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Notice of Filing Pesticide Petitions to Establish Tolerances 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: May 23, 2000 (Volume 65, Number 100)]
[Notices]
[Page 33318-33322]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my00-51]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-941; FRL-6557-1]


Notice of Filing Pesticide Petitions to Establish Tolerances 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 a pesticide
petition

[[Page 33319]]

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-941, must be
received on or before June 22, 2000.

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. To ensure
proper receipt by EPA, it is imperative that you identify docket
control number PF-941 in the subject line on the first page of your
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Sheila Moats, EPA
Biopesticides and Pollution Prevention Division (7505C), Office of
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg.,
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number:
(703) 308-1259; e-mail address: moats.sheila@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 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'' 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-941. 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.

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-941 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 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 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number PF-941. 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 under FOR FURTHER INFORMATION
CONTACT.

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.

[[Page 33320]]

    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 this petition contains 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 support granting of the petitions. Additional data
may be needed before EPA rules on the petitions.

List of Subjects

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

    Dated: May 4, 2000.
Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

Summaries of Petitions

    The 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 petitioner and represents the view
of the petitioner. The petition summaries announce 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. Natural Plant Products S.A.

0F6073

    EPA has received a pesticide petition 0F6073 from Natural Plant
Products S.A., Route d'Artix, B.P. 80, 64150 Nogueres, France,
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
biochemical pesticide Geraniol [3,7-dimethyl-[E]-2,7-octadien-1-ol] in
or on all raw agricultural commodities (RACs).
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Natural Plant Products S.A. has submitted the following summaries of
information, data, and arguments in support of their pesticide
petitions. The summaries were prepared by Natural Plant Products S.A.
and EPA has not fully evaluated the merits of the pesticide petitions.
The summaries may have been edited by EPA, if the terminology used was
unclear, the summaries contained extraneous material, or the summaries
unintentionally made the reader conclude that the findings reflected
EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

    Geraniol will be incorporated into the end-use product Biomite as
an active ingredient. Biomite is proposed for use as a foliar spray for
the control of Tetranychid mites on a variety of agricultural and
greenhouse crops. The product is used at the first appearance of spider
mite activity on a particular crop, subsequent applications are made as
required but not sooner than every 7 days. The application rates of 76
oz in 200 gallons to 20 oz in 50 gallons/per acre equate to 0.085--
0.315 oz of Geraniol per acre.

B. Product Identity/Chemistry

    Geraniol is a Monoterpene alcohol which is found in over 250
essential oils, and as a semiochemical in more than 14 species of
insects encompassing 7 families from 5 orders. It is a colorless to
pale yellow oily liquid with a sweet, rose odor. Geraniol is listed at
40 CFR 152.25(g) as a minimum risk pesticide active ingredient.

C. Mammalian Toxicological Profile

    The toxicological profile of Geraniol is, acute oral two studies
LD50 3.6 grams/kilograms (g/kg) and 4.8 g/kg in rats: acute
dermal LD50 greater than 5.0 g/kg. Chronic oral toxicity,
1,000 parts per million (ppm) fed to rats daily for 16 weeks produced
no effects; 1,000 ppm fed to rats daily for 28 weeks produced no
effects. Geraniol exhibited severe primary skin irritation in rabbits
100 milligrams (mg)/24 hr.; humans 16 mg/48 hr.; Guinea pigs 100 mg/24
hr. but was non-irritating to miniature pigs at 50 mg in the Draize
test. Geraniol is a sensitizer although it exhibits relatively weak and
variable responses. Geraniol when tested at doses up to 100 micrograms
against Salmonella typhimurium TA 97 and TA 102 exhibited no
mutagenicity. Geraniol was granted generally recognized as safe (GRAS)
status by FEMA in 1965, and is approved as GRAS by the Food and Drug
Administration (FDA) when used as a synthetic flavoring and adjuvant
for direct addition to food for human consumption.
    Waivers are being requested for genotoxicity, reproductive and
developmental toxicity, sub-chronic toxicity and acute toxicity to non-
target species based on Geraniol's ubiquity in nature, long history of
use in the fragrance industry and as a flavoring in alcoholic and non-
alcoholic beverages, ice cream, candies and baked good etc., favorable
toxicological profile in chronic toxicological studies, and the
inconsequential exposure resulting from the label-directed use rates.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Current dietary exposure to Geraniol
occurs from its use as a flavoring agent and adjuvant in food and
beverages (0.8 ppm--11 ppm). Considering the low dose of Geraniol
required to achieve the desired effect and the levels of Geraniol found
in processed food and beverages, it can be concluded that incremental
dietary exposure from the proposed use on agricultural and greenhouse
crops is insignificant.
    ii. Drinking water. Geraniol residues in drinking water are
expected to be minimal from the proposed uses due to the low
application rate, insolubility in water, and the expected rapid
biodegradation in the soil.
    2. Non-dietary exposure. Geraniol is used to the approximate annual
amount of 800,000 lbs as a fragrance component in the manufacture of
detergents, soaps, creams, lotions, perfumes, and aromatherapy
products. Geraniol is also a component of the floral blend used as a
lure in Japanese beetle traps. In the seven currently registered
Japanese beetle traps, the Geraniol is present at a loading of 2.84--
10.70%. The contribution to non-dietary exposure of Geraniol through
the use of Biomite is not expected to pose any risk.

E. Cumulative Exposure

    It is not expected that Geraniol when used as proposed would result
in residues that would remain in human food items at levels which would
be of toxicological concern. Because of the low inherent toxicity, low
agricultural use rates (compared with flavor and fragrance amounts) no
cumulative effects with other substances that might have a common
mechanism of toxicity are anticipated.

[[Page 33321]]

F. Safety Determination

    1. U.S. population. The use of products containing Geraniol, which
is of low toxicity and used in low concentrations is compatible with
the Agency's objectives to register reduced risk pesticides. The
application of a volatile Terpenoid alcohol at the label-directed rates
is expected to result in negligible residues that are of no
toxicological concern, and therefore exposure and risk to the general
U.S. population from these proposed agricultural uses is not
anticipated.
    2. Infants and children. Geraniol is ubiquitous in foodstuffs
beverages, in soaps, detergents, and creams and hence the proposed
agricultural uses pose no threat to infants and children. In fact, as
the Geraniol-containing biopesticide product replaces existing
miticides with less favorable toxicological profiles risk to infants
and children will be reduced.

G. Effects on the Immune and Endocrine Systems

    Oral chronic toxicity studies and mutagenicity studies have been
cited above. There is no literature available to suggest that immune or
endocrine systems will be compromised by the use of Geraniol as an
active ingredient in a biochemical pest control agent used at the
label-directed rates.

H. Existing Tolerances

    There are no known existing tolerances for the use of Geraniol as a
pesticide.

I. International Tolerances

    The Council of Europe listed Geraniol in 1970 giving it an
allowable daily intake (ADI) of 5 milligrams/kilograms bodyweight/day.

2. Natural Plant Products S.A.

0F6145

    EPA has received a pesticide petition 0F6145 from Natural Plant
Products S.A., Route d'Artix, B.P. 80, 64150 Nogueres, France,
proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d),
to amend 40 CFR part 180 to establish an exemption from the requirement
of a tolerance for biochemical pesticide Citronellol [3,7-dimethyl-6-
octen-1-ol] in or on all raw agricultural commodities.

A. Product Name and Proposed Use Practices

    Citronellol will be incorporated into the end-use product Biomite
as an active ingredient. Biomite is proposed for use as a foliar spray
for the control of Tetranychid mites on a variety of agricultural and
greenhouse crops. The product is used at the first appearance of spider
mite activity on a particular crop, subsequent applications are made as
required but not sooner than every 7 days. The application rates of 76
oz in 200 gallons to 20 oz in 50 gallons/per acre equate to 0.085--
0.315 oz of Citronellol per acre.

B. Product Identity/Chemistry

    Citronellol is a Monoterpene alcohol which is found in over 30
essential oils, and as a semiochemical in the spider mite Tetranychus
urticae, the Formicine ant Lasius alienus and the bumble bee Pyrobombus
pratorum. Citronellol also occurs in black currants, certain other
fruits, wines, beer and black tea. It is a colorless to pale yellow
oily liquid with a sweet, rose, leather, musty, floral odor. It is
insoluble in water.

C. Mammalian Toxicological Profile

    The toxicological profile of Citronellol is, acute oral
LD50 3.45 g/kg in rats: acute dermal LD50 2.65 g/
kg (rabbit). Citronellol exhibited severe primary skin irritation in
rabbits and Guinea pigs (100 mg/24 hr) and moderate to humans (16 mg/48
hr). Citronellol when tested at doses up to 100 micrograms against
Salmonella typhimurium TA 97 and TA 102 exhibited no mutagenicity.
Citronellol has GRAS status at 21 CFR 172.515 when used as a synthetic
flavoring and adjuvant for direct addition to foods for humans. Waivers
are being requested for genotoxicity, reproductive and developmental
toxicity, sub-chronic toxicity and acute toxicity to non-target species
based on Citronellol's ubiquity in nature, long history of use in
cosmetics, fragrance, detergent, and household cleaners, its natural
occurrence in fruit and beverages, its wide use as a synthetic
flavoring agent and adjuvant, and the inconsequential exposure
resulting from the label-directed use rates.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Current dietary exposure to
Citronellol occurs from its natural occurrence in fruits and beverages,
and its use as a flavoring agent and adjuvant in food and beverages.
Considering the low dose of Citronellol required to achieve the desired
effect and the levels of Citronellol found in natural and processed
food and beverages, it can be concluded that incremental dietary
exposure from the proposed use on agricultural and greenhouse crops is
insignificant.
    ii. Drinking water. Citronellol residues in drinking water are
expected to be minimal from the proposed uses due to the low
application rate, insolubility in water, and the expected rapid
biodegradation in the soil.
    2. Non-dietary exposure. Citronellol is widely used as a fragrance
component in the manufacture of detergents, soaps, creams, lotions,
perfumes, and aromatherapy products. Citronellol is also a component of
Citronella oil used in candles, sprays, oils, lotions, and towelettes
as a repellent for mosquitoes and other flying insects. Currently there
are 31 active pesticide registrations containing Citronella oil.
Citronellol is also contained in lemongrass oil, an active ingredient
in two currently registered repellents. The contribution to non-dietary
exposure of Citronellol through the use of Biomite is not expected to
pose any risk.

E. Cumulative Exposure

    It is not expected that Citronellol when used as proposed would
result in residues that would remain in human food items at levels
which would be of toxicological concern. Because of the low inherent
toxicity, low agricultural use rates no cumulative effects with other
substances that might have a common mechanism of toxicity are
anticipated.

F. Safety Determination

    1. U.S. population. The use of products containing Citronellol,
which is of low toxicity and used in low concentrations is compatible
with the Agency's objectives to register reduced risk pesticides. The
application of a volatile Terpenoid alcohol at the label-directed rates
is expected to result in negligible residues that are of no
toxicological concern, and therefore, exposure and risk to the general
U.S. population from these proposed agricultural uses, is not
anticipated.
    2. Infants and children. Citronellol is ubiquitous in foodstuffs
and beverages, and in soaps, detergents and creams and hence the
proposed agricultural uses pose no threat to infants and children. In
fact, as the Citronellol-containing biopesticide product replaces
existing miticides with less favorable toxicological profiles risk to
infants and children will be reduced.

G. Effects on the Immune and Endocrine Systems

    Mutagenicity studies have been cited above. There is no literature
available to suggest that immune or endocrine systems will be
compromised by the use of Citronellol as an active ingredient in a
biochemical pest control agent used at the label-directed rates.

[[Page 33322]]

H. Existing Tolerances

    There are no known existing tolerances for the use of Citronellol
as a pesticide.

I. International Tolerances

    The Council of Europe listed Citronellol in 1970 giving it an
allowable daily intake (ADI) of 5 milligrams/kilograms bodyweight/day.

[FR Doc. 00-12961 Filed 5-22-00; 8:45 am]
BILLING CODE 6560-50-F

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