Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5711 

specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolite HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. 

* * * * * 

(2) Tolerances are established for the 

combined residues of the free and 

conjugated forms of sulfentrazone, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only the sum 

of sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. 

Commodity Parts per 

million 

* * * * * 

Brassica, head and stem, subgroup 5A ................................. 0.20 

Brassica, leafy greens, subgroup 

5B ............................................ 0.40 

* * * * * 

Flax ............................................. 0.15 

* * * * * 

Melon, subgroup 9A ................... 0.15 

Pea, succulent ............................ 0.15 

* * * * * 

Strawberry .................................. 0.15 

* * * * * 

Vegetable, fruiting, group 8–10 .. 0.15 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.15 

(b) Section 18 emergency exemptions. 

Time-limited tolerances are established 

for the combined residues of the free 

and conjugated forms of sulfentrazone, 

including its metabolites and 

degradates, in connection with use of 

the pesticide under section 18 

emergency exemptions granted by EPA. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities. These 

tolerances expire and are revoked on the 

dates specified in the following table. 

Commodity Parts per 

million 

Expiration/ 

revocation date 

Flax, seed .................................................................................................................................................... 0.20 12/31/13 

Strawberry .................................................................................................................................................... 0.60 12/31/13 

* * * * * 

(d) Indirect or inadvertent residues. 

Tolerances are established for 

inadvertent and indirect combined 

residues of the free and conjugated 

forms of sulfentrazone, including its 

metabolites and degradates, in or on the 

commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only the sum of 

sulfentrazone (N-[2,4-dichloro-5-[4- 

(difluoromethyl)-4,5-dihydro-3-methyl5-oxo-1H-1,2,4-triazol-1- 

yl]phenyl]methanesulfonamide) and its 

metabolites HMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-3- 

hydroxymethyl-5-oxo-1H-1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide) and 

DMS (N-(2,4-dichloro-5-(4- 

(difluoromethyl)-4,5-dihydro-5-oxo-1H1,2,4-triazol-1- 

yl)phenyl)methanesulfonamide, 

calculated as the stoichiometric 

equivalent of sulfentrazone in or on the 

following commodities when present 

therein as a result of the application of 

sulfentrazone to growing crops. 

* * * * * 

[FR Doc. 2011–1898 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0796; FRL–8860–2] 

Bispyribac-sodium; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of bispyribacsodium in or on fish, freshwater. Valent 

U.S.A. Corporation requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

February 2, 2011. Objections and 

requests for hearings must be received 

on or before April 4, 2011, 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–2009–0796. All documents in the 

docket are listed in the docket index 

available at http://www.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 in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory 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. 


rmajette on DSK29S0YB1PROD with RULES
5712 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 

FOR FURTHER INFORMATION CONTACT: 

Hope Johnson, Registration Division, 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5410; e-mail address: 

johnson.hope@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 those engaged in the 

following activities: 

• 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 to provide 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 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.gpoaccess.gov/ecfr. 

To access the harmonized test 

guidelines referenced in this document 

electronically, please go http:// 

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2009–0796 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 4, 2011. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0796, 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 

Facility’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. Summary of Petitioned-For 

Tolerance 

In the Federal Register of January 6, 

2010 (75 FR 864) (FRL–8801–5), 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 8F7509) by Valent 

U.S.A Corporation, 1600 Riviera 

Avenue, Suite 200, Walnut Creek, CA 

94596. The petition requested that 40 

CFR 180.577 be amended by 

establishing tolerances for residues of 

the herbicide bispyribac-sodium, 

sodium, 2,6-bis[(4,6-dimethoxypyrimidin-2-yl)oxy]benzoate, in or on 

fish, freshwater at 0.01 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Valent U.S.A Corporation, the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA has revised 

the proposed tolerance expression. The 

reason for this change is explained in 

Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 bispyribacsodium including exposure resulting 

from the tolerances established by this 

action. EPA’s assessment of exposures 

and risks associated with bispyribacsodium follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The toxicological database for 

bispyribac-sodium is complete with the 

exception of immunotoxicity, acute 

neurotoxicity, and subchronic 

neurotoxicity studies, as well as a 

28-day inhalation study. Bispyribacsodium has a low acute toxicity profile 

and is not a dermal sensitizer. The liver 

and bile duct were identified as the 

target organs in the subchronic and 

chronic toxicity studies in rats, mice, 

and dogs, and the reproductive toxicity 


rmajette on DSK29S0YB1PROD with RULES
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5713 

study in rats. Repeated dermal 

applications at the limit dose did not 

elicit systemic toxicity or dermal 

irritation. Bispyribac-sodium was 

negative for carcinogenicity in feeding 

studies in rats and mice and is classified 

as a ‘‘not likely human carcinogen’’ and 

mutagenicity studies conducted with 

the parent and three major metabolites 

were negative. There was no evidence of 

fetal toxicity or offspring susceptibility 

in the developmental toxicity studies in 

rats and rabbits or in the reproductive 

toxicity study in rats. Bispyribacsodium has shown no indications of 

central or peripheral nervous system 

toxicity in any study and does not 

appear to be structurally related to any 

other chemical that causes adverse 

nervous system effects. 

Acute and subchronic neurotoxicity 

studies are not available for bispyribacsodium. There were clinical signs of 

potential neurotoxicity (i.e., 

piloerection, subnormal temperature, 

and decreased spontaneous motor 

activity) in the combined rat chronic/ 

carcinogenicity study. However, these 

clinical signs occurred at a low 

incidence in the high dose group and 

were not dose-dependent. The primary 

effects of the study were based on 

macro- and microscopic changes in the 

liver and choldedochus, decreased body 

weights, and decreased food efficiency. 

There are no other signs of neurotoxicity 

in the database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by bispyribac-sodium as 

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

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Bispyribac-sodium; Human-Health 

Risk Assessment for New Product 

Registration for Aquatic Uses on 

Freshwater Fish’’ at page 28 in docket ID 

number EPA–HQ–OPP–2009–0796. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). For non-threshold 

risks, the Agency assumes that any 

amount of exposure will lead to some 

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 Bispyribacsodium used for human risk assessment 

is shown in Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR BISPYRIBAC-SODIUM FOR USE IN HUMAN HEALTH

RISK ASSESSMENT

Exposure scenario Dose used in risk 

assessment, UF 

FQPA SF and LOC for 

risk assessment Study and toxicological effects 

Acute Dietary all populations.No appropriate endpoint attributable to a single exposure was identified. 

Chronic Dietary all populations.NOAEL = 10 mg/kg/day .......

UF = 100 

FQPA SF = 1X .....................

cPAD = cRfD = 0.1 mg/kg/ 

day 

Chronic Toxicity Study—Dog 

LOAEL = 100 mg/kg/day based on dose-related increases in hyperplasia of the intrahepatic bile ducts 

in males and females and granulation of the liver in 

the females. 

Short-Term Incidental 

Oral (1–30 days) (Residential).

NOAEL = 100 mg/kg/day ..... LOC for MOE = 100 (includes FQPA SF = 1X).Developmental Toxicity Study—Rabbit Maternal 

LOAEL = 300 mg/kg/day based on lethargy, diarrhea and decreased body-weight gain in the rangefinding study. 

Intermediate-Term Incidental Oral (1–6 

months) (Residential).

NOAEL = 100 mg/kg/day ..... LOC for MOE = 100 (includes FQPA SF = 1X).90–Day Feeding Study—Dog LOAEL = 600 mg/kg/ 

day based upon salivation and slight proliferation of 

intrahepatic bile duct. 

Short-Term Inhalation (1– 

30 days) (Occupational/Residential).

Oral study NOAEL = 100 

mg/kg/day (inhalation absorption rate = 100%).

LOC for MOE = 100 (Occupational) LOC for MOE = 

100 (Residential, includes 

the FQPA SF = 1X).

Developmental Toxicity Study—Rabbit Maternal 

LOAEL = 300 mg/kg/day based on lethargy, diarrhea and decreased body-weight gain in the rangefinding study. 

Intermediate-Term Inhalation (1–6 months) 

(Occupational/Residential).

Oral study NOAEL = 100 

mg/kg/day (inhalation absorption rate = 100%).

LOC for MOE = 100 (Occupational) LOC for MOE = 

100 (Residential, includes 

the FQPA SF = 1X).

90-Day feeding study—Dog LOAEL = 600 mg/kg/day 

based upon salivation and slight proliferation of 

intrahepatic bile duct. 

Long-Term Inhalation (≤6 

months) (Occupational/ 

Residential).

Oral study NOAEL = 10 mg/ 

kg/day (inhalation absorption rate = 100%).

LOC for MOE = 100 (Occupational) LOC for MOE = 

100 (Residential, includes 

the FQPA SF = 1X).

Chronic Toxicity Study—Dog LOAEL = 100 mg/kg/day 

based on dose-related increases in hyperplasia of 

the intrahepatic bile ducts in males and females 

and granulation of the liver in the females. 

Cancer (oral, dermal, inhalation).Not likely to be carcinogenic to humans. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 


rmajette on DSK29S0YB1PROD with RULES
5714 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to bispyribac-sodium, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing bispyribac-sodium tolerances in 

40 CFR 180.577. EPA assessed dietary 

exposures from bispyribac-sodium 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 bispyribacsodium; 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 

CSFII. As to residue levels in food, EPA 

assumed tolerance-level residues (for all 

registered and proposed new uses), 

default processing factors, and 100% 

crop treated (CT). 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that bispyribac-sodium 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 bispyribac-sodium. Tolerance level 

residues and/or 100% CT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. Because currently used Tier 1 

aquatic exposure models are used to 

simulate agricultural uses and are not 

appropriate for determining estimated 

drinking water concentrations (EDWCs) 

for aquatic uses of pesticides applied 

directly to surface water bodies, the 

Agency used the maximum annual label 

target rate of 180 ppb for subsurface 

injection of bispyribac-sodium into 

water. This value represents the 

maximum cumulative concentration in 

water based on four applications, at 

unspecified intervals, needed to achieve 

a 45-ppb level of bispyribac-sodium in 

the water column. Because bispyribacsodium is only moderately persistent 

and will undergo degradation in the 

environment between applications, this 

value can be considered conservative. 

For chronic dietary risk assessment, 

the water concentration of value 180 

ppb was used to assess the contribution 

to drinking water and was incorporated 

directly into the dietary assessment. 

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). 

Bispyribac-sodium is currently 

registered for the following uses that 

could result in residential exposures: 

golf courses and sod farms. EPA 

assessed residential exposure using the 

following assumptions: No residential 

handler exposure is expected from the 

proposed and registered uses of 

bispyribac-sodium. Residential 

postapplication exposure following use 

of bispyribac-sodium on golf courses 

and sod farms is possible. A dermal 

postapplication assessment was not 

performed since there is no short-term 

dermal point of departure. For the 

proposed aquatic use, there is a 

potential for exposure to recreational 

users (i.e., swimmers) in these water 

bodies. Postapplication exposure and 

risks were developed for the noncompetitive adult and child swimmer. 

Exposure is expected to be short-term; 

however, since the short- and 

intermediate-term points of departure 

are the same, the short-term assessment 

is protective of intermediate-term 

exposures. Only oral postapplication 

exposure to recreational swimmers was 

assessed. 

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 bispyribac-sodium 

to share a common mechanism of 

toxicity with any other substances, and 

bispyribac-sodium does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that bispyribac-sodium 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. 

There is no indication of quantitative or 

qualitative increased susceptibility of 

rats or rabbits to in utero or postnatal 

exposure to bispyribac-sodium. In the 

rat prenatal developmental toxicity 

study in rats, no toxicity was observed 

in the dams or the fetuses up to the 

highest dose tested (1000 mg/kg/day). In 

the rabbit prenatal developmental 

toxicity study, the dams were more 

susceptible than the fetuses. Maternal 

toxicity at the LOAEL of 300 mg/kg/day 

included lethargy, diarrhea, and 

decreased body weight gain. There were 

no fetal effects. In the 2-generation 

reproduction study, the parents were 

more susceptible to than the offspring. 

At the parental LOAEL of 75.7 mg/, 

effects observed included mild 

choledocus (bile duct) hyperplasia. 

There were no reproductive effects. At 

the offspring LOAEL of 759 mg/kg/day, 

effects observed were decreased body 

weights and body-weight gains, liver 

weights, and increased incidence of 

consolidation and circumscribed areas 

in the liver. 

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 bispyribacsodium is complete with the exception 

of immunotoxicity, acute neurotoxicity, 

subchronic neurotoxicity and a 28-day 

inhalation study. 

The concern for neurotoxicity is low 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. There are no indications 

in any of the studies available that the 

nervous system is a target for 


rmajette on DSK29S0YB1PROD with RULES
Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5715 

bispyribac-sodium. Although there were 

clinical signs potentially indicative of 

neurotoxicity (e.g., piloerection, 

subnormal temperature, and decreased 

spontaneous motor activity) in the 

combined rat chronic/carcinogenicity 

study, these effects were considered 

secondary to the critical effects (macroand microscopic changes in the liver 

and choldedochus, decreased body 

weights, and decreased food efficiency). 

Additionally, treatment-related clinical 

signs only occurred at the highest dose 

tested (404 mg/kg/day) and were not 

dose-dependent. These effects are 

therefore attributed to general, systemic 

toxicity, not neurotoxicity. Although 

acute and subchronic neurotoxicity 

studies are now required as part of the 

revisions to 40 CFR part 158, the 

Agency does not believe that conducting 

these studies will result in a lower point 

of departure (POD) than that currently 

used for overall risk assessment, and 

therefore, a database uncertainty factor 

(UFDB) is not needed to account for lack 

of these studies. The toxicology 

database for bispyribac-sodium does not 

show any evidence of treatment-related 

effects on the immune system. The 

overall weight of evidence suggests that 

this chemical does not directly target 

the immune system. An immunotoxicity 

study is required as a part of new data 

requirements in the 40 CFR part 158 for 

conventional pesticide registration; 

however, the Agency does not believe 

that conducting a functional 

immunotoxicity study will result in a 

lower point of departure than that 

currently used for overall risk 

assessment, and therefore, a database 

uncertainty factor (UFDB) is not needed 

to account for lack of this study. A 28- 

day inhalation study is not available; 

however, the Agency has determined 

that the additional FQPA SF is not 

needed. Based on the very low vapor 

pressure of bispyribac-sodium (3.79 × 

10¥11 at 25°C) and because the 

residential use pattern is limited to golf 

courses and swimming areas, minimal 

potential for inhalation exposure is 

expected. Therefore, the risk estimate is 

conservative and is considered 

protective and the additional FQPA SF 

is not needed. 

ii. There is no indication that 

bispyribac-sodium 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 

bispyribac-sodium 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% CT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to bispyribacsodium in drinking water. EPA used 

similarly conservative assumptions to 

assess postapplication exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by bispyribac-sodium. 

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, bispyribac-sodium 

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 bispyribacsodium from food and water will utilize 

12.5% of the cPAD for infants (<1 year 

old) the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

bispyribac-sodium is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Bispyribac-sodium 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 

bispyribac-sodium. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 25,000 for the U.S. general 

population, 26,000 for adults 50+ years 

old, and 7,700 for all infants (<1 year 

old). Because EPA’s level of concern for 

bispyribac-sodium is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, bispyribac-sodium 

is not expected to pose an intermediateterm risk. However, since the short- and 

intermediate-term points of departure 

are the same, the short-term aggregate 

assessment is protective of intermediateterm exposures. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

bispyribac-sodium 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 bispyribacsodium residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-performance liquid 

chromatography (HPLC) with tandem 

mass spectroscopy detection (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; e-mail 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 U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 


rmajette on DSK29S0YB1PROD with RULES
5716 Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 

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 bispyribac-sodium. 

C. Revisions to Petitioned-For 

Tolerances 

EPA is revising the requested 

tolerance expression for bispyribacsodium. The revised tolerance 

expression makes clear that the 

tolerances cover residues of the 

herbicide bispyribac-sodium, including 

its metabolites and degradates, but that 

compliance with the tolerance levels is 

to be determined by measuring only 

bispyribac-sodium, (2,6-bis[(4,6- 

dimethoxy-2-pyrimidinyl)oxy]benzoic 

acid, sodium salt), in or on the 

commodity. EPA has determined that it 

is reasonable to make this change final 

without prior proposal and opportunity 

for comment, because public comment 

is not necessary, in that the change has 

no substantive effect on the tolerance, 

but rather is merely intended to clarify 

the existing tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of bispyribac-sodium, 

including its metabolites and 

degradates, in or on fish, freshwater at 

0.01 ppm. Compliance with the 

tolerance level is to be determined by 

measuring only bispyribac-sodium, (2,6- 

bis[(4,6-dimethoxy-2- 

pyrimidinyl)oxy]benzoic acid, sodium 

salt), in or on the commodity. 

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, 

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 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) (Pub. L. 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: January 18, 2011. 

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 180.577 is amended by 

revising paragraph (a) introductory text 

and alphabetically adding the following 

commodity to the table in paragraph (a) 

to read as follows: 

§ 180.577 Bispyribac-sodium; tolerances 

for residues. 

(a) General. Tolerances are 

established for residues of the herbicide 

bispyribac-sodium, including its 

metabolites and degradates, in or on the 

commodity listed below. Compliance 

with the tolerance level specified below 

is to be determined by measuring only 

bispyribac-sodium, (2,6-bis[(4,6- 

dimethoxy-2-pyrimidinyl)oxy]benzoic 

acid, sodium salt), in or on the 

following raw agricultural commodities: 

Commodity Parts 

per million 

Fish, freshwater .......................... 0.01 

* * * * * 

* * * * * 

[FR Doc. 2011–2266 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 


rmajette on DSK29S0YB1PROD with RULES