[Federal Register Volume 65, Number 194 (Thursday, October 5, 2000)]
[Rules and Regulations]
[Pages 59346-59350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25598]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301030; FRL-6599-1]
RIN 2070-AB


Phosphorous Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a

[[Page 59347]]

tolerance for residues of phosphorous acid and its ammonium, sodium and 
potassium salts in or on all food commodities when used as an 
agricultural fungicide on food crops. Agtrol International submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act, as 
amended by the Food Quality Protection Act of 1996, requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of phosphorous acid and its ammonium, sodium and potassium 
salts.

DATES: This regulation is effective October 5, 2000. Objections and 
requests for hearings, identified by docket control number [OPP-
301030], must be received by EPA, on or before December 4, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
[OPP-301030] in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Driss Benmhend, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9525; and e-mail 
address: benmhend.driss @epa.gov.

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 control number OPP-301030. The official record 
consists of the documents specifically referenced in this action, 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.

II. Background and Statutory Findings

    In the Federal Register of December 16, 1999 (64 FR 70255) (FRL-
6393-4), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e), as amended by 
the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing 
the filing of a pesticide tolerance petition by Agtrol International, 
7322 Southwest Freeway, Suite 1400, Houston, TX 77074. This notice 
included a summary of the petition prepared by the petitioner Agtrol 
International.
    EPA received a comment from Aventis CropScience that requested EPA 
deny the waiver for residue chemistry data requirements for phosphorous 
acid. Aventis claims that phosphorous acid does not degrade rapidly in 
the environment, and that significant residues of phosphorous acid are 
expected to be found in or on raw agricultural commodities treated with 
products containing the active ingredient phosphorous acid. These 
residues of phosphorous acid according to Aventis, in or on food crops, 
cannot be considered to be negligible. EPA reviewed the data submitted 
by Aventis and concluded the following:
    1. Phosphorous acid and its salts are important fertilizer 
compounds and used in significant quantities in this country. Tests 
performed using the Agtrol product showed an LD50 of greater 
than 5,000 milligrams per kilogram of bodyweight. Human toxicity from 
consumption of crops treated with phosphorus acid fertilizers would be 
well known, if it occurred. The lack of reported dietary toxicity from 
consumption of crops treated with phosphorous acid fertilizers is 
further supporting evidence that use of phosphorous acid applications 
as a fungicide should not result in dietary toxicity. EPA does not 
require residue chemistry data in cases where the toxicity is so low 
and the use pattern will result in exposures much lower than the 
highest dose tested without an effect.
    2. The Agency does note that the information provided by Aventis on 
the dissociation of phosphorous acid actually supports the tolerance 
exemption request. Further details on the dissociation of phosphorous 
acid at a pH of 7 indicates that the equilibrium ratio of acid 
phosphite ion to undissolved phosphorous acid is 500,000 to 1, and that 
the ratio of phosphite ion to acid phosphite ion is 2 to 1. This 
indicates the presence of almost no undissociated phosphorous acid.
    3. Phosphorous is a required substance in the human body in the 
form of phosphates. This and the above are among the reasons why EPA 
does not regulate residues of phosphorous acid arising from the 
application of another pesticide which dissociates to phosphorous acid 
and is produced by Aventis. Also included were toxicological 
information provided by Aventis which proved to EPA there was no need 
to monitor the phosphorous acid residue.

[[Page 59348]]

    As a result, EPA does not believe phosphorous acid and its salts 
should be denied the exemption from the requirement of a tolerance 
because of the reasons given by Aventis CropScience.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of phosphorous acid.

III. Risk Assessment

    New section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....'' Additionally, section 408(b)(2)(D) requires that the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

IV. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness, and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children.
    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-Phostrol 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 of bodyweight. The acute dermal LD50 in the rat 
was greater than 5,000 milligrams per kilogram of bodyweight. The acute 
inhalation LC50 in the rat was greater than 2.06 milligrams 
per liter. The product was found slightly irritating to the skin of 
guinea pigs and produced irritation to the eyes of 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 the current 
use patterns for the mineral acids, EPA did not require these studies 
as part of the Reregistration Eligibility Decision (RED) on the Mineral 
Acids (EPA 738-R-029; December 1993).

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).
    1. Dietary exposure. 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.
    2. Drinking water exposure. No significant exposure is expected to 
result from phosphorous acid because it is likely to be degraded in the 
terrestrial and aquatic environments to hydrogen and phosphite ions. 
The effects on humans resulting from anticipated concentrations to 
these ions due to 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.
    3. Other non-occupational 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.
    Dermal inhalation exposures are expected to be minimal to 
applicators because of the label mitigating language.

VI. Cumulative Effects

    Agri-Phostrol Agricultural Fungicide may share a common metabolic 
mechanism with other salts of phosphorous acid (such as calcium); 
however, due to the lack of toxicity of Agri-Phostrol Agricultural 
Fungicide and lack of reported dietary toxicity associated with the use 
of phosphorous fertilizers on crops, no cumulative effect from the use 
of Agri-Phostrol Agricultural Fungicide is expected.

VII. Determination of Safety for U.S. Population, Infants and 
Children

    1. U.S. general 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 generally recognized as safe 
(GRAS). Therefore, the health risk to humans is negligible based on the 
low toxicity of these ions and a low application rate for the active 
ingredient, 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

[[Page 59349]]

exposures. This chemical will be applied to agricultural food crops. 
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.'' 
Therefore, the health risk to humans is negligible based on the low 
toxicity of PhostrolTM Agricultural Fungicide and these ions 
and a low application rate for the active ingredient. 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.

VIII. Other Considerations

    Phosphorous acid and its salts are rapidly dissociated in the 
environment to yield hydrogen and phosphite ions. Release of hydrogen 
ions will increase the pH of the plant's 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).

A. 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.

B. 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 
raw agricultural commodities, because once this chemical is released 
into the environment it dissociates rapidly to form the less toxic 
compounds, hydrogen and phosphite ions.

C. Codex Maximum Residue Level

    No maximum residue levels (MRLs) have been established for 
phosphorous acid by the Codex Alimentarius Commission (CODEX).

IX. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301030 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before December 
4, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit IX.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket number OPP-301030, to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the

[[Page 59350]]

material submitted shows the following: There is a genuine and 
substantial issue of fact; there is a reasonable possibility that 
available evidence identified by the requestor would, if established 
resolve one or more of such issues in favor of the requestor, taking 
into account uncontested claims or facts to the contrary; and 
resolution of the factual issues(s) in the manner sought by the 
requestor would be adequate to justify the action requested (40 CFR 
178.32).

X. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994); or require OMB review or any Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a petition under FFDCA section 408(d), such as the tolerance 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4).

XI. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 27, 2000.
Susan B. Hazen,
Acting Director, Office of Pesticide Programs.


    Therefore, 40 CFR chapter I is amended as follows:

PART 180-[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


    2. Section 180.1210 is added to subpart D to read as follows:


Sec. 180.1210  Phosphorous acid, exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of phosphorous acid and its ammonium, sodium and potassium 
salts in or on all food commodities when used as an agricultural 
fungicide on food crops.

[FR Doc. 00-25598 Filed 10-4-00; 8:45 am]
BILLING CODE 6560-50-F