Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations 35141 

TEXAS—2015 8-HOUR OZONE NAAQS 

[Primary and Secondary] 

Designated area 1

Designation Classification 

Date 2 Type Date 2 Type 

*******

San Antonio, TX ................................................................................................. 9/24/2018 Nonattainment .. 9/24/2018 Marginal. 

Bexar County.

* * * * * * * 

Rest of State: 

* * * * * * * 

Atascosa County ......................................................................................... 9/24/2018 Attainment/ 

Unclassifiable.

* * * * * * * 

Bandera County .......................................................................................... 9/24/2018 Attainment/ 

Unclassifiable.

* * * * * * * 

Comal County ............................................................................................. 9/24/2018 Attainment/ 

Unclassifiable.

* * * * * * * 

Guadalupe County ...................................................................................... 9/24/2018 Attainment/ 

Unclassifiable.

* * * * * * * 

Kendall County ............................................................................................ 9/24/2018 Attainment/

Unclassifiable.

* * * * * * * 

Medina County ............................................................................................ 9/24/2018 Attainment/ 

Unclassifiable.

* * * * * * * 

Wilson County ............................................................................................. 9/24/2018 Attainment/

Unclassifiable.

* * * * * * * 

1 Includes any Indian country in each county or area, unless otherwise specified. EPA is not determining the boundaries of any area of Indian 

country in this table, including any area of Indian country located in the larger designation area. The inclusion of any Indian country in the designation area is not a determination that the state has regulatory authority under the Clean Air Act for such Indian country. 2This date is August 3, 2018, unless otherwise noted. 

[FR Doc. 2018–15919 Filed 7–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0226; FRL–9979–81] 

Florasulam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of florasulam in 

or on teff forage, teff grain, teff hay, and 

teff straw. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

25, 2018. Objections and requests for 

hearings must be received on or before 

September 24, 2018, 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–2017–0226, 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 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: 

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 


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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–2017–0226 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 September 24, 2018. 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– 

2017–0226, 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 October 23, 

2017 (82 FR 49020) (FRL–9967–37), 

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 7E8549) by IR–4, 

Rutgers, The State University of New 

Jersey, 500 College Road East, Suite 201 

W, Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the herbicide florasulam N- 

(2,6-difluorophenyl)-8-fluoro-5-methoxy 

(1,2,4)triazolo(1,5-c)pyrimidine-2- 

sulfonamide in or on the raw 

agricultural commodities teff, forage at 

0.05 parts per million (ppm); teff, grain 

at 0.01 ppm; teff, straw at 0.05 ppm; and 

teff, hay at 0.05 ppm. That document 

referenced a summary of the petition 

prepared by Dow AgroSciences, the 

registrant, which is available in the 

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

comment was received on the notice of 

filing. EPA’s response to this comment 

is discussed in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for florasulam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with florasulam 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. 

There was slight nephrotoxicity 

(increased kidney weights, hypertrophy, 

and degeneration/regeneration and 

inflammation of the descending portion 

of proximal tubules) observed in the 

kidneys of rats (both sexes) after 

subchronic exposure to florasulam (90 

days) at or greater than 500 milligrams/ 

kilogram/day (mg/kg/day). Chronic 

exposure in rats led to slight 

nephrotoxicity (increased kidney 

weights, hypertrophy, and slight multifocal mineralization of the papilla) at 

250 and 500 mg/kg/day in males only. 

Additionally, at 500 mg/kg/day, 

papillary necrosis and hyperplasia of 

the transitional epithelium (papilla) 

were observed in the kidney (males). 

Decreases in body weight and body 

weight gain were also observed in 

females after subchronic (500 mg/kg/ 

day) and chronic exposure (250 mg/kg/ 

day). Liver toxicity was observed in 

dogs (both sexes) in the form of 

increased alkaline phosphatase activity 

(59–127%), increased liver weights, 

hypertrophy, and hepatic vacuolation at 

50 mg/kg/day after 90 days. After 1 year, 

there were increases in alkaline 

phosphatase (233–783%) in dogs (both 

sexes) but no changes in liver weights 

or gross or microscopic pathology at 50 

mg/kg/day. Additionally, there were 

decreases in body weight, body weight 

gain and food consumption, as well as 

vacuolation of the zona reticularis and 

zona fasciculate in the adrenal gland 

(consistent with fatty change) in both 

sexes. There were no adverse effects 

noted after subchronic/chronic exposure 

to florasulam in mice up to the limit 

dose of 1,000 mg/kg/day. 

There was no evidence of 

developmental toxicity or indications of 


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neonatal sensitivity in the 

developmental and reproduction 

toxicity studies (rats and rabbits). In the 

rat developmental toxicity study, 

decreased body weights and decreased 

food consumption were observed. There 

were also slight decreases observed in 

fetal body weight and delays in 

ossification observed in fetuses at the 

high dose. However, the minor 

differences were not considered adverse 

since there was no clear dose-response 

relationship and the values (both 

findings) fell within historical control 

values. Furthermore, the findings were 

attributed to the associated decreases in 

maternal body weights. There were no 

treatment-related effects observed in 

dams or offspring in the developmental 

toxicity study in rabbits. In the 

reproduction toxicity study in rats, there 

were decreased body weights, body 

weight gains, and food consumption, as 

well as increased kidney weights and 

hypertrophy in both sexes at 500 mg/kg/ 

day. Additionally, at 500 mg/kg/day, 

transient decreases in pup body weights 

were observed on post-natal day 4 preculling (F1 and F2 males) and post-natal 

day 7 (F1 females and F2 males and 

females); however, by post-natal day 21, 

all treated groups were similar to 

controls. The decreases observed were 

associated with decreased maternal 

body weight and food consumption and 

were transient in nature; thus, they were 

not considered adverse. 

Dermal exposure to florasulam did 

not result in systemic toxicity up to the 

limit dose of 1,000 mg/kg/day. There is 

no evidence of neurotoxicity, 

mutagenicity, or carcinogenicity after 

exposure to florasulam. In addition, 

there is no evidence of endocrine 

related toxicity. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by florasulam 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 the document 

titled ‘‘Florasulam: Human Health Risk 

Assessment for proposed use on 

Turfgrass’’ (‘‘2009 Florasulam Turfgrass 

Assessment’’) on pages 35–39 in docket 

ID number EPA–HQ–OPP–2017–0226. 

The Agency is relying on this risk 

assessment because the toxicological 

profile for florasulam has not changed 

since that risk assessment was 

conducted and as indicated in a more 

recent assessment for use on teff, the 

Agency has concluded that registering 

use on teff would not alter the Agency’s 

previously assessed exposure estimates 

for florasulam. See ‘‘Florasulam: Human 

Health Risk Assessment for Proposed 

Use on Teff’’ (Dec. 6, 2017) (‘‘2017 

Florasulam Teff Assessment’’), which 

can also be found in http://

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2017–0226. 

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://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides. 

A summary of the toxicological 

endpoints for florasulam used for 

human risk assessment is shown in 

Table 1 of this unit. 

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

ASSESSMENT

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All populations) .. No appropriate endpoint identified. 

Chronic dietary (All populations) NOAEL = 5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.05 

mg/kg/day.

cPAD = 0.05 mg/kg/ 

day.

Chronic toxicity—dogs. 

LOAEL = 50 mg/kg/day, based on decreased body weights 

(17%), body weight gains (68%), and food consumption in 

the females; adverse liver alterations; slight vacuolation of 

the zona reticularis and zona fasciculata in the adrenal gland 

(fatty change) in both sexes. 

Incidental oral short-term (1–30 

days).

NOAEL = 5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Subchronic toxicity—dogs. 

LOAEL = 50 mg/kg/day based on hepatotoxicity (increases in 

alkaline phosphatase activity and hepatic vacuolation) observed in both sexes. 

Inhalation short-term (1–30 

days).

Oral study NOAEL = 

5 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Subchronic toxicity—dogs. 

LOAEL = 50 mg/kg/day based on hepatotoxicity (increases in 

alkaline phosphatase activity and hepatic vacuolation) observed in both sexes. 


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

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and 

uncertainty/safety 

factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Cancer (Oral, dermal, inhalation).Not Likely to be Carcinogenic to Humans. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in 

sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. EPA’s most recent 

quantitative dietary assessment was 

conducted in connection with the 

registration of turfgrass uses for 

florasulam. See 2009 Florasulam 

Turfgrass Assessment. That document 

considered dietary exposure for residues 

of florasulam in food associated with 

the all existing florasulam tolerances in 

40 CFR 180.633 as described in Unit 

III.C.1. of the 2007 rulemaking 

establishing those tolerances. 72 FR 

55073 (Sept. 28, 2007). EPA has 

determined that approval of the use on 

teff will not change those dietary 

exposure estimates for residues of 

florasulam in or on food. The Agency 

expects residues on teff to be similar to 

those residues in or on wheat because 

of the similarity in use pattern and 

application rates. Teff is prepared like 

other whole grains, such as rice and 

barley, and may also be used to make 

flour in a manner similar to wheat and 

other cereal grains. As a flour, the 

Agency expects that teff will likely 

substitute in the diet for cereal grain 

foods rather than add to dietary 

exposure. With respect to livestock 

commodities, residues of florasulam in 

teff livestock feeds are expected to be 

similar to those in other forages, hays, 

and silages for which florasulam is 

currently registered. Therefore, there 

would be no increase in the livestock 

dietary burden should teff be 

substituted in the livestock diet for 

other hays and silages; residues in meat, 

milk, poultry and eggs will remain the 

same. 

2. Dietary exposure from drinking 

water. In the 2009 Florasulam Turfgrass 

Assessment, the Agency used screeninglevel water exposure models in the 

dietary exposure analysis and risk 

assessment for florasulam in drinking 

water. These simulation models take 

into account data on the physical, 

chemical, and fate/transport 

characteristics of florasulam. Further 

information regarding EPA drinking 

water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

To arrive at the total EDWC (estimated 

drinking water concentrations), the 

maximum surface water and ground 

water values for the parent was added 

to the maximum surface water and 

ground water value for the major 

degradate. Based on the FQPA Index 

Reservoir Screening Tool (FIRST), and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of florasulam use on turfgrass 

for chronic exposures are estimated to 

be 1.36 parts per billion (ppb) for 

surface water and 0.06 ppb for ground 

water. 

The Agency has concluded that the 

teff use will not increase drinking water 

exposure estimates because the teff use 

pattern is similar to the use patterns on 

wheat and barley. The wheat and barley 

use patterns yield EDWCs that are 

approximately nine times lower than 

the use on turfgrass and thus would not 

be used to assess dietary exposure. 

Therefore, the Agency used the same 

modeled estimates of drinking water 

concentrations from the 2009 

Florasulam Turfgrass Assessment: For 

the chronic dietary risk assessment, the 

water concentration of value 1.36 ppb 

was used to assess the contribution to 

drinking water. 

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). 

Florasulam is currently registered for 

the following uses that could result in 

residential exposures: Turf. The new 

use on teff is not a residential use. 

Therefore, EPA is relying on its 2009 

Florasulam Turfgrass Assessment to 

assess residential exposures. EPA 

assessed residential exposure using the 

following assumptions: Short-term 

inhalation exposure is expected to 

handlers as a result of applying 

florasulam to turf. There is no shortterm dermal endpoint for florasulam, 

and therefore, no dermal risks were 

assessed for residential handlers. The 

scenarios assessed for handlers was 

mixing/loading/applying florasulam to 

turf with various application 

equipment. 

For post-application, the Agency 

determined there is a potential for 

exposure from entering florasulamtreated residential areas, such as lawns, 

sports fields, and golf courses that could 

lead to post-application exposures to 

adults and children. No short-term 

dermal point of departure was identified 

for florasulam. Therefore, no dermal 

risks were assessed for residential postapplication exposures. 

The Agency assumed that inhalation 

exposures are minimal following 

outdoor applications of an active 

ingredient with low vapor pressure. 

Since the proposed use of florasulam 

include only outdoor applications and 

florasulam has a low vapor pressure, 

post-application inhalation exposures 

and risks were not assessed. The 

scenario resulting in the highest 

exposure was short-term incidental oral 

risks for toddlers after applications of 

florasulam to lawns. The exposure 

scenarios include hand to mouth, object 

to mouth, incidental soil ingestion and 

the combination of all three of these 

scenarios. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www2.epa.gov/pesticidescience-and-assessing-pesticide-risks/ 

standard-operating-proceduresresidential-pesticide. 

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 


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substances that have a common 

mechanism of toxicity.’’ 

EPA has not found florasulam to share 

a common mechanism of toxicity with 

any other substances, and florasulam 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that florasulam 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 website at http:// 

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides. 

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 

developmental toxicity or indications of 

neonatal sensitivity in the 

developmental and reproduction 

toxicity studies (rats and rabbits). In the 

rat developmental toxicity study (750 

mg/kg/day) body weights were 

decreased by 4–6% during gestation 

days 6–19, resulting in a 16% decrease 

in body weight gains during treatment 

(gestation days 6–16); food consumption 

was also decreased (not statistically 

analyzed) by 6–13% during the 

treatment period. Additionally, at this 

dose, absolute and relative (to body 

weight) kidney weights were increased 

(p<= 0.05) by 8 and 12%, respectively. 

At 250 and 750 mg/kg/day, slight 

decreases (3–4%) were observed in fetal 

body weight. Additionally, there were 

delays in ossification observed in 

fetuses at 750 mg/kg/day. However, the 

minor differences were not considered 

adverse since there was no clear doseresponse and the values (both findings) 

fell within historical control values. 

Furthermore, the findings were 

attributed to the associated decreases in 

maternal body weights. There were no 

treatment-related effects observed in 

dams or offspring in the developmental 

toxicity study in rabbits. In the 

reproduction toxicity study in rats, there 

were decreased body weights, body 

weight gains, and food consumption, as 

well as increased kidney weights and 

hypertrophy in both sexes at 500 mg/kg/ 

day. Additionally, at 500 mg/kg/day, 

transient decreases in pup body weights 

were observed on post-natal day 4 preculling (F1 and F2 males) and post-natal 

day 7 (F1 females and F2 males and 

females); however, by post-natal day 21, 

all treated groups were similar to 

controls. The decreases observed were 

associated with decreased maternal 

body weight and food consumption and 

were transient in nature; thus, they were 

not considered adverse 

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 florasulam 

is complete. 

ii. There is no indication that 

florasulam is a neurotoxic chemical and 

there is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

florasulam results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to florasulam in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by florasulam. 

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. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, florasulam is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to florasulam 

from food and water will utilize less 

than 1% of the cPAD for all population 

groups. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of florasulam is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Florasulam is currently registered for 

uses that could result in short-term 

residential exposure, and the Agency 

has determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to florasulam. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 14,000 for children, 98,000 for 

the general U.S. population, and 

114,000 for adult females. Because 

EPA’s level of concern for florasulam is 

a MOE of 100 or below, these MOEs are 

not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

An intermediate-term adverse effect 

was identified; however, florasulam is 

not registered for any use patterns that 

would result in intermediate-term 

residential exposure. Intermediate-term 

risk is assessed based on intermediateterm residential exposure plus chronic 

dietary 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 intermediate-term risk), no 

further assessment of intermediate-term 


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35146 Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

florasulam. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

florasulam 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 florasulam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(capillary gas chromatography and mass 

selective detection (GC–MSD)) 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 florasulam on teff. 

C. Response to Comments 

A single comment was received that 

appeared to be in support of the petition 

and read in part that ‘‘the proposed 

regulation of pesticide residuals is . . . 

a very reasonable proposal.’’ The 

commenter also expressed concern 

regarding the consequences for not 

meeting the residue levels. The 

commenter’s concern is outside the 

scope of this rulemaking, which is 

concerned with assessing the safety of 

these tolerances. 

V. Conclusion 

Therefore, tolerances are established 

for residues of florasulam, including its 

metabolites and degradates, in or on teff, 

forage at 0.05 ppm; teff, grain at 0.01 

ppm; teff, hay at 0.05 ppm; and teff, 

straw at 0.05 ppm. 

In addition, in accordance with 

Agency policy, EPA is revising the 

introductory language in paragraph (a) 

to clarify (1) that, as provided in FFDCA 

section 408(a)(3), the tolerance covers 

metabolites and degradates of 

florasulam not specifically mentioned; 

and (2) that compliance with the 

specified tolerance levels is to be 

determined by measuring only the 

specific compounds mentioned in the 

tolerance expression. EPA has 

determined that it is reasonable to make 

this change final without prior proposal 

and opportunity for comment, because 

public comment is not necessary, in that 

the change has no substantive effect on 

the tolerance, but rather is merely 

intended to clarify the existing tolerance 

expression. 

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), nor is it considered a 

regulatory action under Executive Order 

13771, entitled ‘‘Reducing Regulations 

and Controlling Regulatory Costs’’ (82 

FR 9339, February 3, 2017). 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. 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 143 / Wednesday, July 25, 2018 / Rules and Regulations 35147 

Dated: July 16, 2018. 

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 § 180.633: 

■ i. Revise paragraph (a) introductory 

text; and 

■ ii. Add alphabetically the 

commodities ‘‘Teff, forage,’’ ‘‘Teff, 

grain,’’ ‘‘Teff, hay,’’ and ‘‘Teff, straw’’ to 

the table in paragraph (a). 

The revision and additions read as 

follows: 

§ 180.633 Florasulam; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

florasulam, including its metabolites 

and degradates, in or on the 

commodities below. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only 

florasulam, N-(2, 6-difluorophenyl)-8- 

fluoro-5-methoxy (1, 2, 4) triazole (1, 5- 

c)pyrimidine-2-sulfonamide, in or on 

the commodities. 

Commodity Parts per 

million 

* * * * * 

Teff, forage ............................... 0.05 

Teff, grain ................................. 0.01 

Teff, hay .................................... 0.05 

Teff, straw ................................. 0.05 

* * * * * 

* * * * * 

[FR Doc. 2018–15916 Filed 7–24–18; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 64 

[Docket ID FEMA–2018–0002: Internal 

Agency Docket No. FEMA–8539] 

Suspension of Community Eligibility 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: This rule identifies 

communities where the sale of flood 

insurance has been authorized under 

the National Flood Insurance Program 

(NFIP) that are scheduled for 

suspension on the effective dates listed 

within this rule because of 

noncompliance with the floodplain 

management requirements of the 

program. If the Federal Emergency 

Management Agency (FEMA) receives 

documentation that the community has 

adopted the required floodplain 

management measures prior to the 

effective suspension date given in this 

rule, the suspension will not occur and 

a notice of this will be provided by 

publication in the Federal Register on a 

subsequent date. Also, information 

identifying the current participation 

status of a community can be obtained 

from FEMA’s Community Status Book 

(CSB). The CSB is available at https:// 

www.fema.gov/national-floodinsurance-program-community-statusbook. 

DATES: The effective date of each 

community’s scheduled suspension is 

the third date (‘‘Susp.’’) listed in the 

third column of the following tables. 

FOR FURTHER INFORMATION CONTACT: If 

you want to determine whether a 

particular community was suspended 

on the suspension date or for further 

information, contact Adrienne L. 

Sheldon, PE, CFM, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 400 C 

Street SW, Washington, DC 20472, (202) 

212–3966. 

SUPPLEMENTARY INFORMATION: The NFIP 

enables property owners to purchase 

Federal flood insurance that is not 

otherwise generally available from 

private insurers. In return, communities 

agree to adopt and administer local 

floodplain management measures aimed 

at protecting lives and new construction 

from future flooding. Section 1315 of 

the National Flood Insurance Act of 

1968, as amended, 42 U.S.C. 4022, 

prohibits the sale of NFIP flood 

insurance unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed in this document no 

longer meet that statutory requirement 

for compliance with program 

regulations, 44 CFR part 59. 

Accordingly, the communities will be 

suspended on the effective date in the 

third column. As of that date, flood 

insurance will no longer be available in 

the community. We recognize that some 

of these communities may adopt and 

submit the required documentation of 

legally enforceable floodplain 

management measures after this rule is 

published but prior to the actual 

suspension date. These communities 

will not be suspended and will continue 

to be eligible for the sale of NFIP flood 

insurance. A notice withdrawing the 

suspension of such communities will be 

published in the Federal Register. 

In addition, FEMA publishes a Flood 

Insurance Rate Map (FIRM) that 

identifies the Special Flood Hazard 

Areas (SFHAs) in these communities. 

The date of the FIRM, if one has been 

published, is indicated in the fourth 

column of the table. No direct Federal 

financial assistance (except assistance 

pursuant to the Robert T. Stafford 

Disaster Relief and Emergency 

Assistance Act not in connection with a 

flood) may be provided for construction 

or acquisition of buildings in identified 

SFHAs for communities not 

participating in the NFIP and identified 

for more than a year on FEMA’s initial 

FIRM for the community as having 

flood-prone areas (section 202(a) of the 

Flood Disaster Protection Act of 1973, 

42 U.S.C. 4106(a), as amended). This 

prohibition against certain types of 

Federal assistance becomes effective for 

the communities listed on the date 

shown in the last column. The 

Administrator finds that notice and 

public comment procedures under 5 

U.S.C. 553(b), are impracticable and 

unnecessary because communities listed 

in this final rule have been adequately 

notified. 

Each community receives 6-month, 

90-day, and 30-day notification letters 

addressed to the Chief Executive Officer 

stating that the community will be 

suspended unless the required 

floodplain management measures are 

met prior to the effective suspension 

date. Since these notifications were 

made, this final rule may take effect 

within less than 30 days. 

National Environmental Policy Act. 

FEMA has determined that the 

community suspension(s) included in 

this rule is a non-discretionary action 

and therefore the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321 et seq.) does not apply. 

Regulatory Flexibility Act. The 

Administrator has determined that this 

rule is exempt from the requirements of 

the Regulatory Flexibility Act because 

the National Flood Insurance Act of 

1968, as amended, Section 1315, 42 

U.S.C. 4022, prohibits flood insurance 

coverage unless an appropriate public 

body adopts adequate floodplain 

management measures with effective 

enforcement measures. The 

communities listed no longer comply 

with the statutory requirements, and 

after the effective date, flood insurance 


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