[Federal Register Volume 66, Number 225 (Wednesday, November 21, 2001)]
[Notices]
[Pages 58481-58485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28740]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[PF-1044; FRL-6802-2]
Notice of Filing of Pesticide Petitions to Establish a Tolerance
for a Certain Pesticide Chemical in or on Food
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of pesticide
petitions proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket control number PF-1044, must be
received on or before December 21, 2001.
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-1044 in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number: (703) 308-9525; 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
[[Page 58482]]
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 persons 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/.
2. In person. The Agency has established an official record for
this action under docket control number PF-1044. 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 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.
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-1044 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, 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 Hwy., 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: [email protected], 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-1044. 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 persons listed 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.
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 the following pesticide petitions proposing the
establishment and/or amendment of regulations for residues of a certain
pesticide chemical in or on various food commodities under section 408
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that these pesticide petitions contain data or
information regarding the elements set forth in section 408(d)(2) of
FFDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of
these pesticide petitions. Additional data may be needed before EPA
rules on these pesticide petitions.
[[Page 58483]]
List of Subjects
Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: October 17, 2001.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Summary of Petitions
The petitioner summary for each pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
pesticide petition was prepared by the petitioner and represents the
view of the petitioner. The pesticide 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.
I. SciReg, Inc./Micro Flo Company
PP 1F6324
EPA has received a pesticide petition 1F6324 from SciReg, Inc., on
behalf of Micro Flo Company, 12733 Director's Loop, Woodbridge, VA
22192, proposing pursuant to section 408(d) of the FFDCA, 21 U.S.C.
346a(d), to amend 40 CFR part 180 to establish an amendment/expansion
of an existing tolerance exemption for the microbial pesticide Bacillus
cereus strain BP01 in or on all raw agricultural commodities.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
SciReg, Inc., on behalf of Micro Flo Company has submitted the
following summary of information, data, and arguments in support of
their pesticide petition. This summary was prepared by SciReg, Inc., on
behalf of Micro Flo Company and EPA has not fully evaluated the merits
of the pesticide petition. The summary may have been edited by EPA if
the terminology used was unclear, the summary contained extraneous
material, or the summary 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
Micro Flo Company's Bacillus cereus strain BPO1 is a foliar-
applied plant regulator. When combined with the plant growth regulator,
mepiquat chloride, for use on cotton, it allows the grower to manage
the cotton plant for short-season production leading to reduced risk of
yield and quality loss due to delayed and prolonged harvest. Benefits
derived from BPO1 in conjunction with mepiquat chloride include
increased early boll retention and/or larger bolls, reduced plant
height which provides a more open canopy, less boll rot, improved
defoliation, less trash and lower ginning costs, better harvest
efficiency, and a darker leaf color. Micro Flo is currently exploring
the potential use of BPO1 on soybeans.
The maximum application rate for BPO1 on all crops will be less
than 2 grams/acre/application and up to 20 grams/acre/year. This
tolerance exemption amendment is for use of Bacillus cereus strain BPO1
up to 20 grams/acre/year. There is a 30-day pre-harvest interval (PHI).
Livestock should not be fed or permitted to graze on BPO1-treated
forage.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The ATCC
classification of Micro Flo's Bacillus cereus strain BPO1 is 55675.
Only residues of BPO1 would be present, and these residues are
indistinguishable from naturally occurring Bacillus cereus without
using specific genetic testing procedures for differentiating them.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. No magnitude of residue studies have not been
conducted on BPO1 as total application rates are exceedingly low,
cotton: average, 0.2 gram BPO1/acre/year; maximum, 0.75 gram/acre/year;
soybeans and other crops: 20 gram BPO1/acre/year and it is
toxicologically innocuous. The PHI is currently 30 days. Bacillus
cereus is indigenous and widespread throughout the United States and
the rest of the world.
3. Analytical method. As indicated above, the naturally occurring
population of Bacillus cereus make it impossible to distinguish between
natural and introduced microbial populations without utilizing genetic
differentiation techniques and therefore to establish and enforce
tolerances for BPO1. In addition, the PHI interval is currently 30
days.
C. Mammalian Toxicological Profile
Acute mammalian toxicity studies via oral, dermal, inhalation,
eye, intratracheal, and intravenous routes were conducted with Bacillus
cereus strain BPO1. No pathogenicity was observed. BPO1 was also tested
for entero-toxin and emetic-toxin production; no toxins were detected.
In a blood agar hemolysis assay conducted with BPO1, weak alpha
hemolysis was observed. Based on the results of the above studies,
subchronic, reproductive, teratology, chronic, and mutagenicity studies
were not deemed necessary.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Bacillus cereus strain BPO1 is
currently registered for use on cotton at rates up to 0.75 gram/acre/
year. Micro Flo Company is currently evaluating BPO1 for future
registration for use on soybeans and other crops (e.g., corn) at rates
up to 20 gram/acre/year. Considering the extremely low application
rates, the potential dietary exposure to BPO1 is minuscule.
ii. Drinking water. Bacillus cereus strain BP01 is prohibited on
the label from direct application to water, and is not a known aquatic
bacterium, and therefore is not expected to proliferate in aquatic
environments. Typical agricultural practices are carried out such that
spray drift is minimal. Although possible minimal spray drift may
contact drinking water, both soil percolation and municipal drinking
water treatment processes would further reduce or eliminate the
possibility of exposure via potable water. Again, considering the
extremely low application rates, the minimal toxicity, lack of
pathogenicity and infectivity, and plant regulator mode of action
versus the insecticidal or fungicidal properties of other Bacillus
products, the potential drinking water exposure to and toxic potential
of BP01 are minuscule.
2. Non-dietary exposure. There is no anticipated non-dietary
exposure to Bacillus cereus strain BPO1. Contact with naturally
occurring populations of Bacillus cereus is common throughout the
world, and residue exposure through contact with BPO1-treated crops has
been theoretically considered. Based on the absence of toxicity,
infectivity, pathogenicity, and mode of action of BPO1, residues that
may be present are unlikely to be of concern.
E. Cumulative Exposure
Although there are other currently registered Bacillus cereus,
Bacillus subtilis and Bacillus thuringiensis products, some of which
hold tolerance exemptions, their modes of action are unlike BP01.
Specifically, the other products typically produce toxin which, when
the bacteria producing it is consumed by insect pests, causes the pest
to die. As previously indicated, BP01 does not produce toxin (diarrheal
or emetic), but instead appears to enable the target plant to more
readily and
[[Page 58484]]
efficiently uptake and utilize growth nutrients. BP01 is a true growth
regulator and to our knowledge does not have classic pesticidal
activity. Based on the above, it is therefore felt that BP01 should not
be considered similar to existing Bacillus products.
F. Safety Determination
1. U.S. population. Since the maximum current use rate is 0.75 gram
BPO1/acre/year for use on cotton and 20 gram/acre/year on soybeans and
other crops for which registration applications have not yet been
submitted, the associated anticipated minute residue levels are
extremely unlikely to add appreciably to the natural, indigenous
background levels of Bacillus cereus. BPO1 does not produce
enterotoxin, diarrheal or emetic, and the toxicity/pathogenicity/
infectivity studies show virtually no negative effects, BPO1 should be
considered safe when used on raw agricultural commodities and meets the
reasonable certainty of no harm requirement.
2. Infants and children. As previously discussed, based on the
quantities of BPO1 used, its lack of toxicity and pathogenicity, and
its mode of action, it is exceedingly improbable that infants or
children would be at greater risk to BPO1 exposure than would adults.
BPO1 should be considered safe when used on raw agricultural
commodities and meets the reasonable certainty of no harm requirement.
G. Effects on the Immune and Endocrine Systems
There are no known effects on the immune and endocrine systems,
nor are any effects expected. Bacillus cereus strain BP01 is not
structurally related to any known neurotoxins or endocrine disruptors.
Additionally, per the Agency's Registration Eligibility Document for
Bacillus cereus strain BP01, July 1997):
There is no known metabolite that acts as an endocrine disrupter
produced by this microorganism. The toxicity/pathogenicity studies
in the rodent required for microbial pesticides indicate that
following several routes of exposure, the immune system is still
intact and able to process and clear the active ingredient.
Therefore, no adverse effects to the endocrine or immune systems are
known or expected.
H. Existing Tolerances
There is currently a tolerance exemption for Bacillus cereus
strain BPO1 at 40 CFR 180.1181 for residues in or on cottonseed.
I. International Tolerances
There are no Codex Maximum Residue Levels or tolerance exemptions
for Bacillus cereus strain BPO1.
II. Platte Chemical Company
PP 1F6316
EPA has received a pesticide petition [1F6316] from Platte Chemical
Company, 419 18h Street, Greeley, CO 80632, 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
the biochemical pesticide diallyl sulfides (DADs).
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Platte Chemical Company has submitted the following summary of
information, data, and arguments in support of their pesticide
petition. This summary was prepared by Platte Chemical Company and EPA
has not fully evaluated the merits of the pesticide petition. The
summary may have been edited by EPA if the terminology used was
unclear, the summary contained extraneous material, or the summary
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
DADs are proposed for use as a soil fumigant solution for the
control of white rot (Sclerotium cepivorum) in onions, garlic, shallots
and leeks. The end-use product (trade name: Alli-Up) contains 90% DADs
in a liquid formulation (8.3 lb of active ingredient per gallon).
Application is recommended for any field that shows evidence or has a
history of white rot infestations. When applied to infected soils in
conjunction with a rotational crop, DADs will mimic the presence of an
Allium crop, which will in turn stimulate the germination of white rot
spores (sclerotia). The germinated spores will subsequently perish
since no host crop is present. The product is applied through
conventional soil fumigation equipment such as an enclosed shanking
system.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. Diallyl
Sulfides (DADs). DADs consist of 86.90% diallyl disulfide, 8.90%
diallyl monosulfide, 3.90% diallyl trisulfide, and 0.30% diallyl
tetrasulfide. DADs are a composite of diallyl sulfides and exists in a
state of dynamic equilibrium. Diallyl disulfide CAS No. 2179-59-9;
dially sulfide (monosulfide) CAS No. 592-88-1; diallyl trisulfide CAS
No. 2050-87-5; diallyl tetrasulfide CAS No. 2444-49-7.
2. Magnitude of residue at the time of harvest and method used to
determine the residue. Residues of DADs are not expected on
agricultural commodities.
3. Analytical method. An analytical method for residues is not
applicable. Residues of DADs are not expected on agricultural
commodities.
C. Mammalian Toxicological Profile
DADs are found naturally in allium crops, including onions and
garlic. The acute oral toxicity LD50 (rat) of technical DADs
are 346 mg/kg. The acute dermal toxicity LD50 (rabbit) is
1,967 mg/kg. DADs are considered a moderate eye irritant to the ocular
tissue of the rabbit; primary irritation index was found to be 5.42.
Dermal irritation is severe to the skin of the rabbit. DADs were found
to be a dermal contact sensitizer in guinea pigs. Diallyl disulfide,
the main component of DADs, was not mutagenic in an Ames test using
Salmonella typhimurium strain TA100 with and without S-9 activation. A
waiver has been requested for acute inhalation toxicity based on the
fact that DADs will be applied by soil injection via an enclosed-cab
method of application. Because it is composed of diallyl sulfides that
are found in garlic and other allium crops, DADs have an extremely
strong, obnoxious odor. As such, every effort will be taken to ensure
that mixers and handlers have minimal inhalation potential. Personal
protective equipment and the method of application mitigates the
potential for exposure. In addition, a waiver has been requested for
immunotoxicity based on the fact that no immunotoxic effects, such as
induced dysfunction or inappropriate suppressive or stimulatory
responses in components of the immune system of test animals, are
known, have been reported, or are expected from DADs.
Results from acute toxicological testing show test animals
displaying symptoms of hemolytic anemia when exposed to DADs. Hemolytic
anemia has been documented for both livestock and laboratory test
animals fed either DADs, onion or garlic. Both onion and garlic are
rich in DADs and other sulfur containing analogs. Hemolytic anemia
results in a reduction of red blood cells and consequently a reduction
in the amount of oxygen available to the central nervous system of
treated susceptible animal species, such as rats and rabbits. There are
no reported incidents of humans experiencing hemolytic anemia following
[[Page 58485]]
consumption of either allium crops or DADs enriched products, such as
garlic oils and pills. Extensive medical research has shown that garlic
is considered a beneficial food with possible medicinal value.
A study done on the antimutagenic activities of garlic extract for
the purpose of cancer research indicates that aqueous garlic extract
possesses antimutagenic properties toward ionizing radiation,
peroxides, adriamycin and N-methyl-N'-nitro-nitroguanidine. Results
obtained with garlic extract in preliminary experiments with Chinese
hamster ovary cells suggest that the antimutagenic properties of garlic
extract were not restricted to prokaryotic cells. Diallyl sulfide and
diallyl disulfide were found to have clastogenic activity in a Chinese
hamster ovary cell assay and was considered to have potential
carcinogenic activity. However, further analysis found that these two
compounds might not present a tumorigenic hazard in vivo if consumed as
part of a normal diet. Diallyl sulfide was found to be among the most
effective agents in inhibiting the expression of benzo[a]pyrene-induced
nucleotoxicity in the colon. Rats fed 5 mL of raw garlic extract per kg
body weight in a prolonged feeding study either died or experienced
anemia, weight loss, and retarded growth. Long-term chronic garlic
powder administration to rats significantly reduced serum/liver
cholesterol, serum triglycerides, phospholipids and transaminase enzyme
activity. Garlic has been shown to have a potential reversal effect on
the risk of stomach cancer. Research suggests that the antitumor effect
of DADs is due to its ability to alter cancer-cell sulfur compounds
linked to cell division. Research also suggests that aged garlic
extract and its constituents have demonstrated anti-cancer effects in
an array of cancer models. There have been no incidents of
hypersensitivity reported by researchers, manufacturers or users of
Alli-Up or DADs, when used for agricultural purposes.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Dietary exposure from use of DADs, as
proposed, is minimal. DADs are applied to the soil by closed system
soil injection, they are not applied to growing crops directly.
Residues of DADs are not expected on agricultural commodities. DADs are
volatile compounds, and tend to move more readily through dry soils at
higher soil temperatures. When applied according to label directions,
the effective duration of response to DADs is approximately 2.5 months
at temperatures of 48 to 70 deg.F. The class of diallyl sulfides that
make up DADs is ubiquitous in garlic and garlic products, such as
garlic pills (non-prescription diet or herbal supplements). DADs may
also be present as an added food flavoring ingredients. The estimated
upper limit for human intake of garlic is reported to be 5.5 g/day,
which is equivalent to 3.3 mg/day of DADs. Researchers have measured up
to 2.39 mg/g of DADs and related compounds in steam distilled
commercial garlic products.
ii. Drinking water. Similarly, exposure to humans from residues of
DADs in consumed drinking water would be unlikely. DADs are volatile
compounds applied to the soil by closed system soil injection; they are
not applied to growing crops directly. Potential exposure to surface
water would be negligible and exposure to drinking water (well or
ground water) would be impossible to measure.
2. Non-dietary exposure. The potential for non-dietary exposure to
the general population, including infants and children, is unlikely as
the proposed use sites are agricultural settings. However, non-dietary
exposures would not be expected to pose any quantifiable risk due to a
lack of residues of toxicological concern. Personal protective
equipment (PPE) mitigates the potential for exposure to applicators and
handlers of the proposed products, when used in agricultural settings.
E. Cumulative Exposure
It is not expected that, when used as proposed, DADs would result
in residues that would remain in human food items. Levels of exposure
resulting from the proposed use of DADs would be significantly lower
than those found in the general population's consumption of onion and
garlic foods (raw, cook and processed) and diet/herbal supplement
products. PPE will mitigate the potential for exposure to applicators
and handlers of the proposed product, when used in agricultural
settings.
F. Safety Determination
1. U.S. population. DADs are applied to the soil, they are applied
to growing crops directly. Residues of DADs are not expected on
agricultural commodities, and therefore, exposure to the general U.S.
population, from the proposed uses, is not anticipated. The class of
diallyl sulfides that make up DADs is already ubiquitous in garlic and
garlic products, such as garlic pills (non-prescription diet or herbal
supplements).
2. Infants and children. As mentioned above, residues of DADs are
not expected on agricultural commodities. There is a reasonable
certainty of no harm for infants and children from exposure to DADs
from the proposed uses.
G. Effects on the Immune and Endocrine Systems
To date there is no evidence to suggest that DADs act as an
endocrine disrupter. Research on garlic powder has suggested an
antiandrogenic activity of garlic on rats. Adult male rats gavaged
daily with 50 mg of garlic powder, and sacrificed at 45 and 70 days
displayed reduced testicular function. Except for the garlic powder
effect on rat testes, no further information suggests DADs will
adversely affect the immune or endocrine system in humans and other
mammals, or any other animal system.
H. Existing Tolerances
There is no U.S. EPA tolerance. DADs are listed in 21 CFR 172.515
by the Food and Drug Administration (FDA) as an approved direct food
additive. Additionally, DADs were given Generally Recognized as Safe
(GRAS) status No. 2028, 1965 by the FDA. The Council of Europe (1981)
has included it in the list of substances that may be added to food
without a hazard to public health.
I. International Tolerances
There is no Codex Alimentarium Commission Maximum Residue Level
for DADs.
[FR Doc. 01-28740 Filed 11-20-01; 8:45 am]
BILLING CODE 6560-50-S