Document ID: EPA-HQ-OPP-2005-0515-0001
Agency: epa
Document Type: Rule
Title: Sorbitol Octanoate; Exemption from the Requirement of a Tolerance
Posted Date: 2006-01-27T13:30:10Z

[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]

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