[Federal Register Volume 76, Number 22 (Wednesday, February 2, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2266]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Bispyribac-sodium; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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
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)
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: firstname.lastname@example.org.
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
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
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
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
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
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
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
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.
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.
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
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
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
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
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
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-
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
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
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
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: email@example.com.
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
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.
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
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: January 18, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
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:
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:
Fish, freshwater............................................ 0.01
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[FR Doc. 2011-2266 Filed 2-1-11; 8:45 am]
BILLING CODE 6560-50-P