5600 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 

Priority Mail Express, Priority Mail & FirstClass Package Service Contract 6 

Priority Mail & First-Class Package Service 

Contract 2 

Priority Mail & First-Class Package Service 

Contract 3 

Priority Mail & First-Class Package Service 

Contract 4 

Priority Mail & First-Class Package Service 

Contract 5 

Priority Mail & First-Class Package Service 

Contract 6 

Priority Mail & First-Class Package Service 

Contract 7 

Priority Mail & First-Class Package Service 

Contract 8 

Priority Mail & First-Class Package Service 

Contract 9 

Outbound International* 

Global Expedited Package Services (GEPS) 

Contracts GEPS 3 

Global Bulk Economy (GBE) Contracts 

Global Plus Contracts 

Global Plus 1C 

Global Plus 2C 

Global Reseller Expedited Package 

Contracts 

Global Reseller Expedited Package Services 

1 

Global Reseller Expedited Package Services 

2 

Global Reseller Expedited Package Services 

3 

Global Reseller Expedited Package Services 

4 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 2 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 3 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 4 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 5 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 6 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 7 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 8 

Global Expedited Package Services 

(GEPS)—Non-Published Rates 9 

Priority Mail International Regional Rate 

Boxes—Non-Published Rates 

Outbound Competitive International 

Merchandise Return Service Agreement 

with Royal Mail Group, Ltd. 

Priority Mail International Regional Rate 

Boxes Contracts 

Priority Mail International Regional Rate 

Boxes Contracts 1 

Competitive International Merchandise 

Return Service Agreements with Foreign 

Postal Operators 

Inbound International* 

International Business Reply Service 

(IBRS) Competitive Contracts 

International Business Reply Service 

Competitive Contract 1 

International Business Reply Service 

Competitive Contract 3 

Inbound Direct Entry Contracts with 

Customers 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 1 

Inbound EMS 

Inbound EMS 2 

Inbound Air Parcel Post (at non-UPU rates) 

Royal Mail Group Inbound Air Parcel Post 

Agreement 

Inbound Competitive Multi-Service 

Agreements with Foreign Postal 

Operators 1 

Special Services* 

Address Enhancement Services 

Greeting Cards, Gift Cards, and Stationery 

International Ancillary Services 

International Money Transfer Service— 

Outbound 

International Money Transfer Service— 

Inbound 

Premium Forwarding Service 

Shipping and Mailing Supplies 

Post Office Box Service 

Competitive Ancillary Services 

Nonpostal Services* 

Advertising 

Licensing of Intellectual Property other 

than Officially Licensed Retail Products 

(OLRP) 

Mail Service Promotion 

Officially Licensed Retail Products (OLRP) 

Passport Photo Service 

Photocopying Service 

Rental, Leasing, Licensing or other NonSale Disposition of Tangible Property 

Training Facilities and Related Services 

USPS Electronic Postmark (EPM) Program 

Market Tests* 

International Merchandise Return Service 

(IMRS)—Non-Published Rates 

Customized Delivery 

Stacy L. Ruble, 

Secretary. 

[FR Doc. 2016–01947 Filed 2–2–16; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0263; FRL–9940–46] 

Cyazofamid; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of cyazofamid in 

or on the herb subgroup 19A and the 

bulb vegetable group 3–07. Interregional 

Research Project Number 4 (IR–4) 

requested the herb subgroup 19A 

tolerances, and ISK Biosciences 

requested the bulb vegetable group 3–07 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 3, 2016. Objections and 

requests for hearings must be received 

on or before April 4, 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–2015–0263, 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. 


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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–2015–0263 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 April 4, 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– 

2015–0263, 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 two 

pesticide petitions: One by ISK 

Biosciences Corporation, 7470 Auburn 

Road, Suite A, Concord, Ohio 44077 (PP 

5F8352) that requested to establish 

tolerances in 40 CFR 180.601 for 

residues of the fungicide cyazofamid 

and its metabolite (4-chloro-5-(4- 

methylphenyl)-1H-imidazole-2- 

carbonitrile) in or on bulb vegetables 

(crop group 3–07) at 2.0 parts per 

million (ppm); and one by IR–4, 500 

College Road East, Suite 201W, 

Princeton, NJ 08540 (PP 5E8350) that 

requested to establish tolerances in 40 

CFR 180.601 for residues of the 

fungicide cyazofamid in or on the herb 

subgroup 19A at 90 ppm and also to 

remove the existing tolerances for 

residues of cyazofamid and its 

metabolite in or on basil, dried leaves at 

90 ppm and basil, fresh leaves at 30 

ppm upon approval of the herb 

subgroup 19A tolerances. That 

document referenced summaries of the 

two petitions 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 

notices 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 cyazofamid 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with cyazofamid 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 target organ for cyazofamid in 

rats is the kidney, with an increased 

incidence of basophilic tubules, 

increased urinary volume, pH, and 

protein noted in male rats after 

subchronic exposure. Female rats were 

less sensitive, with only a marginal 

increase in urinary volume, and pH. 

These findings were noted in a 90-day 

oral toxicity study, and similar findings 

were noted in the 28-day oral toxicity 

range-finding study in rats. In the twogeneration reproductive study in rats, 

there was an increased incidence of 

inflammation and nephropathy in the 

high-dose male rats as compared to the 

controls. Basophilic tubules are 

indicative of a regenerative process, but 

they can be more difficult to identify in 

older animals (i.e., tubular basophilia 

can be obscured by nephropathy or 

included as part of the nephropathy 

constellation). No kidney effects were 

observed in the chronic oral toxicity 

study in rats; however, this study did 

not test up to doses as high as those 

eliciting kidney effects in the 

subchronic and two-generation 

reproduction toxicity studies. The only 

relevant finding in the dog was an 

incidence of parathyroid cysts in males 

at the limit dose in the chronic study. 

The pre- and post-natal toxicology 

database for cyazofamid includes rat 

and rabbit developmental toxicity 

studies and a two-generation 

reproduction toxicity study in rats. The 

prenatal developmental study in rats 

showed evidence of increased 

quantitative susceptibility following in 

utero exposure as a marginally 

increased incidence of bent ribs was 

noted in fetuses at the limit dose, 

whereas no maternal toxicity was noted. 

No adverse effects were seen in a 

route-specific dermal toxicity study. 

Skin lesions were observed in males 

following oral exposure in the mouse 

carcinogenicity study, and are thought 

to be caused by an allergic reaction to 

systemic exposure because they did not 

occur following exposure via the dermal 

route. Cyazofamid is classified as ‘‘not 

likely to be carcinogenic to humans’’ 

based on the lack of evidence for 

carcinogenicity in mice and rats and a 

lack of mutagenic potential. 


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Specific information on the studies 

received and the nature of the adverse 

effects caused by cyazofamid 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, ‘‘Cyazofamid. Human Health Risk 

Assessment for Proposed New Uses on 

Use on Crop Subgroup 19A, Peppers 

and Tomatoes Grown in Greenhouses, 

and on Bulb Vegetables Crop Group 03– 

07’’ on pp. 32 in docket ID number 

EPA–HQ–OPP–2015–0263. 

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 the NOAEL and the 

LOAEL are identified. 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 cyazofamid used for 

human risk assessment is shown in 

Table 1 of this unit. 

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

ASSESSMENT

Exposure/Scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (All Populations) No appropriate toxicological effect attributable to a single dose was observed. Therefore, a dose and endpoint 

were not identified for this risk assessment. 

Chronic dietary (All populations) NOAEL= 94.8 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.948 

mg/kg/day.

cPAD = 0.948 mg/

kg/day.

18-Month Mouse Oral Carcinogenicity. 

LOAEL = 985 mg/kg/day based on increased skin lesions. 

Incidental oral short-term (1 to 

30 days).

NOAEL= 171 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Co-critical 90-Day and chronic oral toxicity studies in rats. 

LOAEL= 295 mg/kg based on increased incidence of basophilic 

tubules in the kidneys, increased urinary volume, pH, & protein. 

Inhalation short-term (1 to 30 

days).

Oral study NOAEL= 

171 mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Co-critical 90-Day and chronic oral toxicity studies in rats. 

LOAEL= 295 mg/kg based on increased incidence of basophilic 

tubules in the kidneys, increased urinary volume, pH, & protein. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not likely to be Carcinogenic to Humans’’ based on the absence of treatment-related tumors in 

two adequate rodent carcinogenicity studies. 

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 cyazofamid, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing cyazofamid tolerances in 40 

CFR 180.601. EPA assessed dietary 

exposures from cyazofamid 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 cyazofamid; 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 (USDA’s) National Health 

and Nutrition Examination Survey, 

What We Eat in America, (NHANES/

WWEIA). As to residue levels in food, 

EPA assumed tolerance-level residues 

and 100 percent crop treated (PCT) for 

all commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that cyazofamid 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 

cyazofamid. Tolerance-level residues 

and 100 PCT were assumed for all food 

commodities. 

2. Dietary exposure from drinking 

water. Available environmental fate 

studies suggest cyazofamid is not very 


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mobile and quickly degrades into a 

number of degradation products under 

different environmental conditions. The 

highest estimated chronic drinking 

water concentrations resulted from 

modeling which assumed application of 

100% molar conversion of the parent 

into the terminal degradate CTCA. EPA 

used these estimates of CTCA (4-chloro5-p-tolylimidazole-2-carboxylic acid) in 

its dietary exposure assessments, a 

conservative approach that likely 

overestimates the exposure contribution 

from drinking water. 

The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for cyazofamid and its degradates in 

drinking water. These simulation 

models take into account data on the 

physical, chemical, and fate/transport 

characteristics of cyazofamid and its 

degradates. 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 Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Pesticide 

Root Zone Model Ground Water (PRZM 

GW), the estimated drinking water 

concentrations (EDWCs) of the 

degradate CTCA for chronic exposures 

are estimated to be 133.5 parts per 

billion (ppb) for surface water and 211 

ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 211 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, termiticide, and flea 

and tick control on pets). 

Cyazofamid is currently registered for 

use on turf at golf courses, sod farms, 

seed farms, college and professional 

sports fields, residential and 

commercial lawns, and on ornamental 

plants in landscapes and those grown in 

commercial greenhouses and nurseries. 

EPA assessed residential exposure using 

the following scenarios: 

• Adult handlers. The worst-case 

scenario was determined to be shortterm inhalation exposures from mixing, 

loading, and applying cyazofamid to 

turf; and 

• Children. The worst-case scenario 

was determined to be short-term postapplication incidental oral exposure 

from hand-to-mouth activities on turf. 

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 cyazofamid to 

share a common mechanism of toxicity 

with any other substances, and 

cyazofamid does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that cyazofamid 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 

Food Quality Protection Act Safety 

Factor (FQPA SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

The developmental rabbit and twogeneration reproduction toxicity study 

in rats did not show any evidence of 

increased susceptibility developmental 

or offspring, respectively. However, 

there was increased quantitative 

susceptibility in the rat developmental 

study; concentrations up to the limit 

dose did not cause maternal systemic 

toxicity, but there was an increased 

incidence of bent ribs. Concern is low 

based on the following: (1) The increase 

was marginal, (2) bent ribs are 

considered a variation rather than a 

malformation, (3) the effect was only 

seen at the limit dose, (4) there is a clear 

NOAEL for the effect, and (5) the 

selected endpoints address any 

concerns for this effect. 

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 

cyazofamid is complete. 

ii. There is no indication that 

cyazofamid is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors (UFs) to 

account for neurotoxicity. 

iii. As noted in Section D.2., there was 

increased quantitative susceptibility in 

the rat developmental study, however, 

concern is low due to the reasons cited. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to cyazofamid 

and its degradates in drinking water. 

EPA used similarly conservative 

assumptions to assess post-application 

exposure of children as well as 

incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by cyazofamid. 

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 


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selected. Therefore, cyazofamid 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 cyazofamid 

from food and water will utilize 2% of 

the cPAD for children 1–2 years old, 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 cyazofamid 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). Cyazofamid 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 

cyazofamid. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 14,000 for adults and 6,100 for 

children 1–2 years old. Because EPA’s 

level of concern for cyazofamid 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, cyazofamid 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 

cyazofamid. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

cyazofamid is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children 

from aggregate exposure to cyazofamid 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An enforcement method for non-fatty 

commodities is available, FDA’s Multiresidue Protocol D (without cleanup). 

The method completely recovers (≤80% 

recovery) cyazofamid and its metabolite 

(4-chloro-5-(4-methylphenyl)-1Himidazole-2-carbonitrile). In addition, 

the high-performance liquid 

chromatography method with 

ultraviolent light detection (HPLC/UV) 

method is acceptable for use as a single 

analyte enforcement method provided a 

confirmatory method such as the liquid 

chromatography method with tandem 

mass-spectrometric detection (LC/MS/

MS) method is used. 

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 

Aliment-arius Commission (Codex), as 

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

The Codex Aliment-arius 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 are no Codex MRLs established 

for cyazofamid in/on the commodities 

included in this action. 

V. Conclusion 

Therefore, tolerances are established 

for residues of cyazofamid (4-chloro-2- 

cyano-N,N-dimethyl-5-(4- 

methylphenyl)-1H-imidazole-1- 

sulfonamide) and is metabolite (4- 

chloro-5-(4-methylphenyl)-1Himidazole-2-carbonitrile) in or on the 

herb subgroup 19A at 90 ppm; and bulb 

vegetables, group 3–07 at 2.0 ppm. In 

addition, the existing tolerances for 

residues of cyazofamid and its 

metabolite (4-chloro-5-(4- 

methylphenyl)-1H-imidazole-2- 

carbonitrile) in or on basil, dried leaves 

and basil, fresh leaves are removed as 

unnecessary. 

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 


tkelley on DSK3SPTVN1PROD with RULES
Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Rules and Regulations 5605 

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: January 21, 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 § 180.601, in the table in 

paragraph (a): 

■ a. Remove the entries for ‘‘Basil, dried 

leaves’’ and ‘‘Basil, fresh leaves’’. 

■ b. Add alphabetically entries for 

‘‘Bulb vegetables, group 3–07’’ and 

‘‘Herb subgroup 19A’’. 

The additions read as follows: 

§ 180.601 Cyazofamid; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

* * * * * 

Bulb vegetables, group 3–07 ... 2.0 

* * * * * 

Herb subgroup 19A .................. 90 

* * * * * 

* * * * * 

[FR Doc. 2016–01993 Filed 2–2–16; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 1 

[GN Docket No. 09–51, WC Docket No. 07– 

25; FCC 15–151] 

Pole Attachment Rates 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: In this document, the 

Commission builds on its prior efforts to 

harmonize pole attachment rates that 

cable and telecom service providers pay 

utility pole owners. The 

Communications Act of 1934, as 

amended (Act), contains two formulas 

for calculating pole attachment rates, a 

formula adopted in 1978 applicable to 

cable television systems solely 

providing cable service, and a formula 

adopted in 1996 applicable to 

telecommunications carriers providing 

telecommunications service. 

DATES: Effective April 1, 2016. 

ADDRESSES: You may submit comments, 

identified by WC Docket No. 07–245, 

GN Docket No. 09–51 and FCC 15–151, 

by any of the following methods: 

• Federal Communications 

Commission’s Web site: http://

apps.fcc.gov/ecfs/. Follow the 

instructions for submitting comments. 

• People with Disabilities: Contact the 

FCC to request reasonable 

accommodations (accessible format 

documents, sign language interpreters, 

CART, etc.) by email: FCC504@fcc.gov 

or phone: 202–418–0530 or TTY: 202– 

418–0432. 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Reel, Wireline Competition 

Bureau, Competition Policy Division, 

(202) 418–0637, or send an email to 

jonathan.reel@fcc.gov. 

SUPPLEMENTARY INFORMATION: This is a 

summary of the Commission’s Order on 

Reconsideration in GN Docket No. 09– 

51, WC Docket No. 07–245, and FCC 

15–151, adopted November 17, 2015 

and released November 24, 2015. The 

full text of this document is available for 

public inspection during regular 

business hours in the FCC Reference 

Information Center, Portals II, 445 12th 

Street SW., Room CY–A257, 

Washington, DC 20554. It is available on 

the Commission’s Web site at http://

www.fcc.gov. 

I. Introduction 

1. In this Order on Reconsideration 

(Order), the Commission builds on its 

prior efforts to harmonize pole 

attachment rates that cable and telecom 

service providers pay utility pole 

owners. The Communications Act of 

1934, as amended (Act), contains two 

formulas for calculating pole attachment 

rates, a formula adopted in 1978 

applicable to cable television systems 

solely providing cable service, and a 

formula adopted in 1996 applicable to 

telecommunications carriers providing 

telecommunications service. Following 

the implementation of the 1996 Act 

through 2011, rates calculated using the 

telecom rate formula have typically 

been higher than rates calculated using 

the cable formula in similar 

circumstances. In 2011, the Commission 

revised the formulas as described in 

greater detail below to improve 

efficiency, reduce potentially excessive 

costs of network deployment and 

accelerate broadband buildout, and 

eliminate the wide disparity between 

the telecom and cable rate formulas. The 

2011 revisions sought to bring the 

telecom and cable rates into parity. In 

the intervening time, the Commission 

has seen that its revisions did not fully 

achieve that objective. Today, the 

Commission takes the next logical step 

in achieving the goals set forth in 2011. 

2. As detailed below, the Commission 

takes these actions in response to a 

Petition for Reconsideration or 

Clarification in this proceeding. The 

rule revisions that the Commission 

adopts amend the Commission’s rules 

by defining ‘‘cost,’’ for the purpose of 

calculating the rates that 

telecommunications carriers pay for 

pole attachments, as a percentage of 

fully allocated costs that will depend on 

whether the average number of 

attaching entities in a service area is 2, 

3, 4, or 5. The rates that attachers pay 

to attach to poles are currently 

determined, among other things, by 

whether the attacher is a ‘‘cable 

television system solely . . . provid[ing] 

cable service’’ or a ‘‘telecommunications 


tkelley on DSK3SPTVN1PROD with RULES