiabendazole in or on Brussels sprout, cabbage, and 
cauliflower. This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on Brussels sprout, cabbage, and cauliflower. This regulation 
establishes a maximum permissible level for residues of thiabendazole 
in these food commodities. The tolerances expire and are revoked on 
December 31, 2009.

DATES: This regulation is effective January 31, 2007. Objections and 
requests for hearings must be received on or before April 2, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0962. All documents in the 
docket are listed on the regulations.gov website. Although listed in 
the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either in the electronic docket at https://
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 Building), 2777 S. Crystal Drive 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 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Stacey Groce, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-2505; e-mail address: groce.stacey@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

[[Page 4436]]

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. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. You must file your objection or 
request a hearing on this regulation in accordance with the 
instructions provided in 40 CFR part 178. To ensure proper receipt by 
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0962 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before April 2, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0962 by one of the following methods:
     Federal eRulemaking Portal: https://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 
Building), 2777 S.Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing time-limited tolerances for residues of 
the fungicide thiabendazole in or on Brussels sprout, cabbage, and 
cauliflower at 0.05 parts per million (ppm). These tolerances expire 
and are revoked on December 31, 2009. EPA will publish a document in 
the Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 of the FFDCA and the new safety standard to 
other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA 
to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Thiabendazole on Brussels sprout, cabbage, 
nd cauliflower and FFDCA Tolerances

    The fungus Phoma lingam is the cause of a destructive disease 
(black leg disease) on crucifer crops and has caused periodic epidemics 
in the United States. The applicants from California and Washington 
state that an emergency situation has existed since the registration 
for the pesticide product that had been the industry standard was 
cancelled in 2002. The applicants asserted that without the requested 
use of thiabendazole to control this disease, significant economic 
losses would occur. EPA has authorized under FIFRA section 18 the use 
of thiabendazole on Brussels sprout, cabbage, and cauliflower seeds for 
control of black leg disease caused by Phoma lingam in California and 
Washington State. After having reviewed the submission, EPA concurs 
that emergency conditions exist for these States.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of thiabendazole in 
or on Brussels sprout, cabbage, and cauliflower. In doing so, EPA 
considered the safety

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standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerances under section 408(l)(6) of the FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemptions in 
order to address the urgent non-routine situations and to ensure that 
the resulting food is safe and lawful, EPA is issuing these tolerances 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of the FFDCA. Although these tolerances expire and 
are revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerances remaining in or on Brussels sprout, cabbage, and cauliflower 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA, and the residues do not exceed 
a level that was authorized by these tolerances at the time of that 
application. EPA will take action to revoke these tolerances earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether thiabendazole 
meets EPA's registration requirements for use on Brussels sprout, 
cabbage, and cauliflower seeds or whether permanent tolerances for 
these uses would be appropriate. Under these circumstances, EPA does 
not believe that these time-limited tolerances serve as a basis for 
registration of thiabendazole by a State for special local needs under 
FIFRA section 24(c). Nor do these time-limited tolerances serve as the 
basis for any States other than California and Washington to use this 
pesticide on these crop seeds under section 18 of FIFRA without 
following all provisions of EPA's regulations implementing FIFRA 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for thiabendazole, contact the 
Agency's Registration Division at the address provided under FOR 
FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action. EPA has sufficient data to assess the hazards of 
thiabendazole and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for time-limited 
tolerances for residues of thiabendazole in or on Brussels sprout, 
cabbage, and cauliflower seeds at 0.05 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing these 
tolerances follows.

A. Toxicological Endpoints

    The dose at which no adverse effects are observed (the NOAEL) from 
the toxicology study identified as appropriate for use in risk 
assessment is used to estimate the toxicological endpoint. However, the 
lowest dose at which adverse effects of concern are identified (the 
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved 
in the toxicology study selected. An uncertainty factor (UF) is applied 
to reflect 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. An UF of 100 
is routinely used, 10X to account for interspecies differences and 10X 
for intraspecies differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA SF.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the level of concern (LOC). For example, when 100 is the 
appropriate UF (10X to account for interspecies differences and 10X for 
intraspecies differences) the LOC is 100. To estimate risk, a ratio of 
the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is 
calculated and compared to the LOC.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify carcinogenic risk. The Q* 
approach assumes that any amount of exposure will lead to some degree 
of cancer risk. A Q* is calculated and used to estimate risk which 
represents a probability of occurrence of additional cancer cases 
(e.g., risk is expressed as 1 x 10\6\ or one in a million). Under 
certain specific circumstances, MOE calculations will be used for the 
carcinogenic risk assessment. In this non-linear approach, a ``point of 
departure'' is identified below which carcinogenic effects are not 
expected. The point of departure is typically a NOAEL based on an 
endpoint related to cancer effects though it may be a different value 
derived from the dose response curve. To estimate risk, a ratio of the 
point of departure to exposure (MOEcancer = point of 
departure/exposures) is calculated. A summary of the toxicological 
endpoints used for human risk assessment is discussed in Table 1 on 
page 8 of the human health risk assessment dated November 20, 2006: 
Section 18 Exemptions for the Use of Thiabendazole on Brussels sprout, 
Cabbage, and Cauliflower as a Seed Treatment, available in the docket 
for this action.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.242) for the residues of thiabendazole in or on 
a variety of raw agricultural commodities. Tolerances have also been 
established for thiabendazole and its metabolite 5-hydroxythiabendazole 
at 0.4 ppm in milk, 0.1 ppm in eggs, and 0.1 ppm in meat, fat, and meat 
byproducts of livestock and poultry. Risk assessments were conducted by 
EPA to assess dietary exposures from thiabendazole in food as follows:
    i. Acute exposure. Since there are no toxic effects noted in the 
database that are likely the result of a single exposure to 
thiabendazole, no acute dietary endpoints have been selected.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEMTM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 and 1998 nationwide Continuing 
Surveys of Food Intake by Individuals (CSFII) and accumulated exposure 
to the chemical for each commodity. The following assumptions were made 
for the chronic exposure assessments: The chronic dietary exposure 
analysis for thiabendazole is partially refined. For the use of 
thiabendazole as a seed treatment, the Agency used the analytical 
method limit of quantitation (LOQ) of 0.05 ppm as the appropriate 
residue value for Brussels

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sprout, cabbage, and cauliflower and assumed 100% crop treated as 
inputs into the DEEM chronic dietary analysis. Inputs into the DEEM 
analysis for all existing uses incorporated PDP data for many 
commodities, experimental processing factors, anticipated residues for 
animal commodities and percent crop treated information. Further, 
estimated thiabendazole residues in drinking water were incorporated 
directly into the dietary assessment using the highest chronic 
estimated environmental concentration (EEC) value for surface water.
    iii. Cancer. Thiabendazole has been classified as ``not likely to 
be carcinogenic to humans at doses that do not alter rat thyroid 
hormone homeostasis.'' Chronic dietary risk is currently being 
regulated with a chronic RfD that reflects a dose level below the dose 
levels at which thyroid hormone balance is impacted. Since chronic 
dietary risk is below the Agency's level of concern, there is no 
concern for dietary cancer risk arising from existing uses as well as 
the use of thiabendazole as a seed treatment on Brussels sprout, 
cabbage, and cauliflower.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for thiabendazole in drinking 
water. Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of thiabendazole. Further, information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/oppefed1/models/water/index.htm.
    The treatment of seeds for purposes of the section 18 request is 
expected to be an indoor activity with no potential concern for 
leaching to ground water or run off to surface water. However, there is 
some potential for transfer of residues of thiabendazole to the 
environment with the planting of treated seed in the field. Drinking 
water was incorporated directly into the dietary assessment by 
extrapolation of the drinking water concentrations generated as a 
result of planting treated seed. Based on the GENEEC and SCI-GROW 
models, the estimated environmental concentrations (EECs) of for acute 
exposures are estimated to be 2.4 parts per billion (ppb) for surface 
water and 0.01 ppb for ground water. The EECs for chronic exposures are 
estimated to be 0.52 ppb for surface water and 0.01 ppb for ground 
water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). The Agency has 
concluded that there is low potential for residential exposure based on 
thiabendazole's use profile, and the proposed section 18 uses of 
thiabendazole on Brussels sprout, cabbage, and cauliflower seeds do not 
result in new residential exposure scenarios. Currently, there are no 
thiabendazole products registered for use by residential users. 
However, thiabendazole is incorporated in low concentrations into 
paints, adhesives, paper, and carpet. This incorporation greatly 
reduces the potential for exposure. The Agency has calculated worst 
case scenarios for thiabendazole exposure to thiabendazole treated 
carpet and paint. A summary of the residential exposure and risk 
estimates for thiabendazole are summarized in Table 6 on page 16 of the 
human health risk assessment dated November 20, 2006: Section 18 
Exemptions for the Use of Thiabendazole on Brussels sprout, Cabbage, 
and Cauliflower as a Seed Treatment, available in the docket for this 
action.
    4. 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 thiabendazole and any 
other substances and thiabendazole 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 thiabendazole 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/.

C. Safety Factor for Infants and Children

    1. In general. Section 408 of the FFDCA provides that EPA shall 
apply an additional 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 that a different margin of safety will be safe 
for infants and children. Margins of safety are incorporated into EPA 
risk assessments either directly through use of a MOE analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans.
    2. Developmental toxicity studies. The toxicity database for 
thiabendazole includes an acceptable prenatal developmental toxicity 
study in rats and rabbits, which shows no increased sensitivity to 
fetuses. A neurotoxicity study is not required since there is no 
evidence in the database that supports a requirement for a 
developmental neurotoxicity study.
    3. Reproductive toxicity study. Based on data submitted to the 
Agency as well as data from the open literature, there was no evidence 
of reproductive toxicity in the prenatal developmental toxicity studies 
in rats, rabbits, and mice or in the two-generation reproduction study 
in rats.
    4. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility in rats, rabbits, or mice to in utero or early 
postnatal exposure to thiabendazole based on the prenatal developmental 
toxicity study rats, rabbits, and mice and in the two-generations 
reproduction study in rats. The developmental effects in the fetuses 
occurred at or above doses that caused maternal or paternal toxicity.
    5. Conclusion. There is a complete toxicity database for 
thiabendazole and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. In terms of 
hazard, there are low concerns and no residual uncertainties regarding 
prenatal and/or postnatal toxicity.

D. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate 
exposure to a pesticide from food, drinking water, and residential 
uses. First, a screening assessment can be used, in which the Agency 
calculates drinking water levels of comparison (DWLOCs), which are used 
as a point of comparison against estimated drinking water 
concentrations

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(EDWCs). The DWLOC values are not regulatory standards for drinking 
water, but are theoretical upper limits on a pesticide's concentration 
in drinking water in light of total aggregate exposure to a pesticide 
in food and residential uses. More information on the use of DWLOCs in 
dietary aggregate risk assessments can be found at http:/www.epa.gov/
oppfead1/trac/science/screeningsop.pdf. More recently, the Agency has 
used another approach to estimate aggregate exposure through food, 
residential and drinking water pathways. In this approach, modeled 
surface water and ground water EDWCs are directly incorporated into the 
dietary exposure analysis, along with food. This approach provides a 
more realistic estimate of exposure because actual body weights and 
water exposures are then added to estimated and water consumption form 
the CSFII are used. The combined food and water exposures are then 
added to estimated exposure from residential sources to calculate 
aggregate risks. The resulting exposure and risk estimates are still 
considered to be high end, due to the assumptions used in developing 
drinking water modeling inputs. The risk assessment for thiabendazole 
used in this tolerance document uses this approach of incorporating 
water exposure directly into the dietary exposure analysis.
    EPA conducted partially refined chronic dietary assessments, which 
included the use of thiabendazole used as a seed treatment in/on 
Brussels sprout, cabbage, cauliflower seeds in addition to the existing 
use for thiabendazole that results in a chronic dietary exposure (food 
and water) for the U.S. population equivalent to 1.4% of the cPAD. The 
most highly exposed population subgroup is children 1 to 2 years of age 
with a chronic dietary exposure (food and water) which is equivalent to 
4.2% of the cPAD. Since chronic dietary (food and water) estimates of 
risk for the U.S. population and all subgroups are below 100% of the 
cPAD, the Agency has no concern for chronic dietary risk from the use 
of thiabendazole as a seed treatment for use on Brussels sprout, 
cabbage, and cauliflower seeds.
    1. Acute risk. EPA did not assess acute dietary risk for 
thiabendazole because no acute dietary endpoint of concern was 
identified for the general population or any subpopulation.
    2. Chronic risk. EPA concluded that chronic aggregate exposure to 
thiabendazole from food and water will utilize 4.2% of the cPAD for the 
most highly exposed population subgroup, which is children 1 to 2 years 
of age. This chronic aggregate risk estimate is based on dietary risk 
from food and water. Since the estimated thiabendazole chronic 
aggregate dietary exposure from food and water for the general 
population and all subpopulations results in an estimated risk value 
less than 100% of the cPAD, EPA has no concern for chronic aggregate 
risk. Using the exposure assumptions described in this unit for chronic 
exposure, EPA has concluded that exposure to from food will utilize 
1.4% of the cPAD for the U.S. population, 4.2% of the cPAD for the most 
highly exposed subpopulation (children 1-2 years of age) and 1.2 % of 
the cPAD for females 13 to 49 years of age.
    3. Short and Intermediate-term risk. Short-and intermediate-term 
aggregate exposure takes into account non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level). EPA does not expect short-and intermediate-
term aggregate exposure to exceed the Agency's level of concern. The 
Agency has concluded that there is low potential for residential 
exposure based on thiabendazole's use profile. There are currently no 
thiabendazole products registered for use by residential users. 
However, thiabendazole is incorporated in low concentrations into 
paints, adhesives, paper, and carpet. This incorporation greatly 
reduces the potential for exposure. To assess short-and intermediate-
term aggregate exposure likely to result from the use of thiabendazole 
on Brussels sprout, cabbage, and cauliflower as a seed treatment, as 
well as existing uses, the Agency combined average food and water 
exposure values with estimates of residential exposure. For adult 
populations, the Agency assumed that both painting with thiabendazole 
treated paint and contact with thiabendazole treated carpet could occur 
simultaneously and combined those exposures for the purpose of 
calculating the aggregate risk estimates. For infant and child 
populations, the Agency assumed that residential exposure was a result 
of contact with treated carpet only.
    More detailed information on the short-and intermediate-term 
exposure and risk estimates for thiabendazole are summarized and can be 
found in the document entitled Section 18 Exemptions for the Use of 
Thiabendazole on Brussels sprout, Cabbage, and Cauliflower as a Seed 
Treatment, dated November 20, 2006 in Table 7 on page 17 of the human 
health risk assessment, by going to http:www.regulations.gov, and 
searching for docket ID number EPA-HQ-OPP-2006-0962. Double - click on 
the document to view the referenced information.
    4. Aggregate cancer risk for U.S. population. Thiabendazole has 
been classified as ``not likely to be carcinogenic to humans at doses 
that do not alter rat thyroid hormone homeostasis.'' Since the chronic 
aggregate exposure is below the level that would alter rat thyroid 
hormone homeostasis, there is no concern for aggregate cancer risk 
arising from existing uses or the use of thiabendazole use as a seed 
treatment in/on Brussels sprout, cabbage, and cauliflower seeds.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population and to infants and children from aggregate 
exposure to thiabendazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (example--gas chromatography) is 
available to enforce the tolerance expression. 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.

B. International Residue Limits

    No specific CODEX, Canadian or Mexican maximum residue limits 
(MRLs) or tolerances have been established for thiabendazole in or on 
Brussels sprout, cabbage, or cauliflower. Therefore, international 
harmonization is not an issue at this time.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
thiabendazole in or on Brussels sprout, cabbage, or cauliflower at 0.05 
ppm. These tolerances expire and are revoked on December 31, 2009.

VII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under section 
408 of the FFDCA. 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). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211,

[[Page 4440]]

Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does 
not contain any information collections subject to OMB approval under 
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). Nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does 
not involve any technical standards that would require Agency 
consideration of voluntary consensus standards pursuant to section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, such as the 
tolerances in this final rule, do not require the issuance of a 
proposed rule, the requirements of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this 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 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 rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: January 18, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
Section 180.242 is amended by alphabetically adding the following 
commodites to paragraph (b) to read as follows:


Sec.  180.242  Thiabendazole; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                          Expiration/
             Commodity              Parts per million   revocation date
------------------------------------------------------------------------
Brussels sprout...................               0.05           12/31/09
Cabbage...........................               0.05           12/31/09
Cauliflower.......................               0.05           12/31/09
                                * * * * *
------------------------------------------------------------------------


[[Page 4441]]

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[FR Doc. E7-1234 Filed 1-30-07; 8:45 am]
BILLING CODE 6560-50-S