Kasugamycin; Pesticide Tolerances for Emergency Exemptions, 19268-19272 [2010-8133]
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Inert ingredients
Limits
Uses
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Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10–
3, 2601–33–4 and 693–33–4
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20% by weight in pesticide formulation
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§ 180.930 Inert ingredients applied to
animals; exemptions from the requirement
of a tolerance.
3. In §180.930, in the table add
alphabetically the following inert
ingredient to read as follows:
■
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Inert ingredients
Limits
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Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10–
3, 2601–33–4 and 693–33–4
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20% by weight in pesticide formulation
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[FR Doc. 2010–8298 Filed 4–13–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2008–0695; FRL–8808–7]
Kasugamycin; Pesticide Tolerances for
Emergency Exemptions
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
This regulation establishes a
time-limited tolerance for residues of
kasugamycin, 3-O-[2-amino-4[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol in or on apples. This
action is in response to EPA’s granting
of an emergency exemption under
section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the agricultural
bactericide on apples. This regulation
establishes a maximum permissible
level for residues of kasugamycin in this
food commodity. The time-limited
tolerance expires and is revoked on
December 31, 2012.
DATES: This regulation is effective April
14, 2010. Objections and requests for
hearings must be received on or before
June 14, 2010, 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–2008–0695. All documents in the
docket are listed in the docket index
available in https://www.regulations.gov.
SUMMARY:
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Surfactant
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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:
Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9367; e-mail address:
ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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Uses
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This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Get Electronic Access to
Other Related Information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
OPPTS harmonized test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/oppts and select ‘‘Test
Methods and Guidelines.’’
C. Can I File an Objection or Hearing
Request?
Under section 408(g) of the Federal
Food, Drug, and Cosmetic Act (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. The EPA procedural
regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2008–0695 in the subject line on
the first page of your submission. All
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requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before June 14, 2010.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2008–0695, 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. Background and Statutory Findings
EPA, on its own initiative, in
accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e)
and 346a(1)(6), is establishing a timelimited tolerance for residues of the
agricultural bactericide kasugamycin,3O-[2-amino-4[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol in or on apples at 0.05
parts per million (ppm). This timelimited tolerance expires and is revoked
on December 31, 2012. EPA will publish
a document in the Federal Register to
remove the revoked tolerances from the
CFR.
Section 408(l)(6) of FFDCA requires
EPA to establish a time-limited
tolerance or exemption from the
requirement for a tolerance for pesticide
chemical residues in food that will
result from the use of a pesticide under
an emergency exemption granted by
EPA under section 18 of FIFRA. Such
tolerances can be established without
providing notice or period for public
comment. EPA does not intend for its
actions on FIFRA section 18 related
time-limited tolerances to set binding
precedents for the application of section
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408 of FFDCA and the new safety
standard to other tolerances and
exemptions. Section 408(e) of FFDCA
allows EPA to establish a tolerance or an
exemption from the requirement of a
tolerance on its own initiative, i.e.,
without having received any petition
from an outside party.
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. . . .’’
Section 18 of FIFRA authorizes EPA
to exempt any Federal or State agency
from any provision of FIFRA, if EPA
determines that ‘‘emergency conditions
exist which require such exemption.’’
EPA has established regulations
governing such emergency exemptions
in 40 CFR part 166.
III. Emergency Exemption for
Kasugamycin on Apples and FFDCA
Tolerances
The State of Michigan requested the
use of kasugamycin on apples to control
severe infestations of the bacteria
responsible for the disease fire blight.
After having reviewed the submission,
EPA determined that emergency
conditions exist for this State, and that
the criteria for an emergency exemption
are met. EPA has authorized under
FIFRA section 18 the use of
kasugamycin on apples for control of
fire blight in Michigan.
As part of its evaluation of the
emergency exemption application, EPA
assessed the potential risks presented by
residues of kasugamycin in or on
apples. In doing so, EPA considered the
safety standard in section 408(b)(2) of
FFDCA, and EPA decided that the
necessary tolerance under section
408(l)(6) of FFDCA would be consistent
with the safety standard and with
FIFRA section 18. Consistent with the
need to move quickly on the emergency
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exemption in order to address an urgent
non-routine situation and to ensure that
the resulting food is safe and lawful,
EPA is issuing this tolerance without
notice and opportunity for public
comment as provided in section
408(l)(6) of FFDCA. Although these
time-limited tolerances expire and are
revoked on December 31, 2012, under
section 408(l)(5) of FFDCA, residues of
the pesticide not in excess of the
amounts specified in the tolerance
remaining in or on apples after that date
will not be unlawful, provided the
pesticide was applied in a manner that
was lawful under FIFRA, and the
residues do not exceed a level that was
authorized by these time-limited
tolerances at the time of that
application. EPA will take action to
revoke these time-limited tolerances
earlier if any experience with, scientific
data on, or other relevant information
on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances
are being approved under emergency
conditions, EPA has not made any
decisions about whether kasugamycin
meets FIFRA’s registration requirements
for use on apples or whether permanent
tolerances for this use would be
appropriate. Under these circumstances,
EPA does not believe that this timelimited tolerance decision serves as a
basis for registration of kasugamycin by
a State for special local needs under
FIFRA section 24(c). Nor does this
tolerance serve as the basis for persons
in any State other than Michigan to use
this pesticide on these crops under
FIFRA section 18 absent the issuance of
an emergency exemption applicable
within that State. For additional
information regarding the emergency
exemption for kasugamycin, contact the
Agency’s Registration Division at the
address provided under FOR FURTHER
INFORMATION CONTACT.
IV. 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
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give special consideration to exposure
of infants and children to the pesticide
chemical residue in establishing a
tolerance and to ‘‘ensure that there is a
reasonable certainty that no harm will
result to infants and children from
aggregate exposure to the pesticide
chemical residue....’’
Consistent with the factors specified
in FFDCA section 408(b)(2)(D), EPA has
reviewed the available scientific data
and other relevant information in
support of this action. EPA has
sufficient data to assess the hazards of
and to make a determination on
aggregate exposure expected as a result
of this emergency exemption request
and the time-limited tolerances for
residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol on apples at 0.05 ppm.
EPA’s assessment of exposures and risks
associated with establishing timelimited tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, a toxicological point of departure
(POD) is identified as the basis for
derivation of reference values for risk
assessment. The POD may be defined as
the highest dose at which no adverse
effects are observed (the NOAEL) in the
toxicology study identified as
appropriate for use in risk assessment.
However, if a NOAEL cannot be
determined, the lowest dose at which
adverse effects of concern are identified
(the LOAEL) or a benchmark dose
(BMD) approach is sometimes used for
risk assessment. Uncertainty/safety
factors (UFs) 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,
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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.
A summary of the toxicological
endpoints for kasugamycin used for
human risk assessment can be found at
https://www.regulations.gov in document
‘‘Kasugamycin. Human Health Risk
Assessment for the Proposed Food/Feed
Use of the Fungicide (Associated with
Section 18 Registration) on Apples in
Michigan,’’ page 8 in docket ID number
EPA–HQ–OPP–2008–0695. On page 9 of
that assessment there is also a
qualitative evaluation of the risks for
development of resistant pathogenic
bacteria, in consideration of factors
recommended by public health experts
to sustain the effectiveness of antibiotic
materials. Field use of this chemical
under the section 18 involved measures
and requirements to limit, manage, and
monitor for resistant bacteria. The terms
of use are included in this docket.
B. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to kasugamycin, EPA
considered exposure under the timelimited tolerances established by this
action as well as all existing
kasugamycin tolerances in (40 CFR
180.614). EPA assessed dietary
exposures from kasugamycin in food as
follows:
i. Acute exposure. No such effects
were identified in the toxicological
studies for kasugamycin; 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 100 percent crop treated (PCT)
and default processing factors were
used. The chronic dietary assessment is
highly conservative, and therefore
provides an upper-bound estimate of
dietary exposure and risk.
iii. Cancer. Kasugamycin has been
classified by the Agency as not likely to
be carcinogenic to humans and
therefore, a cancer exposure assessment
was not conducted.
iv. Anticipated residue and PCT
information. EPA did not use
anticipated residue and/or PCT
information in the dietary assessment
for kasugamycin. Tolerance level
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residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking
water. The Agency used screening level
water exposure models in the dietary
exposure analysis and risk assessment
for kasugamycin in drinking water.
These simulation models take into
account data on the physical, chemical,
and fate/transport characteristics of
kasugamycin. 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.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated drinking
water concentrations (EDWCs) of
kasugamycin for chronic exposures for
non-cancer assessments are estimated to
be 0.0214 ppb for surface water and
0.278 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 0.278 ppb
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).
Kasugamycin is not registered for any
specific use patterns that would result
in residential exposure.
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 kasugamycin to
share a common mechanism of toxicity
with any other substances, and
kasugamycin does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that kasugamycin 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 the policy statements
released by EPA’s Office of Pesticide
Programs concerning common
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mechanism determinations and
procedures for cumulating effects from
substances found to have a common
mechanism on EPA’s website at https://
www.epa.gov/pesticides/cumulative.
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C. 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 SF. In applying this provision,
EPA either retains the default value of
10X, or uses a different additional SF
when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity.
No increased quantitative or qualitative
susceptibility was observed in the
developmental rat or rabbit studies or in
the 2–generation reproduction study. No
offspring toxicity was observed at any of
the doses tested in these three studies.
Reproductive toxicity was noted in the
F1 generation of the 2–generation
reproduction study. However, because
parental toxicity (decreased body
weights and body weight gains)
occurred at a lower dose than that
which resulted in effects on
reproduction, there is no increased
quantitative or qualitative susceptibility
of the offspring.
3. Conclusion. There was no evidence
of neurotoxicity in any of the studies
available in the toxicology database,
including the subchronic feeding
studies, the chronic feeding studies, the
developmental toxicity studies, and the
2–generation reproduction study.
Therefore, acute and subchronic
neurotoxicity studies are not required. A
developmental neurotoxicity study is
not required because:
EPA has determined that reliable data
show that 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
kasugamycin is considered adequate to
characterize potential toxic effects on
infants and children.
ii. There is no indication that
kasugamycin is a neurotoxic chemical
and there is no need for a
developmental neurotoxicity study or
additional UFs to account for
neurotoxicity.
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iii. There is no evidence that
kasugamycin results in increased
susceptibility in in utero rats or rabbits
in the prenatal developmental studies or
in young rats in the 2–generation
reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100 PCT and
tolerance-level residues. EPA made
conservative (protective) assumptions in
the ground and surface water modeling
used to assess exposure to kasugamycin
in drinking water. These assessments
will not underestimate the exposure and
risks posed by kasugamycin.
to kasugamycin through food and water
and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S.
population. Kasugamycin is classified as
a not likely to be carcinogenic to
humans, and therefore, EPA does not
expect kasugamycin to pose a cancer
risk.
5. 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 kasugamycin
residues.
D. 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,
therefore, no acute dietary endpoint was
selected. Therefore, kasugamycin 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 kasugamycin
from food and water will utilize 20% of
the cPAD for all infants less than 1 year
old, the population group receiving the
greatest exposure. There are no
residential uses for kasugamycin.
3. Short-and intermediate term risk.
Short- and intermediate-term aggregate
exposure take into account short- and
intermediate-term residential exposure
plus chronic exposure to food and water
(considered to be a background
exposure level).
Kasugamycin is not registered for any
use patterns that would result in
residential exposure. Therefore, the
short- and intermediate-term aggregate
risk is the sum of the risk from exposure
A. Analytical Enforcement Methodology
Adequate enforcement methodology
is available to enforce the tolerance
expression. The method may be
requested from: Chief, Analytical
Chemistry Branch, Environmental
Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755–5350; telephone
number: (410) 305–2905; e-mail address:
residuemethods@epa.gov.
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V. Other Considerations
B. International Residue Limits
There are no established Canadian,
Mexican, or Codex Maximum Residue
Limits (MRLs) for kasugamycin residues
in apple commodities.
VI. Conclusion
Therefore, a time-limited tolerance is
established for residues of kasugamycin,
3-O-[2-amino-4[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol in or on apples at 0.05
ppm. This tolerance expires and is
revoked on December 31, 2012.
VII. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under sections 408(e) and 408(l)(6) of
FFDCA. 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
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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 in accordance with
sections 408(e) and 408(l)(6) of FFDCA,
such as the tolerance in this final rule,
do not require the issuance of a
proposed rule, the requirements of the
Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
VIII. 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
VerDate Nov<24>2008
16:13 Apr 13, 2010
Jkt 220001
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: April 1, 2010.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
■
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.614 is amended by
revising paragraph (b) to read as follows:
■
§ 180.614 Kasugamycin; tolerances for
residues.
*
*
*
*
*
(b) Section 18 emergency exemptions.
Time-limited tolerances specified in the
following table are established for
residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6tetradeoxy-a-D-arabino-hexopyranosyl]D-chiro-inositol in or on the specified
agricultural commodities, resulting from
use of the pesticide pursuant to FFIFRA
section 18 emergency exemptions. The
tolerances expire and are revoked on the
date specified in the table.
Commodity
Apple
*
Parts per million
0.05
*
*
*
Expiration/
revocation
date
12/31/12
*
[FR Doc. 2010–8133 Filed 4–13–10; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2009–0134; FRL–8818-9]
Thifensulfuron methyl; Pesticide
Tolerances
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes a
tolerance for residues of thifensulfuron
methyl in or on safflower, seed.
Interregional Research Project Number 4
PO 00000
Frm 00088
Fmt 4700
Sfmt 4700
(IR-4) requested this tolerance under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
DATES: This regulation is effective April
14, 2010. Objections and requests for
hearings must be received on or before
June 14, 2010, 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–2009–0134. 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:
Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–6463; e-mail address:
madden.barbara@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
E:\FR\FM\14APR1.SGM
14APR1
Agencies
[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Rules and Regulations]
[Pages 19268-19272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8133]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0695; FRL-8808-7]
Kasugamycin; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a time-limited tolerance for
residues of kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-
2,3,4,6-tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in
or on apples. This action is in response to EPA's granting of an
emergency exemption under section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the
agricultural bactericide on apples. This regulation establishes a
maximum permissible level for residues of kasugamycin in this food
commodity. The time-limited tolerance expires and is revoked on
December 31, 2012.
DATES: This regulation is effective April 14, 2010. Objections and
requests for hearings must be received on or before June 14, 2010, 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-2008-0695. All documents in the
docket are listed in the docket index available in 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9367; e-mail address: ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Electronic Access to Other Related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines
referenced in this document electronically, please go to https://www.epa.gov/oppts and select ``Test Methods and Guidelines.''
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the Federal Food, Drug, and Cosmetic Act
(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.
The EPA procedural regulations which govern the submission of
objections and requests for hearings appear in 40 CFR part 178. You
must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2008-0695 in the subject line on the first page of your submission. All
[[Page 19269]]
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before June 14, 2010.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2008-0695, 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. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a
time-limited tolerance for residues of the agricultural bactericide
kasugamycin,3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on
apples at 0.05 parts per million (ppm). This time-limited tolerance
expires and is revoked on December 31, 2012. EPA will publish a
document in the Federal Register to remove the revoked tolerances from
the CFR.
Section 408(l)(6) of FFDCA requires EPA to establish a time-limited
tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
FIFRA section 18 related time-limited tolerances to set binding
precedents for the application of section 408 of FFDCA and the new
safety standard to other tolerances and exemptions. Section 408(e) of
FFDCA allows EPA to establish a tolerance or an exemption from the
requirement of a tolerance on its own initiative, i.e., without having
received any petition from an outside party.
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. . .
.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' EPA has established
regulations governing such emergency exemptions in 40 CFR part 166.
III. Emergency Exemption for Kasugamycin on Apples and FFDCA Tolerances
The State of Michigan requested the use of kasugamycin on apples to
control severe infestations of the bacteria responsible for the disease
fire blight. After having reviewed the submission, EPA determined that
emergency conditions exist for this State, and that the criteria for an
emergency exemption are met. EPA has authorized under FIFRA section 18
the use of kasugamycin on apples for control of fire blight in
Michigan.
As part of its evaluation of the emergency exemption application,
EPA assessed the potential risks presented by residues of kasugamycin
in or on apples. In doing so, EPA considered the safety standard in
section 408(b)(2) of FFDCA, and EPA decided that the necessary
tolerance under section 408(l)(6) of FFDCA would be consistent with the
safety standard and with FIFRA section 18. Consistent with the need to
move quickly on the emergency exemption in order to address an urgent
non-routine situation and to ensure that the resulting food is safe and
lawful, EPA is issuing this tolerance without notice and opportunity
for public comment as provided in section 408(l)(6) of FFDCA. Although
these time-limited tolerances expire and are revoked on December 31,
2012, under section 408(l)(5) of FFDCA, residues of the pesticide not
in excess of the amounts specified in the tolerance remaining in or on
apples after that date will not be unlawful, provided the pesticide was
applied in a manner that was lawful under FIFRA, and the residues do
not exceed a level that was authorized by these time-limited tolerances
at the time of that application. EPA will take action to revoke these
time-limited tolerances earlier if any experience with, scientific data
on, or other relevant information on this pesticide indicate that the
residues are not safe.
Because these time-limited tolerances are being approved under
emergency conditions, EPA has not made any decisions about whether
kasugamycin meets FIFRA's registration requirements for use on apples
or whether permanent tolerances for this use would be appropriate.
Under these circumstances, EPA does not believe that this time-limited
tolerance decision serves as a basis for registration of kasugamycin by
a State for special local needs under FIFRA section 24(c). Nor does
this tolerance serve as the basis for persons in any State other than
Michigan to use this pesticide on these crops under FIFRA section 18
absent the issuance of an emergency exemption applicable within that
State. For additional information regarding the emergency exemption for
kasugamycin, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.
IV. 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
[[Page 19270]]
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue....''
Consistent with the factors specified in FFDCA section
408(b)(2)(D), EPA has reviewed the available scientific data and other
relevant information in support of this action. EPA has sufficient data
to assess the hazards of and to make a determination on aggregate
exposure expected as a result of this emergency exemption request and
the time-limited tolerances for residues of kasugamycin, 3-O-[2-amino-
4-[(carboxyiminomethyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-arabino-
hexopyranosyl]-D-chiro-inositol on apples at 0.05 ppm. EPA's assessment
of exposures and risks associated with establishing time-limited
tolerances follows.
A. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
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.
A summary of the toxicological endpoints for kasugamycin used for
human risk assessment can be found at https://www.regulations.gov in
document ``Kasugamycin. Human Health Risk Assessment for the Proposed
Food/Feed Use of the Fungicide (Associated with Section 18
Registration) on Apples in Michigan,'' page 8 in docket ID number EPA-
HQ-OPP-2008-0695. On page 9 of that assessment there is also a
qualitative evaluation of the risks for development of resistant
pathogenic bacteria, in consideration of factors recommended by public
health experts to sustain the effectiveness of antibiotic materials.
Field use of this chemical under the section 18 involved measures and
requirements to limit, manage, and monitor for resistant bacteria. The
terms of use are included in this docket.
B. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to kasugamycin, EPA considered exposure under the time-limited
tolerances established by this action as well as all existing
kasugamycin tolerances in (40 CFR 180.614). EPA assessed dietary
exposures from kasugamycin in food as follows:
i. Acute exposure. No such effects were identified in the
toxicological studies for kasugamycin; 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 100 percent
crop treated (PCT) and default processing factors were used. The
chronic dietary assessment is highly conservative, and therefore
provides an upper-bound estimate of dietary exposure and risk.
iii. Cancer. Kasugamycin has been classified by the Agency as not
likely to be carcinogenic to humans and therefore, a cancer exposure
assessment was not conducted.
iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for kasugamycin. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for kasugamycin in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of kasugamycin. 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.
Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of kasugamycin for
chronic exposures for non-cancer assessments are estimated to be 0.0214
ppb for surface water and 0.278 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 0.278 ppb 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).
Kasugamycin is not registered for any specific use patterns that
would result in residential exposure.
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 kasugamycin to share a common mechanism of
toxicity with any other substances, and kasugamycin does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
kasugamycin 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 the policy statements
released by EPA's Office of Pesticide Programs concerning common
[[Page 19271]]
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at https://www.epa.gov/pesticides/cumulative.
C. 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 SF. In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional SF when reliable data available to EPA
support the choice of a different factor.
2. Prenatal and postnatal sensitivity. No increased quantitative or
qualitative susceptibility was observed in the developmental rat or
rabbit studies or in the 2-generation reproduction study. No offspring
toxicity was observed at any of the doses tested in these three
studies. Reproductive toxicity was noted in the F1 generation of the 2-
generation reproduction study. However, because parental toxicity
(decreased body weights and body weight gains) occurred at a lower dose
than that which resulted in effects on reproduction, there is no
increased quantitative or qualitative susceptibility of the offspring.
3. Conclusion. There was no evidence of neurotoxicity in any of the
studies available in the toxicology database, including the subchronic
feeding studies, the chronic feeding studies, the developmental
toxicity studies, and the 2-generation reproduction study. Therefore,
acute and subchronic neurotoxicity studies are not required. A
developmental neurotoxicity study is not required because:
EPA has determined that reliable data show that 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 kasugamycin is considered adequate to
characterize potential toxic effects on infants and children.
ii. There is no indication that kasugamycin 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 kasugamycin results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to kasugamycin in drinking water. These assessments
will not underestimate the exposure and risks posed by kasugamycin.
D. 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, therefore, no acute dietary endpoint was selected.
Therefore, kasugamycin 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
kasugamycin from food and water will utilize 20% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for kasugamycin.
3. Short-and intermediate term risk. Short- and intermediate-term
aggregate exposure take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Kasugamycin is not registered for any use patterns that would
result in residential exposure. Therefore, the short- and intermediate-
term aggregate risk is the sum of the risk from exposure to kasugamycin
through food and water and will not be greater than the chronic
aggregate risk.
4. Aggregate cancer risk for U.S. population. Kasugamycin is
classified as a not likely to be carcinogenic to humans, and therefore,
EPA does not expect kasugamycin to pose a cancer risk.
5. 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 kasugamycin residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail
address: residuemethods@epa.gov.
B. International Residue Limits
There are no established Canadian, Mexican, or Codex Maximum
Residue Limits (MRLs) for kasugamycin residues in apple commodities.
VI. Conclusion
Therefore, a time-limited tolerance is established for residues of
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on
apples at 0.05 ppm. This tolerance expires and is revoked on December
31, 2012.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under sections 408(e) and
408(l)(6) of FFDCA. 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
[[Page 19272]]
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 in accordance
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VIII. 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: April 1, 2010.
Lois 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. Section 180.614 is amended by revising paragraph (b) to read as
follows:
Sec. 180.614 Kasugamycin; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances
specified in the following table are established for residues of
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on
the specified agricultural commodities, resulting from use of the
pesticide pursuant to FFIFRA section 18 emergency exemptions. The
tolerances expire and are revoked on the date specified in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Apple 0.05 12/31/12
------------------------------------------------------------------------
* * * * *
[FR Doc. 2010-8133 Filed 4-13-10; 8:45 am]
BILLING CODE 6560-50-S