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[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55804-55807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23159]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0496; FRL-8881-6]

Dicamba; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of dicamba 
in or on teff, forage; teff, grain; teff, straw; and teff, hay. 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 9, 2011. Objections and 
requests for hearings must be received on or before November 8, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0496. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7390; e-mail address: nollen.laura@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 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. To access the 
harmonized test guidelines referenced in this document electronically, 
please go http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

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-2010-0496 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 
November 8, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked

[[Page 55805]]

confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit a copy of your non-CBI objection or 
hearing request, identified by docket ID number EPA-HQ-OPP-2010-0496, 
by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 22, 2010 (75 FR 65321) (FRL-
8851-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E7779) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. 
The petition requested that 40 CFR 180.227 be amended by establishing a 
tolerance for residues of the herbicide dicamba, 3,6-dichloro-o-anisic 
acid, and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH 
dicamba), in or on teff, forage at 90.0 parts per million (ppm); teff, 
grain at 6.0 ppm; teff, straw at 30.0 ppm; and teff, hay at 40.0 ppm. 
That notice referenced a summary of the petition prepared on behalf of 
IR-4 by Helena Chemical Company, the registrant, which is available in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the tolerance expression for all established commodities to be 
consistent with current Agency policy. The reason for this change is 
explained 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 dicamba including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with dicamba 
follows.
    In the Federal Register of April 2, 2008 (73 FR 17914) (FRL-8356-
6), EPA published a final rule establishing tolerances for combined 
residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, and its 
metabolite, 3,6-dichloro-5-hydroxy-o-anisic acid in or on corn, sweet, 
forage at 0.50 ppm; corn, sweet, kernel plus cob with husks removed 
0.04 ppm; and corn, sweet, stover at 0.50 ppm, based on EPA's 
conclusion that aggregate exposure to dicamba is safe for the general 
population, including infants and children. Since 2008, there have been 
no additional tolerance actions for dicamba.
    As noted in this unit, the current action concerns a tolerance for 
dicamba on teff. Teff is an intermediate grass that is morphologically 
and taxonomically similar to other cereal grains, including wheat. It 
is used to make flour in a manner similar to wheat and other cereal 
grains. EPA recently assessed the proposed use of dicamba on teff. In 
that assessment, EPA determined that aggregate dicamba exposures and 
risks will not increase as a result of the addition of the proposed 
teff uses to the uses assessed as part of the 2008 rulemaking. Teff is 
not included in the Continuing Survey of Food Intakes by Individuals 
(CSFII). However, because it is used to make flour in a manner similar 
to wheat and other cereal grains, it will likely substitute in the diet 
for cereal grain foods which will contain similar residues of dicamba; 
therefore, a significant increase in dietary exposure to residues of 
dicamba from consumption of teff-containing foods will not occur. 
Furthermore, residues of dicamba in teff livestock feeds will be 
similar to those in other forages, hays, and silages for which 
tolerances of dicamba are currently established. As such, there would 
be no increase in the livestock dietary burden should teff be 
substituted in the livestock diet for other hays and silages; residues 
in meat, milk, poultry and eggs will remain the same.
    Further information about EPA's risk assessment and determination 
of safety for this action can be found at http://www.regulations.gov in 
document ``2,4-D and Dicamba: Petition for the Establishment of 
Tolerances on Teff; Request for Registration of Latigo (EPA Reg. No. 
5905-564) on Teff.'' in docket ID number EPA-HQ-OPP-2010-0496. Except 
as supplemented by the information described in this unit, EPA is 
relying on the safety finding in the 2008 rulemaking and the risk 
assessment underlying that action in establishing the tolerances for 
dicamba on teff, forage; teff, grain; teff, straw; and teff, hay. 
Further information regarding the safety finding for the last 
rulemaking can be found in the Federal Register of April 2, 2008 (73 FR 
17917) (FRL-8356-6), at http://www.epa.gov/fedrgstr/EPA-PEST/2008/April/Day-02/p6674.htm.
    For the 2008 rulemaking, the toxicity database was considered 
complete. However, recent changes to 40 CFR part 158 imposed new data 
requirements for immunotoxicity testing (OPPTS Guideline 870.7800) and 
acute and subchronic neurotoxicity testing (OPPTS Guideline 870.6200) 
for pesticide registration. The toxicity database for dicamba includes 
acceptable acute and subchronic neurotoxicity studies; therefore, the 
requirements for the neurotoxicity screening battery have been met. 
Additionally, an immunotoxicity study was recently submitted and is 
currently under review. A screening level review of this study 
indicates that no effects, including immunotoxic effects, were observed 
at the highest dose tested of approximately 307 milligrams/
kilograms(mg/kg/day). This value is higher than the doses currently 
used for risk assessment; therefore, risk assessment endpoints will not 
change and the toxicity database is considered complete.
    Based upon the 2008 rulemaking and the other information discussed 
in this unit, EPA concludes that there is a

[[Page 55806]]

reasonable certainty that no harm will result to the general 
population, and to infants and children, from aggregate exposure to 
dicamba residues. Refer to the April 2, 2008 (73 FR 17914) (FRL-8356-6) 
Federal Register document, available at http://www.regulations.gov, for 
a detailed discussion of the aggregate risk assessments and 
determination of safety. EPA relies upon those risk assessments and the 
findings made in the Federal Register document in support of this 
action.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies, Methods I and II--gas 
chromatography with electron capture detection (GC/ECD), are available 
to enforce the tolerance expression. The methods are published in the 
Pesticide Analytical Manual (PAM) Volume II. 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; e-mail address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established MRLs for dicamba in or on commodities 
associated with this action.

C. Revisions to Petitioned-For Tolerances

    The EPA has revised the tolerance expression to clarify:
    1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of dicamba not specifically 
mentioned; and
    2. That compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of dicamba, 3,6-
dichloro-o-anisic acid, including its metabolites and degradates, in or 
on teff, forage at 90.0 ppm; teff, grain at 6.0 ppm; teff, straw at 
30.0 ppm; and teff, hay at 40.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA 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 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 on the basis 
of a petition under section 408(d) of FFDCA, 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 final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: August 31, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.227 is amended by revising the introductory text in 
paragraphs (a)(1), (2), and (3); and alphabetically adding the 
following commodities to the table in paragraph (a)(1) to read as 
follows:

Sec.  180.227  Dicamba; tolerances for residues.

    (a) General. (1) Tolerances are established for the residues of the 
herbicide dicamba (3,6-dichloro-o-anisic

[[Page 55807]]

acid), including its metabolites and degradates, in or on the 
commodities in the table below. Compliance with the tolerance levels is 
to be determined by measuring only the sum of the residues of dicamba 
(3,6-dichloro-o-anisic acid) and its metabolite, 3,6-dichloro-5-
hydroxy-o-anisic acid, calculated as the stoichiometric equivalent of 
dicamba, in or on the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Teff, forage................................................        90.0
Teff, grain.................................................         6.0
Teff, hay...................................................        40.0
Teff, straw.................................................        30.0
 
                                * * * * *
------------------------------------------------------------------------

     (2) Tolerances are established for residues of the herbicide 
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels is to be determined by measuring only the 
residues of dicamba (3,6-dichloro-o-anisic acid) and its metabolite, 
3,6-dichloro-2-hydroxybenzoic acid, calculated as the stoichiometric 
equivalent of dicamba, in or on the following commodities:
* * * * *
    (3) Tolerances are established for residues of the herbicide 
dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and 
degradates, in or on the commodities in the table below. Compliance 
with the tolerance levels is to be determined by measuring only the 
residues of dicamba, 3,6-dichloro-o-anisic acid, and its metabolites, 
3,6-dichloro-5-hydroxy-o-anisic acid, and 3,6-dichloro-2-hydroxybenzoic 
acid, calculated as the stoichiometric equivalent of dicamba, in or on 
the following commodities:
* * * * *
[FR Doc. 2011-23159 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P
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