[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