Document ID: EPA-HQ-OPP-2007-0557-0001
Agency: epa
Document Type: Rule
Title: Furilazole; Inert Ingredient Tolerances
Posted Date: 2007-10-10T04:00Z

[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

[[Page 57492]]

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]

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