[Federal Register Volume 63, Number 184 (Wednesday, September 23, 1998)]
[Notices]
[Pages 50903-50906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25315]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-833; FRL-6026-1]
Notice of Filing of Pesticide Petitions
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 the docket control number PF-833, must
be received on or before October 23, 1998.
ADDRESSES: By mail submit written comments to: Public Information and
Records Integrity Branch (7502C), Information Resources and Services
Division, Office of Pesticides Programs,
[[Page 50904]]
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
In person bring comments to: Rm. 119, CM #2, 1921 Jefferson Davis
Highway, Arlington, VA.
Comments and data may also be submitted electronically to: docket@epamail.epa.gov. Follow the instructions under ``SUPPLEMENTARY
INFORMATION.'' No confidential business information should be submitted
through e-mail.
Information submitted as a comment concerning this document may be
claimed confidential by marking any part or all of that information as
``Confidential Business Information'' (CBI). CBI should not be
submitted through e-mail. Information marked as CBI will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2. A copy of the comment that does not contain CBI must be submitted
for inclusion in the public record. Information not marked confidential
may be disclosed publicly by EPA without prior notice. All written
comments will be available for public inspection in Rm. 119 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: The Regulatory Action Leader listed in
the table below:
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Office location/
Regulatory Action Leader telephone number Address
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Diana Horne................... 9th Floor, CM #2, 703- 1921 Jefferson
308-8367, e-mail: Davis Hwy,
[email protected] Arlington, VA
pa.gov.
Sheila A. Moats............... 9th Floor, CM #2, 703- Do.
308-1259, e-mail:
moats.sheila@epamail..
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SUPPLEMENTARY INFORMATION: 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.
The official record for this notice of filing, as well as the
public version, has been established for this notice of filing under
docket control number [PF-833] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The official record is located at the address in
``ADDRESSES'' at the beginning of this document.
Electronic comments can be sent directly to EPA at:
opp-docket@epamail.epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comment and data
will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number [PF-833] and appropriate petition number.
Electronic comments on this notice may be filed online at many Federal
Depository Libraries.
List of Subjects
Environmental protection, Agricultural commodities, Food additives,
Feed additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: September 8, 1998.
Kathleen D. Knox,
Acting 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. EDEN Bioscience Corporation
PP 8F4975
EPA has received a pesticide petition (PP) 8F4975 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, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to
establish an exemption from the requirement of a temporary tolerance
for the biological pesticide Harpin in or on all food commodities.
Harpin will be utilized on under the conditions of Experimental Use
Permit 69834-EUP-R.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, EDEN
Bioscience Corporation has submitted the following summary of
information, data and arguments in support of their pesticide petition.
This summary was prepared by EDEN Bioscience Corporation and EPA has
not fully evaluated the merits of the petition. The summary may have
been edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary was not clear that it
reflected the conclusion of the petitioner and not necessarily EPA.
A. Proposed Use Practices
The proposed experimental program will be conducted in Alabama,
Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa,
Idaho, Illinois, Kansas, Kentucky, Louisiana, Michigan, Minnesota,
Mississippi, Montana, North Carolina, North Dakota, New Jersey, New
Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, South
Dakota, Tennessee, Texas, Virginia, and Washington. The following crops
are to be treated: tomatoes (fresh market and processing), peppers
(bell and chile), cotton, cucurbits (cucumbers, squash, and melons),
rice, ornamental roses, ornamentals (greenhouse foliage and bedding
plants), strawberries, tobacco (burley and flue-cured), small grains
(winter or spring wheat and barley), peanuts, conifer seedlings,
alfalfa, potatoes, grapes (wine and table varieties), turf (lawn and
garden), apples, citrus (oranges, grapefruit, lemons, limes,
tangerines, and tangelos), soybeans (dry), blueberry, cranberry,
raspberry, corn, sweet corn, and sugar cane. The proposed experimental
program would utilize 559.98 pounds of
[[Page 50905]]
active ingredient per year on 4,997 acres during 1998-2000. Harpin will
be applied by various methods at a maximum rate of 0.06 pounds to 0.39
pounds active ingredient per acre per site during the season, depending
on the crop. For tomatoes and peppers, which represent the majority of
the acreage to be treated, all plants will be treated once or twice
prior to transplanting to the field, minimizing any potential
environmental impact of product application in the field. Application
methods may include seed treatments by soaking or dusting, root or
seedling drenches, drenches at transplanting and foliar sprays during
the growing season, with emphasis on pre-flowering applications.
Standard spray equipment is appropriate for foliar applications.
B. Product Identity/Chemistry
Harpin is a bacterial protein product that is produced by
fermentation. The harpin protein confers systemic resistance to
multiple diseases in numerous crops. The dried formulated product
containing harpin is MessengerTM. In addition to broad-
spectrum control of diseases caused by bacteria, fungi, and some
viruses, MessengerTM also provides enhanced plant growth in
many crops. Such enhancements include improved germination, increased
overall plant vigor, accelerated flowering and fruit set, advanced
maturity, and increased yield and quality of the final harvest.
MessengerTM may enhance plant growth in the absence of
detectable plant disease. Finally, treatment with
MessengerTM provides substantial tolerance to certain soil-
borne plant pathogens, reducing the need for toxic, conventional
chemical means of control.
An analytical method for residues is not applicable, since the
petitioner has requested an exemption from the requirement of a
tolerance.
C. Mammalian Toxicological Profile
Harpin is a naturally occurring protein derived from the plant
pathogenic bacterium, Erwinia amylovora, the causative agent for fire
blight disease. Because of its role in plant host-parasite
relationships, harpin is presumed to have been present in E. amylovora
for as long as the bacterium has been involved in the fire blight
disease. As such, harpin protein has been constantly produced and
secreted by E. amylovora on or in edible fruits such as apple or pear
with no apparent adverse effects on humans.
EDEN has conducted studies to evaluate the mammalian toxicology of
the harpin protein. The results of these studies indicate that harpin
is a Toxicity Category III or IV substance and that it poses no
significant human health risks. No toxicity was observed in either of
the acute oral toxicity studies conducted with the harpin technical
grade active ingredient (TGAI) or a concentrated harpin TGAI. Acute
oral LD50 values for both harpin protein technical and
concentrated harpin protein technical were greater than 2,000 mg/kg in
the rat (Toxicity Category IV). The 4-hour LC50 for harpin
was determined to be greater than 2 mg/L in an acute inhalation study
with rats. EDEN has not observed any incidents of harpin-induced
hypersensitivity in individuals exposed to harpin during research,
production, and/or field testing. The harpin end product produced
minimally and mildly irritating results in the eye irritation and
dermal irritation studies, respectively.
The proteinaceous nature of harpin, in combination with its lack of
acute toxicity, lends an additional measure of safety because when
proteins are toxic, they are known to act via acute mechanisms and at
very low dose levels (LDLs) (Sjoblad, Roy D., et al. ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9). Therefore,
because no significant adverse effects were observed, even at the limit
doses, harpin is not considered to be an acutely toxic protein.
D. Aggregate Exposure
1. Dietary exposure-- Food. Because of the low rate of application
and rapid degradation of harpin in the environment, residues of harpin
in or on treated raw agricultural commodities are expected to be
negligible. Moreover, because harpin exhibits no mammalian toxicity,
any dietary exposure, if it occurred, would not be harmful to humans.
2. Drinking water. Residues of harpin are unlikely to occur in
drinking water, due to the low application rate of the product and its
rapid degradation in soil and water and on foliar surfaces.
3. Non-dietary exposure. Increased non-dietary exposure of harpin
via lawn care, topical insect repellents, etc., is not applicable to
this EUP application.
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. Based on lack
of toxicity and low exposure, there is a reasonable certainty that no
harm to adults, infants, or children will result from aggregate
exposure to harpin residue. Exempting harpin from the requirement of a
tolerance should pose no significant risk to humans or the environment.
2. Infants and children.
See Unit F.1. above.
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. International Tolerances
EDEN Bioscience Corporation is not aware of any tolerances,
exemptions from tolerance, or MRL's issued for harpin outside of the
United States.
2. Stoller Enterprises, Inc.
PP 8F4960
EPA has received a pesticide petition (PP 8F4960) from Stoller
Enterprises, Inc., 8580 Katy Freeway, Suite 200, Houston, Texas 70024,
proposing pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act, 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, salicylic acid, in or on all raw agricultural commodities.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Stoller Enterprises, Inc. has submitted the following summary of
information, data and arguments in support of their pesticide petition.
This summary was prepared by Stoller Enterprises, Inc. and EPA has not
fully evaluated the merits of the petition. The summary may have been
edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary was not clear that it
reflected the conclusion of the petitioner and not necessarily EPA.
A. Product Name and Proposed Use Practices
Salicylic acid will be incorporated into the end-use product,
Adjust I, as an active ingredient. Adjust I is proposed
[[Page 50906]]
for use on a variety of agricultural, horticultural, and floricultural
applications to enhance plant defense against pathogens.
Depending on the crop, the first application of Adjust I is made at
the 3-5 leaf stage or other prescribed growth stage. Subsequent
applications may be made at 12-day intervals. The rate is 2 quarts of
formulated product/acre per treatment. This equates to the application
of 20 grams/acre salicylic acid.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Salicylic
acid is a phenolic acid found in insects and plants as free acid or
bound. The biochemical is a white, practically odorless, free-flowing
crystalline powder. It is slightly soluble in water, forming acidic
solutions.
2. Magnitude of the residue at time of harvest and method used to
determine residue. An analytical method using High Performance Liquid
Chromatography (HPLC), UV spectrophotometery, and Gas Chromatography
for determining salicylic acid content in Adjust I is available.
3. A statement of why an analytical method for detecting the levels
and measuring of the pesticide residue is not needed. Because this
phenolic acid is found naturally in plants, residue analysis would not
yield meaningful results, i.e., the analysis would not discern whether
the salicylic acid source was the plant or from treatment.
Additionally, phenolic levels harmful to plants and animals are highly
unlikely to occur when the product is applied according to label
instructions.
C. Mammalian Toxicological Profile
Salicylic acid is highly regulated in man and other organisms, the
mechanisms of which are well understood. Salicylic acid has been
administered to numerous species in long term dietary studies without
adverse effects at a range of concentrations. The end-use product
containing salicylic acid, Adjust I, has been evaluated for acute
toxicity. Acute oral toxicity in rats is greater than 3,000 milligrams/
kilogram (mg/kg) (Toxicity Category III). Acute dermal toxicity in
rabbits is greater than 5,050 mg/kg (Toxicity Category III). In an eye
irritation study, there were no signs of irritation following
administration of Adjust I (Toxicity Category IV). A rabbit dermal
irritation study with Adjust I resulted in no signs of irritation
(Toxicity Category IV). There was no indication of dermal sensitization
in a guinea pig dermal sensitization study.
Waivers have been requested for genotoxicity, reproductive and
developmental toxicity, subchronic toxicity, chronic toxicity, and
acute toxicity to nontarget species based on salicylic acid's ubiquity
in nature, long history of medicinal uses, favorable toxicological
profile in chronic toxicology studies, and inconsequential exposure
resulting from label-directed use rates.
D. Aggregate Exposure
1. Dietary exposure-- Food. Salicylic acid is ubiquitous in nature
and is found in lower and higher plant species, insects, cosmetics,
over-the-counter medications and natural and processed foods. Many
items in the human daily diet contain appreciable quantities of free
and bound salicylic acid. Dietary exposure due to topical applications
of salicylic acid is difficult to estimate because of the phenolic
acid's prevalence in skin care products and over-the-counter
medications.
Considering the low dose of salicylic acid required to achieve the
desired effect, the levels of salicylic acid found naturally in the
diet and the quantity consumed from processed foods, it can be
concluded that incremental dietary exposure to salicylic acid resulting
from Adjust I applications is negligible.
2. Drinking water. The active ingredient, salicylic acid,
decomposes readily in water and sunlight. The oxidation reactions of
ultraviolet radiation/H202/O2 with
either phenol or salicylic acid successfully degrade those compounds,
which are building blocks of aquatic humic substances. Many compounds,
including salicylic acid, have been identified by means of spectroscopy
and chromatography. The degradation pathway is thought to involve
hydroxylation of the aromatic ring and abstraction of a hydrogen atom
to form 1,2-benzoquinone, which is cleaved to form muconic acid. The
muconic acid is converted to maleic acid, fumaric acid, and oxalic
acid. Fumaric and maleic acids eventually become malic acid, and the
oxalic acid is degraded to formic acid and then CO2. These
reactions demonstrate how phenolics substances are converted to
biodegradable ones.
3. Non-dietary exposure. Adjust I is proposed for use on non-
residential turf and ornamentals. Exposure from turf grass applications
is expected to be minimal because turf users will be protected by shoes
and socks. Further, based on the limited frequency of use on turf
grass, this non-food use is not likely to result in potential chronic
exposure and thus should not be factored into a chronic exposure
assessment. Exposures resulting from application to ornamentals is also
anticipated to be negligible because consumers normally will not be in
contact with treated plants.
E. Cumulative Exposure
Salicylic acid is highly regulated in plants and mammals, the
mechanisms of which are well understood. This phenolic acid is not
intended for pesticidal use and does not share a common mechanism of
toxicity with currently available pesticides, thus Adjust I anticipate
no cumulative effects with other substances.
F. Safety Determination
1. U.S. population. Because the use of salicylic acid will be
delivered at label rates concentrations that are less than or equal to
those found in plants, and because the active ingredient has a
favorable toxicological profile, the use of the salicylic acid when
delivered at label rates poses a negligible, or nonexistent, risk to
the U.S. population.
2. Infants and children. Salicylic acid and its conjugates, esters,
and metabolites are ingested and excreted daily. The compound and its
analogs are ubiquitous in the food chain. When used at label rates, the
product poses no threat to infants and children. In fact as the product
replaces existing fungicides with less favorable toxicological profiles
the risk to infants and children will be reduced.
G. Effects on the Immune and Endocrine Systems
There is no literature available to suggest the immune or endocrine
systems will be compromised with the use of salicylic acid as an active
ingredient at recommended rates.
H. Existing Tolerances
There are no known existing tolerances for the use of salicylic
acid for use as a pesticide.
I. International Tolerances
There are no CODEX tolerances or international tolerance exemptions
for salicylic acid at this time.
[FR Doc. 98-25315 Filed 9-22-98; 8:45 am]
BILLING CODE 6560-50-F
