Document ID: EPA-HQ-OPP-2011-0783-0001
Agency: epa
Document Type: Rule
Title: Exemptions from Requirement of a Tolerance: Aureobasidium pullulans strains DSM 14940 and DSM 14943
Posted Date: 2012-02-15T05:00Z

[Federal Register Volume 77, Number 31 (Wednesday, February 15, 2012)]
[Rules and Regulations]
[Pages 8741-8746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3283]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0783; FRL-9332-9]

Spirotetramat; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of spirotetramat in or on onion, dry bulb under section 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(l)(6). This action is in response to EPA's granting of an 
emergency exemption under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide 
on dry bulb onions. This regulation establishes a maximum permissible 
level for residues of spirotetramat in or on these commodities. The 
time-limited tolerances expire on December 31, 2014.

DATES: This regulation is effective February 15, 2012. Objections and 
requests for hearings must be received on or before April 16, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0783. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose

[[Page 8742]]

disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The Docket Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; email address: pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://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 section 408(g) of the FFDCA, 21 U.S.C. 346a(g), 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-2011-0783 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 April 16, 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0783, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for combined residues of spirotetramat, 
including its metabolites and degradates, in or on onion, dry bulb at 
0.3 parts per million (ppm). This time-limited tolerance expires on 
December 31, 2014.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of section 408 of FFDCA and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemptions for Spirotetramat on Dry Bulb Onions and 
FFDCA Tolerances

    Thrips rasp the onion tissue and drain the exuding sap, causing 
stunted and deformed plants. High thrip populations during bulbing can 
reduce yield. In addition, high thrip populations and the associated 
damage can shift the onion bulb size distribution downward and reduce 
onion quality. Of even more concern, thrips can infect plants with iris 
yellow spot virus. The virus in conjunction with thrips feeding 
activity can result in an average 25-35%

[[Page 8743]]

decrease in yield with yield losses observed as high as 53% in some 
fields. Onion thrips thrive under hot, dry conditions, and can increase 
and spread very quickly. In addition to their ability to rapidly 
increase in population, thrips also migrate into onion fields from 
adjacent crops. For example, as nearby cereal crops dry down in the 
early summer and alfalfa fields are harvested, large populations of 
thrips can migrate to onions. There are a number of products registered 
for thrips control on onions. Many were never effective or have become 
ineffective due to development of resistance. Due to the label 
restrictions on the available effective insecticides, it is currently 
infeasible for producers to control thrips for the entire production 
season with the available insecticides in most areas of onion 
production.
    After having reviewed the submissions, EPA determined that an 
emergency condition exists for eleven states (Colorado, Idaho, 
Michigan, Minnesota, Nevada, New York, Oregon, Texas, Utah, Washington, 
and Wisconsin), and that the criteria for approval of emergency 
exemptions are met. EPA has authorized specific exemptions under FIFRA 
section 18 for the use of spirotetramat on dry bulb onion for control 
of onion thrips (Thrips tabaci) in the 11 states listed in this unit.
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of spirotetramat 
in or on onion, dry bulb. In doing so, EPA considered the safety 
standard in section 408(b)(2) of FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of FFDCA. Although this time-limited tolerance 
expires on December 31, 2014, under section 408(l)(5) of FFDCA, 
residues of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on onion, dry bulb after that date will not 
be unlawful, provided the pesticide was applied in a manner that was 
lawful under FIFRA, and the residues do not exceed a level that was 
authorized by this time-limited tolerance at the time of that 
application. EPA will take action to revoke this time-limited tolerance 
earlier if any experience with, scientific data on, or other relevant 
information on this pesticide indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
spirotetramat meets FIFRA's registration requirements for domestic use 
on dry bulb onions or whether permanent tolerances for this use would 
be appropriate. Under these circumstances, EPA does not believe that 
this time-limited tolerance decision serves as a basis for registration 
of spirotetramat by a State for special local needs under FIFRA section 
24(c). Nor does this tolerance by itself serve as the authority for 
persons in any State other than the 11 states listed in this unit to 
use this pesticide on the applicable crops under FIFRA section 18 
absent the issuance of an emergency exemption applicable within that 
State. For additional information regarding the emergency exemption for 
spirotetramat, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of spirotetramat and 
its metabolites and degradates on onion, dry bulb at 0.3 ppm. EPA's 
assessment of exposures and risks associated with establishing time-
limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for spirotetramat used for 
human risk assessment is discussed in Unit III. of the final rules 
published in the Federal Register of July 9, 2008 (73 FR 39251) (FRL-
8367-1) and May 18, 2011 (76 FR 28675) (FRL-8865-8). The final rule of 
July 9, 2008 established a number of tolerances for residues of 
spirotetramat, including onion, bulb, subgroup 3A-07. Subsequently, in 
the final rule published in the Federal Register of May 18, 2011, EPA 
added a footnote to the established tolerance for onion, bulb, subgroup 
3A-07 to indicate that currently there are no U.S. registrations for 
onions. Use on onions at that time was assessed for import tolerances 
only.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spirotetramat, EPA considered exposure under the time-
limited tolerances established by this action as well as all existing 
spirotetramat tolerances in 40 CFR 180.641. EPA assessed dietary 
exposures from spirotetramat in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure. Such effects were identified 
for spirotetramat. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
assumed 100 percent crop treated (PCT) and tolerance-level residues for 
all foods. Empirical and Dietary Exposure Evaluation Model (DEEM\TM\) 
(ver. 7.81) default processing factors were used for processed 
commodities. Residues in drinking water were addressed by

[[Page 8744]]

incorporating directly in the dietary assessment the acute 
concentrations of spirotetramat residues in surface water estimated by 
the First Index Reservoir Screening Tool (FIRST) model.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a 
conservative chronic dietary assessment assuming tolerance-level 
residues, empirical and DEEM\TM\ (ver. 7.81) default processing 
factors, and 100 PCT. Drinking water was incorporated directly in the 
dietary assessment using the chronic concentrations for surface water.
    iii. Cancer. Based on the data summarized in Unit IV.A., EPA has 
concluded that spirotetramat does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for spirotetramat. Tolerance level residues and 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for spirotetramat in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of spirotetramat. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FIRST and Screening Concentration in Ground Water 
(SCI-GROW) models, the estimated drinking water concentrations (EDWCs) 
of spirotetramat for acute exposures are estimated to be 0.212 parts 
per billion (ppb) for surface water; and 3.96 x 10-4 ppb for 
ground water.
    For chronic exposures for non-cancer assessments, the EDWCs are 
estimated to be 1.37 x 10-3 ppb for surface water and 3.96 x 
10-4 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model.
    For acute dietary risk assessment, the most conservative water 
concentration value of 0.212 ppb was used to assess the contribution to 
drinking water based on the use of spirotetramat on pome fruit (0.4 lb 
ai/A/year).
    For chronic dietary risk assessment, the most conservative water 
concentration of value 1.37 x 10-3 ppb was used to assess 
the contribution to drinking water, based on the use of spirotetramat 
on Christmas trees (0.32 lb ai/A/year).
    3. Sources of non-dietary exposure. The term ``residential 
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure (e.g., for lawn and garden pest control, indoor pest 
control, termiticides, and flea and tick control on pets). 
Spirotetramat is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found spirotetramat to share a common mechanism of 
toxicity with any other substances, and spirotetramat does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
spirotetramat 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.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased susceptibility of rat or rabbit to prenatal or postnatal 
exposure to spirotetramat. In the rat developmental toxicity study, 
toxicity to offspring was observed at the same dose as maternal 
toxicity, which was also the limit dose. In the developmental toxicity 
study in the rabbit, only maternal toxicity was observed. In both 
reproductive toxicity studies, toxicity to offspring (decreased body 
weight) was observed at the same dose as parental toxicity. Therefore, 
no evidence of increased susceptibility of offspring was found across 
four relevant toxicity studies with spirotetramat.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children are adequately protected at the FQPA SF 
of 1X. That decision is based on the following findings:
    i. The toxicity database for spirotetramat is complete except for 
an immunotoxicity study and a subchronic neurotoxicity study which are 
considered to be outstanding due to recent amendments to the data 
requirements in 40 CFR part 158. Despite the absence of these studies, 
other related studies indicate that the immunotoxicity study and 
subchronic neurotoxicity study are unlikely to show risks to infants 
and children that would warrant an additional safety factor. The only 
indication of possible immunotoxicity in the toxicology database for 
spirotetramat is a 90-day oral toxicity study in dogs that shows 
effects in the thymus gland, an organ of the immune system. However, 
the endpoint selected for risk assessment is protective against these 
thyroid effects, as it was based on accelerated thymus involution and 
decreased thyroid hormone levels in the dog. Moreover, thymus 
involution has been demonstrated to occur in animals when the thyroid 
is induced to decrease hormone levels, so it is reasonable to conclude 
that the thymus involution in these dogs was secondary to the thyroid 
effects, rather than a direct effect on the immune system. The dose at 
which these effects were observed was chosen as a point of departure 
because there was some consistency of dose and effect seen across the 
subchronic and chronic toxicity studies. However, the effects occurred 
in relatively few animals and thus selection of this endpoint is 
considered a very protective point of departure; it is at least tenfold 
lower than any other potential point of departure. With respect to 
immunotoxicity, no immunotoxic effects were seen in rats or mice, the 
species in which immunotoxicity studies are conducted. Thus, the Agency 
does not believe that conducting a functional immunotoxicity study in 
any rodent species will result in a lower POD than that currently used 
for overall risk assessment. For this reason and because the current 
POD is considered

[[Page 8745]]

extremely protective, an uncertainty factor (UFDB) is not 
needed to account for the lack of this study. Data regarding 
neurotoxicity is discussed in Unit III.C.3.ii.
    ii. EPA has concluded that spirotetramat is not a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. Although a subchronic 
neurotoxicity study is now required as part of the revisions to 40 CFR 
part 158, the existing toxicological database indicates that 
spirotetramat is not a neurotoxic chemical in mammals. The only 
clinical signs at any dose in the acute neurotoxicity study were 
staining of the fur or perianal region with urine and decreased motor 
activity. The urine staining that was identified is not considered a 
neurotoxic effect and was likely due to a colored metabolite that was 
excreted into the urine or feces or to a change in the pH of the urine 
due to an excreted metabolite. The decreased motor activity observed is 
not considered evidence of neurotoxicity because there were no effects 
on movement or gait and there were no confirmatory findings of 
neurological pathology. Thus, both of these effects are considered 
signs of general toxicity (malaise). Further, the effects seen in the 
acute neurotoxicity study are not corroborated by any other study in 
the database. Although brain dilation was found in one dog in the one-
year dog study, EPA concluded that this effect was most likely not 
caused by administration of spirotetramat given evidence showing this 
to be a congenital anomaly in the test species, and because there is no 
other evidence of brain pathology in the database. Finally, the 
conclusion that spirotetramat is not a neurotoxic chemical is supported 
by the fact that the acute, subchronic and developmental neurotoxcity 
studies available for structurally-related compounds (spirodiclofen and 
spiromesifen) do not show evidence of neurotoxicity in adults or young.
    iii. There is no evidence that spirotetramat results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. There was no evidence of increased susceptibility of offspring 
following pre- or post-natal exposure in any study. In the rat 
developmental toxicity study, toxicity to offspring was observed at the 
same dose as maternal toxicity, which was also the limit dose. In the 
developmental toxicity study in the rabbit, only maternal toxicity was 
observed. In both reproductive toxicity studies, toxicity to offspring 
(decreased body weight) was observed at the same dose as parental 
toxicity. Therefore, no evidence of increased susceptibility of 
offspring was found across four relevant toxicity studies with 
spirotetramat.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dataset used to establish a tolerance for spirotetramat 
and its metabolites on onion, bulb, subgroup 3A-07 consisted of field 
trial data representing application rates of ~0.26 a.i./A (Northern EU, 
100 OD formulation) with a 7-day PHI. As specified by the Guidance for 
Setting Pesticide Tolerances Based on Field Trial Data SOP, the field 
trial application rates and PHIs are within 25% of the maximum label 
application rate and minimum label PHI, respectively. The dietary food 
exposure assessments were performed based on 100 PCT and tolerance-
level residues. EPA made conservative (protective) assumptions in the 
ground and surface water modeling used to assess exposure to 
spirotetramat in drinking water. These assessments will not 
underestimate the exposure and risks posed by spirotetramat.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to spirotetramat will occupy 11% of the aPAD for children 1-2 yrs old, 
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
spirotetramat from food and water will utilize 93% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for spirotetramat.
    3. Short-term risk. Spirotetramat is not registered for any use 
patterns that would result in short-term residential exposure.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Spirotetramat is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to spirotetramat through food and water, which has already been 
addressed, and will not be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, spirotetramat is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to spirotetramat residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high performance liquid 
chromatography with tandem mass spectrometry (HPLC-MS/MS)) is available 
to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

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 U.N. 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

[[Page 8746]]

U.S. provided the primary review of the available toxicology studies, 
and Canada provided the primary review of the residue chemistry data. 
All of the residues of concern for tolerances and MRLs have been 
harmonized among Austria, Canada and the U.S. All toxicology endpoints 
have been harmonized, with the exception of the acute reference dose 
(aRfd), which has been harmonized with Canada. The Codex has not 
established MRLs for spirotetramat on onion, dry bulb. This time-
limited tolerance is harmonized with the Canadian MRL for spirotetramat 
on onion, dry bulb.

VI. Conclusion

    Therefore, time-limited tolerances are established for combined 
residues of spirotetramat, including its metabolites and degradates in 
or on onion, dry bulb at 0.3 ppm. These tolerances expire on December 
31, 2014.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under sections 408(e) and 
408(l)(6) of FFDCA. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled Actions Concerning Regulations That Significantly 
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) 
or Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L.104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 1, 2012.
Lois Rossi,
Director, Registration 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:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.641 is amended by revising paragraph (b) to read as 
follows:

Sec.  [emsp14]180.641  Spirotetramat; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
spirotetramat, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only the sum of spirotetramat (cis-3-(2,5-dimethlyphenyl)-8-
methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its 
metabolites cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-
azaspiro[4.5]dec-3-en-2-one, cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-
methoxy-1-azaspiro[4.5]decane-2,4-dione, cis-3-(2,5-dimethylphenyl)-8-
methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and 
cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-
one, calculated as the stoichiometric equivalent of spirotetramat, in 
or on the specified agricultural commodities, resulting from use of the 
pesticide pursuant to FIFRA section 18 emergency exemptions. The 
tolerances expire on the date specified in the table.

------------------------------------------------------------------------
                                         Parts
              Commodity                   per        Expiration  date
                                        million
------------------------------------------------------------------------
Onion, dry bulb......................       0.3  December 31, 2014.
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-3283 Filed 2-14-12; 8:45 am]
BILLING CODE 6560-50-P