17084 Federal Register / Vol. 81, No. 59 / Monday, March 28, 2016 / Rules and Regulations 

or anchor in the safety zone while it is 

being enforced without permission of 

the Captain of the Port Lake Michigan 

or a designated representative. 

DATES: The regulation in 33 CFR 

165.929 will be enforced for the safety 

zone listed as (e)(35) in Table 165.929 

on July 4, 2016 from 8:45 p.m. until 9:45 

p.m. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this notice of 

enforcement, call or email LT Lindsay 

Cook, Waterways Management Division, 

Marine Safety Unit Chicago, at 630– 

986–2155, email address 

Lindsay.N.Cook@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the Michigan City 

Summerfest listed as item (e)(35) in 

Table 165.929 of 33 CFR 165.929 from 

8:45 p.m. until 9:45 p.m. on July 4, 

2016. This action is being taken to 

provide for the safety of life on a 

navigable waterway during the 

fireworks display. Section 165.929 lists 

many annual events requiring safety 

zones in the Captain of the Port Lake 

Michigan Zone. This safety zone 

encompasses all waters of Michigan City 

Harbor and Lake Michigan within the 

arc of a circle with a 1,000 foot radius 

from the launch site located in position 

41°43.700′ N., 086°54.617′ W. During 

the enforcement period, no vessel may 

transit this regulated area without 

approval from the Captain of the Port 

Lake Michigan (COTP) or a COTP 

designated representative. Vessels and 

persons granted permission to enter the 

safety zone shall obey all lawful orders 

or directions of the Captain of the Port 

Lake Michigan, or his or her on-scene 

representative. 

This notice of enforcement is issued 

under authority of 33 CFR 165.929, 

Safety Zones; Annual events requiring 

safety zones in the Captain of the Port 

Lake Michigan zone and 5 U.S.C. 552 

(a). In addition to this notification in the 

Federal Register, the Coast Guard will 

provide the maritime community with 

advance notification of this enforcement 

period via Broadcast Notice to Mariners 

or Local Notice to Mariners. The 

Captain of the Port Lake Michigan, or a 

designated on-scene representative may 

be contacted via Channel 16, VHF–FM. 

Dated: March 18, 2016. 

A.B. Cocanour, 

Captain, U.S. Coast Guard, Captain of the 

Port Lake Michigan. 

[FR Doc. 2016–06910 Filed 3–25–16; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0031; FRL–9943–00] 

Mandipropamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases 

existing tolerances for residues of 

mandipropamid in or on potato, wet 

peel, and the vegetable, tuberous and 

corm subgroup 1C. Syngenta Crop 

Protection requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 28, 2016. Objections and requests 

for hearings must be received on or 

before May 27, 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–2015–0031, 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–2015–0031 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 May 27, 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– 

2015–0031, 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. 


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• 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 March 4, 

2015 (80 FR 11611) (FRL–9922–68), 

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 4F8329) by 

Syngenta Crop Protection, LLC., 410 

Swing Road, P.O. Box 18300, 

Greensboro, NC 27419. The petition 

requested that 40 CFR 180.637 be 

amended by establishing a tolerance for 

residues of the fungicide 

mandipropamid in or on potato at 0.08 

parts per million (ppm). The petition 

also requested to amend the tolerance in 

40 CFR 180.637 for residues of 

mandipropamid in or on potato, wet 

peel at 0.12 ppm, and amend the current 

tolerance commodity terminology 

which contains potato from ‘‘vegetable, 

tuberous and corm, subgroup 1C,’’ to 

‘‘vegetable, tuberous and corm, 

subgroup 1C, except potato.’’ That 

document referenced a summary of the 

petition prepared by Syngenta Crop 

Protection, 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 

modified the tolerances being 

established by this document. The 

reason for these changes are 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 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for mandipropamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with mandipropamid 

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. 

Subchronic and chronic studies 

indicate that the liver is the primary 

target organ for mandipropamid. Liver 

effects were identified in subchronic 

studies with rats, mice, and dogs. Liver 

effects included: Periportal hypertrophy 

(rats), increased eosinophilia (rats and 

mice), increased plasma albumin, total 

protein, cholesterol, and gammaglutamyl transferase (rats), increased 

liver weights (rats, mice and dogs), 

increased liver enzymes (dogs), 

increased pigment in hepatocytes and 

Kupffer cells (dogs), and centrilobular 

hepatocyte vacuolation (dogs). In the 

chronic dog study, increases in 

microscopic pigment in the liver and 

increased liver enzymes were observed. 

No liver effects were observed in 

chronic rat and mouse studies up to the 

highest doses tested. Instead, 

nephrotoxicity was observed in the 

chronic rat study and only decreased 

body weight and food utilization was 

observed in the chronic mouse study. 

The findings of liver toxicity and 

nephrotoxicity are consistent with the 

results from metabolism studies where 

the tissues with the highest levels of 

radioactivity were the liver followed by 

the kidney. 

No evidence of neurotoxicity was 

observed in the acute or subchronic 

neurotoxicity screening battery. No 

systemic or dermal toxicity was 

observed following dermal exposure for 

28 days up to the limit dose. 

No evidence of increased quantitative 

or qualitative susceptibility was seen in 

developmental toxicity studies in rats 

and rabbits or in a reproduction study 

in rats. The only effects observed in 

fetuses or pups were in the twogeneration reproduction study, where 

decreased pup body weight was 

observed in the presence of maternal 

toxicity (decreased body weight, body 

weight gain, and food utilization). In 

addition, there was a delay in preputial 

separation in F1 males which was 

considered to be the result of lower 

body weights. 

There was no evidence of tumors in 

the carcinogenicity study in mice or in 

the chronic/carcinogenicity study in rats 

and there was no evidence that 

mandipropamid was mutagenic or 

clastogenic. Therefore, mandipropamid 

is classified as ‘‘not likely to be 

carcinogenic to humans.’’ 

Specific information on the studies 

received and the nature of the adverse 

effects caused by mandipropamid as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

titled ‘‘Mandipropamid: Human Health 

Risk Assessment For Amended Use of 

the Fungicide on Potato, to Replace the 

Established Tolerance in Tuberous and 

Corm Vegetable Subgroup 1C, and to 

Revise the Established Tolerance in 

Potato Wet Peel’’ on page 30 in docket 

ID number EPA–HQ–OPP–2015–0031. 

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 


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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 mandipropamid used for 

human risk assessment is discussed in 

Unit III.B. of the final rule published in 

the Federal Register of December 20, 

2013 (78 FR 76987) (FRL–9903–57). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mandipropamid. EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing mandipropamid tolerances in 

40 CFR 180.637. EPA assessed dietary 

exposures from mandipropamid 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 

mandipropamid; 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). As 

to residue levels in food, EPA assumed 

100 percent crop treated (PCT) and 

tolerance level residues, with the 

exception of vegetable, tuberous and 

corm, subgroup 1C, which was assessed 

at 0.115 ppm, assuming tolerance-level 

residues of parent mandipropamid (0.09 

ppm) and including the SYN 500003 

metabolite in parent-equivalents (at 

0.025 ppm). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that mandipropamid 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 

mandipropamid. Tolerance-level 

residues and 100 PCT were assumed for 

all existing and proposed food 

commodities, except subgroup 1C, as 

described above. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for mandipropamid in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

mandipropamid. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www2.epa.gov/

pesticide-science-and-assessingpesticide-risks/about-water-exposuremodels-used-pesticide. 

Based on the Food Quality Protection 

Act (FQPA) Index Reservoir Screening 

Tool (FIRST) model for surface water 

and both the Screening Concentration in 

Ground Water (SCI–GROW) and 

Pesticide Root Zone Model Ground 

Water (PRZM GW) models, the 

estimated drinking water concentrations 

(EDWCs) of mandipropamid for chronic 

exposures are estimated to be 9.0 parts 

per billion (ppb) for surface water and 

79 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 79 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). 

Mandipropamid is not registered for 

any specific use patterns that would 

result in residential exposure. 

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 mandipropamid to 

share a common mechanism of toxicity 

with any other substances, and 

mandipropamid does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that mandipropamid 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 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 were no treatment-related effects 

observed in dams or fetuses in the 

developmental toxicity studies in rats or 

rabbits up to the limit dose of 1,000 mg/ 

kg/day. In the rat reproductive study, 

decreased pup weight occurred only in 

the presence of comparable maternal 

toxicity (decreased body weight). 

Therefore, the Agency concludes that 

there is no increased quantitative or 

qualitative susceptibility to rat or rabbit 

offspring exposed in utero or postnatally to mandipropamid, and there are 

no residual uncertainties with respect to 

pre- or postnatal exposure. 

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 

mandipropamid is complete. 

ii. There is no indication that 

mandipropamid is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. There is no evidence that 

mandipropamid results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 


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tolerance-level residues, except for 

subgroup 1C, as described in Section 

C.1.ii. EPA made conservative 

(protective) assumptions in the ground 

and surface water modeling used to 

assess exposure to mandipropamid in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by mandipropamid. 

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, mandipropamid 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 

mandipropamid from food and water 

will utilize 42% of the cPAD for 

children 1–2 years old, the population 

group receiving the greatest exposure. 

There are no residential uses for 

mandipropamid. 

3. Short-and Intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Both a short- and intermediate-term 

adverse effects were identified; 

however, mandipropamid is not 

registered for any use patterns that 

would result in either short- or 

intermediate-term residential exposure. 

Short- and intermediate-term risk is 

assessed based on short- and 

intermediate-term residential exposure 

plus chronic dietary exposure. Because 

there is no short- or 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 short-term risk), 

no further assessment of short- or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short- and 

intermediate-term risk for 

mandipropamid. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

mandipropamid 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 

mandipropamid residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high performance liquid 

chromatography with tandem mass 

spectrometric detection (LC/MS/MS)) is 

available to enforce the tolerance 

expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. 

There is a Codex MRL established on 

potato at 0.01 ppm. With the increased 

tolerance in subgroup 1C to 0.09 ppm, 

the U.S. tolerance will no longer be in 

harmonization with Codex’s MRL in 

potato. Harmonization with the Codex 

value is not feasible, given that the 

Codex MRL is based on the foliar use 

pattern only, and the U.S. tolerance is 

based on the proposed combination 

of seed piece treatment and foliar 

uses. 

C. Revisions to Petitioned-For 

Tolerances 

Instead of the proposed tolerance in 

potato (0.08 ppm), EPA is revising the 

existing tolerance for residues in 

tuberous and corm vegetable subgroup 

1C from 0.01 to 0.09 ppm. The proposed 

tolerance was based on a dataset that 

only included results from trials 

conducted in the U.S. The calculated 

tolerance in subgroup 1C, based on US 

and Canadian potato field trial data 

entered into the Organization for 

Economic Cooperation and 

Development’s (OECD) tolerance 

calculation procedure, was 0.07 ppm. 

However, EPA is establishing a 

tolerance in subgroup 1C of 0.09 ppm, 

in order to harmonize with Canada’s 

recommended MRL. 

The proposed tolerance in potato wet 

peel (0.12 ppm) was based on the 

average processing factor (2.0X) 

multiplied by the highest average field 

trial (HAFT) (0.056 ppm). However, the 

tolerance being established (0.15 ppm) 

is based on the rounding protocol in the 

User Guide for the OECD tolerance 

calculation procedure. 

It is not appropriate to establish the 

proposed tolerance in tuberous and 

corm vegetable subgroup 1C (except 

potato), because potato is the only 

representative commodity for subgroup 

1C. For the same reason, the proposed 

separate tolerance in potato is 

unnecessary. 

V. Conclusion 

Therefore, the existing tolerance for 

residues of mandipropamid on ‘‘potato, 

wet peel’’ is modified from 0.03 ppm to 

0.15 ppm and the existing tolerance on 

‘‘vegetable, tuberous and corm, 

subgroup 1C’’ is modified from 0.01 to 

0.09 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 


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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. 

Dated: March 16, 2016. 

Susan Lewis, 

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 § 180.637, revise the entries for 

‘‘Potato, wet peel’’ and ‘‘Vegetable, 

tuberous and corm, subgroup 1C’’ to the 

table in paragraph (a) to read as follows: 

§ 180.637 Mandipropamid; tolerances for 

residues. 

(a) * * * 

Commodity 

Parts 

per 

million 

* * * * * 

Potato, wet peel .......................... 0.15 

* * * * * 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.09 

* * * * * 

[FR Doc. 2016–06948 Filed 3–25–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 73 

[GN Docket No. 12–268; FCC 14–50] 

Expanding the Economic and 

Innovation Opportunities of Spectrum 

Through Incentive Auctions 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the Federal 

Communications Commission 

(Commission) announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, 

certain information collection 

requirements associated with the 

Commission’s Expanding the Economic 

and Innovation Opportunities of 

Spectrum Through Incentive Auctions 

Report and Order (Incentive Auction 

Report and Order), FCC 14–50. This 

document is consistent with the 

Incentive Auction Report and Order, 

which stated that the Commission 

would publish a document in the 

Federal Register announcing OMB 

approval and the effective date of the 

new 

DATES: 47 CFR 73.3700(b)(1)(i) through 

(v), (b)(2)(i) and (ii), (b)(3), (b)(4)(i) and 

(ii), and (b)(5); 73.3700(c); 73.3700(d); 

73.3700(f); 73.3700(g); 73.3700(h)(5), 

and FCC Form 2100, Schedules A, B, E 

and F, published at 79 FR 48442, 

August 15, 2014, are effective March 28, 

2016. OMB approved the information 

collection requirements in 47 CFR 

73.3700(b)(1)(vii) and (h)(2) on March 

17, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Cathy Williams, Cathy.Williams@

fcc.gov, (202) 418–2918. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on March 17, 

2016, OMB approved the information 

collection requirements contained in the 

Commission’s Incentive Auction Report 

and Order, FCC 14–50, published at 79 

FR 48442, August 15, 2014. The OMB 

Control Numbers are 3060–0016, 3060– 

0027, 3060–0386, 3060–0837, 3060– 

0928, 3060–0932 and 3060–1216. The 

Commission publishes this document as 

an announcement of the effective date of 

the requirements. If you have any 

comments on the burden estimates 

listed below, or how the Commission 

can improve the collections and reduce 

any burdens caused thereby, please 

contact Cathy Williams, Federal 

Communications Commission, Room 1– 

C823, 445 12th Street SW., Washington, 

DC 20554. Please include the OMB 

Control Number, 3060–1194, in your 

correspondence. The Commission will 

also accept your comments via the 

Internet if you send them to PRA@

fcc.gov. 

To request materials in accessible 

formats for people with disabilities 

(Braille, large print, electronic files, 

audio format), send an email to fcc504@

fcc.gov or call the Consumer and 

Governmental Affairs Bureau at (202) 

418–0530 (voice), (202) 418–0432 

(TTY). 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on March 17, 

2016, for some of the information 


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