Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 46929 

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 exemptions 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). 

VIII. 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: September 5, 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 § 180.910, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Tall oil fatty acids 

(CAS Reg. No. 

61790–12–3).

............ Solvent/carrier. 

* * * * * 

■ 3. In § 180.930, add alphabetically the 

inert ingredient to the table to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * 

Tall oil fatty acids 

(CAS Reg. No. 

61790–12–3).

............ Solvent/carrier. 

* * * * * 

■ 4. In § 180.940(a), add alphabetically 

the inert ingredient to the table to read 

as follows: 

§ 180.940(a) Tolerance exemptions for 

active and inert ingredients for use in 

antimicrobial formulations (Food contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Inert ingredients Limits Uses 

* * * * * 

Tall oil fatty acid 

(CAS Reg. No. 

61790–12–3).

............ Solvent/carrier. 

* * * * * 

* * * * * 

[FR Doc. 2017–21787 Filed 10–6–17; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0309; FRL–9967–72] 

Tolfenpyrad; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

tolfenpyrad in or on dry bulb onion and 

watermelon. This action is in response 

to EPA’s granting of emergency 

exemptions under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use of the 

pesticide on dry bulb onion and 

watermelon. This regulation establishes 

maximum permissible levels for 

residues of tolfenpyrad in or on these 

commodities. The time-limited 

tolerances expire on December 31, 2020. 

DATES: This regulation is effective 

October 10, 2017. Objections and 

requests for hearings must be received 

on or before December 11, 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–2017–0309, 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 https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Michael L. Goodis, 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: 


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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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at https://

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 https://

www.epa.gov/aboutepa/about-officechemical-safety-and-pollutionprevention-ocspp and select ‘‘Test 

Guidelines for Pesticides and Toxic 

Substances.’’ 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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–2017–0309 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 December 11, 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– 

2017–0309, by one of the following 

methods: 

• Federal eRulemaking Portal: 

https://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 https://

www.epa.gov/dockets/where-sendcomments-epa-dockets. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at https:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6) of, 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing time-limited 

tolerances for residues of tolfenpyrad (4- 

chloro-3-ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide), including its metabolites 

and degradates, in or on dry bulb onion 

at 0.09 parts per million (ppm), and 

watermelon at 0.7 ppm. These timelimited tolerances expire on December 

31, 2020. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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. . . .’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemptions for 

Tolfenpyrad on Dry Bulb Onion and 

Watermelon, and FFDCA Tolerances 

The Texas Department of Agriculture 

(TDA) stated that an emergency 

situation required the use of tolfenpyrad 

on dry bulb onions (Allium cepa) to 

control onion thrips (Thrips tabaci 

Lindeman) in the Texas counties of 

Cameron, Dimmitt, Frio, Hidalgo, 

Maverick, Starr, Uvalde, Willacy and 

Zavala. According to TDA, this year’s 

exceptionally mild winter and record 

high heat caused the development of 

large populations of onion thrips, a 

principle pest of onions, early in the 

onion crop cycle. The threshold level 

for applying pesticides to control thrips 

in onions is 5 to 25 thrips per plant, and 

TDA stated that over 100 thrips per 

plant were observed in Texas’ dry bulb 

onion fields in early March, 2017. TDA 

stated that multiple applications of 

registered pesticides were not 

controlling these extreme population 

levels which can reduce yields and bulb 

size by as much as 50%. In addition, the 

transmission of iris yellow spot virus in 

onions, exclusively vectored by onion 

thrips, is a concern, and several onion 

fields have been observed with positive 

symptoms. TDA stated that this virus 

severely affects the shipping quality of 

onions, and can be more devastating 

than damage from the thrips themselves. 

Upon EPA concurrence, TDA allowed 

the use of tolfenpyrad under the 

provisions of a crisis exemption 

beginning on March 17, 2017, and 


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subsequently requested a specific 

exemption to allow the use of 

tolfenpyrad in dry bulb onions to 

continue beyond the 15 days provided 

by a crisis exemption alone. 

Separately, the Hawaii Department of 

Agriculture (HDA) stated that an 

emergency developed due to outbreaks 

of melon thrips in watermelon fields at 

unusually high levels, (up to 200 thrips 

per leaf), which registered pesticides 

were not controlling. HDA stated that 

above-average rainfall caused rapid 

growth of host plants, leading to 

development of very high levels of 

melon thrips in areas near watermelon 

fields. Subsequently, a 6-week drought 

caused early dry-down of this rainyseason vegetation, prompting massive 

migrations of melon thrips into 

neighboring watermelon fields. HDA 

stated that the melon thrips infestations 

have caused stunted vines, foliage 

discoloration, and in some instances 

have caused such severe damage that 

the plants no longer produce fruit. The 

melon aphid also transmits the tomato 

spotted wilt virus, which causes silver 

mottle disease in watermelon, further 

damaging the plants and causing 

additional yield losses. HDA stated that 

some watermelon acreage was 

abandoned due to the high level of 

damage from melon thrips infestations, 

and that significant yield and economic 

losses would occur in the remaining 

watermelon acreage without the 

requested use of tolfenpyrad. Upon EPA 

concurrence, HDA allowed the use of 

tolfenpyrad under the provisions of a 

crisis exemption, beginning on May 31, 

2017, subsequently requesting a specific 

exemption to allow the use of 

tolfenpyrad in watermelon to continue 

beyond the 15 days provided under a 

crisis exemption alone. 

After having reviewed the 

submissions, EPA determined that 

emergency conditions exist for these 

States, and that the criteria for approval 

of the emergency exemptions had been 

met. Therefore, EPA authorized specific 

exemptions under FIFRA section 18 for 

the use of tolfenpyrad on dry bulb onion 

for control of onion thrips in Texas, and 

on watermelon for control of melon 

thrips in Hawaii. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of tolfenpyrad in or on dry bulb 

onion and watermelon. In doing so, EPA 

considered the safety standard in 

FFDCA section 408(b)(2), and decided 

that the necessary tolerances under 

FFDCA section 408(l)(6) would be 

consistent with the safety standard and 

with FIFRA section 18. Consistent with 

the need to move quickly on the 

emergency exemptions in order to 

address urgent, non-routine situations 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing these 

tolerances without notice and 

opportunity for public comment as 

provided in FFDCA section 408(l)(6). 

Although these time-limited tolerances 

expire on December 31, 2020, under 

FFDCA section 408(l)(5), residues of the 

pesticide not in excess of the amounts 

specified in the tolerances remaining in 

or on dry bulb onion or watermelon 

after that date will not be unlawful, 

provided the pesticide was applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by these timelimited tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether tolfenpyrad 

meets FIFRA’s registration requirements 

for use on dry bulb onion and 

watermelon or whether permanent 

tolerances for these uses would be 

appropriate. Under these circumstances, 

EPA does not believe that these timelimited tolerance decisions serve as 

bases for registration of tolfenpyrad by 

a State for special local needs under 

FIFRA section 24(c), nor do these 

tolerances by themselves serve as the 

authority for persons in any States other 

than Texas and Hawaii to use this 

pesticide on the applicable crops under 

FIFRA section 18, absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemptions for tolfenpyrad, contact the 

Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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 expected as a result 

of these emergency exemptions and the 

time-limited tolerances for residues of 

tolfenpyrad on dry bulb onion at 0.09 

ppm, and watermelon at 0.7 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing the timelimited tolerances follows. 

A. 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 to humans by 

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 https://

www.epa.gov/pesticide-science-andassessing-pesticide-risks. 

A summary of the toxicological 

profile and endpoints for tolfenpyrad 

used for human health risk assessment 

is discussed in Table 1 of the final rule 

published in the Federal Register of 

January 9, 2014, (79 FR 1599) (FRL– 

9904–70). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to tolfenpyrad, EPA 

considered exposures under the timelimited tolerances established by this 

action as well as all existing tolfenpyrad 

tolerances in 40 CFR 180.675. EPA 

assessed dietary exposures from 

tolfenpyrad in food as follows: 

i. Acute exposure. Acute dietary 

exposure is quantified and risk 

assessments are performed for a fooduse 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; such effects were 

identified for tolfenpyrad. In estimating 

acute dietary exposure, EPA used food 

consumption information from the 

United States Department of Agriculture 

(USDA) 2003–2008 National Health and 

Nutrition Examination Survey/What We 


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Eat in America (NHANES/WWEIA). For 

the purposes of this acute exposure 

assessment, EPA assumed tolerancelevel residues and 100 percent crop 

treated (PCT) for those crops on which 

tolfenpyrad use is registered and 

proposed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA 2003–2008 NHANES/ 

WWEIA. For the purposes of this 

chronic exposure assessment, EPA 

assumed 100 PCT and incorporated 

average residue levels from crop field 

trials for registered and proposed uses of 

tolfenpyrad. 

iii. Cancer. No evidence of 

carcinogenicity was observed in cancer 

studies with mice and rats. For further 

detail on the results of these studies see 

‘‘Tolfenpyrad. Human Health Risk 

Assessment’’ at https://

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2012–0909. 

Therefore, in accordance with EPA’s 

Final Guidelines for Carcinogen Risk 

Assessment (March 2005), tolfenpyrad 

is classified as ‘‘not likely to be 

carcinogenic to humans’’ and a cancer 

risk assessment is unnecessary. 

iv. Anticipated residue and percent 

crop treated (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. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for tolfenpyrad in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of tolfenpyrad. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

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 

tolfenpyrad are 26.9 ppb for acute 

exposure and 12.2 ppb for chronic 

exposure. These modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model. 

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). 

Tolfenpyrad is not registered for any 

specific use patterns that would result 

in residential exposure. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at: 

https://www.epa.gov/pesticide-scienceand-assessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

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.’’ 

EPA has not found tolfenpyrad to 

share a common mechanism of toxicity 

with any other substances, and 

tolfenpyrad does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that tolfenpyrad 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 https:// 

www.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

C. 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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

No evidence of increased quantitative or 

qualitative susceptibility was observed 

in developmental toxicity studies in rats 

or rabbits or a reproduction toxicity 

study in rats. However, the 

developmental immunotoxicity study 

(DIT) in rats suggests increased 

qualitative susceptibility in the young 

since toxicity observed in offspring 

animals was more pronounced than 

toxicity seen in maternal animals at the 

same dose. No evidence of quantitative 

susceptibility was seen in the study. 

There is low concern and there are no 

residual uncertainties regarding the 

increased qualitative prenatal and/or 

postnatal susceptibility observed for 

tolfenpyrad. When the DIT and the 

reproduction study are considered 

together, the offspring toxicity in the 

DIT is comparable in severity to 

maternal toxicity observed at the same 

dose in the reproduction study. Since 

the adverse effects in young occurred at 

exposure levels that have shown 

comparable effects in adults, EPA does 

not consider the DIT persuasive 

evidence of an increased susceptibility 

of infants or children to tolfenpyrad. 

Additionally, the effects observed in the 

DIT study are well-characterized, a clear 

NOAEL was identified, and the 

endpoints chosen for risk assessment 

are protective of potential offspring 

effects since a dermal hazard was not 

identified for tolfenpyrad, inhalation 

risk assessments are based on a route 

specific inhalation study, and the POD 

used for chronic dietary risk assessment 

is lower than where offspring effects 

were seen in the DIT study. 

3. Conclusion. EPA has determined 

that reliable data show that 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 

tolfenpyrad is complete. 

ii. There is no indication that 

tolfenpyrad is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. Although there is possibly 

increased qualitative susceptibility in 

the young in the DIT study in rats, there 

are no residual uncertainties regarding 

increased susceptibility for tolfenpyrad 

since, (1) comparable maternal toxicity 

was observed at the same dose in the 


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reproduction study, (2) the offspring 

effects observed in the DIT study are 

well characterized and there is a clear 

NOAEL for the effects seen, (3) no 

evidence of quantitative susceptibility 

was seen in the DIT study and 

susceptibility was not observed 

(quantitative or qualitative) in rat or 

rabbit developmental toxicity or 

reproduction studies tested at similar 

doses, (4) the endpoints and PODs 

selected for risk assessment are 

protective, and (5) direct non-dietary 

exposure to children is not anticipated 

since there are no residential uses for 

tolfenpyrad. Thus, an additional FQPA 

safety factor is not necessary to protect 

infants and children. 

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 tolfenpyrad in drinking water. 

Accordingly, these assessments will not 

underestimate the exposure and risks 

posed by tolfenpyrad. 

D. 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, drinking water 

and relevant residential exposure 

scenarios. Since there are no residential 

uses for tolfenpyrad, acute residential 

exposure is not anticipated and acute 

aggregate exposure results from dietary 

exposure to residues in food and 

drinking water alone. Therefore, acute 

aggregate risk estimates are equivalent 

to the acute dietary risk estimates. Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food and water to 

tolfenpyrad will occupy 56% of the 

aPAD for the general U.S. population. 

Children 3–5 years old are the highestexposed population subgroup with an 

estimated acute dietary exposure of 80% 

of the aPAD. Typically, EPA has 

concerns when estimated exposures 

exceed 100% of the acute or chronic 

population-adjusted dose (aPAD or 

cPAD). Acute dietary risk estimates are 

below EPA’s level of concern for all 

populations. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

chronic exposure estimates from dietary 

consumption of food and drinking water 

and relevant residential exposure 

scenarios. Since there are no residential 

uses for tolfenpyrad, chronic residential 

exposure is not anticipated and chronic 

aggregate exposure to tolfenpyrad 

results from dietary exposure to 

residues in food and drinking water 

alone. Therefore, chronic aggregate risk 

estimates for tolfenpyrad are equivalent 

to the chronic dietary risk estimates. 

Using the exposure assumptions 

described in this unit for chronic 

exposure, EPA has concluded that 

chronic exposure to tolfenpyrad from 

food and water will utilize 32% of the 

cPAD for the general U.S. population, 

and 81% of the cPAD for children 1–2 

years old (the population group 

receiving the greatest exposure). 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic dietary exposure from food and 

water (considered to be a background 

(average) exposure level). A short-term 

adverse effect was identified; however, 

tolfenpyrad is not registered for any use 

patterns that would result in short-term 

residential exposure. Because there is 

no short-term residential exposure and 

chronic dietary exposure has already 

been assessed under the appropriately 

protective cPAD (which is at least as 

protective as the POD used to assess 

short-term risk), no further assessment 

of short-term risk is necessary, and EPA 

relies on the chronic dietary risk 

assessment for evaluating short-term 

risk for tolfenpyrad. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

dietary exposure from food and water 

(considered to be a background 

exposure level). An intermediate-term 

adverse effect was identified; however, 

tolfenpyrad is not registered for any use 

patterns that would result in 

intermediate-term residential exposure. 

Because there is no intermediate-term 

residential exposure and chronic dietary 

exposure has already been assessed 

under the appropriately protective 

cPAD (which is at least as protective as 

the POD used to assess intermediateterm risk), no further assessment of 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating intermediateterm risk for tolfenpyrad. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

tolfenpyrad is not expected to pose a 

cancer risk to humans. 

6. 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 tolfenpyrad 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(liquid chromatography/tandem mass 

spectrometry (LC/MS/MS)) 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 MRLs for tolfenpyrad 

residues in dry bulb onion or 

watermelon. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of tolfenpyrad 

(4-chloro-3-ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide), including its metabolites 

and degradates, in or on onion, dry bulb 

at 0.09 ppm, and watermelon at 0.7 

ppm. These tolerances expire on 

December 31, 2020. 


Pmangrum on DSK3GDR082PROD with RULES
46934 Federal Register / Vol. 82, No. 194 / Tuesday, October 10, 2017 / Rules and Regulations 

VII. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

such as the tolerances 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). 

VIII. 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: September 25, 2017. 

Michael L. 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 § 180.675, revise paragraph (b) to 

read as follows: 

§ 180.675 Tolfenpyrad; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of tolfenpyrad, (4-chloro-3- 

ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide, including its metabolites 

and degradates, in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FIFRA 

section 18 emergency exemptions. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only tolfenpyrad, 4-chloro-3- 

ethyl-1-methyl-N-[4-(ptolyloxy)benzyl]pyrazole-5- 

carboxamide. The tolerances expire on 

the dates specified in the table. 

Commodity Parts per 

million 

Expiration 

date 

Onion, dry bulb ........................................................................................................................................................ 0.09 12/31/2020 

Vegetable, fruiting, group 8–10 ............................................................................................................................... 0.70 12/31/19 

Watermelon .............................................................................................................................................................. 0.70 12/31/2020 

* * * * * 

[FR Doc. 2017–21797 Filed 10–6–17; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

[Docket No. 150121066–5717–02] 

RIN 0648–XF727 

Atlantic Highly Migratory Species; 

Atlantic Bluefin Tuna Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure of the 

General category fishery. 

SUMMARY: NMFS closes the General 

category fishery for large medium and 

giant (i.e., measuring 73 inches curved 

fork length or greater) Atlantic bluefin 

tuna (BFT) until the General category 

reopens on December 1, 2017. This 

action is being taken to prevent 

overharvest of the General category 

October through November 2017 BFT 

subquota and help ensure reasonable 


Pmangrum on DSK3GDR082PROD with RULES