
[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Rules and Regulations]
[Pages 57450-57458]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22833]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0268; FRL-9915-78]


Thiabendazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
thiabendazole in or on multiple commodities which are identified and 
discussed later in this document. Syngenta Crop Protection, LLC., 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective September 25, 2014. Objections and 
requests for hearings must be received on or before November 24, 2014, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2013-0268, is available at http://www.regulations.gov or at the Office of Pesticide Programs

[[Page 57451]]

Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2013-0268 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
November 24, 2014. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    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 (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2013-0268, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F8166) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.242 be amended by 
establishing tolerances for residues of the fungicide thiabendazole (2-
(4-thiazolyl)benzimidazole) and its metabolite benzimidazole, in or on 
vegetable, root (except sugar beet), subgroup 1B at 0.02 ppm; radish, 
tops at 0.02 ppm; onion, bulb, subgroup 3-07A at 0.02 ppm; Brassica, 
head and stem, subgroup 5-A at 0.02 ppm; vegetable, cucurbit group 9 at 
0.02 ppm; barley, grain at 0.05 ppm; barley, hay at 0.30 ppm; barley, 
straw at 0.30 ppm; wheat, grain at 0.05 ppm; wheat, straw at 0.30 ppm; 
wheat, hay at 0.30 ppm; wheat, forage 0.30 ppm; oats, grain at 0.05 
ppm; oats, hay at 0.30 ppm; oats, straw at 0.30 ppm; oats, forage at 
0.30 ppm; rye, grain at 0.05 ppm; rye, straw at 0.30 ppm; rye, forage 
at 0.30 ppm; triticale, grain at 0.05 ppm; triticale, hay at 0.30 ppm; 
triticale, straw at 0.30 ppm; triticale, forage at 0.30 ppm; alfalfa, 
forage at 0.02 ppm; alfalfa, hay at 0.02 ppm; and spinach at 0.02 ppm. 
That document referenced a summary of the petition prepared by Syngenta 
Crop Protection, the registrant, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.
    The Notice of Filing (NOF) published on August 1, 2014 (79 FR 
44729) supersedes an earlier NOF for the same petition for 
thiabendazole that was issued in the Federal Register of June 5, 2013 
(78 FR 33785) (FRL-9386-2).

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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 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 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. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 and to make a 
determination on aggregate exposure for thiabendazole including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with thiabendazole 
follows.

[[Page 57452]]

A. Toxicological Profile

    EPA has evaluated the available toxicity data 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.
    The thyroid and liver (centrilobular hypertrophy) are the primary 
target organs of thiabendazole toxicity. Thiabendazole produced a 
treatment-related increase in absolute and relative liver weights in 
both sexes in a chronic dog study. Other treatment related effects 
reported were histopathological changes in kidneys (hyperplasia of 
transitional epithelium, tubular degeneration) and spleen (congested 
and pigmented) in rats. Additional toxic effects observed in these 
studies included decreases in body weight and/or food consumption. The 
available database indicates that thiabendazole is not neurotoxic. In 
an acute neurotoxicity rat study (ACN), decreases in the Functional 
Observation Battery (FOB) (reduced body temperature in males, reduced 
rearing in females, and reduced locomotor activity in males and females 
at time of peak effect (approximately 3 hours post-dose) were seen 
without morphological or histopathological effects on the brain. 
Thiabendazole was not neurotoxic in rats in a subchronic neurotoxicity 
study. In a 21-day dermal toxicity study in rats, no systemic or dermal 
effects were seen at the limit dose (1,000 milligram/kilogram/day (mg/
kg/day)). In prenatal developmental toxicity studies in rats, rabbits, 
and mice and in the 2-generation reproduction study in rats, effects in 
the fetuses or neonates occurred at or above doses that caused maternal 
or parental toxicity.
    In the adult animal, effects on the thyroid following thiabendazole 
exposure were observed at a dose lower than the neurotoxicity dose 
observed in the ACN. There are no thiabendazole data with which to 
determine whether this is also the case in the fetus/postnatal animal. 
Based on a weight of evidence (WOE) approach considering all the 
available hazard and exposure information for thiabendazole, the Agency 
concluded that a developmental thyroid toxicity study is required since 
there is clear evidence of thyroid toxicity in adult animals and thus a 
concern for potential toxicity during pregnancy, infancy and childhood. 
The developmental thyroid toxicity study will better address this 
concern than a developmental neurotoxicity study.
    In an immunotoxicity study, thiabendazole produced significant 
decreased spleen activity at the highest dose tested (5,000 ppm 
equivalent to 1,027 mg/kg/day) which also produced significant 
increased liver weight.
    The genetic toxicology studies on thiabendazole indicate that it is 
not genotoxic in in vivo and in vitro assays. Review of literature 
studies indicated that thiabendazole has weak aneugenic activity in 
both somatic and germinal cells. In a chronic rat study, thiabendazole 
induced thyroid tumors in males only. Thiabendazole did not induce 
tumors in mice. Thiabendazole has been classified by the Agency as 
``likely to be carcinogenic at doses high enough to cause a disturbance 
of the thyroid hormonal balance but not likely to be carcinogenic at 
doses lower than those which could cause a disturbance of this hormonal 
balance.'' Taking into account all of this information, the Agency has 
determined that quantification of risk using a non-linear approach 
(i.e., chronic population adjusted dose (cPAD)) will adequately account 
for all chronic toxicity, including carcinogenicity that could result 
from exposure to thiabendazole.
    Specific information on the studies received and the nature of the 
adverse effects caused by thiabendazole as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled ``Thiabendazole: Human 
Health Risk Assessment for the Requested Increase in the Currently 
Registered Seed Treatment Use Rate on Soybeans and the New Section 3 
Uses of Thiabendazole for Seed Treatment on Assorted Vegetables and 
Small Grains Including: Vegetable, Root (Except Sugar Beet), Subgroup 
1B; Radish Tops; Onion, Bulb, Subgroup 3-07A; Brassica, Head and Stem, 
Subgroup 5A; Vegetable, Cucurbit Group 9; Alfalfa; Spinach; and a 
Number of Small Grains (Barley, Oats, Rye, and Triticale)'' on pages 
45-53 in docket ID number EPA-HQ-OPP-2013-0268.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern (LOC) to use in evaluating the risk posed by human exposure to 
the pesticide. For hazards that have a threshold below which there is 
no appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. 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.
    A summary of the toxicological endpoints for thiabendazole used for 
human risk assessment is shown in the following table of this unit.

[[Page 57453]]



  Table--Summary of Toxicological Doses and Endpoints for Thiabendazole for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (general population  NOAEL = 50 mg/kg/day  Acute RfD = 0.05 mg/ Acute neurotoxicity study.
 including females 13-49 years of  UFA = 10x...........   kg/day.             LOAEL = 200 mg/kg based decreases
 age and children).                UFH = 10x...........  aPAD = 0.05 mg/kg/    in the FOB (reduced body
                                   FQPA SF = UFDB 10x..   day.                 temperature in males, and reduced
                                                                               rearing in females, reduced
                                                                               locomotor activity in males and
                                                                               females, at time of peak effect
                                                                               (approximately 3 hours post-
                                                                               dose). Reduced body weight gain
                                                                               and food consumption occurred on
                                                                               day 1.
Chronic dietary (all populations)  NOAEL= 10 mg/kg/day.  Chronic RfD = 0.033  2-year chronic carcinogenicity in
                                   UFA = 3x............   mg/kg/day.           the rat.
                                   UFH = 10x...........  cPAD = 0.033 mg/kg/  Chronic LOAEL = 30 mg/kg/day based
                                   FQPA SF = UFDB 10x..   day.                 on decreased body weight gains
                                                                               and liver hypertrophy.
                                                                               Thiabendazole induced thyroid
                                                                               adenomas in male rats at dosages
                                                                               of >=30 mg/kg/day. Supported by
                                                                               subchronic toxicity rat study.
                                                                              Subchronic LOAEL = 40 mg/kg/based
                                                                               on reduced body weight and body
                                                                               weight gains and
                                                                               histopathological changes in the
                                                                               bone marrow (erythroid
                                                                               hyperplasia), liver
                                                                               (centrilobular hypertrophy),
                                                                               thyroid (follicular cell
                                                                               hypertrophy) and spleen
                                                                               (pigmented).
Incidental oral short-term (1 to   NOAEL= 10 mg/kg/day.  LOC for MOE = 300..  Subchronic oral toxicity study--
 30 days) and intermediate-term    UFA = 3x............                        rat.
 (1 to 6 months).                  UFH = 10x...........                       LOAEL = 40 mg/kg/day based on
                                   FQPA SF = 10x UFDB..                        reduced body weight gains and
                                                                               histopathological changes in the
                                                                               bone marrow, liver and thyroid.
Dermal short-term (1 to 30 days)   Dermal (or oral)      LOC for MOE = 300..  Subchronic oral toxicity study--
 and intermediate-term (1 to 6      study.                                     rat.
 months).                          NOAEL = 10 mg/kg/day                       LOAEL = 40 mg/kg/day based on
                                    (dermal absorption                         reduced body weight gains and
                                    rate = 0.5%.                               histopathological changes in the
                                   UFA = 3x............                        bone marrow, liver and thyroid.
                                   UFH = 10x...........
                                   FQPA SF = 10x UFDB..
Inhalation short-term (1 to 30     NOAEL= 10 mg/kg/day.  LOC for MOE = 300..  Subchronic oral toxicity study--
 days) and intermediate-term (1    UFA = 3x............                        rat.
 to 6 months).                     UFH = 10x...........                       LOAEL = 40 mg/kg/day based on
                                   FQPA SF = 10x UFDB..                        reduced body weight gains and
                                                                               histopathological changes in the
                                                                               bone marrow, liver and thyroid.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Likely to be carcinogenic at doses high enough to cause a disturbance of the
                                    thyroid hormonal balance but not likely to be carcinogenic at doses lower
                                    that those which could cause a disturbance of this hormonal balance.
                                    Quantification of risk using a non-linear approach (i.e., cPAD) will
                                    adequately account for all chronic toxicity, including carcinogenicity that
                                    could result from exposure to thiabendazole.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiabendazole, EPA considered exposure under the 
petitioned-for tolerances as well as all existing thiabendazole 
tolerances in 40 CFR 180.242. EPA assessed dietary exposures from 
thiabendazole in food 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.
    Such effects were identified for thiabendazole. In estimating acute 
dietary exposure, EPA used food consumption data from the U.S. 
Department of Agriculture's (USDA's) National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to 
residue levels in food, EPA used a refined acute probabilistic dietary 
exposure assessment for thiabendazole using both anticipated residue 
estimates based on USDA Pesticide Data Program (PDP) monitoring data 
and percent crop treated (PCT) information for soybean and wheat and 
assumed 100 PCT for all other commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used food consumption data from the USDA NHANES/WWEIA. 
As to residue levels in food, EPA used a refined chronic probabilistic 
dietary exposure assessment for thiabendazole using both anticipated 
residue estimates based on USDA PDP monitoring data and PCT information 
for soybean and wheat and assumed 100 PCT for all other commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
Cancer risk is quantified using a linear or nonlinear approach. If 
sufficient information on the carcinogenic mode of action is available, 
a threshold or nonlinear approach is used and a cancer RfD is 
calculated based on an earlier noncancer key event. If carcinogenic 
mode of action data are not available, or if the mode of action

[[Page 57454]]

data determines a mutagenic mode of action, a default linear cancer 
slope factor approach is utilized. Based on the data summarized in Unit 
III.A., EPA has concluded that a nonlinear RfD approach is appropriate 
for assessing cancer risk to thiabendazole. Cancer risk was assessed 
using the same exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Acute dietary risk assessment: soybeans 2.5%; wheat 2.5%.
    Chronic dietary risk assessment: soybeans 1%; wheat 1%.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6-7 
years. EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available public and private market survey data for that use, averaging 
across all observations, and rounding to the nearest 5%, except for 
those situations in which the average PCT is less than one. In those 
cases, 1% is used as the average PCT and 2.5% is used as the maximum 
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The 
maximum PCT figure is the highest observed maximum value reported 
within the recent 6 years of available public and private market survey 
data for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including several regional 
groups. Use of this consumption information in EPA's risk assessment 
process ensures that EPA's exposure estimate does not understate 
exposure for any significant subpopulation group and allows the Agency 
to be reasonably certain that no regional population is exposed to 
residue levels higher than those estimated by the Agency. Other than 
the data available through national food consumption surveys, EPA does 
not have available reliable information on the regional consumption of 
food to which thiabendazole may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for thiabendazole in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of thiabendazole. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated 
drinking water concentrations (EDWCs) of thiabendazole for acute 
exposures are estimated to be 3.80 parts per billion (ppb) for surface 
water and 0.62 ppb for ground water and for chronic exposures are 
estimated to be 0.47 ppb for surface water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 3.80 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.47 ppb was used to 
assess the contribution to drinking 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). Thiabendazole is 
currently registered for use as antimicrobial ingredient in paint, 
sponges, carpet backing, canvas textiles, wallboard and ceiling tiles, 
polyurethane foam, plastics and rubber, paper, and coatings and filters 
used in HVAC systems. There are two antimicrobial exposure scenarios 
that were assessed for residential exposures: Treated paint and 
impregnated sponges. The other antimicrobial uses of thiabendazole 
(carpet backing, canvas textiles, wallboard and ceiling tiles, 
polyurethane foam, plastics and rubber, paper, and coatings and filters 
used in HVAC systems) are not expected to cause exposure in residential 
settings because there is no direct contact to the treated articles, 
the vapor pressure of thiabendazole is very low, and the unlikelihood 
that the treated plastics and rubbers would be used in toys.
    EPA assessed residential exposure to treated paint and impregnated 
sponges using the following assumptions: For treated paint, residential 
short-term dermal and inhalation exposure to residential handlers using 
brush/roller application and airless sprayer application; for the 
impregnated sponge use, short- and intermediate-term incidental oral 
exposure. Thiabendazole treated sponges are limited to 600 ppm 
thiabendazole on a sponge. Various residue amounts may be transferred 
from the sponge to food contact surfaces, such as countertops and 
utensils/glassware, and then to food and subsequently ingested. An 
assessment was conducted for incidental oral exposure assuming that 
100% of the thiabendazole on a treated sponge is transferred to 
surfaces over 20 days and that each 20 days the user would use a new 
sponge (5% released per day). This assumption is considered 
conservative because (1) sponges will generally be used much longer 
than 20 days; (2) it is

[[Page 57455]]

unlikely that 100% of the thiabendazole would be released from the 
sponge in such a short period; and (3) it is very unlikely that 100% of 
any released thiabendazole would be transferred to countertops because 
this assumption does not account any thiabendazole that is washed down 
the sink or that normally degrades. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of 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.''
    EPA has not found thiabendazole to share a common mechanism of 
toxicity with 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 assumed that 
thiabendazole does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) 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 (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. No evidence of increased 
quantitative or qualitative susceptibility was seen following in utero 
exposure to thiabendazole with rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. There is no evidence for neurotoxicity following oral exposures 
to thiabendazole. Thyroid toxicity was seen following subchronic and 
chronic exposures to adult rats in multiple studies. There is, however, 
no data regarding the potential effects of thiabendazole on thyroid 
homeostasis in the young animals. This lack of characterization creates 
uncertainty with regards to potential life stage sensitivities due to 
exposure to thiabendazole. Therefore, the Agency is requiring a 
developmental thyroid assay in rats with thiabendazole. This study will 
better address the concern for potential thyroid toxicity in the young. 
Although the Agency is asking for the developmental thyroid study, EPA 
does not expect it to result in a lower point of departure than what 
the Agency is regulating from and therefore the 10X is protective. 
There are no residual uncertainties in the thiabendazole residue 
database with regards to dietary or occupational exposure. Therefore, 
the FQPA SF is retained at 10X in the form of a database uncertainty 
factor (UFDB). For the acute dietary endpoint the total UF 
is 1,000 (an interspecies scaling factor of 10X, an intraspecies 
variability factor of 10X, a FQPA database uncertainty factor of 10X 
for lack of a developmental thyroid study). For the remaining 
endpoints, the combined total UF is 300 (an interspecies scaling factor 
of 3X, lowered from 10X for toxicodynamic reasons (rats eliminate 
thyroxine (a thyroid hormone) at a higher rate than humans), an 
intraspecies variability factor of 10X, an FQPA database uncertainty 
factor of 10X for lack of a developmental thyroid study was applied).
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF is retained at 10X in the form of a database uncertainty factor 
(UFDB). That decision is based on the following findings:
    i. The toxicology database for thiabendazole is complete with the 
exception of a developmental thyroid toxicity study. Based on a WOE 
approach considering all the available hazard and exposure information 
for thiabendazole, the Agency concluded that a developmental thyroid 
toxicity study is required since there is clear evidence of thyroid 
toxicity in adult animals and thus a concern for potential toxicity 
during pregnancy, infancy and childhood. The developmental thyroid 
toxicity study will better address this concern than a developmental 
neurotoxicity study. Acceptable studies are available for 
developmental, reproduction, chronic, subchronic, subchronic 
neurotoxicity and immunotoxicity.
    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. The data submitted to the Agency, as well as those from 
published literature, demonstrate no increased susceptibility in rats, 
rabbits, or mice to in utero and/or early postnatal exposure to 
thiabendazole. In the prenatal developmental toxicity studies in rats, 
rabbits, and mice and in the 2-generations reproduction study in rats, 
developmental effects in the fetuses or neonates occurred at or above 
doses that caused maternal or parental toxicity. A developmental 
neurotoxicity study with thiabendazole was deemed not required by the 
Agency.
    There is evidence of thyroid toxicity following subchronic and 
chronic exposures to rats characterized as histopathological changes in 
the thyroid in multiple studies in rats. Disruption of thyroid 
homeostasis is the initial, critical effect that may lead to adverse 
effects on the developing nervous system. Thus, as noted above, a 
developmental thyroid study is required.
    iv. There are no residual uncertainties in the exposure database. 
The dietary risk assessment is conservative and will not underestimate 
dietary and/or non-dietary occupational exposure to thiabendazole. The 
acute and chronic dietary assessments conducted with the Dietary 
Exposure Evaluation Model software with the Food Commodity Intake 
Database (DEEM-FCID) were refined analyses. The assessments utilized 
anticipated residues, default processing factors, and available percent 
crop treated data. The DEEM analysis also used Tier 1 drinking water 
estimates. For these reasons it can be concluded that the DEEM-FCID 
analysis does not underestimate risk from acute or chronic exposure to 
thiabendazole. Similarly, EPA does not believe that the non-dietary 
occupational exposures are underestimated because they are also based 
on conservative assumptions, including maximum application rates, and 
standard values for unit exposures and acreage treated/amount handled. 
These assessments will not underestimate the exposure and risks posed 
by thiabendazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are

[[Page 57456]]

safe by comparing aggregate exposure estimates to the acute PAD (aPAD) 
and chronic PAD (cPAD). For linear cancer risks, EPA calculates the 
lifetime probability of acquiring cancer given the estimated aggregate 
exposure. Short-, intermediate-, and chronic-term risks are evaluated 
by comparing the estimated aggregate food, water, and residential 
exposure to the appropriate PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to thiabendazole will occupy 69% of the aPAD for children 1-2 years 
old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
thiabendazole from food and water will utilize 4.7% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
thiabendazole is not expected.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Thiabendazole is currently registered for uses that could result in 
short- and intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short- and intermediate-term residential exposures 
to thiabendazole.
    Using the exposure assumptions described in this unit for short- 
and intermediate-term exposures, EPA has concluded the combined short- 
and intermediate-term food, water, and residential exposures result in 
aggregate MOEs from the paint use of 2,000 for all population subgroups 
and aggregate MOEs from the sponge use of 1,400 for children 1-2 years 
old and 7,300 for the general population. Because EPA's level of 
concern for thiabendazole is a MOE of 300 or below, these MOEs are not 
of concern.
    4. Aggregate cancer risk for U.S. population. Since thiabendazole 
is classified as likely to be carcinogenic at doses high enough to 
cause a disturbance of the thyroid hormonal balance but not likely to 
be carcinogenic at doses lower than those which could cause a 
disturbance of this hormonal balance, a cancer dietary exposure 
assessment is not required. EPA is currently regulating chronic dietary 
risk with a chronic RfD 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.
    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, or to infants and children from aggregate 
exposure to thiabendazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Acceptable enforcement analytical methods are available for 
thiabendazole and benzimidazole in plant commodities. Four 
spectrophotofluorometric methods for the determination of thiabendazole 
are published in the Pesticide Analytical Manual (PAM) Vol. II, and a 
high performance liquid chromatography (HPLC) method with fluorescence 
detection (FLD) for the determination of benzimidazole (free and 
conjugated) is identified in the U.S. EPA Index of Residue Analytical 
Methods under thiabendazole as Study No. 93020.
    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; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for thiabendazole on any of the 
commodities cited in this document.

C. Revisions to Petitioned-For Tolerances

    Finally, EPA has revised the tolerance expression to clarify (1) 
that, as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of thiabendazole not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of 
thiabendazole, [2-(4-thiazolyl) benzimidazole] and its metabolite 
benzimidazole (free and conjugated), in or on alfalfa, forage at 0.02 
ppm; alfalfa, hay at 0.02 ppm; barley, grain at 0.05 ppm; barley, hay 
at 0.30 ppm; barley, straw at 0.30 ppm; Brassica, head and stem, 
subgroup 5A at 0.02 ppm; oat, forage at 0.30 ppm; oat, grain at 0.05 
ppm; oat, hay at 0.30 ppm; oat, straw at 0.30 ppm; onion, bulb, 
subgroup 3-07A at 0.02 ppm; radish, tops at 0.02 ppm; rye, forage at 
0.30 ppm; rye, grain at 0.05 ppm; rye, straw at 0.30 ppm; spinach at 
0.02 ppm; triticale, forage at 0.30 ppm; triticale, grain at 0.05 ppm; 
triticale, hay at 0.30 ppm; triticale, straw at 0.30 ppm; vegetable, 
cucurbit, group 9 at 0.02 ppm; vegetable, root (except sugarbeet), 
subgroup 1B at 0.02 ppm; wheat, forage at 0.30 ppm; and wheat, hay at 
0.30 ppm. In addition, the following existing tolerances are modified: 
wheat, grain from 1.0 ppm to 0.05 ppm; and wheat straw from 1.0 ppm to 
0.30 ppm.
    Also, the time-limited tolerances for beet, sugar, dried pulp; 
beet, sugar, roots; and beet, sugar, tops, are removed because they 
expired on 12/25/10.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the Agency. 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``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 and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule does not

[[Page 57457]]

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).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 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.
    This final rule 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 FFDCA section 408(n)(4). 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'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: September 18, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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
2. In Sec.  180.242, revise paragraph (a)(1) and the introductory text 
of paragraph (a)(2) to read as follows:


Sec.  180.242  Thiabendazole; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of 
thiabendazole, including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels 
specified below is to be determined by measuring only the sum of 
thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite 
benzimidazole (free and conjugated), calculated as the stoichiometric 
equivalent of thiabendazole, in or on the commodity.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Alfalfa, forage.........................................            0.02
Alfalfa, hay............................................            0.02
Apple, wet pomace.......................................            12.0
Avocado \1\.............................................            10.0
Banana, postharvest.....................................             3.0
Barley, grain...........................................            0.05
Barley, hay.............................................            0.30
Barley, straw...........................................            0.30
Bean, dry, seed.........................................             0.1
Brassica, head and stem, subgroup 5A....................            0.02
Cantaloupe \1\..........................................            15.0
Carrot, roots, postharvest..............................            10.0
Citrus, oil.............................................            15.0
Corn, field, forage.....................................            0.01
Corn, field, grain......................................            0.01
Corn, field, stover.....................................            0.01
Corn, pop, forage.......................................            0.01
Corn, pop, grain........................................            0.01
Corn, pop, stover.......................................            0.01
Corn, sweet, forage.....................................            0.01
Corn, sweet, kernels plus cop with husks removed........            0.01
Corn, sweet, stover.....................................            0.01
Fruit, citrus, group 10, postharvest....................            10.0
Fruit, pome, group 11, postharvest......................             5.0
Mango...................................................            10.0
Mushroom................................................            40.0
Oats, forage............................................            0.30
Oats, grain.............................................            0.05
Oats, hay...............................................            0.30
Oats, straw.............................................            0.30
Onion, bulb, subgroup 3-07A.............................            0.02
Papaya, postharvest.....................................             5.0

[[Page 57458]]

 
Potato, postharvest.....................................            10.0
Radish, tops............................................            0.02
Rye, forage.............................................            0.30
Rye, grain..............................................            0.05
Rye, straw..............................................            0.30
Soybean.................................................             0.1
Spinach.................................................            0.02
Strawberry \1\..........................................             5.0
Sweet potato (postharvest to sweet potato intended only             0.05
 for use as seed).......................................
Triticale, forage.......................................            0.30
Triticale, grain........................................            0.05
Triticale, hay..........................................            0.30
Triticale, straw........................................            0.30
Vegetable, cucurbit, group 9............................            0.02
Vegetable, root (except sugarbeet), subgroup 1B.........            0.02
Wheat, forage...........................................            0.30
Wheat, grain............................................            0.05
Wheat, hay..............................................            0.30
Wheat, straw............................................            0.30
------------------------------------------------------------------------
\1\There are no U.S. registrations on the indicated commodity.

    (2) Tolerances are established for residues of thiabendazole, 
including its metabolites and degradates, in or on the commodities in 
the table below. Compliance with the tolerance levels specified below 
is to be determined by measuring only the sum of thiabendazole (2-(4-
thiazolyl)benzimidazole) and its metabolites 5-hydroxythiabendazole 
(free and conjugated) and benzimidazole (free and conjugated), 
calculated as the stoichiometric equivalent of thiabendazole, in or on 
the commodity.
* * * * *
[FR Doc. 2014-22833 Filed 9-24-14; 8:45 am]
BILLING CODE 6560-50-P


