[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Rules and Regulations]
[Pages 67282-67285]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27403]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0755; FRL-9366-3]


Dinotefuran; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes time-limited tolerances for 
residues of dinotefuran in or on pome fruits and stone fruits. This 
action is in response to EPA's granting of emergency exemptions under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on pome fruits and stone fruits. This 
regulation establishes a maximum permissible level for residues of 
dinotefuran in or on these commodities. The time-limited tolerances 
expire on December 31, 2015.
    This regulation also makes the systematic chemical name for 
dinotefuran consistent within the section and with EPA's policy on 
chemical nomenclature.

DATES: This regulation is effective November 9, 2012. Objections and 
requests for hearings must be received on or before January 8, 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-2012-0755, 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: Andrea Conrath, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9356; email address: conrath.andrea@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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 identify docket ID number EPA-HQ-OPP-
2012-0755 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 January 8, 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-2012-0755, 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 
time-limited tolerances for combined residues of dinotefuran, (RS)-1-
methyl-2-nitro-3-((tetrahydro-3-furanyl)methyl)guanidine, including its 
metabolites and degradates, in or on pome fruits and stone fruits at 
1.0 part per million (ppm). These time-limited tolerances expire 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

[[Page 67283]]

received any petition from an outside party.
    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 Dinotefuran on Pome Fruits and Stone 
Fruits and FFDCA Tolerances

    Several States requested emergency exemptions claiming that the 
abrupt increase and spread of damaging populations of the Brown 
Marmorated Stink Bug (BMSB) resulted in an urgent and non-routine pest 
control situation. The available insecticides for BMSB control are 
either ineffective, adversely impact integrated pest management 
programs, and/or have use limitations that make them unsuitable for 
season-long control of BMSB. The States asserted that without the use 
of dinotefuran as an additional pest management tool for pome and stone 
fruit orchards, uncontrolled infestations of BMSB are likely to result 
in economic losses in excess of 20%. After having reviewed the 
submissions, EPA determined that an emergency condition exists for 
these States, and that the criteria for approval of the emergency 
exemptions were met. EPA authorized specific exemptions under FIFRA 
section 18 for the use of dinotefuran on pome fruits and stone fruits 
for control of the BMSB in Delaware, Maryland, New Jersey, North 
Carolina, Pennsylvania, Virginia, and West Virginia.
    Consistent with the need to move quickly on the emergency 
exemptions in order to address an urgent non-routine situation and to 
ensure that the resulting food is safe and lawful, EPA is issuing these 
tolerances 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 
tolerances remaining in or on pome fruits and stone fruits 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 
dinotefuran meets FIFRA's registration requirements for use on pome 
fruits and stone fruits or whether permanent tolerances for this use 
would be appropriate. Under these circumstances, EPA does not believe 
that these time-limited tolerance decisions serve as a basis for 
registration of dinotefuran by a State for special local needs under 
FIFRA section 24(c). Nor do these tolerances by themselves serve as the 
authority for persons in any State other than Delaware, Maryland, New 
Jersey, North Carolina, Pennsylvania Virginia, and West Virginia 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 exemptions for 
dinotefuran, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

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 * * 
*.''
    As part of its evaluation of the emergency exemption applications, 
EPA assessed the potential risks presented by residues of dinotefuran 
in or on pome fruits and stone fruits. In doing so, EPA considered the 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18.
    EPA has evaluated the use of dinotefuran on pome fruits and stone 
fruits, as well as various other crops, and recently established 
tolerances for similar use patterns, in the Federal Register issue of 
September 12, 2012 (77 FR 56133) (FRL-9359-6) in association with 
requests for tolerances to support registrations of dinotefuran under 
section 3 of FIFRA.
    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 dinotefuran including exposure 
resulting from the tolerances established by this action.
    In the September 12, 2012 Federal Register issue, EPA published a 
final rule establishing tolerances for residues of dinotefuran in 40 
CFR 180.603(a) in or on berry, low growing, except strawberry, subgroup 
13-07H; fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 
13-07F; onion, bulb, subgroup 3-07A; onion, green, subgroup 3-07B; 
peach; tea, dried; vegetable, tuberous and corm, subgroup 1C; and 
watercress. A summary of the toxicological endpoints for dinotefuran 
used for human risk assessment is discussed in Units III.A. and B. of 
the September 12, 2012 final rule.
    The human health risk assessment used to support the September 12, 
2012 final rule (``Dinotefuran: Human Health Risk Assessment for 
Proposed Section 3 Uses on Tuberous and Corm Vegetables Subgroup 1C, 
Onion Subgroup 3-07A, Onion Subgroup 3-07B, Small Fruit Subgroup 13-
07F, Berry Subgroup 13-07H, Peach, and Watercress, And a Tolerance on 
Imported Tea''), took into account the assumption that dinotefuran 
would be used on pome fruits and stone fruits pursuant to emergency 
exemptions.
    Therefore the aggregate risks for dinotefuran for this action are 
not changed from those discussed in the September 12, 2012 final rule.
    In its aggregate assessment of exposures and risks associated with 
dinotefuran, EPA concluded the following: That the acute dietary 
exposure from food and water to dinotefuran will occupy 5.8% of the 
acute population adjusted dose (aPAD) for children 1-2 years old, the 
population group receiving the greatest exposure; that chronic exposure 
to dinotefuran from food and water will utilize 2.6% of the chronic 
population adjusted dose (cPAD) for children 1-2 years old, the 
population group

[[Page 67284]]

receiving the greatest exposure; and that the combined short-term risk 
from food, water, and residential exposures result in an aggregate 
margin of exposure (MOE) of 3,000 for children 1-2 years old from hand 
to mouth exposure from treated turf, the scenario with the highest 
exposure. Because EPA's level of concern for dinotefuran is a MOE of 
100 or below, the MOEs are not of concern. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, dinotefuran is not expected to pose a cancer risk to humans.
    Therefore, EPA concluded that there is a reasonable certainty that 
no harm will result to the general population and to infants and 
children from aggregate exposure to dinotefuran residues. Refer to the 
September 12, 2012 final rule, available at http://www.regulations.gov, 
for a summary of the aggregate risk assessments and determination of 
safety. A more detailed discussion of the aggregate risk assessments 
and determination of safety may be found at http://www.regulations.gov 
in the document titled ``Revised: Dinotefuran: Human Health Risk 
Assessment for Proposed Section 3 Uses on Tuberous and Corm Vegetables 
Subgroup 1C, Onion Subgroup 3-07A, Onion Subgroup 3-07B, Small Fruit 
Subgroup 13-07F, Berry Subgroup 13-07H, Peach, and Watercress, And a 
Tolerance on Imported Tea'' in docket ID number EPA-HQ-OPP-2011-0433.
    EPA relies upon those risk assessments and the findings made in the 
Federal Register document in support of this action.

V. Other Considerations

A. Analytical Enforcement Methodology

    There are several analytical methods available for determination of 
residues of dinotefuran and its metabolites. For determination of 
dinotefuran and its metabolites, DN, 1-methyl-3-(tetrahydro-3-
furylmethyl)guanidine, and UF, 1-methyl-3-(tetrahydro-3-
furylmethyl)urea, a high performance liquid chromatography/tandem mass 
spectrometry (HPLC/MS/MS) method is available. For the determination of 
residues of dinotefuran only, an HPLC/ultraviolet (UV) detection method 
is available. For the determination of only the metabolites (DN and 
UF), HPLC/MS and HPLC/MS/MS methods are available. These methods are 
adequate to enforce the tolerance expression.
    The methods 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.
    There are currently no Codex, Canadian or Mexican MRLs established 
for dinotefuran.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
dinotefuran, (RS)-1-methyl-2-nitro-3-((tetrahydro-3-
furanyl)methyl)guanidine, including its metabolites and degradates, in 
or on fruit, pome, group 11 and fruit, stone, group 12 at 1.0 ppm. 
These tolerances expire on December 31, 2015.
    EPA is also revising 40 CFR 180.603(b) to use the same systematic 
chemical name for dinotefuran as is presently used in 40 CFR 
180.603(a), for purposes of consistency within the section and with 
EPA's policy regarding chemical nomenclature.

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, 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).

[[Page 67285]]

List of Subjects in 40 CFR Part 180

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

    Dated: November 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. In Sec.  180.603, revise paragraph (b) to read as follows:


Sec.  180.603  Dinotefuran; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of dinotefuran, (RS)-1-methyl-2-nitro-3-
((tetrahydro-3-furanyl)methyl)guanidine, including its metabolites and 
degradates, in or on the commodities in the following table, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. Compliance with the tolerance levels specified in the table 
is to be determined by measuring only the sum of dinotefuran and its 
metabolites DN, 1-methyl-3-(tetrahydro-3-furylmethyl)guanidine, and UF, 
1-methyl-3-(tetrahydro-3-furylmethyl)urea, calculated as the 
stoichiometric equivalent of dinotefuran, in or on the commodities 
listed in the table. The tolerances expire and are revoked on the dates 
specified in the table.

------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Fruit, pome, group 11...................             1.0        12/31/15
Fruit, stone, group 12..................             1.0        12/31/15
Rice, grain.............................             2.8        12/31/12
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-27403 Filed 11-8-12; 8:45 am]
BILLING CODE 6560-50-P