[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]


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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.

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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