Document ID: EPA-HQ-OPP-2012-0900-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Spirotetramat
Posted Date: 2012-12-26T05:00Z

[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75855-75859]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30854]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0900; FRL-9373-2]

Spirotetramat; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for 
residues of spirotetramat in or on watercress. This action is in 
response to EPA's granting of an emergency exemption under the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on watercress. This regulation establishes a maximum 
permissible level for residues of spirotetramat in or on watercress. 
The time-limited tolerance expires on December 31, 2015.

DATES: This regulation is effective December 26, 2012. Objections and 
requests for hearings must be received on or before February 25, 2013, 
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-2012-0900, 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: Keri Grinstead, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8373; email address: grinstead.keri@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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]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.

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

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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

[[Page 75856]]

identify docket ID number EPA-HQ-OPP-2012-0900 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 February 25, 2013. 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-2012-0900, 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

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6), 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
a time-limited tolerance for residues of spirotetramat, including its 
metabolites and degradates, in or on watercress at 1.5 parts per 
million (ppm). This time-limited tolerance expires on December 31, 
2015.
    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 FIFRA 
section 18. 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 FFDCA section 408 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 Exemption for Spirotetramat on Watercress and FFDCA 
Tolerances

    This is the first Section 18 request received for the use of 
spirotetramat on watercress. Florida and Tennessee are experiencing 
high pest pressure from melon/cotton aphids in the watercress industry. 
Aphids infest watercress fields from surrounding areas, and attack the 
apical stem tips of plants. Watercress plants respond with reduced 
vigor (growth rate) and yields per acre (bunch number) are subsequently 
reduced. Due to lack of effective alternative insecticides, increasing 
resistance to the historically effective insecticide imidacloprid, and 
marketable yield losses, the Agency has determined the situation is 
non-routine and urgent and likely to result in significant economic 
losses. After having reviewed the submission, EPA determined that an 
emergency condition exists for these States, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of spirotetramat 
on watercress for control of melon/cotton aphids in Florida and 
Tennessee.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of spirotetramat 
in or on watercress. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) 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 FFDCA section 408(l)(6). Although 
these time-limited tolerances expire on December 31, 2015, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on watercress 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 these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
spirotetramat meets FIFRA's registration requirements for use on 
watercress 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 Florida and Tennessee, 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.

[[Page 75857]]

IV. 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 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 the emergency exemption requests and 
the time-limited tolerance for residues of spirotetramat, including its 
metabolites and degradates, in or on watercress at 1.5 ppm. EPA's 
assessment of exposures and risks associated with establishing a time-
limited tolerance 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 (LOC) 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.B. of the final rule published in the Federal Register of 
May 18, 2011 (76 FR 28675) (FRL-8865-8).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to spirotetramat, EPA considered exposure under the time-
limited tolerance established by this action as well as all existing 
spirotetramat tolerances in Sec.  180.641. EPA assessed dietary 
exposures from spirotetramat in food as follows:
    i. Acute and chronic exposure. Such effects were identified for 
spirotetramat. In estimating acute and chronic dietary exposure, EPA 
used food consumption information from the U.S. Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). As to residue levels in food, EPA 
used tolerance-level residues and 100 percent crop treated (PCT) for 
all commodities. Empirical processing factors were used for apple, 
orange, grape and tomato juice, applesauce, and dried apples, and 
Dietary Exposure Evaluation Model (DEEM (Ver. 7.81)) default processing 
factors were used for the remaining processed commodities (where 
provided).
    ii. 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.
    iii. 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 Tier 1 Rice Model and Screening Concentration in 
Ground Water (SCI-GROW) models, the estimated drinking water 
concentrations (EDWCs) of total toxic residues (TTR) of spirotetramat, 
spirotetramat-enol, and spirotetramat-ketohydroxy for acute and chronic 
exposures are estimated to be 158 parts per billion (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 and chronic dietary 
risk assessment, the water concentration value of 158 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). There are currently 
no registered or proposed residential uses for spirotetramat; therefore 
a residential exposure assessment was not conducted.
    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

[[Page 75858]]

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 Food Quality Protection Act Safety Factor (FQPA 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. Based on the results of 
developmental toxicity studies in rats and rabbits and two reproduction 
studies in rats with spirotetramat, there was no evidence of increased 
susceptibility of offspring following prenatal or postnatal exposure.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
Food Quality Protection Act (Pub. L. 104-170) Safety Factor (FQPA SF) 
were reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for spirotetramat is complete, except for 
a subchronic neurotoxicity study which is now required as part of the 
revisions to 40 CFR part 158. However, the existing toxicological 
database indicates that spirotetramat is not a neurotoxic chemical in 
mammals. In addition, acute, subchronic and developmental neurotoxicity 
studies available for structurally-related compounds (spirodiclofen and 
spiromesifen) do not show evidence of neurotoxicity in adults or young.
    ii. There is no indication that spirotetramat is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    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 both the 1- and 2-generation 
reproduction studies.
    iv. There are no residual uncertainties identified in the exposure 
databases that will result in underestimation of exposure. 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 10% of the aPAD for children ages 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 83% of the cPAD for 
children ages 1-2 years old, the population group receiving the 
greatest exposure. There are no residential uses for spirotetramat.
    3. Short-term and Intermediate-term risk. Short- and intermediate-
term aggregate exposure takes into account short-term and intermediate-
term residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). A short-term and 
intermediate-term adverse effect was identified; however, spirotetramat 
is not registered for any use patterns that would result in short-term 
or intermediate-term residential exposure. Short-term and intermediate-
term risk is assessed based on short-term or intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term 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-term or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short-term 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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high-performance liquid 
chromatography with tandem 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.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
spirotetramat, including its metabolites and degradates, in or on 
watercress at 1.5 ppm. This tolerance expires on December 31, 2015.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA sections 408(e) 
and 408(l)(6). 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,

[[Page 75859]]

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 FFDCA sections 408(e) and 408(l)(6), 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 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).

VIII. 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: December 12, 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. In Sec.  180.641, add alphabetically the following new entry to the 
table in paragraph (b).

Sec.  180.641  Spirotetramat; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                             Parts per      Expiration
                Commodity                     million          date
------------------------------------------------------------------------
 
                                * * * * *
Watercress..............................            1.5        12/31/15
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-30854 Filed 12-21-12; 4:15 pm]
BILLING CODE 6560-50-P