6-Benzyladenine; Exemption from the Requirement of a Tolerance, 13174-13179 [07-1386]
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13174
Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations
Authority: 21 U.S.C. 321(q), 346a and 371.
hop, dried cones; horse, liver; and
sheep, liver.
I ii. Revising the remainder of the
entries listed.
2. The table in paragraph (a) of
§ 180.495 is amended by:
I i. Alphabetically adding amaranth,
grain, stover; cattle, liver; goat, liver;
I
The additions and revisions to the
table in paragraph (a) read as follows:
§ 180.495 Spinosad; tolerances for
residues.
(a) * * *
Commodity
Parts per million
*
*
*
*
*
Amaranth, grain, stover ...............................................................................................................................
*
*
*
*
*
Cattle, fat .....................................................................................................................................................
Cattle, liver ...................................................................................................................................................
Cattle, meat .................................................................................................................................................
Cattle, meat byproducts, except liver ..........................................................................................................
*
*
*
*
*
Egg ...............................................................................................................................................................
*
*
*
*
*
Goat, fat .......................................................................................................................................................
Goat, liver ....................................................................................................................................................
Goat, meat ...................................................................................................................................................
Goat, meat byproducts, except liver ............................................................................................................
*
*
*
*
*
Hop, dried cones .........................................................................................................................................
Horse, fat .....................................................................................................................................................
Horse, liver ...................................................................................................................................................
Horse, meat .................................................................................................................................................
Horse, meat byproducts, except liver ..........................................................................................................
*
*
*
*
*
Milk ...............................................................................................................................................................
Milk, fat ........................................................................................................................................................
*
*
*
*
*
Poultry, fat ....................................................................................................................................................
Poultry, meat ................................................................................................................................................
Poultry, meat byproducts .............................................................................................................................
*
*
*
*
*
Sheep, fat ....................................................................................................................................................
Sheep, liver ..................................................................................................................................................
Sheep, meat ................................................................................................................................................
Sheep, meat byproducts, except liver .........................................................................................................
*
*
*
*
*
ENVIRONMENTAL PROTECTION
AGENCY
amended by the Food Quality Protection
Act of 1996 (FQPA), requesting an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of 6benzyladenine.
40 CFR Part 180
DATES:
*
*
*
*
*
[FR Doc. E7–4760 Filed 3–20–07; 8:45 am]
BILLING CODE 6560–50–S
[EPA–HQ–OPP–2006–0325; FRL–8117–9]
6-Benzyladenine; Exemption from the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
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EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0325. All documents in the
docket are listed in the index for the
docket. 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
ADDRESSES:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of the biochemical
pesticide, 6-benzyladenine (6–BA), in or
on pear when applied/used as a plant
regulator. Valent BioSciences
Corporation (Valent) submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), as
VerDate Aug<31>2005
This regulation is effective
March 21, 2007. Objections and requests
for hearings must be received on or
before May 21, 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).
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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
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
telephone number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT:
Denise Greenway, Biopesticides and
Pollution Prevention Division (7511P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–8263; e-mail address:
greenway.denise@epa.gov.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations
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.
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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–2006–0325 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 21, 2007.
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15:10 Mar 20, 2007
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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–2006–0325, 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 Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 305–
5805.
II. Background and Statutory Findings
In the Federal Register of April 19,
2006 (71 FR 20100) (FRL–8058–1), EPA
issued a notice pursuant to section
408(d)(3) of the FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 6F7035)
by Valent BioSciences Corporation
(Valent), 870 Technology Way,
Libertyville, IL 60048–6316. The
petition requested that 40 CFR part 180
(specifically, § 180.1150) be amended
by establishing an exemption from the
requirement of a tolerance for residues
of 6-benzyladenine (6–BA) in or on pear
when applied at a rate of ≤182 grams of
active ingredient per acre per season.
The electronic docket (EPA–HQ–OPP–
2006–0325) for this notice includes a
summary of the petition prepared by the
petitioner, Valent. Previously, on April
2, 2004 (69 FR 17304; FRL–7347–6),
EPA issued a final rule granting a
permanent exemption from the
requirement of a tolerance for residues
of 6–BA in or on pistachio when
applied at a rate of ≤60 grams of active
ingredient per acre per season, and the
existing permanent tolerance exemption
for apple was amended to expand the
uses (by adding a post-bloom-applied
stand-alone fruitlet thinner use) and
increase the permissible application rate
to ≤182 grams of active ingredient per
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acre per season. Both apple and the
subject new crop, pear, are pome fruit
and, therefore, botanically similar. The
two crops are grown in the same
climatic/geographic regions, and are
similarly cultivated. For both crops, 6–
BA is applied for the same purpose, on
the same schedule, at the same
application rate and with the same 86–
day pre-harvest interval restriction.
Based on these similarities, the Agency
has determined for the purpose of
establishing the requested tolerance
exemption that previously-submitted
and reviewed information and data
supporting the current tolerance
exemption for apple will apply equally
to the new crop, pear. In submitting this
petition, therefore, Valent is relying on
information previously submitted in
connection with seeking and obtaining
the tolerance exemption for the
expanded use of 6–BA on apple, which
was summarized in the April 2, 2004,
final rule, and also on new data
summarized in the cited petition
summary (i.e., PP 6F7035). New data
submitted to the Agency by Valent on
October 20, 2004 and summarized by
the company in the current petition are
a two-generation rat reproduction study,
which is data not required for U.S.
registration of this biochemical active
ingredient, but rather was conducted to
satisfy the registration requirements of
other countries and submitted by the
petitioner to augment the Agency’s 6–
BA data base.
In response to EPA’s April 19, 2006
notice, no comments were submitted in
accordance with the instructions for
submitting comments set forth in the
notice. However, one informal comment
was received from a private citizen who
opposed issuance of a final rule. The
commenter expressed concern regarding
the hazard associated with plant
regulator use in general, stated the
unsupported belief that more testing
needs to be done, and was generally
opposed to the establishment of an
exemption from the requirement of a
tolerance as proposed in the subject
pesticide tolerance petition for 6–BA.
The Agency understands and recognizes
that some individuals believe that
pesticides, which include plant
regulators, should be banned
completely. Notwithstanding such
beliefs, pursuant to its authority under
the FFDCA, EPA has conducted a
comprehensive assessment of 6–BA and
has concluded that there is a reasonable
certainty that no harm will result from
dietary exposure to this chemical when
its use is limited by the specified
maximum application rates.
Section 408(c)(2)(A)(i) of the FFDCA
allows EPA to establish an exemption
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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 exemption 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. Pursuant to
section 408(c)(2)(B) of the FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of the FFDCA, which
require 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.... ’’ Additionally, section
408(b)(2)(D) of the FFDCA requires that
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.’’
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. Toxicological Profile
Consistent with section 408(b)(2)(D)
of the FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness, and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
The toxicological profile for 6–BA
was published by the Agency in the
June 1994 N6-Benzyladenine
(synonymous with the subject active
ingredient, 6-benzyladenine)
Reregistration Eligibility Decision (RED)
document (https://www.epa.gov/
oppsrrd1/REDs/old_reds/
n6benzyladenine.pdf). The summarized
values and categories for the various,
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previously reviewed studies for the
technical active ingredient are presented
here.
1. Acute toxicity. Toxicity Category III
was assigned to the acute oral toxicity
study in the rat (lethal dose (LD)50 = 1.3
grams/kilogram (g/kg)), and in the eye
irritation study in the rabbit (moderate
irritant). Toxicity Category IV (the least
toxic category) was assigned to the acute
dermal toxicity study in the rabbit (LD50
>5 g/kg), the acute inhalation toxicity
study in the rat (lethal concentration
(LC)50 = 5.2 milligrams/liter (mg/L)),
and to the dermal irritation study in the
rabbit (slight irritant). Additionally,
from a dermal sensitization study in the
guinea pig, it was determined that 6–BA
is not a dermal sensitizer. There have
been no reported incidents of
hypersensitivity directly linked to 6–
BA. Nevertheless, to comply with
section 6(a)(2) of the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA), any incident of
hypersensitivity associated with the use
of this pesticide must be reported to the
Agency.
2. Genotoxicity. From three
mutagenicity studies (Ames test, mouse
micronucleus assay, and unscheduled
DNA synthesis assay in the rat), it was
determined that 6–BA is not mutagenic.
3. Developmental toxicity. The no
observed adverse effect levels (NOAEL)
and the lowest observed adverse effect
levels (LOAEL) for maternal and
developmental toxicity in rats,
respectively, were found to be 50 and
175 milligrams/kilogram body weight/
day (mg/kg bwt/day), respectively.
4. Subchronic toxicity. For rats of both
sexes, the NOAEL was approximately
111 mg/kg bwt/day and the LOAEL was
approximately 304 mg/kg bwt/day.
In addition to the previously reviewed
studies discussed above, a twogeneration rat reproduction study was
relied upon by Valent to support the
current petition to establish an
exemption from the requirement of a
tolerance for residues of 6–BA in or on
pear. The lowest-LOAEL for parental
systemic toxicity of technical 6–BA is
750 ppm (58.6–70.4 mg/kg bwt/day) and
is based on reduced body weight and
weight gain in F0 and F1 male rats1.The
NOAEL is 400 ppm (31.5–37.5 mg/kg
bwt/day)1 . This systemic adult
endpoint was used in the dietary risk
assessment. Although the systemic
endpoint is similar to that used in
previous occupational risk assessments,
the previous toxicological endpoint (40
1 USEPA. N6-Benzyladenine: Review of
Information for an Exemption from the Requirement
of a Tolerance. K. R. Carlson to D. Greenway;
December 5, 2006.
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mg/kg bwt/day) has been modified to
more precisely reflect the composition
of test diets, rat body weights, and food
consumption estimates1.
Because only systemic and no
reproductive effects were observed, the
LOAEL for reproductive toxicity of
technical 6–BA in rats could not be
determined. The NOAEL, therefore, is
>1,500 ppm (115.7–144.2 mg/kg bwt/
day for males and 133.0–139.2 mg/kg
bwt/day for females), the highest dose
tested1.
The LOAEL for offspring toxicity of
technical 6–BA in rats is 750 ppm
(66.7–68.1 mg/kg bwt/day) and is based
on decreased body weight and weight
gain in F1 and F2 male and female pups.
The NOAEL is 400 ppm (35.8–36.0 mg/
kg bwt/day)1.
Uncertainty factors for inter- and
intra-species variation (10X each) and
subchronic to chronic extrapolation (3X)
were used to modify the toxicity
NOAEL.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of the FFDCA directs EPA
to consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational 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).
A. Dietary Exposure
1. Food. Apple field trials yielded
acceptable magnitude of the residue
data. In apples, residues of 6–BA were
consistently near the limit of
quantitation (LOQ). However, the
residue levels for processed
commodities did not increase relative to
those on the raw commodity, and were
below the LOQ. The apple field data are
adequate to support the tolerance
exemption for pear, limited by a
maximum application rate of ≤182
grams of active ingredient per acre per
season, because of the shared physical,
compositional and cultural
characteristics of the two botanically
similar pome fruits, which also are
grown in the same climatic/geographic
regions. The proposed use pattern; low
application rate, frequency and timing;
and 86–day pre-harvest interval are
identical for apple and pear. Because
application precedes harvest by
approximately 2.5 months for apple and
pear, the potential for dietary exposure
is reduced. Due to the low anticipated
dietary intake of 6–BA residues relative
to the chronic and acute population
adjusted doses (see Unit VI.), and the
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fact that actual exposure will probably
be considerably less because the dietary
exposure analysis was based on worstcase assumptions (such as
conservatively assuming: That 100% of
the crop is treated, that non-detected or
<LOQ residue concentrations are
present, and that chronic exposure from
the few seasonal applications made 60–
86 days before harvest could occur), it
is highly unlikely that the proposed new
use of 6–BA on pear will result in
adverse effects to human health.
2. Drinking water exposure. The
proposed use on pear is not expected to
add potential exposure to residues of 6–
BA in drinking water. Soil leaching
studies have suggested that 6–BA is
relatively immobile, adsorbing to
sediment, and is degraded in the soil.
Migration to potable water resources,
therefore, is highly improbable.
However, any residues that do reach
surface waters from field runoff should
quickly adsorb to sediment particles and
be partitioned from the water column. 6Benzyladenine also has low solubility in
water, 76 ±2 mg/L at 20° C, and
detections in ground water are not
expected. Together, these data indicate
that residues are not expected in
drinking water.
B. Other Non-Occupational Exposure
The potential for non-dietary, nonoccupational exposure to 6–BA residues
for the general population, including
infants and children, is unlikely because
the uses, both those currently allowed
and the one currently being established,
are limited to applications in certain
tree fruit and nut tree orchards.
Additionally, because 6–BA is a
naturally-occurring cytokinin plant
regulator (having been detected in all
higher plants tested for its presence), it
is a normal part of the human diet.
Moreover, the proposed use rates are
well below the toxicity NOAELs (see
Unit III.), and the residues resulting
from applications made in accordance
with the proposed use rates indicate
dietary exposures that are <1.0% of the
chronic and acute population adjusted
doses. Therefore, not only is there a
great likelihood of prior exposure for
most, if not all, individuals to 6–BA,
due to its natural presence in food
crops, the data submitted also
demonstrate that any incremental
increased exposure due to the proposed
use would be negligible due to the lack
of residue in comparison with the
toxicity NOAELs.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
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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.’’ These
considerations include the possible
cumulative effects of such residues on
infants and children.
EPA does not have, at this time,
available data to suggest whether 6–BA
has a common mechanism of toxicity
with other substances. 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 6–BA and any
other substances and 6–BA 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 6–
BA 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 web site at https://
www.epa.gov/pesticides/cumulative/.
VI. Determination of Safety for U.S.
Population, Infants and Children
A. U.S. Population
When assessing the contributions of
apple and pistachio, the Agency’s
analysis estimated that the chronic
exposures for the overall U.S.
population was 0.000002 mg/kg/day
(<1.0% of the chronic population
adjusted dose (cPAD))1. Similarly, the
acute dietary estimated exposure was
0.000069 mg/kg/day (<1.0% of the acute
population adjusted dose (aPAD)) for
the overall U.S. population. Critical
exposure commodity analysis showed
that apple juice contributed the most to
dietary exposure for the overall
population. Dietary exposure to 6–BA
residues in or on pear did not add
significantly to the current dietary
exposure to 6–BA from its use in or on
apple or pistachio. Due to the low
anticipated dietary intake of 6–BA
residues relative to the chronic and
acute population adjusted doses, and
the fact that actual exposure will
probably be considerably less because
the dietary exposure analysis was made
based on worst-case assumptions (such
as conservatively assuming: That 100%
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of the crop is treated, that non-detected
or <LOQ residue concentrations are
present, and that chronic exposure from
the few seasonal applications made 60–
86 days before harvest could occur), the
Agency is reasonably certain that no
dietary harm will result from aggregate
exposure to 6–BA residues, including
all anticipated dietary exposures
(including the proposed new use of 6–
BA on pear) and all other exposures for
which there is reliable information.
B. Infants and Children
Section 408(b)(2)(C) of the FFDCA
provides that EPA shall apply an
additional ten-fold margin of exposure
(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, unless
EPA determines that a different margin
of exposure (safety) will be safe for
infants and children. Margins of
exposure (safety) are often referred to as
uncertainty (safety) factors. In the case
of 6–BA, the safety factor was reduced
from 10X to 3X based on adequate data
from a new 2-generation rat
reproduction study, and from a rat
developmental toxicity study, neither of
which demonstrated unique fetal
susceptibility (i.e., fetal or neonatal
effects occurred only at maternally toxic
doses)1. Additionally, genotoxicity and
mutagenicity tests were negative. EPA
did not reduce the uncertainty factor
any further, however, because of the
lack of a developmental toxicity study
in a second species, and the resulting
residual uncertainties for 6–BA-induced
pre-/post-natal toxicity. The analysis
estimated that the chronic exposures for
the most highly exposed subgroup, nonnursing infants, was 0.000012 mg/kg/
day (<1.0% of the cPAD). The acute
dietary estimated exposure was
0.000361 mg/kg/day (<1.0% of aPAD)
for the most highly exposed subgroup,
non-nursing infants. Critical exposure
commodity analysis showed that apple
juice contributed the most to dietary
exposure for all infants. Due to the low
anticipated dietary intake of 6–BA
residues relative to the chronic and
acute PAD, and the fact that actual
exposure will probably be considerably
less because the dietary exposure
analysis was made based on worst-case
assumptions (such as conservatively
assuming: that 100% of the crop is
treated, that non-detected or <LOQ
residue concentrations are present, and
that chronic exposure from the few
seasonal applications made 60–86 days
before harvest could occur), it is
reasonably certain that no dietary harm
will result to infants and children from
aggregate exposure to residues of 6–BA
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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations
resulting from all currently-registered
uses, as well as from the proposed new
use of 6–BA on pear.
VII. Other Considerations
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A. Endocrine Disruptors
EPA is required under the FFDCA as
amended by FQPA, to develop a
screening program to determine whether
certain substances (including all
pesticide active and other ingredients)
‘‘may have an effect in humans that is
similar to an effect produced by a
naturally occurring estrogen, or other
such endocrine effects as the
Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there is no
scientific basis for including, as part of
the program, the androgen and thyroid
hormone systems in addition to the
estrogen hormone system. EPA also
adopted EDSTAC’s recommendation
that the program include evaluations of
potential effects in wildlife. For
pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in
wildlife may help determine whether a
substance may have an effect in
humans, FFDCA authority to require
wildlife evaluations. As the science
develops and resources allow, screening
of additional hormone systems may be
added to the Endocrine Disruptor
Screening Program (EDSP). When the
appropriate screening and/or testing
protocols being considered under the
Agency’s EDSP have been developed, 6–
BA may be subjected to additional
screening and/or testing to better
characterize any possible effects related
to endocrine disruption. Based on
available data, no endocrine systemrelated effects have been identified with
consumption of 6–BA. To date, there is
no evidence to suggest that 6–BA affects
the immune system, functions in a
manner similar to any known hormone,
or that it acts as an endocrine disruptor.
B. Analytical Methods
The Agency is establishing an
exemption from the requirement of a
tolerance for the reasons stated above.
For the same reasons, the Agency has
concluded that an analytical method is
not required for enforcement purposes
for 6–BA. Nonetheless, analytical
methods for apple (a pome fruit
botanically similar to the new crop,
pear), both raw agricultural and
processed commodities, and for
pistachio have been developed and
submitted by the registrant. The
analytical method for apple is expected
to be fully applicable (have the same
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sensitivity) to pear because the two
pome fruits are physically and
compositionally comparable, and
therefore should present similar
sequestration and matrix interference
characteristics.
C. Codex Maximum Residue Level
Currently, there are no Codex,
Canadian or Mexican maximum residue
levels for residues of 6–BA in or on
pear.
VIII. Conclusions
Based on the toxicology information
submitted and reviewed previously and
summarized in the June 1994 N6Benzyladenine RED, in combination
with the newly submitted two
generation rat reproduction study and
other information available to the
Agency, there is a reasonable certainty
that no harm will result to the U.S.
population, including infants and
children, from aggregate exposure to
residues of 6–BA under reasonably
foreseeable circumstances, when 6–BA
is used as a biochemical pesticide in
accordance with its label and good
agricultural practices. This includes all
anticipated dietary exposures and all
other exposures for which there is
reliable information. The Agency has
arrived at this conclusion based on the
data submitted previously and
summarized in the RED, as well as that
data submitted to support this tolerance
exemption, demonstrating negligible
dietary exposure in comparison with the
toxicity NOAELs. As a result, EPA is
establishing an exemption (albeit,
limited by a maximum application rate)
from the tolerance requirements
pursuant to section 408(c) and (d) of the
FFDCA for residues of 6–BA in or on
pear.
IX. Statutory and Executive Order
Reviews
This final rule establishes an
exemption from the requirement of a
tolerance under section 408(d) of the
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
PO 00000
Frm 00014
Fmt 4700
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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 the FFDCA,
such as the exemption from the
requirement of a 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 the
FFDCA. For these same reasons, the
Agency has determined that this rule
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does not have any ‘‘tribal implications’’
as described in Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, 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.
X. 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
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Therefore, 40 CFR chapter I is
amended as follows:
I
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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 180.1150 is revised to read
as follows:
I
§ 180.1150 6-Benzyladenine; exemption
from the requirement of a tolerance.
The biochemical plant regulator 6benzyladenine (6–BA) is exempt from
the requirement of a tolerance in or on
apple and pear when applied at a rate
of ≤182 grams of active ingredient per
acre per season, and in or on pistachio
when applied at a rate of ≤60 grams of
active ingredient per acre per season.
[FR Doc. 07–1386 Filed 3–20–07; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0208; FRL–8117–1]
Thifensulfuron Methyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of thifensulfuron
methyl in or on rice, grain; rice, straw;
sorghum, grain, forage; sorghum, grain,
grain; and sorghum, grain, stover. E. I.
DuPont de Nemours and Company
requested these tolerances 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 21, 2007. Objections and requests
for hearings must be received on or
before May 21, 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).
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0208. To access the
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
website 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
ADDRESSES:
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: February 25, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
PART 180—[AMENDED]
PO 00000
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13179
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
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:
Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 305–5704; e-mail address:
walters.vickie@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),
e.g., agricultural workers; greenhouse,
nursery, and floriculture workers;
farmers.
• Animal production (NAICS code
112), e.g., cattle ranchers and farmers,
dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code
311), e.g., agricultural workers; farmers;
greenhouse, nursery, and floriculture
workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS
code 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
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]]>Agencies
[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Rules and Regulations]
[Pages 13174-13179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-1386]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0325; FRL-8117-9]
6-Benzyladenine; 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 the biochemical pesticide, 6-
benzyladenine (6-BA), in or on pear when applied/used as a plant
regulator. Valent BioSciences Corporation (Valent) 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. This regulation
eliminates the need to establish a maximum permissible level for
residues of 6-benzyladenine.
DATES: This regulation is effective March 21, 2007. Objections and
requests for hearings must be received on or before May 21, 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-2006-0325. All documents in the
docket are listed in the index for the docket. 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 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 telephone
number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8263; e-mail address: greenway.denise@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 13175]]
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-2006-0325 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 21, 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-2006-0325, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 19, 2006 (71 FR 20100) (FRL-8058-
1), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F7035) by Valent BioSciences Corporation (Valent), 870
Technology Way, Libertyville, IL 60048-6316. The petition requested
that 40 CFR part 180 (specifically, Sec. 180.1150) be amended by
establishing an exemption from the requirement of a tolerance for
residues of 6-benzyladenine (6-BA) in or on pear when applied at a rate
of <=182 grams of active ingredient per acre per season. The electronic
docket (EPA-HQ-OPP-2006-0325) for this notice includes a summary of the
petition prepared by the petitioner, Valent. Previously, on April 2,
2004 (69 FR 17304; FRL-7347-6), EPA issued a final rule granting a
permanent exemption from the requirement of a tolerance for residues of
6-BA in or on pistachio when applied at a rate of <=60 grams of active
ingredient per acre per season, and the existing permanent tolerance
exemption for apple was amended to expand the uses (by adding a post-
bloom-applied stand-alone fruitlet thinner use) and increase the
permissible application rate to <=182 grams of active ingredient per
acre per season. Both apple and the subject new crop, pear, are pome
fruit and, therefore, botanically similar. The two crops are grown in
the same climatic/geographic regions, and are similarly cultivated. For
both crops, 6-BA is applied for the same purpose, on the same schedule,
at the same application rate and with the same 86-day pre-harvest
interval restriction. Based on these similarities, the Agency has
determined for the purpose of establishing the requested tolerance
exemption that previously-submitted and reviewed information and data
supporting the current tolerance exemption for apple will apply equally
to the new crop, pear. In submitting this petition, therefore, Valent
is relying on information previously submitted in connection with
seeking and obtaining the tolerance exemption for the expanded use of
6-BA on apple, which was summarized in the April 2, 2004, final rule,
and also on new data summarized in the cited petition summary (i.e., PP
6F7035). New data submitted to the Agency by Valent on October 20, 2004
and summarized by the company in the current petition are a two-
generation rat reproduction study, which is data not required for U.S.
registration of this biochemical active ingredient, but rather was
conducted to satisfy the registration requirements of other countries
and submitted by the petitioner to augment the Agency's 6-BA data base.
In response to EPA's April 19, 2006 notice, no comments were
submitted in accordance with the instructions for submitting comments
set forth in the notice. However, one informal comment was received
from a private citizen who opposed issuance of a final rule. The
commenter expressed concern regarding the hazard associated with plant
regulator use in general, stated the unsupported belief that more
testing needs to be done, and was generally opposed to the
establishment of an exemption from the requirement of a tolerance as
proposed in the subject pesticide tolerance petition for 6-BA. The
Agency understands and recognizes that some individuals believe that
pesticides, which include plant regulators, should be banned
completely. Notwithstanding such beliefs, pursuant to its authority
under the FFDCA, EPA has conducted a comprehensive assessment of 6-BA
and has concluded that there is a reasonable certainty that no harm
will result from dietary exposure to this chemical when its use is
limited by the specified maximum application rates.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption
[[Page 13176]]
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
exemption 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. Pursuant to section 408(c)(2)(B) of the FFDCA,
in establishing or maintaining in effect an exemption from the
requirement of a tolerance, EPA must take into account the factors set
forth in section 408(b)(2)(C) of the FFDCA, which require 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.... '' Additionally, section 408(b)(2)(D) of the FFDCA requires
that 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.''
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. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
The toxicological profile for 6-BA was published by the Agency in
the June 1994 N6-Benzyladenine (synonymous with the subject active
ingredient, 6-benzyladenine) Reregistration Eligibility Decision (RED)
document (https://www.epa.gov/oppsrrd1/REDs/old_reds/
n6benzyladenine.pdf). The summarized values and categories for the
various, previously reviewed studies for the technical active
ingredient are presented here.
1. Acute toxicity. Toxicity Category III was assigned to the acute
oral toxicity study in the rat (lethal dose (LD)50 = 1.3
grams/kilogram (g/kg)), and in the eye irritation study in the rabbit
(moderate irritant). Toxicity Category IV (the least toxic category)
was assigned to the acute dermal toxicity study in the rabbit
(LD50 >5 g/kg), the acute inhalation toxicity study in the
rat (lethal concentration (LC)50 = 5.2 milligrams/liter (mg/
L)), and to the dermal irritation study in the rabbit (slight
irritant). Additionally, from a dermal sensitization study in the
guinea pig, it was determined that 6-BA is not a dermal sensitizer.
There have been no reported incidents of hypersensitivity directly
linked to 6-BA. Nevertheless, to comply with section 6(a)(2) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), any
incident of hypersensitivity associated with the use of this pesticide
must be reported to the Agency.
2. Genotoxicity. From three mutagenicity studies (Ames test, mouse
micronucleus assay, and unscheduled DNA synthesis assay in the rat), it
was determined that 6-BA is not mutagenic.
3. Developmental toxicity. The no observed adverse effect levels
(NOAEL) and the lowest observed adverse effect levels (LOAEL) for
maternal and developmental toxicity in rats, respectively, were found
to be 50 and 175 milligrams/kilogram body weight/day (mg/kg bwt/day),
respectively.
4. Subchronic toxicity. For rats of both sexes, the NOAEL was
approximately 111 mg/kg bwt/day and the LOAEL was approximately 304 mg/
kg bwt/day.
In addition to the previously reviewed studies discussed above, a
two-generation rat reproduction study was relied upon by Valent to
support the current petition to establish an exemption from the
requirement of a tolerance for residues of 6-BA in or on pear. The
lowest-LOAEL for parental systemic toxicity of technical 6-BA is 750
ppm (58.6-70.4 mg/kg bwt/day) and is based on reduced body weight and
weight gain in F0 and F1 male rats\1\.The NOAEL
is 400 ppm (31.5-37.5 mg/kg bwt/day)\1\ . This systemic adult endpoint
was used in the dietary risk assessment. Although the systemic endpoint
is similar to that used in previous occupational risk assessments, the
previous toxicological endpoint (40 mg/kg bwt/day) has been modified to
more precisely reflect the composition of test diets, rat body weights,
and food consumption estimates\1\.
---------------------------------------------------------------------------
\1\ USEPA. N6-Benzyladenine: Review of Information for an
Exemption from the Requirement of a Tolerance. K. R. Carlson to D.
Greenway; December 5, 2006.
---------------------------------------------------------------------------
Because only systemic and no reproductive effects were observed,
the LOAEL for reproductive toxicity of technical 6-BA in rats could not
be determined. The NOAEL, therefore, is >1,500 ppm (115.7-144.2 mg/kg
bwt/day for males and 133.0-139.2 mg/kg bwt/day for females), the
highest dose tested\1\.
The LOAEL for offspring toxicity of technical 6-BA in rats is 750
ppm (66.7-68.1 mg/kg bwt/day) and is based on decreased body weight and
weight gain in F1 and F2 male and female pups.
The NOAEL is 400 ppm (35.8-36.0 mg/kg bwt/day)\1\.
Uncertainty factors for inter- and intra-species variation (10X
each) and subchronic to chronic extrapolation (3X) were used to modify
the toxicity NOAEL.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the 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).
A. Dietary Exposure
1. Food. Apple field trials yielded acceptable magnitude of the
residue data. In apples, residues of 6-BA were consistently near the
limit of quantitation (LOQ). However, the residue levels for processed
commodities did not increase relative to those on the raw commodity,
and were below the LOQ. The apple field data are adequate to support
the tolerance exemption for pear, limited by a maximum application rate
of <=182 grams of active ingredient per acre per season, because of the
shared physical, compositional and cultural characteristics of the two
botanically similar pome fruits, which also are grown in the same
climatic/geographic regions. The proposed use pattern; low application
rate, frequency and timing; and 86-day pre-harvest interval are
identical for apple and pear. Because application precedes harvest by
approximately 2.5 months for apple and pear, the potential for dietary
exposure is reduced. Due to the low anticipated dietary intake of 6-BA
residues relative to the chronic and acute population adjusted doses
(see Unit VI.), and the
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fact that actual exposure will probably be considerably less because
the dietary exposure analysis was based on worst-case assumptions (such
as conservatively assuming: That 100% of the crop is treated, that non-
detected or 2 mg/L at 20[deg] C, and detections in ground water are not
expected. Together, these data indicate that residues are not expected
in drinking water.
B. Other Non-Occupational Exposure
The potential for non-dietary, non-occupational exposure to 6-BA
residues for the general population, including infants and children, is
unlikely because the uses, both those currently allowed and the one
currently being established, are limited to applications in certain
tree fruit and nut tree orchards. Additionally, because 6-BA is a
naturally-occurring cytokinin plant regulator (having been detected in
all higher plants tested for its presence), it is a normal part of the
human diet. Moreover, the proposed use rates are well below the
toxicity NOAELs (see Unit III.), and the residues resulting from
applications made in accordance with the proposed use rates indicate
dietary exposures that are <1.0% of the chronic and acute population
adjusted doses. Therefore, not only is there a great likelihood of
prior exposure for most, if not all, individuals to 6-BA, due to its
natural presence in food crops, the data submitted also demonstrate
that any incremental increased exposure due to the proposed use would
be negligible due to the lack of residue in comparison with the
toxicity NOAELs.
V. 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.'' These considerations include the
possible cumulative effects of such residues on infants and children.
EPA does not have, at this time, available data to suggest whether
6-BA has a common mechanism of toxicity with other substances. 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 6-BA and any other substances and
6-BA 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 6-BA 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 web site at http:/
/www.epa.gov/pesticides/cumulative/.
VI. Determination of Safety for U.S. Population, Infants and Children
A. U.S. Population
When assessing the contributions of apple and pistachio, the
Agency's analysis estimated that the chronic exposures for the overall
U.S. population was 0.000002 mg/kg/day (<1.0% of the chronic population
adjusted dose (cPAD))\1\. Similarly, the acute dietary estimated
exposure was 0.000069 mg/kg/day (<1.0% of the acute population adjusted
dose (aPAD)) for the overall U.S. population. Critical exposure
commodity analysis showed that apple juice contributed the most to
dietary exposure for the overall population. Dietary exposure to 6-BA
residues in or on pear did not add significantly to the current dietary
exposure to 6-BA from its use in or on apple or pistachio. Due to the
low anticipated dietary intake of 6-BA residues relative to the chronic
and acute population adjusted doses, and the fact that actual exposure
will probably be considerably less because the dietary exposure
analysis was made based on worst-case assumptions (such as
conservatively assuming: That 100% of the crop is treated, that non-
detected or
