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[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Rules and Regulations]
[Pages 16302-16306]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06981]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0632; FRL-9924-86]

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 banana. Taminco US, Inc. requested this tolerance under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 27, 2015. Objections and 
requests for hearings must be received on or before May 26, 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-2014-0632, 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.

[[Page 16303]]

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-2014-0632 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 
May 26, 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-2014-0632, 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 
4E8268) by Taminco US, Inc., Two Windsor Plaza, Suite 411, 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 
banana at 0.8 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.

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 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 prenatal 
and postnatal 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 no-observed-adverse-effect-level (NOAEL) and this endpoint is 
used for assessing the acute dietary risk for the most sensitive

[[Page 16304]]

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 NOAEL and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be 
found at http://www.regulations.gov in document ``Thiram. Update to the 
Aggregate Risk Assessment to Support the Requested PHI Reduction and 
Increased Tolerance Request on Strawberry,'' p. 9 in docket ID number 
EPA-HQ-OPP-2012-0925.

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), tolerance-level 
residues the highest residue found during field-trials, distributions 
of field trial residues, and empirical processing factors.
    ii. Chronic exposure. Tolerances-level residues for banana and 
average field trial residues for apples, peaches, and strawberries 
along 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 PCT information. EPA did not use PCT 
information in the dietary assessment for thiram. The acute dietary 
assessment used 100 PCT, tolerance-level residues, the highest residue 
found during field-trials, distributions of field trial residues, and 
empirical processing factors; the chronic dietary assessment used 
average field trial residues along with tolerance-level residues. In 
addition, 100 PCT were assumed for all food commodities. 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/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 parts per million (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 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 postnatal 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 prenatal and postnatal 
toxicity.
    Consequently, there are no residual uncertainties for prenatal and 
postnatal 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 postnatal toxicity.
    iii. There are no residual uncertainties identified in the exposure 
databases.
    EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to thiram in drinking 
water. In addition, the acute dietary exposure analysis used field 
trial data along with the 100 PCT. The chronic dietary exposure 
analysis used tolerance level residues or average field residues along 
with the 100 PCT. In addition, washing studies were incorporated into 
the dietary analyses since thiram is not a systemic pesticide and will 
wash off during normal washing procedures. These assessments will not 
underestimate the exposure and risks posed by thiram. 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 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

[[Page 16306]]

(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 
banana.

V. Conclusion

    Therefore, EPA is removing the expiration/revocation date for the 
current tolerance for residues of thiram, in or on banana at 0.80 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: March 19, 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, the table in paragraph (a) is revised to read as 
follows:

Sec.  180.132  Thiram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Apple...................................................            7.0
Banana \1\..............................................            0.80
Peach...................................................            7.0
Strawberry..............................................           20
------------------------------------------------------------------------
\1\ No U.S. registrations as of September 23, 2009.

* * * * *
[FR Doc. 2015-06981 Filed 3-26-15; 8:45 am]
 BILLING CODE 6560-50-P
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