Federal Register / Vol. 80, No. 118 / Friday, June 19, 2015 / Rules and Regulations 35249 

U.S.C. 101(24)(B) and (C). If an 

individual described in this paragraph 

develops a disease listed in 38 CFR 

3.309(e) as specified in paragraph 

(a)(6)(ii) of this section, it will be 

presumed that the individual concerned 

became disabled during that service for 

purposes of establishing that the 

individual served in the active military, 

naval, or air service. 

* * * * * 

(Authority: 38 U.S.C. 101(24), 501(a), 

1116(a)(3), and 1821) 

[FR Doc. 2015–14995 Filed 6–18–15; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0249; FRL–9928–82] 

Thiram; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of thiram in or on 

avocado. Taminco US, Inc. requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective June 

19, 2015. Objections and requests for 

hearings must be received on or before 

August 18, 2015, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2014–0249, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

is open from 8:30 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/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–2014–0249 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 18, 2015. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2014–0249, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of December 

17, 2014 (79 FR 75107) (FRL–9918–90), 

EPA issued a document pursuant to 

FFDCA section 408(d)(3), 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 4E8250) by 

Taminco US, Inc., Two Windsor Plaza, 

Suite 411, 7540 Windsor Drive, 

Allentown, PA 18195. The petition 

requested that 40 CFR 180.132 be 

amended by establishing a tolerance for 

residues of the fungicide thiram in or on 

avocado at 8 parts per million (ppm). 

That document referenced a summary of 

the petition prepared by Taminco US, 

Inc, the petitioner, which is available in 

the docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

For reasons that are discussed in Unit 

IV.C., EPA is establishing a tolerance for 

avocado at 15 ppm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 


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give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for thiram including 

exposure resulting from the tolerances 

established by this action. EPA’s 

assessment of exposures and risks 

associated with thiram follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Thiram is a dimethyl dithiocarbamate 

fungicide. Thiram has been shown to 

cause neurotoxicity following acute and 

subchronic exposures. In the acute and 

subchronic neurotoxicity studies 

submitted, neurotoxicity is 

characterized as lethargy, reduced and/ 

or tail pinch response, changes in the 

functional-observation battery (FOB) 

parameters, increased hyperactivity, 

changes in motor activity, and increased 

occurrences of rearing events. No 

treatment-related changes were 

observed in brain weights or in the 

histopathology of the nervous system. In 

a non-guideline study published in the 

open literature, chronic feeding of 

thiram to rats caused neurotoxicity, 

with onset of ataxia in some animals 5– 

19 months after beginning of treatment. 

However, no evidence of neurotoxicity 

was seen following chronic exposures in 

mice or rats in guideline studies 

submitted to the Agency. The chronic 

toxicity profile for thiram indicates that 

the liver, blood, and urinary system are 

the target organs for this chemical in 

mice, rats, and dogs. There is no 

evidence for increased susceptibility 

following in utero exposures to rats or 

rabbits and following pre- and 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 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. Revised Human Health Risk 

Assessment for the Import Use of 

Thiram on Avocado, PP#4E8250 and 

Banana, PP#4E8268’’. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for thiram used for human 

risk assessment is discussed in Unit 

III.B. of the final rule published in the 

Federal Register of February 12, 2014 

(79 FR 8295) (FRL–9904–22). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to thiram, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing thiram 

tolerances in 40 CFR 180.132. EPA 

assessed dietary exposures from thiram 

in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. 

A partially refined probabilistic acute 

dietary-exposure assessment was 

performed using 100 percent crop 

treated (PCT), average field trial 

residues or pulp residues for blended 

commodities, distributions of field trial 

residues, highest pulp residue, and 

empirical processing factors. 

ii. Chronic exposure. Tolerances-level 

residues, average field-trial residues, 

and highest pulp residues for avocado 

with 100 PCT were used for the chronic 

dietary exposure analysis for all crops. 

Empirical processing factors were also 

used. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that thiram does not pose a 

cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use PCT information in the dietary 

assessment for thiram. Section 

408(b)(2)(E) of FFDCA authorizes EPA 

to use available data and information on 

the anticipated residue levels of 

pesticide residues in food and the actual 

levels of pesticide residues that have 

been measured in food. If EPA relies on 

such information, EPA must require 

pursuant to FFDCA section 408(f)(1) 

that data be provided 5 years after the 

tolerance is established, modified, or 

left in effect, demonstrating that the 

levels in food are not above the levels 

anticipated. For the present action, EPA 

will issue such data call-ins as are 

required by FFDCA section 408(b)(2)(E) 

and authorized under FFDCA section 

408(f)(1). Data will be required to be 

submitted no later than 5 years from the 

date of issuance of these tolerances. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for thiram in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 


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transport characteristics of thiram. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www.epa.gov/oppefed1/models/ 

water/index.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Ground Water (SCI– 

GROW) models, the estimated drinking 

water concentrations (EDWCs) of thiram 

for acute exposures are 0.0478 ppm and 

0.0025 ppm for chronic exposures (for 

non-cancer assessments) for surface 

water. Ground water sources were not 

included (for acute or chronic 

exposures), as the EDWCs for ground 

water are minimal in comparison to 

those for surface water. Surface water 

EDWCs were incorporated in Dietary 

Exposure Evaluation Model Food 

Commodity Intake Database (DEEM– 

FCID) into the food categories ‘‘water, 

direct, all sources’’ and ‘‘water, indirect, 

all sources’’ for the dietary assessments. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to 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. Revised Human 

Health Risk Assessment For Import Use 

of Thiram on Avocado,’’ p. 14. 

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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

susceptibility following in utero 

exposure to rats or rabbits or following 

prenatal and post-natal exposures to 

rats. There is evidence of quantitative 

susceptibility in the DNT study. 

However, there is low concern for the 

enhanced susceptibility seen in the DNT 

study because: 

i. Clear NOAELs/LOAELs were 

established for the offspring effects. 

ii. The dose-response is well defined. 

iii. The behavioral effect of concern 

were observed only in females on one 

evaluation time period. 

iv. The dose/endpoint is used for 

acute dietary risk for the most sensitive 

population subgroup (females 13–49 

years old). Consequently, there are no 

residual uncertainties for pre- and 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 post-natal toxicity. 

iii. There are no residual uncertainties 

in the thiram database with regards to 

dietary exposure. A refined probabilistic 

acute dietary-exposure assessment was 

performed using maximum PCT, 

tolerance, the highest residue found 

during field-trials, distribution of field 

trial residues, Federal Drug 

Administration (FDA) monitoring data 

for apples, and empirical processing 

factors. A refined chronic dietaryexposure assessment was performed 

using tolerances and average estimated 

PCT. EPA made conservative 

(protective) assumptions in the water 

modeling used to assess exposure to 

thiram in drinking water. EPA used 

similarly conservative assumptions to 

assess postapplication exposure of 

children. These assessments will not 

underestimate the exposure and risks 

posed by thiram. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. The acute dietary risk estimates 

are not of concern to EPA (<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. 

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. 

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 


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golfer scenario for adult males, adult 

females, and children >6 years old, 

combined with the applicable 

subpopulation with the greatest dietary 

exposure, the total short/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 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for thiram in or on 

avocado. 

C. Revisions to Petitioned-For 

Tolerances 

The petitioner requested a tolerance 

for residues of thiram on avocado at 8 

ppm. EPA is establishing a tolerance at 

15 ppm based on available data and the 

Organization for Economic Cooperation 

and Development (OECD) Tolerance 

Calculation Procedures. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of thiram in or on avocado 

at 15 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

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

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

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

VII. Congressional Review Act 

Pursuant to the Congressional Review 

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

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

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

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 9, 2015. 

Susan Lewis, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 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, alphabetically add the 

commodity ‘‘avocado’’ to the table in 

paragraph (a) to read as follows: 

§ 180.132 Thiram; tolerance for residues. 

(a) * * * 


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1See: 49 CFR part 172 Subpart F—Placarding 

Commodity Parts per 

million 

*****

Avocado 1 .............................. 15 

*****

1 No U.S. registrations as of September 23, 

2009. 

* * * * * 

[FR Doc. 2015–14944 Filed 6–18–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 385 

Hazardous Materials Safety Permit 

(HMSP) Program: Amendment to 

Enforcement Policy 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), DOT. 

ACTION: Amendment to enforcement 

policy. 

SUMMARY: Section 33014 of the Moving 

Ahead for Progress in the 21st Century 

Act (MAP–21) required the Secretary of 

the U.S. Department of Transportation 

(DOT) to conduct a study and submit a 

report to Congress on the 

implementation of the DOT Hazardous 

Materials Safety Permit (HMSP) 

program. DOT completed the study and 

submitted a report to Congress in March 

2014. This document announces 

implementation of two of the six 

recommendations in the report to 

Congress: Fully utilize the Safety 

Measurement System (SMS) as part of 

the HMSP review process and institute 

an ongoing requirement to conduct 

compliance reviews for HMSP motor 

carriers with insufficient data to utilize 

SMS. These recommendations are being 

implemented under the existing Safety 

Fitness Procedure regulations. FMCSA 

will use SMS scores to provide 

enhanced oversight of HMSP holders, to 

identify poor-performing carriers for a 

safety fitness compliance review, and to 

provide grounds for suspension or 

revocation. Both of these processes 

afford the motor carrier the right to 

administrative review and the 

opportunity to present corrective action. 

DATES: The changes to the enforcement 

policy will take effect on August 18, 

2015. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Paul Bomgardner, (202) 493–0027, or 

Paul.Bomgardner@dot.gov, Chief of the 

Hazardous Materials Division, Office of 

Enforcement and Compliance, Federal 

Motor Carrier Safety Administration, 

1200 New Jersey Ave. SE., Washington, 

DC 20590. Office hours are from 9 a.m. 

to 5 p.m., E.T., Monday through Friday, 

except for Federal holidays. 

SUPPLEMENTARY INFORMATION: 

Background 

On January 1, 2005, the Federal Motor 

Carrier Safety Administration (FMCSA) 

began the HMSP program for intrastate, 

interstate, and foreign motor carriers 

transporting specified types and 

amounts of particularly dangerous 

hazardous material. HMSPs are required 

for a small subset of motor carriers 

transporting the following DOTregulated hazardous material: 

1. Highway Route Controlled Quantity 

(HRCQ) of a Class 7 (radioactive) 

material; 

2. More than 55 pounds of a Division 

1.1, 1.2, or 1.3 Explosive, or an amount 

of a Division 1.5 material requiring 

placarding; 

3. Certain Poison by Inhalation 

Hazard (PIH) materials, including 

anhydrous ammonia, and 

4. Compressed or refrigerated 

liquefied methane or liquefied natural 

gas in packaging equal to or greater than 

3,500 water gallons. 

FMCSA’s Motor Carrier Management 

Information System (MCMIS) contains 

records for approximately 525,000 

active interstate motor carriers operating 

in the United States. MCMIS records 

show almost 11,000 interstate and 

intrastate motor carriers that have had 

an inspection indicating that they 

transport hazardous material requiring 

placards.1 Approximately 1,500 motor 

carriers possess an HMSP. 

The HMSP program is based on the 

premise that carriers transporting 

certain amounts of particularly 

dangerous hazardous material must 

maintain a higher minimum level of 

safety in their operations than other 

carriers and must additionally 

demonstrate compliance with the 

critical regulatory requirements in the 

DOT Hazardous Materials Regulations 

(HMR), 49 CFR parts 171–180, and 

Federal Motor Carrier Safety 

Regulations (FMCSR), 49 CFR parts 

350–399. Under FMCSA’s current 

program, in order to obtain or renew a 

HMSP, a carrier must demonstrate that 

it meets the following regulatory 

requirements specified in the FMCSR at 

49 CFR 385.407 and 387.7: 

1. Maintains the minimum level of 

financial responsibility required by 49 

CFR part 387. 

2. Maintains current Pipeline and 

Hazardous Materials Safety 

Administration (PHMSA) registration. 

3. Certifies that it has security and 

communications plans that comply with 

49 CFR part 172 of the HMR and 49 CFR 

part 385 of the FMCSR. 

4. Is assigned a ‘‘satisfactory’’ safety 

fitness rating. 

5. Additionally, at the time of initial 

application and renewal, the carrier’s 

crash and inspection records in MCMIS 

for the prior 12 month period may not 

exceed the threshold rate established by 

FMCSA, based on crash and out-ofservice rates for the hazardous material 

motor carrier industry, indicating that 

the carrier has: 

a. A crash rate in the ‘‘top 30 percent 

of the national average,’’ or 

b. A driver, vehicle, hazardous 

material, or total out-of-service (OOS) 

rate in the ‘‘top 30 percent of the 

national average.’’ 

As stated above, section 33014 of 

MAP–21, Pub. L. 112–141, div. C, title 

III, 126 Stat. 405, 840 (July 6, 2012) (set 

out as a note to 49 U.S.C. 5109) required 

the Secretary to conduct a study and 

submit a report to Congress on the 

implementation of the DOT’s HMSP 

program. Congress further directed the 

Secretary to include in the study a 

review of ‘‘actions the Secretary could 

implement to improve the program, 

including whether to provide 

opportunities for an additional level of 

fitness review prior to the denial, 

revocation, or suspension of a safety 

permit.’’ Finally, section 33014 required 

the Secretary to institute a rulemaking 

to make any necessary improvements to 

the HMSP program or publish in the 

Federal Register the Secretary’s 

justification for why a rulemaking is not 

necessary. 

DOT completed the study and 

submitted its ‘‘Hazardous Materials 

Safety Permit Program Implementation 

Report’’ (HMSP Report) to Congress in 

March 2014. This notice announces 

implementation of two of the six 

recommendations in the report to 

Congress: (1) Fully utilize the Safety 

Measurement System (SMS) as part of 

the HMSP review process and (2) 

institute an ongoing requirement to 

conduct comprehensive investigations 

for HMSP motor carriers with 

insufficient data to utilize SMS. This 

Federal Register publication provides 

notice of the Agency’s revised 

interpretation of certain regulations in 

49 CFR part 385, subpart E, in 

accordance with congressional 

directives and the recommendations in 

the report to Congress. 

On December 16, 2014, Congress 

passed the 2015 Omnibus 


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