16302 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

appropriately enforced under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) as use 

directions on the label. 

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: March 18, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.435, paragraph (a)(2) is 

revised to read as: 

§ 180.435 Deltamethrin; tolerances for 

residues. 

(a) General. * * * 

* * * * * 

(2) A tolerance of 0.05 ppm is 

established for residues of the 

insecticide deltamethrin, including its 

metabolites and degradates, in or on all 

food/feed items (other than those 

covered by a higher tolerance as a result 

of use on growing crops) when 

deltamethrin is used in food/feed 

handling establishments or as a widearea mosquito adulticide. Compliance 

with the tolerance levels specified is to 

be determined by measuring only 

deltamethrin, (1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylic acid 

(S)-alpha-cyano-3-phenoxybenzyl ester, 

and its major metabolites, transdeltamethrin, (S)-alpha-cyano-mphenoxybenzyl(1R,3S)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate, and 

alpha-R-deltamethrin, (R)-alpha-cyanom-phenoxybenzyl-(1R,3R)-3-(2,2- 

dibromovinyl)-2,2- 

dimethylcyclopropanecarboxylate, in or 

on the commodity. 

* * * * * 

[FR Doc. 2015–06861 Filed 3–26–15; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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. 


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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 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/textidx?&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-observedadverse-effect-level (NOAEL) and this 

endpoint is used for assessing the acute 

dietary risk for the most sensitive 


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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 acutetoxicity 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-observedadverse-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 fieldtrials, 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 fieldtrials, 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 nonoccupational, 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 <11 years old, children 11 

to <16 years old, and adults as described 

in document ‘‘Thiram. Update to the 

Aggregate Risk Assessment to Support 

the Requested PHI Reduction and 

Increased Tolerance Request on 

Strawberry,’’ p. 15 in docket ID number 

EPA–HQ–OPP–2012–0925. 

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.’’ 

Unlike the N-methyl carbamate 

pesticides, EPA has not found thiram (a 

dithiocarbamate) to share a common 

mechanism of toxicity with any other 


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substances, and thiram does not appear 

to produce a toxic metabolite produced 

by other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that thiram does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

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 (<100% 

aPAD) at the 95th exposure percentile 

for the general U.S. population and all 

other population subgroups. The acute 

dietary exposure was 62% of the aPAD 

for females 13–49 years old, the 

population subgroup with the highest 

percent aPAD. Therefore, the acute 

aggregate risk associated with the 

proposed uses of thiram is not of 

concern to EPA for the general U.S. 

population or any population 

subgroups. 

2. Chronic risk. The chronic aggregate 

risk assessment takes into account 

exposure estimates from dietary 

consumption of thiram (food and 

drinking water). The chronic dietary 

risk estimates are not of concern to EPA 

(<100% cPAD) for the general U.S. 

population and all other population 

subgroups. The chronic dietary 

exposure was 70% of the cPAD for 

children 1–2 years old, the population 

subgroup with the highest estimated 

chronic dietary exposure. Therefore, the 

chronic aggregate risk associated with 

the proposed uses of thiram is not of 

concern to EPA for the general U.S. 

population or any population 

subgroups. 

3. Short-term and intermediate-term 

risk. In aggregating short- and 

intermediate-term risk, the Agency 

routinely combines background chronic 

dietary exposure (food + water) with 

short/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/intermediateterm 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 <6 years old, 

there is no residential exposure, 

therefore, a short/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 


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16306 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Rules and Regulations 

(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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.132, the table in paragraph 

(a) is revised to read as follows: 

§ 180.132 Thiram; tolerances for residues. 

(a) * * * 

Commodity Parts per 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 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 622 

[Docket No. 130403320–4891–02] 

RIN 0648–XD828 

Fisheries of the Caribbean, Gulf of 

Mexico, and South Atlantic; SnapperGrouper Resources of the South 

Atlantic; 2015–2016 Recreational 

Fishing Season for Black Sea Bass 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; recreational 

season length. 

SUMMARY: NMFS announces that the 

length of the recreational season for 

black sea bass in the exclusive economic 

zone (EEZ) of the South Atlantic will 

extend throughout the fishing year. 

Announcing the length of recreational 

season for black sea bass is one of the 

accountability measures (AMs) for the 

recreational sector. This announcement 

allows recreational fishermen to 

maximize their opportunity to harvest 

the recreational annual catch limit 

(ACL) for black sea bass during the 

fishing season while managing harvest 

to protect the black sea bass resource. 

DATES: This rule is effective from 12:01 

a.m., local time, April 1, 2015, until 

12:01 a.m., local time, April 1, 2016, 

unless changed by subsequent 

notification in the Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Nikhil Mehta, NMFS Southeast Regional 

Office, telephone: 727–824–5305, email: 

nikhil.mehta@noaa.gov. 

SUPPLEMENTARY INFORMATION: The 

snapper-grouper fishery includes black 

sea bass in the South Atlantic and is 

managed under the Fishery 

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