[Federal Register: January 27, 2006 (Volume 71, Number 18)]
[Rules and Regulations]
[Page 4512-4518]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja06-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0515; FRL-7757-2]
Sorbitol Octanoate; 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 sorbitol octanoate on
all food commodities when applied/used in accordance with label
directions. AVA Chemical Ventures, L. L. C. 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 sorbitol
octanoate.
DATES: This regulation is effective January 27, 2006. Objections and
requests for hearings must be received on or before March 28, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-OPP-2005-0515. All documents in the
docket are listed on the http://www.regulations.gov website. (EDOCKET, EPA's
electronic public docket and comment system was replaced on November
25, 2005, by an enhanced federal-wide electronic docket management and
comment system located at http://www.regulations.gov/. Follow the
online instructions.) Although listed in the index, some information is
not publicly available, i.e., CBI or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically in EDOCKET or in hard copy at the
Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
[[Page 4513]]
FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511C), 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:
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 and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of September 29, 2004 (69 FR 58166) (FRL-
7679-1), 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 2E6389) by AVA Chemical Ventures, L. L. C., 80
Rochester Avenue, Suite 214, Portsmouth, NH, 03801. The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of sorbitol octanoate.
This notice included a summary of the petition prepared by the
petitioner AVA Chemical Ventures, L. L. C. There were no comments
received in response to the notice of filing.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the 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), 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), 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.
Sorbitol octanoate is a fatty acid ester made from sorbitol and
caprylic acid. Caprylic acid, also known as octanoic acid, is a common
fatty acid in plants that is derived from edible oils or fats. It also
is produced in small quantities in the human body and is marketed as a
human dietary supplement (Ref. 1). Sorbitol, a food grade sweetener
with about half the sweetness of sucrose, is a hexahydric alcohol and
occurs naturally in fruits such as apples, plums, pears, cherries,
dates, peaches, and apricots (Ref. 2). Both sorbitol and octanoic acid
are on the Agency's List 4 Inerts of Minimal Concern. Sorbitol is
cleared for food use in unlimited quantities as an antidusting agent
(40 CFR 180.910). While sorbitol octanoate is the subject of this final
rule, the raw materials from which it is made are common in crops eaten
regularly by humans and animals.
Furthermore, sorbitol octanoate is chemically and toxicologically
similar to certain groups of compounds, namely certain sorbitan esters
and certain sucrose octanoate esters that have been FDA-approved since
1983 when used as direct additives in food, as emulsifiers in certain
processed foods, and as post-harvest protective coatings for certain
fruits (21 CFR 172.836, 172.838, 172.840, 172.842 and 172.859). In
1995, FDA expanded the range of foods in which sucrose octanoate esters
(SOEs) are permitted (August 29, 1995, 60 FR 44756). Sorbitol octanoate
and SOEs both are fatty acid esters, and both are made by reacting
sugars with octanoic acid (i.e., both are non-ionic surfactants
manufactured by esterifying C8 fatty acid with a sugar:
sorbitol in the case of sorbitol octanoate and sucrose in the case of
SOEs). Sorbitol octanoate and SOEs have similar solubility in water,
similar degrees of stability, and require a similar concentration to
achieve droplet spread. FDA-approved sorbitan esters are different from
sorbitol octanoate only in that sorbitol has one more water molecule
than sorbitan. Therefore, the toxicological data associated with SOEs
and sorbitan esters can be used to support an exemption from the
requirement of a tolerance for sorbitol octanoate.
The applicant collected and summarized the toxicological data
associated with the cited FDA food-use approvals for SOEs which
included sorbitan esters (as they are chemically similar), and
submitted this information in support of an earlier tolerance exemption
request (64 FR 49010, September 9, 1999) for SOEs (Ref. 3). In turn,
the Agency reviewed and accepted both the summaries and the underlying
data in granting the tolerance exemption for SOEs (67 FR 60146,
September 25, 2002). Because of the substantial similarity between the
two active
[[Page 4514]]
ingredients (i.e., sorbitol octanoate and SOEs), the Agency allowed the
applicant to ``bridge'' to that previously-submitted data/information
to support the tolerance exemption requested for sorbitol octanoate.
Toxicity information/data submitted in support of this tolerance
exemption are referenced below. Toxicity data requirements that relate
to or aggregate with human dietary risk were addressed by requests for
data waivers, which were based on publically available information/data
that were previously submitted by the applicant, and reviewed and
accepted by the Agency, in support of the tolerance exemption that the
Agency granted for the chemically-similar SOEs (Refs. 3, 4, and 6). In
addition, the Agency found relevant data from additional public
sources, including EPA's National Toxicology Program, which contributed
to the Agency's review (Ref. 1). All of this information/data, which,
in combination, was equivalent to what would normally be provided by
guideline studies, and therefore would likely have been adequate to
meet each toxicology requirement had they been submitted as such
pursuant to 40 CFR 152.90(b)(4), was deemed adequate to support the
waiver requests. Sorbitan esters and sucrose fatty acid esters, which
are used as food emulsifiers and as post-harvest fruit protectants,
have been found to be of no particular toxic concern in studies used to
support their safety to the FDA. Sorbitol octanoate is different from
the FDA-approved sorbitan esters in that octanoate is the sole fatty
acid component and sorbitan anhydrides are derived from sorbitol by
removal of one molecule of water. Therefore, results from studies on
sorbitan esters can be used to support lack of toxicity concern with
sorbitol octanoate. Sorbitol octanoate also rapidly hydrolyzes to
sorbitol and octanoic acid, both of which are common human dietary
components of no toxicological concern. Both sorbitol and octanoic acid
are included in EPA's List 4 inert ingredients, and thus are of minimal
concern. Sucrose octanoate has previously been registered by EPA (EPA
Reg. No. 70950-2). The rationales for waiver requests for all required
mammalian toxicological studies are acceptable. More detailed analyses
of these data and information can be found in specific Agency reviews
of the studies and technical literature (Refs. 1, 6, 7, 8 and 9).
1. Acute oral toxicity waiver (OPPTS 870.1100) MRID 444158-03, and
amendment number 1. Acute oral and dietary toxicity data, previously
evaluated in three publications by the Food and Agriculture
Organization (FAO) of the United Nations World Health Organization
(WHO), were submitted in support of this data waiver request (Refs. 3
and 4). The data contained in these reports demonstrated that sorbitan
esters and sucrose octanoate esters had extremely low oral toxicity (in
laboratory studies), even at concentrations substantially higher than
are found in human food.
In studies with rats and humans, it was demonstrated that sorbitan
esters and sucrose octanoate esters were rapidly hydrolyzed and
absorbed by the body. Sorbitol octanoate is different from the sorbitan
esters approved by FDA for direct addition to food for human
consumption in the degree to which water is removed during the
manufacturing process and the specific fatty acid that is used to make
the esters. Sorbitan is a generic name for anhydrides (cyclic ether
tetrahydric alcohols) derived from sorbitol by removal of one molecule
of water. Octanoic acid is used to make sorbitol octanoate, but the
sorbitan esters are made with mixtures of several longer-chain fatty
acids. Sorbitan monopalmitate in the diet of rats; sorbitan
monostearate in the diet of rats; sorbitan tristearate administered to
rats by gavage; and sorbitan monopalmitate, sorbitan monostearate, and
sorbitan tristearate in rats (maximum oral dose) caused no toxic
symptoms/mortality. The acute oral LD50s for monoleate and
sorbitan monolaurate in rats were 39.8 and 37.5 grams/kilogram (g/kg),
respectively. An estimate of acceptable daily intake in man of 0-25
milligrams/kilogram (mg/kg) was set by the Expert Committee on Food
Additives. Sorbitol octanoate hydrolyzed rapidly to sorbitol and
octanoic acid. The LD50s for sorbitol in mice/rats dosed
intravenously or orally ranged from 7,100 to 25,700 mg/kg,
respectively. The oral LD50s for octanoic acid were 1,283
mg/kg (one study, male rats) and 10,080 mg/kg (another study, male and
female rats), amounts far greater than humans would encounter via the
oral exposure route from pesticidal use of sorbitol octanoate. Sorbitol
(21 CFR 184.1835) and ocatanoic acid (21 CFR 184.1025) are classified
as GRAS by the FDA and are in EPA's List 4 - Inerts of Minimal Concern.
Because sorbitol octanoate is chemically similar to SOEs, for which an
exemption from tolerance already is established, and octanoic acid is a
sorbitol octanoate constituent/degradate of no toxicological concern,
the information/data described above support waiver from the data
requirements for acute oral toxicity studies (classification:
acceptable; Toxicity Category IV for the manufacturing-use product and
end-use product).
2. Acute dermal toxicity waiver (OPPTS 870.1200) MRID 444158-03 and
amendment number 1. A data waiver was granted for this guideline study
based on the strength of the supporting information/data submitted by
the registrant in connection with the tolerance exemption granted for
SOEs, which as noted above are chemically and toxicologically similar
to sorbitol octanoate. Also, dermal toxicity data on the sorbitan
esters is relevant to sorbitol octanoate. The only difference between
the sorbitan esters used in cosmetics and sorbitol octanoate is in the
degree to which water is removed during the manufacturing process.
Sorbitan fatty acid esters were generally minimal to mild skin
irritants in animals and humans. In addition, publically available
sources list the rabbit dermal LD50 for octanoic acid (a
sorbitol octanoate constituent/degradate of no toxicological concern)
as > 5,000 mg/kg (Ref. 1), an amount far greater than humans would
encounter via the dermal exposure route from pesticidal use of sorbitol
octanoate and which places it in the Toxicity Category of no concern
(IV) (classification: acceptable; Toxicity Category IV for the
manufacturing-use product and end-use product).
3. Acute inhalation toxicity waiver (OPPTS 870.1300) MRID 444158-03
and Amendment number 1. A data waiver was granted for this guideline
study based on the strength of the supporting information/data
submitted by the registrant in connection with the tolerance exemption
granted for SOEs, which as noted above are chemically and
toxicologically similar to sorbitol octanoate (Refs. 1,3,4 and 6). No
adverse effects have been reported by researchers working with sorbitol
octanoate, and the compound is not volatile. The sorbitol octanoate
constituents sorbitol and octanoic acid are classified as Generally
Recognized as Safe (GRAS) by the FDA and are among EPA's List 4 Inerts
of Minimal Concern. The chemically-similar sorbitan fatty acid esters
are waxy solids or viscous liquids which cannot be inhaled
(classification: acceptable; Toxicity Category IV for the
manufacturing-use product and end-use product).
4. Hypersensitivity study waiver (OPPTS 870.2600) MRID 455973-01.
No hypersensitivity incidents have been reported for laboratory workers
regularly exposed to sorbitol octanoate for up to 7 years. Neither have
there been reports of hypersensitivity from
[[Page 4515]]
those working with the chemically-similar sucrose octanoate. A waiver
for conduct of a dermal sensitization study for sorbitol octanoate thus
can be supported. In addition, the registrant is obliged under the
Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA) section
6(a)(2) to notify the Agency in the event of such incidents
(classification: acceptable).
5. Genotoxicity and mutagenicity waiver (OPPTS 870.5300, 870.5195)
MRID 444158-03 and amendment number 1. No guideline studies were
submitted, but it was determined that none are required because
acceptable information/data were submitted from the open technical
literature to scientifically justify a waiver of the data requirements
for genotoxicity and mutagenicity. This information/data demonstrate
that SOEs and sorbitol octanoate (because of their chemical and
toxicological similarities) are not genotoxic and/or mutagenic, nor is
the active ingredient structurally and/or chemically similar to known
mutagens or known classes of mutagens (Refs. 3, 4 and 6). In addition,
a study reported by EPA's National Toxicology Program shows octanoic
acid, a sorbitol octanoate constituent/degradate of no toxicological
concern, to be negative for genotoxicity/mutagenicity (Ref. 1)
(classification: acceptable).
6. Other data requirements waived. Immune response and all
remaining Tier I biochemical toxicology data requirements that relate
to or aggregate with human dietary risk were waived (see OPPTS 880.3800
through 870.4200, MRID 444158-03 and amendment number 1) due to the low
toxicity of the chemically similar SOEs, as reported in the open
technical literature (Refs. 3, 4, 5, 6 and 7). In addition, octanoic
acid, a sorbitol octanoate constituent/degradate of no toxicological
concern, is considered a nonteratogenic compound even at the very high
dose rate of 18.75 millimoles/kg (Ref. 1).
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. An Acceptable Daily Intake (ADI) of SOEs for humans was
estimated by FAO/WHO to be up to 16 mg/kg body weight/day, which is
equivalent to 1.28 kg of SOEs per day for a 176 lb person (Refs. 3, 4,
and 6). There are no reasonably foreseeable circumstances in which the
residue levels of SOEs or the chemically- and toxicologically-similar
compound sorbitol octanoate would ever approach this amount. Sorbitol
octanoate hydrolyzes into its constituents (sorbitol and octanoic acid)
shortly after application and then biodegrades. In studies with rats
and humans, it was demonstrated that SOEs were rapidly hydrolyzed and
absorbed by the body (Ref. 6). Because sorbitol octanoate is made from
sorbitol (present in certain fruits) and caprylic acid (derived from
edible oils and fats), there is a great likelihood of exposure in the
normal human diet to both SOEs (derived from sugar and edible tallow or
edible vegetable oils) and sorbitol octanoate, and their components for
most, if not all, individuals, including infants and children. Sorbitol
and octanoic acid are common components of the human diet. Thus,
sorbitol octanoate may be considered a normal part of the human diet.
To date, there have been no reports of any hypersensitivity incidents
or reports of any known adverse reactions in humans resulting from
exposure to either SOEs (which for years have been FDA-approved food
emulsifiers) or the chemically-similar sorbitol octanoate. Even if
there is a significant increase in dietary exposure to sorbitol
octanoate due to its use as a pesticide, the acute toxicity information
from the National Toxicology Program and the information submitted by
the registrant demonstrating extremely low mammalian toxicity (Toxicity
Category IV) for SOEs (which, again, are chemically similar to sorbitol
octanoate) indicate that any possible risk associated with acute
exposures by the oral, dermal and inhalation routes to sorbitol
octanoate would be low to non-existent. Further, any increased exposure
due to the proposed products would be negligible because the active
ingredient sorbitol octanoate will rapidly hydrolyze into its
constituent components (sorbitol and octanoic acid), which subsequently
will be rapidly metabolized by soil bacteria, thus limiting the general
public's contact with treated plants or food products.
2. Drinking water exposure. No drinking water exposure is expected.
Sorbitol octanoate is not applied directly to water, does not persist
in the environment and biodegrades following application/use. Even if
sorbitol octanoate residues were to enter drinking water, we do not
expect any significant risk since sorbitol octanoate will rapidly
hydroloyze into its consituent components (sorbitol and octanoic acid),
which then would biodegrade prior to consumption by microorganisms
before the general public would contact drinking water containing
residues of sorbitol octanoate.
B. Other Non-Occupational Exposure
The potential for non-dietary exposure to sorbitol octanoate
residues for the general population, including infants and children, is
unlikely because the uses are limited to applications to horticultural
and agricultural crops. The sorbitol octanoate constituents sorbitol
and octanoic acid are normal parts of the human diet. Sorbitol
octanoate toxicity from a dietary exposure standpoint has been
determined to be extremely low. Therefore, while there exists a great
likelihood of prior exposure for most, if not all, individuals to both
sorbitol octanoate and SOEs, any increased non-occupational exposure
due to the proposed products would be negligible because the active
ingredient sorbitol octanoate will rapidly hydrolyze into its
constituent components (sorbitol and octanoic acid) which will be
rapidly metabolized by soil bacteria, thus limiting the general
public's contact with treated plants or food products via the dermal or
inhalation routes.
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.
Except through ocular exposure, which is only expected in the
occupational setting and can be prevented by the use of protective
eyewear, neither sorbitol octanoate nor SOEs are toxic, and it is not
anticipated that there would be cumulative effects from common
mechanisms of toxicity. EPA does not have, at this time, available data
to suggest whether sorbitol octanoate 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
[[Page 4516]]
finding as to sorbitol octanoate and any other substances and sorbitol
octanoate does not appear to produce a toxic metabolite produced by
other substances. For the purpose of this tolerance action, therefore,
EPA has not assumed that sorbitol octanoate 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
1. U.S. population. The Agency has determined that there is a
reasonable certainty that no harm will result from aggregate exposure
to residues of sorbitol octanoate to the U.S. population. This includes
all anticipated dietary exposures and other non-occupational exposures
for which there is reliable information. The Agency arrived at this
conclusion based on the extremely low levels of mammalian dietary
toxicity associated with SOEs and, by extension, sorbitol octanoate due
to the fact it is nearly identical chemically. Accordingly, it is
unlikely that any toxic effects will result from exposure to sorbitol
octanoate via the oral, dermal or inhalation pathways when the
registered sorbitol octanoate products are used according to proposed
label directions (Ref. 6). Based upon the data submitted in connection
with SOEs and, by extension, the chemically-similar compound sorbitol
octanoate, the amount of sorbitol octanoate applied to food crops is
many orders of magnitude lower than the concentrations of sorbitol
octanoate needed to cause toxicological effects. Because the worst case
scenario exposure is far below the level of any dietary toxicity known
for SOEs or sorbitol octanoate, or their components and degradates, EPA
has determined that residues will not pose a dietary risk under
reasonably foreseeable circumstances and that granting a tolerance
exemption is appropriate.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure for infants and children
in the case of threshold effects unless the Agency determines, based on
reliable data, that a different margin is safe. Margins of exposure are
referred to as uncertainty or safety factors, and are used to account
for potential prenatal and postnatal toxicity and any lack of
completeness in the data base. Based on all the reliable available
information the Agency reviewed on SOEs and, by extension, sorbitol
octanoate due to the fact that it is nearly identical chemically, the
Agency concludes that sorbitol octanoate is practically non-toxic to
mammals from a dietary standpoint, including infants and children.
Thus, there are no threshold effects of concern and an additional
margin of safety is not necessary to protect infants and children.
VII. Other Considerations
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, sorbitol
octanoate may be subjected to additional screening and/or testing to
better characterize effects related to endocrine disruption. Based on
available data, no endocrine system-related effects have been
identified with consumption of sorbitol octanoate. To date, there is no
evidence to suggest that sorbitol octanoate affects the immune system,
functions in a manner similar to any known hormone, or that it acts as
an endocrine disruptor.
B. Analytical Method(s)
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation for the reasons stated
above, including low toxicity and low exposure from the pesticidal use
of sorbitol octanoate. For the same reasons, the Agency concludes that
an analytical method is not required for enforcement purposes for
sorbitol octanoate.
C. Codex Maximum Residue Level
There are no CODEX maximum residue levels for sorbitol octanoate.
VIII. Conclusions
Based on the toxicology information/data submitted and other
information available to the Agency, there is a reasonable certainty
that no harm will result from aggregate exposure to residues of
sorbitol octanoate to the U.S. population, including infants and
children, under reasonably foreseeable circumstances, when the
biochemical pesticide is used in accordance with product label
directions and good agricultural practices. This includes all
anticipated dietary exposures and all other non-occupational exposures
for which there is reliable information. The Agency has arrived at this
conclusion based on the information/data submitted (and publically
available) demonstrating negligible toxicity of the chemically-similar
SOEs and sorbitan esters, and of sorbitol octanoate's constituents
(sorbitol and octanoic acid). As a result, EPA is establishing an
exemption from the tolerance requirements pursuant to FFDCA section
408(c) for residues of sorbitol octanoate in or on all food
commodities.
IX. Objections and Hearing Requests
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. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period
[[Page 4517]]
for filing objections is now 60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number EPA-HQ-OPP-2005-0515 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 March 28,
2006.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14th St.,
NW., Washington, DC 20005. The Office of the Hearing Clerk is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit IX.A.1.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number EPA-HQ-OPP-2005-0515, to:
Public Information and Records Integrity Branch, Information Technology
and Resources Management Division (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. In person or by courier, bring a copy to the
location of the PIRIB described in ADDRESSES. You may also send an
electronic copy of your request via e-mail to: opp-docket@epa.gov.
Please use an ASCII file format and avoid the use of special characters
and any form of encryption. Copies of electronic objections and hearing
requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII
file format. Do not include any CBI in your electronic copy. You may
also submit an electronic copy of your request at many Federal
Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
X. References
1. USEPA. Brief summary of toxicity information to support
registration/tolerance exemptions for sucrose octanoate. R. S. Jones to
D. Greenway; August 8, 2002.
2. Lawson, M.E. 1997. Kirk-Othmer's Encyl Chem Tech. 4th Ed. J.I.
Kroschwitz (ed). John Wiley & Sons, NY.
3. Barrington, T., and C. L. Hartman. Sucrose fatty acid esters-
Safety data in support of petition proposing a temporary (sic)
exemption from the requirement of a tolerance for use in all food
commodities (MRID 444158-03); October 2, 1997.
4. Barrington, T. and W. L. Biehn. Sucrose fatty acid esters-safety
data in support of petition proposing an exemption from the requirement
of a tolerance for use in all food commodities, Amendment number 1 to
MRID 444158-03; July 13, 1998.
5. Barrington, A. Waiver request; July 12, 2002.
6. USEPA. Science review in support of registration of sucrose
octanoate esters. R.S. Jones to D. Greenway; February 14, 2000.
7. USEPA. Sucrose octanoate esters; A request for concurrence on a
decision to waive the requirement for 90-day feeding study (870.3100)
and Developmental Toxicity (Teratogenicity (870.3700) studies, based on
the Registrant's correspondence of July 12, 2002. D. Greenway to R. S.
Jones; August 7, 2002.
8. USEPA. Secondary Review of Data/information submitted to support
Registration of Sorbitol Octanoate R.D. Sjoblad to D. Greenway;
December 29, 2004
9. USEPA. Endangered Species Risk Assessment for Sorbitol
Octanoate. R. S. Jones to D. Greenway; September 13, 2005.
XI. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement 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 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 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
[[Page 4518]]
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 does not have any ``tribal implications''
as described in Executive Order 13175, entitledConsultation 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.
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: January 13, 2006.
James Jones,
Director, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1262 is added to subpart D to read as follows:
Sec. 180.1262 Sorbitol octanoate; exemption from the requirement of a
tolerance.
An exemption from the requirement of a tolerance is established for
residues of sorbitol octanoate in or on all food commodities when used
in accordance with label directions.
[FR Doc. 06-756 Filed 1-26-06; 8:45 am]
BILLING CODE 6560-50-S