38844 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations 

* * * * * 

[FR Doc. 2017–17231 Filed 8–15–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2016–0286; FRL–9964–40] 

Prothioconazole; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of 

prothioconazole in or on Sunflower 

subgroup 20B at 0.2 parts per million 

(ppm). Bayer CropScience requested 

this tolerance under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

August 16, 2017. Objections and 

requests for hearings must be received 

on or before October 16, 2017, 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–2016–0286, 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: 

Michael L. Goodis, P.E., Director, 

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–2016–0286 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 October 16, 2017. 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– 

2016–0286, 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 July 20, 

2016 (81 FR 47150) (FRL–9948–45), 

EPA issued a document pursuant to 

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

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

pesticide petition (PP 6E8469) by Bayer 

CropScience, P.O. Box 12014, 2 T.W. 

Alexander Drive, Research Triangle 

Park, NC 27709. This petition requested 

that 40 CFR 180.626 be amended by 

establishing tolerances for residues of 

prothioconazole in or on imported 

commodities in the sunflower subgroup 

20B at 0.2 ppm. This document 

referenced a summary of a petition 

prepared by Bayer CropScience, the 

registrant, which are available in the 

docket, http://www.regulations.gov. No 

comments were 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 


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Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations 38845 

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 prothiconazole 

including exposure resulting from the 

tolerance established by this action. 

A. Risk Assessment 

In the Federal Register of November 

10, 2016 (81 FR 78917) (FRL–9953–71), 

EPA established tolerances for residues 

of prothioconazole in or on cotton, gin 

byproducts at 4.0 ppm and the 

cottonseed subgroup 20C at 0.4 ppm. 

Because much of the safety assessment 

of prothioconazole for the current action 

remains the same, EPA is relying in part 

upon the findings made in the 

November 10, 2016 final rule in support 

of this action. 

A summary of the toxicological 

profile and endpoints used for human 

risk assessment is discussed in Units 

III.A. and III.B of the November 10, 2016 

final rule. 

In evaluating dietary exposure for this 

action, EPA considered exposure under 

the petitioned-for tolerances as well as 

all existing prothioconazole tolerances 

in 40 CFR 180.626. The residue data 

used for the acute and chronic dietary 

exposure assessments have not changed 

since the assessment supporting the 

November 10, 2016 final rule, except to 

incorporate the recommended tolerance 

on commodities associated with 

Sunflower subgroup 20B, for which the 

Agency assumed tolerance-level 

residues and 100 percent crop treated. 

For a summary of how EPA assessed 

these dietary exposures, see Unit III.C.1 

of the November 10, 2016 final rule. 

In addition, because the requested 

sunflower subgroup tolerance is not 

accompanied by a corresponding 

request for a U.S. registration for use of 

prothioconazole on the commodities in 

the sunflower subgroup, the drinking 

water and residential exposure 

assessments remain the same. A 

summary of EPA’s assessment of 

drinking water exposure and residential 

exposure is discussed in Units III.C.2. 

and III.C.3. 

A summary of EPA’s conclusions 

about the cumulative effects of 

prothioconazole can be found in Unit 

III.C.4. of the November 10, 2016 final 

rule; however, since the November 10, 

2016 final rule was published, the 

Agency has updated its dietary exposure 

and risk analysis for the common 

triazole metabolites 1,2,4-triazole (T), 

triazolylalanine (TA), triazolylacetic 

acid (TAA), and triazolylpyruvic acid 

(TP). The update was completed in 

association with registration requests for 

several triazole fungicides and includes, 

inter alia, the potential exposure to the 

common triazole metabolites resulting 

from the use of prothioconazole on 

commodities in the sunflower subgroup 

20B. That analysis concluded that risk 

estimates were below the Agency’s level 

of concern for all population groups. 

This assessment may be found on http:// 

www.regulations.gov by searching for 

the following title and docket number: 

‘‘Common Triazole Metabolites: 

Updated Dietary (Food + Water) 

Exposure and Risk Assessment to 

Address the New Section 3 Registrations 

For Use of Difenoconazole on Rice and 

Cotton.’’ (located in docket ID number 

EPA–HQ–OPP–2016–0254). 

Because there have been no changes 

to the potential for prenatal and 

postnatal toxicity or in the completeness 

of data with respect to toxicity and 

exposure, EPA has determined that 

reliable data show the safety of infants 

and children would be adequately 

protected if the additional tenfold (10×) 

margin of safety required under section 

408(b)(2)(C) (‘‘FQPA safety factor’’) were 

reduced to 1×. A summary of EPA’s 

rationale for this determination is 

discussed in Unit III.D. of the November 

10, 2016 final rule. 

B. Determination of Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute populationadjusted dose (aPAD) and chronic 

population-adjusted dose (cPAD). 

Short-, intermediate-, and chronic-term 

risks are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

points of departure to ensure that an 

adequate margin of exposure exists. 

Using the exposure assumptions 

discussed above and in the November 

10, 2016 final rule, EPA assessed acute 

and chronic dietary exposure from food 

and drinking water and concluded that 

the new tolerances on sunflower 

subgroup 20B do not change the risk 

estimates from the November 10, 2016 

final rule. The acute dietary exposure 

utilized 40% of the aPAD for females 

13–49 years old at the 95th percentile. 

The chronic dietary exposure utilized 

32% of the cPAD for the U.S. 

population, and 77% for all infants (<1 

year), the most highly exposed 

population subgroup. 

Because there are no existing or 

proposed residential uses for 

prothioconazole, there are no exposures 

expected via the residential exposure 

pathway. Therefore, all aggregate risk 

estimates are expected to be equivalent 

to dietary (food and drinking water) risk 

estimates mentioned above. 

Therefore, 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 prothioconazole residues. 

For a detailed discussion of the 

aggregate risk assessments and 

determination of safety for these 

tolerances, please refer both to the 

November 10, 2016 final rule and its 

supporting documents, available at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2015–0722, and 

to the risk assessment for this current 

action ‘‘Prothioconazole: Human Health 

Risk Assessment for the Petition for a 

Tolerance Without U.S. Registration for 

Residues in/on sunflower subgroup 

20B.’’ in docket ID number EPA–HQ– 

OPP–2016–0286. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate liquid chromatography with 

tandem mass spectrometry (LC/MS/MS) 

methods are available for enforcing 

prothioconazole tolerances in crop and 

livestock commodities. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–350; 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. 

There is currently a Codex MRL for 

sunflower/safflower established at 0.05 

ppm. The U.S. EPA is establishing a 

tolerance on sunflower at 0.2 ppm to 

harmonize with a major trading partner, 

Canada, in order to have a harmonized 

North America MRL for the Sunflower 

subgroup 20B. A tolerance cannot be 

established at the lower Codex MRL 


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38846 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Rules and Regulations 

because it would present a trade irritant 

for sunflower commodities coming into 

the United States. 

V. Conclusion 

Therefore, a tolerance is established 

for residues of prothioconazole, in or on 

sunflower subgroup 20B at 0.2 parts 

ppm. 

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: July 26, 2017. 

Michael Goodis, 

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 § 180.626, add alphabetically the 

entry ‘‘Sunflower subgroup 20B’’ to the 

table in paragraph (a)(1), and add 

footnote 1 to the table to read as follows: 

§ 180.626 Prothioconazole; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Sunflower subgroup 20B1 .......... 0.2 

* * * * * 

1There are no U.S. registrations allowing 

use of prothioconazole on the commodities in 

the Sunflower subgroup 20B as of August 16, 

2017. 

* * * * * 

[FR Doc. 2017–17336 Filed 8–15–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0108; FRL–9964–53] 

Fatty Acids, Rape-Oil, Triesters With 

Polyethylene Glycol Ether With 

Glycerol (3:1); Tolerance Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of fatty acids, 

rape-oil, triesters with polyethylene 

glycol ether with glycerol (3:1) (CAS 

Reg. No. 688045–21–8) when used as an 

inert ingredient in a pesticide chemical 

formulation. Seppic, Inc. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of fatty acids, rape-oil, 

triesters with polyethylene glycol ether 

with glycerol (3:1) on food or feed 

commodities. 

DATES: This regulation is effective 

August 16, 2017. Objections and 

requests for hearings must be received 

on or before October 16, 2017, 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–2017–0108, 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 


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