Phosphorous Acid; Exemption from the Requirement of a Tolerance, 49368-49373 [E6-13954]
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49368
Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Rules and Regulations
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Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires
EPA to develop an accountable process
to ensure ‘‘meaningful and timely input
by State and local officials in the
development of regulatory policies that
have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is
defined in the Executive order to
include regulations that have
‘‘substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this 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
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 rule.
VII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
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the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 11, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.566 is amended by
removing paragraph (a)(1), by
redesignating paragraph (a)(2) as
paragraph (a)(1), by revising the table in
newly redesignated paragraph (a)(1),
and by redesignating paragraphs (a)(3)
and (a)(4) as paragraphs (a)(2) and (a)(3),
respectively, to read as follows:
I
(a) *
(1) *
Fenpyroximate; tolerances for
*
*
*
*
Parts per
million
Commodity
Almond, hulls ........................
Citrus, dried pulp ..................
Citrus, oil ...............................
Cotton, gin byproducts .........
Cotton undelinted seed ........
Fruit, citrus, group 10 ...........
Fruit, pome, group 11 ...........
Grape ....................................
Hop, dried cones ..................
Nut, tree, group 14 ...............
Peppermint, tops ..................
Pistachio ...............................
Spearmint, tops ....................
*
*
*
*
3.0
2.5
10
10
0.10
0.60
0.40
1.0
10
0.10
7.0
0.10
7.0
*
[FR Doc. E6–13761 Filed 8–22–06; 8:45 am]
BILLING CODE 6560–50–S
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40 CFR Part 180
[EPA–HQ–OPP–2006–0561; FRL–8084–3]
Phosphorous Acid; Exemption from
the Requirement of a Tolerance
List of Subjects in 40 CFR Part 180
§ 180.566
residues.
ENVIRONMENTAL PROTECTION
AGENCY
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes an
exemption from the requirement of a
tolerance for residues of phosphorous
acid and its ammonium, sodium, and
potassium salts in or all food
commodities to allow for post-harvest
application to stored potatoes at 35,600
parts per million (ppm) or less of
phosphorus acid. This exemption is
being issued at EPA’s own initiative
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from
the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of phosphorous acid and its
ammonium, sodium, and potassium
salts.
This regulation is effective
August 23, 2006. Objections and
requests for hearings must be received
on or before September 7, 2006, and
must be filed in accordance with the
instructions provided in 40 CFR part
178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2006–0561. All documents in the
docket are listed in the index for the
docket. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information (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 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 Docket Facility is open 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
DATES:
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Pollution Prevention Division (7511P),
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).
• 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. 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. How Can I Access Electronic Copies
of this Document?
In addition to accessing an electronic
copy of this Federal Register document
through the electronic docket at https://
www.regulations.gov, you may access
this ‘‘Federal Register’’ document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr. You may
also access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
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C. Can I File an Objection or Hearing
Request?
Under section 408(g) of FFDCA, as
amended by the FQPA, any person may
file an objection to any aspect of this
regulation and may also request a
hearing on those objections. The EPA
procedural regulations which govern the
submission of objections and requests
for hearings appear in 40 CFR part 178.
You must file your objection or request
a hearing on this regulation in
accordance with the instructions
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provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2006–0561 in the subject line on
the first page of your submission. All
requests must be in writing, and must be
mailed or delivered to the Hearing Clerk
on or before September 7, 2006.
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket that is described in
ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit your
copies, identified by docket 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.
II. Background and Statutory Findings
In the Federal Register of June 28,
2006 (71 FR 36731–36736) (FRL–8075–
5), EPA issued a notice pursuant to
section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the Agency
initiated proposed rule. The proposed
rule proposed to amend 40 CFR part 180
by establishing an exemption from the
requirement of a tolerance for residues
of phosphorous acid and its ammonium,
sodium and potassium salt. There were
no comments received in response to
the Agency initiated proposed rule.
Section 408(c)(2)(A)(i) of 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 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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49369
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 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.’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness, and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
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 65
FR 59346 (October 5, 2000). 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,
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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 (TGAI) 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 a 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
kilogram (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 milligrams/kilogram
of bodyweight (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
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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 postharvest 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 a
thousandfold.
The toxicological profile of a solution
containing 53.8% phosphorous acid is
briefly summarized below.
1. Acute oral (rat) 449404–04. LD50 >
5,000 mg/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 demonstrate
that a dilution of the active ingredient
significantly decreases the order of
toxicity as compared to the technical
grade of the active ingredient (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.
2. Acute dermal (rat) 449404–05. LD50
> 5,000 mg/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.
3. 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
milligrams/liter (mg/L).
4. 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,
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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,
section 408 of FFDCA 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
buildings (residential and other indoor
uses).
A. Dietary Exposure
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
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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 degradates of
phosphorous acid, hydrogen and
phosphite ions are important nutrients
for plants and animals. Formation of
these degradates 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. Food. 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 as a post-harvest
treatment to potatoes because
phosphorous acid rapidly degrades, is
very soluble in water and is applied in
storage facilities.
B. 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
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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 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 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 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, nonoccupational 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 degradates may be
compromised when phosphorous acid is
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49371
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
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
A. Endocrine Disruptors
EPA is required under section 408(p)
of FFDCA, as amended by FQPA, to
develop a screening program to
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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 weightof-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 are 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 rule amending the phosphorous
acid exemption from the requirement of
a tolerance.
sroberts on PROD1PC70 with RULES
B. Analytical Method(s)
Through this action, the Agency is
amending the existing exemption from
the requirement of a tolerance for
phosphorous acid to include postharvest 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).
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15:49 Aug 22, 2006
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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 final rule establishes an
exemption from the requirement of a
tolerance under section 408(d) of
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 rule has been exempted
from review under Executive Order
12866 due to its lack of significance,
this 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 final rule
does not contain any information
collections subject to OMB approval
under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4). Nor does it require any
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
tolerances and exemptions that are
established on the basis of a petition
under section 408(d) of FFDCA, such as
the exemption from the requirement of
a tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
PO 00000
Frm 00064
Fmt 4700
Sfmt 4700
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. The Agency hereby
certifies that this rule 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
responsibilities among the various
levels of government.’’ This final rule
directly regulates growers, food
processors, food handlers and food
retailers, not States. This action does not
alter the relationships or distribution of
power and responsibilities established
by Congress in the preemption
provisions of section 408(n)(4) of
FFDCA. For these same reasons, the
Agency has determined that this 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
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.
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Federal Register / Vol. 71, No. 163 / Wednesday, August 23, 2006 / Rules and Regulations
Thus, Executive Order 13175 does not
apply to this rule
GENERAL SERVICES
ADMINISTRATION
X. Congressional Review Act
41 CFR Parts 301–10, 301–11, 301–50,
301–52, 301–71, and 301–73
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of this final
rule in the Federal Register. This final
rule is not a ‘‘major rule’’ as defined by
5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 14, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution
Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1210 is revised to read
as follows:
I
§ 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. E6–13954 Filed 8–22–06; 8:45 am]
sroberts on PROD1PC70 with RULES
BILLING CODE 6560–50–S
[FTR Amendment 2006–04; FTR Case 2005–
305]
RIN 3090–AI19
Federal Travel Regulation; E-Gov
Travel Service (ETS) and Use of
Contract City-Pair Fares
Office of Governmentwide
Policy, General Services Administration
(GSA).
ACTION: Final rule.
AGENCY:
SUMMARY: The General Services
Administration (GSA) is amending the
Federal Travel Regulation (FTR), by
adding new requirements that address
the use of other-than contract city pair
airfares, the handling of receipts under
the E-Gov Travel Service (ETS)
environment, and new responsibilities
for reviewing officials. This final rule
also introduces and defines the term
‘‘online self-service booking tool’’ and
provides for exceptions under certain
circumstances to the required use of an
agency’s current Travel Management
Service (TMS) or ETS once the agency
has fully deployed ETS. Finally, this
final rule requires agencies to develop
and submit upon request to the ETS
Program Management Office, a plan for
maximizing the agency’s adoption rate
(i.e., achieving the highest possible rate
of use of the agency’s online self-service
booking tool) once the agency has fully
deployed ETS. The explanation of
changes is addressed in the
supplementary information below. The
FTR and any corresponding documents
may be accessed at GSA’s Web site at
https://www.gsa.gov/ftr.
DATES: Effective Date: September 22,
2006.
FOR FURTHER INFORMATION CONTACT: The
Regulatory Secretariat (VIR), Room
4035, GS Building, Washington, DC,
20405, (202) 208–7312, for information
pertaining to status or publication
schedules. For clarification of content,
contact Ms. Umeki Gray Thorne, Office
of Governmentwide Policy, Travel
Management Policy, at (202) 208–7636.
Please cite FTR Amendment 2006–04;
FTR case 2005–305.
SUPPLEMENTARY INFORMATION:
Background
This final rule amends the Federal
Travel Regulation as follows:
• Sections 301–10.106 and 301–
10.107 are redesignated as sections 301–
10.105 and 301–10.106, respectively.
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15:49 Aug 22, 2006
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49373
• Newly redesignated section 301–
10.106 language is revised by removing
exceptions to the use of a contract citypair fare and incorporating them into
new section 301–10.107. Note to section
301–10.106 indicates that employees of
the Government of the District of
Columbia, with the exception of the
District of Columbia Courts, are not
eligible to use contract city-pair fares
even though these employees otherwise
may be covered by the FTR.
• New section 301–10.107 ‘‘Are there
any exceptions to the use of a contract
city-pair fare,’’ incorporates exceptions
to use of a contract city-pair fare
(formerly contained in section 301–
10.107, redesignated as section 301–
10.106) for agency consideration in
deciding whether to approve the use of
other-than a contract city-pair fare. Note
1 to section 301–10.107 (previously
Note 2 to this section) is revised to state
that any group of 10 or more passengers
traveling together on the same day, on
the same flight, for the same mission
requiring group integrity and identified
as a group by the travel management
system upon booking, may request
contract city-pair service on an optional
basis.
Note 2 to section 301–10.107 is added
to clarify that contractors are not eligible
to use contract city-pair fares in the
performance of their contract.
Note 3 to section 301–10.107 is added
to encourage agencies to optimize
savings from the contract city pair
program by comparing the cost savings
achieved by use of capacity-controlled
coach class contract city-pair fares
(MCA, QCA, VCA, etc.) to the
unrestricted coach class contract fare
(YCA), when capacity-controlled fares
are available and meet mission needs.
• Section 301–10.108 is amended by
informing travelers that they are
required to document on their travel
authorization the approval and use of a
non-contract city-pair air fare. This
section also adds a note to clarify that
air carrier preference is not a valid
reason for approving the use of a noncontract airfare.
• Section 301–11.25 is revised to
address the handling of receipts when
an agency has fully deployed ETS.
• The section heading for section 301–
50.3 is revised to include the term
‘‘TMS’’ and references to exceptions are
included in the text.
• Sections 301–50.4 is revised to add
TMS in its section heading and to
incorporate when an exception to the
use of an agency’s current TMS may be
granted.
• Section 50.6 is redesignated as
section 50.8.
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]]>Agencies
[Federal Register Volume 71, Number 163 (Wednesday, August 23, 2006)]
[Rules and Regulations]
[Pages 49368-49373]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13954]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0561; FRL-8084-3]
Phosphorous Acid; Exemption from the Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of phosphorous acid and its ammonium,
sodium, and potassium salts in or all food commodities to allow for
post-harvest application to stored potatoes at 35,600 parts per million
(ppm) or less of phosphorus acid. This exemption is being issued at
EPA's own initiative under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of phosphorous acid and its ammonium, sodium, and
potassium salts.
DATES: This regulation is effective August 23, 2006. Objections and
requests for hearings must be received on or before September 7, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0561. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Docket Facility is open 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
[[Page 49369]]
Pollution Prevention Division (7511P), 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).
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. 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. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at https://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at https://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at https://
www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, as amended by the FQPA, any person
may file an objection to any aspect of this regulation and may also
request a hearing on those objections. The EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2006-0561 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk on or before September 7,
2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket 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.
II. Background and Statutory Findings
In the Federal Register of June 28, 2006 (71 FR 36731-36736) (FRL-
8075-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the Agency initiated proposed rule. The
proposed rule proposed to amend 40 CFR part 180 by establishing an
exemption from the requirement of a tolerance for residues of
phosphorous acid and its ammonium, sodium and potassium salt. There
were no comments received in response to the Agency initiated proposed
rule.
Section 408(c)(2)(A)(i) of 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 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 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.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
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 65 FR 59346 (October 5, 2000).
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,
[[Page 49370]]
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 (TGAI) 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 a 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 kilogram (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 milligrams/kilogram of
bodyweight (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 a thousandfold.
The toxicological profile of a solution containing 53.8%
phosphorous acid is briefly summarized below.
1. Acute oral (rat) 449404-04. LD50 > 5,000 mg/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 demonstrate that a
dilution of the active ingredient significantly decreases the order of
toxicity as compared to the technical grade of the active ingredient
(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.
2. Acute dermal (rat) 449404-05. LD50 > 5,000 mg/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.
3. 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 milligrams/liter (mg/L).
4. 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, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
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
[[Page 49371]]
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 degradates of phosphorous acid, hydrogen
and phosphite ions are important nutrients for plants and animals.
Formation of these degradates 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. Food. 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 as a post-
harvest treatment to potatoes because phosphorous acid rapidly
degrades, is very soluble in water and is applied in storage
facilities.
B. 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 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 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 degradates 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 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
A. Endocrine Disruptors
EPA is required under section 408(p) of FFDCA, as amended by FQPA,
to develop a screening program to
[[Page 49372]]
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 are 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 rule amending the
phosphorous acid exemption from the requirement of a tolerance.
B. Analytical Method(s)
Through this action, the Agency is amending 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 final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of 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 rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this 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 final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any 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
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the exemption from the
requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. The Agency
hereby certifies that this rule 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 responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this 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 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.
[[Page 49373]]
Thus, Executive Order 13175 does not apply to this rule
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 14, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Division, Office of Pesticide
Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
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. E6-13954 Filed 8-22-06; 8:45 am]
BILLING CODE 6560-50-S
