
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55814-55817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22984]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0905; FRL-8881-7]


2,4-D; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 2,4-D 
in or on teff, bran; teff, forage; teff, grain; and teff, straw. 
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-2010-0905. 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.

[[Page 55815]]

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-2010-0905 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 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-2010-0905, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online 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 February 4, 2011 (76 FR 6465) (FRL-8858-
7), 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 
0F7796) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. PP 0F7796 was incorrectly reported and should have read PP 
0E7796, the correct petition number. The petition requested that 40 CFR 
180.142 be amended by establishing a tolerance for residues of the 
herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), both free and 
conjugated, determined as the acid, in or on teff, bran at 4.0 parts 
per million (ppm); teff, forage at 25.0 ppm; teff, grain at 2.0 ppm; 
and teff, straw at 50.0 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. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    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 these changes is 
explained in Unit IV.D.

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 2,4-D including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with 2,4-D follows.
    In the Federal Register of July 27, 2005 (70 FR 43298) (FRL-7726-
8), EPA published a final reestablishing tolerances for combined 
residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), in or 
on hops, wild rice, and soybeans, based on upon EPA's conclusion that 
aggregate exposure to 2,4-D is safe for the general population, 
including infants and children. Since 2005, there have been no 
additional tolerance actions for 2,4-D.
    As noted in this unit, the current action concerns a tolerance for 
2,4-D 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 2,4-D on teff. In 
that assessment, EPA determined that aggregate 2,4-D 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 2005 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 2,4-D; 
therefore, a significant increase in dietary exposure to residues of 
2,4-D from consumption of teff-containing foods will not occur. 
Furthermore, residues of 2,4-D in teff livestock feeds will be similar 
to those in other forages, hays, and silages for which tolerances of 
2,4-D 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-2010-0905. Except 
as supplemented by the information described in this unit, EPA

[[Page 55816]]

is relying on the safety finding in the 2005 rulemaking and the risk 
assessment underlying that action in establishing tolerances for 2,4-D 
on teff, bran; teff, forage; teff, grain; and teff, straw. Further 
information regarding the safety finding for the last rulemaking can be 
found in the Federal Register of July 27, 2005 (70 FR 43307) (FRL-7726-
8), at http://www.epa.gov/fedrgstr/EPA-PEST/2005/July/Day-27/p14886.htm.
    For the 2005 rulemaking, the 2,4-D toxicity database was considered 
complete except for the submission of a developmental neurotoxicity 
study (DNT) and a repeat 2-generation reproduction study. The absence 
of these studies led EPA to retain an additional safety factor for the 
protection of infants and children as provided by FFDCA section 
408(b)(2)(C). Additionally, 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. All of these data 
requirements have now been met. The toxicity database for 2,4-D 
includes acceptable acute and subchronic neurotoxicity studies; 
therefore, the requirements for the neurotoxicity screening battery 
have been met. To address the other deficiencies, the registrant 
submitted an F1-extended 1-generation toxicity study in rats. This 
study has been reviewed and found acceptable, and fulfills the 
outstanding requirements for a DNT study, a repeat 2-generation 
reproduction study, and immunotoxicity testing. After review of these 
studies, EPA has concluded that they do not affect EPA's derivation of 
2,4-D's acute reference dose (aRfD) or chronic reference dose (cRfD). 
It is likely, however, that in the future EPA will remove the 
additional safety factor for the protection of infants and children now 
that the 2,4-D database is complete. Thus, once a full reassessment of 
2,4-D is completed, estimated risks are likely to decline 
substantially. However, because a full reassessment of 2,4-D risk 
taking into account the new studies has not been formally conducted, 
EPA is relying primarily on the 2005 rulemaking to support this action. 
Therefore, the safety finding for this action relies on the additional 
margin of safety provided by retaining the additional safety factor for 
protection of infants and children. For further information on EPA's 
review of these studies, information is available at http://www.regulations.gov, in docket ID number EPA-HQ-OPP-2010-0905.
    In the 2005 rulemaking, EPA relied upon data showing the percent of 
crops treated with 2,4-D in assessing chronic risk. In evaluating the 
proposed teff tolerances, EPA considered updated data on percent crop 
treated and has concluded that the updated data would increase the 
chronic risk estimates from the 2005 assessment for the general 
population and children 1-6 years old (the most sensitive 
subpopulation) by 2.2% and 3.1% of the cPAD, respectively. Because the 
chronic risk estimates for the 2005 assessment were well below the 
level of concern, these differences are considered insignificant.
    Therefore, based upon the 2005 rulemaking and the other information 
discussed in this unit, EPA concludes that there is a reasonable 
certainty that no harm will result to the general population, and to 
infants and children from aggregate exposure to 2,4-D residues. Refer 
to the July 27, 2005 (70 FR 43298) (FRL-7726-8) 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 methodology, a gas chromatography with 
electron capture detection (GC/ECD) method, designated as EN-CAS Method 
No. ENC-2/93, 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; 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 2,4-D in or on any 
commodities associated with this action.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a 
general objection to proposed new tolerances and new tolerance 
exemptions for several chemicals, including 2,4-D. The commenter 
additionally noted that, ``prior to approval of these or other 
chemicals in the food system the EPA must be confident that these will 
not cause harm'' and ``only long term studies can provide data on the 
health impact of exposure to these chemicals.'' The commenter stated 
that none of the mentioned chemicals, including 2,4-D, should be 
permitted in food.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that certain pesticide chemicals should not be 
permitted in our food. However, the existing legal framework provided 
by section 408 of the FFDCA states that tolerances may be set when 
persons seeking such tolerances or exemptions have demonstrated that 
the pesticide meets the safety standard imposed by that statute. When 
new or amended tolerances are requested for residues of a pesticide in 
food or feed, the Agency, as is required by section 408 of the FFDCA, 
estimates the risk of the potential exposure to these residues. The 
Agency has concluded after this assessment, which includes the 
consideration of long-term animal studies with 2,4-D, that there is a 
reasonable certainty that no harm will result from aggregate human 
exposure to 2,4-D and that, accordingly, the 2,4-D tolerances on teff 
are ``safe.''

D. Revisions to Petitioned-For Tolerances

    The EPA has revised the tolerance expression to clarify:
    1. Tvided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of 2,4-D not specifically mentioned; and 2. 
Tcompliance 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 2,4-D (2,4-
dichlorophenoxyacetic acid), including its metabolites and degradates, 
in or on teff, bran at 4.0 ppm; teff, forage at 25.0

[[Page 55817]]

ppm; teff, grain at 2.0 ppm; and teff, straw at 50.0 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 180.142 is amended by revising the introductory text in 
paragraphs (a), (c), and (d); and alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:


Sec.  180.142  2,4-D; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide, plant regulator, and fungicide 2,4-D, 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 residues of 2,4-D (2,4-dichlorophenoxyacetic acid), both free 
and conjugated, determined as the acid, in or on the following 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Teff, bran..................................................         4.0
Teff, forage................................................        25.0
Teff, grain.................................................         2.0
Teff, straw.................................................        50.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec.  180.1(l), are established 
for residues of the herbicide, plant regulator, and fungicide 2,4-D, 
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 residues of 2,4-D (2,4-dichlorophenoxyacetic 
acid), both free and conjugated, determined as the acid, in or on the 
follow commodities:
* * * * *
    (d) Indirect or inadvertent residues. Tolerances are established 
for indirect or inadvertent residues of the herbicide, plant regulator, 
and fungicide 2,4-D, including its metabolites and degradates, in or on 
the commodities in the table below. Compliance with the tolerances 
levels is to be determined by measuring residues of 2,4-D (2,4-
dichlorophenoxyacetic acid), both free and conjugated, determined as 
the acid, in or on the following commodities:
* * * * *
[FR Doc. 2011-22984 Filed 9-8-11; 8:45 am]
BILLING CODE 6560-50-P


