[Federal Register: October 10, 2007 (Volume 72, Number 195)]
[Rules and Regulations]
[Page 57489-57492]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc07-6]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0557; FRL-8145-2]
Furilazole; Inert Ingredient Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine;
(CAS Reg. No. 121776-33-8) under 40 CFR 180.471 when used as a
pesticide inert ingredient safener on the sorghum commodities forage,
grain, and stover at 0.01 parts per million (ppm). The Monsanto Company
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
DATES: This regulation is effective October 10, 2007. Objections and
requests for hearings must be received on or before December 10, 2007,
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-2007-0557. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in 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 either 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: Karen Angulo, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@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:
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 provides
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 Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2007-0557 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before December 10, 2007.
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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
[[Page 57490]]
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0557, 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'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. Background and Statutory Findings
In the Federal Register of June 1, 2005 (70 FR 31459) (FRL-7715-7),
EPA issued a notice pursuant to section 408 of the Federal Food, Drug,
and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food
Quality Protection Act (FQPA), announcing the filing of a pesticide
petition (PP 5E6919) by the Monsanto Company. The petition requested
that 40 CFR 180.471 be amended by the addition of tolerances for
residues of furilazole (3-dichloroacetyl-5-(2-furanyl)-2, 2-
dimethyloxazolidine; (CAS Reg. No. 121776-33-8) on the sorghum
commodities bran, flour, forage, grain, and stover at 0.01 parts per
million (ppm). That notice included a summary of the petition prepared
by the petitioner. No comments were received in response to the notice
of filing.
Section 408(b)(2)(A)(i) of the 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(c)(2)(A)(ii) of the 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 the 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. . .
.'' These provisions were added to the FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
III. Risk Characterization and Conclusions
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children. The nature of the toxic effects caused
by furilazole is discussed in this unit. EPA has sufficient data to
assess the hazards of and make a determination on aggregate exposure
for the chemical. The following provides a brief summary of the risk
assessment and conclusions for the Agency's review of furilazole. The
full decision document for this action is available on EPA's Electronic
Docket at http://www.regulations.gov/ under docket number EPA-HQ-OPP-
2007-0557.
A. Human Health
The Agency reviewed the available information on furilazole
submitted by the petitioner and determined that the toxicity database
is sufficient. The toxicity studies used here were submitted for the
establishment of tolerances of furilazole on corn commodities (Federal
Register of April 3, 2002 (67 FR 15727) (FRL-6828-4). Laboratory
studies in rodents show that exposure to furilazole may cause effects
to the liver. In a 90-day oral toxicity study on rodents, the no
observed effects level (NOAEL) was 7 milligrams/kilograms/day (mg/kg/
day) and the lowest observed effects level (LOAEL) was 34/38 mg/kg/day
(male/female), and in a chronic toxicity study on the rat the NOAEL was
0.26 mg/kg/day and the LOAEL was 5.05 mg/kg/day. Evidence of
carcinogenicity was observed in rodents. For developmental toxicity,
effects (increased number of re-sorptions; NOAEL was 10 mg/kg/day and
the LOAEL was 75 mg/kg/day) were observed at maternally toxic doses. In
the final rule, the Agency concluded ``no qualitative or quantitative
evidence of increased susceptibility in the rat or rabbit fetuses
following in-utero exposure in the developmental toxicity studies nor
to the offspring following prenatal/postnatal exposure in the 2-
generation reproduction study.'' The Agency further concluded ``taking
into account the lack of increased susceptibility and the completeness
of the data on toxicity and exposure, EPA determined that the 10X
safety factor to protect infants and children should be removed.''
There are no residual uncertainties regarding prenatal and/or postnatal
toxicity.
B. Exposure Assessment
The potential for exposure to residues of furilazole is adequately
characterized based on the results of modeling and the crop residue
studies. The results of the Dietary Exposure Evaluation Model (DEEM)
model developed when tolerances for furilazole were first established
on corn estimated that the amount of the dietary chronic population
adjusted dose (cPAD) for the U.S. population was 1.4%, and the highest
amount of the cPAD was 3.4% for all infants less than 1 year old.
Estimates for potential cancer risks were also very low.
Residue studies (crop field trials and processed) show that
residues of furilazole on sorghum commodities were non-quantifiable
(less than the Limit of Quantitation (LOQ) of 0.010 ppm) in all samples
of sorghum forage, grain, and stover.
Considering the results of the residue studies for furilazole on
sorghum commodities and exposure modeling, the Agency concludes that
dietary (food and drinking water) exposures of concern are not
anticipated from the inert ingredient use of furilazole on the sorghum
commodities forage, grain, and stover. Residential exposure is not
expected because applications are limited to the agricultural crop
sorghum. EPA is not aware of non-pesticide uses of furilazole,
therefore, no further aggregate assessment is necessary.
C. Safety Factor for Infants and Children
Section 408 of the FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
analysis or through using uncertainty (safety) factors in calculating a
dose level that poses no appreciable risk to humans. The toxicity
database is sufficient for furilazole and
[[Page 57491]]
potential exposure is adequately characterized based on results of the
residue studies for furilazole on sorghum commodities and exposure
modeling. In terms of hazard, there are low concerns and no residual
uncertainties regarding prenatal and/or postnatal toxicity. Taking into
account the lack of increased susceptibility and the completeness of
the data on toxicity and exposure, EPA determined that the 10X safety
factor to protect infants and children should be removed.
D. Cumulative Exposure
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding as to furilazole and any other substances, and the chemical
does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has not assumed that furilazole has a common mechanism of toxicity with
other substances. For information regarding EPA's efforts to determine
which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative
.
E. Other Considerations
1. Analytical methods. Adequate enforcement methodology (capillary
gas chromotography using electron capture detection) is available to
enforce the tolerance exemption 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.
2. International tolerances. The Agency is not aware of any country
requiring a tolerance for furilazole nor have any CODEX Maximum Residue
Levels (MRLs) been established for any food crops at this time.
F. Determination of Safety and Conclusions
The petitioner requested tolerances for sorghum flour and bran,
nevertheless, these tolerances are not being established. The Agency
has determined that tolerances for these processed commodities are not
necessary because the residue data showed that residues of furilazole
were non-quantifiable (less than 0.010 ppm) in all samples of grain
(RAC) and processed fractions.
Laboratory studies in show that exposure to furilazole may cause
effects to the liver and evidence of carcinogenicity was observed.
Developmental effects were observed at maternally toxic doses and there
was no qualitative or quantitative evidence of increased susceptibility
in the rat or rabbit fetuses. Therefore, the 10X safety factor to
protect infants and children is removed.
The results of the DEEM model that was developed when tolerances
for furilazole were first established estimated the amount of the
dietary cPAD for the U.S. population was 1.4%, and the highest amount
of the cPAD was 3.4% for all infants less than 1 year old. Estimates
for potential cancer risks were also very low. Residue studies (crop
field trials and processed) on sorghum commodities show that residues
of furilazole were non-quantifiable (less than the LOQ of 0.010 ppm).
Considering the results of the residue studies and the conservative
exposure modeling, the Agency concludes that dietary (food and drinking
water) exposures of concern are not anticipated from the inert
ingredient use of furilazole on sorghum commodities. Residential
exposure is not expected because applications are limited to the
agricultural crop sorghum. The Agency is not aware of any non-pesticide
uses of furilazole, therefore, no further exposure assessment is
necessary.
Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm to the general population,
including infants and children, from aggregate exposure to residues of
furilazole. Accordingly, EPA finds that establishing tolerances for
furilazole will be safe. EPA is establishing tolerances under 40 CFR
180.471 for residues of furilazole in or on the sorghum commodities
forage, grain, and stover at 0.01 ppm when it is used as an inert
ingredient safener.
In addition, the annual application rate limitation found in 40 CFR
180.471 is being removed because it is unnecessary. The establishment
of tolerance levels provides adequate regulation under FFDCA.
IV. 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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 6,
2000) do not apply to this rule. In addition, This 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) (Public Law
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
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Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113,
section 12(d) (15 U.S.C. 272 note).
V. 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: September 27, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
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. 180.471, paragraph (a) is amended by revising the
introductory text and by alphabetically adding commodities to the table
to read as follows:
Sec. 180.471 Furilazole; tolerances for residues.
(a) General. Tolerances are established for residues of furilazole;
3-dichloroacetyl-5-(2-furanyl)-2, 2-dimethyloxazolidine (CAS Reg. No.
121776-33-8) when used as an inert ingredient (safener) in pesticide
formulations in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Sorghum, forage............................................ 0.01
Sorghum, grain............................................. 0.01
Sorghum, stover............................................ 0.01
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* * * * *
[FR Doc. E7-19829 Filed 10-9-07; 8:45 am]
BILLING CODE 6560-50-S