27448 Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 

is in a fixed (non-transportation) 

operating mode. 

* * * * * 

[FR Doc. 07–2404 Filed 5–15–07; 8:45 am] 

BILLING CODE 6560–50–M 

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. 

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-HQOPP-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-HQOPP-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 


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Federal Register / Vol. 72, No. 94 / Wednesday, May 16, 2007 / Rules and Regulations 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 μm, 

approximately 68% of the particles were 

≤3.75 μm. 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 μm, approximately 

68% of the particles were ≤3.75 μm. 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° 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° C, and no growth at any temperature 

on animal tissue-based growth media. 


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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 overthe-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 longsleeved 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 tissuebased media. In addition, its growth 

tapers off as temperature approaches 

normal human body temperature of 37° 

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 naturallyoccurring 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 nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

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 


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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, endocrinerelated 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 


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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. 

■ Therefore, 40 CFR part 180 is 

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 180.1275 is added to 

subpart D to read as follows: 

§ 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] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0800; FRL–8128–2] 

Chlorantraniliprole; Time-Limited 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

chlorantraniliprole in or on apple and 

apple, wet pomace, celery, cucumber, 

head and leaf lettuce, pear, pepper, 

spinach, squash, tomato and 

watermelon commodities. DuPont Crop 

Protection requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). The tolerances will expire on 

May 1, 2010. 

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–2006–0800. 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 either in the electronic docket 

at http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

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: 

Kable Bo Davis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 703 

306-0415; e-mail address: 

kable.davis@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 

discussed 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. 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 


jlentini on PROD1PC65 with RULES