Document ID: EPA-HQ-OPP-2011-1028-0003
Agency: epa
Document Type: Rule
Title: Amendments to Exemptions from Requirements of Tolerance: Polyoxin D zinc salt
Posted Date: 2012-09-12T04:00Z

[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]

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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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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: 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 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