Document ID: EPA-HQ-OPP-2006-0561-0003
Agency: epa
Document Type: Rule
Title: Phosphorous Acid; Exemption from the Requirement of a Tolerance
Posted Date: 2006-08-23T12:55:33Z

[Federal Register: August 23, 2006 (Volume 71, Number 163)]
[Rules and Regulations]               
[Page 49368-49373]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au06-18]                         

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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.

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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 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 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 http://www.regulations.gov
, you may access this ``Federal Register'' document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://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 http://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: 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.

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