Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8295 

Cosmetic Act (FFDCA) Considerations 

for Bacillus thuringiensis Cry1F 

Protein.’’ This document, as well as 

other relevant information, is available 

in the docket for this action as described 

under ADDRESSES. 

B. Analytical Enforcement Methodology 

EPA is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. An 

analytical method for enforcement 

purposes was, however, submitted by 

Dow AgroSciences LLC and determined 

by the Agency to be suitable for 

quantitative measurements of the Cry1F 

protein in soybean tissue. The Dow 

AgroSciences LLC Cry1F EnzymeLinked Immunosorbent Assay (ELISA) 

method is fully discussed in the January 

13, 2014 document entitled, ‘‘Federal 

Food, Drug and Cosmetic Act (FFDCA) 

Considerations for Bacillus 

thuringiensis Cry1F Protein.’’ 

IV. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under FFDCA section 408(d) 

in response to a petition submitted to 

the Agency. The Office of Management 

and Budget (OMB) has exempted these 

types of actions from review under 

Executive Order 12866, entitled 

‘‘Regulatory Planning and Review’’ (58 

FR 51735, October 4, 1993). Because 

this final rule has been exempted from 

review under Executive Order 12866, 

this final rule is not subject to Executive 

Order 13211, entitled ‘‘Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled ‘‘Protection of Children from 

Environmental Health Risks and Safety 

Risks’’ (62 FR 19885, April 23, 1997). 

This final rule does not 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 exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

V. 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 174 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 30, 2014. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 174—[AMENDED] 

■ 1. The authority citation for part 174 

continues to read as follows: 

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

■ 2. Revise § 174.504 to read as follows: 

§ 174.504 Bacillus thuringiensis Cry1F 

protein; exemption from the requirement of 

a tolerance. 

Residues of Bacillus thuringiensis 

Cry1F protein in the food and feed 

commodities of corn, field; corn, sweet; 

corn, pop; cotton; and soybean are 

exempt from the requirement of a 

tolerance when used as a plantincorporated protectant in corn, field; 

corn, sweet; corn, pop; cotton, and 

soybean. 

§ 174.520 [Removed] 

■ 3. Remove § 174.520. 

[FR Doc. 2014–02932 Filed 2–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0925; FRL–9904–22] 

Thiram; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thiram in or 

on strawberry. Taminco, Inc. requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 12, 2014. Objections and 

requests for hearings must be received 

on or before April 14, 2014, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0925, 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), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 


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DC 20460–0001; 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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2012–0925 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 April 14, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0925, 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.htm. 

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 January 16, 

2013 (78, FR 3379) (FRL–9375–4), 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 2F8106) by Taminco, Inc., 

7540 Windsor Drive, Suite 411, 

Allentown, PA 18195. The petition 

requested that 40 CFR 180.132 be 

amended by increasing the level of the 

tolerance for residues of the fungicide 

thiram, in or on strawberry to 20 parts 

per million (ppm). This request was 

made to support a change in the 

preharvest interval (PHI) from 3 days to 

1 day for strawberry on the label for 

Spotrete-F (EPA Reg. No. 45728–26). 

That document referenced a summary of 

the petition prepared by Taminco, Inc., 

the registrant, 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. In addition, no 

adverse effects on the developing fetal 

nervous system were seen in a DNT 

study. 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 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8297 

susceptibility following in utero 

exposures to rats or rabbits and 

following pre- and post-natal exposures 

to rats for two 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-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 at page 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. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIRAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/ 

Scenario PoD Uncertainty/FQPA SFs 

RfD, PAD, LOC for 

risk assessment 

Study and toxicological 

effects 

Acute Dietary (General 

Population).

BMDL10 = 64.94 mg/

kg.

UFA = 10x .................

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.6494 

mg/kg/day.

aPAD = 0.6494 mg/

kg/day 

Acute Neurotoxicity Study—Rat. MRID 

42912401. 

LOAEL = 150 mg/kg/day based on FOB effects (lethargy, lower temperature, reduced startle response, no tail-pinch response), reduced motor activity, and reduced brain weights. 

Acute Dietary (Females 

13–49 years old).

NOAEL = 1.4 mg/kg UFA = 10x .................

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.014 

mg/kg/day.

aPAD = 0.014 mg/kg/

day 

Dev. Neurotoxicity Study—Rat. MRID 

46455201. 

LOAEL = 3.7 mg/kg/day based on increases in motor activity seen in female 

offspring on PND 17. 

Chronic Dietary (All populations).NOAEL = 1.5 mg/kg UFA = 10x .................

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.015 

mg/kg/day.

cPAD = 0.015 mg/kg/

day.

Co-critical: (1) Combined Chronic Toxicity/

Carcinogenicity Study—Rat and (2) 

Chronic Oral Toxicity-Dog. 

LOAEL = 7.3 mg/kg/day based on changes 

in hematology, clinical chemistry, 

incidences of bile duct hyperplasia, and 

reduction in mean body-weight gain from 

the chronic toxicity/carcinogenicity rat 

study in conjunction with elevated cholesterol levels and increased liver weights 

reported in the Chronic Oral Toxicity 

Study in Dogs at a LOAEL = 7.23 mg/kg/

day. 

Short- and IntermediateTerm Incidental Oral.No incidental oral residential exposure. 

Short-Term Dermal (1–30 

days).

NOAEL = 1.4 mg/kg/

day.

UFA = 10x .................

UFH = 10x 

FQPA SF = 1x (Dermal-absorption factor = 1%) 

Residential LOC for 

MOE = 100.

Occupational LOC for 

MOE = 100 

Dev. Neurotoxicity Study—Rat MRID 

46455201. 

LOAEL = 3.7 mg/kg/day based on increases in motor activity seen in female 

offspring on PND 17. 

Intermediate-Term Dermal (1 to 6 months).NOAEL = 1.4 mg/kg/

day.

UFA = 10x .................

UFH = 10x 

FQPA SF = 1x (Dermal-absorption factor = 1%) 

Residential LOC for 

MOE = 100.

Occupational LOC for 

MOE = 100 

Dev. Neurotoxicity Study—Rat MRID 

46455201. 

LOAEL = 3.7 mg/kg/day based on increases in motor activity seen in female 

offspring on PND 17. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR THIRAM FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/ 

Scenario PoD Uncertainty/FQPA SFs 

RfD, PAD, LOC for 

risk assessment 

Study and toxicological 

effects 

Short- and IntermediateTerm Inhalation.Current assessment does not warrant an inhalation assessment. 

Cancer (oral, dermal, inhalation).‘‘Not Likely to be Carcinogenic to Humans’’. 

Point of Departure (PoD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (intraspecies). UFH = 

potential variation in sensitivity among members of the human population (interspecies). FQPA SF = Food Quality Protection Act Safety Factor. 

PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

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 refined probabilistic acute dietary 

exposure assessment was performed 

using maximum percent crop treated 

(PCT) values, 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. Dietary 

risk estimates were determined 

considering exposures from food and 

drinking water using estimated drinking 

water concentrations (EDWCs) for 

surface water sources. 

ii. Chronic exposure. A refined 

chronic dietary-exposure assessment 

was performed using tolerance level 

residues and average estimated PCT. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

classified thiram as ‘‘Not Likely to be 

Carcinogenic to Humans,’’ therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 

show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. 

In addition, the Agency must provide 

for periodic evaluation of any estimates 

used. To provide for the periodic 

evaluation of the estimate of PCT as 

required by FFDCA section 408(b)(2)(F), 

EPA may require registrants to submit 

data on PCT. 

The Agency estimated the PCT in the 

acute dietary risk assessment for 

existing uses as follows apples: 10%; 

peaches: 2.5%; and strawberry: 30%. 

The Agency estimated the PCT in the 

chronic dietary risk assessments for 

existing uses as follows apples: 5%; 

peaches: 1.0%; and strawberry: 20%. 

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 chemical name 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 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8299 

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 

billion (ppb) and 0.0025 ppb 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 applicable to thiram. 

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. When use 

is restricted to greens and tees, the 

duration of exposure is 1 hour to reflect 

the anticipated time a player would be 

spending in contact with those areas. 

Inhalation post-application exposures 

for golf courses were not assessed since 

inhalation exposures are thought to be 

negligible in outdoor post-application 

scenarios. 

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 

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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility following in utero 

exposure to rats or rabbits or following 

pre- and post natal exposures to rats. 

There is evidence of quantitative 

susceptibility in the DNT study. 

Offspring effects (increased locomotor 

activity in females on PND 17) occurred 

at a lower dose than maternal effects 

(increased number of rearing events and 

elevated incidences of hyperactivity in 

females at weeks 8 and 13). There is low 

concern for the enhanced susceptibility 

seen in the DNT study because: (1) Clear 

NOAELs/LOAELs were established for 

the offspring effects; (2) the doseresponse is well defined; (3) the 

behavioral effect of concern were 

observed only in females on one 

evaluation time period; and (4) 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. Thiram has been shown to cause 

neurotoxicity following acute and 

subchronic exposures only. There was 

no evidence of increased susceptibility 

following in utero exposure to rats or 

rabbits or following pre- and post-natal 

exposures to rats. Evidence of 

quantitative susceptibility was 

demonstrated in the DNT study; 

however, there is low concern for the 

susceptibility seen in the DNT study 

because clear NOAELs/LOAELs were 

established for the offspring effects, the 

dose-response is well defined, and the 

dose/endpoint is used for acute dietary 

risk for the most sensitive population 

(females 13–49 years old) and therefore 

is protective. Consequently, there are no 

residual uncertainties for pre- and postnatal toxicity. 

iii. There is no other evidence that 

thiram results in increased 

susceptibility in in utero, rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study, only in the DNT. 

iv. 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 

FDA apple monitoring data and field 

trial data along with the maximum 

percent crop treated. The chronic 

dietary exposure analysis used tolerance 

level residues except for apple along 

with the average percent crop treated. 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. 

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 


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exposure estimates from dietary 

consumption of food and drinking 

water. Using DEEM–FCIDTM, acute 

dietary exposure at the 99.9th exposure 

percentile is estimated at 0.020104 mg/ 

kg bw/day for the general U.S. 

population (3.1% of the aPAD) and 

0.010887 mg/kg bw/day (78% of the 

aPAD) for females 13–49 years old, the 

population subgroup with the highest 

estimated acute dietary exposure to 

thiram. 

2. Chronic risk. The chronic aggregate 

risk assessment takes into account 

exposure estimates from dietary 

consumption of thiram (food and 

drinking water). Dietary risk estimates 

were determined considering exposures 

from food and drinking water using 

EDWCs for surface water sources. Using 

DEEM–FCIDTM, dietary exposure is 

estimated at 0.001384 mg/kg bw/day for 

the general U.S. population (9.2% of the 

cPAD) and 0.008369 mg/kg bw/day 

(56% of the cPAD) for children 1–2 

years old, the population subgroup with 

the highest estimated chronic dietary 

exposure to thiram. 

3. Short-term and Intermediate-term 

risk. Short-term aggregate exposure 

takes into account short-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

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 600, 600, and 370, 

respectively. As these MOEs are greater 

than 100, the short- and intermediateterm aggregate risks do not exceed the 

Agency’s LOC. 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. Thiram is classified as ‘‘Not 

Likely to be Carcinogenic to Humans’’ 

based on lack of evidence for 

carcinogenicity in mice or rats; 

therefore, thiram is not expected to pose 

a cancer risk. 

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 established MRLs for 

‘‘total dithiocarbamates, determined and 

expressed as mg carbon disulfide per 

kg’’ in or on strawberry at 5 ppm. This 

MRL differs from the tolerance 

amendment for thiram on strawberry 

that was requested by the petitioner. As 

U.S. tolerances are currently established 

on the individual dithiocarbamates, 

compatibility is not possible with the 

proposed tolerances. EPA is considering 

modifying all tolerances for 

dithiocarbamates, including thiram, to 

express them in terms of carbon 

disulfide. At that time, the tolerance 

expression will be compatible with 

CODEX; however, the U.S. tolerance 

level for strawberry cannot be 

harmonized with the CODEX MRL level 

because of differences in agricultural 

practices between the U.S. and foreign 

countries where strawberries are grown. 

Actual residues seen in the U.S. field 

trials submitted to support the proposed 

strawberry tolerance amendment 

exceeded the CODEX MRL. 

C. Revisions to Petitioned-for Tolerances 

The Agency has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of thiram 

not specifically mentioned. 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, the tolerance for residues 

of thiram, in or on strawberry, is 

amended to increase the level of the 

tolerance to 20 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 


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Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Rules and Regulations 8301 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 27, 2014. 

Lois Rossi, 

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, revise the introductory 

text of paragraph (a) and revise the entry 

for ‘‘Strawberry’’ in the table in 

paragraph (a) to read as follows: 

§ 180.132 Thiram; tolerances for residues. 

(a) General. Tolerances for residues of 

the fungicide thiram (tetramethyl 

thiuram disulfide), including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified is to be determined by 

measuring only thiram. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

* * * * * 

Strawberry ........ 20 None. 

* * * * * 

[FR Doc. 2014–03074 Filed 2–11–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0791; FRL–9905–22] 

Linuron; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of linuron in or 

on multiple commodities which are 

identified and discussed later in this 

document. This regulation additionally 

removes a tolerance with regional 

registrations in or on parsley leaves, as 

it will be superseded by a tolerance 

without regional registrations. IR–4 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 12, 2014. Objections and 

requests for hearings must be received 

on or before April 14, 2014, and must 

be filed in accordance with 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–2012–0791, 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), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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/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–2012–0791 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 April 14, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 


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