[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Proposed Rules]
[Page 36731-36736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn06-36]
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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
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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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: http://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
http://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 http://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
http://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 http://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
[[Page 36736]]
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]
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