[Federal Register: August 19, 2009 (Volume 74, Number 159)]
[Rules and Regulations]
[Page 41794-41798]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19au09-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2004-0285; FRL-8430-6]
1,2-ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-
oxybis[2-chloroethane]; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance under 40 CFR 180.920 for residues of 1,2-ethanediamine,
N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS
Reg. No. 31075-24-8) when used as an inert ingredient in pesticide
formulations applied to cotton or wheat crops only. Buckman
Laboratories International, Inc submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of 1,2-
ethanediamine, N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-
chloroethane].
DATES: This regulation is effective August 19, 2009. Objections and
requests for hearings must be received on or before October 19, 2009,
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-2004-0285. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.
[[Page 41795]]
FOR FURTHER INFORMATION CONTACT: Keri Grinstead, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8373; e-mail address: grinstead.keri@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 electronically available documents 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 e-CFR cite at http://www.gpoaccess.gov/
ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2004-0285 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 19, 2009.
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-2004-0285, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 17, 2004 (69 FR 56062) (FRL-
7675-9), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, as amended by Food Quality Protection Act (FQPA) (Public
Law 104-170), announcing the filing of a pesticide petition (PP 4E6841)
by Buckman Laboratories International, Inc., 1256 North McLean Blvd.,
Memphis, TN 38108. The petition requested that 40 CFR 180.920 be
amended by establishing an exemption from the requirement of a
tolerance for residues of 1,2-ethanediamine,N,N,N ',N '-tetramethyl-,
polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No. 31075-24-8) in
or on raw agricultural commodities when used as an inert ingredient in
pesticide formulations. That notice included a summary of the petition
prepared by the petitioner. There were no substantive comments received
in response to the notice of filing. The petitioner subsequently
specified that the inert ingredient use of the chemical will be as an
adjuvant or water conditioner in pesticide products applied only to
cotton and to wheat prior to boot stage.
For ease of reading in this document, 1,2-ethanediamine,N,N,N ',N
'-tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] is herein
referred to as BCETMD copolymer.
Section 408(b)(2)(A)(i) of 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(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. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the
[[Page 41796]]
low toxicity of the individual inert ingredients.
IV. Toxicological Profile
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 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 1,2-
ethanediamine,N,N,N ',N '-tetramethyl-, polymer with 1,1'-oxybis[2-
chloroethane are discussed in this unit.
The following provides a brief summary of the risk assessment and
conclusions from the Agency's review of BCETMD copolymer. The Agency's
full risk assessment for this action, ``Inert Ingredient Decision
Document for Pesticide Petition 4E6841: 1,2-ethanediamine, N,N,N ',N '-
tetramethyl-, polymer with 1,1'-oxybis[2-chloroethane] (CAS Reg. No.
31075-24-8)'', is available in the docket (EPA-HQ-OPP-2004-0285).
Sufficient data were submitted to the Agency in support of this
action. In acute toxicity studies, BCETMD copolymer exhibits low to
moderate oral toxicity, slight irritation to the rabbit eye and skin,
and is not a skin sensitizer in Guinea pigs. A subchronic study in rats
had a no observed adverse effect level (NOAEL) of 221 milligrams/
kilogram/day (mk/kg/day) and a lowest observed adverse level (LOAEL) of
752 mg/kg/day due to mineralization of the renal tubules. The following
were observed at the two highest dosages: Decreases in body weights and
possibly absolute organ weights (heart, liver, kidney and gonads); an
equivocal decrease in red blood cell counts; elevated leukocyte counts;
non-suppurative inflammation of the choroid plexus of the brain; and
death. A chronic study in the dog showed: In males, a NOAEL of 250 mg/
kg/day and a LOAEL of 500 mg/kg/day based on testicular hypoplasia,
atrophy/degeneration, aspermia, dysplasia and cellular debris of
testicular origin in epididymis; and, in females, a NOAEL of 500 mg/kg/
day and a LOAEL of 1,000 mg/kg/day based on gastrointestinal
disturbances, emaciation and neurological signs, bloody stools, weight
loss and ataxia. Reproductive/developmental toxicity was only seen at
dosage levels at or above those which also caused maternal effects.
BCETMD copolymer was determined not to be mutagenic or carcinogenic. In
metabolism studies, most (>86%) of the chemical was excreted in the
feces.
V. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
The primary route of exposure to BCETMD copolymer from its use as
an inert ingredient in pesticide products applied to cotton and wheat
crops would most likely be through consumption of food to which
pesticide products containing it as an inert ingredient have been
applied, and possibly through drinking water (from runoff). The use of
this chemical is limited to pesticide formulations applied to cotton
and wheat crops only, therefore, there are no residential uses of this
chemical, and thus no residential (dermal and inhalation) exposures are
expected.
No adverse effects attributable to a single exposure of BCETMD
copolymer were seen in the toxicity database. Therefore, an acute
dietary risk assessment is not required.
There are no data provided regarding BCETMD copolymer residues in
food or any other nonoccupational exposures to BCETMD copolymer. In the
absence of actual residue data for BCETMD copolymer, the Agency
performed a chronic dietary (food and drinking water) exposure
assessment for BCETMD copolymer when used as an inert ingredient in
pesticide formulations applied pre-harvest to cotton and wheat using a
series of very conservative assumptions. This exposure assessment was
calculated based on the following assumptions:
1. BCETMD copolymer would be used as an inert ingredient in all
food use pesticide formulations applied pre-harvest to cotton and wheat
crops.
2. A hundred percent of all cotton and wheat crops would be treated
with pesticide products containing BCETMD copolymer.
3. BCETMD copolymer residues would be present in all cotton and
wheat crops at levels equal to or exceeding the highest established
tolerance levels for any pesticide active ingredient.
4. A conservative default value of 1,000 parts per billion (ppb)
for the concentration of an inert ingredient in all sources of drinking
water was used. This approach is highly conservative as it is extremely
unlikely that BCETMD copolymer would have such use as a pesticide
product inert ingredient and be present in cotton and wheat food
commodities and drinking water at such high levels.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of 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 pesticide ingredients 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 BCETMD
copolymer and any other substances and BCETMD copolymer 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
BCETMD copolymer 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
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.
[[Page 41797]]
VII. Determination of Safety for Infants and Children
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) 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 based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA safety factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
EPA has determined that reliable data show the safety of infants
and children would be adequately protected if the FQPA SF were reduced
to 1X. That decision is based on the following findings:
1. The database is considered adequate for FQPA assessment. The
studies included in the toxicological database are: 90-day toxicity
study in rats via the oral route, 90-day dermal toxicity study in
rabbits, chronic toxicity study in dogs, carcinogenicity study in mice,
combined chronic/carcinogenicity study in rats, several mutagenicity
studies (in vivo and in vitro), metabolism study in rats and dermal
penetration study in rats. There are no acute and/or subchronic
neurotoxicity studies available in the database. There was no evidence
of clinical signs of neurotoxicity in the database except ataxia in the
chronic toxicity study in dogs (1,000 mg/kg/day) and convulsions in a
carcinogenicity study in mice (1,200 mg/kg/day). These effects are
considered due to excessive toxicity and not of a neurologic origin.
Therefore, there is no need for acute and subchronic neurotoxicity
studies for this chemical. EPA also concluded that there is no need for
a developmental neurotoxicity study for this chemical because there is
no evidence in the database of neurotoxicity or increased
susceptibility to infants and children.
2. There is no evidence of increased qualitative or quantitative
susceptibility in the developmental toxicity study in rats and rabbits
and in the two-generation reproduction study in rats. No developmental
effects were observed in the rat developmental toxicity study at doses
up to 500 mg/kg/day highest dose tested (HDT) in the presence of
maternal toxicity. In the rabbit developmental toxicity study, the
maternal and developmental NOAELs were 45 mg/kg/day. In this study,
skeletal variations (developmental effects) were observed in the
presence of equally severe maternal toxicity (abortions). In the 2-
generation reproduction study in rats, pup weights were decreased at a
dose level higher than the dose that produced maternal toxicity.
3. The highly conservative dietary exposure assessment using
default assumptions would not underestimate the risk to infants and
children.
VIII. Determination of Safety for U.S. Population
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. Uncertainty/
safety factors (UFs) are used in conjunction with the POD to take into
account 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. Safety is
assessed for acute and chronic dietary risks by comparing aggregate
food and water exposure to the pesticide to the acute population
adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The
aPAD and cPAD are calculated by dividing the POD by all applicable UFs.
Residues of concern are not anticipated for dietary exposure (food
and drinking water) from the use of BCETMD copolymer as an inert
ingredient in pesticide products applied pre-harvest to cotton and
wheat and there are no residential uses/exposures from this use. The
toxicology data indicate that BCETMD copolymer does not pose an acute
risk and, therefore, derivation of an aPAD is unnecessary. Chronic risk
was assessed by comparing aggregate exposure to BCETMD copolymer to a
cPAD of .45 mg/kg/day (based on a NOAEL of 45 mg/kg/day in the
developmental toxicity study in rabbits and a safety/uncertainty factor
of 100X (10X for interspecies and 10X for intraspecies variations).
Utilizing the highly conservative aggregate exposure assessment
described above, the resulting chronic exposure estimates do not exceed
the Agency's level of concern; the chronic dietary estimate for the
U.S. population was 6.7% (non-nursing infants were the most highly
exposed population with the chronic exposure estimates occupying 20.0%
of the cPAD).
Taking into consideration all available information on BCETMD
copolymer and the limitations in the proposed tolerance exemption, EPA
has determined that there is a reasonable certainty that no harm to any
population subgroup will result from aggregate exposure to BCETMD
copolymer under reasonable foreseeable circumstances. Therefore, the
establishment of an exemption from tolerance under 40 CFR 180.920 for
residues of BCETMD copolymer when used as an inert ingredient in
pesticide formulations applied pre-harvest to cotton and wheat only, is
safe under section 408 of the FFDCA.
IX. Other Considerations
A. Analytical Method
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. Existing Exemptions
There are no existing exemptions for BCETMD copolymer.
C. International Tolerances
The Agency is not aware of any country requiring a tolerance for
BCETMD copolymer nor have any CODEX Maximum Residue Levels been
established for any food crops at this time.
X. Conclusions
Therefore, an exemption from the requirement of tolerance is
established under 40 CFR 180.920 for BCETMD copolymer (CAS Reg. No.
31075-24-8) when used as an inert ingredient (adjuvant or water
conditioner) in pesticide formulations applied to cotton or wheat only.
XI. 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 final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May
[[Page 41798]]
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 in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (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).
XII. 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 6, 2009.
G. Jeffrey Herndon,
Acting 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. 180.920, the table is amended by adding alphabetically the
following inert ingredient.
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * * * *
1,2-ethanediamine,N,N,N ', N '- For use in Adjuvant or water
tetramethyl-, polymer with 1,1'- pesticide conditioner
oxybis[2-chloroethane] (CAS formulations
Reg. No. 31075-24-8) applied to cotton
or wheat only
* * * * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E9-19762 Filed 8-18-09; 8:45 am]
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