Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8); Exemption from the Requirement of a Tolerance, 45653-45656 [E7-16055]
Download as PDF
<![CDATA[
Federal Register / Vol. 72, No. 157 / Wednesday, August 15, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
NJ (virus cellular receptors and cell
membrane changes, p. 299–300).
• Fulton R. Practices and precautions
in the use of cross protection for plant
virus disease control. Annual Review of
Phytopathology 1986; 24:67–81.
• Jones L, Anderson E, Burnett G. The
latent virus of potatoes. Journal of
Phytopathology 1934; 7:93–115.
• McKinney HH. Mosaic diseases in
the Canary Islands, West Africa, and
Gibraltar. Journal of Agricultural
Research 1929; 39:557–78.
• Palukaitis P. Virus-mediated genetic
transfer in plants. In: Levin M, Strauss
H. Risk Assessment in Genetic
Engineering. New York: McGraw-Hill,
1991:140–62.
• Provvidenti R, Gonsalves D.
Occurrence of ZYMV in cucurbits from
Connecticut, New York, Florida, and
California. Plant Disease 1984; 68:443–
6. Palukaitis P. Virus-mediated genetic
transfer in plants. In: Levin M, Strauss
H. Risk Assessment in Genetic
Engineering. New York: McGraw-Hill,
1991:140–62.
Plant viruses Online, 2007. https://
image.fs.uidaho.edu/vide/descr909.htm
IX. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of 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, 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 exemption from the requirement of
a tolerance in this final rule, do not
VerDate Aug<31>2005
14:56 Aug 14, 2007
Jkt 211001
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
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
X. 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.
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
45653
Dated: August 1, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1279 is added to
subpart D to read as follows:
I
§ 180.1279 Zucchini yellow mosaic virus weak strain; exemption from the
requirement of a tolerance.
An exemption from the requirement
of a tolerance for residues of the ZYMVWK strain in or on all raw cucurbits
when applied/used in accordance with
label directions.
[FR Doc. E7–16057 Filed 8–14–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2007–0220; FRL–8122–3]
Cis-isomer of 1-(3-chloroallyl)-3,5,7triaza-1-azoniaadamantane chloride
(CAS Reg. No. 51229–78–8); Exemption
from the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of cis-isomer of 1(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride (CAS Reg.
No. 51229–78–8) under 40 CFR 180.920
(growing crops) when used as an inert
ingredient as a preservative at 0.14% by
weight (wt) or less of pesticide
formulations. Dow Chemical 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
August 15, 2007. Objections and
requests for hearings must be received
on or before October 15, 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–2007–0220. To access the
E:\FR\FM\15AUR1.SGM
15AUR1
45654
Federal Register / Vol. 72, No. 157 / Wednesday, August 15, 2007 / Rules and Regulations
electronic docket, go to https://
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 https://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:
ebenthall on PRODPC61 with RULES
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
VerDate Aug<31>2005
14:56 Aug 14, 2007
Jkt 211001
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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://
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–2007–0220 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 October 15, 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
without prior notice. Submit your
copies, identified by docket ID number
EPA–HQ–OPP–2007–0220, by one of
the following methods:
• Federal eRulemaking Portal: https://
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 Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of December
17, 2003 (67 FR 70251) (FRL–7336–4),
EPA issued a notice pursuant to section
408 of the FFDCA, 21 U.S.C. 346a, as
amended by the FQPA (Public Law 104170), announcing the filing of a
pesticide petition (PP 3E6656) by Dow
Chemical Company, Building 1803,
Midland, Michigan 48674. The petition
requested that 40 CFR 180.920 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride. That notice
included a summary of the petition
prepared by the petitioner. Dow
Chemical Company requested the use of
cis-isomer of 1-(3-chloroallyl)-3,5,7triaza-1-azoniaadamantane chloride as a
preservative at 0.14% by weight or less
in pesticide formulations. No comments
were received in response to the notice
of filing.
Section 408(b)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
from the requirement for 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
Conclusion.
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,
E:\FR\FM\15AUR1.SGM
15AUR1
Federal Register / Vol. 72, No. 157 / Wednesday, August 15, 2007 / Rules and Regulations
ebenthall on PRODPC61 with RULES
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 cisisomer of 1-(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride are
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 cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride. The full
decision document for this action is
available on EPA’s Electronic Docket at
https://www.regulations.gov/ under
docket number EPA–HQ–OPP–2007–
0220.
A. Human Health
The Agency reviewed the available
information on cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride submitted
by the petitioner as well as additional
information available to EPA and the
data evaluated in the 1995
DowicilCTAC RED. The toxicity
database is sufficient for cis-isomer of 1(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride. In
laboratory animal studies measuring
acute toxicity, cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride is slightly
toxic in acute inhalation and oral
toxicity studies. Dermal effects were
observed in rabbits at close to the limit
dose (no observed adverse effect level of
1,000 milligram/kilogram/day (mg/kg/
day)) in a subchronic study, and in a
dermal acute toxicity study the LD50
was determined to be 923 mg/day. The
chemical was mutagenic in the in vitro
Chinese hamster ovary cell HGPRT
(Hypoxanthine guanine phophoribosyl
transferase)forward mutation assay with
activation, but was nonmutagenic
without activation. It was negative in
two other mutagenicity studies.
Developmental effects were observed at
or above the level of maternal toxicity
(optic malformations may be linked to
genetic issues rather than exposure to
the chemical). Chronic toxicity studies
are not available, nevertheless,
sufficient information is available in
sub-chronic and developmental toxicity
studies.
B. Exposure Assessment
The potential for exposure to residues
of cis-isomer of 1-(3-chloroallyl)-3,5,7-
VerDate Aug<31>2005
14:56 Aug 14, 2007
Jkt 211001
triaza-1-azoniaadamantane chloride is
adequately characterized based on the
chemical’s non-persistent nature and
ready dissipation in the environment
and the low use rate. Exposures from
residues in food and drinking water are
expected to be minimal. Residential
exposure (inhalation and dermal) is also
expected to be minimal from the use of
the chemical in pesticides considering
the low application rate. Residential
exposures from non-pesticides uses are
not anticipated to be of concern
considering the low dermal toxicity
findings. The Agency concludes dietary
and residential exposures of concern are
not anticipated from the inert ingredient
use of cis-isomer of 1-(3-chloroallyl)3,5,7-triaza-1-azoniaadamantane
chloride considering its non-persistent
nature in the environment, low toxicity,
and the limitations imposed on its
proposed use under 40 CFR 180.920 as
a preservative at 0.14% by weight (wt)
or less of the pesticide formulation.
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 MOE
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 cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride and
potential exposure is adequately
characterized based on the low use rate.
In terms of hazard, there are low
concerns and no residual uncertainties
regarding prenatal and/or postnatal
toxicity.
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 cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1-
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
45655
azoniaadamantane chloride 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 cisisomer of 1-(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride 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 https://
www.epa.gov/pesticides/cumulative.
E. Other Considerations
1. Analytical methods. Adequate
enforcement methodology 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. Residues are
not expected because of the chemical’s
ready degradation in the environment
and the low amount that will be
permitted in the pesticide formulation
(limited to 0.14% by weight (wt) or
less).
2. International tolerances. The
Agency is not aware of any country
requiring a tolerance for cis-isomer of 1(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride (CAS Reg.
No. 51229–78–8) nor have any CODEX
Maximum Residue Levels (MRLs) been
established for any food crops at this
time.
F. Determination of Safety and
Conclusions
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 cis-isomer of 1-(3chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride.
Accordingly, EPA finds that exempting
cis-isomer of 1-(3-chloroallyl)-3,5,7triaza-1-azoniaadamantane chloride
from the requirement of a tolerance will
be safe. EPA is establishing a tolerance
exemption in 40 CFR 180.920 for cisisomer of 1-(3-chloroallyl)-3,5,7-triaza-1azoniaadamantane chloride when it is
used as an inert ingredient as a
preservative at 0.14% by weight or less
in pesticide formulations.
E:\FR\FM\15AUR1.SGM
15AUR1
45656
Federal Register / Vol. 72, No. 157 / Wednesday, August 15, 2007 / Rules and Regulations
IV. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
exemption 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
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: August 3, 2007.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.920, is amended by
adding alphabetically the inert
ingredient to read as follows:
I
§ 180.920 Inert ingredients used preharvest; exemptions from the requirement
of a tolerance.
*
*
*
*
Inert ingredients
Limits
*
*
*
*
*
*
Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (CAS Reg. No.
51229–78–8)
*
*
*
*
*
*
*
Maximum of 0.14% by
weight of formulation
*
[FR Doc. E7–16055 Filed 8–14–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
ebenthall on PRODPC61 with RULES
[EPA–HQ–OPP–2005–0545; FRL–8143–1]
Lambda-Cyhalothrin; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
AGENCY:
ACTION:
Final rule.
VerDate Aug<31>2005
14:56 Aug 14, 2007
Jkt 211001
SUMMARY: This regulation establishes
tolerances for the combined residues of
lambda-cyhalothrin, 1:1 mixture of (S)a-cyano-3-phenoxybenzyl-(Z)-(1R,3R)-3(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2dimethylcyclopropanecarboxylate and
(R)-a-cyano-3-phenoxybenzyl-(Z)(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2dimethylcyclopropanecarboxylate and
its epimer expressed as epimer of
lambda-cyhalothrin, a 1:1 mixture of
(S)-a-cyano-3-phenoxybenzyl-(Z)(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2dimethylcyclopropanecarboxylate and
(R)-a-cyano-3-phenoxybenzyl-(Z)-
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
*
Uses
Preservative
(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop1-enyl)-2,2dimethylcyclopropanecarboxylate in or
on cucurbit vegetables (Group 9),
tuberous and corm vegetables (Subgroup
1C), grass (forage, fodder, and hay)
(Group 17), barley, buckwheat, oat, rye,
wild rice, and pistachios. Syngenta Crop
Protection, Inc. and the Interregional
Project No. 4 (IR-4) requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
This regulation is effective
August 15, 2007. Objections and
requests for hearings must be received
on or before October 15, 2007, and must
be filed in accordance with the
DATES:
E:\FR\FM\15AUR1.SGM
15AUR1
]]>Agencies
[Federal Register Volume 72, Number 157 (Wednesday, August 15, 2007)]
[Rules and Regulations]
[Pages 45653-45656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-16055]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0220; FRL-8122-3]
Cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride (CAS Reg. No. 51229-78-8); Exemption from the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) under 40
CFR 180.920 (growing crops) when used as an inert ingredient as a
preservative at 0.14% by weight (wt) or less of pesticide formulations.
Dow Chemical 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 August 15, 2007. Objections and
requests for hearings must be received on or before October 15, 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-2007-0220. To access the
[[Page 45654]]
electronic docket, go to https://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 https://
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://
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-2007-0220 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 October 15, 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
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0220, by one of the following methods:
Federal eRulemaking Portal: https://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
Building), 2777 S. Crystal Drive, 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 telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of December 17, 2003 (67 FR 70251) (FRL-
7336-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, as amended by the FQPA (Public Law 104-170), announcing
the filing of a pesticide petition (PP 3E6656) by Dow Chemical Company,
Building 1803, Midland, Michigan 48674. The petition requested that 40
CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride. That notice
included a summary of the petition prepared by the petitioner. Dow
Chemical Company requested the use of cis-isomer of 1-(3-chloroallyl)-
3,5,7-triaza-1-azoniaadamantane chloride as a preservative at 0.14% by
weight or less in pesticide formulations. No comments were received in
response to the notice of filing.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for 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 Conclusion.
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,
[[Page 45655]]
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 cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride are 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 cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride. The full decision document for this action is available on
EPA's Electronic Docket at https://www.regulations.gov/ under docket
number EPA-HQ-OPP-2007-0220.
A. Human Health
The Agency reviewed the available information on cis-isomer of 1-
(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride submitted by
the petitioner as well as additional information available to EPA and
the data evaluated in the 1995 Dowicil[reg]CTAC RED. The toxicity
database is sufficient for cis-isomer of 1-(3-chloroallyl)-3,5,7-
triaza-1-azoniaadamantane chloride. In laboratory animal studies
measuring acute toxicity, cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride is slightly toxic in acute inhalation and
oral toxicity studies. Dermal effects were observed in rabbits at close
to the limit dose (no observed adverse effect level of 1,000 milligram/
kilogram/day (mg/kg/day)) in a subchronic study, and in a dermal acute
toxicity study the LD50 was determined to be 923 mg/day. The
chemical was mutagenic in the in vitro Chinese hamster ovary cell HGPRT
(Hypoxanthine guanine phophoribosyl transferase)forward mutation assay
with activation, but was nonmutagenic without activation. It was
negative in two other mutagenicity studies. Developmental effects were
observed at or above the level of maternal toxicity (optic
malformations may be linked to genetic issues rather than exposure to
the chemical). Chronic toxicity studies are not available,
nevertheless, sufficient information is available in sub-chronic and
developmental toxicity studies.
B. Exposure Assessment
The potential for exposure to residues of cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride is adequately
characterized based on the chemical's non-persistent nature and ready
dissipation in the environment and the low use rate. Exposures from
residues in food and drinking water are expected to be minimal.
Residential exposure (inhalation and dermal) is also expected to be
minimal from the use of the chemical in pesticides considering the low
application rate. Residential exposures from non-pesticides uses are
not anticipated to be of concern considering the low dermal toxicity
findings. The Agency concludes dietary and residential exposures of
concern are not anticipated from the inert ingredient use of cis-isomer
of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride
considering its non-persistent nature in the environment, low toxicity,
and the limitations imposed on its proposed use under 40 CFR 180.920 as
a preservative at 0.14% by weight (wt) or less of the pesticide
formulation.
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 MOE 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 cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride and potential exposure is adequately
characterized based on the low use rate. In terms of hazard, there are
low concerns and no residual uncertainties regarding prenatal and/or
postnatal toxicity.
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 cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride 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 cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-
azoniaadamantane chloride 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 https://
www.epa.gov/pesticides/cumulative.
E. Other Considerations
1. Analytical methods. Adequate enforcement methodology 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.
Residues are not expected because of the chemical's ready degradation
in the environment and the low amount that will be permitted in the
pesticide formulation (limited to 0.14% by weight (wt) or less).
2. International tolerances. The Agency is not aware of any country
requiring a tolerance for cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-
1-azoniaadamantane chloride (CAS Reg. No. 51229-78-8) nor have any
CODEX Maximum Residue Levels (MRLs) been established for any food crops
at this time.
F. Determination of Safety and Conclusions
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
cis-isomer of 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane
chloride. Accordingly, EPA finds that exempting cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride from the
requirement of a tolerance will be safe. EPA is establishing a
tolerance exemption in 40 CFR 180.920 for cis-isomer of 1-(3-
chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride when it is used
as an inert ingredient as a preservative at 0.14% by weight or less in
pesticide formulations.
[[Page 45656]]
IV. Statutory and Executive Order Reviews
This final rule establishes a tolerance exemption 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 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: August 3, 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. Section 180.920, is amended by adding alphabetically the inert
ingredient to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
Cis-isomer of 1-(3-chloroallyl)- Maximum of 0.14% Preservative
3,5,7-triaza-1-azoniaadamantane by weight of
chloride (CAS Reg. No. 51229-78- formulation
8)
* * * * * * *
------------------------------------------------------------------------
[FR Doc. E7-16055 Filed 8-14-07; 8:45 am]
BILLING CODE 6560-50-S
