[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Rules and Regulations]
[Pages 16308-16311]
From the Federal Register Online via the Government Printing 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: shah.pv@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://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
[[Page 16309]]
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:
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
[[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).
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Parts per
Commodity million
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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