Boscalid; Pesticide Tolerances, 47440-47445 [E9-22163]
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DATES:
Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations
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§ 1253.7
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Dated: September 11, 2009.
Adrienne C. Thomas,
Acting Archivist of the United States.
[FR Doc. E9–22403 Filed 9–15–09; 8:45 am]
BILLING CODE 7515–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0624; FRL–8431–1]
Boscalid; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of boscalid in or
on coffee, green bean imported and
amends the tolerance for banana,
imported. BASF, Inc., requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA). This
regulation is also a removing tolerance
for cucumber, and one tolerance for
vegetable, root, subgroup 1A, except
sugar beet, garden beet, radish, and
turnip which are superceded with
higher tolerances formerly published in
the Federal Register of March 28, 2008
(73 FR 16553) (FRL–8354–4).
DATES: This regulation is effective
September 16, 2009. Objections and
requests for hearings must be received
on or before November 16, 2009, 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–2008–0624. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
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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
https://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.
FOR FURTHER INFORMATION CONTACT:
Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–0025; e-mail address:
crowe.bryant@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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
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this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0624 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
as required by 40 CFR part 178 on or
before November 16, 2009.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit this copy,
identified by docket ID number EPA–
HQ–OPP–2008–0624, by one of the
following methods:
• Federal eRulemaking Portal: https://
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. Petition for Tolerances
In the Federal Register of November
5, 2008 (73 FR 65849) (FRL–8385–1),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
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pesticide petitions (PP 8E7366, PP
8E7367) by BASF Corporation, P.O. Box
13528, 26 Davis Drive, Research
Triangle, NC 27709. The petitions
requested that 40 CFR 180.589 be
amended by increasing the tolerance for
residues of the fungicide boscalid, 3pyridinecarboxamide, 2-chloro-N-(4′chloro(1,1′-biphenyl))-2-yl, in or on
banana from 0.2 parts per million (ppm)
to 0.5 ppm (PP 8E7366), and
establishing a tolerance for coffee, green
bean at 0.05 ppm (PP 8E7367). That
notice referenced a summary of the
petitions prepared by BASF
Corporation, the registrant, which is
available to the public in the docket,
https://www.regulations.gov. One
comment was received from a private
citizen. EPA’s response to comment is
discussed in Unit IV.C.
Additionally, in this action EPA is
correcting an error in a prior tolerance
rulemaking for boscalid (73 FR 16553)
(March 28, 2008). In that action, EPA
amended the boscalid tolerances for
cucumber and vegetable, root, subgroup
1A , except sugar beet, garden beet,
radish, and turnip by increasing the
level of each of those tolerances.
Inadvertently, however, the revised
tolerance levels were added to the CFR
without removing the prior tolerances.
This action removes the prior
tolerances.
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
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sufficient data to assess the hazards of
and to make a determination on
aggregate exposure for the petitioned-for
tolerances for residues of boscalid on
banana, imported at 0.40 ppm, and
coffee, green bean, imported at 0.05
ppm. EPA’s assessment of exposures
and risks associated with establishing
tolerances follow.
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.
Boscalid has low acute toxicity via the
oral, dermal, and inhalation routes of
exposure and is not an eye or skin
irritant. Dermal sensitization could not
be determined because the skin
sensitization study was inadequate. The
target organs for boscalid are the thyroid
and liver.
An acute endpoint was not selected
because no adverse effects attributable
to a single exposure to boscalid were
seen in the database, including the
developmental toxicity studies. The
chronic dietary, incidental oral, dermal,
and inhalation endpoints were all
selected from three co-critical studies:
The chronic rat study, the rat
carcinogenicity study, and a 1-year
feeding study in dogs. The dose selected
for regulation of oral, dermal, and
inhalation risk at all durations, for all
populations, is the ‘‘no- observedadverse-effect level’’ of 21.8 milligrams/
kilogram/day (mg/kg/day) based on
thyroid and hepatic toxicity seen in rats
and dogs at higher dose levels.
Boscalid is classified as exhibiting
‘‘suggestive evidence of
carcinogenicity.’’ Evidence of
carcinogenicity was seen in males
(significant trend, and pair-wise at the
high dose) and in females (trend only)
in rats or mice or both; however, in both
sexes no malignancies were seen. Only
benign tumors were observed, and these
occurred at dose levels above the dose
level used to establish the chronic
population adjusted dose (cPAD).
Additionally, there is no concern for
mutagencity. EPA has concluded that
the cPAD is protective of any tumor
response seen in the boscalid cancer
studies.
Specific information on the studies
received and the nature of the adverse
effects caused by boscalid as well as the
no-observed-adverse-effect-level
(NOAEL) and the lowest-observed-
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adverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the ‘‘Boscalid –
Human Health Risk Assessment of the
Proposed Food Use of the Fungicide on
Imported Coffee’’ on pages 16–21 in
docket ID number EPA–HQ–OPP–2008–
0624.
B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which the NOAEL in
the toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a Benchmark Dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) are used in conjunction
with the POD to take into account
uncertainties inherent in the
extrapolation from laboratory animal
data to humans and in the variations in
sensitivity among members of the
human population as well as other
unknowns. Safety is assessed for acute
and chronic dietary risks by comparing
aggregate food and water exposure to
the pesticide to the acute population
adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The
aPAD and cPAD are calculated by
dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and
chronic-term risks are evaluated by
comparing food, water, and residential
exposure to the POD to ensure that the
margin of exposure (MOE) called for by
the product of all applicable UFs is not
exceeded. This latter value is referred to
as the Level of Concern (LOC).
For non-threshold risks, the Agency
assumes that any amount of exposure
will lead to some degree of risk. Thus,
the Agency estimates risk in terms of the
probability of an occurrence of the
adverse effect greater than that expected
in a lifetime. For more information on
the general principles EPA uses in risk
characterization and a complete
description of the risk assessment
process, see https://www.epa.gov/
pesticides/factsheets/riskassess.htm;
https://www.epa.gov/oppfead1/trac/
science, and https://www.epa.gov/
pesticides/trac/science/aggregate.pdf.
A summary of the toxicological
endpoints for boscalid used for human
risk assessment can be found at https://
www.regulations.gov in the ‘‘Boscalid –
Human Health Risk Assessment of the
Proposed Food Use of the Fungicide on
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Imported Coffee’’ on pages 6–7 in
docket ID number EPA–HQ–OPP–2008–
0624.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to boscalid, EPA considered
exposure under the petitioned-for
tolerances as well as all existing
boscalid tolerances in (40 CFR part
180.589). EPA assessed dietary
exposures from boscalid 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 boscalid; therefore, a quantitative
acute dietary exposure assessment was
not conducted.
ii. Chronic exposure. In conducting
the chronic dietary exposure assessment
EPA used the food consumption data
from the U.S. Department of Agriculture
(USDA) 1994–1996 and 1998
Nationwide Continuing Surveys of Food
Intake by Individuals (CSFII), and
accumulated exposure to the chemical
for each commodity. As to residue
levels in food, EPA made the following
assumption for the chronic exposure
assessments: The assessment was based
on tolerance level residues for existing
uses, recommended tolerance levels for
banana and coffee, and 100% crop
treated assumptions.
iii. Cancer. For the reasons set forth
in Unit II.A., EPA has concluded that
the cPAD is protective of any cancer
effects with boscalid. EPA’s estimate of
chronic exposure as described above is
relied upon to evaluate whether any
exposure could exceed the cPAD and
thus pose a cancer risk.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for boscalid in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of boscalid.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www.epa.gov/oppefed1/models/
water/index.htm.
The current requests for an increased
tolerance in banana, and a new use on
coffee, do not affect the estimated
drinking water concentrations (EDWCs)
because both requests are for tolerances
on imported commodities. As a result,
the EDWCs used in the previous
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assessment ‘‘Boscalid - Human Health
Risk Assessment to support proposed
new uses on fresh herbs (herbs subgroup
19A), avocado, black sapote, canistel,
mamey sapote, mango, papaya,
sapodilla, star apple and cotton’’ on
page 15 in docket ID number EPA–HQ–
OPP–2008–0624 at https://
www.regulations.gov were used in this
assessment as well. The EDWCs were
based on the turf use.
Based on the First Index Reservoir
Screening Tool (FIRST), and Screening
Concentration in Ground Water (SCIGROW) models, the EDWCs of boscalid
for chronic exposures for non-cancer
assessments are estimated to be 29.6
ppb for surface water and 0.63 ppb for
ground water.
Modeled estimates of drinking water
concentrations were directly entered
into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 0.029 ppm
was used to assess the contribution to
drinking water.
3. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Boscalid is currently registered for the
following uses that could result in
residential exposures: Golf course turf,
strawberries, caneberries, and tree fruit
grown at ‘‘U-pick’’ farms and orchards.
EPA assessed residential exposure using
the following assumptions: Dermal postapplication exposure for golfers exposed
to treated turf. The duration of exposure
is anticipated to be short-term.
Based on the low vapor pressure of
boscalid (7 x 10-9 hPa), the outdoor
nature of the uses, and the weight of
evidence from available residue studies,
the Agency does not anticipate postapplication inhalation exposures from
the currently approved uses of boscalid.
In addition, U-pick activities are
considered to be one-time (<1 day)
events. As no adverse effects were seen
in the boscalid toxicity database
resulting from a single exposure to the
chemical a post-application exposure
assessment is not required for this
scenario.
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.’’
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EPA has not found boscalid to share
a common mechanism of toxicity with
any other substances, and boscalid does
not appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
boscalid does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s website at https://
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.
In the 2-generation reproduction study
in rats, body weight effects were seen in
the mid-and-high doses in the second
generation male pups. However, the
degree of concern is low for the
quantitative evidence of susceptibility
seen in this study, since the body
weight effects were seen in only one sex
and only after dosing for two
generations. There is a clear NOAEL for
the body weight effects seen in the rat
2-generation reproduction study and
EPA is regulating based on a POD below
where these effects are seen.
In the developmental neurotoxicity
study, transient body weight effects
were seen in one sex at postnatal days
1–4 with the animals recovering by
postnatal day 11. Body weight effects
were also seen in the high dose, which
was the limit dose. The degree of
concern for these effects are low since
the effects are either transient in nature
or occurred at the limit dose and EPA
is regulating based on a POD below
where these effects are seen.
While qualitative sensitivity was seen
in the rabbit developmental study, the
fetal effects were seen only at the limit
dose in the presence of maternal
toxicity. Further, since EPA is regulating
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based on a POD which is an order of
magnitude below where these effects are
seen in the rabbit developmental study,
EPA concludes that the qualitative
sensitivity evidenced in the fetuses in
the rabbit developmental study does not
require retention of the 10X children’s
safety factor.
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 boscalid is
adequate for risk assessment, however
an immunotoxicity study (OPPTS
Guideline 870.7800) in rats and/or mice
is required under the new 40 CFR part
158 data regulations. No indication of
immunotoxicity was observed in the
toxicity database; therefore, an
additional 10X database uncertainty
factor (UF) is not warranted.
ii. There is no indication that boscalid
is a neurotoxic chemical and there is no
need for additional UFs to account for
neurotoxicity. There is no evidence of
neurotoxicity in the acute subchronic,
or developmental neurotoxicity studies.
The toxicity studies for boscalid
demonstrate that, in general, the
chemical has low mammalian toxicity,
and the database reveals no
reproductive, developmental, or
developmental neurotoxicity concerns.
iii. Data involving the testing of young
animals did show increased quantitative
sensitivity in the young with regard to
body weight effects, and qualitative
sensitivity was seen in one
developmental study. However, clear
NOAELs were identified for all of these
effects. Moreover, the body weight
effects at the LOAELs in these studies
were either transient or inconsistent,
and qualitative sensitivity occurred at
the limit dose in the presence of
maternal toxicity. Additionally, EPA is
regulating based on a POD below where
these effects are seen. EPA concludes
that there are no residual uncertainties
for pre- and/or post-natal toxicity.
iv. There are no residual uncertainties
identified in the exposure databases.
EPA has conservatively estimated
human exposure to boscalid, relying on
worst case exposures in food (assuming
all registered crops contain residues at
the tolerance level), and conservative
models, as well as pesticide-specific
data, in estimating exposure from
residues in drinking water, and from
residential uses. These assessments will
not underestimate the exposure and
risks posed by boscalid.
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E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic pesticide exposures are safe by
comparing aggregate exposure estimates
to the aPAD and cPAD. The aPAD and
cPAD represent the highest safe
exposures, taking into account all
appropriate SFs. EPA calculates the
aPAD and cPAD by dividing the POD by
all applicable UFs. For linear cancer
risks, EPA calculates the probability of
additional cancer cases given the
estimated aggregate exposure. Short-,
intermediate-, and chronic-term risks
are evaluated by comparing the
estimated aggregate food, water, and
residential exposure to the POD to
ensure that the MOE called for by the
product of all applicable UFs is not
exceeded.
1. Acute risk. An acute aggregate risk
assessment takes into account exposure
estimates from acute dietary
consumption of food and drinking
water. No adverse effect resulting from
a single-oral exposure was identified
and no acute dietary endpoint was
selected. Therefore, boscalid 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 boscalid from
food and water will utilize 33% of the
cPAD for children 1 to 2 years of age,
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
boscalid 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). Boscalid is currently
registered for use(s) that could result in
short-term residential exposure and the
Agency has determined that it is
appropriate to aggregate chronic
exposure through food and water with
short-term residential exposures to
boscalid.
Using the exposure assumptions
described in this unit for short-term
exposures, EPA has concluded the
combined short-term food, water, and
residential exposures aggregated result
in aggregate MOEs of 950 for the U.S.
population, 1,200 for females 13–49
years old, and 1,300 for youth 13–19
years old.
4. Intermediate-term risk.
Intermediate-term aggregate exposure
takes into account residential exposure
plus chronic exposure to food and water
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(considered to be a background
exposure level). Because no
intermediate term, non-occupational
exposures are anticipated from the use
of boscalid, an intermediate-term
aggregate risk assessment is not required
for boscalid.
5. Aggregate cancer risk for U.S.
population. Boscalid is classified as
exhibiting ‘‘suggestive evidence of
carcinogenicity.’’ Evidence of
carcinogenicity was seen in males
(significant trend, and pair-wise at the
high dose) and in females (trend only);
however, in both sexes no malignancies
were seen. Only benign tumors were
observed, and these occurred at dose
levels above the dose level used to
establish the cPAD. Additionally, there
is no concern for mutagencity.
Quantification of human cancer risk is
not required. Aggregate cancer exposure
and risk are not of concern. Therefore,
an aggregate risk assessment was not
conducted.
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 boscalid
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies
high performance liquid
chromatography/ultra violet (HPLC/
UV), and liquid chromatography/mass
spectrometry/tandem mass spectrometry
(LC/MS/MS) are available to enforce the
tolerance expressions. The methods 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.
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B. International Residue Limits
The Codex Alimentarius Commission
has established a MRL for residues of
boscalid in or on banana at 0.2 ppm,
which is equivalent to the current U.S.
tolerance. However, the recommended
U.S. tolerance is higher than the Codex
MRL. In the submitted field trials,
residues above the Codex MRL were
observed. As a result, it is not possible
to harmonize the banana tolerance with
the Codex MRL. There is a Codex
Maximum Residue for the residues of
boscalid in/on coffee beans at 0.05 ppm.
C. Response to Comments
One anonymous public comment was
received on November 5, 2008. The
commenter claimed that there was
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16:10 Sep 15, 2009
Jkt 217001
suggestive evidence of carcinogenic
effects from boscalid but that EPA had
not assessed these effects. In response,
EPA notes that, for the reasons set forth
in Unit II.A., EPA has concluded that
boscalid cPAD provides an adequate
margin of safety with regard to the
benign tumors seen in cancer studies
with boscalid.
D. Revisions to Petitioned-For
Tolerances
The petition requested that 40 CFR
180.589 be amended by increasing the
tolerance for residues of boscalid in or
on banana from 0.2 ppm to 0.5 ppm.
Based on the output from the tolerance
spreadsheet, the Agency recommends in
favor of the establishment of an import
tolerance of 0.40 ppm.
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an
Agency for good cause finds that notice
and public procedure are impracticable,
unnecessary or contrary to the public
interest, the Agency may issue a final
rule without providing notice and an
opportunity for public comment. EPA
has determined that there is good cause
for making today’s technical correction
final without prior proposal and
opportunity for comment, because EPA
is correcting an error in a prior tolerance
rulemaking for boscalid (73 FR 16553)
(March 28, 2008). In that action, EPA
amended the boscalid tolerances for
cucumber and vegetable, root, subgroup
1A , except sugar beet, garden beet,
radish, and turnip by increasing the
level of each of those tolerances.
Inadvertently, however, the revised
tolerance levels were added to the CFR
without removing the prior tolerances.
This action removes the prior
tolerances. EPA finds that this
constitutes good cause under 5 U.S.C.
553(b)(B).
V. Conclusion
Therefore, tolerances are amended for
residues of boscalid, in or on banana,
imported at 0.40 ppm, and established
for coffee, green bean, imported at 0.05
ppm. Additionally, the duplicate
boscalid tolerances for cucumber at 0.20
ppm, and vegetable, root, subgroup 1A,
except sugar beet, garden beet, radish,
and turnip at 0.7 ppm are removed
correcting the error in which these
superceded tolerances were not deleted
despite their amendment.
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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
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Federal Register / Vol. 74, No. 178 / Wednesday, September 16, 2009 / Rules and Regulations
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
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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).
*
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[FR Doc. E9–22163 Filed 9–15–09; 8:45 am]
BILLING CODE 6560–50–S
16:10 Sep 15, 2009
Jkt 217001
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5218; e-mail address:
stanton.susan@epa.gov.
SUPPLEMENTARY INFORMATION:
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0002; FRL–8434–1]
Acetochlor; Pesticide Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes
tolerances for residues of acetochlor,
including its metabolites and
degradates, in or on cotton, gin
byproducts; cotton, undelinted seed;
List of Subjects in 40 CFR Part 180
soybean, meal; and soybean, seed.
Environmental protection,
Monsanto Company requested these
Administrative practice and procedure,
tolerances under the Federal Food,
Agricultural commodities, Pesticides
Drug, and Cosmetic Act (FFDCA). This
and pests, Reporting and recordkeeping regulation also removes the existing
requirements.
tolerance for indirect or inadvertent
residues of acetochlor on soybean, seed.
Dated: August 25, 2009.
DATES: This regulation is effective
Lois A. Rossi,
September 16, 2009. Objections and
Director, Registration Division, Office of
requests for hearings must be received
Pesticide Programs.
on or before November 16, 2009, and
■ Therefore, 40 CFR chapter I is
must be filed in accordance with the
amended as follows:
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
PART 180—[AMENDED]
SUPPLEMENTARY INFORMATION).
■ 1. The authority citation for part 180
ADDRESSES: EPA has established a
continues to read as follows:
docket for this action under docket
Authority: 21 U.S.C. 321(q), 346a and 371.
identification (ID) number EPA–HQ–
OPP–2009–0002. All documents in the
■ 2. In § 180.589, the table to paragraph
docket are listed in the docket index
(a)(1) is amended by alphabetically
available at https://www.regulations.gov.
adding an entry for ‘‘coffee, green bean,
Although listed in the index, some
imported’’, by revising the entry for
information is not publicly available,
‘‘banana, import’’ and by removing the
e.g., Confidential Business Information
entry for ‘‘cucumber’’ with the limit of
(CBI) or other information whose
0.20 ppm and the entry for ‘‘vegetable,
disclosure is restricted by statute.
root, subgroup 1A, except sugar beet,
Certain other material, such as
garden beet, radish, and turnip’’ with
copyrighted material, is not placed on
the limit of 0.7 ppm. The added and
the Internet and will be publicly
revised entries read as follows:
available only in hard copy form.
Publicly available docket materials are
§ 180.589 Boscalid; tolerances for
available in the electronic docket at
residues.
https://www.regulations.gov, or, if only
(a)* * *(1) * * *
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
Parts per
Commodity
million
One Potomac Yard (South Bldg.), 2777
S. Crystal Dr., Arlington, VA. The
*
*
*
*
*
Docket Facility is open from 8:30 a.m.
Banana, import \1\ ....................
0.40 to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
*
*
*
*
*
Facility telephone number is (703) 305–
Coffee, green bean, import \1\ ..
0.05 5805.
*
*
*
*
*
FOR FURTHER INFORMATION CONTACT:
Susan Stanton, Registration Division
1No US registrations as of September 16,
(7505P), Office of Pesticide Programs,
2009.
Environmental Protection Agency, 1200
VerDate Nov<24>2008
47445
PO 00000
Frm 00011
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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 Access Electronic Copies
of this Document?
In addition to accessing electronically
available documents at https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of EPA′s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office′s e-CFR
cite at https://www.gpoaccess.gov/ecfr.
To access the OPPTS Harmonized
Guidelines referenced in this document,
go directly to the guidelines at https://
www.epa.gov/opptsfrs/home/
guidelin.htm.
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
E:\FR\FM\16SER1.SGM
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Agencies
[Federal Register Volume 74, Number 178 (Wednesday, September 16, 2009)]
[Rules and Regulations]
[Pages 47440-47445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22163]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0624; FRL-8431-1]
Boscalid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
boscalid in or on coffee, green bean imported and amends the tolerance
for banana, imported. BASF, Inc., requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation is also a
removing tolerance for cucumber, and one tolerance for vegetable, root,
subgroup 1A, except sugar beet, garden beet, radish, and turnip which
are superceded with higher tolerances formerly published in the Federal
Register of March 28, 2008 (73 FR 16553) (FRL-8354-4).
DATES: This regulation is effective September 16, 2009. Objections and
requests for hearings must be received on or before November 16, 2009,
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-2008-0624. All documents in the
docket are listed in the docket index available at https://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 https://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.
FOR FURTHER INFORMATION CONTACT: Bryant Crowe, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-0025; e-mail address: crowe.bryant@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 Access Electronic Copies of this Document?
In addition to accessing electronically available documents at
https://www.regulations.gov, you may access
[[Page 47441]]
this Federal Register document electronically through the EPA Internet
under the ``Federal Register'' listings at https://www.epa.gov/fedrgstr.
You may also access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at https://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2008-0624 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before November 16, 2009.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0624, by one of the following methods:
Federal eRulemaking Portal: https://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. Petition for Tolerances
In the Federal Register of November 5, 2008 (73 FR 65849) (FRL-
8385-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
8E7366, PP 8E7367) by BASF Corporation, P.O. Box 13528, 26 Davis Drive,
Research Triangle, NC 27709. The petitions requested that 40 CFR
180.589 be amended by increasing the tolerance for residues of the
fungicide boscalid, 3-pyridinecarboxamide, 2-chloro-N-(4'-chloro(1,1'-
biphenyl))-2-yl, in or on banana from 0.2 parts per million (ppm) to
0.5 ppm (PP 8E7366), and establishing a tolerance for coffee, green
bean at 0.05 ppm (PP 8E7367). That notice referenced a summary of the
petitions prepared by BASF Corporation, the registrant, which is
available to the public in the docket, https://www.regulations.gov. One
comment was received from a private citizen. EPA's response to comment
is discussed in Unit IV.C.
Additionally, in this action EPA is correcting an error in a prior
tolerance rulemaking for boscalid (73 FR 16553) (March 28, 2008). In
that action, EPA amended the boscalid tolerances for cucumber and
vegetable, root, subgroup 1A , except sugar beet, garden beet, radish,
and turnip by increasing the level of each of those tolerances.
Inadvertently, however, the revised tolerance levels were added to the
CFR without removing the prior tolerances. This action removes the
prior tolerances.
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 the petitioned-for
tolerances for residues of boscalid on banana, imported at 0.40 ppm,
and coffee, green bean, imported at 0.05 ppm. EPA's assessment of
exposures and risks associated with establishing tolerances follow.
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.
Boscalid has low acute toxicity via the oral, dermal, and
inhalation routes of exposure and is not an eye or skin irritant.
Dermal sensitization could not be determined because the skin
sensitization study was inadequate. The target organs for boscalid are
the thyroid and liver.
An acute endpoint was not selected because no adverse effects
attributable to a single exposure to boscalid were seen in the
database, including the developmental toxicity studies. The chronic
dietary, incidental oral, dermal, and inhalation endpoints were all
selected from three co-critical studies: The chronic rat study, the rat
carcinogenicity study, and a 1-year feeding study in dogs. The dose
selected for regulation of oral, dermal, and inhalation risk at all
durations, for all populations, is the ``no- observed-adverse-effect
level'' of 21.8 milligrams/kilogram/day (mg/kg/day) based on thyroid
and hepatic toxicity seen in rats and dogs at higher dose levels.
Boscalid is classified as exhibiting ``suggestive evidence of
carcinogenicity.'' Evidence of carcinogenicity was seen in males
(significant trend, and pair-wise at the high dose) and in females
(trend only) in rats or mice or both; however, in both sexes no
malignancies were seen. Only benign tumors were observed, and these
occurred at dose levels above the dose level used to establish the
chronic population adjusted dose (cPAD). Additionally, there is no
concern for mutagencity. EPA has concluded that the cPAD is protective
of any tumor response seen in the boscalid cancer studies.
Specific information on the studies received and the nature of the
adverse effects caused by boscalid as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-
[[Page 47442]]
adverse-effect-level (LOAEL) from the toxicity studies can be found at
https://www.regulations.gov in the ``Boscalid - Human Health Risk
Assessment of the Proposed Food Use of the Fungicide on Imported
Coffee'' on pages 16-21 in docket ID number EPA-HQ-OPP-2008-0624.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which the
NOAEL in the toxicology study identified as appropriate for use in risk
assessment. However, if a NOAEL cannot be determined, the lowest dose
at which adverse effects of concern are identified (the LOAEL) or a
Benchmark Dose (BMD) approach is sometimes used for risk assessment.
Uncertainty/safety factors (UFs) are used in conjunction with the POD
to take into account uncertainties inherent in the extrapolation from
laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns. Safety
is assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Aggregate short-, intermediate-, and chronic-term risks are evaluated
by comparing food, water, and residential exposure to the POD to ensure
that the margin of exposure (MOE) called for by the product of all
applicable UFs is not exceeded. This latter value is referred to as the
Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticides/factsheets/riskassess.htm; https://www.epa.gov/oppfead1/trac/science, and https://www.epa.gov/pesticides/trac/science/aggregate.pdf.
A summary of the toxicological endpoints for boscalid used for
human risk assessment can be found at https://www.regulations.gov in the
``Boscalid - Human Health Risk Assessment of the Proposed Food Use of
the Fungicide on Imported Coffee'' on pages 6-7 in docket ID number
EPA-HQ-OPP-2008-0624.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to boscalid, EPA considered exposure under the petitioned-for
tolerances as well as all existing boscalid tolerances in (40 CFR part
180.589). EPA assessed dietary exposures from boscalid 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 boscalid; therefore, a
quantitative acute dietary exposure assessment was not conducted.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the U.S. Department
of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys
of Food Intake by Individuals (CSFII), and accumulated exposure to the
chemical for each commodity. As to residue levels in food, EPA made the
following assumption for the chronic exposure assessments: The
assessment was based on tolerance level residues for existing uses,
recommended tolerance levels for banana and coffee, and 100% crop
treated assumptions.
iii. Cancer. For the reasons set forth in Unit II.A., EPA has
concluded that the cPAD is protective of any cancer effects with
boscalid. EPA's estimate of chronic exposure as described above is
relied upon to evaluate whether any exposure could exceed the cPAD and
thus pose a cancer risk.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for boscalid in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of boscalid. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
https://www.epa.gov/oppefed1/models/water/index.htm.
The current requests for an increased tolerance in banana, and a
new use on coffee, do not affect the estimated drinking water
concentrations (EDWCs) because both requests are for tolerances on
imported commodities. As a result, the EDWCs used in the previous
assessment ``Boscalid - Human Health Risk Assessment to support
proposed new uses on fresh herbs (herbs subgroup 19A), avocado, black
sapote, canistel, mamey sapote, mango, papaya, sapodilla, star apple
and cotton'' on page 15 in docket ID number EPA-HQ-OPP-2008-0624 at
https://www.regulations.gov were used in this assessment as well. The
EDWCs were based on the turf use.
Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the EDWCs of
boscalid for chronic exposures for non-cancer assessments are estimated
to be 29.6 ppb for surface water and 0.63 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.029 ppm was used to
assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Boscalid is currently registered for the following uses that could
result in residential exposures: Golf course turf, strawberries,
caneberries, and tree fruit grown at ``U-pick'' farms and orchards. EPA
assessed residential exposure using the following assumptions: Dermal
post-application exposure for golfers exposed to treated turf. The
duration of exposure is anticipated to be short-term.
Based on the low vapor pressure of boscalid (7 x 10-9 hPa), the
outdoor nature of the uses, and the weight of evidence from available
residue studies, the Agency does not anticipate post-application
inhalation exposures from the currently approved uses of boscalid.
In addition, U-pick activities are considered to be one-time (<1
day) events. As no adverse effects were seen in the boscalid toxicity
database resulting from a single exposure to the chemical a post-
application exposure assessment is not required for this scenario.
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.''
[[Page 47443]]
EPA has not found boscalid to share a common mechanism of toxicity
with any other substances, and boscalid does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that boscalid does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's website at https://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. In the 2-generation
reproduction study in rats, body weight effects were seen in the mid-
and-high doses in the second generation male pups. However, the degree
of concern is low for the quantitative evidence of susceptibility seen
in this study, since the body weight effects were seen in only one sex
and only after dosing for two generations. There is a clear NOAEL for
the body weight effects seen in the rat 2-generation reproduction study
and EPA is regulating based on a POD below where these effects are
seen.
In the developmental neurotoxicity study, transient body weight
effects were seen in one sex at postnatal days 1-4 with the animals
recovering by postnatal day 11. Body weight effects were also seen in
the high dose, which was the limit dose. The degree of concern for
these effects are low since the effects are either transient in nature
or occurred at the limit dose and EPA is regulating based on a POD
below where these effects are seen.
While qualitative sensitivity was seen in the rabbit developmental
study, the fetal effects were seen only at the limit dose in the
presence of maternal toxicity. Further, since EPA is regulating based
on a POD which is an order of magnitude below where these effects are
seen in the rabbit developmental study, EPA concludes that the
qualitative sensitivity evidenced in the fetuses in the rabbit
developmental study does not require retention of the 10X children's
safety factor.
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 boscalid is adequate for risk
assessment, however an immunotoxicity study (OPPTS Guideline 870.7800)
in rats and/or mice is required under the new 40 CFR part 158 data
regulations. No indication of immunotoxicity was observed in the
toxicity database; therefore, an additional 10X database uncertainty
factor (UF) is not warranted.
ii. There is no indication that boscalid is a neurotoxic chemical
and there is no need for additional UFs to account for neurotoxicity.
There is no evidence of neurotoxicity in the acute subchronic, or
developmental neurotoxicity studies. The toxicity studies for boscalid
demonstrate that, in general, the chemical has low mammalian toxicity,
and the database reveals no reproductive, developmental, or
developmental neurotoxicity concerns.
iii. Data involving the testing of young animals did show increased
quantitative sensitivity in the young with regard to body weight
effects, and qualitative sensitivity was seen in one developmental
study. However, clear NOAELs were identified for all of these effects.
Moreover, the body weight effects at the LOAELs in these studies were
either transient or inconsistent, and qualitative sensitivity occurred
at the limit dose in the presence of maternal toxicity. Additionally,
EPA is regulating based on a POD below where these effects are seen.
EPA concludes that there are no residual uncertainties for pre- and/or
post-natal toxicity.
iv. There are no residual uncertainties identified in the exposure
databases. EPA has conservatively estimated human exposure to boscalid,
relying on worst case exposures in food (assuming all registered crops
contain residues at the tolerance level), and conservative models, as
well as pesticide-specific data, in estimating exposure from residues
in drinking water, and from residential uses. These assessments will
not underestimate the exposure and risks posed by boscalid.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
boscalid 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
boscalid from food and water will utilize 33% of the cPAD for children
1 to 2 years of age, 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
boscalid 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). Boscalid is
currently registered for use(s) that could result in short-term
residential exposure and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to boscalid.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures aggregated result in aggregate MOEs of 950
for the U.S. population, 1,200 for females 13-49 years old, and 1,300
for youth 13-19 years old.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water
[[Page 47444]]
(considered to be a background exposure level). Because no intermediate
term, non-occupational exposures are anticipated from the use of
boscalid, an intermediate-term aggregate risk assessment is not
required for boscalid.
5. Aggregate cancer risk for U.S. population. Boscalid is
classified as exhibiting ``suggestive evidence of carcinogenicity.''
Evidence of carcinogenicity was seen in males (significant trend, and
pair-wise at the high dose) and in females (trend only); however, in
both sexes no malignancies were seen. Only benign tumors were observed,
and these occurred at dose levels above the dose level used to
establish the cPAD. Additionally, there is no concern for mutagencity.
Quantification of human cancer risk is not required. Aggregate cancer
exposure and risk are not of concern. Therefore, an aggregate risk
assessment was not conducted.
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 boscalid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodologies high performance liquid
chromatography/ultra violet (HPLC/UV), and liquid chromatography/mass
spectrometry/tandem mass spectrometry (LC/MS/MS) are available to
enforce the tolerance expressions. The methods 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
The Codex Alimentarius Commission has established a MRL for
residues of boscalid in or on banana at 0.2 ppm, which is equivalent to
the current U.S. tolerance. However, the recommended U.S. tolerance is
higher than the Codex MRL. In the submitted field trials, residues
above the Codex MRL were observed. As a result, it is not possible to
harmonize the banana tolerance with the Codex MRL. There is a Codex
Maximum Residue for the residues of boscalid in/on coffee beans at 0.05
ppm.
C. Response to Comments
One anonymous public comment was received on November 5, 2008. The
commenter claimed that there was suggestive evidence of carcinogenic
effects from boscalid but that EPA had not assessed these effects. In
response, EPA notes that, for the reasons set forth in Unit II.A., EPA
has concluded that boscalid cPAD provides an adequate margin of safety
with regard to the benign tumors seen in cancer studies with boscalid.
D. Revisions to Petitioned-For Tolerances
The petition requested that 40 CFR 180.589 be amended by increasing
the tolerance for residues of boscalid in or on banana from 0.2 ppm to
0.5 ppm. Based on the output from the tolerance spreadsheet, the Agency
recommends in favor of the establishment of an import tolerance of 0.40
ppm.
Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(B), provides that, when an Agency for good cause finds that
notice and public procedure are impracticable, unnecessary or contrary
to the public interest, the Agency may issue a final rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making today's technical
correction final without prior proposal and opportunity for comment,
because EPA is correcting an error in a prior tolerance rulemaking for
boscalid (73 FR 16553) (March 28, 2008). In that action, EPA amended
the boscalid tolerances for cucumber and vegetable, root, subgroup 1A ,
except sugar beet, garden beet, radish, and turnip by increasing the
level of each of those tolerances. Inadvertently, however, the revised
tolerance levels were added to the CFR without removing the prior
tolerances. This action removes the prior tolerances. EPA finds that
this constitutes good cause under 5 U.S.C. 553(b)(B).
V. Conclusion
Therefore, tolerances are amended for residues of boscalid, in or
on banana, imported at 0.40 ppm, and established for coffee, green
bean, imported at 0.05 ppm. Additionally, the duplicate boscalid
tolerances for cucumber at 0.20 ppm, and vegetable, root, subgroup 1A,
except sugar beet, garden beet, radish, and turnip at 0.7 ppm are
removed correcting the error in which these superceded tolerances were
not deleted despite their amendment.
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) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology
[[Page 47445]]
Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113,
section 12(d) (15 U.S.C. 272 note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 25, 2009.
Lois A. Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. In Sec. 180.589, the table to paragraph (a)(1) is amended by
alphabetically adding an entry for ``coffee, green bean, imported'', by
revising the entry for ``banana, import'' and by removing the entry for
``cucumber'' with the limit of 0.20 ppm and the entry for ``vegetable,
root, subgroup 1A, except sugar beet, garden beet, radish, and turnip''
with the limit of 0.7 ppm. The added and revised entries read as
follows:
Sec. 180.589 Boscalid; tolerances for residues.
(a)* * *(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Banana, import \\1\\....................................... 0.40
* * * * *
Coffee, green bean, import \\1\\........................... 0.05
* * * * *
------------------------------------------------------------------------
1No US registrations as of September 16, 2009.
* * * * *
[FR Doc. E9-22163 Filed 9-15-09; 8:45 am]
BILLING CODE 6560-50-S