[Federal Register Volume 67, Number 186 (Wednesday, September 25, 2002)]
[Rules and Regulations]
[Pages 60146-60152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24224]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0016; FRL-7199-1


Sucrose Octanoate Esters; 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 certain sucrose octanoate esters on all 
food commodities when applied/used in accordance with good agricultural 
practices. 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 (FQPA) of 1996, requesting an exemption 
from the requirement of a tolerance. This regulation eliminates the 
need to establish a maximum permissible level for residues of sucrose 
octanoate esters.

DATES: This regulation is effective September 25, 2002. Objections and 
requests for hearings, identified by docket identification (ID) number 
OPP-2002-0016, must be received on or before November 25, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket ID number OPP-
2002-0016 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Denise Greenway, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington,

[[Page 60147]]

DC 20460-0001; telephone number: (703) 308-8263; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS Codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet home page at http://www.epa.gov/. 
To access this document, on the home page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml --00/Title--40/40cfr180--00.html, a beta site 
currently under development. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0016. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of September 9, 1999 (64 FR 49010) (FRL-
6095-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 
U.S.C. 346a(d)(3), as amended by FQPA (Public Law 104-170), announcing 
the filing of a pesticide tolerance petition (PP 8E4926) by AVA 
Chemical Ventures, L.L.C., 65 Aviation Avenue (now at 80 Rochester 
Avenue, Suite 214), Portsmouth, NH 03801. 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.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of sucrose fatty acid esters. EPA has determined that the 
designation ``sucrose fatty acid esters'' is too broad, in that it 
could include other compounds not intended by the registrant, and for 
which the Agency has not reviewed relevant data. The data and 
information submitted by the registrant in support of the petition 
cover an exemption from the requirement of a tolerance for sucrose 
octanoate esters, which have been identified as the specific type of 
sucrose fatty acid esters that act as the active ingredient (a.i.) in 
the petitioner's pending products. EPA's general policy is to establish 
a tolerance or exemption from the requirement of a tolerance for the 
actual a.i. contained in the registrant's products. Because the a.i. 
for which the registrant actually is petitioning is technically defined 
as sucrose octanoate esters [([alpha]-D-glucopyranosyl-[beta]-D-
fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose 
octanoate], all discussions in this rule and in the resulting tolerance 
exemption expression refer only to ``sucrose octanoate esters 
[([alpha]-D-glucopyranosyl-[beta]-D-fructofuranosyl-octanoate), mono-, 
di-, and triesters of sucrose octanoate].'' Hereinafter, EPA uses the 
terms ``sucrose octanoate esters'' and ``SOEs'' to mean sucrose 
octanoate esters [([alpha]-D-glucopyranosyl-[beta]-D-fructofuranosyl-
octanoate), mono-, di-, and triesters of sucrose octanoate].

III. Statutory Authority

    This exemption from the requirement of a tolerance is being issued 
under the authority of section 408(c) of FFDCA (21 U.S.C. 346a(c)). 
Under FFDCA section 408, EPA regulates pesticide chemical residues by 
establishing tolerances limiting the amounts of residues that may be 
present in or on food, or by establishing exemptions from the 
requirement of a tolerance for such residues. Food includes articles 
used for food or drink by humans or other animals. A food containing 
pesticide residues may not be moved in interstate commerce without an 
appropriate tolerance or an exemption from the requirement of a 
tolerance.
    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 tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....'' FFDCA section 408(b)(2)(D) specifies other, general 
factors EPA must consider in establishing an exemption, including the 
consideration of the cumulative effects of a particular pesticide's 
residues and ``other substances that have a common mechanism of 
toxicity.'' FFDCA section 408(c)(3) prohibits an exemption unless

[[Page 60148]]

there is either a practical method for detecting and measuring levels 
of pesticide chemical residue in or on food or EPA determines that 
there is no need for such a method and states the reason for such 
determination.
    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.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    Sucrose octanoate esters are made from a caprylic fatty acid ester 
derived from an edible oil or fat, and sucrose. Sucrose is the primary 
product of photosynthesis (Reference 1) and therefore, common in food 
crops eaten regularly by humans and animals. Sucrose, also known as 
table sugar, has an exceedingly long history of human dietary exposure 
(Reference 1). The octanoate esters are made from octanoic acid 
(caprylic acid), a common fatty acid in plants, which is produced in 
small quantities in the human body and is marketed as a human dietary 
supplement (Reference 1). Sucrose octanoate esters derived from edible 
vegetable oils, edible tallow or hydrogenated edible tallow have been 
FDA-approved since 1983 (21 CFR 172.859) when used (as an additive for 
direct addition to food) as emulsifiers in certain processed foods and 
as post-harvest protective coatings for certain fruits. FDA expanded in 
1995 the range of foods in which SOEs are permitted, to include use in 
emulsifiers, stabilizers, and texturizers in chewing gum, confections, 
and frostings; texturizers in surimi-based fabricated seafood products; 
and emulsifiers in coffee and tea beverages with added dairy 
ingredients and/or dairy product analogs (60 FR 44755). The applicant 
collected and summarized the toxicological data associated with the 
cited FDA food-use approvals and submitted this information in support 
of their tolerance exemption request (Reference 2). The Agency reviewed 
both the summaries and the underlying data.
    Toxicity information/data submitted in support of this tolerance 
exemption are referenced below. New studies were contracted by the 
petitioner only for primary eye irritation and primary dermal 
irritation. Data waivers were requested and granted for all other 
toxicity data requirements. Publically available information/data were 
submitted, in lieu of studies, as part of the scientific justification 
necessary to support the data waiver requests (References 2, 3, and 4). 
In addition, the Agency has found additional relevant data from 
additional public sources including the National Toxicology Program 
which have been of value to the Agency's review of this petition 
(Reference 1). The submitted information/data, in combination, were 
found 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). More detailed analyses of these data and information 
can be found in specific Agency reviews of the studies and technical 
literature (References 1, 5, and 6).
    1. Primary eye irritation (OPPTS 870.2400, 152-13) MRIDs 446101-05 
and 446101-06: Following ocular instillation of 0.1 mL of undiluted 
manufacturing-use product into the eyes of rabbits, moderate to severe 
eye irritation and mild corneal opacity was observed in the treated 
eyes of all rabbits at 24 hours post-dosing, and persisted in 1 rabbit 
to 21 days post-dosing. Mild iritis was exhibited in 3 rabbits at 24 
hours post-dosing, and persisted in 1 rabbit to 72 hours. 
Classification: Acceptable; Toxicity Category I for the manufacturing-
use product. In a second primary eye irritation study, following ocular 
instillation of 0.1 mL of undiluted end-use product into the eyes of 
rabbits, moderate to severe eye irritation was observed in the treated 
eyes of all 6 rabbits at 72 hours post-dosing, was mild at 7 days, and 
cleared by 14 days. Mild corneal opacity was observed in all 6 rabbits 
at 24 hours, and persisted to 7 days in 1 rabbit, then cleared by 14 
days post-dosing. Mild iritis persisted in 4 rabbits to 72 hours, then 
cleared. Classification: Acceptable; Toxicity Category II for the end-
use product.
    2. Primary dermal irritation (OPPTS 870.2500, 152-14) MRIDs 446101-
03 and 446101-04: Following dermal application of 0.5 mL of undiluted 
manufacturing-use product to the skin of rabbits, 5 rabbits exhibited 
very slight erythema and one exhibited well-defined erythema at 1 hour 
post-treatment. Very slight erythema persisted on 4 rabbits to 24 
hours, then cleared. No edema was observed on any rabbit. 
Classification: Acceptable; Toxicity Category IV for the manufacturing-
use product. In a second primary dermal irritation study, following 
dermal application of 0.5 mL of undiluted end-use product to the skin 
of rabbits, very slight erythema was exhibited by 6 rabbits at 0.5 hour 
post-treatment and 5 rabbits exhibited very slight to slight edema. All 
symptoms cleared by 24 hours. Classification: Acceptable; Toxicity 
Category IV for the end-use product.
    Data waivers were requested for the following studies. Although no 
acute toxicity studies were conducted by the registrant, acceptable 
information/data was submitted from the open technical literature to 
support the data waiver requests.
    3. Acute oral toxicity waiver (OPPTS 870.1100, 152-10) 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 
(References 2, and 3). The data contained in these reports demonstrated 
that SOEs had extremely low oral toxicity (in laboratory studies), even 
at concentrations substantially higher than are found in human food. 
Extremely high concentrations were needed to produce toxic symptoms in 
laboratory studies (LD50 <20,000 milligrams/kilogram (mg/
kg)). Long-term and short-term dietary studies (100 days to 2.5 years), 
evaluated in the aforementioned FAO/WHO reports, demonstrated that 
dietary consumption at levels of up to 3% in the diets of rats, mice 
and dogs caused no substantial toxicological effects. An acceptable 
daily intake (ADI) of SOEs for humans was estimated 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. In studies with rats and humans, it was demonstrated 
that SOEs were rapidly hydrolyzed and absorbed by the body. In 
addition, the National Toxicology Program lists the octanoic acid oral 
LD50 for rats as 10,080 mg/kg (Reference 1). The 
information/data described above supports waivers from the data 
requirements for acute oral toxicity studies. The Agency concludes that 
SOEs have extremely low toxicity. Classification: Acceptable; Toxicity 
Category IV for the manufacturing-use product and end-use product.

[[Page 60149]]

    4. Acute dermal toxicity waiver (OPPTS 870.1200, 152-11) 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 addition, publically available 
sources list the octanoic acid dermal LD50 for rabbits as > 
5,000 mg/kg (Reference 1). Classification: Acceptable; Toxicity 
Category IV for the manufacturing-use product and end-use product.
    5. Acute inhalation toxicity waiver (OPPTS 870.1300, 152-12) 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 (References 2, 3, and 5). 
Classification: Acceptable; Toxicity Category IV for the manufacturing-
use product and end-use product.
    6. Hypersensitivity study waiver (OPPTS 870.2600, 152-15) MRID 
444158-04: No hypersensitivity incidents (152.16) have been reported 
for laboratory workers regularly exposed to SOEs for up to 6 years. 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.
    7. Genotoxicity and Mutagenicity waiver (OPPTS 870.5300, 870.5195; 
152-17, and 152-19) 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 are not genotoxic and/or mutagenic, nor is the 
a.i. structurally and/or chemically similar to known mutagens or known 
classes of mutagens (References. 2, 3, and 5). In addition, a study 
reported by the National Toxicology Program shows octanoic acid to be 
negative for genotoxicity/mutagenicity (Reference 1). Classification: 
Acceptable.
    8. Immune response and other Subdivision M toxicity data waivers 
(OPPTS 880.3800 through 870.4200, 152-18 through 152-29) MRID 444158-03 
and Amendment number 1: Due to the low toxicity of SOEs (as 
demonstrated in the cited open technical literature (References 2, 3, 
4, 5, and 6), the Agency granted waivers from all other Subdivision M 
toxicity data requirements, including the 90-day feeding and 
teratogenicity studies. In addition, octanoic acid is considered a 
nonteratogenic compound even at the very high dose rate of 18.75 
millimoles/kg (Reference 1).

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 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 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 (References. 2, 3, and 5). There are no 
reasonably foreseeable circumstances in which the residue levels of 
SOEs would ever approach this amount. Sucrose octanoate esters break 
down into their natural constituents (sugar and fatty acids) shortly 
after application. The foliar application rate for the product would be 
at a volume to volume rate of 0.32% to 0.40% (Reference 7) for the 
a.i.. Likewise the a.i. use rate when applied to honey bees would be 
0.25%, and would range from 0.5% to 1.0% when treating mushroom growing 
media. In studies with rats and humans, it was demonstrated that SOEs 
were rapidly hydrolyzed and absorbed by the body (Reference 5). Because 
SOEs are the mono-, di- and tri-esters of sucrose with fatty acids and 
are derived from sucrose (sugar) and edible tallow or edible vegetable 
oils, there is a great likelihood of exposure in the normal human diet 
to SOEs and SOEs' components for most, if not all individuals, 
including infants and children. Sucrose octanoate esters are a sucrose 
fatty acid ester, and sucrose fatty acid esters are a normal part of 
the human diet. Thus SOEs 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 SOEs, which have been FDA-approved food emulsifiers 
and post-harvest protective fruit coatings since 1983. Even if there is 
a significant increase in exposure to SOEs due to their use as a 
pesticide, the acute toxicity information and data available from the 
National Toxicology Program and submitted by the registrant 
demonstrating extremely low mammalian toxicity (Toxicity Category IV) 
indicate that risk associated with acute exposures by the oral, dermal 
and inhalation routes would be low to non-existent.
    2. Drinking water exposure. No drinking water exposure is expected, 
as SOEs are not soluble in water, do not persist in the environment, 
and are biodegradable within approximately five days at approximately 
20-27[deg]C, in both aerobic and anaerobic conditions (Reference 5). 
Because SOEs have extremely low toxicity, have been approved for food 
use by FDA, and are present as direct food additives in many foods, 
should exposure through drinking water occur, no risk is anticipated.

B. Other Non-Occupational Exposure

    The potential for non-dietary exposure to SOEs residues for the 
general population, including infants and children, is unlikely because 
potential use sites are commercial, agricultural, and large-scale 
horticultural. Sucrose octanoate esters' constituent sugars and fatty 
acids are normal parts of the human diet. Sucrose octanoate esters' 
toxicity has been determined to be extremely low (except via the ocular 
exposure route). Therefore, while there exists a great likelihood of 
prior exposure for most, if not all, individuals to both SOEs and SOEs' 
components, any increased exposure due to the proposed products would 
be negligible because the product would very likely be degraded to 
sugars and fatty acids and/or consumed by microorganisms before the 
general public would come in contact with treated plants or food 
products from treated plants.

VI. Cumulative Effects

    The Agency has considered the cumulative effects of SOEs and other 
substances in relation to a common mechanism of toxicity. These 
considerations include the possible cumulative effects of such residues 
on infants and children. There is no indication of mammalian toxicity 
from the submitted information/data (except by the ocular route of 
exposure) for SOEs. Therefore, no adverse cumulative effects are 
expected.

VII. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. There is a reasonable certainty that no harm 
will result from aggregate exposure to residues of SOEs to the U.S. 
population. This includes all anticipated dietary exposures and all 
other exposures for which there is reliable information. The Agency has 
arrived at this conclusion based on the extremely low levels of 
mammalian toxicity associated with

[[Page 60150]]

SOEs (except for risk from ocular exposure, which will be mitigated via 
precautionary label language). Sucrose octanoate esters have extremely 
low toxicity (LD50 >20,000 mg/kg in laboratory studies of 
oral exposure), and it is unlikely that any toxic effects will result 
from exposure to SOEs via the oral, dermal or inhalation pathways when 
the products are used according to proposed label directions (Reference 
5). The amount of SOEs applied to food crops is many orders of 
magnitude lower than the concentrations of SOEs needed to cause 
toxicological effects. Because the worst case scenario exposure is far 
below the level of any dietary toxicity known for SOEs or their 
components and degradates, EPA has determined that residues will not 
pose a dietary risk under reasonably foreseeable circumstances and that 
the setting of a tolerance exemption is appropriate.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
apply an additional ten-fold margin of exposure (safety) for infants 
and children in the case of threshold effects to account for pre-natal 
and post-natal toxicity and the completeness of the data base unless 
EPA determines that a different margin of exposure (safety) will be 
safe for infants and children. Margins of exposure (safety) are often 
referred to as uncertainty (safety) factors. In this instance, based on 
all the available information, the Agency concludes that SOEs are 
practically non-toxic to mammals, including infants and children 
(except via ocular exposure). Thus, there are no threshold effects of 
concern, and so the provision requiring an additional margin of safety 
does not apply. Further, the provisions of consumption patterns, 
special susceptibility, and cumulative effects do not apply. As a 
result, EPA has not used a margin of exposure (safety) approach to 
assess the safety of SOEs.

VIII. 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, SOEs 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 SOEs. It is an FDA-approved direct 
food additive comprised of sugars and fatty acids, having an ADI of 16 
mg/kg body weight/day. To date, there is no evidence to suggest that 
SOEs affect the immune system, function in a manner similar to any 
known hormone, or that they act 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 SOEs' low mammalian toxicity (except by ocular 
exposure). For the same reasons, the Agency has concluded that an 
analytical method is not required for enforcement purposes for SOEs.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels (MRLs) established for 
residues of SOEs.

IX. Conclusions

    Based on the toxicology information/data submitted and publically 
available, there is a reasonable certainty that no harm will result 
from aggregate exposure of residues of SOEs to the U.S. population, 
including infants and children, under reasonably foreseeable 
circumstances, when the biochemical pesticide is used in accordance 
with good agricultural practices. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. The Agency has arrived at this conclusion based on the 
information/data submitted and publically available data demonstrating 
no toxicity, except from ocular exposure. Potential risk from ocular 
exposure will be effectively addressed under FIFRA by mitigating 
precautionary label language. As a result, EPA establishes an exemption 
from the tolerance requirements pursuant to FFDCA 408(c) and (d) for 
residues of SOEs in or on all food commodities.

X. 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 of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) 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), as was provided in the old FFDCA sections 408 and 409. 
However, the period 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 OPP-2002-0016 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 November 
25, 2002.
    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

[[Page 60151]]

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 (1900C), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your written request to 
the Office of the Hearing Clerk in Rm. 104, Crystal Mall  2, 
1921 Jefferson Davis Hwy., Arlington, VA. 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 (703) 603-0061.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket ID number OPP-2002-0016, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services 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 Unit I.B.2. You may also send an electronic copy of 
your request via e-mail to: [email protected]. 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).

XI. 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. 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.
    3. 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.
    4. Barrington, A. Waiver request; July 12, 2002.
    5. USEPA. Science review in support of registration of sucrose 
octanoate esters. R.S. Jones to D. Greenway; February 14, 2000.
    6. USEPA. Sucrose octanoate esters; A request for concurrence on a 
decision to waive the requirement for 90-day feeding (152-20) and 
teratogenicity (152-23) studies, based on the Registrant's 
correspondence of July 12, 2002. D. Greenway to R. S. Jones; August 7, 
2002.
    7. Barrington, A. Sucrose octanoate esters - per-acre application 
rates; July 12, 2002.

XII. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 FFDCA section 408(d), 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 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

[[Page 60152]]

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 FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 11, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.

    2. Section 180.1222 is added to subpart D to read as follows:


Sec.  180.1222  Sucrose octanoate esters; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of sucrose octanoate esters [([alpha]-D-glucopyranosyl-[beta]-
D-fructofuranosyl-octanoate), mono-, di-, and triesters of sucrose 
octanoate] in or on all food commodities when used in accordance with 
good agricultural practices.
[FR Doc. 02-24224 Filed 9-24-02; 8:45 am]
BILLING CODE 6560-50-S