Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 75855 

environment. This rule is categorically 

excluded, under Figure 2–1, paragraph 

(34)(g), of the Instruction. This rule 

involves establishing a temporary safety 

zone that will be enforced for a total of 

five hours. An environmental analysis 

checklist and a categorical exclusion 

determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add a temporary § 165.T07–0956 to 

read as follows: 

§ 165.T07–0956 Safety Zone; Bone Island 

Triathlon, Atlantic Ocean, Key West, FL. 

(a) Regulated Area. All waters of the 

Atlantic Ocean located south of Key 

West encompassed within a line 

connecting the following points are 

designated a safety zone: Starting at 

Point 1 in position 24°32′49′′ N, 

81°47′21′′ W; thence south to Point 2 in 

position 24°32′33′′ N, 81°47′05′′ W; 

thence northeast to Point 3 in position 

24°32′56′′ N, 81°45′40′′ W; thence north 

to Point 4 in position 24°33′09′′ N, 

81°45′40′′ W; thence southwest 

following the shoreline back to origin. 

All coordinates are North American 

Datum. 

(b) Definition. The term ‘‘designated 

representative’’ means Coast Guard 

Patrol Commanders, including Coast 

Guard coxswains, petty officers, and 

other officers operating Coast Guard 

vessels, and Federal, state, and local 

officers designated by or assisting the 

Captain of the Port Key West in the 

enforcement of the regulated area. 

(c) Regulations. (1) All persons and 

vessels, except those participating in the 

event, are prohibited from entering, 

transiting through, anchoring in, or 

remaining within the regulated area 

unless authorized by the Captain of the 

Port Key West or a designated 

representative. 

(2) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain within the regulated area may 

contact the Captain of the Port Key West 

by telephone at (305) 292–8727, or a 

designated representative via VHF radio 

on channel 16, to request authorization. 

If authorization to enter, transit through, 

anchor in, or remain within the 

regulated area is granted by the Captain 

of the Port Key West or a designated 

representative, all persons and vessels 

receiving such authorization must 

comply with the instructions of the 

Captain of the Port Key West or a 

designated representative. 

(3) The Coast Guard will provide 

notice of the regulated area by Local 

Notice to Mariners, Broadcast Notice to 

Mariners, and on-scene representatives. 

(d) Effective Date. This rule is 

effective from 7:00 a.m. until 12:00 p.m. 

on January 12, 2013. 

Dated: December 6, 2012. 

A.S. Young Sr., 

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

Port Key West. 

[FR Doc. 2012–30913 Filed 12–21–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0900; FRL–9373–2] 

Spirotetramat; Pesticide Tolerance for 

Emergency Exemption 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

spirotetramat in or on watercress. This 

action is in response to EPA’s granting 

of an emergency exemption under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on watercress. This 

regulation establishes a maximum 

permissible level for residues of 

spirotetramat in or on watercress. The 

time-limited tolerance expires on 

December 31, 2015. 

DATES: This regulation is effective 

December 26, 2012. Objections and 

requests for hearings must be received 

on or before February 25, 2013, 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–2012–0900, 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), EPA West 

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: Keri 

Grinstead, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8373; email address: 

grinstead.keri@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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http://ecfr.

gpoaccess.gov/cgi/t/text/text-idx?&c=

ecfr&tpl=/ecfrbrowse/Title40/40tab_

02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

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 


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75856 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

identify docket ID number EPA–HQ– 

OPP–2012–0900 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 February 25, 2013. 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– 

2012–0900, 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.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at http:// 

www.epa.gov/dockets. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with FFDCA sections 408(e) 

and 408(l)(6), 21 U.S.C. 346a(e) and 

346a(1)(6), is establishing a time-limited 

tolerance for residues of spirotetramat, 

including its metabolites and 

degradates, in or on watercress at 1.5 

parts per million (ppm). This timelimited tolerance expires on December 

31, 2015. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under FIFRA section 18. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of FFDCA 

section 408 and the safety standard to 

other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

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. * * *’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Spirotetramat on Watercress and 

FFDCA Tolerances 

This is the first Section 18 request 

received for the use of spirotetramat on 

watercress. Florida and Tennessee are 

experiencing high pest pressure from 

melon/cotton aphids in the watercress 

industry. Aphids infest watercress fields 

from surrounding areas, and attack the 

apical stem tips of plants. Watercress 

plants respond with reduced vigor 

(growth rate) and yields per acre (bunch 

number) are subsequently reduced. Due 

to lack of effective alternative 

insecticides, increasing resistance to the 

historically effective insecticide 

imidacloprid, and marketable yield 

losses, the Agency has determined the 

situation is non-routine and urgent and 

likely to result in significant economic 

losses. After having reviewed the 

submission, EPA determined that an 

emergency condition exists for these 

States, and that the criteria for approval 

of an emergency exemption are met. 

EPA has authorized a specific 

exemption under FIFRA section 18 for 

the use of spirotetramat on watercress 

for control of melon/cotton aphids in 

Florida and Tennessee. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of spirotetramat in or on 

watercress. In doing so, EPA considered 

the safety standard in FFDCA section 

408(b)(2), and EPA decided that the 

necessary tolerance under FFDCA 

section 408(l)(6) would be consistent 

with the safety standard and with 

FIFRA section 18. Consistent with the 

need to move quickly on the emergency 

exemption in order to address an urgent 

non-routine situation, and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance without 

notice and opportunity for public 

comment as provided in FFDCA section 

408(l)(6). Although these time-limited 

tolerances expire on December 31, 2015, 

under FFDCA section 408(l)(5), residues 

of the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on watercress after that 

date will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by these time-limited 

tolerances at the time of that 

application. EPA will take action to 

revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether spirotetramat 

meets FIFRA’s registration requirements 

for use on watercress or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that this time-limited tolerance decision 

serves as a basis for registration of 

spirotetramat by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance by itself serve as the 

authority for persons in any State, other 

than Florida and Tennessee, to use this 

pesticide on the applicable crops under 

FIFRA section 18 absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemption for spirotetramat, contact the 

Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 


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Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 75857 

IV. 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 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 expected as a result 

of the emergency exemption requests 

and the time-limited tolerance for 

residues of spirotetramat, including its 

metabolites and degradates, in or on 

watercress at 1.5 ppm. EPA’s assessment 

of exposures and risks associated with 

establishing a time-limited tolerance 

follows. 

A. 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 (LOC) to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

degree of risk. Thus, the Agency 

estimates risk in terms of the probability 

of an occurrence of the adverse effect 

expected in a lifetime. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. A summary of the 

toxicological endpoints for 

spirotetramat used for human risk 

assessment is discussed in Unit III.B. of 

the final rule published in the Federal 

Register of May 18, 2011 (76 FR 28675) 

(FRL–8865–8). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to spirotetramat, EPA 

considered exposure under the timelimited tolerance established by this 

action as well as all existing 

spirotetramat tolerances in § 180.641. 

EPA assessed dietary exposures from 

spirotetramat in food as follows: 

i. Acute and chronic exposure. Such 

effects were identified for spirotetramat. 

In estimating acute and chronic dietary 

exposure, EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA used 

tolerance-level residues and 100 percent 

crop treated (PCT) for all commodities. 

Empirical processing factors were used 

for apple, orange, grape and tomato 

juice, applesauce, and dried apples, and 

Dietary Exposure Evaluation Model 

(DEEM (Ver. 7.81)) default processing 

factors were used for the remaining 

processed commodities (where 

provided). 

ii. Cancer. Based on the data 

summarized in Unit IV.A., EPA has 

concluded that spirotetramat does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iii. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for spirotetramat. Tolerance level 

residues and 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 spirotetramat in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

spirotetramat. 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 

Screening Concentration in Ground 

Water (SCI–GROW) models, the 

estimated drinking water concentrations 

(EDWCs) of total toxic residues (TTR) of 

spirotetramat, spirotetramat-enol, and 

spirotetramat-ketohydroxy for acute and 

chronic exposures are estimated to be 

158 parts per billion (ppb) for surface 

water and 3.96 × 10¥4 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute and chronic dietary risk 

assessment, the water concentration 

value of 158 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). There are 

currently no registered or proposed 

residential uses for spirotetramat; 

therefore a residential exposure 

assessment was not conducted. 

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 spirotetramat to 

share a common mechanism of toxicity 

with any other substances, and 

spirotetramat does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that spirotetramat 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. 

C. 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 


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75858 Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 

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 SF when reliable data 

available to EPA support the choice of 

a different factor. 

2. Prenatal and postnatal sensitivity. 

Based on the results of developmental 

toxicity studies in rats and rabbits and 

two reproduction studies in rats with 

spirotetramat, there was no evidence of 

increased susceptibility of offspring 

following prenatal or postnatal 

exposure. 

3. Conclusion. EPA has determined 

that reliable data show that the safety of 

infants and children would be 

adequately protected if the Food Quality 

Protection Act (Pub. L. 104–170) Safety 

Factor (FQPA SF) were reduced to 1X. 

That decision is based on the following 

findings: 

i. The toxicity database for 

spirotetramat is complete, except for a 

subchronic neurotoxicity study which is 

now required as part of the revisions to 

40 CFR part 158. However, the existing 

toxicological database indicates that 

spirotetramat is not a neurotoxic 

chemical in mammals. In addition, 

acute, subchronic and developmental 

neurotoxicity studies available for 

structurally-related compounds 

(spirodiclofen and spiromesifen) do not 

show evidence of neurotoxicity in 

adults or young. 

ii. There is no indication that 

spirotetramat 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 

spirotetramat results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats, in both the 1- and 2- 

generation reproduction studies. 

iv. There are no residual uncertainties 

identified in the exposure databases that 

will result in underestimation of 

exposure. 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 spirotetramat in drinking water. 

These assessments will not 

underestimate the exposure and risks 

posed by spirotetramat. 

D. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

spirotetramat will occupy 10% of the 

aPAD for children ages 1–2 years old, 

the population group receiving the 

greatest exposure. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to spirotetramat 

from food and water will utilize 83% of 

the cPAD for children ages 1–2 years 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for spirotetramat. 

3. Short-term and Intermediate-term 

risk. Short- and intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). A 

short-term and intermediate-term 

adverse effect was identified; however, 

spirotetramat is not registered for any 

use patterns that would result in shortterm or intermediate-term residential 

exposure. Short-term and intermediateterm risk is assessed based on shortterm or intermediate-term residential 

exposure plus chronic dietary exposure. 

Because there is no short-term 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-term or 

intermediate-term risk is necessary, and 

EPA relies on the chronic dietary risk 

assessment for evaluating short-term 

and intermediate-term risk for 

spirotetramat. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

spirotetramat 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 spirotetramat 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology, 

high-performance liquid 

chromatography with tandem 

spectrometry (HPLC–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. The Codex has not 

established a MRL for spirotetramat. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of spirotetramat, 

including its metabolites and 

degradates, in or on watercress at 1.5 

ppm. This tolerance expires on 

December 31, 2015. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA sections 408(e) and 

408(l)(6). 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, 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 247 / Wednesday, December 26, 2012 / Rules and Regulations 75859 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule 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 final rule 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 in accordance with 

FFDCA sections 408(e) and 408(l)(6), 

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 final rule 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(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 of 1995 

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

VIII. 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: December 12, 2012. 

Lois Rossi, 

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 § 180.641, add alphabetically the 

following new entry to the table in 

paragraph (b). 

§ 180.641 Spirotetramat; tolerances for 

residues. 

* * * * * 

(b) * * * 

Commodity Parts per 

million 

Expiration 

date 

* * * * * 

Watercress .... 1.5 12/31/15 

* * * * * 

[FR Doc. 2012–30854 Filed 12–21–12; 4:15 pm] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0750; FRL–9373–5] 

Pyraflufen-Ethyl; Extension of TimeLimited Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation extends 

already established time-limited 

tolerances for residues of pyraflufenethyl in or on cattle, meat byproducts; 

goat, meat byproducts; horse, meat 

byproducts; sheep, meat byproducts; 

and milk. Nichino America, Inc. 

requested the tolerance extensions 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

December 26, 2012. Objections and 

requests for hearings must be received 

on or before February 25, 2013, 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–2012–0750, 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), EPA West 

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: 

Kathryn Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; email address: 

montague.kathryn@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 40 CFR part 180 


tkelley on DSK3SPTVN1PROD with