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Flonicamid; Pesticide Tolerance  [Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Rules and Regulations]
[Page 15604-15608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr06-13]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0132; FRL-7769-1]

Flonicamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of flonicamid and its metabolites in or on head and stem brassica and
mustard greens. ISK Biosciences Corporation requested this tolerance
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 29, 2006. Objections and
requests for hearings must be received on or before May 30, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2004-0132. All documents in the docket
are listed on the http://www.regulations.gov web site. (EDOCKET,
EPA's electronic public docket and comment system was replaced on November
25, 2005, by an enhanced Federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the
on-line instructions.) Although listed in the index, some information is
not publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall #2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Ann Sibold, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6502; e-mail address: sibold.ann@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 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
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 underFOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.II. Background and Statutory Findings
In the Federal Register of July 7, 2004 (69 FR 40916) (FRL-7362-5),
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 4F6832)
by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord,
Ohio 44077. The petition requested that 40 CFR 180.613 be amended by
establishing a tolerance for combined residues of the insecticide
flonicamid [N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide]
and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide] TFNG [N-(4-
trifluoromethylnicotinoyl)glycine] in or on the raw agricultural
commodities brassica, head and stem, subgroup 5A at 1.5 parts per
million (ppm) and mustard greens at 11 ppm. That notice included a
summary of the petition prepared by ISK Biosciences Corporation, the
registrant. There were no comments received in response to the notice
of filing. There was one comment received in response to the final rule
published in the Federal Register of August 31, 2005 (70 FR 51604)
(FRL-7731-6), which is referenced in today's rule. The Agency's
response is set forth in Unit IV.C.

[[Page 15605]]

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. . . .''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of flonicamid
[N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its
metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide] TFNG [N-(4-
trifluoromethylnicotinoyl)glycine] in or on the raw agricultural
commodities brassica, head and stem, subgroup 5A at 1.5 ppm and mustard
greens at 11 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Specific information on the studies received and the nature
of the toxic effects caused by flonicamid and its metabolites as well
as the no observed adverse effect level (NOAEL) and the lowest observed
adverse effect level (LOAEL) from the toxicity studies can be found at
Unit III.A. of the final rule published in the Federal Register of
August 31, 2005 (70 FR 51604) (FRL-7731-6).

B. Toxicological Endpoints

For hazards that have a threshold below which there is no
appreciable risk, the dose at which no adverse effects are observed
(the NOAEL) from the toxicology study identified as appropriate for use
in risk assessment is used to estimate the toxicological level of
concern (LOC). However, the lowest dose at which adverse effects of
concern are identified (the LOAEL) is sometimes used for risk
assessment if no NOAEL was achieved in the toxicology study selected.
An uncertainty factor (UF) is applied to reflect uncertainties inherent
in the extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases.
A summary of the toxicological endpoints for flonicamid used for
human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of August 31, 2005 (70 FR 51604)
(FRL-7731-6).

C. Exposure Assessment

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.613) for the combined residues of flonicamid
[N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide] and its
metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide] and TFNG [N-(4-
trifluoromethylnicotinoyl)glycine], in or on a variety of raw
agricultural commodities. Risk assessments were conducted by EPA to
assess dietary exposures from flonicamid and its metabolites in food as
follows:

i. Acute exposure. No acute dietary exposure and risk assessment
was conducted as discussed in the final rule published in the Federal
Register of August 31, 2005.

ii. Chronic exposure. The proposed tolerances for head and stem
brassica and mustard greens were included in the chronic dietary
exposure assessment for flonicamid residues on certain commodities as
set forth in the final rule published in the Federal Register of August
31, 2005. Tolerances for head and stem brassica and mustard greens were
not established in that final rule for the following reason: Acceptable
residue chemistry data for a commodity is required before a tolerance
may be established; the review of residue chemistry data for head and
stem brassica and mustard greens had not been completed at that time.
The residue chemistry data review for head and stem brassica and
mustard greens is now complete. There is no increment to dietary
exposure as it has already been taken into account.

2. Dietary exposure from drinking water. The dietary exposure from
drinking water is discussed in the final rule published in the Federal
Register of August 31, 2005.

3. From non-dietary exposure. As discussed in the final rule
published in the Federal Register of August 31, 2005, flonicamid is not
registered for any uses that are likely to result in non-dietary exposure.

4. Cumulative effects from substances with a common mechanism of
toxicity. 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 flonicamid and any other
substances and flonicamid 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 flonicamid 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
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from

[[Page 15606]]

substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

D. Safety Factor for Infants and Children

1. In general. Section 408 of 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 data base on toxicity and exposure
unless EPA determines based on reliable data 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
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. As discussed in the final
rule published in the Federal Register of August 31, 2005, there is no
evidence of prenatal or postnatal sensitivity.

3. Conclusion. As discussed in the final rule published in the
Federal Register of August 31, 2005, the FQPA Safety Factor is reduced
to 1X because:

i. There is a complete toxicity data base.

ii. There is a lack of susceptibility evidence in the developmental
studies and reproductive study (The effects seen in offspring were mild
and occurred only in one species.

iii. The dietary food exposure assessment utilizes proposed
tolerance level, or higher residues and 100% crop treated information
for all commodities.

iv. The dietary drinking water assessment (Tier 1 estimates)
utilizes values generated by model and associated modeling parameters
which are designed to provide conservative, health protective, high-end
estimates of water concentrations.

E. Aggregate Risks and Determination of Safety

1. Acute risk. No acute risk is expected for reasons that are
discussed in the final rule published in the Federal Register of August
31, 2005.

2. Chronic risk. The proposed tolerances for head and stem brassica
and mustard greens were included in the chronic dietary risk assessment
for flonicamid residues on certain commodities as set forth in the
final rule published in the Federal Register of August 31, 2005.
Chronic risk does not exceed levels of concern.

3. Short-term and intermediate-term risk. Short-term and
intermediate-term risk assessment was not conducted because residential
exposure is not expected from the use pattern and/or appropriate
toxicity endpoints were not identified.

4. Determination of safety. 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
flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology
Adequate enforcement methodology liquid chromatography/mass
spectrometry (LC/MS) 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
There are no Codex, Mexican or Canadian Maximum residue limits
tolerances. Therefore, no compatibility questions exist with respect to
Codex.

C. Response to Comments

One comment was received from a private citizen who opposes the
approval of any pesticide that leaves a residue on food. The comment
contained no specific information pertaining to flonicamid but was
limited to general claims such as EPA was providing inadequate
protection for Americans. The Agency has received the same comment from
this commentor on numerous previous occasions and rejects it for the
reasons previously stated (70 FR 1349, 1354, January 7, 2005), (70 FR
37686, June 30, 2005), and (69 FR 63096, 63098, (October 29, 2004).

V. Conclusion

Therefore, the tolerance is established for combined residues of
flonicamid [N-(cyanomethyl)-4-(trifluoromethyl)-3-pyridinecarboxamide]
and its metabolites TFNA [4-trifluoromethylnicotinic acid], TFNA-AM [4-
trifluoromethylnicotinamide] TFNG [N-(4-
trifluoromethylnicotinoyl)glycine] in or on the raw agricultural
commodities brassica, head and stem, subgroup 5A at 1.5 ppm and mustard
greens at 11 ppm.

VI. Objections and Hearing Requests
Under section 408(g) of FFDCA, as amended by 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. Although the procedures in those regulations require
some modification to reflect the amendments made to FFDCA by FQPA, EPA
will continue to use those procedures, with appropriate adjustments,
until the necessary modifications can be made. The new section 408(g)
of FFDCA provides essentially the same process for persons to
``object'' to a regulation for an exemption from the requirement of a
tolerance issued by EPA under new section 408(d) of FFDCA, as was
provided in the old sections 408 and 409 of FFDCA. However, the period
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2004-0132 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 May 30, 2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issue(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,

[[Page 15607]]

DC 20460-0001. You may also deliver your request to the Office of the
Hearing Clerk in Suite 350, 1099 14\th\ St., NW., Washington, DC 20005.
The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The telephone number for the
Office of the Hearing Clerk is (202) 564-6255.

2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VI.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number EPA-HQ-OPP-2004-0132, to: Public
Information and Records Integrity Branch, Information Technology and
Resources Management Division (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issue(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VII. Statutory and Executive Order Reviews

This final rule establishes a tolerance 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 due to its lack of
significance, 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). 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., or 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). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VIII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 20, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
• Therefore, 40 CFR chapter I is amended as follows:

[[Page 15608]]

PART 180--AMENDED

• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.

• 2. Section 180.613 is amended by alphabetically adding commodities to
the table in paragraph (a)(1) to read as follows:
Sec. 180.613 Flonicamid; tolerances for residues.
(a) General. (1) * * *

* * * * *
[FR Doc. 06-2977 Filed 3-28-06; 8:45 am]
BILLING CODE 6560-50-S