Notice of Filing Pesticide Petitions To Establish a Tolerance for Certain Pesticide Chemicals in or on Food

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: September 9, 1999 (Volume 64, Number 174)]
[Notices]
[Page 49010-49014]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se99-52]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-892; FRL-6095-9]

Notice of Filing Pesticide Petitions To Establish a Tolerance for
Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-892, must be
received on or before October 12, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To
ensure proper receipt by EPA, it is imperative that you identify docket
control number PF-892 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT: By mail: The Regulatory Action
Leader, Biopesticides and Pollution Prevention Division (7511C), Office
of Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460 listed in the table below:

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Office location/telephone
Regulatory Action Leader number Address Petition number
----------------------------------------------------------------------------------------------------------------
Denise Greenway..................... 9th Floor, CM #2, 703-308- 1921 Jefferson Davis PP 8E4926
8263, e-mail: Hwy, Arlington, VA
greenway.denise@epa.gov.
Diana Horne......................... 9th Floor, CM #2, 703-308- Do. PP 9F6027
8367, e-mail:
horne.diana@epa.gov.
----------------------------------------------------------------------------------------------------------------

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 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 in the ``FOR FURTHER INFORMATION
CONTACT'' section.

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'' 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/.
2. In person. The Agency has established an official record for
this action under docket control number PF-892. The official record
consists of the documents specifically referenced in this action, any
public comments received during an applicable comment period, 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 Highway, 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.

[[Page 49011]]

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or
electronically. To ensure proper receipt by EPA, it is imperative that
you identify docket control number PF-892 in the subject line on the
first page of your response.
1. By mail. Submit your comments to: Public Information and Records
Integrity Branch (PIRIB), Information Resources and Services Division
(7502C), Office of Pesticide Programs (OPP), Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.
2. In person or by courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Information Resources
and Services Division (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
PIRIB telephone number is (703) 305-5805.
3. Electronically. You may submit your comments electronically by
E-mail to: ``opp-docket@epa.gov ,'' or you can submit a computer disk
as described above. Do not submit any information electronically that
you consider to be CBI. Avoid the use of special characters and any
form of encryption. Electronic submissions will be accepted in
Wordperfect 5.1/6.1 or ASCII file format. All comments in electronic
form must be identified by docket control number PF-892. Electronic
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want To Submit to the Agency?

Do not submit any information electronically that you consider to
be CBI. You may claim information that you submit to EPA in response to
this document as CBI 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. In addition to one complete
version of the comment that includes any information claimed as CBI, a
copy of the comment that does not contain the information claimed as
CBI must be submitted for inclusion in the public version of the
official record. Information not marked confidential will be included
in the public version of the official record without prior notice. If
you have any questions about CBI or the procedures for claiming CBI,
please consult the person identified in the ``FOR FURTHER INFORMATION
CONTACT'' section.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you
used that support your views.
4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Make sure to submit your comments by the deadline in this
notice.
7. To ensure proper receipt by EPA, be sure to identify the docket
control number assigned to this action in the subject line on the first
page of your response. You may also provide the name, date, and Federal
Register citation.

II. What Action Is the Agency Taking?

EPA has received pesticide petitions as follows proposing the
establishment and/or amendment of regulations for residues of certain
pesticide chemicals in or on various food commodities under section 408
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these petitions contain data or information
regarding the elements set forth in section 408(d)(2); however, EPA has
not fully evaluated the sufficiency of the submitted data at this time
or whether the data supports granting of the petition. Additional data
may be needed before EPA rules on the petition.

List of Subjects

Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

Dated: August 30, 1999.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide petitions are printed below
as required by section 408(d)(3) of the FFDCA. The summaries of the
petitions were prepared by the petitioners and represent the views of
the petitioners. EPA is publishing the petition summaries verbatim
without editing them in any way. The petition summary announces the
availability of a description of the analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.

1. AVA Chemical Ventures, L.L.C.

PP 8E4926

EPA has received a pesticide petition (PP 8E4926) from AVA Chemical
Ventures, L.L.C., 65 Aviation Avenue, Portsmouth, New Hampshire, 03801
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. 346a, to amend 40 CFR part 180 by establishing
an exemption from the requirement of a tolerance for residues of
sucrose fatty acid esters in or on all food commodities. Pursuant to
section 408(d)(2)(A)(i) of the FFDCA, as amended, AVA Chemical
Ventures, L.L.C. has submitted the following summary of information,
data, and arguments in support of their pesticide petition.

A. Proposed Use Practices

Sucrose octanoate fatty acid esters made with caprylic acid derived
from 21 CFR-approved edible fats and oils are contact insecticides that
are effective against whiteflies, aphids, mites, thrips and other soft-
bodied insects. The mode of action is physical, whereby the surfactant
effect of sucrose octanoate fatty acid esters de-waxes the cuticle of
the target insect, causing it to dessicate.
Sucrose octanoate fatty acid esters are sprayed in a water solution
at the rate of 0.2-0.5% volume/volume throughout the growing season at
intervals of 3-10 days, as needed, to control soft-bodied insects.
Treatments are applied up to 2 days before harvest.

B. Product Identity/Chemistry

Sucrose octanoate fatty acid esters are manufactured by the
transesterification of sucrose and a caprylic fatty acid ester derived
from an edible oil or fat in the presence of a polar solvent, such as
dimethylsulfoxide (DMSO). Mono-, di-, and tri-esters of sucrose are
formed (i.e., sucrose octanoate, sucrose dioctanoate and sucrose
trioctanoate). The crude transesterification product is purified in a
series of unit operations that may include vacuum distillation,
filtration and liquid-liquid extraction. The resulting material is a
high quality non-ionic surfactant.

[[Page 49012]]

C. Toxicological Profile

Sucrose fatty acid esters derived from edible vegetable oils,
edible tallow or hydrogenated edible tallow were approved in 1983 by
the Food and Drug Administration (FDA) for use as emulsifiers in
certain foods and as post-harvest protective coatings for certain
fruits (21 CFR 172.859). The range of foods in which use of sucrose
fatty acid esters is permitted was expanded by the FDA in 1995. Since
the initial approval for food use of sucrose fatty acid esters was
granted in Japan in 1959, other major regulatory bodies, including the
World Health Organization (WHO), have granted similar approvals.
Toxicological studies were conducted in connection with the above-
referenced approvals of sucrose fatty acid esters for use as food
emulsifiers. AVA Chemical Ventures, L.L.C. has reviewed these
toxicological studies and summaries are presented below.
1. Acute toxicity. Sucrose fatty acid esters and sucroglycerides
were evaluated by the WHO for acceptable daily intake (ADI) for man in
1969, 1973, 1976, and 1980.
WHO Food Additive Series No. 15 (1980), titled, ``Toxicological
Evaluation of Certain Food Additives,'' reports on the results of
sucrose fatty acid esters administered in short-term feeding studies of
dogs and a long-term feeding study of rats. No effects attributable to
the ingestion of sucrose fatty acid esters were found in any of the
studies. The WHO concluded the ingestion level causing no toxicological
effect in rat to be 10,000 parts per million (ppm) (1.0%) in the diet,
equivalent to 500 milligrams/kilograms (mg/kg) of body weight (bwt).
The estimate of ADI for man was 0-10 mg/kg of bwt.
Primary skin irritation and primary eye irritation studies
performed on rabbits by AVA Chemical Ventures, L.L.C. with
Manufacturing Use Product (MUP) and End Use Product (EUP) sucrose
octanoate fatty acid esters have been submitted to EPA. The MUP was
found to be slightly irritating to the skin and severely irritating to
the eye. The EUP was found to be slightly irritating to the skin and to
cause substantial but temporary eye injury.
2. Genotoxicity. The components of sucrose octanoate fatty acid
esters (sucrose and caprylic acid) already have regulatory approval and
are commonly consumed as foods or food components. Caprylic acid
(octanoic acid) is obtained from coconut oil or palm oil where it is
present in concentrations of 7.5% and 3.3%, respectively. Caprylic acid
(octanoic acid) is approved by the FDA as a generally recognized as
safe (GRAS) substance and direct food additive (21 CFR 184.1025 and 21
CFR 172.860)
3. Reproductive and developmental toxicity. In 1976, in WHO Food
Additive Series No. 10, the WHO reported on the results of a
reproduction study over three generations of rats using sucrose fatty
acid esters at 0 and 1% of the diet for control and test groups,
respectively. Mean litter size, physical appearance and growth of
litter were comparable among test and control groups.
4. Subchronic toxicity. WHO Food Additive Series No. 15 (1980)
reports the findings of a study in which sucrose fatty acid esters made
from beef tallow were fed to beagle dogs at concentrations of 3,000,
10,000 or 30,000 ppm for 26-weeks. A control group was fed an identical
diet with the exception of the sucrose fatty acid esters. Body weight
changes, food intake and water consumption were not affected by the
administration of the esters. The opthalmic and haemotologic
examinations, urinalysis, organ weights and macroscopic examinations
revealed no adverse effects which could be attributed to the intake of
the sucrose fatty acid esters. The blood chemistry studies showed that
the majority of parameters measured were within acceptable limits.
5. Chronic toxicity. An unpublished paper titled, ``Study of
Chronic Toxicity of a Sucrose Ester of Fatty Acids'' (undated) was
submitted to the FDA in connection with the registration of sucrose
fatty acid esters for use as food additives. For up to 76 weeks mice
and rats were fed standard feed to which had been added up to 3.0%
sucrose fatty acid esters. Animals were examined for body weight, feed
consumption, hematological findings, organ weights and histopathology
of organs. No particular changes resulting from administration of
sucrose fatty acid esters were found.
6. Animal metabolism. Sucrose fatty acid esters are derived from
fatty acids produced from 21 CFR-approved edible fats and oils. Ethyl
alcohol and butanol, two of the solvents used to produce sucrose
octanoate fatty acid esters, are exempted from the requirement of a
tolerance under 40 CFR 180.1001(c). DMSO, the other solvent used to
produce sucrose octanoate fatty acid esters, is approved for use in the
manufacture of food-grade sucrose fatty acid esters under 21 CFR
172.859.
7. Metabolite toxicology. The components of sucrose octanoate fatty
acid esters (sucrose and caprylic acid) already have regulatory
approval and are commonly consumed as foods or food components.
Caprylic acid (octanoic acid) is obtained from coconut oil or palm
kernal oil where it is present at concentrations of 7.5% and 3.3%,
respectively. Caprylic acid (octanoic acid) is approved by the FDA as a
GRAS substance and direct food additive (21 CFR 184.1025 and 21 CFR
172.860).
8. Endocrine disruption. Sucrose fatty acid esters are not derived
from nor contain any compounds which are known to be, or suspected to
be, endocrine disruptors. Sucrose fatty acid esters are derived from a
variety of 21 CFR-approved edible fats and oils.

D. Aggregate Exposure

AVA Chemical Ventures, L.L.C. believes that sufficient data exist
to assess the hazards of sucrose fatty acid esters and to make a
determination on aggregate exposure, consistent with section 408(c)(2),
for an exemption from the requirement of a tolerance. Such data were
submitted to the FDA prior to that agency's approval of sucrose fatty
acid esters for use as an emulsifier in foods and as fruit coatings.
1. Dietary exposure from food and feed uses, drinking water and
non-dietary exposure-- i. Dietary exposure. Sucrose fatty acid esters
made from 21 CFR-approved edible fats and oils and conforming to 21 CFR
172.860 are approved for use as food emulsifiers and as fruit coatings
(21 CFR 172.859). They are also approved for food use in Europe and by
the WHO Joint Expert Committee on Food Additives, with an acceptable
daily intake (ADI) of 10 mg/kg body weight/day. Current world
consumption in food applications is estimated to be 5,000 metric tons.
Pesticide use would increase usage by approximately 1,000 metric tons,
much of which will biodegrade prior to consumption of the crops to
which it is applied.
ii. Drinking water. No drinking water exposure is anticipated as
sucrose fatty acid esters are not soluble in water and biodegrade
rapidly following use.
iii. Non-dietary exposure. Non-occupational, non-dietary exposure
is highly unlikely given that the inhalation potential or dermal
absorption of these substances are not feasible.

E. Cumulative Exposure

Sucrose octanoate fatty acid esters are non-toxic materials made
from edible starting materials (sucrose and caprylic acid), which are
commonly consumed as foods or food components. Sucrose fatty acid
esters also biodegrade rapidly following use. A cumulative risk
assessment is therefore not necessary.

F. Safety Determination

1. U.S. population. Sucrose fatty acid esters derived from edible
fats and oils

[[Page 49013]]

are approved for use as food emulsifiers and as fruit coatings under 21
CFR 172.859. The components of sucrose octanoate fatty acid esters
(sucrose and caprylic acid) are commonly consumed as foods or food
components.
Based on these materials' low-risk profiles, there is reasonable
certainty that no harm to the U.S. population will result from
aggregate exposure to sucrose fatty acid esters.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Margins of safety are incorporated into EPA risk assessments
either directly or through the use of margin of exposure analysis
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans.
Due to the extensive toxicology data base that exists for the
sucrose fatty acid esters, their widespread approval for use as food
emulsifiers and as a component in protective coatings applied to
fruits, as well as the fact that their starting materials are edible
food commodities, AVA Chemical Ventures, L.L.C. does not believe a
safety factor analysis is necessary in assessing the risk of these
compounds. For the same reason, we believe an additional safety factor
analysis is unnecessary.

G. Analytical Method

An analytical method for residues is not applicable as this
petition proposes an exemption from the requirement of a tolerance.

H. Existing Tolerances

Sucrose fatty acid esters derived from edible fats and oils are
approved for use as food emulsifiers and as fruit coatings under 21 CFR
172.859. Sucrose fatty acid esters are approved for use as food
emulsifiers in Europe under E-470 and by the Joint FAO/WHO Expert
Committee on Food Additives at an ADI of 10 mg/kg bwt/day.
There are no known approved CODEX maximum residue levels (MRLs)
established for residues of sucrose fatty acid esters.

I. Conclusion

Based on the information and data considered, AVA Chemical
Ventures, L.L.C. proposes that sucrose fatty acid esters derived from
edible fats and oils be exempted from the requirement of a tolerance in
or on all food commodities, when used as an insecticide in accordance
with good agricultural practices.

2. EDEN Bioscience Corporation

PP 9F6027

A. Proposed Use Practices

EPA has received a pesticide petition PP 9F6027, from EDEN
Bioscience Corporation, 11816 North Creek Parkway N., Bothell, WA
98011-8205, proposing pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180 to establish an exemption from the requirement of a tolerance for
the biochemical pesticide Harpin protein in or on all food crops.
The commercial name for the end product containing harpin is
Messenger <greek-T><greek-M>. The product uses include the management
of plant diseases, the significant improvement in growth and yields,
and the suppression of certain insects and other pests.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Harpin is
a protein that is derived from and is chemically identical to a protein
produced by a bacterium that is commonly found in nature. The harpin
protein is an acidic, heat-stable, cell envelope associated protein
with a molecular weight of about 40 kilodaltons. The protein consists
of approximately 400 amino acid residues with no Cysteine. Harpin is
characterized by its mobility on polyacrylamide SDS gel and high
performance liquid chromotography (HPLC), and by laser desorption mass
spectrometry.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. No residues of harpin protein are expected to
occur at the time of harvest, as this proposes an exemption from the
requirement of a tolerance.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. This
notice proposes an exemption from the requirement of a tolerance, and
thus no analytical method is required.

C. Mammalian Toxicological Profile

Messenger exhibits little or no mammalian toxicity and studies
indicate that Messenger is a Toxicity Category IV substance. No
toxicity was observed in acute oral toxicity studies conducted with
Messenger. Acute oral and dermal toxicity LD<INF>50</INF> values for
Messenger were greater than 5,000 mg/kg in rat (Toxicity Category IV).
The LC<INF>50</INF> for Messenger was greater than 2 mg/L in an acute
inhalation study in rat. Messenger showed no effect in eye and dermal
irritation studies. For example, the dermal irritation index for
Messenger was zero at 500 mg and no eye irritation was shown in rabbit
at 100 mg. There have been no reported incidents of Messenger-induced
hypersensitivity in individuals exposed to Messenger during research,
production, and/or field testing and there are no published reports
indicating that harpin proteins are toxic. Further, the harpin protein
has a non-toxic mode of action by eliciting a systemic acquired
resistance response in plants, and it has been demonstrated that the
product has no direct antimicrobial effect on bacteria and fungi. Based
on these studies, EDEN Bioscience Corporation has concluded that harpin
poses no unique or additional risk to children or infants, and has
proposed an exemption from the requirement of a tolerance for harpin.

D. Aggregate Exposure

1. Dietary exposure-- i. Food. Messenger is applied at very low
rates of application (generally 2 to 7 grams of active ingredient per
acre). Because of the low use rates, no active ingredient residues are
detectable, using available methods, on treated crops even immediately
after application. Dietary exposure to harpin via consumption of
treated food or feed is very negligible, if any at all. The product's
other ingredients, which generally represent over 90% of the product,
consist of food grade substances or other such low risk compounds.
ii. Drinking water. The active ingredient of Messenger is highly
sensitive to very small amounts of chlorine as contained in many
municipal water systems. Therefore, residues of harpin are unlikely to
occur in drinking water or food, given the low application rate of the
product and its rapid degradation in soil and water.
2. Non-dietary exposure. The Company believes that the potential
for non-dietary exposure to the general population including infants
and children is unlikely as the proposed use sites are primarily
commercial, agricultural and horticultural settings and that non-
dietary exposures would not be expected to pose any quantifiable risks
due to lack of residues of toxicological concern. Increased non-dietary
exposure of harpin via lawn care, etc., is not considered likely
because of the low use rates and the lack

[[Page 49014]]

of persistence of the active ingredient in the environment.

E. Cumulative Exposure

Consideration of a common mode of toxicity is not appropriate,
given that there is no indication of mammalian toxicity of harpin
protein and no information that indicates that toxic effects would be
cumulative with any other compounds. Moreover, harpin does not exhibit
a toxic mode of action in its target pests or diseases.

F. Safety Determination

1. U.S. population. Harpin's lack of toxicity has been demonstrated
by the results of acute toxicity testing in mammals in which harpin
caused no adverse effects when dosed orally and via inhalation at the
limit dose for each study. Thus, the aggregate exposure to harpin over
a lifetime should pose negligible risks to human health.
2. Infants and children. Based on the lack of toxicity and low
exposure, there is a reasonable certainty that no harm to infants,
children, or adults will result from aggregate exposure to harpin
residues. Exempting harpin from the requirement of a tolerance should
pose no significant risk to humans or the environment.

G. Effects on the Immune and Endocrine Systems

EDEN Bioscience Corporation has no information to suggest that
harpin will adversely affect the immune or endocrine systems.

H. Existing Tolerances

There are no existing tolerances for harpin protein in the United
States.

I. International Tolerances

EDEN Bioscience Corporation is not aware of any tolerances,
exemptions from tolerance or MRL's issued for harpin protein outside of
the United States.

[FR Doc. 99-23414 Filed 9-8-99; 8:45 am]
BILLING CODE 6560-50-F

Notice of Filing Pesticide Petitions To Establish a Tolerance for Certain Pesticide Chemicals in or on Food

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