[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Rules and Regulations]
[Pages 13174-13179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1386]
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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.
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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 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 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: [email protected].
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 http://www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-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: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket 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 (http://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\.
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\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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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
[[Page 13177]]
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