Polyoxin D Zinc Salt; Amendment to an Exemption From the Requirement of a Tolerance, 56128-56133 [2012-22315]
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56128
Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations
EPA-APPROVED REGULATIONS IN THE WEST VIRGINIA SIP
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–1028; FRL–9360–6]
RIN 2070
Polyoxin D Zinc Salt; Amendment to an
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation amends the
existing exemption from the
requirement of a tolerance for residues
of polyoxin D zinc salt when used as a
fungicide on almonds, cucurbit
vegetables, fruiting vegetables, ginseng,
grapes, pistachios, pome fruits, potatoes,
and strawberries by expanding the
current exemption to include all food
commodities. This regulation
establishes an exemption from the
requirement of a tolerance for residues
of polyoxin D zinc salt in or on all food
commodities when applied as a
fungicide and used in accordance with
good agricultural practices. On behalf of
Kaken Pharmaceutical Co., Ltd., Conn &
Smith, Inc. submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting that
EPA amend the existing exemption from
the requirement of a tolerance for
polyoxin D zinc salt. This regulation
eliminates the need to establish a
maximum permissible level for residues
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Incorporation by reference of
the National Ambient Air
Quality Standards.
Revised section moved from
45–8–3 to 45–8–2.
Section was revised to read
new title and content.
Revised section moved from
45–8–7 to 45–8–4.
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I. General Information
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
DATES:
18:29 Sep 11, 2012
*
This regulation is effective
September 12, 2012. Objections and
requests for hearings must be received
on or before November 13, 2012, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
BILLING CODE 6560–50–P
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of polyoxin D zinc salt under the
FFDCA.
*
[FR Doc. 2012–22338 Filed 9–11–12; 8:45 am]
SUMMARY:
Additional explanation/
citation at 40 CFR 52.2565
EPA approval date
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–1028, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets .
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Colin G. Walsh, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; telephone number:
(703) 308–0298; email address:
walsh.colin@epa.gov.
SUPPLEMENTARY INFORMATION:
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A. Does this action apply to me?
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://
ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
To access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines. ’’
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
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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–2011–1028 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 13, 2012. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2011–1028, by one of the following
methods:
• Federal eRulemaking Portal : https://
www.regulations.gov . Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be (CBI) or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of March 14,
2012 (77 FR 15012) (FRL–9335–9), EPA
issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
tolerance petition (PP 1F7940) by Conn
& Smith, Inc., Agent, 6713 Catskill
Road, Lorton, VA 22079, on behalf of
Kaken Pharmaceutical Co., Ltd. The
petition requested that 40 CFR 180.1285
be amended by expanding the current
exemption to include all food
commodities, thus establishing an
exemption from the requirement of a
tolerance for residues of polyoxin D zinc
salt in or on all food commodities. This
notice referenced a summary of the
petition prepared by the petitioner Conn
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& Smith, Inc., on behalf of Kaken
Pharmaceutical Co., Ltd., which is
available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(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. Pursuant to
FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in FFDCA section
408(b)(2)(C), which require 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. * * * ’’ Additionally,
FFDCA section 408(b)(2)(D) requires
that the Agency consider’’ available
information concerning the cumulative
effects of such residues and other
substances that have a common
mechanism of toxicity.’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
Consistent with FFDCA section
408(b)(2)(D), EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness and reliability, and the
relationship of this information 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.
EPA established a tolerance
exemption for polyoxin D zinc salt in a
final rule published in the Federal
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56129
Register on November 19, 2008, (73 FR
69559) (FRL–8389–5), which supported
the uses as a fungicide on almonds,
cucurbit vegetables, fruiting vegetables,
ginseng, grapes, pistachios, pome fruits,
potatoes, and strawberries. The
toxicological data submitted to support
the previous tolerance exemption
included the following: Acute (six-pack)
toxicity, mutagenicity, subchronic (90day oral), developmental, and chronic/
oncogenicity studies. All of the studies/
information submitted to support the
previous tolerance exemption indicated
a lack of toxicity hazards for mammals,
and EPA concluded that there is a
reasonable certainty of no harm to
humans, including infants and children,
from the proposed food uses of polyoxin
D zinc salt. This amendment proposes
to expand the tolerance exemption to
include all food commodities when
applied as a fungicide and used in
accordance with good agricultural
practices. In support of this expansion
of the tolerance exemption, new data
have been generated by the petitioner
and reviewed by EPA to further address
the developmental toxicity (OCSPP
Guideline No. 870.3700) and
mutagenicity (OCSPP Guideline Nos.
870.5100 and 870.5375) data
requirements. The data are required
when the use of the substance under
widespread and commonly recognized
practices may reasonably be expected to
result in significant exposure to
humans, specifically females of childbearing age for the developmental
toxicity data requirement. The rest of
the toxicological profile as stated in the
Federal Register of November 19, 2008,
and referenced herein, has not changed.
A copy of the November 19, 2008 final
rule document (73 FR 69559) is located
under docket ID number EPA–HQ–
OPP–2008–0417. A copy of the risk
assessment cited herein (See Ref.) is
located under docket ID number EPA–
HQ–OPP–2011–1028.
As discussed in the Federal Register
of November 19, 2008 polyoxin D zinc
salt is a brown musty smelling powder
derived through the fermentation of the
microbe Streptomyces cacaoi var.
asoensis , which was isolated from a soil
sample collected from Japan. This
biochemical active ingredient has a nontoxic mode of action, which acts against
fungi by inhibiting chitin growth in the
cell walls, thus precluding the
development of fungal colonies. Its
effects are considered fungi-exclusive in
that it has no mode of action relative to
mammals and passes through
mammalian digestive systems. Polyoxin
D zinc salt does not persist in the
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environment and has a well understood
low toxicity profile.
As stated previously in this Unit (III),
new toxicity data have been submitted
in support of the request by the
petitioner to expand the current
tolerance exemption to cover all food
commodities. These data include:
1. A prenatal developmental toxicity
study; and
2. Two mutagenicity studies.
All new data, coupled with the data
submitted to support the previous
tolerance exemption (73 FR 69561),
confirm a lack of human health hazard,
as noted and reported in the original
assessment of the tolerance exemption,
associated with dietary exposures of
polyoxin D zinc salt and fully
demonstrate the lack of acute,
subchronic, and chronic toxicity.
Summaries of the new toxicological data
submitted in support of the expansion
of the tolerance exemption follow.
A. Mutagenicity
Two new mutagenicity studies were
performed for polyoxin D zinc salt to
support the expansion of the tolerance
exemption. The mutagenicity studies as
described herein, along with the
mutagenicity studies submitted to
support the previous tolerance
exemption (73 FR 69561), confirm that
polyoxin D zinc salt is not a mutagen
and that consumption of food
commodities that have been treated
with this substance when used as a
pesticide is safe and will not result in
any harm to human health from dietary
exposure.
1. A reverse gene mutation assay in
bacteria Master Record Identification
Number ((MRID) 48653313) using the
technical grade of polyoxin D zinc salt,
dissolved in dimethyl sulfoxide
(DMSO), with and without metabolic S9
activation, showed no mutagenic effects
or evidence of cytotoxicity or
insolubility even at the limiting dose of
5,000 ug/plate (See Ref.). Therefore,
polyoxin D zinc salt is considered to be
non-mutagenic under the conditions of
this assay.
2. An in vitro mammalian
chromosome aberration test (MRID
48653314) using the technical grade of
polyoxin D zinc salt, dissolved in
DMSO, with and without metabolic S9
activation, showed clastogenic potential
in Chinese hamster lung cells (CHL/IU)
with and without activation (See Ref.).
In Experiment I, polyoxin D zinc salt
was tested up to dose levels that caused
>50% cell lethality without activation
(260 mg/mL) and with activation (1,600
mg/mL). Without activation, the
frequencies of the metaphases with
structural chromosome aberrations
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(excluding gaps) were 14.5% and 7.5%
at test article concentrations of 186 and
260mg/mL, respectively. With activation,
the frequency of metaphase cells with
structural chromosome aberrations
(excluding gaps) was 9.5% at a test
article concentration of 1,600 mg/mL.
The frequency of polyploid metaphase
cells showed no increases either
without or with activation. In
Experiment II, a 24-hour continuous
treatment without activation resulted in
a 8.0% frequency of metaphases with
structural chromosome aberrations
(excluding gaps) at the concentration of
133 mg/mL. There were no increases in
the frequency of polyploid metaphases.
Although the submitted in vitro
mammalian chromosome aberration test
showed clastogenic potential, the results
were not reproducible at the dose levels
reported in the experiment. In addition,
the mutagenicity data submitted to
support the previous tolerance
exemption (73 FR 69562), which
included three complimentary Tier I
mutagenicity tests and a Tier II
mammalian erythrocyte micronucleus
in vivo test, showed no mutagenic
effects, including no clastogenic
potential (no chromosomal aberrations).
Furthermore, the lack of systemic
toxicity noted in the following
developmental toxicity section (Unit
III.B) and the fact that no effects were
reported in the Tier III 2-generation
reproduction study submitted for the
previous tolerance exemption (73 FR
69562), indicate that polyoxin D zinc
salt is not mutagenic or clastogenic.
Therefore, based on the weight of
evidence of the mutagenicity data
submitted to support this expansion of
the tolerance exemption and the
previous tolerance exemption (73 FR
69561), the mutagenicity data and
information are sufficient to confirm
that polyoxin D zinc salt is not a
mutagen, and that consumption of food
commodities that have been treated
with this substance when used as a
pesticide is safe and will not result in
any harm to human health from dietary
exposure.
B. Developmental Toxicity
A new developmental study (MRID
48653315) was performed for polyoxin
D zinc salt to support the expansion of
the tolerance exemption. No treatmentrelated effects were observed in general
appearance, body weight, adjusted for
gravid uterine weight, weight gain, or
food consumption in maternal rats at
the doses tested (0, 100, 300, and 1,000
milligrams/kilograms bodyweight/day
(mg/kg bw/day) (See Ref.). Necropsy
observations showed that almost all rats
(20/24) in the 1,000 mg/kg/day group
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highest dose tested (HDT) had
thickening of the limiting ridge.
Therefore, the lowest observed adverse
effect level (LOAEL) for maternal
toxicity of polyoxin D zinc salt in rats
is 1,000 mg/kg bw/day based on gross
lesions in the stomach (thickening of the
limiting ridge). The no observed adverse
effect level (NOAEL) for maternal
toxicity is 300 mg/kg bw/day based on
no effects observed at this dose.
Although an effect of gross lesions in
the stomach was found in maternal rats
at the limit dose tested (1,000 mg/kg
bw/day), there were no reported
systemic effects in maternal rats at this
dose. The effect in the stomach lining
was limited to a localized gastric
irritation due to the route of entry (oral
gavage) at the limit dose tested (1,000
mg/kg bw/day), which is typical of the
nature of the test substance.
For developmental toxicity, no
treatment-related effects were observed
on developmental parameters including
gravid uterine weight, placental weight,
mean numbers of corpora lutea and
implantation sites, numbers of early and
later resorptions (dead or resorbed
embryos or fetuses), number of live
fetuses per dam, implantation index,
viability index, sex ratio, and male and
female body weight. The incidence of
external, visceral, and skeletal
variations and anomalies were not
affected by treatment of polyoxin D zinc
salt. Based on no effects observed for
developmental toxicity at any doses
tested, the NOAEL for developmental
toxicity is greater than 1,000 mg/kg bw/
day HDT. The LOAEL was not
identified for developmental toxicity,
suggesting that the test animals could
have tolerated a higher dose.
Based on the developmental toxicity
data submitted for this expansion to the
tolerance exemption, and the Tier III 2generation reproduction study
submitted for the previous tolerance
exemption (73 FR 69562), which
showed no reproductive effects at the
limit dose tested, there are sufficient
data and information to confirm that
polyoxin D zinc salt is not a
developmental toxicant, and that
consumption of food commodities that
have been treated with this substance
when used as a pesticide is safe and will
not result in any harm to human health
from dietary exposure.
IV. Aggregate Exposures
In examining aggregate exposure,
FFDCA section 408 directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
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surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
Dietary risks to humans are
considered negligible based on the lack
of dietary toxicological endpoints for
polyoxin D zinc salt and its non-toxic
mode of action as a fungi-specific chitin
synthetase inhibitor that passes through
mammalian digestive systems. No
significant acute, subchronic,
mutagenic, immunotoxic,
developmental, or chronic dietary
toxicity hazards were identified in the
studies submitted to support this
expansion of the tolerance exemption or
the previous tolerance exemption (73 FR
69562). Based on polyoxin D zinc salt’s
lack of dietary toxicity hazards for
mammals, no aggregate dietary exposure
concerns are expected.
1. Food . The petitioner submitted
three nature of residue studies (MRIDs
486533–09 through –11) in plants
(grapes, tomatoes, and lettuce) to
support this expansion of the tolerance
exemption. The three nature of residue
studies represent EPA Crop Groups 13
(grapes), 08 (tomatoes), and 04 (lettuce).
The total radioactive residue (TRR)
levels measured were 0.520 parts per
million (ppm) at day 1; 0.538 ppm at
day 14; and 0.495 ppm at day 30 after
the final application for the grape plant
(See Ref.). For tomato plants, 0.073 ppm
of polyoxin D was found 14 days after
the last treatment on the tomato fruit.
For lettuce, 0.025 ppm at day 7 and
0.107 ppm at day 14 were detected in
the head of lettuce after final
application.
In addition, a terrestrial exposure
model (T-Rex) was performed for the
previous tolerance exemption (73 FR
69562), which indicated that it is highly
unlikely that there will be adverse
effects resulting from the use of
polyoxin D zinc salt via the oral route
of exposure. EPA’s T-Rex calculations
delimit aggregate dietary consumption
of residues to no more than 40 ppm, a
level that is far below the HDT in any
of the toxicity testing.
Based on the residue data submitted
for this expansion of the tolerance
exemption, and the T-Rex residue
modeling data from the previous
tolerance exemption (73 FR 69562), any
residues found are far below any
toxicological endpoints identified in
this expansion of the tolerance
exemption (developmental toxicity
NOAEL greater than 1,000 mg/kg bw/
day; maternal toxicity NOAEL of 300
mg/kg/day) or in the previous tolerance
exemption (73 FR 69561). The previous
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tolerance exemption showed an acute
oral toxicity median lethal dose (LD50)
greater than 10,000 mg/kg; a subchronic
oral toxicity NOAEL of greater than
1,333 mg/kg/day and 119 mg/kg/day in
female and male rats, respectively; a
subchronic oral toxicity LOAEL of 1,166
mg/kg/day in male rats based on
decreased body weight gain, food
consumption, and food efficiency; and a
chronic oral toxicity NOAEL 2,058.7
mg/kg bw/day in male rats and 2,469.8
mg/kg bw/day in female rats.
In summary, the residue and toxicity
data demonstrate a lack of aggregate
dietary risk that is sufficient to support
this expansion of the tolerance
exemption.
2. Drinking water exposure . As stated
in the previous tolerance exemption (73
FR 69562), there is a small potential for
trace amounts of polyoxin D zinc salt to
enter drinking water sources after a
significant rainfall, via surface water
runoff, and/or via incidental spray drift.
The petitioner submitted a
photodegradation in water study (MRID
48653305) to support this tolerance
exemption. The results of the study
show that polyoxin D zinc salt has a net
photolytic half-life of 0.4 days in sterile
natural water (See Ref.) . Even if
residues of polyoxin D zinc salt enter
water sources, residues are expected to
degrade and be so diluted as to be
negligible. The data and information
demonstrate a lack of aggregate dietary
risk via drinking water and is sufficient
to support this expansion of the
tolerance exemption.
B. Other Non-Occupational Exposure
No new non-occupational exposure is
expected to result from the new food
uses of polyoxin D zinc salt. No health
risks are expected from any nonoccupational exposure to polyoxin D
zinc salt based on the data submitted for
the previous tolerance exemption (73 FR
69562) and for this expansion of the
tolerance exemption.
1. Dermal exposure . No new nonoccupational dermal exposures are
expected to result from the new food
uses of polyoxin D zinc salt resulting
from this expansion of the tolerance
exemption. Any new dermal exposure
associated with this expansion of the
tolerance exemption is expected to be
occupational in nature.
2. Inhalation exposure . No new nonoccupational inhalation exposures are
expected to result from the new food
uses of polyoxin D zinc salt resulting
from this expansion of the tolerance
exemption. Any new inhalation
exposure associated with this expansion
of the tolerance exemption is expected
to be occupational in nature.
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V. 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 polyoxin D zinc
salt to share a common mechanism of
toxicity with any other substances, and
polyoxin D zinc salt does not appear to
produce a toxic metabolite produced by
other substances. For the purposes of
this tolerance action, therefore, EPA has
assumed that polyoxin D zinc salt does
not have a common mechanism of
toxicity with other substances. For
information regarding EPA’s efforts to
determine which chemicals have a
common mechanism of toxicity and to
evaluate the cumulative effects of such
chemicals, see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S.
Population, Infants and Children
FFDCA section 408(b)(2)(C) provides
that EPA shall assess the available
information about consumption patterns
among infants and children, special
susceptibility of infants and children to
pesticide chemical residues, and the
cumulative effects on infants and
children of the residues and other
substances with a common mechanism
of toxicity. In addition, FFDCA section
408(b)(2)(C) provides that EPA shall
apply an additional tenfold 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 unless
EPA determines that a different margin
of safety will be safe for infants and
children. Margins of exposure safety,
which are often referred to as
uncertainty factors, are incorporated
into EPA risk assessments either
directly or through the use of a margin
of exposure analysis, or by using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk.
Relevant data and information
submitted for the previous tolerance
exemption (73 FR 69560) and for this
expansion of the tolerance exemption
indicate that polyoxin D zinc salt has
negligible acute, subchronic, chronic,
and developmental toxicity. Moreover,
polyoxin D zinc salt is defined by its
fungistatic non-toxic mode of action,
and demonstrates no significant
mammalian effect. Therefore, the
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Agency concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to the residues of polyoxin D
zinc salt. This includes all anticipated
dietary exposures and all other
exposures for which there is reliable
information. EPA has arrived at this
conclusion because the data and
information available on polyoxin D
zinc salt do not demonstrate toxic
potential to mammals. Thus, there are
no threshold effects of concern and, as
a result, an additional margin of safety
is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes for the
reasons stated above, and because EPA
is establishing an exemption from the
requirement of a tolerance without any
numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for polyoxin D zinc salt.
srobinson on DSK4SPTVN1PROD with RULES
VIII. Conclusions
EPA concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of polyoxin D zinc
salt. Therefore, the existing exemption
from the requirement of a tolerance for
residues of polyoxin D zinc salt when
used as a fungicide on almonds,
cucurbit vegetables, fruiting vegetables,
ginseng, grapes, pistachios, pome fruits,
potatoes, and strawberries is amended
by establishing an exemption from the
requirement of a tolerance for residues
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17:19 Sep 11, 2012
Jkt 226001
of polyoxin D zinc salt in or on all food
commodities when applied as a
fungicide and used in accordance with
good agricultural practices.
IX. References
The reference used in this document
is in the OPP docket listed under docket
ID EPA–HQ–OPP–2011–1028 and may
be seen by accessing the
www.regulations.gov Web site. A copy
of the previous final rule published in
the Federal Register on November 19,
2008, is in the OPP docket listed under
docket ID EPA–HQ–OPP–2008–0417.
U.S. EPA. 2011. Memorandum from
Manying Xue to Colin Walsh. Polyoxin
D zinc salt (EPA Reg. #: 68173–1),
Containing 23.8% of Polyoxin D Zinc
Salt (Active Ingredient). Science Review
of Product Chemistry, Residue
Chemistry, Non-Target Organism and
Toxicity Data in Support of label
Amendment. U.S. Environmental
Protection Agency Office of Pesticide
Programs. May 11, 2012.
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under FFDCA section 408(d) 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 FFDCA section 408(d), such as
the tolerance exemption 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.
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq .).
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) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq .), 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 the rule in the Federal
Register. This action 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 29, 2012.
Keith A. Matthews,
Director, Biopesticides and Pollution
Prevention 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:
■
E:\FR\FM\12SER1.SGM
12SER1
Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
FOR FURTHER INFORMATION CONTACT:
§ 180.1285 Polyoxin D zinc salt; exemption
from the requirement of a tolerance.
An exemption from the requirement
of a tolerance is established for the
residues of polyoxin D zinc salt in or on
all food commodities when applied as a
fungicide and used in accordance with
good agricultural practices.
Andrew Ertman, Registration Division,
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–9367; email address:
ertman.andrew@epa.gov.
SUPPLEMENTARY INFORMATION:
2. Section 180.1285 is revised to read
as follows:
■
[FR Doc. 2012–22315 Filed 9–11–12; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2011–0433; FRL–9359–6]
Dinotefuran; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of dinotefuran in
or on multiple commodities which are
identified and discussed later in this
document. Also, due to the tolerances
established by this document, the
Agency is removing the existing
tolerances for grape and potato as
unnecessary. Interregional Research
Project Number 4 (IR–4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective
September 12, 2012. Objections and
requests for hearings must be received
on or before November 13, 2012, 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: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2011–0433, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave.
NW., Washington, DC 20460–0001. The
Public Reading Room is open from 8:30
a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, and
the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
srobinson on DSK4SPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
17:19 Sep 11, 2012
Jkt 226001
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. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://ecfr.gpoaccess.gov/cgi/t/
text/text-idx?&c=ecfr&tpl=/ecfrbrowse/
Title40/40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2011–0433 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before November 13, 2012. Addresses
for mail and hand delivery of objections
and hearing requests are provided in 40
CFR 178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
56133
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2011–0433, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of September
7, 2011 (76 FR 55329) (FRL–8886–7),
EPA issued a notice pursuant to FFDCA
section 408(d)(3), 21 U.S.C. 346a(d)(3),
announcing the filing of a pesticide
petition (PP 1E7863) by IR–4, 500
College Rd. East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.603 be
amended by establishing tolerances for
residues of the insecticide dinotefuran,
(RS)-1-methyl-2-nitro-3-((tetrahydro-3furyl)methyl)guanidine, including its
metabolites and degradates, in or on
berry, low growing, except strawberry,
subgroup 13–07H at 0.2 parts per
million (ppm); watercress at 5.0 ppm;
onion, green, subgroup 3–07B at 6.0
ppm; onion, bulb, subgroup 3–07A at
0.07 ppm; peach at 0.9 ppm; vegetable,
tuberous and corm, subgroup 1C at 0.05
ppm; fruit, small, vine climbing, except
fuzzy kiwifruit, subgroup 13–07F at 0.9
ppm; and tea, plucked leaves at 25.0
ppm. That notice referenced a summary
of the petition prepared by Mitsui
Chemicals Agro, Inc., the registrant,
which is available in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Also, due to the tolerances established
by this document, the following existing
tolerances are being removed as
unnecessary: Grape and potato.
Based upon review of the data
supporting the petition, EPA has
E:\FR\FM\12SER1.SGM
12SER1
]]>Agencies
[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Rules and Regulations]
[Pages 56128-56133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22315]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-1028; FRL-9360-6]
RIN 2070
Polyoxin D Zinc Salt; Amendment to an Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation amends the existing exemption from the
requirement of a tolerance for residues of polyoxin D zinc salt when
used as a fungicide on almonds, cucurbit vegetables, fruiting
vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, and
strawberries by expanding the current exemption to include all food
commodities. This regulation establishes an exemption from the
requirement of a tolerance for residues of polyoxin D zinc salt in or
on all food commodities when applied as a fungicide and used in
accordance with good agricultural practices. On behalf of Kaken
Pharmaceutical Co., Ltd., Conn & Smith, Inc. submitted a petition to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
that EPA amend the existing exemption from the requirement of a
tolerance for polyoxin D zinc salt. This regulation eliminates the need
to establish a maximum permissible level for residues of polyoxin D
zinc salt under the FFDCA.
DATES: This regulation is effective September 12, 2012. Objections and
requests for hearings must be received on or before November 13, 2012,
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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-1028, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at https://www.epa.gov/dockets .
FOR FURTHER INFORMATION CONTACT: Colin G. Walsh, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (703) 308-0298; email
address: walsh.colin@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
To access the OCSPP test guidelines referenced in this document
electronically, please go to https://www.epa.gov/ocspp and select ``Test
Methods and Guidelines. ''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection
[[Page 56129]]
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-2011-1028 in the
subject line on the first page of your submission. All objections and
requests for a hearing must be in writing, and must be received by the
Hearing Clerk on or before November 13, 2012. Addresses for mail and
hand delivery of objections and hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2011-1028, by one of
the following methods:
Federal eRulemaking Portal : https://www.regulations.gov .
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be (CBI) or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.
II. Background and Statutory Findings
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
1F7940) by Conn & Smith, Inc., Agent, 6713 Catskill Road, Lorton, VA
22079, on behalf of Kaken Pharmaceutical Co., Ltd. The petition
requested that 40 CFR 180.1285 be amended by expanding the current
exemption to include all food commodities, thus establishing an
exemption from the requirement of a tolerance for residues of polyoxin
D zinc salt in or on all food commodities. This notice referenced a
summary of the petition prepared by the petitioner Conn & Smith, Inc.,
on behalf of Kaken Pharmaceutical Co., Ltd., which is available in the
docket, https://www.regulations.gov. There were no comments received in
response to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(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. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require 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. * *
* '' Additionally, FFDCA section 408(b)(2)(D) requires that the Agency
consider'' available information concerning the cumulative effects of
such residues and other substances that have a common mechanism of
toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability,
and the relationship of this information 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.
EPA established a tolerance exemption for polyoxin D zinc salt in a
final rule published in the Federal Register on November 19, 2008, (73
FR 69559) (FRL-8389-5), which supported the uses as a fungicide on
almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes,
pistachios, pome fruits, potatoes, and strawberries. The toxicological
data submitted to support the previous tolerance exemption included the
following: Acute (six-pack) toxicity, mutagenicity, subchronic (90-day
oral), developmental, and chronic/oncogenicity studies. All of the
studies/information submitted to support the previous tolerance
exemption indicated a lack of toxicity hazards for mammals, and EPA
concluded that there is a reasonable certainty of no harm to humans,
including infants and children, from the proposed food uses of polyoxin
D zinc salt. This amendment proposes to expand the tolerance exemption
to include all food commodities when applied as a fungicide and used in
accordance with good agricultural practices. In support of this
expansion of the tolerance exemption, new data have been generated by
the petitioner and reviewed by EPA to further address the developmental
toxicity (OCSPP Guideline No. 870.3700) and mutagenicity (OCSPP
Guideline Nos. 870.5100 and 870.5375) data requirements. The data are
required when the use of the substance under widespread and commonly
recognized practices may reasonably be expected to result in
significant exposure to humans, specifically females of child-bearing
age for the developmental toxicity data requirement. The rest of the
toxicological profile as stated in the Federal Register of November 19,
2008, and referenced herein, has not changed. A copy of the November
19, 2008 final rule document (73 FR 69559) is located under docket ID
number EPA-HQ-OPP-2008-0417. A copy of the risk assessment cited herein
(See Ref.) is located under docket ID number EPA-HQ-OPP-2011-1028.
As discussed in the Federal Register of November 19, 2008 polyoxin
D zinc salt is a brown musty smelling powder derived through the
fermentation of the microbe Streptomyces cacaoi var. asoensis , which
was isolated from a soil sample collected from Japan. This biochemical
active ingredient has a non-toxic mode of action, which acts against
fungi by inhibiting chitin growth in the cell walls, thus precluding
the development of fungal colonies. Its effects are considered fungi-
exclusive in that it has no mode of action relative to mammals and
passes through mammalian digestive systems. Polyoxin D zinc salt does
not persist in the
[[Page 56130]]
environment and has a well understood low toxicity profile.
As stated previously in this Unit (III), new toxicity data have
been submitted in support of the request by the petitioner to expand
the current tolerance exemption to cover all food commodities. These
data include:
1. A prenatal developmental toxicity study; and
2. Two mutagenicity studies.
All new data, coupled with the data submitted to support the previous
tolerance exemption (73 FR 69561), confirm a lack of human health
hazard, as noted and reported in the original assessment of the
tolerance exemption, associated with dietary exposures of polyoxin D
zinc salt and fully demonstrate the lack of acute, subchronic, and
chronic toxicity. Summaries of the new toxicological data submitted in
support of the expansion of the tolerance exemption follow.
A. Mutagenicity
Two new mutagenicity studies were performed for polyoxin D zinc
salt to support the expansion of the tolerance exemption. The
mutagenicity studies as described herein, along with the mutagenicity
studies submitted to support the previous tolerance exemption (73 FR
69561), confirm that polyoxin D zinc salt is not a mutagen and that
consumption of food commodities that have been treated with this
substance when used as a pesticide is safe and will not result in any
harm to human health from dietary exposure.
1. A reverse gene mutation assay in bacteria Master Record
Identification Number ((MRID) 48653313) using the technical grade of
polyoxin D zinc salt, dissolved in dimethyl sulfoxide (DMSO), with and
without metabolic S9 activation, showed no mutagenic effects or
evidence of cytotoxicity or insolubility even at the limiting dose of
5,000 ug/plate (See Ref.). Therefore, polyoxin D zinc salt is
considered to be non-mutagenic under the conditions of this assay.
2. An in vitro mammalian chromosome aberration test (MRID 48653314)
using the technical grade of polyoxin D zinc salt, dissolved in DMSO,
with and without metabolic S9 activation, showed clastogenic potential
in Chinese hamster lung cells (CHL/IU) with and without activation (See
Ref.). In Experiment I, polyoxin D zinc salt was tested up to dose
levels that caused >50% cell lethality without activation (260
[micro]g/mL) and with activation (1,600 [micro]g/mL). Without
activation, the frequencies of the metaphases with structural
chromosome aberrations (excluding gaps) were 14.5% and 7.5% at test
article concentrations of 186 and 260[micro]g/mL, respectively. With
activation, the frequency of metaphase cells with structural chromosome
aberrations (excluding gaps) was 9.5% at a test article concentration
of 1,600 [micro]g/mL. The frequency of polyploid metaphase cells showed
no increases either without or with activation. In Experiment II, a 24-
hour continuous treatment without activation resulted in a 8.0%
frequency of metaphases with structural chromosome aberrations
(excluding gaps) at the concentration of 133 [micro]g/mL. There were no
increases in the frequency of polyploid metaphases.
Although the submitted in vitro mammalian chromosome aberration
test showed clastogenic potential, the results were not reproducible at
the dose levels reported in the experiment. In addition, the
mutagenicity data submitted to support the previous tolerance exemption
(73 FR 69562), which included three complimentary Tier I mutagenicity
tests and a Tier II mammalian erythrocyte micronucleus in vivo test,
showed no mutagenic effects, including no clastogenic potential (no
chromosomal aberrations). Furthermore, the lack of systemic toxicity
noted in the following developmental toxicity section (Unit III.B) and
the fact that no effects were reported in the Tier III 2-generation
reproduction study submitted for the previous tolerance exemption (73
FR 69562), indicate that polyoxin D zinc salt is not mutagenic or
clastogenic. Therefore, based on the weight of evidence of the
mutagenicity data submitted to support this expansion of the tolerance
exemption and the previous tolerance exemption (73 FR 69561), the
mutagenicity data and information are sufficient to confirm that
polyoxin D zinc salt is not a mutagen, and that consumption of food
commodities that have been treated with this substance when used as a
pesticide is safe and will not result in any harm to human health from
dietary exposure.
B. Developmental Toxicity
A new developmental study (MRID 48653315) was performed for
polyoxin D zinc salt to support the expansion of the tolerance
exemption. No treatment-related effects were observed in general
appearance, body weight, adjusted for gravid uterine weight, weight
gain, or food consumption in maternal rats at the doses tested (0, 100,
300, and 1,000 milligrams/kilograms bodyweight/day (mg/kg bw/day) (See
Ref.). Necropsy observations showed that almost all rats (20/24) in the
1,000 mg/kg/day group highest dose tested (HDT) had thickening of the
limiting ridge. Therefore, the lowest observed adverse effect level
(LOAEL) for maternal toxicity of polyoxin D zinc salt in rats is 1,000
mg/kg bw/day based on gross lesions in the stomach (thickening of the
limiting ridge). The no observed adverse effect level (NOAEL) for
maternal toxicity is 300 mg/kg bw/day based on no effects observed at
this dose. Although an effect of gross lesions in the stomach was found
in maternal rats at the limit dose tested (1,000 mg/kg bw/day), there
were no reported systemic effects in maternal rats at this dose. The
effect in the stomach lining was limited to a localized gastric
irritation due to the route of entry (oral gavage) at the limit dose
tested (1,000 mg/kg bw/day), which is typical of the nature of the test
substance.
For developmental toxicity, no treatment-related effects were
observed on developmental parameters including gravid uterine weight,
placental weight, mean numbers of corpora lutea and implantation sites,
numbers of early and later resorptions (dead or resorbed embryos or
fetuses), number of live fetuses per dam, implantation index, viability
index, sex ratio, and male and female body weight. The incidence of
external, visceral, and skeletal variations and anomalies were not
affected by treatment of polyoxin D zinc salt. Based on no effects
observed for developmental toxicity at any doses tested, the NOAEL for
developmental toxicity is greater than 1,000 mg/kg bw/day HDT. The
LOAEL was not identified for developmental toxicity, suggesting that
the test animals could have tolerated a higher dose.
Based on the developmental toxicity data submitted for this
expansion to the tolerance exemption, and the Tier III 2-generation
reproduction study submitted for the previous tolerance exemption (73
FR 69562), which showed no reproductive effects at the limit dose
tested, there are sufficient data and information to confirm that
polyoxin D zinc salt is not a developmental toxicant, and that
consumption of food commodities that have been treated with this
substance when used as a pesticide is safe and will not result in any
harm to human health from dietary exposure.
IV. Aggregate Exposures
In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from ground water or
[[Page 56131]]
surface water and exposure through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses).
A. Dietary Exposure
Dietary risks to humans are considered negligible based on the lack
of dietary toxicological endpoints for polyoxin D zinc salt and its
non-toxic mode of action as a fungi-specific chitin synthetase
inhibitor that passes through mammalian digestive systems. No
significant acute, subchronic, mutagenic, immunotoxic, developmental,
or chronic dietary toxicity hazards were identified in the studies
submitted to support this expansion of the tolerance exemption or the
previous tolerance exemption (73 FR 69562). Based on polyoxin D zinc
salt's lack of dietary toxicity hazards for mammals, no aggregate
dietary exposure concerns are expected.
1. Food . The petitioner submitted three nature of residue studies
(MRIDs 486533-09 through -11) in plants (grapes, tomatoes, and lettuce)
to support this expansion of the tolerance exemption. The three nature
of residue studies represent EPA Crop Groups 13 (grapes), 08
(tomatoes), and 04 (lettuce). The total radioactive residue (TRR)
levels measured were 0.520 parts per million (ppm) at day 1; 0.538 ppm
at day 14; and 0.495 ppm at day 30 after the final application for the
grape plant (See Ref.). For tomato plants, 0.073 ppm of polyoxin D was
found 14 days after the last treatment on the tomato fruit. For
lettuce, 0.025 ppm at day 7 and 0.107 ppm at day 14 were detected in
the head of lettuce after final application.
In addition, a terrestrial exposure model (T-Rex) was performed for
the previous tolerance exemption (73 FR 69562), which indicated that it
is highly unlikely that there will be adverse effects resulting from
the use of polyoxin D zinc salt via the oral route of exposure. EPA's
T-Rex calculations delimit aggregate dietary consumption of residues to
no more than 40 ppm, a level that is far below the HDT in any of the
toxicity testing.
Based on the residue data submitted for this expansion of the
tolerance exemption, and the T-Rex residue modeling data from the
previous tolerance exemption (73 FR 69562), any residues found are far
below any toxicological endpoints identified in this expansion of the
tolerance exemption (developmental toxicity NOAEL greater than 1,000
mg/kg bw/day; maternal toxicity NOAEL of 300 mg/kg/day) or in the
previous tolerance exemption (73 FR 69561). The previous tolerance
exemption showed an acute oral toxicity median lethal dose
(LD50) greater than 10,000 mg/kg; a subchronic oral toxicity
NOAEL of greater than 1,333 mg/kg/day and 119 mg/kg/day in female and
male rats, respectively; a subchronic oral toxicity LOAEL of 1,166 mg/
kg/day in male rats based on decreased body weight gain, food
consumption, and food efficiency; and a chronic oral toxicity NOAEL
2,058.7 mg/kg bw/day in male rats and 2,469.8 mg/kg bw/day in female
rats.
In summary, the residue and toxicity data demonstrate a lack of
aggregate dietary risk that is sufficient to support this expansion of
the tolerance exemption.
2. Drinking water exposure . As stated in the previous tolerance
exemption (73 FR 69562), there is a small potential for trace amounts
of polyoxin D zinc salt to enter drinking water sources after a
significant rainfall, via surface water runoff, and/or via incidental
spray drift. The petitioner submitted a photodegradation in water study
(MRID 48653305) to support this tolerance exemption. The results of the
study show that polyoxin D zinc salt has a net photolytic half-life of
0.4 days in sterile natural water (See Ref.) . Even if residues of
polyoxin D zinc salt enter water sources, residues are expected to
degrade and be so diluted as to be negligible. The data and information
demonstrate a lack of aggregate dietary risk via drinking water and is
sufficient to support this expansion of the tolerance exemption.
B. Other Non-Occupational Exposure
No new non-occupational exposure is expected to result from the new
food uses of polyoxin D zinc salt. No health risks are expected from
any non-occupational exposure to polyoxin D zinc salt based on the data
submitted for the previous tolerance exemption (73 FR 69562) and for
this expansion of the tolerance exemption.
1. Dermal exposure . No new non-occupational dermal exposures are
expected to result from the new food uses of polyoxin D zinc salt
resulting from this expansion of the tolerance exemption. Any new
dermal exposure associated with this expansion of the tolerance
exemption is expected to be occupational in nature.
2. Inhalation exposure . No new non-occupational inhalation
exposures are expected to result from the new food uses of polyoxin D
zinc salt resulting from this expansion of the tolerance exemption. Any
new inhalation exposure associated with this expansion of the tolerance
exemption is expected to be occupational in nature.
V. 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 polyoxin D zinc salt to share a common mechanism
of toxicity with any other substances, and polyoxin D zinc salt does
not appear to produce a toxic metabolite produced by other substances.
For the purposes of this tolerance action, therefore, EPA has assumed
that polyoxin D zinc salt does not have a common mechanism of toxicity
with other substances. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold 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 unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure safety, which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
Relevant data and information submitted for the previous tolerance
exemption (73 FR 69560) and for this expansion of the tolerance
exemption indicate that polyoxin D zinc salt has negligible acute,
subchronic, chronic, and developmental toxicity. Moreover, polyoxin D
zinc salt is defined by its fungistatic non-toxic mode of action, and
demonstrates no significant mammalian effect. Therefore, the
[[Page 56132]]
Agency concludes that there is a reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to the residues of polyoxin D zinc salt. This
includes all anticipated dietary exposures and all other exposures for
which there is reliable information. EPA has arrived at this conclusion
because the data and information available on polyoxin D zinc salt do
not demonstrate toxic potential to mammals. Thus, there are no
threshold effects of concern and, as a result, an additional margin of
safety is not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes for
the reasons stated above, and because EPA is establishing an exemption
from the requirement of a tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for polyoxin D zinc salt.
VIII. Conclusions
EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of polyoxin D zinc salt. Therefore,
the existing exemption from the requirement of a tolerance for residues
of polyoxin D zinc salt when used as a fungicide on almonds, cucurbit
vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome
fruits, potatoes, and strawberries is amended by establishing an
exemption from the requirement of a tolerance for residues of polyoxin
D zinc salt in or on all food commodities when applied as a fungicide
and used in accordance with good agricultural practices.
IX. References
The reference used in this document is in the OPP docket listed
under docket ID EPA-HQ-OPP-2011-1028 and may be seen by accessing the
www.regulations.gov Web site. A copy of the previous final rule
published in the Federal Register on November 19, 2008, is in the OPP
docket listed under docket ID EPA-HQ-OPP-2008-0417.
U.S. EPA. 2011. Memorandum from Manying Xue to Colin Walsh.
Polyoxin D zinc salt (EPA Reg. : 68173-1), Containing 23.8% of
Polyoxin D Zinc Salt (Active Ingredient). Science Review of Product
Chemistry, Residue Chemistry, Non-Target Organism and Toxicity Data in
Support of label Amendment. U.S. Environmental Protection Agency Office
of Pesticide Programs. May 11, 2012.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
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 FFDCA section 408(d), such as the tolerance
exemption 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq .).
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) (15 U.S.C. 272 note).
XI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq .),
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
the rule in the Federal Register. This action 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 29, 2012.
Keith A. Matthews,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
[[Page 56133]]
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1285 is revised to read as follows:
Sec. 180.1285 Polyoxin D zinc salt; exemption from the requirement of
a tolerance.
An exemption from the requirement of a tolerance is established for
the residues of polyoxin D zinc salt in or on all food commodities when
applied as a fungicide and used in accordance with good agricultural
practices.
[FR Doc. 2012-22315 Filed 9-11-12; 8:45 am]
BILLING CODE 6560-50-P
