Document ID: EPA-HQ-OPP-2015-0679-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Spirotetramat
Posted Date: 2016-10-25T04:00Z

[Federal Register Volume 81, Number 206 (Tuesday, October 25, 2016)]
[Rules and Regulations]
[Pages 73342-73347]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25638]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0679; FRL-9951-80]

Spirotetramat; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
spirotetramat in or on asparagus. Bayer CropScience LP requested this 
tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 25, 2016. Objections and 
requests for hearings must be received on or before December 27, 2016, 
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-2015-0679, 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), West William Jefferson Clinton 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: Michael Goodis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@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 EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0679 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 
December 27, 2016. 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-2015-0679, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online

[[Page 73343]]

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.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of May 19, 2016 (81 FR 31581) (FRL-9946-
02), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
5E8376) by Bayer CropScience LP, P.O. Box 12014, 2 T.W. Alexander Dr., 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
180.641 be amended by establishing tolerances for residues of the 
insecticide spirotetramat in or on asparagus at 0.10 parts per million 
(ppm). That document referenced a summary of the petition prepared by 
Bayer CropScience, the registrant, which is available in the docket, 
http://www.regulations.gov. A comment was received on the notice of 
filing. EPA's response to this comment is discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and 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 for spirotetramat including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with spirotetramat 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies 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.
    The target organs of toxicity following subchronic and chronic oral 
exposures to spirotetramat were different in rats and dogs. The thyroid 
and thymus glands were the target organs identified in subchronic and 
chronic toxicity studies in dogs while the testes were the target 
organs identified in rats. The dog was the most sensitive species, and 
in both rats and dogs, males were more sensitive than females. The 
thyroid effects in the dog consisted of lower circulating levels of 
thyroid hormones (T3 and/or T4) along with a reduction in follicle 
size, a possible indication of reduced amount of colloid. The effects 
in the dog thymus were described microscopically as involution, which 
also resulted in decreased organ weight.
    In rats, reported testicular effects consisted of abnormal 
spermatozoa and hypospermia in the epididymis, decreased testicular 
weights, and testicular degenerative vacuolation. An investigative 
subchronic study where rats were dosed with a primary enol metabolite 
of spirotetramat reproduced the same testicular effects as the parent 
chemical, suggesting that this metabolite is, at minimum, a primary 
contributor to the observed male reproductive toxicity. Consistent with 
this notion, orally administered spirotetramat was demonstrated in rats 
to be extensively metabolized, and males were noted to achieve much 
higher systemic exposures than their female counterparts, which helps 
explain the higher sensitivity of males. Other effects reported in a 
rat chronic toxicity study were associated with kidney effects 
consisting of decreased organ weight and tubular dilatation.
    In one- and two-generation rat reproductive toxicity studies, male 
reproductive toxicity (abnormal sperm cells and reproductive 
performance) similar to that reported in subchronic toxicity studies 
with adult rats was reported in the first generation (F1) 
males at relatively high dose levels. In all cases, a well-defined no-
observed adverse-effect level (NOAEL) was established.
    There was evidence of increased qualitative susceptibility in the 
rat developmental study with reduced fetal weight and increased 
incidences of malformations and skeletal deviations observed at the 
limit dose, while maternal effects at this dose consisted of only body 
weight decrements. There was no evidence of increased quantitative or 
qualitative susceptibility to offspring following pre- or postnatal 
exposure to spirotetramat in the rabbit developmental or two-generation 
reproduction studies.
    The only evidence of neurotoxicity in the rat acute neurotoxicity 
study was based on decreased motor and locomotor activity, which 
occurred only at relatively high dose levels. The rat subchronic 
neurotoxicity (SCN) study does not indicate a concern for 
neurotoxicity, even at relatively high dose levels.
    The results of an immunotoxicity study in rats do not indicate any 
functional deficits in immune function. There is no evidence of 
carcinogenicity in chronic toxicity/carcinogenicity studies performed 
in rats and mice and spirotetramat was also negative for mutagenicity 
and clastogenicity in guideline in vivo and in vitro assays.
    Specific information on the studies received and the nature of the 
adverse effects caused by spirotetramat as well as the NOAEL and the 
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies 
can be found at http://www.regulations.gov in the document titled 
``Spirotetramat. Human Health Risk Assessment for the Petition for a 
Tolerance for Residues in/on Asparagus Without a U.S. Registration'' at 
page 19 in docket ID number EPA-HQ-OPP-2015-0679.

B. 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

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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 shown in Table 1 of this unit.

 Table 1--Summary of Toxicological Doses and Endpoints for Spirotetramat for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1.0 mg/  Acute neurotoxicity (rat).
 including infants and children).   day.                  kg/day.             LOAEL = 200 mg/kg based on
                                   UFA = 10x...........  aPAD = 1.0 mg/kg/     clinical signs and decreased
                                   UFH = 10x...........   day..                motor activity in males.
                                   FQPA SF = 1x........
Chronic dietary (All populations)  NOAEL = 5 mg/kg/day.  Chronic RfD = 0.05   Chronic toxicity (dog).
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 20 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.05 mg/kg/    thymus involution in males.
                                   FQPA SF = 1x........   day..
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``not likely to be carcinogenic to humans'' based on lack of
                                    evidence of carcinogenicity in rats and mice.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spirotetramat, EPA considered exposure under the 
petitioned-for tolerances 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's (USDA's) 2003-2008 National Health 
and Nutrition Examination Survey, What We Eat in America, (NHANES/
WWEIA). As to residue levels in food, EPA assumed tolerance-level 
residues for all foods, Dietary Exposure Evaluation Model (DEEM) 7.81 
default processing factors where provided, and 100 percent crop treated 
(PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed average 
field trial residues for some commodities, tolerance-level residues for 
the remaining commodities, and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.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. Section 408(b)(2)(E) 
of FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) that data be provided 5 years after the tolerance is 
established, modified, or left in effect, demonstrating that the levels 
in food are not above the levels anticipated. For the present action, 
EPA will issue such data call-ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    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 Tier 1 Rice Model and Pesticide Root Zone Model Ground 
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of 
spirotetramat and its metabolites for acute exposures are estimated to 
be 395 parts per billion (ppb) for surface water and 7.99 ppb for 
ground water, and for chronic exposures are estimated to be 395 ppb for 
surface water and 5.36 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For both the acute and chronic 
dietary risk assessments, the water concentration

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value of 395 ppb was used to assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Spirotetramat is currently registered for the following uses that 
could result in residential exposures: golf courses and residential 
citrus trees. The golf course use could result in potential post-
application dermal exposure; however, there is no dermal hazard and 
therefore, quantification of dermal risk is not necessary. For the 
residential citrus tree use, because the product is sold in bulk 
packaging for agricultural uses and the label requires that handlers 
wear specific clothing (e.g., long-sleeve shirt/long pants) and the use 
of personal-protective equipment (e.g., gloves), based on current 
Agency policy, EPA has made the assumption that this product is not 
meant for homeowner use, and therefore, there is no need to conduct a 
quantitative residential handler assessment.
    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.

D. 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 safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
quantitative susceptibility of offspring following pre- or postnatal 
exposure. There is evidence of qualitative susceptibility in the rat 
developmental study, such that reduced fetal weight and increased 
incidences of malformations and skeletal deviations were observed at 
the limit dose, while maternal effects at this dose consisted of only 
body weight decrements. Concern is low since effects were only seen at 
the limit dose, effects were seen in the presence of maternal toxicity, 
and selected endpoints are protective of the observed effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1x. That decision is based on the following 
findings:
    i. The toxicity database for spirotetramat is complete.
    ii. Although there is evidence of neurotoxicity in the acute 
neurotoxicity study, concern is low since the effects are well-
characterized with clearly established NOAEL/LOAEL values, the selected 
endpoints are protective of the observed neurotoxic effect, there are 
no neurotoxic effects seen in the subchronic neurotoxicity study, and 
the existing toxicological database indicates that spirotetramat is not 
a neurotoxic chemical.
    iii. There was no evidence of quantitative susceptibility of 
offspring following pre- or postnatal exposure. There is evidence of 
qualitative susceptibility in the rat developmental study; however, 
there is no residual uncertainty concerning these effects due to the 
clear NOAEL/LOAELs in the study for these effects. Moreover, concern 
for these effects is low since effects were only seen at the limit 
dose, effects were seen in the presence of maternal toxicity, and 
selected endpoints are protective of the observed effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The acute dietary food and drinking water exposure 
assessment utilizes tolerance-level residues and 100 PCT information 
for all commodities. The chronic dietary food and drinking water 
exposure assessment utilizes average field trial residues for some 
commodities, tolerance-level residues for the remaining commodities, 
and 100 PCT. The chronic assessment is somewhat refined; however, since 
it is based on reliable data, it will not underestimate exposure and 
risk. The drinking water assessments provide conservative, health-
protective, high-end estimates of water concentrations that will not 
likely be exceeded. These assessments of exposure are not likely to 
underestimate the resulting estimates of risk from exposure to 
spirotetramat.

E. 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 16% of the aPAD for children 1-2 years 
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 77% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for spirotetramat resulting in 
long-term exposure that require a quantitative risk assessment.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). A short- and 
intermediate-term inhalation adverse effect was identified; however, 
spirotetramat is not registered for any use patterns that would result 
in either short- or intermediate-term inhalation residential exposure. 
In a dermal toxicity study, no evidence of dermal hazard was found; 
therefore, dermal risk was not included in the aggregate assessment. 
Short- and intermediate-term risk is assessed based on short- and 
intermediate-term residential exposure plus chronic dietary exposure. 
Because

[[Page 73346]]

there is no short- or intermediate-term residential exposure and 
chronic dietary exposure has already been assessed under the 
appropriately protective cPAD (which is at least as protective as the 
POD used to assess short-term risk), no further assessment of short- or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for spirotetramat.
    4. 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.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to spirotetramat residues.

IV. 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 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 spirotetramat in or on 
asparagus.

C. Response to Comments

    EPA received one comment to the Notice of Filing noting general 
concerns about the potential effects on the cornea, thymus and thyroid, 
and testicular histopathy and stating, in part, that EPA should deny 
any approval of use of this chemical on any food products. The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances 
may be set when persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute. EPA has assessed the effects of this chemical on human 
health and determined that aggregate exposure to it will be safe. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

V. Conclusion

    Therefore, tolerances are established for residues of 
spirotetramat, including its metabolites and degradates, in or on 
asparagus at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(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 (NTTAA) (15 U.S.C. 272 note).

VII. 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.

[[Page 73347]]

    Dated: October 14, 2016.
Michael Goodis,
Acting 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. In Sec.  180.641:
0
a. Add alphabetically the commodity ``Asparagus'' to the table in 
paragraph (a)(1); and
0
b. Revise the footnote at the end of the table in paragraph (a)(1).
    The additions and revisions read as follows:

Sec.  180.641  Spirotetramat; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                            Parts per
                       Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Asparagus \1\..........................................            0.10
 
                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations for these commodities.

* * * * *
[FR Doc. 2016-25638 Filed 10-24-16; 8:45 am]
 BILLING CODE 6560-50-P