26722 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 

WISCONSIN—2008 8-HOUR OZONE NAAQS—Continued 

[Primary and secondary] 

Designated area 

Designation Classification 

Date 1 Type Date 1 Type 

Sheboygan County.

* * * * * * * 

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

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

* * * 

4Attainment date is extended to July 20, 2016. 

* * * * * 

[FR Doc. 2016–09729 Filed 5–3–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0014; FRL–9944–82] 

Mefenoxam; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mefenoxam in 

or on rapeseed subgroup 20A. Syngenta 

Crop Protection, LLC., requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

4, 2016. Objections and requests for 

hearings must be received on or before 

July 5, 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–2015–0014, 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–2015–0014 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 July 5, 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– 

2015–0014, 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 April 6, 

2015 (80 FR 18327) (FRL–9924–00), 

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 4F8323) by 

Syngenta Crop Protection, LLC., 410 

Swing Road, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.546 


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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 26723 

be amended by establishing tolerances 

for residues of the fungicide 

mefenoxam, methyl N-(2,6- 

dimethylphenyl)-N-(methoxyacetyl)-DLalaninate, in or on rapeseed crop 

subgroup 20A at 0.05 parts per million 

(ppm). That document referenced a 

summary of the petition prepared by 

Syngenta Crop Protection, LLC, the 

registrant, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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

reviewed the available scientific data 

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 mefenoxam 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with mefenoxam 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. Mefenoxam is the 

enriched R-enantiomer of metalaxyl 

which is a racemic mixture that 

contains approximately 50% each of the 

R- and S-enantiomers. EPA conducted 

side-by-side comparison of the available 

toxicity data for mefenoxam and 

metalaxyl and concluded that 

mefenoxam has similar toxicity to that 

of metalaxyl. Therefore, the metalaxyl 

data may be used to support regulatory 

actions for mefenoxam. 

The Agency reassessed the toxicity 

databases for metalaxyl and mefenoxam 

in accordance with current policies and 

determined that many of the effects 

previously noted in several toxicological 

studies are no longer considered to be 

adverse (i.e. body weight gain without 

changes in absolute body weight; 

hepatocyte hypertrophy without 

necrosis; enzyme leakage to bloodstream 

or disruption of lipid homeostasis). In 

rat and dog repeat dose (i.e., subchronic 

and chronic) oral toxicity studies, there 

were no indications of adverse effects 

up to the highest dose tested (HDT). 

Adverse effects were only observed 

from acute exposure to rats. In the rat 

developmental toxicity study of 

metalaxyl, maternal toxicity consisted of 

dose-related increased incidence of 

convulsions that occurred shortly after 

dosing, as well as other clinical signs. In 

a range-finding acute neurotoxicity 

study of mefenoxam, females showed 

abnormal functional observation battery 

(FOB) findings at lower doses than 

males. However, there was no 

indication of toxicity up to the HDT in 

the mefenoxam subchronic 

neurotoxicity study, which confirms the 

lack of adverse effects observed in all 

other repeated-dose studies. 

There was no indication of 

developmental toxicity in studies of 

mefenoxam or metalaxyl. There was no 

indication of immunotoxicity in a 

mouse immunotoxicity study of 

mefenoxam. Metalaxyl and mefenoxam 

have been classified as ‘‘not likely to be 

carcinogenic in humans’’ based on the 

results for metalaxyl in the 

carcinogenicity study in mice and the 

combined chronic toxicity and 

carcinogenicity study in rats. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mefenoxam 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 document 

‘‘Mefenoxam, Human Health Risk 

Assessment’’ at pages 14–17 in docket 

ID number EPA–HQ–OPP–2015–0014. 

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 mefenoxam used for 

human risk assessment is shown in 

Table 1 of this unit. 


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26724 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM 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 (General population including infants, children, and females 13–50 

years of age.

NOAEL = 50 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.5 mg/

kg/day.

aPAD = 0.5 mg/kg/

day 

Metalaxyl Prenatal Developmental Toxicity—Rat 

LOAEL = 250 mg/kg/day based on dose-related increases in 

clinical signs of toxicity (e.g., post-dosing convulsions). 

Chronic dietary (All populations) No endpoint was identified. No systemic toxicity was observed in any toxicity study where the animals were 

administered metalaxyl or mefenoxam in the diet. Acute dietary assessment is protective of all other durations 

of exposure. 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 50 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat 

LOAEL = 250 mg/kg/day based on dose-related increases in 

clinical signs of toxicity (e.g., post-dosing convulsions). 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

No endpoint was identified. No systemic toxicity was observed at the limit dose (1,000 mg/kg/day) in rabbits 

treated with metalaxyl during a 21-day dermal toxicity study. 

For converting oral to dermal doses for risk assessment, the Dermal Absorption Factor (DAF) = 35%. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

NOAEL = 50 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Note: Toxicity via the 

inhalation and oral 

routes are assumed to be 

equivalent. 

LOC for MOE = 100 Metalaxyl Prenatal Developmental Toxicity—Rat 

LOAEL = 250 mg/kg/day based on dose-related increases in 

clinical signs of toxicity (e.g., post-dosing convulsions). 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the absence of treatment-related increases in tumor incidence in adequately conducted carcinogenicity studies in rats and mice treated with 

metalaxyl. 

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. In evaluating dietary 

exposure to mefenoxam, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing mefenoxam tolerances in 40 

CFR 180.546 and metalaxyl tolerances 

40 CFR 180.408. EPA assessed dietary 

exposures from mefenoxam/metalaxyl 

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 

mefenoxam. In estimating acute dietary 

exposure, EPA used food consumption 

information from the United States 

Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey/What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, EPA 

conducted a somewhat refined acute 

dietary exposure assessment for the 

proposed food use of mefenoxam on the 

rapeseed subgroup 20A and the existing 

uses of both metalaxyl and mefenoxam. 

Residues were assumed to be present at 

tolerance levels in plant commodities, 

with additional factors applied to 

certain plant commodities to include all 

residues of concern for risk assessment. 

Tolerance-level residues adjusted 

upward to account for metalaxyl/

mefenoxam residues of concern in 

livestock commodities were used and 

based on data from metabolism studies 

on goats and hens. DEEM default and 

empirical processing factors were used 

as available. It was assumed that 100% 

of the crops were treated (100% CT). 

ii. Chronic exposure. No such effects 

were identified in the toxicological 

studies for mefenoxam; therefore, a 

quantitative chronic dietary exposure 

assessment is unnecessary. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that mefenoxam 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 percent 

crop treated (PCT) information. EPA did 

not use anticipated residue and/or PCT 

information in the dietary assessment 

for mefenoxam. Tolerance-level residues 

and/or 100% CT 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 mefenoxam in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of mefenoxam. 

Further information regarding EPA 

drinking water models used in pesticide 

exposure assessment can be found at 

http://www2.epa.gov/pesticide-scienceVerDate Sep<11>2014 17:12 May 03, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\FR\FM\04MYR1.SGM 04MYR1

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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 26725 

and-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide. 

Based on the Surface Water 

Concentration Calculator (SWCC) and 

the Pesticide Root Zone Model-Ground 

Water (PRZM GW), the estimated 

drinking water concentrations (EDWCs) 

of mefenoxam for acute exposures are 

estimated to be 741 parts per billion 

(ppb) for surface water and 3,700 ppb 

for ground water. These modeled 

estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Mefenoxam is currently registered for 

the following uses that could result in 

residential exposures: Residential turf 

and ornamentals, including nonbearing 

citrus trees. EPA assessed residential 

exposure using the following 

assumptions: Residential handler 

exposure is expected to be short-term in 

duration. Intermediate-term exposures 

are not likely because of the intermittent 

nature of applications by homeowners. 

Residential post-application exposure 

was assessed based on short-term 

incidental oral risk estimates for 

children 1 < 2 years old. Dermal postapplication risk assessments were not 

conducted because an adverse systemic 

dermal hazard was not identified for 

mefenoxam. Further information 

regarding EPA standard assumptions 

and generic inputs for residential 

exposures may be found at http://

www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ EPA has not 

found mefenoxam to share a common 

mechanism of toxicity with any other 

substances, and mefenoxam does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

mefenoxam 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-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 that mefenoxam 

results in increased susceptibility from 

in utero exposure to rats or rabbits in 

the prenatal developmental studies or 

exposure to young rats in the 2- 

generation reproduction study. 

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 metalaxyl 

and mefenoxam is complete. 

ii. In the rat prenatal developmental 

toxicity with metalaxyl, maternal 

animals exhibited clinical signs 

indicative of neurobehavioral effects as 

previously discussed. 

In the range-finding acute 

neurotoxicity study with mefenoxam, 

females exhibited abnormal functional 

observation battery (FOB) findings at 

doses lower than in males. In the 

subchronic neurotoxicity study with 

mefenoxam, there were no indications 

of neurotoxicity up to the HDT. In 

metalaxyl and mefenoxam treated adult 

animals, clinical signs and abnormal 

FOB findings were noted. However, a 

developmental neurotoxicity (DNT) 

study is not required for metalaxyl or 

mefenoxam because (1) there are no 

indications of increased susceptibility 

for infants or children; (2) the 

convulsions observed in the rat prenatal 

developmental toxicity study occurred 

in the maternal animals with no effects 

being observed in the young; (3) the 

convulsions occurred only after a bolus 

dose; (4) the available developmental 

and range-finding acute neurotoxicity 

studies provided clear NOAELs and 

LOAELs for evaluating effects; (5) the 

current POD is below the level at which 

any effects were seen in either study, 

and (6) there were no other indications 

of neurotoxicity in the mefenoxam or 

metalaxyl databases, which include a 

subchronic (adult rat) neurotoxicity 

study for mefenoxam. Therefore, there is 

no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. In metalaxyl and mefenoxam 

treated animals, there was no evidence 

of increased susceptibility following 

pre-/postnatal exposure in the prenatal 

developmental toxicity studies or the 

reproduction and fertility effects study. 

There is no evidence that mefenoxam 

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% CT and 

tolerance levels or upper bound residue 

estimates. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to mefenoxam 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 mefenoxam. 

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. The acute aggregate risk 

assessment considers exposure 

estimates from dietary consumption of 

mefenoxam (food and drinking water). 

Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to mefenoxam will 

occupy 95% of the aPAD for children <1 

years old, the population group 


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26726 Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 

receiving the greatest exposure, but this 

is below the level of concern. 

2. Chronic risk. A chronic aggregate 

risk assessment takes into account 

chronic exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

repeated exposure was identified and no 

chronic dietary endpoint was selected. 

Therefore, mefenoxam is not expected 

to pose a chronic risk. 

3. Short-term and Intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

both short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Mefenoxam is currently registered for 

uses that could result in short-term and 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate short-term 

and intermediate-term residential 

exposures to mefenoxam. Using the 

exposure assumptions described in this 

unit for short-term and intermediateterm exposures, EPA has concluded the 

combined short-term and intermediateterm food, water, and residential 

exposures result in aggregate MOEs of 

79,000 for adult; and 1,000 for children 

1 < 2 years old. Because EPA’s level of 

concern for mefenoxam is a MOE of 100 

or below, these MOEs are not of 

concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mefenoxam is not expected to pose a 

cancer risk to humans. 

5. 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 mefenoxam 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Several methods are available for 

enforcing tolerances: (1) A gas-liquid 

chromatography procedure employing 

an alkali flame ionization detector 

(GLC/AFID); (2) a method using GLC/

nitrogen phosphorus detection; and (3) 

a multi-residue method in PAM, Vol 1. 

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 mefenoxam for the rapeseed crop 

subgroup 20A. 

V. Conclusion 

Therefore, tolerances are established 

for residues of mefenoxam, methyl N- 

(2,6-dimethylphenyl)-N- 

(methoxyacetyl)-DL-alaninate, in or on 

rapeseed subgroup 20A at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This action establishes tolerances 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this action 

has been exempted from review under 

Executive Order 12866, this action is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This action does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

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

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.), do not apply. 

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, not States or tribes, nor does 

this action alter the relationships or 

distribution of power and 

responsibilities established by Congress 

in the preemption provisions of FFDCA 

section 408(n)(4). As such, the Agency 

has determined that this action will not 

have a substantial direct effect on States 

or tribal governments, on the 

relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act (UMRA) (2 U.S.C. 

1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 


asabaliauskas on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations 26727 

Dated: April 21, 2016. 

Daniel J. Rosenblatt, 

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 § 180.546, add alphabetically the 

entry for ‘‘Rapeseed subgroup 20A’’ to 

the table in paragraph (a) to read as 

follows: 

§ 180.546 Mefenoxam; tolerances for 

residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Rapeseed subgroup 20A ............ 0.05 

* * * * * 

* * * * * 

[FR Doc. 2016–10389 Filed 5–3–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No.: 151210999–6348–02] 

RIN 0648–BF59 

Fisheries of the Northeastern United 

States; Atlantic Sea Scallop Fishery; 

Framework Adjustment 27 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: NMFS approves and 

implements through regulations the 

measures included in Framework 

Adjustment 27 to the Atlantic Sea 

Scallop Fishery Management Plan, 

which the New England Fishery 

Management Council adopted and 

submitted to NMFS for approval. The 

purpose of Framework 27 is to prevent 

overfishing, improve yield-per-recruit, 

and improve the overall management of 

the Atlantic sea scallop fishery. 

Framework 27 sets specifications for the 

scallop fishery for fishing year 2016, 

including days-at-sea allocations, 

individual fishing quotas, and sea 

scallop access area trip allocations; 

creates a new rotational closed area 

south of Closed Area 2 to protect small 

scallops; opens the northern portion of 

the Nantucket Lightship Access Area to 

the Limited Access General Category 

fleet; transfers 19 percent of the Limited 

Access General Category access area 

trips from the Mid-Atlantic Access Area 

to the northern portion of the Nantucket 

Lightship Access Area; and implements 

an accountability measure to the fishing 

year 2016 Northern Gulf of Maine Total 

Allowable Catch as a result of a fishing 

year 2015 catch overage. 

DATES: Effective May 4, 2016. 

ADDRESSES: The Council developed an 

environmental assessment (EA) for this 

action that describes the action and 

other considered alternatives and 

provides a thorough analysis of the 

impacts of these measures. Copies of the 

Framework, the EA, and the Initial 

Regulatory Flexibility Analysis (IRFA), 

are available upon request from Thomas 

A. Nies, Executive Director, New 

England Fishery Management Council, 

50 Water Street, Newburyport, MA 

01950. The EA/IRFA is also accessible 

via the Internet at: http://

www.nefmc.org/scallops/index.html or 

http://

www.greateratlantic.fisheries.noaa.gov/

sustainable/species/scallop/. 

Copies of the small entity compliance 

guide are available from John K. 

Bullard, Regional Administrator, NMFS, 

Greater Atlantic Regional Fisheries 

Office, 55 Great Republic Drive, 

Gloucester, MA 01930–2298, or 

available on the internet at: http://

www.greateratlantic.fisheries.noaa.gov/

sustainable/species/scallop/. 

FOR FURTHER INFORMATION CONTACT: 

Travis Ford, Fishery Policy Analyst, 

978–281–9233. 

SUPPLEMENTARY INFORMATION: 

Background 

The Council adopted Framework 27 

on December 3, 2015, and submitted a 

draft of the framework to NMFS on 

December 22, 2015, that presented 

Council recommended measures, 

rationale, impacts for review, and a draft 

EA. NMFS published a proposed rule, 

including a reference on how to obtain 

the framework and the draft final EA, 

for approving and implementing 

Framework 27 on February 24, 2016 (81 

FR 9151). The proposed rule included a 

30-day public comment period that 

closed on March 25, 2016. The Council 

submitted a final EA to NMFS on March 

14, 2016, for approval. This annual 

action includes catch, effort, and quota 

allocations and adjustments to the 

rotational area management program for 

fishing year 2016. Framework 27 

specifies measures for fishing year 2016, 

and includes fishing year 2017 measures 

that will go into place as a default 

should the next specifications-setting 

framework be delayed beyond the start 

of fishing year 2017. NMFS has 

approved all of the measures 

recommended by the Council and 

described below. The MagnusonStevens Fishery Conservation and 

Management Act (Magnuson-Stevens 

Act) permits NMFS to approve, partially 

approve, or disapprove measures 

proposed by the Council based only on 

whether the measures are consistent 

with the fishery management plan, the 

Magnuson-Stevens Act and its National 

Standards, and other applicable law. We 

must defer to the Council’s policy 

choices unless there is a clear 

inconsistency with the law or the FMP. 

Details concerning the development of 

these measures were contained in the 

preamble of the proposed rule and are 

not repeated here. 

Specification of Scallop Overfishing 

Limit (OFL), Acceptable Biological 

Catch (ABC), Annual Catch Limits 

(ACLs), Annual Catch Targets (ACTs), 

and Set-Asides for the 2016 Fishing 

Year and Default Specifications for 

Fishing Year 2017 

Table 1 outlines the scallop fishery 

catch limits derived from the ABC 

values. 

TABLE 1—SCALLOP CATCH LIMITS (MT) 

FOR FISHING YEARS 2016 AND 2017 

FOR THE LIMITED ACCESS AND LIMITED ACCESS GENERAL CATEGORY

(LAGC) INDIVIDUAL FISHING QUOTA

(IFQ) FLEETS

2016 2017 

(default) 

OFL ....................... 68,418 68,418 

ABC/ACL (discards 

removed) ........... 37,852 37,852 

Incidental Catch .... 23 23 

Research SetAside (RSA) ...... 567 567 

Observer SetAside ................. 379 379 

ACL for fishery ...... 36,884 36,884 

Limited Access 

ACL ................... 34,855 34,855 

LAGC ACL ............ 2,029 2,029 

LAGC IFQ ............. 1,845 1,845 

Limited Access 

with LAGC IFQ .. 184 184 

Limited Access 

ACT ................... 18,290 18,290 

This action deducts 1.25 million lb 

(567 mt) of scallops annually for 2016 

and 2017 from the ABC and sets it aside 


asabaliauskas on DSK3SPTVN1PROD with RULES