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[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Rules and Regulations]
[Pages 35249-35253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14944]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0249; FRL-9928-82]

Thiram; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of thiram 
in or on avocado. Taminco US, Inc. requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective June 19, 2015. Objections and 
requests for hearings must be received on or before August 18, 2015, 
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-2014-0249, 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: Susan Lewis, 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/Title40/40tab_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-2014-0249 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 
August 18, 2015. 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-2014-0249, 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 December 17, 2014 (79 FR 75107) (FRL-
9918-90), 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 
4E8250) by Taminco US, Inc., Two Windsor Plaza, Suite 411, 7540 Windsor 
Drive, Allentown, PA 18195. The petition requested that 40 CFR 180.132 
be amended by establishing a tolerance for residues of the fungicide 
thiram in or on avocado at 8 parts per million (ppm). That document 
referenced a summary of the petition prepared by Taminco US, Inc, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    For reasons that are discussed in Unit IV.C., EPA is establishing a 
tolerance for avocado at 15 ppm.

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

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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 thiram including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with thiram 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 
children.
    Thiram is a dimethyl dithiocarbamate fungicide. Thiram has been 
shown to cause neurotoxicity following acute and subchronic exposures. 
In the acute and subchronic neurotoxicity studies submitted, 
neurotoxicity is characterized as lethargy, reduced and/or tail pinch 
response, changes in the functional-observation battery (FOB) 
parameters, increased hyperactivity, changes in motor activity, and 
increased occurrences of rearing events. No treatment-related changes 
were observed in brain weights or in the histopathology of the nervous 
system. In a non-guideline study published in the open literature, 
chronic feeding of thiram to rats caused neurotoxicity, with onset of 
ataxia in some animals 5-19 months after beginning of treatment. 
However, no evidence of neurotoxicity was seen following chronic 
exposures in mice or rats in guideline studies submitted to the Agency. 
The chronic toxicity profile for thiram indicates that the liver, 
blood, and urinary system are the target organs for this chemical in 
mice, rats, and dogs. There is no evidence for increased susceptibility 
following in utero exposures to rats or rabbits and following pre- and 
post-natal exposures to rats for 2 generations. There is evidence of 
quantitative susceptibility in the developmental neurotoxicity (DNT) 
study. However, there is low concern for the increased susceptibility 
seen in the DNT study since the dose response is well defined with a 
clear NOAEL and this endpoint is used for assessing the acute dietary 
risk for the most sensitive population. Thiram is classified as ``not 
likely to be carcinogenic to humans'' based on lack of evidence for 
carcinogenicity in mice or rats. There are no mutagenic/genotoxic 
concerns with thiram. The available toxicological database for thiram 
suggests that this chemical has a low to moderate acute-toxicity 
profile.
    Specific information on the studies received and the nature of the 
adverse effects caused by thiram 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 document ``Thiram. Revised Human Health Risk 
Assessment for the Import Use of Thiram on Avocado, PP#4E8250 and 
Banana, PP#4E8268''.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for thiram used for human 
risk assessment is discussed in Unit III.B. of the final rule published 
in the Federal Register of February 12, 2014 (79 FR 8295) (FRL-9904-
22).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thiram, EPA considered exposure under the petitioned-for 
tolerances as well as all existing thiram tolerances in 40 CFR 180.132. 
EPA assessed dietary exposures from thiram 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.
    A partially refined probabilistic acute dietary-exposure assessment 
was performed using 100 percent crop treated (PCT), average field trial 
residues or pulp residues for blended commodities, distributions of 
field trial residues, highest pulp residue, and empirical processing 
factors.
    ii. Chronic exposure. Tolerances-level residues, average field-
trial residues, and highest pulp residues for avocado with 100 PCT were 
used for the chronic dietary exposure analysis for all crops. Empirical 
processing factors were also used.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that thiram does not pose a cancer risk to humans. Therefore, 
a dietary exposure assessment for the purpose of assessing cancer risk 
is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use PCT information in the dietary assessment for thiram. 
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.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk 
assessment for thiram in drinking water. These simulation models take 
into account data on the physical, chemical, and fate/

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transport characteristics of thiram. 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 Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
thiram for acute exposures are 0.0478 ppm and 0.0025 ppm for chronic 
exposures (for non-cancer assessments) for surface water. Ground water 
sources were not included (for acute or chronic exposures), as the 
EDWCs for ground water are minimal in comparison to those for surface 
water. Surface water EDWCs were incorporated in Dietary Exposure 
Evaluation Model Food Commodity Intake Database (DEEM-FCID) into the 
food categories ``water, direct, all sources'' and ``water, indirect, 
all sources'' for the dietary assessments.
    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). Thiram is not 
available for sale or use by homeowner applicators; therefore, there 
are no residential handler exposure scenarios. However, there is 
potential for residential post-application dermal exposure from treated 
golf course greens and tees. Residential exposures resulting from 
dermal contact with thiram-treated turf were assessed for children 6 to 
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 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. There was no evidence of 
increased susceptibility following in utero exposure to rats or rabbits 
or following prenatal and post-natal exposures to rats. There is 
evidence of quantitative susceptibility in the DNT study. However, 
there is low concern for the enhanced susceptibility seen in the DNT 
study because:
    i. Clear NOAELs/LOAELs were established for the offspring effects.
    ii. The dose-response is well defined.
    iii. The behavioral effect of concern were observed only in females 
on one evaluation time period.
    iv. The dose/endpoint is used for acute dietary risk for the most 
sensitive population subgroup (females 13-49 years old). Consequently, 
there are no residual uncertainties for pre- and post-natal toxicity.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for thiram is complete with acceptable 
neurotoxicity, developmental, and reproductive toxicity studies.
    ii. As explained in this unit, there are no residual uncertainties 
for prenatal and post-natal toxicity.
    iii. There are no residual uncertainties in the thiram database 
with regards to dietary exposure. A refined probabilistic acute 
dietary-exposure assessment was performed using maximum PCT, tolerance, 
the highest residue found during field-trials, distribution of field 
trial residues, Federal Drug Administration (FDA) monitoring data for 
apples, and empirical processing factors. A refined chronic dietary-
exposure assessment was performed using tolerances and average 
estimated PCT. EPA made conservative (protective) assumptions in the 
water modeling used to assess exposure to thiram in drinking water. EPA 
used similarly conservative assumptions to assess postapplication 
exposure of children. These assessments will not underestimate the 
exposure and risks posed by thiram.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. The acute dietary risk estimates are not of concern to 
EPA (intermediate-term 
residential exposure (dermal only). The combined exposure may then be 
used to calculate an MOE for aggregate risk. Using the

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golfer scenario for adult males, adult females, and children >6 years 
old, combined with the applicable subpopulation with the greatest 
dietary exposure, the total short/intermediate-term food and 
residential aggregate MOEs are 570, 540, and 280, respectively. As 
these MOEs are above the target MOE of 100, the short- and 
intermediate-term aggregate risks are not of concern. For children 
intermediate term aggregate risk assessment is not required for this 
population.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, thiram is not expected to pose a cancer risk to humans.
    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 thiram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (colorimetric analytical method) 
is available to enforce the tolerance expression. The method may be 
requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; 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 thiram in or on avocado.

C. Revisions to Petitioned-For Tolerances

    The petitioner requested a tolerance for residues of thiram on 
avocado at 8 ppm. EPA is establishing a tolerance at 15 ppm based on 
available data and the Organization for Economic Cooperation and 
Development (OECD) Tolerance Calculation Procedures.

V. Conclusion

    Therefore, a tolerance is established for residues of thiram in or 
on avocado at 15 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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: June 9, 2015.
Susan Lewis,
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.  180.132, alphabetically add the commodity ``avocado'' to 
the table in paragraph (a) to read as follows:

Sec.  180.132  Thiram; tolerance for residues.

    (a) * * *

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------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Avocado \1\.............................................              15
 
                               * * * * *
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\1\ No U.S. registrations as of September 23, 2009.

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[FR Doc. 2015-14944 Filed 6-18-15; 8:45 am]
BILLING CODE 6560-50-P
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