Thiabendazole; Pesticide Tolerances for Emergency Exemptions, 42397-42400 [2015-17681]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Rules and Regulations]
[Pages 42397-42400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17681]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0396; FRL-9929-95]


Thiabendazole; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of thiabendazole in or on succulent shelled peas.
    This action is associated with the utilization of a crisis 
exemption under the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide as a seed treatment on 
succulent pea seeds. This regulation establishes a maximum permissible 
level for residues of thiabendazole in or on this commodity. The time-
limited tolerance expires on December 31, 2018.

DATES: This regulation is effective July 17, 2015. Objections and 
requests for hearings must be received on or before September 15, 2015, 
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-2015-0396, is available at https://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 https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, 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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at https://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 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-
2015-0396 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 September 15, 2015. 
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-2015-0396, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://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 the combined residues of the fungicide 
thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite 
benzimidazole (free and conjugated) in or on pea, succulent shelled at 
0.02 parts per million (ppm). This time-limited tolerance expires on 
December 31, 2018.
    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

[[Page 42398]]

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 Thiabendazole on Succulent Peas and FFDCA 
Tolerances

    The emergency exemption to treat pea seed with thiabendazole was 
requested by the State of Idaho (Applicant) because the seed will be 
treated in Idaho. However, the seed is being planted in Minnesota, 
Illinois, and Wisconsin, where the emergency conditions exist. Pea 
growers in these states are faced with a new complex of pea root and 
foliar disease pathogens that current cultural practices, varieties, 
and seed treatments do not manage. Pea crop failure in commercial 
fields has become a severe problem and growers have experienced rapidly 
increasing yield losses within the pea production area each year for 
several years.
    The Applicant asserts that an emergency condition exists in 
accordance with the criteria for approval of an emergency exemption, 
and has utilized a crisis exemption under FIFRA section 18 to allow the 
use of thiabendazole on as a seed treatment on succulent peas in Idaho 
for control of Fusarium and Ascochyta blight in Minnesota, Illinois, 
and Wisconsin.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of thiabendazole 
in or on succulent peas. 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 
this time-limited tolerance expires on December 31, 2018, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on succulent peas 
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 this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
thiabendazole meets FIFRA's registration requirements for use on 
succulent peas 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 
thiabendazole 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 Idaho 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 thiabendazole, 
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. . . 
.''
    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 tolerance for combined residues of the fungicide 
thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite 
benzimidazole (free and conjugated) on succulent shelled peas at 0.02 
ppm.
    EPA recently updated its dietary risk assessment in connection with 
a Federal Register rule on September 25, 2014 (79 FR 57450) (FRL-9915-
78) establishing permanent tolerances for residues of thiabendazole in 
or on multiple commodities, and has evaluated the potential increase in 
exposure resulting from the Section 18 emergency exemption use of 
thiabendazole on succulent shelled peas (Pisum spp., including English 
pea, garden pea, and green pea). Based on the supporting residue 
chemistry data, the combined residues of thiabendazole and 
benzimidazole in/on succulent shelled peas (Pisum spp., including 
English pea, garden pea, and green pea) are estimated at 0.01 ppm 
(i.e., \1/2\ limit on quantitation (LOQ) for each analyte) for the 
Section 18 emergency exemption use. To estimate the contribution to 
drinking water residues resulting from the emergency seed treatment use 
on succulent shelled peas, EPA relied on

[[Page 42399]]

the drinking water residue estimates for the currently registered seed 
treatment use on wheat at 0.20 lbs. active ingredient/acre (ai/A), 
which is higher than the 0.083 lbs. ai/A maximum seed treatment use 
allowed under the emergency exemption. The addition of the emergency 
use on succulent shelled peas and the assumption of 100% of succulent 
shelled peas treated did not change the findings of the most recent 
dietary exposure and risk assessment which are discussed in the Federal 
Register of September 25, 2014. The Agency's exposure and risk 
assessment for the emergency use on succulent shelled peas is discussed 
in greater detail in ``Section 18 Emergency Exemption for the Use of 
Thiabendazole as a Seed Treatment on Succulent Peas in Bonneville and 
Latah Counties in Idaho,'' May 14, 2015, available in docket at the 
address provided under ADDRESSES.
    Because the Section 18 emergency use of thiabendazole on succulent 
shelled peas will result in negligible increases in dietary exposure to 
all subgroups relative to the safety findings reached in the September 
25, 2014 Federal Register Notice, 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 
thiabendazole residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Acceptable enforcement analytical methods are available for 
thiabendazole and benzimidazole in plant commodities. Four spectrophoto 
fluoro metric methods for the determination of thiabendazole are 
published in the Pesticide Analytical Manual (PAM) Vol. II, and a high 
performance liquid chromatography (HPLC) method with fluorescence 
detection (FLD) for the determination of benzimidazole (free and 
conjugated) is identified in the U.S. EPA Index of Residue Analytical 
Methods under thiabendazole as Study No. 93020.

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 thiabendazole in or on the 
requested commodity.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
thiabendazole (2-(4-thiazolyl)benzimidazole) and its metabolite 
benzimidazole (free and conjugated), calculated as the stoichiometric 
equivalent of thiabendazole, in or on pea, succulent shelled at 0.02 
ppm. This tolerance expires on December 31, 2018.

VII. Statutory and Executive Order Reviews

    This action 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 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 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 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).

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: July 9, 2015.
Susan Lewis,
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.  180.242, revise paragraph (b) to read as follows:

[[Page 42400]]

Sec.  [emsp14]180.242  Thiabendazole; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
thiabendazole, including its metabolites and degradates, in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to FIFRA section 18 emergency exemptions. Compliance with the 
tolerance levels specified below is to be determined by measuring only 
the sum of thiabendazole (2-(4-thiazolyl)benzimidazole) and its 
metabolite benzimidazole (free and conjugated), calculated as the 
stoichiometric equivalent of thiabendazole. The tolerances expire on 
the date specified in the table.

------------------------------------------------------------------------
                                  Parts per
          Commodity                million          Expiration date
------------------------------------------------------------------------
Pea, succulent shelled.......            0.02  December 31, 2018.
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[FR Doc. 2015-17681 Filed 7-16-15; 8:45 am]
 BILLING CODE 6560-50-P