[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Rules and Regulations]
[Pages 56128-56133]
From the Federal Register Online via the Government Publishing 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 http://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 http://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: [email protected].
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 http://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 http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines. ''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection
[[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 : http://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 http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://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, http://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 http://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