8658 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 

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

Subpart J—District of Columbia 

■ 2. In § 52.470, the table in paragraph 

(c) is amended by: 

■ a. Revising the entry for ‘‘Section 

199.’’ 

■ b. Removing ‘‘Chapter 10 Nitrogen 

Oxides Emissions Budget Program 

(Sections 1000–1099).’’ 

■ c. Adding a new Chapter 10 entitled 

‘‘Air Quality—Non-EGU Limits on 

Nitrogen Oxides Emissions.’’ 

The revision and addition read as 

follows: 

§ 52.470 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED REGULATIONS AND STATUTES IN THE DISTRICT OF COLUMBIA SIP 

State citation Title/Subject State effective 

date EPA Approval date Additional explanation 

District of Columbia Municipal Regulations (DCMR), Title 20—Environment 

Chapter 1 General 

*******

Section 199 .................................. Definitions and Abbreviations ...... 03/08/15 02/22/16, [insert Federal 

Register citation].

Amended definition of 

‘‘Fossil fuel-fired’’ 

* * * * * * * 

Chapter 10 Air Quality—Non-EGU Limits on Nitrogen Oxides Emissions 

Section 1000 ................................ Applicability .................................. 03/08/15 02/22/16, [insert Federal 

Register citation].

Section 1001 ................................ NOX Emissions Budget and NOX

Limit Per Source.

03/08/15 02/22/16, [insert Federal 

Register citation].

Section 1002 ................................ Emissions Monitoring .................. 03/08/15 02/22/16, [insert Federal 

Register citation].

Section 1003 ................................ Record-Keeping and Reporting ... 03/08/15 02/22/16, [insert Federal 

Register citation].

Section 1004 ................................ Excess Emissions ........................ 03/08/15 02/22/16, [insert Federal 

Register citation].

* * * * * * * 

* * * * * 

[FR Doc. 2016–03489 Filed 2–19–16; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1012; FRL–9941–38] 

Pyriproxyfen; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation increases the 

currently established tolerance for 

residues of pyriproxyfen in or on tea 

from 0.02 parts per million (ppm) to 15 

ppm. Sumitomo Chemical Company, 

Ltd., c/o Valent U.S.A. Corporation, 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 22, 2016. Objections and 

requests for hearings must be received 

on or before April 22, 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–2011–1012, 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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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 8659 

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–2011–1012 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 22, 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– 

2011–1012, 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 December 2, 

2015 (80 FR 75449) (FRL–9939–55), 

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 #4E8326) by 

Sumitomo Chemical Company, Ltd., 

c/o Valent U.S.A. Corporation, 1600 

Riviera Avenue, Suite 200, Walnut 

Creek, CA 94596. The petition requested 

that 40 CFR 180.510 be amended to 

increase the currently established 

tolerance for residues of pyriproxyfen 

in/on tea from 0.02 ppm to 15.0 parts 

per million (ppm). That document 

referenced a summary of the petition 

prepared by Sumitomo Chemical 

Company, Ltd., c/o Valent U.S.A. 

Corporation, the registrant, which is 

available in the docket, http://

www.regulations.gov. There were no 

substantive comments received in 

response to the notice of filing. 

Based upon review of the data 

supporting the petition, the petitionedfor tolerance for residues of 

pyriproxyfen in/on tea (15.0 ppm) must 

be corrected to 15 ppm, consistent with 

current practices for setting tolerances. 

The reason for this change is explained 

in Unit IV.D. 

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 pyriproxyfen 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with pyriproxyfen 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. 

Pyriproxyfen elicits low acute toxicity 

by oral, dermal, inhalation, and ocular 

routes of exposure. Pyriproxyfen is not 

a skin irritant and was negative in the 

dermal sensitization study in guinea 

pigs. Based on repeated dose studies in 

mice, rats, and dogs the liver, kidney, 

and hematopoietic system are the 

primary targets of pyriproxyfen. 

Neurotoxicity, in the form of reduced 

motor activity, occurred only at a doses 

well above those required to elicit 

toxicity in the liver, kidney, and 

hematopoietic system indicating the 

nervous system is not a principle target. 

There was no evidence of prenatal or 

postnatal sensitivity or increased 

susceptibility in developmental toxicity 

studies in rats and rabbits, and in a 2- 

generation reproduction toxicity study 

in rats. An immunotoxicity study 

showed no adverse effects on the 

immune system. No significant systemic 

toxicity was observed in the 21-day 

dermal toxicity study in rats. In a 28-day 

inhalation study, salivation in females 

and sporadic decreased body weight 

gains in males was observed at 1 

milligram/Liter (mg/L); however, these 

effects were not considered biologically 

relevant. There is no evidence for 

carcinogenicity to humans based on the 

absence of carcinogenicity in mice and 

rats. Pyriproxyfen is negative for 

mutagenic activity in a battery of 

mutagenicity studies conducted with 

both the parent and/or metabolites. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyriproxyfen as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov on pp. 10–18 in 

the document titled ‘‘Pyriproxyfen. 

Human Health Risk Assessment for the 

Petition to Increase the Established 

Tolerance in/on Tea with a U.S. 

Registration for Imported Pyriproxyfentreated Tea.’’ in docket ID number EPA– 

HQ–OPP–2011–1012. 

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. 

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8660 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 

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://www.epa.

gov/pesticides/factsheets/

riskassess.htm. 

A summary of the toxicological 

endpoints for pyriproxyfen used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRIPROXYFEN 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) .. An appropriate endpoint attributable to a single oral dose was not identified in the toxicology database, including the developmental and reproduction toxicity studies. 

Chronic dietary (All populations).1NOAEL = 35.1 mg/kg/day ........

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.35 mg/kg/day

cPAD = 0.35 mg/kg/day 

Subchronic (41321716) and chronic 

(43210503)—rat (co-critical). LOAEL = 

141.28 mg/kg/day based on decreased 

body weight and body weight gain, anemia, and increased relative liver weight 

with elevated cholesterol and 

phospholipid levels. 

Incidental oral short-term (1–30 

days).

NOAEL = 100 mg/kg/day .........

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ................. Rat developmental toxicity (44985002). 

Maternal LOAEL = 300 mg/kg/day 

based on decreased body weight, body 

weight gain, and food consumption, and 

increased water consumption. 

Incidental oral intermediateterm (1–6 months).1NOAEL = 35.1 mg/kg/day ........

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ................. Subchronic (41321716) and chronic 

(43210503)—rat (co-critical). LOAEL = 

141.28 mg/kg/day based on decreased 

body weight and body weight gain, anemia, and increased relative liver weight 

with elevated cholesterol and 

phospholipid levels. 

Dermal short- and intermediateterm (1–30 days and 1–6 

months).

Based on the systemic toxicity NOAEL of 1,000 mg/kg/day (limit dose) in the 21 day dermal toxicity study in 

rats, quantification of dermal risks is not required. In addition, no developmental concerns (toxicity) were 

seen in either rats or rabbits. 

Dermal long-term (6 monthslifetime).1NOAEL = 35.1 mg/kg/day ........

DAF = 30% 2

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ................. Subchronic (41321716) and chronic 

(43210503)—rat (co-critical). LOAEL = 

141.28 mg/kg/day based on decreased 

body weight and body weight gain, anemia, and increased relative liver weight 

with elevated cholesterol and 

phospholipid levels. 

Inhalation short- and intermediate-term (1–30 days and 

1–6 months).

Based on the absence of biologically relevant toxicity at 1.0 mg/L, the quantification of inhalation risks is not 

required. In addition, no developmental concerns (toxicity) were seen in either rats or rabbits. 

Inhalation long-term (6 monthslifetime).1NOAEL = 35.1 mg/kg/day ........

UFA = 10x 

UFH = 10x 

LOC for MOE = 100 ................. Subchronic (41321716) and chronic 

(43210503)—rat (co-critical). LOAEL = 

141.28 mg/kg/day based on decreased 

body weight and body weight gain, anemia, and increased relative liver weight 

with elevated cholesterol and 

phospholipid levels. 

Cancer (Oral, dermal, inhalation).No evidence of carcinogenicity in mice and rats (TXR 0012966). 

Point of Departure (POD) = A data point or an estimated point that is derived from observed dose-response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL = no observed adverse effect 

level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = 

potential variation in sensitivity among members of the human population (intraspecies). DAF = dermal absorption factor. 1The NOAEL and LOAEL for the co-critical studies were based on the female endpoints from the chronic and sub-chronic rat studies, respectively. Females demonstrated greater or equivalent sensitivity to oral pyriproxyfen exposure relative to males; therefore, selection of two female 

endpoints accounted for effects observed in the males and preserved consistency between the NOAEL and LOAEL. 2 DAF estimated by comparing the rat developmental LOAEL of 300 mg/kg/day to the 21-day rat dermal study NOAEL of 1,000 mg/kg/day (No 

NOAEL) = 300/1,000 = 30%. 

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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 8661 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyriproxyfen, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyriproxyfen tolerances in 40 

CFR 180.510. EPA assessed dietary 

exposures from pyriproxyfen 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 pyriproxyfen; 

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 USDA 2003–2008 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. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyriproxyfen 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 pyriproxyfen. Tolerance-level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening-level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyriproxyfen in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyriproxyfen. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the Tier 1 Rice Model and 

the Generic Estimated Exposure 

Concentration (GENEEC) model the 

estimated drinking water concentrations 

(EDWCs) of pyriproxyfen for chronic 

exposure assessments are estimated to 

be 2.98 parts per billion (ppb) for 

surface water and 0.006 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 2.98 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). 

Pyriproxyfen is currently registered 

for flea and tick control (home 

environment and pet treatments) as well 

as products for ant and roach control 

(indoor and outdoor applications). 

Formulations include carpet powders, 

foggers, aerosol sprays, liquids 

(shampoos, sprays, and pipettes for pet 

treatments), granules, bait (indoor and 

outdoor), and impregnated materials 

(pet collars). EPA assessed residential 

exposure using the following 

assumptions: Although there is the 

potential for short-term residential 

handler dermal and inhalation exposure 

as well as short or intermediate-term 

post-application exposure from the 

registered uses of pyriproxyfen, there 

are no short or intermediate-term 

dermal or inhalation PODs and 

quantitative assessments were not 

conducted. 

Based on the registered use patterns, 

the following post-application scenarios 

were assessed: Short- and intermediateterm hand-to-mouth exposures for 1 to 

<2 year olds from treated carpets and 

flooring and petting treated animals 

(shampoos, sprays, spot-on treatments 

and collars); long-term hand-to-mouth 

exposures for 1 to <2 year olds from 

treated carpets and flooring and petting 

treated animals; and long-term dermal 

exposures from treated carpets, flooring, 

and pets. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 pyriproxyfen to 

share a common mechanism of toxicity 

with any other substances, and 

pyriproxyfen does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action; therefore, EPA has 

assumed that pyriproxyfen 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:// 

www.epa.gov/pesticides/cumulative. 

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. 

Based on the available data, there is no 

quantitative and qualitative evidence of 

increased susceptibility observed 

following in utero pyriproxyfen 

exposure to rats and rabbits or following 

prenatal/postnatal exposure 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 

pyriproxyfen is complete. 

ii. There is no indication that 

pyriproxyfen is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

pyriproxyfen 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 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to pyriproxyfen 

in drinking water. EPA used similarly 

conservative assumptions to assess postmstockstill on DSK4VPTVN1PROD with RULES

8662 Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 

application exposure of children as well 

as incidental oral exposure of toddlers. 

These assessments will not 

underestimate the exposure and risks 

posed by pyriproxyfen. 

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, pyriproxyfen 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 pyriproxyfen 

from food and water will utilize 12% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. A long-term post-application 

residential assessment was performed 

for toddlers only since they are 

anticipated to have higher exposures 

than adults from treated home 

environments and pets due to their 

behavior patterns. The total chronic 

dietary and residential aggregate MOE is 

230 for children 1 to <2 years old. As 

this MOE is greater than 100, the 

chronic aggregate risk does not exceed 

EPA’s level of concern. 

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). Pyriproxyfen 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 pyriproxyfen. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 2,200 for children 1 to 

<2 years old, the population subgroup 

receiving the greatest exposure. Because 

EPA’s level of concern (LOC) for 

pyriproxyfen is a MOE of 100 or below, 

this MOE is not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pyriproxyfen is currently registered 

for uses that could result in 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

intermediate-term residential exposures 

to pyriproxyfen. 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in an aggregate MOE of 760 for children 

1 to <2 years old, the population 

subgroup receiving the greatest 

exposure. Because EPA’s LOC for 

pyriproxyfen is a MOE of 100 or below, 

this MOE is not of concern. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyriproxyfen 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 pyriproxyfen 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography with NitrogenPhosphorous Detection; GC/NPD) 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. 

No Codex MRL for residues of 

pyriproxyfen is established in/on tea 

commodities. 

C. Revisions to Petitioned-for Tolerances 

Although the petitioner requested a 

tolerance for 15.0 ppm, the Agency is 

establishing a tolerance at 15 ppm, 

consistent with the current practices 

regarding significant figures for 

tolerance setting. 

V. Conclusion 

Therefore, 40 CFR 180.510 is being 

amended to increase the currently 

established tolerance for residues of 

pyriproxyfen in/on tea from 0.02 ppm to 

15 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 

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Federal Register / Vol. 81, No. 34 / Monday, February 22, 2016 / Rules and Regulations 8663 

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: February 4, 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 § 180.510, revise the entry for tea 

in the table in paragraph (a)(1) to read 

as follows: 

§ 180.510 Pyriproxyfen; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Tea ........................................ 15 

* * * * * 

* * * * * 

[FR Doc. 2016–03608 Filed 2–19–16; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

50 CFR Chapter IV 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Chapter IV 

[FWS–HQ–ES–2016–N017; FF09E00000 167 

FXES11130900000] 

Revised Interagency Cooperative 

Policy Regarding the Role of State 

Agencies in Endangered Species Act 

Activities 

AGENCY: Fish and Wildlife Service, 

Interior, and National Marine Fisheries 

Service, National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Notice of policy revision. 

SUMMARY: The Fish and Wildlife Service 

and National Marine Fisheries Service 

announce an interagency policy to 

clarify the role of State agencies in 

activities undertaken by the Services 

under authority of the Endangered 

Species Act of 1973, as amended, and 

associated regulations. The policy, 

which is a revision of a policy issued in 

1994, reflects a renewed commitment by 

the Services and State fish and wildlife 

agencies to work together in conserving 

America’s imperiled wildlife. 

DATES: February 22, 2016. 

FOR FURTHER INFORMATION CONTACT: Gary 

Frazer, Assistant Director for Ecological 

Services, U.S. Fish and Wildlife Service, 

18th and C Streets NW., Washington, 

DC 20240; telephone 202/208–4646; 

facsimile 703/358–5618, or Angela 

Somma, Chief, Endangered Species 

Division, National Marine Fisheries 

Service, 1355 East-West Highway, Silver 

Spring, Maryland 20910; telephone 301/ 

427–8403; facsimile 301/713–0376. If 

you use a telecommunications device 

for the deaf (TDD), call the Federal 

Information Relay Service (FIRS) at 

800–877–8339. 

SUPPLEMENTARY INFORMATION: 

Background 

Congress enacted the Endangered 

Species Act of 1973, as amended (16 

U.S.C. 1531 et seq.) (ESA or Act), to 

establish a program for the conservation 

of endangered and threatened species 

and the ecosystems on which they 

depend. The Secretaries of the Interior 

and Commerce (hereafter referred to as 

‘‘the Secretaries’’) have the 

responsibility for administering the 

ESA. The Secretaries have delegated 

this responsibility to the U.S. Fish and 

Wildlife Service of the Department of 

the Interior and the National Marine 

Fisheries Service of the Department of 

Commerce (hereafter referred to as ‘‘the 

Services’’). 

The Services recognize that, in the 

exercise of their general governmental 

powers, States possess broad trustee and 

police powers over fish, wildlife, and 

plants and their habitats within their 

borders. Unless preempted by Federal 

authority, States possess primary 

authority and responsibility for 

protection and management of fish, 

wildlife, and plants and their habitats. 

State agencies often possess scientific 

data and valuable expertise on the status 

and distribution of endangered, 

threatened, and candidate species of 

wildlife and plants. State agencies, 

because of their authorities and their 

close working relationships with local 

governments and landowners, are in a 

unique position to assist the Services in 

implementing all aspects of the Act. In 

this regard, section 6 of the Act provides 

that the Services shall cooperate to the 

maximum extent practicable with the 

States in carrying out programs 

authorized by the Act. The term State 

agency means any State agency, 

department, board, commission, or 

other governmental entity that is 

responsible for the management and 

conservation of fish, plant, or wildlife 

resources within a State. 

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