[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
------------------------------------------------------------------------
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