[Federal Register Volume 64, Number 241 (Thursday, December 16, 1999)]
[Notices]
[Pages 70255-70258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32654]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-901; FRL-6393-4]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of 
certain pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-901, must be 
received on or before January 18, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-901 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Driss Benmhend, 
Biopesticides and Pollution Prevention Division (7511C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460; telephone number: (703) 308-9525; and

[[Page 70256]]

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            potentially
                                                       affected entities
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Industry
 
 
 
                                  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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-901. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-901 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, 401 M St., SW., 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 control number PF-901. 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petition. Additional data 
may be needed before EPA rules on the petition.

[[Page 70257]]

List of Subjects

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

    Dated: December 2, 1999.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide 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 the petitioner and represents the views of the 
petitioner. 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.

 Agrotol International

 9F6065

    EPA has received a pesticide petition (9F06065) from Agrotol 
International, 7322 Southwest Freeway, Suite 1400, Houston, TX 77074, 
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 phosphorous acid.
    Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, 
Agrotol International has submitted the following summary of 
information, data, and arguments in support of their pesticide 
petition. This summary was prepared by Agrotol International 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

    Agtrol International has applied for registrations of two products 
containing phosphorous acid as the sole active ingredient (a.i). One 
product, Phosphorous Acid Technical, is a manufacturing-use product 
containing the a.i at 71%. This product is intended for use in 
formulating fungicidal products for application to terrestrial food 
crops. The other product, Agri-Phos Agricultural Fungicide, is an end-
use product containing the 56.2% mono- and dibasic sodium, potassium 
and ammonium salts of phosphorous acid (36.3% phosphorous acid). This 
product is a fungicide intended for application to terrestrial food 
crops, i.e., avocado, Brassica crops, caneberry, citrus, curcubit 
crops, ginseng, grape, hops, leafy vegetables, onions (dry bulb), 
pineapple, pome fruit, strawberry, and tomato.

B. Product Identity/Chemistry

    1. Identity of the pesticide and corresponding residues--plant 
metabolism. Phosphorous acid is rapidly degraded in the environment to 
yield hydrogen and phosphite ions. Release of hydrogen ions will 
increase the pH of the plants surface, which will be moderated by the 
amount of neutralizing ions present, the buffering capacity, and the 
amount of dilution possible. Phosphite ions are available for uptake by 
plants usually in the form of ammonium, calcium, and potassium and 
sodium phosphites (phosphite salts).
    2. Magnitude of residue at the time of harvest and method used to 
determine the residue. Magnitude of residue Agtrol has requested a 
waiver for all residue chemistry data requirements because phosphorous 
acid per se is not expected to be found in or on raw agricultural 
commodities (RAC). Phosphorous acid sprayed on plants is expected to 
dissociate rapidly releasing hydrogen and phosphite ions. The ions are 
available for uptake by plants usually in the form of ammonium, calcium 
and potassium and sodium phosphites (phosphite salts). Many phosphite 
salts are generally recognized as safe (GRAS). See 21 CFR 182.3616, 
182.3637, 182.3739, 182.3766, 182.3796, and 184.1764. Moreover, natural 
means are expected to moderate the accumulation of these ions on 
plants.
    3. Analytical method. Agtrol International has not submitted a 
practical analytical method for the detection and measurement of 
pesticide chemical residues. Phosphorous acid per se is not expected to 
be found in or on RACs, because once this chemical is released into the 
environment it dissociates rapidly to form hydrogen and phosphite ions.

C. Mammalian Toxicological Profile

    1. Acute toxicity. Phosphorous acid is of high acute toxicity 
through the oral, dermal, and inhalation routes of exposure. 
Phosphorous acid is corrosive to eyes and skin. However, results of 
studies conducted on Agri-Phos Agricultural Fungicide, the end-use 
product for which Agtrol International has applied for registration, 
demonstrate that this product has a low order of toxicity. The acute 
oral LD50 in the rat was greater than 5,000 milligrams per 
kilograms (mg/kg) of bodyweight. The acute dermal LD50 in 
the rat was greater than 5,000 mg/kg of bodyweight. The acute 
inhalation LC50 in the rat was greater than 2.06 milligrams 
per liter (mg/L). The product was found slightly irritating to the skin 
of guinea pigs and produced irritation to the eyes or rabbits that 
cleared within 48 hours. The product was not positive in guinea pigs 
for skin sensitization.
    2. Developmental/reproductive effects, chronic effects and 
carcinogenicity. There is adequate information available from 
literature sources to characterize the toxicity of phosphorous acid. 
Phosphorous acid can affect human health through inhalation of mist, 
ingestion, and contact with the skin and eyes. It will cause corrosive 
effects (burns or irreversible damage) to the eyes, skin, throat, 
digestive tract, upper respiratory tract and nose. Signs of 
overexposure to this chemical are severe burning of eyes and skin, 
possible nausea and vomiting, coughing, burning and tightness of the 
chest and shortness of breath. Based on corrosiveness and then current 
use patterns for the mineral acids, EPA did not require these studies 
as part of the Reregistration Eligibility Decision on Mineral Acids 
(EPA 738-R-029; December 1993).
    3. Endocrine disruption. Phosphorous acid does not belong to a 
class of chemicals known or suspected of having adverse effects on the 
endocrine system. Further, Agtrol International is not aware of any 
evidence that phosphorous acid has any effect on endocrine function. 
Last, there is no evidence that phosphorous acid bioaccumulates in the 
environment.

D. Aggregate Exposure

    1. Dietary exposure--i. Food. No dietary exposure is expected. When 
phosphorous acid is applied to growing crops in the environment it 
rapidly dissociates to form hydrogen and phosphite ions.
    ii. Drinking water--drinking water exposure. No significant 
exposure is expected to result from phosphorous acid because it is 
likely to be biodegraded in the terrestrial and aquatic environments to 
hydrogen and phosphite ions. The effects on humans resulting from 
anticipated concentrations to these ions due to

[[Page 70258]]

agricultural uses will be moderated by natural means. Moreover, there 
is no potential for either ion to be significantly accumulated by the 
biota. Phosphorous acid is not regulated under the Safe Drinking Water 
Act; therefore; no maximum contaminant level (MCL) has been established 
for it.
    2. Non-dietary exposure. The primary non-pesticidal uses of 
phosphorous acid are industrial in closed production systems. There are 
no residential, indoor, school, or day care uses proposed for this 
product. The proposed use pattern is for agricultural food crops. 
Therefore, there is no potential for non-occupational exposure to the 
general population.

E. Cumulative Exposure

    Agri-Phos Agricultural Fungicide may share a common metabolic 
mechanism with other salts of phosphorous acid (such as calcium); 
however, due to their limited use, these other salts are not expected 
to pose significant contributions to the cumulative effects from the 
agricultural fungicidal use of Agri-Phos Agricultural Fungicide.

F. Safety Determination

    1. U.S. population. Aggregate exposure to phosphorous acid is 
expected to be minimal. There is very little potential for exposure to 
phosphorous acid in drinking water and from non-dietary, non-
occupational exposures. This chemical will be applied to agricultural 
food crops by commercial applicators. Once released into the 
environment, the chemical rapidly dissociates to form hydrogen and 
phosphite ions. The hydrogen ions affect pH, but this is moderated by 
natural means. Many phosphite salts are GRAS. See 21 CFR 182.3616, 
182.3637, 182.3739, 182.3766, 182.3796, and 184.1764. Therefore, the 
health risk to humans is negligible based on the low toxicity of these 
ions and a low application rate for the a.i, and one can conclude that 
there is a reasonable certainty that no harm will result from aggregate 
exposure to phosphorous acid.
    2. Infants and children. Aggregate exposure to phosphorous acid is 
expected to be minimal. There is very little potential for exposure to 
phosphorous acid in drinking water and from non-dietary, non-
occupational exposures. This chemical will be applied to agricultural 
food crops by commercial applicators. Once released into the 
environment, the chemical rapidly dissociates to form hydrogen and 
phosphite ions. The hydrogen ions affect pH, but this is moderated by 
natural means. Many phosphite salts are GRAS. See 21 CFR 182.3616, 
182.3637, 182.3739, 182.3766, 182.3796, and 184.1764. Therefore, the 
health risk to humans is negligible based on the low toxicity of these 
ions and a low application rate for the a.i, and one can conclude that 
there is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to phosphorous acid residues.

G. Effects on the Immune and Endocrine Systems

    Phosphorous acid does not belong to a class of chemicals known or 
suspected of having adverse effects on the immune and endocrine 
systems. Further, Agtrol International is not aware of any evidence 
that phosphorous acid has any effect on immune and endocrine functions. 
Last, there is no evidence that phosphorous acid bioaccumulates in the 
environment.

H. Existing Tolerances

    No tolerances have been established for residues of phosphorous 
acid in RACs and or processed food/feed. Disodium phosphate, 
monoammonium phosphate, diammonium phosphate and potassium phosphate 
have been exempted from the requirement of a tolerance under 40 CFR 
part 180.1001.

I. International Tolerances

    No maximum residue levels (MRLs) have been established for 
phosphorous acid by the Codex Alimentarius Commission (CODEX).
[FR Doc. 99-32654 Filed 12-15-99; 8:45 am]
BILLING CODE 6560-50-F