Document ID: EPA-HQ-OPP-2005-0121-0004
Agency: epa
Document Type: Rule
Title: Pythium Oligandrum DV 74; Exemption from the Requirement of a Tolerance
Posted Date: 2007-05-16T04:00Z

[Federal Register: May 16, 2007 (Volume 72, Number 94)]
[Rules and Regulations]               
[Page 27448-27452]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16my07-17]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0121; FRL-7713-1]

 
Pythium Oligandrum DV 74; 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 Pythium oligandrum DV 74 on food crops. 
Biopreparaty Co. Ltd. submitted a petition to EPA 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 Pythium 
oligandrum DV 74.

DATES: This regulation is effective May 16, 2007. Objections and 
requests for hearings must be received on or before July 16, 2007, 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-2005-EPA-0121. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 

Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. 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 Bldg., 2777 S. Crystal Dr., 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: Tessa Milofsky, Biopesticides and 
Pollution Prevention Division (7511P), Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0455; e-mail address: milofsky.tessa@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. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions. 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 the 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-2005-EPA-0121 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 July 16, 2007.
    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-2005-EPA-0121, 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 
Bldg.), 2777 S. Crystal Dr., 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 May 25, 2005 (70 FR 30105) (FRL-7713-1). 
EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 4F6877) by Biopreparaty, Co. Ltd. Tylisovska I, Prague 6, 
Czech Republic. The petition requested that 40 CFR part 180 be amended 
by establishing an exemption from the requirement Pythium

[[Page 27449]]

oligandrum DV 74. This notice included a summary of the petition 
prepared by the petitioner Biopreparaty Co. Ltd.
    One comment was received from a private citizen opposing the 
``production or selling'' of Pythium oligandrum DV 74. The commentor 
further stated that it was their wish that no exemptions be issued and 
that no tolerances should be approved. The Agency understands the 
commentor's concerns and recognizes that some individuals believe that 
pesticides should be banned completely. However, under the existing 
legal framework provided by section 408 of the FFDCA EPA is required to 
establish pesticide tolerances or exemptions where persons seeking such 
exemptions have demonstrated that the pesticide meets the safety 
standard imposed by that statute. The commentor has not provided the 
Agency with a specific rationale or additional information pertaining 
to the legal standards in FFDCA section 408 for opposing the 
establishment of a tolerance exemption for Pythium oligandrum DV 74. In 
the absence of any additional information of a factual nature, the 
Agency can not effectively respond to the commentor's disagreement with 
the Agency's decision.
    Another comment was received that supported the registration. The 
commentator stated that ``Pythium oligandrum appears to be an unusually 
effective (in its rapidity of action) and exceptionally safe (in terms 
of mammalian toxicity) crop protection product.''
    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.''
    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 the 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.

A. Acute Oral Toxicity and Pathogenicity (Master Record Identification 
numbers 464107-02 and 464109-03; Data Request 152-30; OPPTS Harmonize 
Guideline. 885.3050)

    A guideline acute oral toxicity study was carried out in 2001 using 
mice. Ten mice (five males, five females) were given a total dose of 
5,000 milligrams/kilogram (mg/kg) Pythium oligandrum DV 74 and no 
adverse effects were seen in the mice which were observed for 14 days 
after dosing. The test substance was rated Toxicity Category IV.

B. Acute Dermal Toxicity (Master Record Identification numbers 464109-
04, 464107-02; OPPTS Harmonize Guideline 870.1200)

    A guideline acute dermal toxicity study was conducted using rats. 
The dermal LD50 for males, females, and combined was greater 
than 5,000 mg/kg body wt. Pythium oligandrum DV 74 test substance was 
rated Toxicity Category IV.

C. Acute Inhalation Toxicity (Master Record Identification number 
464109-05; OPPTS Harmonize Guideline 870.1300)

    In a four-hour acute inhalation toxicity study using rats, a limit 
dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality nor 
adverse effects, and no gross abnormalities were seen at necropsy 14 
days later. Although the MMD was 7.45 and [micro]m, approximately 68% 
of the particles were < =3.75 [micro]m. The acute inhalation 
LC50 for males, females, and combined was >5 mg/L for a 4 
hour exposure. The test substance is Toxicity Category IV.

D. Acute Pulmonary Toxicity/Pathogenicity-Waiver Granted (Master Record 
Identification number 464109-10; OPPTS Harmonize Guideline 885.3150)

    In a four-hour acute inhalation toxicity study using rats, a limit 
dose (5 mg/L) of Pythium oligandrum DV 74 produced no mortality or 
adverse effects, and no gross abnormalities were seen at necropsy 14 
days later. Although the MMD was 7.45 [micro]m, approximately 68% of 
the particles were < =3.75 [micro]m. The acute inhalation 
LC50 for males, females, and combined was >5 mg/L for a 4 
hour exposure. The test substance is classified as Toxicity Category 
IV. Infectivity testing was waived for this study based on the results 
of the growth temperature study which showed no growth on plant-based 
growth media at or above 37[deg] C, and no growth at any temperature on 
animal tissue-based growth media.

E. Acute Injection Tocity/Pathogenicity (Master Record Identification 
numbers 465823-01, 467542-01,464109-10, and 469901-01; OPPTS Harmonize 
Guideline 885.3200)

    An acute injection toxicity/pathogenicity study was conducted using 
rats. Storage, stability data showed that after Batch No. 150405 was 
stored for approximately 9 months, of 1.3x106 oospores/g 
active ingredient 80.5% were viable after 120 hours incubation, giving 
1.1x106 cfu/g - however, this study lists Batch No. 150405 
as containing 107 granules/g, so viability would then be 
only 11%. Based on the data submitted, Pythium oligandrum DV 74 does 
not appear toxic nor pathogenic to rats when dosed at 
2.9x104 oospores/animal - although no attempts to isolate 
viable organisms prior to testing, or from test animals after 
inoculation, were made. Therefore, infectivity cannot be assessed in 
the study, initially rated not toxic nor pathogenic. In addition, there 
were discrepancies with characterization of the test substance. 
However, infectivity testing was waived for this study, based on the 
results of the growth temperature study which showed no growth on 
plant-based growth media at or above 37[deg] C, and no growth at any 
temperature on animal tissue-based growth media.

[[Page 27450]]

F. Primary Dermal Irritation (Master Record Identification numbers 
464605-02 and 464107-02; OPPTS Harmonize Guideline 870.2500)

    An acute dermal irritation study was conducted using rabbits. Very 
slight erythema was noted on the skin of three rabbits one hour after 
patch removal, with clearance on two rabbits by 24 hours and on one 
rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 
74 was essentially nonirritating; the test substance was rated Toxicity 
Category IV.

G. Acute Eye Irritation (Master Record Identification number 464109-
06;OPPTS Harmonize Guideline 870.2400)

    An acute eye irritation study was conducted using rabbits. No 
corneal opacity nor iritis was observed during the study. Positive 
conjunctival irritation (score 2) was noted on 2 rabbits 1 hour after 
Pythium oligandrum DV 74 instillation with resolution by 48 hours. The 
maximumaverage score was 6.7 at 24 hours after test material 
instillation. The test substance is Toxicity Category III.

H. Skin sensitization-Waiver Granted (Master Record Identification 
number 464109-10; OPPTS Harmonize Guideline 870.2600)

    A guideline acute dermal toxicity study was conducted using rats. 
The dermal LD50 for males, females, and combined was greater 
than 5,000 mg/kg body wt. Pythium oligandrum DV 74 and rated Toxicity 
Category IV. An acute dermal irritation study was conducted using 
rabbits. Very slight erythema was noted on 3/3 rabbits one hour after 
patch removal, with clearance on two rabbits by 24 hours and on one 
rabbit by 48 hours. The primary irritation index was 0.3. Technical DV 
74 was essentially nonirritating and rated Toxicity Caterogy IV. In 
addition, Pythium oligandrum occurs naturally in a variety of soil 
types over a wide range of environmental conditions. Although 
application of Pythium oligandrum DV 74 to seeds, foliage, or soil will 
likely temporarily increase its concentration in the environment, the 
population is expected to subside to normal levels, because the 
organism does not thrive in the absence of sufficient nutrients. A 
search of the public literature found no reports of Pythium oligandrum 
having adverse effects in humans or other mammals. The only known 
biological effects of Pythium oligandrum are parasitic effects on 
fungal species and stimulation of resistance to parasitic infection in 
plants. Neither the mechanism of the mycoparasitic action nor the 
stimulation of plant resistance is associated with adverse effects in 
mammals. Pythium oligandrum DV 74 is the active ingredient in various 
over-the-counter products sold in Europe, including a mouthwash, a bath 
additive and a skin cream. These products have been on the market in 
parts of the EU since 1999 with no reported adverse effects. The lack 
of any reported sensitization effects from repeated dermal exposure to 
the consumer products suggests that Pythium oligandrum is not a dermal 
sensitizer. To reduce exposure to this active ingredient from its 
pesticide use, the agricultural use label requires that applicators and 
handlers wear a long-sleeved shirt and long pants, waterproof gloves, 
and shoes plus socks.

I. Pathogenicity and Infectivity (Master Record Identification numbers 
469901-01 and 02)

    Pythium oligandrum DV 74 is primarily a fungal hyperparasite that 
exhibits limited growth on plant-based media and no growth on animal 
tissue-based media. In addition, its growth tapers off as temperature 
approaches normal human body temperature of 37[deg] C and there is no 
growth at or above this temperature. Therefore, infectivity testing is 
not possible. This information supports waivers for infectivity testing 
in the acute oral, acute dermal, acute inhalation, and injection 
exposure studies.

J. Subchronic, Chronic Toxicity and Oncogenicity

    Based on the data generated in accordance with Tier I data 
requirements (40 CFR 158.740(c)), Tier II tests (Guidelines 152B-40 
through 152B-49), which include acute oral, acute inhalation, 
subchronic oral, acute intraperitoneal/intracerebral, primary dermal, 
primary eye, immune response, teratogenicity, virulence enhancement, 
and mammalian mutagenicity were not required. Tier III tests 
(Guidelines 152-50 through 53), which include chronic testing, 
oncogenicity testing, mutagenicity, and teratogenicity were also not 
required.

K. Effects on the Endocrine System

    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) 
``humans that is similar to an effect produced by a naturally-occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Pythium oligandrum is not a known endocrine disruptor nor 
is it related to any class of known endocrine disruptors. Consequently, 
endocrine-related concerns did not adversely impact the Agency's safety 
finding for Pythium oligandrum.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the 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

    Due to the proposed use of Pythium oligandrum on food crops, fungal 
residues may be present on agricultural commodities. However, 
negligible to no risk is expected for the general population, including 
infants and children, because Pythium oligandrum demonstrated no 
pathogenicity nor acute oral toxicity at the maximum doses tested.
    1. Food. Due to the proposed use of Pythium oligandrum on food 
crops, fungal residues may be present on agricultural commodities. 
However, negligible to no risk is expected for the general population, 
including infants and children, because Pythium oligandrum demonstrated 
no pathogenicity or oral toxicity at the maximum doses tested.
    2. Drinking water exposure. Pythium oligandrum does not thrive in 
aquatic environments and there are no aquatic use sites for the 
pesticide. Accordingly, application of this pesticide to approved use 
sites is not expected to increase drinking water exposure to Pythium 
oligandrum. Furthermore, any Pythium oligandrum that might be consumed 
through drinking water would pose negligible to the general population, 
including infants and children, due to the pesticide's low toxicity 
classification.

B. Other Non-Occupational Exposure

    Pythium oligandrum will be applied to agricultural fields, turf and 
professional landscapes, and in home gardens. Although some 
applications may be made near residential areas, no harm would be 
expected to result from exposure to Pythium oligandrum due to its low 
toxicity classification.
    1.Dermal exposure. Dermal exposure is limited by use of the 
required PPE and REI in occupational settings, and residential users 
are advised to avoid

[[Page 27451]]

skin contact and to wash any exposed skin or clothing.
    2. Inhalation exposure. The greatest likelihood of inhalation 
exposure would occur in an occupational setting, among mixers/loaders 
and applicators. However, as demonstrated in the acute pulmonary 
toxicity/pathogenicity test, Pythium oligandrum is not infective, 
pathogenic, or toxic to mammals. Despite the benign nature of the 
active ingredient, the agency requires that all workers exposed to 
microbial pesticides must wear a dust/mist filtering respirator. As 
such, the risks anticipated for inhalation exposure are minimal.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to 
consider the cumulative effect of exposure to Pythium oligandrum and to 
other substances that have a common mechanism of toxicity. These 
considerations include the possible cumulative effects of such residues 
on infants and children. As demonstrated in Unit III.A., Pythium 
oligandrum is not toxic or pathogenic to mammals, and only minimally 
irritating to eyes. Consequently, no cumulative effects from the 
residues of this product with other related microbial pesticides are 
anticipated.

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

    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 Pythium oligandrum due to its use as a 
microbial pest control agent. This includes all anticipated dietary 
exposures and all other exposures for which there is reliable 
information. As discussed in UnitIII.A., Pythium oligandrum is not 
toxic or pathogenic to mammals, and only minimally irritating in an eye 
exposure study. Accordingly, exempting Pythium oligandrum from the 
requirement of a tolerance is considered safe and poses no significant 
risks.
    FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional tenfold margin of exposure (safety) 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 margin of exposure 
(safety) will be safe for infants and children. Margins of exposure 
(safety), which often are referred to as uncertainty factors, are 
incorporated into EPA risk assessment either directly or through the 
use of a margin of exposure analysis or by using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk. 
Actual exposures to adults and children through diet are expected to be 
several orders of magnitude less than the doses used in the toxicity 
and pathogenicity tests referenced in Unit III. Thus, the Agency has 
determined that an additional margin of safety for infants and children 
is unnecessary.

VII. Other Considerations

A. Endocrine Disruptors

    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.'' Pythium oligandrum is not a known 
endocrine disruptor nor is it related to any class of known endocrine 
disruptors. Consequently, endocrine-related concerns did not adversely 
impact the Agency's safety finding for Pythium oligandrum.

B. Analytical Method(s)

    The acute oral toxicity and pathogenicity findings discussed in 
Unit III demonstrate that the active ingredient does not pose a dietary 
risk. Nevertheless, the Agency has concluded that for the analysis of 
the pesticide itself, microbiological and biochemical methods exist and 
are acceptable forthe enforcement purposes for product identity of 
Pythium oligandrum DV 74. Other appropriate methods are required for 
quality control to assure that product characterization, the control of 
human pathogens, and other unintentional metabolites or ingredients are 
within regulatory limits, and to ascertain storage stability and 
viability of the pesticidal active ingredient.

C. Codex Maximum Residue Level

    There is no established Codex maximum residue level for residues of 
Pythium oligandrum DV 74.

VIII. Conclusions

    The results of the studies discussed are sufficient to comply with 
the requirements of FQPA. They support an exemption from the 
requirement of tolerance for residues of Pythium oligandrum DV 74, on 
treated food of food commodities. In addition, the Agency is of the 
opinion that, if the microbial active ingredient is used as allowed, 
aggregate and cumulative exposures are not likely to pose any undue 
hazard to the U.S. population of adult, children, and infant humans. 
Therefore, an exemption from the requirement of tolerance is granted in 
response to pesticide petition 4F6877.

IX. Statutory and Executive Order Reviews

    This final rule establishes 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, 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., 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).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the 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.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination

[[Page 27452]]

with Indian Tribal Governments (65 FR 67249, November 6, 2000) do not 
apply to this rule. In addition, This rule does not 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).
    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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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: May 4, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR part 180 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 180.1275 is added to subpart D to read as follows:

Sec.  180.1275  Pythium; Exception from the requirement of a tolerance.

    An exemption from the requirement of tolerance is established on 
all food/feed commodities, for residues of pythium oligandrum DV 74 
when the pesticide is used on food crops.
[FR Doc. E7-9298 Filed 5-15-07; 8:45 am]

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