

[Federal Register: June 28, 2006 (Volume 71, Number 124)]
[Proposed Rules]               
[Page 36731-36736]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28jn06-36]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0561; FRL-8075-5]

 
Phosphorous Acid; Proposed Amendment to Exemption From Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to amend the existing tolerance 
exemption for residues of phosphorous acid and its ammonium, sodium, 
and potassium salts in or on all food commodities to allow for post-
harvest application to stored potatoes at 35,600 ppm or less 
phosphorous acid.

DATES: Comments must be received on or before July 13, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2006-0561, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0561. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
http://www.regulations.gov, including any personal information 

provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov website is an ``anonymous access'' 
system, which means EPA will not know your identity or contact 
information unless you provide it in the body of your comment. If you 
send an e-mail comment directly to EPA without going through 
regulations.gov, your e-mail address will be automatically captured and 
included as part of the comment that is placed in the docket and made 
available on the Internet. If you submit an electronic comment, EPA 
recommends that you include your name and other contact information in 
the body of your comment and with any disk or CD-ROM you submit. If EPA 
cannot read your comment due to technical difficulties and cannot 
contact you for clarification, EPA may not be able to consider your 
comment. Electronic files should avoid the use of special characters, 
any form of encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation 
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Linda Hollis, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8733; e-mail 
address: hollis.linda@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).

[[Page 36732]]

     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in the entities listed 
above. If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
http://www.regulations.gov or e-mail. Clearly mark the part or all of the 

information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI). In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background and Statutory Findings

    Pursuant to section 408(e) of the FFDCA, 21 U.S.C. 346a(e), EPA is 
proposing, on its own initiative, to amend the existing exemption from 
the requirement of a tolerance for residues of phosphorous acid and its 
ammonium, sodium and potassium salts, in or on all food commodities 
when applied as an agricultural fungicide by adding the post-harvest 
treatment of stored potatoes.
    40 CFR 180.1(i) states, ``unless otherwise specified, tolerances 
and exemptions established under the regulation in this part apply to 
residues from only pre harvest application of the chemical.'' As a 
result, a tolerance exemption must specify post-harvest application 
where the Agency intends to exempt such applications. The existing 
tolerance exemption for phosphorous acid (40 CFR 180.1210) does not 
expressly allow for post-harvest application of this chemical. 
Therefore, the Agency has, of its own initiative, prepared this 
proposed amendment to the tolerance exemption for phosphorous acid to 
allow post-harvest applications of this active ingredient.
    As discussed below, in order to determine the exposure and risks 
resulting from post- harvest treatment of potatoes with phosphorous 
acid, the Agency conducted a conservative dietary exposure and risk 
assessment and has concluded that the use of phosphorous acid as a 
post-harvest treatment on stored potatoes presents no new risks as an 
agricultural fungicide because the fungicide is applied at very dilute 
levels, the lack of acute oral toxicity for the tested end use product 
at >5,000 mg/kg body weight, and the rapid degradation of phosphorous 
acid. The Agency concludes that the use of phosphorous acid as a post 
harvest treatment at these application rates meets the FFDCA standard 
of reasonable certainty of no harm.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA 
defines ``safe'' to mean that ``there is a reasonable certainty that no 
harm will result from aggregate exposure to the pesticide chemical 
residue, including all anticipated dietary exposures and all other 
exposures for which there is reliable information.'' This includes 
exposure through drinking water and in residential settings, but does 
not include occupational exposure. Pursuant to section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C), which require EPA to give special consideration 
to exposure of infants and children to the pesticide chemical residue 
in establishing a tolerance and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue....'' 
Additionally, section 408(b)(2)(D) of the FFDCA requires that the 
Agency consider ``available information concerning the cumulative 
effects of a particular pesticide's residues'' and ``other substances 
that have a common mechanism of toxicity.''
    Section 408(c)(1)(B) of the FFDCA allows the EPA to modify a 
regulation on its own initiative under section 408(e). Section 408(e) 
requires the EPA to issue a notice of proposed rulemaking and provide a 
public comment period of not less than 60 days. However, this provision 
also allows the EPA to shorten the comment period ``if the 
Administrator for good cause finds that it would be in the public 
interest to do so and states the reasons for the finding in the notice 
of proposed rulemaking.'' For this particular rule, EPA has shortened 
the public comment period to 30 days because the Agency believes that 
it is in the public interest to do so. Potatoes are an important 
commodity to the agricultural food supply. Post harvest treatment of 
potatoes using fungicides will be initiated in late summer. Phosphorous 
acid provides a safe alternative to other fungicides used on stored 
potatoes. It is therefore important to expedite this tolerance 
exemption on order for phosphorous acid to be applied post harvest to 
potatoes this use season.
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.


III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this action and considered its validity,

[[Page 36733]]

completeness, and reliability and the relationship of this information 
to human risk. EPA has also considered available information concerning 
the variability of the sensitivities of major identifiable subgroups of 
consumers, including infants and children.
    The toxicity profile for phosphorous acid and its ammonium, 
potassium and sodium salts has already been assessed for its pesticidal 
use by the Agency and published in support of the tolerance exemption 
for residues of phosphorous acid in or on all food commodities when 
used as an agricultural fungicide. See the Federal Register of October 
5, 2000 (65 FR 59346) (FRL-6599-1). For the purposes of this tolerance 
exemption amendment, the Agency has relied on the data and/or 
information previously submitted and has reassessed that data in order 
to evaluate the request to add post harvest uses to the tolerance 
exemption. Additionally, the Agency has reviewed publicly available 
data and information on phosphoric acid, which is chemically and 
structurally similar to phosphorous acid. The Agency believes that in 
combination, the data and other information relied upon for this 
tolerance exemption supports its conclusion that there is reasonable 
certainty of no harm that will result from the post harvest treatment 
of potatoes with phosphorous acid when used according to the 
recommended application rate.
    The technical grade of the active ingredient of phosphorous acid 
has also been fully characterized and assessed by the Agency in the 
Mineral Acids RED (December 1993) since it is an ingredient which falls 
within the class of compounds known as the mineral acids. Information 
on phosphorous acid indicates that it is classified in Toxicity 
Category III for the oral and dermal routes of exposure, and that it is 
corrosive to the eyes and skin. The corrosive nature of concentrated or 
technical grade phosphorous acid is not of a concern because phosphorus 
acid is applied at very dilute solutions such as 0.25 pounds of 
phosphorus acid per ton of stored potatoes. Phosphorous acid as applied 
at such very dilute rates is only slightly irritating to the skin. 
Further, when applied at such permissible application rate, the 
residues of the applied phosphorous acid solution have an acute 
toxicity that is several hundred times lower than the acute toxicity of 
phosphorous acid in a 100% pure form.
    As mentioned above, the Agency, on its own initiative, re-examined 
the previously reviewed toxicity data on an end use product that 
contains 35.6% phosphorus acid by weight and would be applied at 0.25 
pounds of active ingredient per ton of stored potatoes. The results 
demonstrated that there is a margin of exposure of nearly 1,000 for 
children or the equivalent of a 30 kg child consuming 932 pounds of 
potatoes at one time. This large margin of exposure provides reasonable 
certainty of no harm at application rates in excess of that for the 
reviewed end use product. Specifically, an end use product containing 
53.8% phosphorous acid by volume (or 35.6% phosphorus acid by weight) 
was tested on rats at > 5,000 mg/kg bodyweight. The total amount of 
phosphorous acid that would be consumed for each kg of potatoes based 
on a 30 kg child was calculated. Based on these calculations the acute 
oral toxicity was estimated to be equivalvent to 1,780 mg PA/kg 
bodyweight for a 30 kg child. This is a conservative scenario which 
assumes that all of the phosphorous acid that is applied to stored 
potatoes will remain on the crop such that a 30 kg child would need to 
consume 424 kg of potatoes (to include peel and flesh) in one sitting. 
The Agency further assumed that there are 2.2lbs/kg of potatoes which 
would mean that a child would need to consume 932 pounds of potatoes 
that have been treated post harvest with phosphorous acid in one 
sitting to achieve the equivalent of a limit dose in laboratory 
animals. This is a margin of exposure of nearly 1,000-fold.
    The toxicological profile of a solution containing 53.8% 
phosphorous acid is briefly summarized below.
    Acute oral (rat) 449404-04. LD50>5,000mg/kg body weight 
(53.8% phosphorous acid aqueous solution). The test material is 
classified as a Toxicity Category IV for acute oral toxicity which 
demonstrates low toxicity. These results also demonstrates that a 
dilution of the active ingredient significantly decreases the order of 
toxicity as compared to the TGAI and supports the Agency conclusion 
that use of the proposed end-use product eliminates the potential of 
the active ingredient to cause acute toxic effects. There were no 
adverse effects reported at 5,000 mg/kg.
    Acute dermal (rat) 449404-05. LD50>5,000mg/kg body 
weight (53.8% phosphorous acid aqueous solution). The test material is 
classified as a Toxicity Category IV for acute dermal toxicity and 
demonstrates that a dilution of the active ingredient significantly 
decreases the order of toxicity as compared to the TGAI and supports 
the Agency conclusion that use of the proposed end-use product will be 
slightly irritating to the skin.
    Acute inhalation (rat) 449404-06. LC50>2.06 mg/L (53.8% 
phosphorous acid aqueous solution). The test material is classified as 
a Toxicity Category IV for acute inhalation toxicity and demonstrates 
that a dilution of the active ingredient to a level that is comparable 
to concentration of phoshporous acid in the proposed end use product 
will not cause acute inhalation effects at greater than 2.06 mg/L.
    Developmental/reproductive effects, chronic effects and 
carcinogenicity. There is adequate information available from 
literature sources to characterize the toxicity of phosphorous acid. 
Phosphorous acid can affect human health through inhalation of mist, 
ingestion, and contact with the skin and eyes. In a concentrated form, 
it will cause corrosive effects (burns or irreversible damage) to the 
eyes, skin, throat, digestive tract, upper respiratory tract and nose. 
Signs of overexposure to this chemical are severe burning of eyes and 
skin, possible nausea and vomiting, coughing, burning and tightness of 
the chest and shortness of breath. Based on corrosivity and the current 
use patterns for the mineral acids, EPA did not require these studies 
as part of the Reregistration Eligibility Decision (RED) on the Mineral 
Acids (EPA 738-R-029; December 1993).
    A typical end use product was tested for acute toxicity. As 
described above, a 53.8% phosphorous acid product did not cause acute 
toxicity at >5,000 mg/kg bodyweight. This product would be further 
diluted when applied to stored potatoes so that something on the order 
of a quarter of a pound of phosphorous acid would be applied to a ton 
of stored potatoes. Calculated estimates of the residue from such an 
application would give a margin of exposure near 1,000 for young 
children
    The Agency concludes therefore that the primary hazards such as 
corrosivity and irritation that are associated with concentrated 
phosphorous acid are significantly reduced when used as a post harvest 
treatment on potatoes at dilute application rates such as those in the 
typical end use product tested and evaluated by the Agency.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or

[[Page 36734]]

buildings (residential and other indoor uses).
    The primary issue for adding post-harvest applications to a 
tolerance exemption is whether such application causes any new exposure 
that would not be safe. In order to evaluate that issue, the Agency 
relied on the existing toxicology data already reviewed on phosphorous 
acid to conduct a conservative dietary exposure and risk assessment to 
evaluate any additional risk that might result from post-harvest 
application of this chemical. In the absence of acute oral studies and 
any magnitude of residue data, the Agency based it's risk assessment on 
default assumptions, (i.e. information from the inhalation data base 
was used to compare to dietary risks, a common approach in the Agency), 
to ensure that the maximum application rates will not result in 
unacceptable dietary risks. As a result of this risk assessment, the 
Agency concludes that the use of phosphorous acid as a post harvest 
treatment to stored potatoes at the recommended application rate will 
not add any new exposures or risks and is considered safe.
    Phosphorous acid rapidly dissociates to form hydrogen and phosphite 
ions when applied to growing crops in the environment and therefore, it 
has already been established that no dietary exposure is expected from 
pre-harvest applications. The degredates of phosphorous acid, hydrogen 
and phosphite ions are important nutrients for plants and animals. 
Formation of these degredates however, may be compromised when 
phosphorous acid is applied as a post harvest treatment. Since post 
harvest treatment of phosphorous acid to potatoes is likely to occur in 
indoor storage facilities, the oxidation process of phosphorous acid 
will most likely be slowed down. The fact that the phosphorous acid at 
the time of post harvest treatment has not been oxidized to its 
degradates is clear and it is unknown how much this oxidation process 
reduces the potential dietary exposure to phosphorous acid under the 
conditions of post harvest treatment. However, even with these 
uncertainties, the Agency believes that when phosphorous acid is used 
as a post harvest treatment at the recommended application rate, the 
remaining residues of PA on stored potatoes will not increase toxicity 
or add any new dietary exposure or risks and the toxicity of 
phosphorous acid would still be classified in category IV (which is low 
toxicity) and will be safe.
    1. Dietary exposure. The Agency has determined that post harvest 
treatment of phosphorous acid to stored potatoes at the typical 
application rate evaluated by the Agency may reduce any new anticipated 
exposure to phosphorous acid. However, even if dietary exposure is not 
reduced, the Agency believes, based on its reassessment of the data and 
information, that post harvest application of phosphorous acid to 
potatoes is safe.
    2. Drinking water exposure. No significant drinking water exposure 
is expected to result from phosphorous acid when applied a post harvest 
treatment to potatoes because phosphorous acid rapidly degrades, is 
very soluble in water and is applied in storage facilities.
    3. Other non-occupational exposure. There are no residential, 
school or day care uses proposed for this product. Since the proposed 
use pattern is for agricultural food crops and post-harvest treatment 
on potatoes, the potential for non-occupational, non-dietary exposures 
to phosphorous acid by the general population, including infants and 
children, is highly unlikely. Further, even if persons were exposed via 
the non-occupational route, the Agency believes that the low toxicity 
from a dilute application such as the one evaluated by the Agency is 
safe and the primary hazards associated with concentrated phosphorous 
acid (corrosivity and irritation) will be significantly reduced because 
the end use products are diluted and the residues following application 
are very low.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.'' These considerations 
include the possible cumulative effects of such residues on infants and 
children.
    BPPD has considered the potential for cumulative effects of 
phosphorous acid and other substances in relation to a common mechanism 
of toxicity. Phosphorous Acid may share a common metabolic mechanism 
with other salts of phosphorous acid (such as calcium); however, due to 
the low order of toxicity associated with and lack of reported dietary 
toxicity associated with the use of phosphorous fertilizers on crops, 
no cumulative effect from the use of phosphorous acid is expected.

VI. Determination of Safety for U.S. Population, Infants and Children

    1. U.S. population. There is reasonable certainty that no harm will 
result to the U.S. population, including infants and children, from 
aggregate exposure to residues of phosphorous acid as a result of 
preharvest and post-harvest uses, as that toxicity and exposure is 
expected to be minimal. This includes all anticipated dietary exposures 
and all other exposures for which there is reliable information. This 
chemical will be applied as a fungicide to agricultural food crops and 
as a post-harvest treatment potatoes to stored potatoes at 35,600 ppm 
or less. There is very little potential for dietary exposure to 
phosphorous acid, exposure in drinking water, and from non-dietary, 
non-occupational exposures. Once released into the environment, the 
chemical rapidly dissociates to form hydrogen and phosphite ions, 
important nutrients for plants and animals. While the formation of 
these degredates may be compromised when phosphorous acid is applied as 
a post harvest treatment, the recommended application rate will 
significantly reduce any new dietary exposure or risks and is 
considered to be safe.
    Many phosphite salts are generally recognized as safe (GRAS). 
Therefore, the health risk to humans is negligible based on the low 
toxicity of these ions and a low application rate and magnitude of 
dilution for post-harvest use of the active ingredient, and one can 
conclude that there is a reasonable certainty that no harm will result 
from aggregate exposure to phosphorous acid.
    2. Infants and children. FFDCA section 408(b)(2)(C) provides that 
EPA shall apply an additional tenfold margin of exposure (MOE) for 
infants and children in the case of threshold effects to account for 
prenatal and postnatal toxicity and the completeness of the data base 
on toxicity and exposure, unless EPA determines that a different MOE 
will be safe for infants and children. Margins of exposure which are 
often referred to as uncertainty (safety) factors, are incorporated 
into EPA risk assessments either directly, or through the use of a MOE 
analysis, or by using uncertainty (safety) factors in calculating a 
dose level that poses no appreciable risk. In this instance, based on 
all reliable available information the Agency has reviewed on 
Phosphorous Acid, the Agency concludes that the additional MOE is not 
necessary to protect infants and children and that not adding any 
additional MOE will be safe for infants and children. Aggregate 
exposure to phosphorous acid is

[[Page 36735]]

expected to be minimal. There is very little potential for exposure to 
phosphorous acid in drinking water and from non-dietary, non-
occupational exposures. This chemical will be applied preharvest to 
agricultural food crops and as a post harvest treatment on potatoes. 
Once released into the environment, the chemical rapidly dissociates to 
form hydrogen and phosphite ions. The hydrogen ions affect pH, but this 
is moderated by natural means. Many phosphite salts are GRAS. 
Therefore, the health risk to humans is negligible based on the low 
toxicity of dilute applications of phosphorous acid. One can conclude 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to phosphorous acid 
residues.

VII. Other Considerations

     Phosphorous acid and its salts are rapidly dissociated in the 
environment to yield hydrogen and phosphite ions. Release of hydrogen 
ions will increase the pH of the plant's surface, which will be 
moderated by the amount of neutralizing ions present, the buffering 
capacity, and the amount of dilution possible. Phosphite ions are 
available for uptake by plants usually in the form of ammonium, 
calcium, and potassium and sodium phosphites (phosphite salts).

A. Endocrine Disruption

    EPA is required under section 408(p) of the FFDCA, as amended by 
FQPA, to develop a screening program to determine whether certain 
substances (including all pesticide active and other ingredients) ``may 
have an effect in humans that is similar to an effect produced by a 
naturally-occurring estrogen, or other such endocrine effects as the 
Administrator may designate.'' Following the recommendations of its 
Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), 
EPA determined that there was scientific basis for including, as part 
of the program, the androgen- and thyroid hormone systems, in addition 
to the estrogen hormone system. EPA also adopted EDSTAC's 
recommendation that the program include evaluations of potential 
effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, 
to the extent that effects in wildlife may help determine whether a 
substance may have an effect in humans, FFDCA authority to require the 
wildlife evaluations. As the science develops and resources allow, 
screening of additional hormone systems may be added to the Endocrine 
Disruptor Screening Program (EDSP).
    At this time, the Agency is not requiring information on the 
endocrine effects of this active ingredient, phosphorous acid. Based on 
the weight of the evidence of available data and the absence of any 
reports to the Agency of sensitivity or other adverse effects, no 
endocrine system related effects are identified for phosphorous acid 
and none is expected because of its use. To date there is no evidence 
that phosphorous acid affects the immune system, functions in a manner 
similar to any known hormone, or that it acts as an endocrine 
disruptor. Thus, there is no impact via endocrine-related effects on 
the Agency's safety finding set forth in this proposed rule amending 
the phosphorous acid exemption from the requirement of a tolerance.

B. Analytical Method

    Through this action, the Agency proposes to amend the existing 
exemption from the requirement of a tolerance for phosphorous acid to 
include post harvest treatment on potatoes for the reasons stated above 
which include low toxicity to mammals and negligible exposure from the 
pesticidal use of products containing phosphorous acid. For the same 
reasons, the Agency concludes that an analytical method is not required 
for enforcement purposes for phosphorous acid.

C. Codex Maximum Residue Level

     No maximum residue levels (MRLs) have been established for 
phosphorous acid by the Codex Alimentarius Commission (CODEX).

VIII. Conclusions

    The Agency concludes that if products containing phosphorous acid 
as an active ingredient are used in accordance with label directions, 
there is a reasonable certainty that no harm to the U.S. population, 
including infants and children, will result from aggregate exposure to 
residues of phosphorous acid, when used as an agricultural fungicide on 
all food commodities or when used as a post-harvest treatment on 
potatoes.

IX. Statutory and Executive Order Reviews

    This proposed rule amends an exemption from the requirement of a 
tolerance under section 408(e) of the FFDCA in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Because this proposed rule has been exempted from review under 
Executive Order 12866 due to its lack of significance, this proposed 
rule is not subject to Executive Order 13211, Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001). This proposed rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. Law 104-4). Nor does 
it require any special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since this 
Agency initiated amendment to an exemption from tolerance requirement, 
issued section 408(e) of the FFDCA, requires the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) apply. The Agency hereby certifies that this 
proposed action will not have significant negative economic impact on a 
substantial number of small entities. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and

[[Page 36736]]

responsibilities among the various levels of government.'' This 
proposed rule directly regulates growers, food processors, food 
handlers and food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this 
proposed rule does not have any ``tribal implications'' as described in 
Executive Order 13175, entitled Consultation and Coordination with 
Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive 
Order 13175, requires EPA to develop an accountable process to ensure 
``meaningful and timely input by tribal officials in the development of 
regulatory policies that have tribal implications.'' ``Policies that 
have tribal implications'' is defined in the Executive order to include 
regulations that have ``substantial direct effects on one or more 
Indian tribes, on the relationship between the Federal Government and 
the Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.'' This proposed rule 
will not have substantial direct effects on tribal governments, on the 
relationship between the Federal Government and Indian tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: June 20, 2006.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as 
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.
    2. Section 180.1210 is revised to read as follows:


Sec.  180.1210  Phosphorous acid; exemption from the requirement of a 
tolerance .

    An exemption from the requirement of a tolerance is established for 
residues of phosphorous acid and its ammonium, sodium, and potassium 
salts in or on all food commodities when used as an agricultural 
fungicide and in or on potatoes when applied as a post-harvest 
treatment at 35,600 ppm or less phosphorous acid.

[FR Doc. E6-10031 Filed 6-27-06; 8:45 am]

BILLING CODE 6560-50-S
