[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Rules and Regulations]
[Pages 65289-65296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21753]



40 CFR Part 180

[EPA-HQ-OPP-2015-0554; FRL-9950-05]

Thiabendazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
thiabendazole in or on the legume vegetable group 6 and foliage of 
legume vegetable group 7. Syngenta Crop Protection requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This 
regulation also assigns an expiration date to existing tolerances for 
bean, dry, seed at 0.1 part per million (ppm) and soybean at 0.1 ppm as 
well as removes a threshold of regulation determination for seed 
treatment use of thiabendazole on dry pea (including field pea, pigeon 
pea, chickpea or lentil). Lastly, this regulation establishes a time-
limited tolerance on sweet potato. The time-limited tolerance is in 
response to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The time-limited 
tolerance will expire and be revoked on December 31, 2019.

DATES: This regulation is effective September 22, 2016. Objections and 
requests for hearings must be received on or before November 21, 2016, 
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-2015-0554, is available at http://www.regulations.gov or at the Office of Pesticide Programs 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: Michael Goodis, 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: [email protected].


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/Title40/40tab_02.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-2015-0554 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 21, 2016. 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-2015-0554, 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 
     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 Agency's Action

A. Petitioned-For Tolerances

    In the Federal Register of September 9, 2015 (80 FR 54257) (FRL-
9933-26), 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 
5F8368) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, 
NC 27419. The petition requested that 40 CFR 180.242

[[Page 65290]]

be amended by establishing tolerances for residues of the fungicide 
thiabendazole in or on legume vegetables (succulent or dried), crop 
group 6 at 0.01 parts per million (ppm); foliage of legume vegetables, 
crop group 7, except pea, field, hay and vines at 0.01 ppm; pea, field, 
hay at 0.15 ppm; and pea, field, vines at 0.03 ppm. The petition also 
requested to amend the tolerances in 40 CFR 180.242 for residues of 
thiabendazole by removing the tolerances in or on bean, dry, seed at 
0.1 ppm and soybean at 0.1 ppm. That document referenced a summary of 
the petition prepared by Syngenta, the registrant, which is available 
in the docket, http://www.regulations.gov. A comment was received on 
the notice of filing. EPA's response to this comment is discussed in 
Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
modified levels at which the tolerances are being established by this 
document. The reason for these changes are explained in Unit IV.D.

B. Thiabendazole Threshold of Regulation Determination

    In 2008, EPA established a rule codifying its determination that 
the use of thiabendazole as a seed treatment for dry pea using a 
maximum application rate of 0.075 pound of active ingredient per 100 
pounds of seed did not require a tolerance because residues were below 
the Agency's threshold of regulation. (73 FR 1976 (Jan. 11, 2008); see 
40 CFR 180.2010). The new tolerances for residues of thiabendazole on 
crop group 6 legume vegetable commodities, including dry pea, and on 
crop group 7, foliage of legume vegetable commodities, which includes 
vines and hay from the legume vegetables that the Agency is 
establishing make the existing threshold of regulation determination 
unnecessary. The new tolerances cover residues on these commodities 
resulting from new seed treatment uses that allow for higher 
application rates and thus residues associated uses covered by the 
threshold of regulation determination are covered by the new 
tolerances. As a result, the Agency is removing this determination from 
section 180.2010.

C. Tolerance for Use of Pesticide Under Emergency Exemption

    In response to a crisis exemption request and authorization of a 
specific exemption request filed under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) on behalf of the 
North Carolina Department of Agriculture and Consumer Services for the 
emergency use of thiabendazole to control black rot disease on sweet 
potato, EPA is establishing pursuant to FFDCA section 408(l)(6) time-
limited tolerances for the use of thiabendazole on sweet potato at 10 
ppm with an expiration date of December 31, 2019.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of thiabendazole 
on sweet potato. In doing so, EPA considered the safety standard in 
section 408(b)(2) of FFDCA, and the Agency decided that the necessary 
tolerance under section 408(l)(6) of FFDCA would be consistent with the 
safety standard and with FIFRA section 18. Consistent with the need to 
move quickly on the emergency exemption in order to address an urgent 
non-routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in section 408(l)(6) of FFDCA. Although 
this time-limited tolerance expires and is revoked on December 31, 
2019, under section 408(l)(5) of FFDCA, residues of the pesticide not 
in excess of the amounts specified in the tolerance remaining in or on 
sweet potato after that date will not be unlawful, provided the 
pesticide was applied in a manner that was lawful under FIFRA, and the 
residues do not exceed a level that was authorized by the time-limited 
tolerance at the time of that application. EPA will take action to 
revoke this time-limited tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions whether 
thiabendazole meets FIFRA's registration requirements for use in or on 
sweet potato or whether a permanent tolerance for this use would be 
appropriate. Under these circumstances, EPA does not believe that this 
time-limited tolerances serves as a basis for registration of 
thiabendazole by a State for Special Local Needs under FIFRA section 
24(c). Nor does this tolerance serve as the basis for persons in any 
State other than North Carolina to use this pesticide on sweet potato 
under FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for thiabendazole, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 

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 assessment 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, including the time-limited 
tolerance, established by this action. EPA's assessment of exposures 
and risks associated with thiabendazole follows.

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 
    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 

[[Page 65291]]

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.'' This 
conclusion is based on the observation that that thiabendazole was not 
mutagenic, but above a threshold dose it interfered with thyroid-
pituitary homeostasis leading to increased thyroid stimulating hormone 
(TSH) stimulation of the thyroid and thyroid tumors. The chronic NOAEL 
(10 mg/kg/day) for non-cancer risk assessment is not expected to alter 
thyroid hormone homeostasis nor result in thyroid tumor formation; 
therefore, 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: ID#16NC02--
Section 18 Specific Emergency Exemption for the Postharvest Use of 
Thiabendazole on Sweet Potatoes in North Carolina'' on page 32 in 
docket ID number EPA-HQ-OPP-2015-0554.

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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for thiabendazole used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of September 25, 2014 (79 FR 57450) 

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 and the tolerance being established in 
response to the Agency issuing a section 18 emergency exemption, 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 2003-2008 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 2003-2008 food consumption data from the USDA's 
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 
    iii. Cancer. 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., chronic exposure.
    iv. Anticipated residue and percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA

[[Page 65292]]

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 
    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.
    For the acute assessment, the Agency estimated the PCT for existing 
uses as follows:

    Soybeans, 2.5%; wheat, 2.5%.

    For the chronic assessment, the Agency estimated the PCT for 
existing uses as follows:

    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
Pesticide Root Zone Model GroundWater (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 the acute dietary risk 
assessment, the water concentration value of 3.80 ppb was used to 
assess the contribution to drinking water.
    For the 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 which are expected to result in the highest exposures from 
these antimicrobial uses: 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 unlikely that 100% of the thiabendazole would 
be released from the sponge in

[[Page 65293]]

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 Food Quality 
Protection Act Safety Factor (FQPA 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.
    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 
    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 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 at the 99.9th percentile of exposure will occupy 68% 
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

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that chronic exposure to thiabendazole from food and water will utilize 
5.1% 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 or greater for all 
population subgroups and aggregate MOEs from the sponge use of 1,400 
for children 1-2 years old and 7,000 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. As discussed in Unit 
III.A., EPA is regulating chronic dietary risk, including cancer risk, 
with a chronic RfD that reflects a dose level below those levels at 
which thyroid hormone balance is impacted, which is protective of 
potential carcinogenic effects. Based on the lack of chronic risk, EPA 
concludes there is not a cancer risk from exposure to thiabendazole.
    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.
    Another adequate analytical method, GRM040.05A, is also available 
for data collection and tolerance enforcement of residues of 
thiabendazole and benzimidazole (free and conjugated) in/on plant 
commodities. Method GRM040.05A, developed by Syngenta Crop Protection, 
LLC, is a high performance liquid chromatography with tandem mass 
spectrometry detection (LC/MS/MS) method used for data collection in 
crop matrices. HED has designated Method GRM040.05A as a new tolerance 
enforcement method.
    Both methods 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: 
[email protected].

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. Response to Comments

    A comment was submitted by the Center for Food Safety and was 
primarily concerned about EPA's consideration of the impacts of 
thiabendazole on the environment, pollinators, and endangered species. 
This comment is not relevant to the Agency's evaluation of safety of 
the thiabendazole tolerances under section 408 of the FFDCA, which 
requires the Agency to evaluate the potential harms to human health, 
not effects on the environment.

D. Revisions to Petitioned-For Tolerances

    The petitioned-for tolerances did not include measurement of 
benzimidazole (free and conjugated) which is a residue of concern for 
regulatory purposes. Therefore, the petitioned-for tolerance for the 
vegetable, legume, group 6 at 0.01 ppm for thiabendazole only, is 
adjusted to 0.02 ppm to account for the combined residues of 
thiabendazole and benzimidazole (free and conjugated). Also, EPA 
concluded that the maximum levels of the combined residues of concern 
in/on the representative crop commodities of vegetable, foliage of 
legume, group 7 are within 5x, and that a crop group 7 tolerance level 
of 0.20 ppm is more appropriate than the petitioned-for separate 
tolerances for pea, field, hay; pea, field, vines; and vegetable, 
foliage of legume, group 7, except pea, field, hay and vines.

E. International Trade Considerations

    In this rulemaking, EPA is adding an expiration date of March 21, 
2017 to the existing tolerances for bean, dry, seed at 0.1 ppm and 
soybean at 0.1 ppm. These tolerances were based on foliar uses of 
thiabendazole which are no longer registered and Syngenta requested 
that these tolerances be removed as part of the petition and notice of 
filing (NOF). The seed treatment uses on dry bean seed and soybean is 
now covered by the tolerance being established on vegetable, legume, 
group 6 at 0.02 ppm. This new tolerance is lower than some existing 
MRLs on these commodities in Europe and other countries.
    In accordance with the World Trade Organization's (WTO) Sanitary 
and Phytosanitary Measures Agreement, EPA notified the WTO of the 
request to revise these tolerances on September 9, 2015, as WTO 
notification G/SPS/N/USA/2779. In this action, EPA is allowing the 
existing higher tolerances to remain in effect for 6 months following 
the publication of this rule in order to allow a reasonable interval 
for producers in exporting countries to adapt to the requirements of 
these modified tolerances. On March 21, 2017, those existing higher 
tolerances will expire, and the new reduced tolerances for vegetable, 
legume, group 6 at 0.02 ppm will remain to cover residues of 
thiabendazole on those commodities. Before that date, residues of 
thiabendazole on those commodities would be permitted up to the higher 
tolerance levels; after that date, residues of thiabendazole on 
vegetable, legume, group 6 will need to comply with the

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new lower tolerance levels. This reduction in tolerance is not 
discriminatory; the same food safety standard contained in the FFDCA 
applies equally to domestically produced and imported foods.

V. Conclusion

    Therefore, tolerances are established for residues of thiabendazole 
in or on vegetable, foliage of legume, group 7 at 0.20 ppm and 
vegetable, legume, group 6 at 0.02 ppm. The Agency is also adding an 
expiration date of March 21, 2017 to the existing tolerances for bean, 
dry, seed at 0.1 ppm and soybean at 0.1 ppm. Residues of thiabendazole 
will be covered by these higher tolerances until the expiration date, 
after which time, they will need to comply with the lower tolerance 
being established today on the vegetable, legume, group 6 at 0.02 ppm. 
The tolerance for group 6 without a time limitation supersedes the 
existing section 18 time-limited tolerance for ``pea, succulent 
shelled''; therefore, the Agency is removing that section 18 tolerance.
    The Agency is also removing the threshold of regulation 
determination for thiabendazole from 180.2010 because it is no longer 
necessary. Lastly, this regulation additionally establishes a time-
limited tolerances for residues of thiabendazole in or on sweet potato 
at 10 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    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 action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (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: August 26, 2016.
Michael Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.242;
a. Revise the entries ``bean, dry, seed'' and ``soybean'' to the table 
in paragraph (a)(1);
b. Add alphabetically the entries ``Vegetable, foliage of legume, group 
7'' and ``Vegetable, legume, group 6'' to the table in paragraph (a)(1)
c. Remove the entry for ``Pea, succulent shelled'' from the table in 
paragraph (b);
d. Add alphabetically the entry ``sweet potato'' to the table in 
paragraph (b).
    The additions and revisions read as follows:

Sec.  180.242  Thiabendazole; tolerances for residues.

    (a) * * *
    (1) * * *

                                                             Parts per
                        Commodity                             million
                                * * * * *
Bean, dry, seed \2\.....................................             0.1
                                * * * * *
Soybean \2\.............................................             0.1
                                * * * * *
Vegetable, foliage of legume, group 7...................            0.20
Vegetable, legume, group 6..............................            0.02
                                * * * * *
\2\ This tolerance expires on March 21, 2017.

    (b) * * *

                                      Parts per
            Commodity                  million         Expiration date
Sweet potato.....................              10   December 31, 2019.

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* * * * *

Sec.  180.2010  [Removed and Reserved]

3. Section 180.2010 is removed and reserved.

[FR Doc. 2016-21753 Filed 9-21-16; 8:45 am]