[Federal Register Volume 67, Number 186 (Wednesday, September 25, 2002)]
[Notices]
[Pages 60233-60236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24343]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0214; FRL-7194-1]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
fora 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 a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket ID number OPP-2002-0214, must be 
received on or before October 25, 2002.

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 ID 
number OPP-2002-0214 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Bryceland,Biochemical 
Pesticides Branch, Biopesticides and Pollution Prevention Division 
(7511C), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 
(703) 305-6928; 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 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,'' ``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 ID number OPP-2002-0214. 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

[[Page 60234]]

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 ID number OPP-2002-0214 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 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: [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 ID number OPP-2002-0214. 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.
    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 a pesticide petition as follows 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 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 petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: September 16, 2002.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticides Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by Certis USA LLC and represents the view of 
Certis USA LLC. EPA is publishing the petition summary verbatim without 
editing it 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.

Certis USA LLC

PP 2F6477

     EPA has received a pesticide petition [2F6477] from Certis USA LLC 
9145 Guild Road, Suite 175, Columbia, MD 21046, proposing pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for the biochemical pesticide ammonium 
bicarbonate.
     Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Certis USA LLC has submitted the following summary of information, 
data, and arguments in support of their pesticide petition. This 
summary was prepared by Certis USA LLC 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

    1. The biochemical ammonium bicarbonate is proposed for use as an 
insect feeding attractant in the end use product olive fly attract and 
kill (A&K) target device; EPA registration pending. Ammonium 
bicarbonate acts as a feeding attractant to the olive fruit fly 
(Bactrocera oleae.) The end use product also contains the active 
ingredients lambda-cyhalothrin insecticide and the pheromone 1,7-
dioxaspiro-(5,5)-undecane. The proposed use of the product is in olive 
orchards to control the olive fruit fly. The active ingredient,

[[Page 60235]]

ammonium bicarbonate, is listed by the U.S. Food and Drug 
Administration as a direct food additive under 21 CFR 73.85, 163.110, 
163.111, 163.112 and is listed as generally recognized as safe (GRAS) 
under 21 CFR 184.1135. It is exempt from the requirement of a tolerance 
under 40 CFR 180.1001(c) when used as an inert ingredient in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest.
    2. The ammonium bicarbonate in the end use product, when exposed to 
air, decomposes and releases gaseous ammonia. Ammonia is a by-product 
of protein decomposition and as such is recognized by the olive fruit 
fly as a potential food source. The ammonia released from the end use 
product attracts the insects to the device. Ammonia per se is exempt 
from the requirement of a tolerance under 40 CFR 180.1003 when used as 
a fungicide applied to grapefruit, lemons, oranges and corn grain.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues. Ammonium 
bicarbonate, CAS number 1066-33-7, is also known as ammonium hydrogen 
carbonate. It is a naturally occurring mineral. It is a white, 
crystalline powder soluble in water but non-soluble in alcohol and 
acetone. It decomposes at 36 to 60 degrees centigrade to ammonia, 
carbon dioxide and water vapor. It has many applications including use 
in baking powders, fire-extinguishing mixtures, agricultural 
fertilizers and is used as a surfactant, suspending agent and 
dispersing agent in pesticide formulations.
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. The end use product contains 4 grams of ammonium 
bicarbonate bound in a polymer. The polymer is attached to a cellulose 
card material which is approximately 19 centimeters (cm) by 20 cm in 
size. The card is suspended from olive tree limbs at a rate of 42 cards 
per acre of olive orchard resulting in 168 grams (0.37 pounds) of 
ammonium bicarbonate per acre of orchard. Being contained in the 
polymer and attached to the cellulose card there is little opportunity 
for the ammonium bicarbonate to come in contact with either the fruit 
or the soil. Upon application the end use product will be constantly 
exposed to sunlight and elevated temperatures which will continually 
release very small amounts of gaseous ammonia.
     Ammonia is a naturally occurring compound which is a key 
intermediate in the nitrogen cycle. Under normal conditions, ammonia is 
essential for many biological processes. Ammonia may be released to the 
atmosphere by volatilization from numerous sources including: Decaying 
organic matter, animal livestock excreta, fertilization of soil, and 
burning of coal, wood, and other natural products. Because of its 
significance in natural cycles, ammonia is found at a local 
concentration in most environmental media. The half-life of atmospheric 
ammonia is estimated to be only a few days. In olive orchards 
atmospheric concentrations of ammonia will be present from the decay of 
organic matter and from the application of fertilizer to soil as 
ammonia, ammonium compounds or ammonia precursors (such as urea). 
Because ammonia, as ammonium ion, is the nutrient of choice for many 
plants, uptake of soil ammonia by living plants is an important fate 
process. The rate of uptake by plants varies with the growing season. 
At normal environmental concentrations, ammonia does not have a very 
long soil half-life. It is either rapidly taken up by plants, 
bioconverted by the microbial population, or volatilized to the 
atmosphere.
     Under the conditions of use proposed and given the natural 
background levels of ammonia in the atmosphere and in the soil, no 
residues of ammonia or of ammonium bicarbonate are expected to occur in 
olive fruit from the use of the olive fly attract and kill (A&K) target 
device.
    3. Residues in olive fruit are not expected from the use of the 
olive fly attract and kill target device; therefore, an analytical 
method is not needed.

C. Mammalian Toxicological Profile

     Because toxicity studies in the scientific literature are limited 
for ammonium bicarbonate, data on the related ammonium salt, ammonium 
chloride, and on the carbonate salt, sodium bicarbonate, are discussed. 
The single dose LD50 of ammonium chloride in the mouse and 
the rat, administered orally, is reported in scientific literature as 
1,300 milligrams/kilogram (mg/kg) and 1,650 mg/kg, respectively. The 
single dose LD50 of sodium bicarbonate in the mouse and rat, 
administered orally, is reported in scientific literature as 5,650 mg/
kg and 3,400 mg/kg, respectively. For ammonia, the acute inhalation 
LC50 in the rat exposed for a single period of 15 minutes, 
was reported in scientific literature as 17,401 parts per million 
(ppm). The acute inhalation LC50 in the mouse exposed for a 
single period of 30 minutes was reported as 21,430 ppm.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. Ammonium bicarbonate as used in the 
olive fly attract and kill target device will not come into direct 
contact with olives. Therefore, no residues of this compound are 
expected to occur in olives. Ammonium bicarbonate is listed by the U.S. 
Food and Drug Administration as a direct food additive and is commonly 
used as a leavening agent in baked goods.
     There is some potential for the decomposition product ammonia gas 
to come into contact with growing olives. However, it is expected that 
levels of gaseous ammonia would be well below the normal background 
levels of atmospheric ammonia present in an area of crop production.
    ii. Drinking water. Given the mode of application whereby the 
ammonium bicarbonate is bound in a polymer matrix attached to a 
cellulose card which is suspended from olive tree branches, there is 
little likelihood that residues of ammonium bicarbonate would occur in 
drinking water from this use.
    2. Non-dietary exposure. When exposed to air, sun and elevated 
temperatures in an olive orchard, the ammonium bicarbonate will slowly 
decompose to ammonia, carbon dioxide, and water vapor. The total amount 
of ammonium bicarbonate applied per acre in the olive fly attract and 
kill target devices is 168 grams. Assuming the complete consumption of 
the ammonium bicarbonate during the growing season, the theoretical 
yield of ammonia would be equal to approximately 36.1 grams. Assuming 
that this amount of ammonia is distributed over an acre of olive 
orchard to a height of 15 feet at a single point in time, this is equal 
to a theoretical concentration of 3 parts per billion (ppb) of ammonia. 
But a more realistic scenario would take into account that the release 
of ammonia would occur over the 4-5 month period after application in 
the orchard resulting in a daily concentration that is approximately 
one hundred times less, i.e. 0.025 ppb. This concentration of ammonia 
would be well below the worldwide atmospheric background concentration 
of ammonia that has been estimated in scientific literature at 
approximately 1-3 ppb. Also by comparison, farmers can be exposed to 
ammonia when applying fertilizer. The ammonia concentration over a 
field during the application of gaseous anhydrous ammonia fertilizer 
was reported in scientific literature as high as 213 microgram/cubic 
meter (ug/m3)

[[Page 60236]]

300 ppb. This is ten thousand fold higher than the theoretical exposure 
from the olive fly attract and kill target device.

E. Cumulative Exposure

     Because of the method of application and the low use rates of 
ammonium bicarbonate, little to no exposure is expected. Since ammonium 
bicarbonate is approved as a direct food additive and is listed as 
``Generally Recognized as Safe'' by the U.S. Food and Drug 
Administration, there is no concern regarding the potential for 
cumulative effects of ammonium bicarbonate from the proposed use with 
other substances due to a common mechanism of action.

F. Safety Determination

    1. U.S. population. Evidence of ammonium bicarbonate's low toxicity 
is demonstrated in the data reported for the related salts, ammonium 
chloride and sodium bicarbonate. The U.S. Food and Drug Administration 
has placed the following limitations on the maximum allowable levels of 
ammonium bicarbonate in processed foods: up to 3.2% in baked goods, 
grain, snack foods and reconstituted vegetables. This is the equivalent 
of 32,000 ppm of ammonium bicarbonate concentration in these foods.
     Ammonium bicarbonate is exempt from the requirement of a tolerance 
under 40 CFR 180.1001(c) when it is used as a surfactant, suspending 
agent or dispensing agent in pesticide formulations applied to growing 
crops or to raw agricultural commodities after harvest. The amount of 
ammonium bicarbonate used in a pesticide formulation is not restricted 
by 40 CFR 180.1001(c). Therefore, any level of residue of ammonium 
bicarbonate in or on olives is currently acceptable when used for these 
purposes.
     Given the method of application of ammonium bicarbonate where it 
is bound in a polymer within a discrete target device it is extremely 
unlikely for this compound to come into contact with and result in 
residues in or on olive fruit. Thus, aggregate exposure to ammonium 
bicarbonate from use in the olive fly attract and kill target device 
and any risk to human health will be negligible.
    2. Infants and children. Given the low toxicity of the related 
salts ammonium chloride and sodium bicarbonate and the allowable levels 
of ammonium bicarbonate in processed foods, there is a reasonable 
certainty of no harm to children and infants from the use of the olive 
fly attract and kill target device in olive orchards.

G. Effects on the Immune and Endocrine Systems

     Certis USA has no information to suggest that ammonium bicarbonate 
will adversely affect the immune or endocrine systems.

H. Existing Tolerances

     Ammonium bicarbonate is exempt from the requirement of a tolerance 
under 40 CFR 180.1001(c) when used as an inert ingredient in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest. Ammonia is exempt from the requirement of a 
tolerance under 40 CFR 180.1003 when used as a fungicide applied to 
grapefruit, lemons, oranges, and corn grain.

I. International Tolerances

     There is no Codex maximum residue level (MRL) for ammonium 
bicarbonate. Canada has established permitted residue levels of 
ammonium bicarbonate in cocoa products and in unstandardized food 
products.
[FR Doc. 02-24343 Filed 9-24-02; 8:45 am]
BILLING CODE 6560-50-S