Document ID: EPA-HQ-OPP-2009-0796-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Bispyribac-sodium
Posted Date: 2011-02-02T05:00Z

[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
[Pages 5711-5716]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2266]

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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.

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SUMMARY: This regulation establishes tolerances for residues of 
bispyribac-sodium 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.

[[Page 5712]]

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-dimethoxy-pyrimidin-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 bispyribac-sodium 
including exposure resulting from the tolerances established by this 
action. EPA's assessment of exposures and risks associated with 
bispyribac-sodium 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. 
Bispyribac-sodium 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

[[Page 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. Bispyribac-
sodium 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 
bispyribac-sodium. 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-effect-level (NOAEL) and the lowest-observed-adverse-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 Bispyribac-sodium 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
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                                    Dose used in risk    FQPA SF and LOC for
        Exposure scenario            assessment, UF        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  FQPA SF = 1X........  Chronic Toxicity Study--Dog
                                  UF = 100............  cPAD = cRfD = 0.1 mg/ LOAEL = 100 mg/kg/day based on
                                                         kg/day.               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  NOAEL = 100 mg/kg/    LOC for MOE = 100     Developmental Toxicity Study--
 days) (Residential).              day.                  (includes FQPA SF =   Rabbit Maternal LOAEL = 300 mg/kg/
                                                         1X).                  day based on lethargy, diarrhea
                                                                               and decreased body-weight gain in
                                                                               the range-finding study.
Intermediate-Term Incidental      NOAEL = 100 mg/kg/    LOC for MOE = 100     90-Day Feeding Study--Dog LOAEL =
 Oral (1-6 months) (Residential).  day.                  (includes FQPA SF =   600 mg/kg/day based upon
                                                         1X).                  salivation and slight
                                                                               proliferation of intrahepatic
                                                                               bile duct.
Short-Term Inhalation (1-30       Oral study NOAEL =    LOC for MOE = 100     Developmental Toxicity Study--
 days) (Occupational/              100 mg/kg/day         (Occupational) LOC    Rabbit Maternal LOAEL = 300 mg/kg/
 Residential).                     (inhalation           for MOE = 100         day based on lethargy, diarrhea
                                   absorption rate =     (Residential,         and decreased body-weight gain in
                                   100%).                includes the FQPA     the range-finding study.
                                                         SF = 1X).
Intermediate-Term Inhalation (1-  Oral study NOAEL =    LOC for MOE = 100     90-Day feeding study--Dog LOAEL =
 6 months) (Occupational/          100 mg/kg/day         (Occupational) LOC    600 mg/kg/day based upon
 Residential).                     (inhalation           for MOE = 100         salivation and slight
                                   absorption rate =     (Residential,         proliferation of intrahepatic
                                   100%).                includes the FQPA     bile duct.
                                                         SF = 1X).
Long-Term Inhalation (>6 months)  Oral study NOAEL =    LOC for MOE = 100     Chronic Toxicity Study--Dog LOAEL
 (Occupational/Residential).       10 mg/kg/day          (Occupational) LOC    = 100 mg/kg/day based on dose-
                                   (inhalation           for MOE = 100         related increases in hyperplasia
                                   absorption rate =     (Residential,         of the intrahepatic bile ducts in
                                   100%).                includes the FQPA     males and females and granulation
                                                         SF = 1X).             of the liver in the females.
                                 -------------------------------------------------------------------------------
Cancer (oral, dermal,                                Not likely to be carcinogenic to humans.
 inhalation).
----------------------------------------------------------------------------------------------------------------
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.

[[Page 5714]]

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 
bispyribac-sodium; 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 bispyribac-sodium 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 non-occupational, 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 non-
competitive 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 bispyribac-sodium 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

[[Page 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 (macro- and 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 x 10-11 at 25[deg]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 bispyribac-sodium 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 
bispyribac-sodium 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 intermediate-term risk. 
However, since the short- and intermediate-term points of departure are 
the same, the short-term aggregate assessment is protective of 
intermediate-term 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 bispyribac-sodium 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

[[Page 5716]]

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 bispyribac-
sodium. 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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
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:

Sec.  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:

------------------------------------------------------------------------
                                                              Parts  per
                          Commodity                             million
------------------------------------------------------------------------
Fish, freshwater............................................        0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-2266 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P