29702 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Rules and Regulations 

Rule No. Rule title 

State 

effective 

date 

EPA 

effective 

date 

Final rule citation, date Comments 

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74:36:21:02 .................... Definitions ...................... 9/13/2017 7/26/2018 [Insert Federal Register 

citation], 6/26/2018.

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74:36:21:04 .................... Visibility impact analysis 9/13/2017 7/26/2018 [Insert Federal Register 

citation], 6/26/2018.

74:36:21:05 .................... BART determination ...... 9/13/2017 7/26/2018 [Insert Federal Register 

citation], 6/26/2018.

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74:36:21:09 .................... Monitoring, recordkeeping, and reporting.9/13/2017 7/26/2018 [Insert Federal Register 

citation], 6/26/2018.

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[FR Doc. 2018–13598 Filed 6–25–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2017–0225; FRL–9978–70] 

Fluroxypyr; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluroxypyr 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 June 

26, 2018. Objections and requests for 

hearings must be received on or before 

August 27, 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–2017–0225, 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 

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–2017–0225 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before August 27, 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– 

2017–0225, 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 


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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 7E8550) 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 herbicide fluroxypyr 1- 

methylheptyl ester [1-methylheptyl ((4- 

amino-3,5-dichloro-6-fluoro-2- 

pyridinyl)oxy) acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid] in or on teff, forage at 12.0 ppm; 

teff, grain at 0.5 ppm; teff, straw at 12.0 

ppm; and teff, hay at 20.0 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. 

There were no comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

changed the numerical expression of the 

proposed tolerance values in order to 

conform to current Agency policy on 

significant figures. 

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 fluroxypyr 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluroxypyr 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. 

The active ingredient used in 

formulating end-use herbicide products 

is fluroxypyr 1-methylheptyl ester. 

However, since the ester form has been 

shown to rapidly hydrolyze to the acid 

form, the residues of fluroxypyr 1- 

methylheptyl ester along with its 

fluroxypyr acid metabolite (free and 

conjugated), are collectively expressed 

as ‘‘fluroxypyr’’ and are therefore 

regulated together for tolerance 

enforcement. In terms of toxicity, the 

ester and acid forms are considered the 

same. 

Fluroxypyr has low acute toxicity by 

the oral and dermal routes of exposure 

and moderate to mild acute toxicity by 

the inhalation route of exposure, based 

on lethality studies. Fluroxypyr is not a 

dermal sensitizer, nor is it irritating to 

the skin; however, it is a mild eye 

irritant. 

The kidney is the target organ for 

fluroxypyr following oral exposure to 

rats, mice, and dogs. In the rat, 

increased kidney weight, 

nephrotoxicity, and death were 

observed in both sexes in the 90-day 

feeding study, and increased kidney 

weight and microscopic kidney lesions 

were observed in both sexes in the 

chronic study. Increased kidney weight 

was also observed in maternal rats in 

the developmental toxicity study, and 

kidney effects (deaths due to renal 

failure; increased kidney weight, and 

microscopic kidney lesions) were 

observed in both sexes in the 2- 

generation reproduction study in rats. 

Although microscopic kidney lesions 

were observed in dogs in the 28-day 

feeding study, no kidney effects or other 

treatment related toxicity were seen in 

the chronic feeding study in dogs at the 

same doses used in the 28-day study. 

Microscopic kidney lesions were 

observed in mice following long-term 

exposure. 

There was no evidence of increased 

susceptibility (quantitative/qualitative) 

following in utero exposure in rats and 

rabbits, or following pre and/or 

postnatal exposure in rats. Neither 

developmental toxicity nor reproductive 

toxicity was observed in rats. In rabbits, 

developmental toxicity was not 

observed following exposure to dose 

levels that resulted in maternal death; 

however, abortions were observed in 

rabbits following exposure to fluroxypyr 

at the limit dose. There was no evidence 

of neurotoxicity or neuropathology in 

any of the studies. An immunotoxicity 

study in rats found no indication of 

immunotoxicity. Fluroxypyr is 

classified ‘‘not likely to be carcinogenic 

to humans’’ due to lack of evidence to 

suggest carcinogenicity in the database, 

and there is no concern for its 

mutagenicity potential. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluroxypyr 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 ‘‘Fluroxypyr: Human Health Risk 

Assessment to Support Proposed New 

Use on Teff’’ on pages 13–16 in docket 

ID number EPA–HQ–OPP–2017–0225. 

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 


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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 fluroxypyr used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of January 16, 2013 

(78 FR 3328) (FRL–9371–1). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluroxypyr, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluroxypyr tolerances in 40 CFR 

180.535. EPA assessed dietary 

exposures from fluroxypyr in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for fluroxypyr; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of 

Agriculture’s National Health and 

Nutrition Examination Survey, ‘‘What 

We Eat in America’’ (NHANES/WWEIA) 

dietary survey conducted in 2003–2008. 

As to residue levels in food, EPA 

assumed tolerance-level residues with 

100 percent crop treated (PCT) for all 

existing and proposed crop uses and 

default processing factors for processed 

commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fluroxypyr does not pose 

a cancer risk to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue or PCT information 

in the dietary assessment for fluroxypyr. 

Tolerance-level residues and 100 PCT 

were assumed for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for fluroxypyr in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fluroxypyr. 

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. 

Based on the Tier 1 Rice Model and 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of fluroxypyr for chronic 

exposures are estimated to be 540 parts 

per billion (ppb) for surface water and 

0.055 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

chronic dietary risk assessment, the 

water concentration value of 540 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). 

Fluroxypyr is currently registered for 

the following uses that could result in 

residential exposures: Residential 

turfgrass, golf courses, parks and sports 

fields. Residential handler exposure was 

not assessed because all the labels 

require the use of personal-protective 

equipment (PPE) and are not intended 

for application by homeowners. 

For post-application exposure, 

although adults and children 

performing physical activities on treated 

turf (e.g., golfing, mowing) may receive 

dermal exposure to fluroxypyr residues, 

a quantitative risk assessment for the 

dermal route of exposure was not 

conducted since there are no toxicity 

findings for the short-term dermal route 

of exposure up to the limit dose. In 

addition, a quantitative post-application 

inhalation exposure assessment was not 

conducted because of the low acute 

inhalation toxicity, low vapor pressure, 

and the relatively low use rate. 

Young children 1 to <2 years old may 

receive incidental oral post-application 

exposure to fluroxypyr from treated turf. 

The post-application exposures for 

children playing on treated turf 

resulting in incidental oral exposure as 

a result of mouthing behaviors were 

assessed. 

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 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found fluroxypyr to share 

a common mechanism of toxicity with 

any other substances, and fluroxypyr 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluroxypyr 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 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence of increased 

qualitative or quantitative susceptibility 

following in utero exposure in rats and 

rabbits or following pre and/or postnatal 

exposure in rats. 

Fluroxypyr is neither a developmental 

nor a reproductive toxicant in rats. 

Fluroxypyr has been evaluated for 

potential developmental effects in the 


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rat and rabbit (gavage administration). 

Maternal toxicity included death in rats 

and rabbits. There were no 

developmental effects in the rat, and 

while abortions were observed in the 

rabbit, they occurred only at the limit 

dose. 

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 fluroxypyr 

is complete. 

ii. There is no indication that 

fluroxypyr 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 

fluroxypyr 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 chronic dietary food exposure 

assessment utilizes tolerance-level 

residue estimates and assumes 100 PCT 

for all commodities. This assessment 

will not underestimate exposure/risk. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to fluroxypyr in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by fluroxypyr. 

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, fluroxypyr 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 fluroxypyr 

from food and water will utilize 3.5% of 

the cPAD for all infants less than 1-yearold, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

fluroxypyr 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). 

Fluroxypyr 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 fluroxypyr. 

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 an 

aggregate MOE of 2,500 for children 1– 

2 years old. Because EPA’s level of 

concern for fluroxypyr is a MOE of 100 

or below, this MOE is 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, fluroxypyr 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 

risk is necessary, and EPA relies on the 

chronic dietary risk assessment for 

evaluating intermediate-term risk for 

fluroxypyr. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

fluroxypyr 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 fluroxypyr 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate GC/ECD (gas 

chromatography/electron-capture 

detection) analytical methods are 

available to enforce the proposed plant 

tolerances. The available methods for 

plant commodities involve extraction of 

fluroxypyr residues with acetone, 

partitioning with hexane, purification 

using a florisil column, and analysis of 

residues by GC/ECD. 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 fluroxypyr on teff. 

V. Conclusion 

Therefore, tolerances are established 

for the combined residues of fluroxypyr 

1-methylheptyl ester [1-methylheptyl 

((4-amino-3,5-dichloro-6-fluoro-2- 

pyridinyl)oxy)acetate] and its metabolite 

fluroxypyr [((4-amino-3,5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetic acid] in or 

on teff, forage at 12 ppm; teff, grain at 

0.50 ppm; teff, hay at 20 ppm; and teff, 

straw at 12 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 


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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. 

Dated: June 8, 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 § 180.535, add alphabetically the 

entries ‘‘Teff, forage’’; ‘‘Teff, grain’’; 

‘‘Teff, hay’’; and ‘‘Teff, straw’’ to the 

table in paragraph (a) to read as follows: 

§ 180.535 Fluroxypyr 1-methylheptyl ester; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Teff, forage ................................. 12 

Teff, grain ................................... 0.50 

Teff, hay ...................................... 20 

Teff, straw ................................... 12 

* * * * * 

* * * * * 

[FR Doc. 2018–13724 Filed 6–25–18; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 228 

[EPA–R10–OW–2018–0284; FRL–9979–31— 

Region 10] 

Ocean Dumping; Withdrawal of 

Designated Disposal Site; Grays 

Harbor, Washington 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is taking direct final 

action to withdraw from EPA regulation 

and management one designated ocean 

dredged material disposal site, the Grays 

Harbor Eight Mile Site, located near the 

mouth of Grays Harbor, Washington. 

This action is pursuant to the Marine 

Protection, Research, and Sanctuaries 

Act, as amended. The disposal site was 

designated by the EPA for a specific 

one-time use in 1990. The Grays Harbor 

Eight Mile Site fulfilled its intended 

purpose in 1990 as a single-use disposal 

site, and monitoring indicates that there 

will be no unacceptable adverse impacts 

to the marine environment once the 

EPA relinquishes management of the 

site. Five other open-water dredged 

material disposal sites remain in close 

proximity to the mouth of Grays Harbor. 

These sites remain available for use for 

the disposal of suitable dredged material 

and are not affected by this withdrawal. 

DATES: This rule is effective on 

September 24, 2018 without further 

notice, unless the EPA receives adverse 

comment by July 26, 2018. If the EPA 

receives adverse comment, the Agency 

will publish a timely withdrawal in the 

Federal Register informing the public 

that the rule will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. [EPA–R10– 

OW–2018–0284; FRL–9979–31—Region 

10], at http://www.regulations.gov. 

Follow the online instructions for 

submitting comments. Once submitted, 

comments cannot be edited or removed 

from Regulations.gov. The EPA may 

publish any comment received to its 

public docket. Do not submit 

electronically any information you 

consider to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Multimedia submissions (audio, video, 

etc.) must be accompanied by a written 

comment. The written comment is 

considered the official comment and 

should include discussion of all points 

you wish to make. The EPA will 

generally not consider comments or 

comment contents located outside of the 


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