Phosphorous Acid; Proposed Amendment to Exemption From Tolerance, 36731-36736 [E6-10031]
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SUPPLEMENTARY INFORMATION:
Authority: This action is issued under the
authority of Section 112 of the Clean Air Act,
as amended, 42 U.S.C. Section 7412.
Dated: June 8, 2006.
Deborah Jordan,
Director, Air Division, Region IX.
[FR Doc. 06–5842 Filed 6–27–06; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0561; FRL–8075–5]
Phosphorous Acid; Proposed
Amendment to Exemption From
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: This document proposes to
amend the existing tolerance exemption
for residues of phosphorous acid and its
ammonium, sodium, and potassium
salts in or on all food commodities to
allow for post-harvest application to
stored potatoes at 35,600 ppm or less
phosphorous acid.
DATES: Comments must be received on
or before July 13, 2006.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2006–0561, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Office of Pesticide Programs
(OPP) Regulatory Public Docket (7502P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460-0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
Protection Agency, Rm. S-4400, One
Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. Deliveries
are only accepted during the Docket’s
normal hours of operation (8:30 a.m. to
4 p.m., Monday through Friday,
excluding legal holidays). Special
arrangements should be made for
deliveries of boxed information. The
Docket telephone number is (703) 3055805.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPP–2006–
0561. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
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website is an ‘‘anonymous access’’
system, which means EPA will not
know your identity or contact
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cannot read your comment due to
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you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the docket index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either in the
electronic docket at https://
www.regulations.gov, or, if only
available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400,
One Potomac Yard (South Building),
2777 S. Crystal Drive, Arlington, VA.
The hours of operation of this Docket
Facility are from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket telephone number
is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT:
Linda Hollis, Biopesticides and
Pollution Prevention Division (7511P),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave, NW., Washington,
DC 20460-0001; telephone number:
(703) 308-8733; e-mail address:
hollis.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
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• Pesticide manufacturing (NAICS
code 32532).
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 this unit could also
be affected. The North American
Industrial Classification System
(NAICS) codes have been provided to
assist you and others in determining
whether this action might apply to
certain entities. To determine whether
you or your business may be affected by
this action, you should carefully
examine the applicability provisions in
the entities listed above. If you have any
questions regarding the applicability of
this action to a particular entity, consult
the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
www.regulations.gov or e-mail. Clearly
mark the part or all of the information
that you claim to be CBI. For CBI
information in a disk or CD ROM that
you mail to EPA, mark the outside of the
disk or CD ROM as CBI and then
identify electronically within the disk or
CD ROM the specific information that is
claimed as CBI). In addition to one
complete version of the comment that
includes 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 docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
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vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background and Statutory Findings
Pursuant to section 408(e) of the
FFDCA, 21 U.S.C. 346a(e), EPA is
proposing, on its own initiative, to
amend the existing exemption from the
requirement of a tolerance for residues
of phosphorous acid and its ammonium,
sodium and potassium salts, in or on all
food commodities when applied as an
agricultural fungicide by adding the
post-harvest treatment of stored
potatoes.
40 CFR 180.1(i) states, ‘‘unless
otherwise specified, tolerances and
exemptions established under the
regulation in this part apply to residues
from only pre harvest application of the
chemical.’’ As a result, a tolerance
exemption must specify post-harvest
application where the Agency intends to
exempt such applications. The existing
tolerance exemption for phosphorous
acid (40 CFR 180.1210) does not
expressly allow for post-harvest
application of this chemical. Therefore,
the Agency has, of its own initiative,
prepared this proposed amendment to
the tolerance exemption for
phosphorous acid to allow post-harvest
applications of this active ingredient.
As discussed below, in order to
determine the exposure and risks
resulting from post- harvest treatment of
potatoes with phosphorous acid, the
Agency conducted a conservative
dietary exposure and risk assessment
and has concluded that the use of
phosphorous acid as a post-harvest
treatment on stored potatoes presents no
new risks as an agricultural fungicide
because the fungicide is applied at very
dilute levels, the lack of acute oral
toxicity for the tested end use product
at >5,000 mg/kg body weight, and the
rapid degradation of phosphorous acid.
The Agency concludes that the use of
phosphorous acid as a post harvest
treatment at these application rates
meets the FFDCA standard of reasonable
certainty of no harm.
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 exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of the FFDCA
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
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other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B), in establishing or
maintaining in effect an exemption from
the requirement of a tolerance, EPA
must take into account the factors set
forth in section 408(b)(2)(C), which
require 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) of the FFDCA 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.’’
Section 408(c)(1)(B) of the FFDCA
allows the EPA to modify a regulation
on its own initiative under section
408(e). Section 408(e) requires the EPA
to issue a notice of proposed rulemaking
and provide a public comment period of
not less than 60 days. However, this
provision also allows the EPA to shorten
the comment period ‘‘if the
Administrator for good cause finds that
it would be in the public interest to do
so and states the reasons for the finding
in the notice of proposed rulemaking.’’
For this particular rule, EPA has
shortened the public comment period to
30 days because the Agency believes
that it is in the public interest to do so.
Potatoes are an important commodity to
the agricultural food supply. Post
harvest treatment of potatoes using
fungicides will be initiated in late
summer. Phosphorous acid provides a
safe alternative to other fungicides used
on stored potatoes. It is therefore
important to expedite this tolerance
exemption on order for phosphorous
acid to be applied post harvest to
potatoes this use season.
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. For
further discussion of the regulatory
requirements of section 408 of the
FFDCA and a complete description of
the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
III. Toxicological Profile
Consistent with section 408(b)(2)(D)
of the FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
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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.
The toxicity profile for phosphorous
acid and its ammonium, potassium and
sodium salts has already been assessed
for its pesticidal use by the Agency and
published in support of the tolerance
exemption for residues of phosphorous
acid in or on all food commodities when
used as an agricultural fungicide. See
the Federal Register of October 5, 2000
(65 FR 59346) (FRL–6599–1). For the
purposes of this tolerance exemption
amendment, the Agency has relied on
the data and/or information previously
submitted and has reassessed that data
in order to evaluate the request to add
post harvest uses to the tolerance
exemption. Additionally, the Agency
has reviewed publicly available data
and information on phosphoric acid,
which is chemically and structurally
similar to phosphorous acid. The
Agency believes that in combination,
the data and other information relied
upon for this tolerance exemption
supports its conclusion that there is
reasonable certainty of no harm that will
result from the post harvest treatment of
potatoes with phosphorous acid when
used according to the recommended
application rate.
The technical grade of the active
ingredient of phosphorous acid has also
been fully characterized and assessed by
the Agency in the Mineral Acids RED
(December 1993) since it is an
ingredient which falls within the class
of compounds known as the mineral
acids. Information on phosphorous acid
indicates that it is classified in Toxicity
Category III for the oral and dermal
routes of exposure, and that it is
corrosive to the eyes and skin. The
corrosive nature of concentrated or
technical grade phosphorous acid is not
of a concern because phosphorus acid is
applied at very dilute solutions such as
0.25 pounds of phosphorus acid per ton
of stored potatoes. Phosphorous acid as
applied at such very dilute rates is only
slightly irritating to the skin. Further,
when applied at such permissible
application rate, the residues of the
applied phosphorous acid solution have
an acute toxicity that is several hundred
times lower than the acute toxicity of
phosphorous acid in a 100% pure form.
As mentioned above, the Agency, on
its own initiative, re-examined the
previously reviewed toxicity data on an
end use product that contains 35.6%
phosphorus acid by weight and would
be applied at 0.25 pounds of active
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ingredient per ton of stored potatoes.
The results demonstrated that there is a
margin of exposure of nearly 1,000 for
children or the equivalent of a 30 kg
child consuming 932 pounds of potatoes
at one time. This large margin of
exposure provides reasonable certainty
of no harm at application rates in excess
of that for the reviewed end use
product. Specifically, an end use
product containing 53.8% phosphorous
acid by volume (or 35.6% phosphorus
acid by weight) was tested on rats at >
5,000 mg/kg bodyweight. The total
amount of phosphorous acid that would
be consumed for each kg of potatoes
based on a 30 kg child was calculated.
Based on these calculations the acute
oral toxicity was estimated to be
equivalvent to 1,780 mg PA/kg
bodyweight for a 30 kg child. This is a
conservative scenario which assumes
that all of the phosphorous acid that is
applied to stored potatoes will remain
on the crop such that a 30 kg child
would need to consume 424 kg of
potatoes (to include peel and flesh) in
one sitting. The Agency further assumed
that there are 2.2lbs/kg of potatoes
which would mean that a child would
need to consume 932 pounds of
potatoes that have been treated post
harvest with phosphorous acid in one
sitting to achieve the equivalent of a
limit dose in laboratory animals. This is
a margin of exposure of nearly 1,000fold.
The toxicological profile of a solution
containing 53.8% phosphorous acid is
briefly summarized below.
Acute oral (rat) 449404-04.
LD50>5,000mg/kg body weight (53.8%
phosphorous acid aqueous solution).
The test material is classified as a
Toxicity Category IV for acute oral
toxicity which demonstrates low
toxicity. These results also demonstrates
that a dilution of the active ingredient
significantly decreases the order of
toxicity as compared to the TGAI and
supports the Agency conclusion that use
of the proposed end-use product
eliminates the potential of the active
ingredient to cause acute toxic effects.
There were no adverse effects reported
at 5,000 mg/kg.
Acute dermal (rat) 449404-05.
LD50>5,000mg/kg body weight (53.8%
phosphorous acid aqueous solution).
The test material is classified as a
Toxicity Category IV for acute dermal
toxicity and demonstrates that a
dilution of the active ingredient
significantly decreases the order of
toxicity as compared to the TGAI and
supports the Agency conclusion that use
of the proposed end-use product will be
slightly irritating to the skin.
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Acute inhalation (rat) 449404-06.
LC50>2.06 mg/L (53.8% phosphorous
acid aqueous solution). The test material
is classified as a Toxicity Category IV for
acute inhalation toxicity and
demonstrates that a dilution of the
active ingredient to a level that is
comparable to concentration of
phoshporous acid in the proposed end
use product will not cause acute
inhalation effects at greater than 2.06
mg/L.
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. In a concentrated form, 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
corrosivity 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).
A typical end use product was tested
for acute toxicity. As described above, a
53.8% phosphorous acid product did
not cause acute toxicity at >5,000 mg/
kg bodyweight. This product would be
further diluted when applied to stored
potatoes so that something on the order
of a quarter of a pound of phosphorous
acid would be applied to a ton of stored
potatoes. Calculated estimates of the
residue from such an application would
give a margin of exposure near 1,000 for
young children
The Agency concludes therefore that
the primary hazards such as corrosivity
and irritation that are associated with
concentrated phosphorous acid are
significantly reduced when used as a
post harvest treatment on potatoes at
dilute application rates such as those in
the typical end use product tested and
evaluated by the Agency.
IV. 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 nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
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buildings (residential and other indoor
uses).
The primary issue for adding postharvest applications to a tolerance
exemption is whether such application
causes any new exposure that would not
be safe. In order to evaluate that issue,
the Agency relied on the existing
toxicology data already reviewed on
phosphorous acid to conduct a
conservative dietary exposure and risk
assessment to evaluate any additional
risk that might result from post-harvest
application of this chemical. In the
absence of acute oral studies and any
magnitude of residue data, the Agency
based it’s risk assessment on default
assumptions, (i.e. information from the
inhalation data base was used to
compare to dietary risks, a common
approach in the Agency), to ensure that
the maximum application rates will not
result in unacceptable dietary risks. As
a result of this risk assessment, the
Agency concludes that the use of
phosphorous acid as a post harvest
treatment to stored potatoes at the
recommended application rate will not
add any new exposures or risks and is
considered safe.
Phosphorous acid rapidly dissociates
to form hydrogen and phosphite ions
when applied to growing crops in the
environment and therefore, it has
already been established that no dietary
exposure is expected from pre-harvest
applications. The degredates of
phosphorous acid, hydrogen and
phosphite ions are important nutrients
for plants and animals. Formation of
these degredates however, may be
compromised when phosphorous acid is
applied as a post harvest treatment.
Since post harvest treatment of
phosphorous acid to potatoes is likely to
occur in indoor storage facilities, the
oxidation process of phosphorous acid
will most likely be slowed down. The
fact that the phosphorous acid at the
time of post harvest treatment has not
been oxidized to its degradates is clear
and it is unknown how much this
oxidation process reduces the potential
dietary exposure to phosphorous acid
under the conditions of post harvest
treatment. However, even with these
uncertainties, the Agency believes that
when phosphorous acid is used as a
post harvest treatment at the
recommended application rate, the
remaining residues of PA on stored
potatoes will not increase toxicity or
add any new dietary exposure or risks
and the toxicity of phosphorous acid
would still be classified in category IV
(which is low toxicity) and will be safe.
1. Dietary exposure. The Agency has
determined that post harvest treatment
of phosphorous acid to stored potatoes
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at the typical application rate evaluated
by the Agency may reduce any new
anticipated exposure to phosphorous
acid. However, even if dietary exposure
is not reduced, the Agency believes,
based on its reassessment of the data
and information, that post harvest
application of phosphorous acid to
potatoes is safe.
2. Drinking water exposure. No
significant drinking water exposure is
expected to result from phosphorous
acid when applied a post harvest
treatment to potatoes because
phosphorous acid rapidly degrades, is
very soluble in water and is applied in
storage facilities.
3. Other non-occupational exposure.
There are no residential, school or day
care uses proposed for this product.
Since the proposed use pattern is for
agricultural food crops and post-harvest
treatment on potatoes, the potential for
non-occupational, non-dietary
exposures to phosphorous acid by the
general population, including infants
and children, is highly unlikely.
Further, even if persons were exposed
via the non-occupational route, the
Agency believes that the low toxicity
from a dilute application such as the
one evaluated by the Agency is safe and
the primary hazards associated with
concentrated phosphorous acid
(corrosivity and irritation) will be
significantly reduced because the end
use products are diluted and the
residues following application are very
low.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, 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.’’ These
considerations include the possible
cumulative effects of such residues on
infants and children.
BPPD has considered the potential for
cumulative effects of phosphorous acid
and other substances in relation to a
common mechanism of toxicity.
Phosphorous Acid may share a common
metabolic mechanism with other salts of
phosphorous acid (such as calcium);
however, due to the low order of
toxicity associated with and lack of
reported dietary toxicity associated with
the use of phosphorous fertilizers on
crops, no cumulative effect from the use
of phosphorous acid is expected.
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VI. Determination of Safety for U.S.
Population, Infants and Children
1. U.S. population. There is
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of phosphorous
acid as a result of preharvest and postharvest uses, as that toxicity and
exposure is expected to be minimal.
This includes all anticipated dietary
exposures and all other exposures for
which there is reliable information. This
chemical will be applied as a fungicide
to agricultural food crops and as a postharvest treatment potatoes to stored
potatoes at 35,600 ppm or less. There is
very little potential for dietary exposure
to phosphorous acid, exposure in
drinking water, and from non-dietary,
non-occupational exposures. Once
released into the environment, the
chemical rapidly dissociates to form
hydrogen and phosphite ions, important
nutrients for plants and animals. While
the formation of these degredates may
be compromised when phosphorous
acid is applied as a post harvest
treatment, the recommended
application rate will significantly
reduce any new dietary exposure or
risks and is considered to be safe.
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 and
magnitude of dilution for post-harvest
use of 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. FFDCA
section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin
of exposure (MOE) for infants and
children in the case of threshold effects
to account for prenatal and postnatal
toxicity and the completeness of the
data base on toxicity and exposure,
unless EPA determines that a different
MOE will be safe for infants and
children. Margins of exposure which are
often referred to as uncertainty (safety)
factors, are incorporated into EPA risk
assessments either directly, or through
the use of a MOE analysis, or by using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk. In this instance, based
on all reliable available information the
Agency has reviewed on Phosphorous
Acid, the Agency concludes that the
additional MOE is not necessary to
protect infants and children and that not
adding any additional MOE will be safe
for infants and children. Aggregate
exposure to phosphorous acid is
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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 preharvest to agricultural food
crops and as a post harvest treatment on
potatoes. 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 dilute applications of
phosphorous acid. 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.
mstockstill on PROD1PC68 with PROPOSALS
VII. 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
EPA is required under section 408(p)
of the FFDCA, as amended by FQPA, to
develop a screening program to
determine whether certain substances
(including all pesticide active and other
ingredients) ‘‘may have an effect in
humans that is similar to an effect
produced by a naturally-occurring
estrogen, or other such endocrine effects
as the Administrator may designate.’’
Following the recommendations of its
Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC),
EPA determined that there was
scientific basis for including, as part of
the program, the androgen- and thyroid
hormone systems, in addition to the
estrogen hormone system. EPA also
adopted EDSTAC’s recommendation
that the program include evaluations of
potential effects in wildlife. For
pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in
wildlife may help determine whether a
substance may have an effect in
humans, FFDCA authority to require the
wildlife evaluations. As the science
develops and resources allow, screening
of additional hormone systems may be
added to the Endocrine Disruptor
Screening Program (EDSP).
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At this time, the Agency is not
requiring information on the endocrine
effects of this active ingredient,
phosphorous acid. Based on the weight
of the evidence of available data and the
absence of any reports to the Agency of
sensitivity or other adverse effects, no
endocrine system related effects are
identified for phosphorous acid and
none is expected because of its use. To
date there is no evidence that
phosphorous acid affects the immune
system, functions in a manner similar to
any known hormone, or that it acts as
an endocrine disruptor. Thus, there is
no impact via endocrine-related effects
on the Agency’s safety finding set forth
in this proposed rule amending the
phosphorous acid exemption from the
requirement of a tolerance.
B. Analytical Method
Through this action, the Agency
proposes to amend the existing
exemption from the requirement of a
tolerance for phosphorous acid to
include post harvest treatment on
potatoes for the reasons stated above
which include low toxicity to mammals
and negligible exposure from the
pesticidal use of products containing
phosphorous acid. For the same reasons,
the Agency concludes that an analytical
method is not required for enforcement
purposes for phosphorous acid.
C. Codex Maximum Residue Level
No maximum residue levels (MRLs)
have been established for phosphorous
acid by the Codex Alimentarius
Commission (CODEX).
VIII. Conclusions
The Agency concludes that if
products containing phosphorous acid
as an active ingredient are used in
accordance with label directions, there
is a reasonable certainty that no harm to
the U.S. population, including infants
and children, will result from aggregate
exposure to residues of phosphorous
acid, when used as an agricultural
fungicide on all food commodities or
when used as a post-harvest treatment
on potatoes.
IX. Statutory and Executive Order
Reviews
This proposed rule amends an
exemption from the requirement of a
tolerance under section 408(e) of the
FFDCA 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).
Because this proposed rule has been
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36735
exempted from review under Executive
Order 12866 due to its lack of
significance, this proposed rule is not
subject to Executive Order 13211,
Actions Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001). This proposed 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) (Pub. Law
104-4). Nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions to
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994); or 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 this
Agency initiated amendment to an
exemption from tolerance requirement,
issued section 408(e) of the FFDCA,
requires the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) apply. The Agency hereby certifies
that this proposed action will not have
significant negative economic impact on
a substantial number of small entities.
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
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Federal Register / Vol. 71, No. 124 / Wednesday, June 28, 2006 / Proposed Rules
responsibilities among the various
levels of government.’’ This proposed
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 section 408(n)(4) of the
FFDCA. For these same reasons, the
Agency has determined that this
proposed rule does not have any ‘‘tribal
implications’’ as described in Executive
Order 13175, entitled Consultation and
Coordination with Indian Tribal
Governments (65 FR 67249, November
6, 2000). Executive Order 13175,
requires EPA to develop an accountable
process to ensure ‘‘meaningful and
timely input by tribal officials in the
development of regulatory policies that
have tribal implications.’’ ‘‘Policies that
have tribal implications’’ is defined in
the Executive order to include
regulations that have ‘‘substantial direct
effects on one or more Indian tribes, on
the relationship between the Federal
Government and the Indian tribes, or on
the distribution of power and
responsibilities between the Federal
Government and Indian tribes.’’ This
proposed rule will not have substantial
direct effects on tribal governments, on
the relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the Federal
Government and Indian tribes, as
specified in Executive Order 13175.
Thus, Executive Order 13175 does not
apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: June 20, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 180—[AMENDED]
mstockstill on PROD1PC68 with PROPOSALS
1. The authority citation for part 180
continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1210 is revised to read
as follows:
§ 180.1210 Phosphorous acid; exemption
from the requirement of a tolerance .
An exemption from the requirement
of a tolerance is established for residues
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of phosphorous acid and its ammonium,
sodium, and potassium salts in or on all
food commodities when used as an
agricultural fungicide and in or on
potatoes when applied as a post-harvest
treatment at 35,600 ppm or less
phosphorous acid.
[FR Doc. E6–10031 Filed 6–27–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–1990–0011; FRL–8188–9]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List
Environmental Protection
Agency (EPA).
ACTION: Notice of intent for partial
deletion of the Ellsworth Air Force Base
Site from the National Priorities List.
AGENCY:
SUMMARY: The Environmental Protection
Agency, Region 8 (EPA) announces its
intent to delete portions of the Ellsworth
Air Force Base (AFB) Site located in
Meade and Pennington Counties, South
Dakota, from the National Priorities List
(NPL) and requests public comment on
this action. The NPL constitutes
Appendix B to the National Oil and
Hazardous Substances Pollution
Contingency Plan (NCP), 40 CFR Part
300, which EPA promulgated pursuant
to Section 105 of the Comprehensive
Environmental Response,
Compensation, and Liability Act
(CERCLA).
The EPA has determined, with the
concurrence of the State of South
Dakota through the Department of
Environment and Natural Resources
(SDDENR) that for the parcels proposed
for deletion, all appropriate actions
under CERCLA have been implemented
to protect human health, welfare and
the environment and no further
response action by responsible parties is
appropriate. This partial deletion
pertains to surface soil, unsaturated
subsurface soil, surface water, and
sediments at Operable Units 2, 3, 4, 5,
6, 7, 8, 9, 10 and 12, and excludes the
ground water medium at these parcels.
The ground water medium at the
Ellsworth AFB Site (OU–11, Basewide
Ground Water), and the soil medium
(surface and unsaturated subsurface
soils) at OU–1, Fire Protection Training
Area, will remain on the NPL and
response activities will continue for
those OUs. Two additional areas not
associated with an operable unit, the
Gateway Lake Ash Study Area and the
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Pride Hangar Study Area, are currently
under investigation and are also not part
of this partial deletion.
DATES: Comments concerning this
proposed partial deletion may be
submitted on or before July 28, 2006.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–HQ–
SFUND–1990–0011, by one of the
following methods:
• https://www.regulations.gov: Follow
the on-line instructions for submitting
comments.
• E-mail:
dalton.john@epamail.epa.gov.
• Fax: 303–312–6961.
• Mail: Mr. John Dalton, Community
Involvement Coordinator (8OC), U.S.
EPA, Region 8, 999 18th Street, Suite
300, Denver, CO 80202–2466.
• Hand Delivery: 999 18th Street,
Suite 300, Denver, CO 80202–2466.
Instructions: Direct your comments to
Docket ID No. EPA–HQ–SFUND–1990–
0011. EPA’s policy is that all comments
received will be included in the public
docket without change and may be
made available online at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov or e-mail. The
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through https://
www.regulations.gov, your e-mail
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid the use of
special characters, any form of
encryption, and be free of any defects or
viruses.
Docket: All documents in the docket
are listed in the https://
www.regulations.gov index. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
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Agencies
[Federal Register Volume 71, Number 124 (Wednesday, June 28, 2006)]
[Proposed Rules]
[Pages 36731-36736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-10031]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0561; FRL-8075-5]
Phosphorous Acid; Proposed Amendment to Exemption From Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to amend the existing tolerance
exemption for residues of phosphorous acid and its ammonium, sodium,
and potassium salts in or on all food commodities to allow for post-
harvest application to stored potatoes at 35,600 ppm or less
phosphorous acid.
DATES: Comments must be received on or before July 13, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0561, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0561. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the docket and made
available on the Internet. If you submit an electronic comment, EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If EPA
cannot read your comment due to technical difficulties and cannot
contact you for clarification, EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at https://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.
FOR FURTHER INFORMATION CONTACT: Linda Hollis, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8733; e-mail
address: hollis.linda@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
[[Page 36732]]
Pesticide manufacturing (NAICS code 32532).
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in the entities listed
above. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI). In addition to one
complete version of the comment that includes 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 docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background and Statutory Findings
Pursuant to section 408(e) of the FFDCA, 21 U.S.C. 346a(e), EPA is
proposing, on its own initiative, to amend the existing exemption from
the requirement of a tolerance for residues of phosphorous acid and its
ammonium, sodium and potassium salts, in or on all food commodities
when applied as an agricultural fungicide by adding the post-harvest
treatment of stored potatoes.
40 CFR 180.1(i) states, ``unless otherwise specified, tolerances
and exemptions established under the regulation in this part apply to
residues from only pre harvest application of the chemical.'' As a
result, a tolerance exemption must specify post-harvest application
where the Agency intends to exempt such applications. The existing
tolerance exemption for phosphorous acid (40 CFR 180.1210) does not
expressly allow for post-harvest application of this chemical.
Therefore, the Agency has, of its own initiative, prepared this
proposed amendment to the tolerance exemption for phosphorous acid to
allow post-harvest applications of this active ingredient.
As discussed below, in order to determine the exposure and risks
resulting from post- harvest treatment of potatoes with phosphorous
acid, the Agency conducted a conservative dietary exposure and risk
assessment and has concluded that the use of phosphorous acid as a
post-harvest treatment on stored potatoes presents no new risks as an
agricultural fungicide because the fungicide is applied at very dilute
levels, the lack of acute oral toxicity for the tested end use product
at >5,000 mg/kg body weight, and the rapid degradation of phosphorous
acid. The Agency concludes that the use of phosphorous acid as a post
harvest treatment at these application rates meets the FFDCA standard
of reasonable certainty of no harm.
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 exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
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. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require 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) of the FFDCA 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.''
Section 408(c)(1)(B) of the FFDCA allows the EPA to modify a
regulation on its own initiative under section 408(e). Section 408(e)
requires the EPA to issue a notice of proposed rulemaking and provide a
public comment period of not less than 60 days. However, this provision
also allows the EPA to shorten the comment period ``if the
Administrator for good cause finds that it would be in the public
interest to do so and states the reasons for the finding in the notice
of proposed rulemaking.'' For this particular rule, EPA has shortened
the public comment period to 30 days because the Agency believes that
it is in the public interest to do so. Potatoes are an important
commodity to the agricultural food supply. Post harvest treatment of
potatoes using fungicides will be initiated in late summer. Phosphorous
acid provides a safe alternative to other fungicides used on stored
potatoes. It is therefore important to expedite this tolerance
exemption on order for phosphorous acid to be applied post harvest to
potatoes this use season.
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see https://www.epa.gov/
fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity,
[[Page 36733]]
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.
The toxicity profile for phosphorous acid and its ammonium,
potassium and sodium salts has already been assessed for its pesticidal
use by the Agency and published in support of the tolerance exemption
for residues of phosphorous acid in or on all food commodities when
used as an agricultural fungicide. See the Federal Register of October
5, 2000 (65 FR 59346) (FRL-6599-1). For the purposes of this tolerance
exemption amendment, the Agency has relied on the data and/or
information previously submitted and has reassessed that data in order
to evaluate the request to add post harvest uses to the tolerance
exemption. Additionally, the Agency has reviewed publicly available
data and information on phosphoric acid, which is chemically and
structurally similar to phosphorous acid. The Agency believes that in
combination, the data and other information relied upon for this
tolerance exemption supports its conclusion that there is reasonable
certainty of no harm that will result from the post harvest treatment
of potatoes with phosphorous acid when used according to the
recommended application rate.
The technical grade of the active ingredient of phosphorous acid
has also been fully characterized and assessed by the Agency in the
Mineral Acids RED (December 1993) since it is an ingredient which falls
within the class of compounds known as the mineral acids. Information
on phosphorous acid indicates that it is classified in Toxicity
Category III for the oral and dermal routes of exposure, and that it is
corrosive to the eyes and skin. The corrosive nature of concentrated or
technical grade phosphorous acid is not of a concern because phosphorus
acid is applied at very dilute solutions such as 0.25 pounds of
phosphorus acid per ton of stored potatoes. Phosphorous acid as applied
at such very dilute rates is only slightly irritating to the skin.
Further, when applied at such permissible application rate, the
residues of the applied phosphorous acid solution have an acute
toxicity that is several hundred times lower than the acute toxicity of
phosphorous acid in a 100% pure form.
As mentioned above, the Agency, on its own initiative, re-examined
the previously reviewed toxicity data on an end use product that
contains 35.6% phosphorus acid by weight and would be applied at 0.25
pounds of active ingredient per ton of stored potatoes. The results
demonstrated that there is a margin of exposure of nearly 1,000 for
children or the equivalent of a 30 kg child consuming 932 pounds of
potatoes at one time. This large margin of exposure provides reasonable
certainty of no harm at application rates in excess of that for the
reviewed end use product. Specifically, an end use product containing
53.8% phosphorous acid by volume (or 35.6% phosphorus acid by weight)
was tested on rats at > 5,000 mg/kg bodyweight. The total amount of
phosphorous acid that would be consumed for each kg of potatoes based
on a 30 kg child was calculated. Based on these calculations the acute
oral toxicity was estimated to be equivalvent to 1,780 mg PA/kg
bodyweight for a 30 kg child. This is a conservative scenario which
assumes that all of the phosphorous acid that is applied to stored
potatoes will remain on the crop such that a 30 kg child would need to
consume 424 kg of potatoes (to include peel and flesh) in one sitting.
The Agency further assumed that there are 2.2lbs/kg of potatoes which
would mean that a child would need to consume 932 pounds of potatoes
that have been treated post harvest with phosphorous acid in one
sitting to achieve the equivalent of a limit dose in laboratory
animals. This is a margin of exposure of nearly 1,000-fold.
The toxicological profile of a solution containing 53.8%
phosphorous acid is briefly summarized below.
Acute oral (rat) 449404-04. LD50>5,000mg/kg body weight
(53.8% phosphorous acid aqueous solution). The test material is
classified as a Toxicity Category IV for acute oral toxicity which
demonstrates low toxicity. These results also demonstrates that a
dilution of the active ingredient significantly decreases the order of
toxicity as compared to the TGAI and supports the Agency conclusion
that use of the proposed end-use product eliminates the potential of
the active ingredient to cause acute toxic effects. There were no
adverse effects reported at 5,000 mg/kg.
Acute dermal (rat) 449404-05. LD50>5,000mg/kg body
weight (53.8% phosphorous acid aqueous solution). The test material is
classified as a Toxicity Category IV for acute dermal toxicity and
demonstrates that a dilution of the active ingredient significantly
decreases the order of toxicity as compared to the TGAI and supports
the Agency conclusion that use of the proposed end-use product will be
slightly irritating to the skin.
Acute inhalation (rat) 449404-06. LC50>2.06 mg/L (53.8%
phosphorous acid aqueous solution). The test material is classified as
a Toxicity Category IV for acute inhalation toxicity and demonstrates
that a dilution of the active ingredient to a level that is comparable
to concentration of phoshporous acid in the proposed end use product
will not cause acute inhalation effects at greater than 2.06 mg/L.
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. In a concentrated form,
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 corrosivity 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).
A typical end use product was tested for acute toxicity. As
described above, a 53.8% phosphorous acid product did not cause acute
toxicity at >5,000 mg/kg bodyweight. This product would be further
diluted when applied to stored potatoes so that something on the order
of a quarter of a pound of phosphorous acid would be applied to a ton
of stored potatoes. Calculated estimates of the residue from such an
application would give a margin of exposure near 1,000 for young
children
The Agency concludes therefore that the primary hazards such as
corrosivity and irritation that are associated with concentrated
phosphorous acid are significantly reduced when used as a post harvest
treatment on potatoes at dilute application rates such as those in the
typical end use product tested and evaluated by the Agency.
IV. 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
[[Page 36734]]
buildings (residential and other indoor uses).
The primary issue for adding post-harvest applications to a
tolerance exemption is whether such application causes any new exposure
that would not be safe. In order to evaluate that issue, the Agency
relied on the existing toxicology data already reviewed on phosphorous
acid to conduct a conservative dietary exposure and risk assessment to
evaluate any additional risk that might result from post-harvest
application of this chemical. In the absence of acute oral studies and
any magnitude of residue data, the Agency based it's risk assessment on
default assumptions, (i.e. information from the inhalation data base
was used to compare to dietary risks, a common approach in the Agency),
to ensure that the maximum application rates will not result in
unacceptable dietary risks. As a result of this risk assessment, the
Agency concludes that the use of phosphorous acid as a post harvest
treatment to stored potatoes at the recommended application rate will
not add any new exposures or risks and is considered safe.
Phosphorous acid rapidly dissociates to form hydrogen and phosphite
ions when applied to growing crops in the environment and therefore, it
has already been established that no dietary exposure is expected from
pre-harvest applications. The degredates of phosphorous acid, hydrogen
and phosphite ions are important nutrients for plants and animals.
Formation of these degredates however, may be compromised when
phosphorous acid is applied as a post harvest treatment. Since post
harvest treatment of phosphorous acid to potatoes is likely to occur in
indoor storage facilities, the oxidation process of phosphorous acid
will most likely be slowed down. The fact that the phosphorous acid at
the time of post harvest treatment has not been oxidized to its
degradates is clear and it is unknown how much this oxidation process
reduces the potential dietary exposure to phosphorous acid under the
conditions of post harvest treatment. However, even with these
uncertainties, the Agency believes that when phosphorous acid is used
as a post harvest treatment at the recommended application rate, the
remaining residues of PA on stored potatoes will not increase toxicity
or add any new dietary exposure or risks and the toxicity of
phosphorous acid would still be classified in category IV (which is low
toxicity) and will be safe.
1. Dietary exposure. The Agency has determined that post harvest
treatment of phosphorous acid to stored potatoes at the typical
application rate evaluated by the Agency may reduce any new anticipated
exposure to phosphorous acid. However, even if dietary exposure is not
reduced, the Agency believes, based on its reassessment of the data and
information, that post harvest application of phosphorous acid to
potatoes is safe.
2. Drinking water exposure. No significant drinking water exposure
is expected to result from phosphorous acid when applied a post harvest
treatment to potatoes because phosphorous acid rapidly degrades, is
very soluble in water and is applied in storage facilities.
3. Other non-occupational exposure. There are no residential,
school or day care uses proposed for this product. Since the proposed
use pattern is for agricultural food crops and post-harvest treatment
on potatoes, the potential for non-occupational, non-dietary exposures
to phosphorous acid by the general population, including infants and
children, is highly unlikely. Further, even if persons were exposed via
the non-occupational route, the Agency believes that the low toxicity
from a dilute application such as the one evaluated by the Agency is
safe and the primary hazards associated with concentrated phosphorous
acid (corrosivity and irritation) will be significantly reduced because
the end use products are diluted and the residues following application
are very low.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, 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.'' These considerations
include the possible cumulative effects of such residues on infants and
children.
BPPD has considered the potential for cumulative effects of
phosphorous acid and other substances in relation to a common mechanism
of toxicity. Phosphorous Acid may share a common metabolic mechanism
with other salts of phosphorous acid (such as calcium); however, due to
the low order of toxicity associated with and lack of reported dietary
toxicity associated with the use of phosphorous fertilizers on crops,
no cumulative effect from the use of phosphorous acid is expected.
VI. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. There is reasonable certainty that no harm will
result to the U.S. population, including infants and children, from
aggregate exposure to residues of phosphorous acid as a result of
preharvest and post-harvest uses, as that toxicity and exposure is
expected to be minimal. This includes all anticipated dietary exposures
and all other exposures for which there is reliable information. This
chemical will be applied as a fungicide to agricultural food crops and
as a post-harvest treatment potatoes to stored potatoes at 35,600 ppm
or less. There is very little potential for dietary exposure to
phosphorous acid, exposure in drinking water, and from non-dietary,
non-occupational exposures. Once released into the environment, the
chemical rapidly dissociates to form hydrogen and phosphite ions,
important nutrients for plants and animals. While the formation of
these degredates may be compromised when phosphorous acid is applied as
a post harvest treatment, the recommended application rate will
significantly reduce any new dietary exposure or risks and is
considered to be safe.
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 and magnitude of
dilution for post-harvest use of 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. FFDCA section 408(b)(2)(C) provides that
EPA shall apply an additional tenfold margin of exposure (MOE) for
infants and children in the case of threshold effects to account for
prenatal and postnatal toxicity and the completeness of the data base
on toxicity and exposure, unless EPA determines that a different MOE
will be safe for infants and children. Margins of exposure which are
often referred to as uncertainty (safety) factors, are incorporated
into EPA risk assessments either directly, or through the use of a MOE
analysis, or by using uncertainty (safety) factors in calculating a
dose level that poses no appreciable risk. In this instance, based on
all reliable available information the Agency has reviewed on
Phosphorous Acid, the Agency concludes that the additional MOE is not
necessary to protect infants and children and that not adding any
additional MOE will be safe for infants and children. Aggregate
exposure to phosphorous acid is
[[Page 36735]]
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 preharvest to
agricultural food crops and as a post harvest treatment on potatoes.
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 dilute applications of phosphorous acid. 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.
VII. 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
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally-occurring estrogen, or other such endocrine effects as the
Administrator may designate.'' Following the recommendations of its
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC),
EPA determined that there was scientific basis for including, as part
of the program, the androgen- and thyroid hormone systems, in addition
to the estrogen hormone system. EPA also adopted EDSTAC's
recommendation that the program include evaluations of potential
effects in wildlife. For pesticide chemicals, EPA will use FIFRA and,
to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).
At this time, the Agency is not requiring information on the
endocrine effects of this active ingredient, phosphorous acid. Based on
the weight of the evidence of available data and the absence of any
reports to the Agency of sensitivity or other adverse effects, no
endocrine system related effects are identified for phosphorous acid
and none is expected because of its use. To date there is no evidence
that phosphorous acid affects the immune system, functions in a manner
similar to any known hormone, or that it acts as an endocrine
disruptor. Thus, there is no impact via endocrine-related effects on
the Agency's safety finding set forth in this proposed rule amending
the phosphorous acid exemption from the requirement of a tolerance.
B. Analytical Method
Through this action, the Agency proposes to amend the existing
exemption from the requirement of a tolerance for phosphorous acid to
include post harvest treatment on potatoes for the reasons stated above
which include low toxicity to mammals and negligible exposure from the
pesticidal use of products containing phosphorous acid. For the same
reasons, the Agency concludes that an analytical method is not required
for enforcement purposes for phosphorous acid.
C. Codex Maximum Residue Level
No maximum residue levels (MRLs) have been established for
phosphorous acid by the Codex Alimentarius Commission (CODEX).
VIII. Conclusions
The Agency concludes that if products containing phosphorous acid
as an active ingredient are used in accordance with label directions,
there is a reasonable certainty that no harm to the U.S. population,
including infants and children, will result from aggregate exposure to
residues of phosphorous acid, when used as an agricultural fungicide on
all food commodities or when used as a post-harvest treatment on
potatoes.
IX. Statutory and Executive Order Reviews
This proposed rule amends an exemption from the requirement of a
tolerance under section 408(e) of the FFDCA 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). Because this proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001). This proposed 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) (Pub. Law 104-4). Nor does
it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or 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 this
Agency initiated amendment to an exemption from tolerance requirement,
issued section 408(e) of the FFDCA, requires the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) apply. The Agency hereby certifies that this
proposed action will not have significant negative economic impact on a
substantial number of small entities. 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
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responsibilities among the various levels of government.'' This
proposed 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 section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled Consultation and Coordination with
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 20, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be 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), 346a and 371.
2. Section 180.1210 is revised 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 and in or on potatoes when applied as a post-harvest
treatment at 35,600 ppm or less phosphorous acid.
[FR Doc. E6-10031 Filed 6-27-06; 8:45 am]
BILLING CODE 6560-50-S