51738 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 

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) (Public Law 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: August 25, 2008. 

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. Section 180.474 is amended in 

paragraph (a)(1) by alphabetically 

adding the commodity pistachio to the 

table to read as follows: 

§180.474 Tebuconazole; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

* * * * * 

Pistachio ................................... 0.05 

* * * * * 

* * * * * 

[FR Doc. E8–20625 Filed 9–4–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007-0366; FRL–8377–6] 

Pyraflufen-ethyl; Time-Limited 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

permanent tolerances for residues of 

pyraflufen-ethyl in or on grass, forage, 

group 17; and grass, hay, group 17; 

establishes time-limited tolerances for 

milk; cattle, meat byproducts; goat, meat 

byproducts; horse, meat byproducts and 

sheep, meat byproducts, and revises the 

existing tolerances for soybean, forage; 

soybean, hay; wheat, forage and wheat, 

hay. Nichino America, Inc. requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). The 

time-limited tolerances expire on 

October 15, 2012. 

DATES: This regulation is effective 

September 5, 2008. Objections and 

requests for hearings must be received 

on or before November 4, 2008, 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: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2007-0366. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either in the electronic docket 

at http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Public Docket, in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Joanne I. Miller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703-305-6224; e-mail address: 

miller.joanne@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. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51739 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2007-0366 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 4, 2008 

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 that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2007-0366, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg., 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerances 

In the Federal Register of June 27, 

2007 (72 FR 35237) (FRL–8133–4), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 7F7190) by 

Nichino America, Inc., 4550 New 

Linden Hill Road, Suite 501, 

Wilmington, DE 19808. The petition 

requested that 40 CFR 180.585 be 

amended by establishing tolerances for 

residues of the herbicide, pyraflufenethyl, ethyl 2-chloro-5-(4-chloro-5- 

difluoromethoxy-1-methyl-1H-pyrazol-3

-yl)-4-fluorophenoxyacetate; and its acid 

metabolite, E-1, 2-chloro-5-4-chloro-5- 

difluoromethoxy-(1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetic acid, 

expressed in terms of the parent in or on 

food commodities: Soybeans, forage at 

0.05 parts per million (ppm); soybean, 

hay at 0.10 ppm; grass, forage, crop 

group 17 at 1.0 ppm; and grass, hay, 

crop group 17 at 1.2 ppm. 

In the Federal Register of June 13, 

2008 (73 FR 33814) (FRL–8367–3), EPA 

issued a second notice pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 7F7190) by 

Nichino America, Inc., 4550 New 

Linden Hill Road, Suite 501, 

Wilmington, DE 19808. The petition 

requested that 40 CFR 180.585 be 

amended by establishing new tolerances 

for residues of the herbicide, pyraflufenethyl, ethyl 2-chloro-5-(4-chloro-5- 

difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetate, and its 

acid metabolite, E-1, 2-chloro-5-(4- 

chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetic 

acid, expressed in terms of the parent, 

in or on food commodities grass, forage, 

group 17 at 1.0 ppm; grass, hay, group 

17 at 1.4 ppm; milk at 0.02 ppm; cattle, 

meat byproducts at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.02 ppm; and sheep, 

meat byproducts at 0.02 ppm, and by 

revising existing tolerances for residues 

of the herbicide, pyraflufen-ethyl, ethyl 

2-chloro-5-(4-chloro-5-difluoromethoxy1-methyl-1H-pyrazol-3-yl)-4- 

fluorophenoxyacetate, and its acid 

metabolite, E-1, 2-chloro-5-(4-chloro-5- 

difluoromethoxy-1-methyl-1H-pyrazol3-yl)-4-fluorophenoxyacetic acid, 

expressed in terms of the parent, in or 

on food commodities soybean, seed to 

0.05 ppm; soybean, hay to 0.10 ppm; 

wheat, forage to 0.02 ppm; and wheat, 

hay to 0.01 ppm.These notices 

referenced a summary of the petition 

prepared by Nichino America, Inc., the 

registrant, which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notices of filing. Tolerances for milk at 

0.02 ppm; cattle, meat byproducts at 

0.02 ppm; goat, meat byproducts at 0.02 

ppm; horse, meat byproducts at 0.02 

ppm; and sheep, meat byproducts at 

0.02 ppm expire on October 15, 2012. A 

time limitation been imposed because of 

the requirement for a cattle feeding 

study conducted to determine residues 

of the E-9 metabolite in milk and cattle 

tissues. 

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 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 the petitioned-for 

tolerances for residues of pyraflufenethyl and its metabolite expressed in 

terms of the parent on grass, forage, 

group 17 at 1.0 ppm; grass, hay, group 

17 at 1.4 ppm; milk at 0.02 ppm; cattle, 

meat byproducts at 0.02 ppm; goat, meat 

byproducts at 0.02 ppm; horse, meat 

byproducts at 0.02 ppm; and sheep, 

meat byproducts at 0.02 ppm, and by 

revising existing tolerances for soybean, 

forage to 0.05 ppm; soybean, hay to 0.10 

ppm; wheat, forage to 0.02 ppm; and 

wheat, hay to 0.01 ppm. EPA’s 

assessment of exposures and risks 

associated with establishing these 

tolerances 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. Specific 

information on the studies received and 

the nature of the toxic effects caused by 


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pyraflufen-ethyl as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies. 

Pyraflufen-ethyl has low to moderate 

toxicity from acute exposure and it is 

not a dermal sensitizer. The liver, 

kidney, and possibly the hematopoietic 

system are the target organs for 

pyraflufen-ethyl in the rat and/or the 

mouse. There is no evidence of 

increased sensitivity to the young in 

developmental and reproductive studies 

with pyraflufen-ethyl. Pyraflufen-ethyl 

was not shown to be mutagenic in a 

battery of tests. Pyraflufen-ethyl was 

classified as ‘‘Likely to be carcinogenic 

to humans’’ based on male mouse 

hepatocellular adenomas, carcinomas 

and/or hepatoblastomas (combined) 

observed in the mouse carcinogenicity 

study. 

Specific information on the studies 

received and the nature of the toxic 

effects caused by pyraflufen-ethyl as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

Pyraflufen-ethyl: Human Health Risk 

Assessment for Pyraflufen-ethyl: 

Proposed New Use on Pasture and 

Rangeland Grasses (PP 7F7190) and 

Amendment to Allow Early Season 

Postemergence Broadcast Uses to Corn 

(excluding sweet corn), Soybeans and 

Wheat at page 13 in docket ID number 

EPA–HQ–OPP–2007–0366. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

the highest dose at which no adverse 

effects are observed (the NOAEL) in the 

toxicology study identified as 

appropriate for use in risk assessment. 

However, if a NOAEL cannot be 

determined, the lowest dose at which 

adverse effects of concern are identified 

(the LOAEL) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs/safety factors) are used in 

conjunction with the POD to take into 

account uncertainties inherent in the 

extrapolation from laboratory animal 

data to humans and in the variations in 

sensitivity among members of the 

human population as well as other 

unknowns. Safety is assessed for acute 

and chronic dietary risks by comparing 

aggregate food and water exposure to 

the pesticide to the acute population 

adjusted dose (aPAD) and chronic 

population adjusted dose (cPAD). The 

aPAD and cPAD are calculated by 

dividing the POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

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 greater than that 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 pyraflufen-ethyl used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

Pyraflufen-ethyl: Human Health Risk 

Assessment for Pyraflufen-ethyl: 

Proposed New Use on Pasture and 

Rangeland Grasses (PP#7F7190) and 

Amendment to Allow Early Season 

Postemergence Broadcast Uses to Corn 

(excluding sweet corn), Soybeans and 

Wheat at page 13 in docket ID number 

EPA–HQ–OPP–2007-0366. Also, a 

summary of the toxicological endpoints 

for pyraflufen-ethyl used for human risk 

assessment is discussed in Unit III.B. of 

the final rule published in the Federal 

Register of April 30, 2003 (68 FR 23046) 

(FRL–7300–9). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraflufen-ethyl, EPA 

considered exposure from the 

petitioned-for tolerances as well as all 

existing pyraflufen-ethyl tolerances in 

40 CFR 180.585. EPA assessed dietary 

exposures from pyraflufen-ethyl 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 pyraflufenethyl; 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 1994–1996 and 1998 

Continuing Surveys of Food Intake by 

Individuals (CSFII). As to residue levels 

in food, the following assumptions were 

made for the chronic exposure 

assessments: 100 percent crop treated 

(PCT) and tolerance-level residues for 

pyraflufen-ethyl on all treated crops 

except corn, cottonseed, potato, soybean 

and wheat for which one half of the 

combined Levels of Quantification 

(LOQs) for the parent and the metabolite 

were used since all field trial data were 

less than the LOQ. 

iii. Cancer. For the cancer dietary 

exposure assessment EPA used the food 

consumption data from the USDA 1994–

1996 and 1998 Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, the following 

assumptions were made for the chronic 

exposure assessments: 100 percent crop 

treated (PCT) and tolerance-level 

residues for pyraflufen-ethyl on all 

treated crops except corn, cottonseed, 

potato, soybean and wheat for which 

one-half of the combined LOQs for the 

parent and the metabolite were used 

since all field trial data were less than 

the LOQ. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraflufen-ethyl in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyraflufen-ethyl. 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 First Index Reservoir 

Screening Tool (FIRST) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

pyraflufen-ethyl for acute exposures are 

estimated to be 1,247 parts per trillion 

(ppt) for surface water and 1.8 ppt for 

ground water. Chronic exposures for 

cancer assessments are estimated to be 

281 ppt for surface water and 1.8 ppt 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 value of 281 ppt 

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). 


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Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51741 

Pyraflufen-ethyl is currently 

registered on the following residential 

non-dietary sites that could result in 

residential exposures: airports, 

nurseries, ornamental turf, golf courses, 

roadsides, railroads, non-crop land, and 

uncultivated agricultural areas. The risk 

assessment was conducted using the 

following residential exposure 

assumptions: adults and children may 

be exposed to residues of pyraflufenethyl through short-term postapplication contact with treated areas 

which may include residential/ 

recreational areas. 

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 pyraflufen-ethyl to 

share a common mechanism of toxicity 

with any other substances, and 

pyraflufen-ethyl does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyraflufen-ethyl 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 website 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. 

There is no evidence of increased 

susceptibility of rat or rabbit fetuses 

following in utero exposure in the 

developmental studies with pyraflufenethyl. There is no evidence of increased 

susceptibility of young rats in the 

reproduction study with pyraflufenethyl. EPA concluded there are no 

residual uncertainties for pre- and/or 

postnatal exposure. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for pyraflufenethyl is complete. 

ii. There is no indication that 

pyraflufen-ethyl 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 

pyraflufen-ethyl 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% of the 

crop treated and a conservative estimate 

of residues in food. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to pyraflufenethyl 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 pyraflufen-ethyl. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute 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, pyraflufen-ethyl 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 pyraflufenethyl from food and water will utilize 

less than 1% of the cPAD for all 

population groups. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

pyraflufen-ethyl is not expected. 

3. Short-term risk. Pyraflufen-ethyl is 

currently registered for use(s) 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 

pyraflufen-ethyl. 

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). A shortterm risk aggregate assessment was not 

performed for adults because no handler 

exposure is expected and postapplication inhalation exposure is 

expected to be negligible (and there are 

no dermal endpoints of concern). A 

short-term aggregate risk assessment 

was performed for infants and children 

because there is a potential for oral postapplication exposure resulting from 

contact with treated areas which may 

include residential/recreational areas. 

Short-term aggregate exposure takes into 

account residential exposure plus 

chronic exposure to food and water. 

Short term aggregate risk is based on 

children’s incidental oral exposure 

(from residential post-application 

treatment) and dietary exposure (food 

and drinking water). The anticipated 

exposure level for children, 1-2 years 

(the highest exposed population) is 

below EPA’s level of concern, with a 

Margin of Exposure (MOE) greater than 

60,000. 

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). 

Pyraflufen-ethyl is not registered for 

any use patterns that would result in 

intermediate-term residential exposure. 

No residential handler exposure is 

expected and post-application 

inhalation exposure is expected to be 

negligible. Post-application exposure to 

infants and children over the 

intermediate term duration (1 to 6) 

months is not likely based on the use 

pattern. Therefore, the intermediateVerDate Aug<31>2005 19:20 Sep 04, 2008 Jkt 214001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\05SER1.SGM 05SER1

hsrobinson on PROD1PC76 with RULES
51742 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 

term aggregate risk is the sum of the risk 

from exposure to pyraflufen-ethyl 

through food and water, which has 

already been addressed, and will not be 

greater than the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. The aggregate cancer risk 

assessment for the general population 

takes into account exposure estimates 

form dietary consumption of pyraflufenethyl from food, residential, and drink 

water sources. Exposures from 

residential uses are based on the 

lifetime average daily dose and assume 

an exposure period of 5 days per year 

and 50 years of exposure in a lifetime 

(70 years). Average food plus water 

source dietary exposure was used. 

Estimated cancer risk for the U.S. 

population includes infants and 

children. The aggregate cancer risk 

estimate for pyraflufen-ethyl is 2.9 x 

10-6. This risk estimate is based, in part, 

on the conservative assumption that 

100% of all crops for which pyraflufenethyl is registered or proposed for 

registration are treated. Additional 

refinement using Percent Crop Treated 

estimates would result in a lower 

estimate of cancer risk. 

EPA generally considers cancer risks 

in the range of 1 in 1 million (1 x 10-6) 

or less to be negligible. The precision 

which can be assumed for cancer risk 

estimates is best described by rounding 

to the nearest integral order of 

magnitude on the log scale; for example, 

risks falling between 3.16 x 10-7 and 

3.16 x 10-6 are expressed as risks in the 

range of 1 x 10-6. Considering the 

precision with which cancer hazard can 

be estimated, the conservativeness of 

low-dose linear extrapolation, and the 

rounding procedure described above, 

cancer risk should generally not be 

assumed to exceed the benchmark LOC 

of the range of 1 x 10-6 until the 

calculated risk exceeds approximately 3 

x 10-6. Since the calculated cancer risk 

for pyraflufen-ethyl does not exceed this 

level, estimated cancer risk is 

considered to be negligible. 

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 pyraflufenethyl residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Gas Chromatography and Mass 

Spectrometry (GC/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 

There are currently no established 

Codex, Canadian or Mexican maximum 

residue limits, for residues of 

pyraflufen-ethyl in/on grass, milk, meat 

byproducts, soybean and wheat. 

V. Conclusion 

Therefore, permanent tolerances are 

established for residues of pyraflufenethyl and its metabolite expressed in 

terms of the parent on grass, forage, 

group 17 at 1.0 ppm; grass, hay, group 

17 at 1.4 ppm. Time-limited tolerances 

are established for milk at 0.02 ppm; 

cattle, meat byproducts at 0.02 ppm; 

goat, meat byproducts at 0.02 ppm; 

horse, meat byproducts at 0.02 ppm; 

and sheep, meat byproducts at 0.02 

ppm. Existing tolerances are revised for 

soybean, forage to 0.05 ppm; soybean, 

hay to 0.10 ppm; wheat, forage to 0.02 

ppm; and wheat, hay to 0.01 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA 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 final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

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 on the basis of a petition 

under section 408(d) of FFDCA, 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 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 section 408(n)(4) of FFDCA. 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) (Public Law 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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. 


hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Rules and Regulations 51743 

Dated: August 25, 2008. 

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. Section 180.585 is amended by 

revising paragraph (a) to read as follows: 

§ 180.585 Pyraflufen-ethyl; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the herbicide, 

pyraflufen-ethyl, ethyl 2-chloro-5-(4- 

chloro-5-difluoromethoxy-1-methyl-1Hpyrazol-3-yl)-4-fluorophenoxyacetate, 

and its acid metabolite, E-1, 2-chloro-5- 

(4-chloro-5-difluoromethoxy-1-methyl1H-pyrazol-3-yl)-4-fluorophenoxyacetic 

acid, expressed in terms of the parent in 

or on the following food commodities: 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Cattle, meat byproducts ........ 0.02 10/15/12 

Corn, field, forage ................ 0.01 None 

Corn, field, grain 0.01 None 

Corn, field, stover ................. 0.01 None 

Cotton, gin byproducts ........ 1.5 None 

Cotton, 

undelinted 

seed .............. 0.04 None 

Goat, meat byproducts ........ 0.02 10/15/12 

Grass, forage, 

group 17 ........ 1.0 None 

Grass, hay, 

group 17 ........ 1.4 None 

Horse, meat byproducts ........ 0.02 10/15/12 

Milk ................... 0.02 10/15/12 

Potato ............... 0.02 None 

Sheep, meat byproducts ........ 0.02 10/15/12 

Soybean, forage 0.05 None 

Soybean, hay .... 0.10 None 

Soybean, seed .. 0.01 None 

Wheat, forage ... 0.02 None 

Wheat, grain ..... 0.01 None 

Wheat, hay ....... 0.01 None 

Wheat, straw ..... 0.01 None 

* * * * * 

[FR Doc. E8–20515 Filed 9–4–08; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 070717340–8451–02] 

RIN 0648–XK16 

Fisheries of the Northeastern United 

States; Atlantic Mackerel, Squid, and 

Butterfish Fisheries; Closure of the 

Directed Butterfish Fishery 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; closure. 

SUMMARY: NMFS announces that the 

directed fishery for butterfish in the 

Exclusive Economic Zone (EEZ) will be 

closed effective 0001 hours, September 

5, 2008. Vessels issued a Federal permit 

to harvest butterfish may not retain or 

land more than 250 lb (0.11–mt) of 

butterfish per trip for the remainder of 

the year (through December 31, 2008). 

This action is necessary to prevent the 

fishery from exceeding its domestic 

annual harvest (DAH) of 500 mt and to 

allow for effective management of this 

stock. 

DATES: Effective 0001 hours, September 

5, 2008, through 2400 hours, December 

31, 2008. 

FOR FURTHER INFORMATION CONTACT: Don 

Frei, Fishery Management Specialist, 

978–281–9221, Fax 978–281–9135. 

SUPPLEMENTARY INFORMATION: 

Regulations governing the butterfish 

fishery are found at 50 CFR part 648. 

The regulations require specifications 

for maximum sustainable yield, initial 

optimum yield, allowable biological 

catch, domestic annual harvest (DAH), 

domestic annual processing, joint 

venture processing, and total allowable 

levels of foreign fishing for the species 

managed under the Atlantic Mackerel, 

Squid, and Butterfish Fishery 

Management Plan. The procedures for 

setting the annual initial specifications 

are described in § 648.21. 

The 2008 specification of DAH for 

butterfish was set at 500 mt (73 FR 

18443, April 4, 2008). 

Section 648.22 requires NMFS to 

close the directed butterfish fishery in 

the EEZ when 80 percent of the total 

annual DAH has been harvested. If 80 

percent of the butterfish DAH is 

projected to be landed prior to October 

1, a 250–lb (0.11–mt) incidental 

butterfish possession limit is put in 

effect for the remainder of the year, and 

if 80 percent of the butterfish DAH is 

projected to be landed on or after 

October 1, a 600–lb (0.27–mt) incidental 

butterfish possession limit is put in 

effect for the remainder of the year. 

NMFS is further required to notify, in 

advance of the closure, the Executive 

Directors of the Mid-Atlantic, New 

England, and South Atlantic Fishery 

Management Councils; mail notification 

of the closure to all holders of butterfish 

permits at least 72 hr before the effective 

date of the closure; provide adequate 

notice of the closure to recreational 

participants in the fishery; and publish 

notification of the closure in the Federal 

Register. The Administrator, Northeast 

Region, NMFS, based on dealer reports 

and other available information, has 

determined that 80 percent of the DAH 

for butterfish in 2008 fishing year will 

be harvested. Therefore, effective 0001 

hours, September 5, 2008, the directed 

fishery for butterfish fishery is closed 

and vessels issued Federal permits for 

butterfish may not retain or land more 

than 250 lb (0.11 mt) of butterfish 

during a calendar day. The directed 

fishery will reopen effective 0001 hours, 

January 1, 2009, when the 2009 DAH 

becomes available. 

Classification 

This action is required by 50 CFR part 

648 and is exempt from review under 

Executive Order 12866. 

Authority: 16 U.S.C. 1801 et seq. 

Dated: September 2, 2008. 

Allan D. Risenhoover, 

Director, Office of Sustainable Fisheries, 

National Marine Fisheries Service. 

[FR Doc. E8–20600 Filed 9–2–08; 4:15 pm] 

BILLING CODE 3510–22–S 


hsrobinson on PROD1PC76 with RULES