Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 20545 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by June 7, 2016. Filing a petition 

for reconsideration by the Administrator 

of this final rule does not affect the 

finality of this action for the purposes of 

judicial review nor does it extend the 

time within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. See section 

307(b)(2). 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Reporting and 

recordkeeping requirements, Volatile 

organic compounds. 

40 CFR Part 81 

Environmental protection, Air 

pollution control. 

Dated: March 29, 2016. 

Heather McTeer Toney, 

Regional Administrator, Region 4. 

40 CFR parts 52 and 81 are amended 

as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart Z—Mississippi 

■ 2. Section 52.1270(e) is amended by 

adding an entry for ‘‘2008 8-hour ozone 

Maintenance Plan for the DeSoto 

County portion of Memphis, TN–AR– 

MS Nonattainment Area’’ at the end of 

the table to read as follows: 

§ 52.1270 Identification of plan. 

* * * * * 

(e) * * * 

EPA APPROVED MISSISSIPPI NON-REGULATORY PROVISIONS

Name of non-regulatory SIP provision 

Applicable 

geographic or 

nonattainment area 

State 

submittal date/

effective date 

EPA Approval date Explanation 

*******

2008 8-hour ozone Maintenance Plan for the 

DeSoto County portion of Memphis, TN– 

AR–MS Nonattainment Area.

DeSoto County portion of Memphis, 

TN–AR–MS Nonattainment Area.

12/2/2015 4/8/2016 [Insert citation of 

publication].

PART 81—DESIGNATION OF AREAS 

FOR AIR QUALITY PLANNING 

PURPOSES 

■ 3. The authority citation for part 81 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 4. In § 81.325, the table entitled 

‘‘Mississippi–2008 8-Hour Ozone 

NAAQS (Primary and secondary)’’ is 

amended under ‘‘Memphis, TN–MS– 

AR:’’ By revising the entry for ‘‘DeSoto 

County (part) Portion along MPO Lines’’ 

to read as follows: 

§ 81.325 Mississippi. 

* * * * * 

MISSISSIPPI–2008 8-HOUR OZONE NAAQS 

[Primary and secondary] 

Designated area 

Designation Classification 

Date 1 Type Date 1 Type 

Memphis, TN–MS–AR: 2 .................... ........................................ ....................

DeSoto County (part) Portion along MPO Lines .................... 4/8/2016 Attainment.

* * * * * * * 

1This date is July 20, 2012, unless otherwise noted. 

2Excludes Indian country located in each area, unless otherwise noted. 

* * * * * 

[FR Doc. 2016–08155 Filed 4–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0197; FRL–9942–99] 

Fluazinam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of fluazinam in 

or on cabbage, mayhaw, the cucurbit 

vegetable crop group 9, and the tuberous 

and corm vegetable subgroup 1C and 

amends the existing tolerance for 

‘‘vegetable, Brassica leafy, group 5’’ to 

read ‘‘vegetable, Brassica leafy, group 5, 

except cabbage.’’ Interregional Research 

Project Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 


asabaliauskas on DSK3SPTVN1PROD with RULES
20546 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 

DATES: This regulation is effective April 

8, 2016. Objections and requests for 

hearings must be received on or before 

June 7, 2016, 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–2015–0197, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), West William 

Jefferson Clinton Bldg., Rm. 3334, 1301 

Constitution Ave. NW., Washington, DC 

20460–0001. The Public Reading Room 

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

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

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

FOR FURTHER INFORMATION CONTACT: 

Susan Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

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

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2015–0197 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 June 7, 2016. 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– 

2015–0197, 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 May 20, 

2015 (80 FR 28925) (FRL–9927–39), 

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 5E8349) by IR–4, 

500 College Road East, Suite 201W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide fluazinam (3- 

chloro-N-[3-chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), 

including its metabolites and degradates 

in or on mayhaw at 2.0 parts per million 

(ppm); cabbage at 3.0 ppm; the squash/ 

cucumber subgroup 9B at 0.05 ppm; and 

vegetable, tuberous and corm, subgroup 

1C at 0.02 ppm. The petition also 

requested to amend the tolerances in 40 

CFR 180.574 in or on the vegetable, 

Brassica leafy, group 5 at 0.01 by 

changing it to read ‘‘vegetable, Brassica 

leafy, group 5, except cabbage’’ at 0.01 

ppm and by removing the existing 

tolerance on potato at 0.02 ppm upon 

approval of the requested tolerance on 

the tuberous and corm subgroup 1C. 

That document referenced a summary of 

the petition prepared by ISK 

Biosciences, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

EPA is combining the existing 

tolerance for the melon subgroup 9A 

tolerance with the proposed squash/

cucumber subgroup 9B tolerance and 

establishing a tolerance for the entire 

cucurbit vegetable crop group 9, rather 

than just subgroup 9B. The reason for 

these changes is explained 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 


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sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for fluazinam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fluazinam 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 liver is a primary target organ for 

fluazinam and numerous liver effects 

were observed in rats, mice, and dogs 

after oral and dermal exposure. After 

inhalation exposure, portal of entry 

effects (increased lung/bronchial 

weights, alveolar macrophages and 

peribronchiolar proliferation) were seen. 

Clinical signs were observed in an 

acute oral neurotoxicity study in rats; 

decreases in motor activity and soft 

stools were seen on the day of dosing at 

the limit dose. These effects were 

attributed to systemic toxicity and were 

not considered to be evidence of frank 

neurotoxicity. In two subchronic 

neurotoxicity studies (evaluated 

together) in rats, no evidence of 

neurotoxicity was observed. A 

neurotoxic lesion was observed initially 

in long-term studies in mice and dogs; 

however, the lesion is reversible and 

was later attributed to the presence of an 

impurity (Impurity-5) in the technical 

material. A NOAEL for the impurity was 

determined (based on the maximum 

concentration of Impurity-5 in technical 

grade fluazinam), equivalent to a 

NOAEL for central nervous system 

(CNS) effects of 20 mg/kg/day for 

technical grade fluazinam. The current 

acute and chronic reference doses 

selected for risk assessment are lower 

than the determined NOAEL and thus, 

protective of any possible neurotoxic 

effects resulting from exposure to 

Impurity-5. 

In an immunotoxicity study in mice, 

significant suppressions of anti-SRBC 

AFC assay response were demonstrated 

at the highest dose tested indicating 

potential immunotoxicity. However, 

clear NOAELs and LOAELs were 

identified for the effects seen in the 

study and the points of departure 

(PODs) and endpoints selected for risk 

assessment are protective of 

immunotoxic effects. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the rabbit developmental or rat 

reproduction studies. However, 

quantitative susceptibility was seen in 

rat developmental and developmental 

neurotoxicity (DNT) studies where fetal/ 

offspring effects were observed in the 

absence of maternal toxicity. The 

concern is low for the increased 

susceptibility noted in the studies since 

clear NOAELs are established, and the 

most sensitive endpoints/PODs are used 

for risk assessment and are protective of 

the observed susceptibility. Therefore, 

the Food Quality Protection Act (FQPA) 

safety factor (SF) has been reduced to 

1x. 

Fluazinam is classified as having 

‘‘Suggestive evidence of carcinogenicity, 

but not sufficient to assess human 

carcinogenic potential,’’ based on 

increases in thyroid gland follicular cell 

tumors in male rats and increases in 

hepatocellular tumors in male mice. 

Although there is evidence of thyroid 

tumors in male rats and liver tumors in 

male mice, the NOAEL used (1.12 mg/ 

kg/day) for establishing the chronic 

reference dose (cRfD) is approximately 

3-fold lower than the lowest dose that 

induced tumors (3.8 mg/kg/day). The 

Agency has determined that 

quantification of cancer risk using a 

non-linear approach (cRfD) would 

adequately account for all chronic 

toxicity, including carcinogenicity, 

which could result from exposure to 

fluazinam. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fluazinam 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 ‘‘Fluazinam. Human Health Risk 

Assessment to Support Section 3 

Registration for New Uses on Tuberous 

and Corm, Subgroup 1C, Mayhaw, 

Squash/Cucumber Subgroup 9B; 

Amended Uses on Cabbage’’ on page 44 

in docket ID number EPA–HQ–OPP– 

2015–0197. 

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 fluazinam used for human 

risk assessment is discussed in Unit 

III.B. of the final rule published in the 

Federal Register of November 7, 2012 

(77 FR 66723) (FRL–9366–6). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fluazinam, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

fluazinam tolerances in 40 CFR 180.574. 

EPA assessed dietary exposures from 

fluazinam 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. Such effects were identified 

for fluazinam. In estimating acute 

dietary exposure, EPA used food 

consumption information from the 

2003–2008 United States Department of 

Agriculture’s (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). As to residue levels in food, 

the acute analysis is based on tolerancelevel residues for all commodities and 

uses high-end residue estimates for the 

metabolite AMGT ((3-[[4-amino-3-[[3- 

chloro-5-(trifluoromethyl)-2- 

pyridinyl]amino]-2-nitro-6- 

(trifluoromethyl) phenyl]thio]-2-(beta-Dglucopyranosyloxy) propionic acid)). In 

addition, the acute assessment assumes 

100 percent crop treated (PCT). 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s NHANES/WWEIA. As 

to residue levels in food, the chronic 


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analysis is based on tolerance-level 

residues for all commodities except 

apples. For apples, the average field trial 

value was used. As with the acute 

assessment, it incorporates high-end 

estimates for AMGT, 100 PCT 

assumptions, default processing factors 

for all relevant processed commodities 

without a separate tolerance. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that a nonlinear RfD 

approach is appropriate for assessing 

cancer risk to fluazinam. Cancer risk 

was assessed using the same exposure 

estimates as discussed in Unit III.C.1.ii. 

iv. Anticipated residue and 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 fluazinam and its transformation 

products, including DCPA (6-(4- 

carboxy-3-chloro-2,6-dinitroanilino)-5- 

chloronicotinic acid), CAPA (3-chloro-6- 

(3-chloro-2,6-dinitro-4-trifluoromethyl 

anilino)nicotinic acid), DAPA (3-chloroN4-(3-chloro-5-trifluoromethyl-2- 

pyridyl)-a,a,a-trifluorotoluene-3,5,5- 

triamine; 3-chloro-2(2,6-diamino-3- 

chloro-a,a,a-trifluoro-p-toluidino)-5- 

(trifluoromethyl) pyridine), HYPA (5- 

[[3-chloro-5-(trifluoromethyl-2- 

pyridyl]amino]-a,a,a-trifluoro-4,6- 

dinitro-o-cresol), and AMPA (2-(6- 

amino-3-chloro-a,a,a-trifluoro-2-nitrop-toluidino)-3-chloro-5- 

(trifluoromethyl)pyridine). 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

fluazinam and its transformation 

products. Further information regarding 

EPA drinking water models used in 

pesticide exposure assessment can be 

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

about-water-exposure-models-usedpesticide. 

Based on the First Index Reservoir 

Screening Tool (FIRST) and the 

Pesticide Root Zone Model Ground 

Water (PRZM GW) models, the 

estimated drinking water concentrations 

(EDWCs) for total residues of fluazinam 

and its transformation products for 

acute exposures are estimated to be 226 

parts per billion (ppb) for surface water 

and 137 ppb for ground water and for 

chronic exposures are estimated to be 

37.8 ppb for surface water and 119 ppb 

for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For the 

acute dietary risk assessment, the water 

concentration value of 226 ppb was 

used to assess the contribution to 

drinking water, and for the chronic 

dietary risk assessment, the water 

concentration of value 119 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). 

Fluazinam is currently registered for 

the following uses that could result in 

residential exposures: golf course turf. 

EPA assessed residential exposure using 

the following assumptions: Only shortterm dermal exposure is expected for 

residential post-application scenarios 

for children, teens, and adults who 

could potentially be exposed when they 

play golf on treated turf. No other 

residential exposures are expected. 

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 fluazinam to share 

a common mechanism of toxicity with 

any other substances, and fluazinam 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fluazinam does not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www2.epa.gov/pesticide-scienceand-assessing-pesticide-risks/

cumulative-assessment-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 SF. In applying this provision, 

EPA either retains the default value of 

10x, or uses a different additional safety 

factor when reliable data available to 

EPA support the choice of a different 

factor. 

2. Prenatal and postnatal sensitivity. 

There was no evidence of increased 

quantitative or qualitative susceptibility 

in the rabbit developmental or rat 

reproduction studies. However, 

quantitative susceptibility was seen in 

rat developmental and DNT studies 

where fetal/offspring effects were 

observed in the absence of maternal 

toxicity. The concern is low for the 

increased susceptibility noted in the 

studies since clear NOAELs are 

established, and the most sensitive 

endpoints/PODs are used for risk 

assessment and are protective of the 

observed susceptibility. 

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 fluazinam 

is complete. 

ii. Although indications of 

neurotoxicity and immunotoxicity were 

observed in the database for fluazinam, 

there were clear NOAELs for these 

effects, and the endpoints and doses for 

risk assessment are protective of the 

potential effects. 

iii. There is no evidence that 

fluazinam results in increased 

susceptibility in the rabbit 

developmental or rat reproduction 

studies. However, quantitative 

susceptibility was seen in rat 

developmental and DNT studies where 

fetal/offspring effects were observed in 


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the absence of maternal toxicity. The 

concern is low for the increased 

susceptibility noted in the studies since 

clear NOAELs are established, and the 

most sensitive endpoints/PODs are used 

for risk assessment. 

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 for all 

commodities except apples, where 

anticipated residues were used in the 

chronic assessment. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to fluazinam 

and its transformation products in 

drinking water. EPA used similarly 

conservative assumptions to assess postapplication exposure of children. These 

assessments will not underestimate the 

exposure and risks posed by fluazinam. 

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. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

fluazinam will occupy 32% of the aPAD 

for females 13–49 years old, the 

population group receiving the greatest 

exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fluazinam from 

food and water will utilize 92% of the 

cPAD for all infants, 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 fluazinam 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). Fluazinam 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 

fluazinam. 

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 690 for children 6 to <11 years 

old, 820 for youth 11 to <16 years old 

and 890 for adults. Because EPA’s level 

of concern for fluazinam 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, fluazinam 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 

fluazinam. 

5. Aggregate cancer risk for U.S. 

population. EPA assessed cancer risk 

using a non-linear approach (i.e., RfD) 

since it adequately accounts for all 

chronic toxicity, including 

carcinogenicity, that could result from 

exposure to fluazinam. As the chronic 

dietary endpoint and dose are protective 

of potential cancer effects, fluazinam is 

not expected to pose an aggregate cancer 

risk. 

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 fluazinam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate Gas Chromatography 

with Electron Capture Detector (GC/

ECD) method is available for enforcing 

fluazinam tolerances on plant 

commodities. 

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 fluazinam for any of the 

commodities covered by this action. 

C. Revisions to Petitioned-For 

Tolerances 

Because the tolerance level for the 

existing melon subgroup 9A is the same 

as the squash/cucumber subgroup 9B 

tolerance the Agency is establishing, the 

Agency is combining the tolerances for 

the two subgroups and establishing a 

tolerance for the entire cucurbit 

vegetable crop group 9. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fluazinam (3-chloro-N-[3- 

chloro-2,6-dinitro-4- 

(trifluoromethyl)phenyl]-5- 

(trifluoromethyl)-2-pyridinamine), 

including its metabolites and degradates 

in or on mayhaw at 2.0 ppm; cabbage at 

3.0 ppm; cucurbit vegetables crop group 

9 at 0.07 ppm; and vegetable, tuberous 

and corm, subgroup 1C at 0.02 ppm. In 

addition, the existing tolerance on the 

vegetable, Brassica leafy, group 5 at 0.01 

is modified to read ‘‘vegetable, Brassica 

leafy, group 5, except cabbage’’ at 0.01 

ppm and the existing tolerance on 

potato at 0.02 ppm is removed as 

unnecessary since it is covered by the 

tolerance on the tuberous and corm 

subgroup 1C, and the melon subgroup 

9A tolerance is removed since it is now 

replaced by the cucurbit vegetables crop 

group 9 tolerance. 


asabaliauskas on DSK3SPTVN1PROD with RULES
20550 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Rules and Regulations 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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). 

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: March 31, 2016. 

G. Jeffrey Herndon, 

Acting 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 § 180.574, amend the table in 

paragraph (a)(1) as follows: 

■ a. Alphabetically add the entries 

‘‘Cabbage’’ and ‘‘Mayhaw’’. 

■ b. Remove the entries ‘‘Melon 

subgroup 9A’’ and ‘‘Potato’’. 

■ c. Remove the entry for ‘‘Vegetable, 

Brassica leafy, group 5’’ and 

alphabetically add entries for 

‘‘Vegetable, Brassica leafy, group 5, 

except cabbage’’ and ‘‘Vegetable, 

tuberous and corm, subgroup 1C‘‘. 

The additions read as follows: 

§ 180.574 Fluazinam; tolerances for 

residues. 

(a) * * * (1) * * * 

Commodity Parts per 

million 

* * * * * 

Cabbage ................................. 3 .0 

* * * * * 

Mayhaw .................................. 2 .0 

Commodity Parts per 

million 

* * * * * 

Vegetable, Brassica leafy, 

group 5, except cabbage .... 0 .01 

Vegetable, cucurbit, group 9 .. 0 .07 

* * * * * 

Vegetable, tuberous and 

corm, subgroup 1C ............. 0 .02 

* * * * * 

[FR Doc. 2016–08138 Filed 4–7–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 229 

[Docket No. 150306230–6303–02] 

RIN 0648–BE88 

List of Fisheries for 2016 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: The National Marine 

Fisheries Service (NMFS) publishes its 

final List of Fisheries (LOF) for 2016, as 

required by the Marine Mammal 

Protection Act (MMPA). The final LOF 

for 2016 reflects new information on 

interactions between commercial 

fisheries and marine mammals. NMFS 

must classify each commercial fishery 

on the LOF into one of three categories 

under the MMPA based upon the level 

of mortality and serious injury of marine 

mammals that occurs incidental to each 

fishery. The classification of a fishery on 

the LOF determines whether 

participants in that fishery are subject to 

certain provisions of the MMPA, such as 

registration, observer coverage, and take 

reduction plan (TRP) requirements. In 

addition, NMFS begins publishing 

online fact sheets for Category III 

fisheries on a rolling basis. 

DATES: The effective date of this final 

rule is May 9, 2016. 

ADDRESSES: Chief, Marine Mammal and 

Sea Turtle Conservation Division, Office 

of Protected Resources, NMFS, 1315 

East-West Highway, Silver Spring, MD 

20910. 

FOR FURTHER INFORMATION CONTACT: Lisa 

White, Office of Protected Resources, 

301–427–8494; Allison Rosner, Greater 

Atlantic Region, 978–281–9328; Jessica 

Powell, Southeast Region, 727–824– 


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