[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16308-16311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-6440]



[[Page 16308]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0477; FRL-8866-2]


Dichlormid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
dichlormid in or on field corn, pop corn, and sweet corn commodities. 
Dow AgroSciences requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 23, 2011. Objections and 
requests for hearings must be received on or before May 23, 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-2005-0477. 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: Pv Shah, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-1846; e-mail address: [email protected].

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://www.gpoaccess.gov/ecfr.

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-2005-0477 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 
May 23, 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-2005-0477, 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 December 22, 2010 (75 FR 80489) (FRL-
8857-8), 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 
9E7517) by Dow AgroSciences, 9330 Zionsville Rd., Indianapolis, IN 
46268. The petition requested that 40 CFR part 180 be amended by 
establishing permanent tolerances for residues of the herbicide safener 
dichlormid, N,N-diallyl-2,2-dichloroacetamide, in or on corn, field, 
forage; corn, field, grain; corn, field, stover; corn, pop, grain; 
corn, pop, stover; corn, sweet, forage; corn, sweet, kernel plus cob 
with husks removed; and corn, sweet, stover at 0.05 parts per million 
(ppm). That notice referenced a summary of the petition prepared by Dow 
AgroSciences, 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.

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

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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 dichlormid including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with dichlormid 
follows.
    In the Federal Register of March 27, 2000 (65 FR 16143) (FRL-6498-
7), EPA published a final rule establishing time-limited tolerances for 
residues of the herbicide safener dichlormid in or on field corn 
forage, grain and stover; and pop corn grain and stover at 0.05 ppm. In 
the Federal Register of September 30, 2004 (69 FR 58285) (FRL-7680-8), 
EPA published a final rule establishing time-limited tolerances for 
residues of dichlormid in or on sweet corn forage, kernel plus cob with 
husks removed, and stover at 0.05 ppm. EPA has extended the expiration 
date of the time-limited tolerances on several occasions, most recently 
in the Federal Register of July 29, 2009 (74 FR 37621) (FRL-8422-2). 
The tolerances expired on December 31, 2010.
    The corn tolerances were time-limited due to an incomplete database 
for dichlormid. Data gaps included several chemistry and toxicology 
studies, as identified in the March 27, 2000 and September 30, 2004 
final rules. In addition, in December, 2007, EPA began requiring 
functional immunotoxicity testing of all food and non-food use 
pesticides (40 CFR part 158, subpart F), including safeners, such as 
dichlormid. The outstanding chemistry and toxicology data (including 
immunotoxicity testing) have all been submitted and reviewed, so that 
the database for dichlormid is now considered complete. No changes in 
tolerance levels or toxicological endpoints and doses used in the human 
health risk assessment for dichlormid are needed as a result of the new 
data. Copies of EPA's reviews of these data may be found in docket ID 
number EPA-HQ-OPP-2005-0477.
    The risk assessments that EPA relied on in establishing and 
extending the time-limited tolerances for dichlormid were highly 
conservative. Due to the nature and number of data gaps and qualitative 
evidence of increased susceptibility of in utero rabbits in a prenatal 
developmental toxicity study, the FQPA safety factor (SF) was retained 
at 10X for the acute dietary risk assessment and increased to 30X for 
the chronic dietary risk assessment. Since the data gaps have been 
filled, uncertainty factors associated with database deficiencies may 
be removed. In addition, EPA used tolerance level residues, 100 percent 
crop treated, and default processing factors in the dietary food 
exposure assessments and made conservative (protective) assumptions in 
the modeling used to assess exposure to dichlormid in drinking water. 
Using these highly conservative assumptions and SFs, acute dietary 
exposure to dichlormid in food was estimated to be less than or equal 
to 7.5% of the acute population adjusted dose (aPAD) for all population 
subgroups; chronic dietary exposure to dichlormid in food was estimated 
to be less than or equal to 15% of the chronic population adjusted dose 
(cPAD) for all populations subgroups.
    Because this prior risk assessment showed dichlormid risks to be 
acceptable and the effect of submission of the required data on the 
assessment of dichlormid risk will be to lower estimated risks (due to 
the removal of additional safety factors), EPA is relying on that prior 
risk assessment and the findings in the prior dichlormid FR notices, 
subject to one modification, to demonstrate the safety of the 
tolerances established in this action. The one modification of the 
prior risk assessment and FR notices is to update how exposure to 
dichlormid in drinking water is factored into the risk assessment.
    Previously, EPA assessed aggregate exposure (food and drinking 
water) to dichlormid using the DWLOC (drinking water level of 
comparison) approach. The DWLOC is the concentration of a chemical in 
drinking water that would be acceptable as an upper limit considering 
total aggregate exposure to that chemical from food, water, and 
residential sources. In this case, there are no residential uses of 
dichlormid. Acute and chronic aggregate risks from dichlormid exposure 
were assessed by comparing the calculated DWLOCs to the estimated 
environmental concentrations (EECs) of dichlormid in surface water and 
groundwater. Since the EECs (< 1 ppm in both surface and groundwater) 
were well below the calculated DWLOCs for acute exposure (73 parts per 
billion (ppb)) and chronic exposure (20 ppb), acute and chronic 
aggregate risks were determined to be below the Agency's level of 
concern. Details of the risk assessment for dichlormid may be found in 
the document ``Human Health Risk Assessment for Dichlormid-Request for 
Establishing Permanent Tolerances for Dichlormid on Corn,'' which is 
available in docket ID number EPA-HQ-OPP-2005-0477.
    The Agency no longer uses the DWLOC approach for assessing 
aggregate exposure to pesticides. Rather, estimated drinking water 
concentrations (EDWCs) are directly entered into the dietary exposure 
model to assess the contribution of drinking water exposure to 
aggregate exposure. EPA then determines whether acute and chronic 
dietary pesticide exposures are safe by comparing aggregate exposure 
estimates to the aPAD and cPAD. Using this approach, together with the 
conservative assumptions and SFs discussed earlier in this unit, EPA 
has concluded that acute and chronic exposure to dichlormid from food 
and water will utilize 56% of the aPAD and 34% of the cPAD for infants, 
less than one year old, the population group receiving the greatest 
exposure.
    Based on the prior and updated risk assessments as well as the 
findings in the prior dichlormid FR notices, 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 
dichlormid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with nitrogen 
selective thermionic detection) 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: 
[email protected].

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

[[Page 16310]]

(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 a MRL for dichlormid in or on corn 
commodities.

C. Response to Comments

    An anonymous comment was received objecting to the presence of any 
pesticide residue on food. The Agency understands the commenter's 
concerns and recognizes that some individuals believe that pesticides 
should be banned completely. However, the existing legal framework 
provided by section 408 of the FFDCA contemplates that tolerances 
greater than zero may be set when persons seeking such tolerances or 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. This citizen's comment appears to be 
directed at the underlying statute and not EPA's implementation of it; 
the citizen has made no contention that EPA has acted in violation of 
the statutory framework.

D. Revisions to Petitioned-for Tolerances

    EPA is revising the requested tolerance expression to clarify the 
chemical moieties that are covered by the tolerances and specify how 
compliance with the tolerances is to be measured. The revised tolerance 
expression makes clear that the tolerances cover residues of the 
herbicide safener dichlormid, including its metabolites and degradates, 
but that compliance with the tolerances is to be determined by 
measuring only dichlormid (2,2-dichloro-N,N-di-2-propenylacetamide). 
EPA has determined that it is reasonable to make this change final 
without prior proposal and opportunity for comment, because public 
comment is not necessary, in that the change has no substantive effect 
on the tolerance, but rather is merely intended to clarify the existing 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of dichlormid, 
including its metabolites and degradates, in or on corn, field, forage; 
corn, field, grain; corn, field, stover; corn, pop, grain; corn, pop, 
stover; corn, sweet, forage; corn, sweet, kernel plus cob with husks 
removed; and corn, sweet, stover at 0.05 ppm. Compliance with the 
tolerances is to be determined by measuring only dichlormid (2,2-
dichloro-N,N-di-2-propenylacetamide).

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: March 8, 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 180.469 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.469  Dichlormid; tolerances for residues.

    (a) General. Tolerances are established for residues of dichlormid, 
including its metabolites and degradates, when used as an inert 
ingredient (herbicide safener) in pesticide formulations, in or on the 
commodities in the following table.

[[Page 16311]]

Compliance with the tolerances is to be determined by measuring only 
dichlormid (2,2-dichloro-N,N-di-2-propenylacetamide).

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................         0.05
Corn, field, grain.........................................         0.05
Corn, field, stover........................................         0.05
Corn, pop, grain...........................................         0.05
Corn, pop, stover..........................................         0.05
Corn, sweet, forage........................................         0.05
Corn, sweet, kernel plus cob with husks removed............         0.05
Corn, sweet, stover........................................         0.05
------------------------------------------------------------------------

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[FR Doc. 2011-6440 Filed 3-22-11; 8:45 am]
BILLING CODE 6560-50-P