55272 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations as required by 

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 other 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 104–13, section 

12(d) (15 U.S.C. 272 note). Pursuant to 

the Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), the Agency 

previously assessed whether revocations 

of tolerances might significantly impact 

a substantial number of small entities 

and concluded that, as a general matter, 

these actions do not impose a significant 

economic impact on a substantial 

number of small entities. This analysis 

was published on December 17, 1997 

(62 FR 66020), and was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. Taking into 

account this analysis, and available 

information concerning the pesticides 

listed in this rule, the Agency hereby 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Specifically, as per the 1997 notice, EPA 

has reviewed its available data on 

imports and foreign pesticide usage and 

concludes that there is a reasonable 

international supply of food not treated 

with canceled pesticides. Furthermore, 

for the pesticides named in this final 

rule, the Agency knows of no 

extraordinary circumstances that exist 

as to the present revocations that would 

change EPA’s previous analysis. In 

addition, the Agency has determined 

that this action will not have a 

substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 2005. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I 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 180.144 is amended by 

revising the table under paragraph (a) to 

read as follows: 

§ 180.144 Cyhexatin; tolerances for 

residues. 

(a) General. * * * 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Orange, juice 0.1 6/13/09 

* * * * * 

[FR Doc. 05–18581 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0221; FRL–7730–3] 

Reynoutria Sachalinensis Extract; 

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 the biochemical 

pesticide Reynoutria sachalinensis 

extract on all food commodities. The 

Interregional Research Project Number 4 

(IR-4), on behalf of KHH Bioscience, 

Inc., 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), 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55273 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Reynoutria sachalinensis 

extract. 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0221. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This 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: 

Driss Benmhend, Biopesticides and 

Pollution Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9525; e-mail address: 

benmhend.driss@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111) 

• Animal production (NAICS code 

112) 

• Food manufacturing (NAICS code 

311) 

• Pesticide manufacturing (NAICS 

code 32532) 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of March 31, 

2004 (69 FR 16925) (FRL–7342–4), 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 3E6751) 

by Interregional Research Project 

Number 4 (IR-4), New Jersey 

Agricultural Experiment Station, 

Technology Center of New Jersey, 681 

U.S. Highway 1 South, North 

Brunswick, NJ 08902–3390, on behalf of 

KHH BioScience Inc., 920 Campus 

Drive, Suite 101, Raleigh, NC 27606. 

The petition requested that 40 CFR part 

180 be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Reynoutria 

sachalinensis extract. This notice 

included a summary of the petition 

prepared by the petitioner IR-4, on 

behalf of KHH BioScience Inc. There 

were no comments received in response 

to the notice of filing. 

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. 

Reynoutria sachalinensis is a 

naturally-occurring plant in the 

environment, commonly known as 

Giant knotweed. It is a rhizomatous, 

herbaceous, perennial, terrestrial plant 

belonging to the Polygonaceae family. 

The plant is a native of East Asia, but 

was introduced into Europe and North 

America in the 19th century as a fodder 

plant for cattle and as an ornamental. 

Reynoutria sachalinensis has a wide 

geographic distribution throughout the 

United States, Europe, and Asia. The 

plant is currently present in 25 U.S. 

States (Alaska, California, Connecticut, 

Idaho, Illinois, Kentucky, Louisiana, 

Maine, Maryland, Massachusetts, 

Michigan, Montana, New Jersey, New 

York, North Carolina, Ohio, Oregon, 

Pennsylvania, Rhode Island, Tennessee, 

Vermont, Virginia, Washington, West 

Virginia and Wisconsin). It is found in 

diverse habitats including riparian 

areas, wet meadows, floodplain forests, 

forest edges, roadsides, railroad and 

utility rights-of way, and open areas. 

The plant has become invasive in 

55274 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

certain regions. According to the 

Invasive Plant Atlas of New England, 

this weed is present in all of the 

northeast U.S., with the exception of 

New Hampshire, as far south as North 

Carolina and Tennessee. It has also been 

reported in Louisiana, Montana, Idaho, 

Alaska, and three west coast States. 

Reynoutria sachalinensis extract is an 

ethanolic extract of dried, ground 

Reynoutria sachalinensis plants, and is 

already approved as an active ingredient 

by EPA for use as a spray on non-food, 

ornamental plants grown in 

greenhouses. The active ingredient has 

been used in this manner for over 4 

years with no reports of harmful health 

effects to greenhouse workers. In 

addition, there is a long history of 

human dermal and oral exposure to 

Reynoutria sachalinensis through its use 

as an ornamental plant, as a human 

medicinal agent, and as human food. 

Humans are regularly, physically 

exposed to the plant when handling it 

as an ornamental and there have been 

no known reports of any adverse health 

effects to humans via physical contact 

with the plant. In Asian folk medicine, 

the rhizomes, leaves, and stems of the 

plant have been used as a laxative, 

diuretic, and for the treatment of 

dermatitis and athlete’s foot. Reynoutria 

sachalinensis has been consumed in the 

human diet in Japan for generations 

without any known negative effects. The 

plant is sold commercially in Japanese 

supermarkets for use in soups, as a 

deep-fried vegetable, and as a vinegared 

side dish. Reynoutria sachalinensis is 

also a floral nectar source for European 

honey bees, and thus many more 

humans are already indirectly exposed 

to the active ingredient via consumption 

of honey. The active ingredient has been 

registered and used in two end use 

products in Germany (Milsana fluessig 

and Milsana Pulver) as a resistance 

enhancer on fruit and vegetables since 

November 2000. To date, there have 

been no reports of adverse health effects 

resulting from the use of Reynoutria 

sachalinensis on food. 

This final rule supports the use of 

Reynoutria sachalinensis extract as the 

active ingredient in an end-use product 

that will be used on food crops to 

enhance the resistance to fungal and 

bacterial diseases. 

Acute toxicity studies were 

previously submitted and reviewed by 

EPA in support of the registrations of 

the manufacturing-use product, 

Reynoutria sachalinensis Bioprotectant, 

and the greenhouse, non-food-use enduse product, Milsana Bioprotectant 

Concentrate. Submitted data for the 

technical grade active ingredient (TGAI) 

and the end-use product, indicate 

Toxicity Category IV for acute oral and 

acute inhalation toxicity. Acute dermal 

toxicity data indicated a Toxicity 

Category III. The data reported for 

primary eye irritation studies showed 

that the test substance was moderately 

irritating, and was given a Toxicity 

Category III when the TGAI was used, 

and Toxicity Category II when the enduse product Milsana is used as a test 

material. Exposure to Milsana 

produced very slight erythema in 

animal tests; as a result, a Toxicity 

Category IV was given for dermal 

irritation. 

The Agency deemed the submitted 

acute toxicity studies acceptable and 

approved the bridging of these studies 

to support this tolerance exemption. A 

summary of these acute toxicity studies 

is presented in the table below. 

ACUTE TOXICITY DATA FOR REYNOUTRIA SACHALINENSIS

Data Requirement Results Toxicity Category MRID No. 

Acute oral toxicity TGAI: Lethal dose (LD)50 > 5,000 

milligrams/kilogram (mg/kg) 

IV 448219–04 

EP: LD50 > 5,000 mg/kg IV 448219–05 

Acute dermal toxicity TGAI: LD50 > 2,000 mg/kg 

EP: LD50 > 5,000 mg/kg 

III 

III 

448219–06 

448219–07 

Acute inhalation toxicity EP: Lethal concentration (LC)50 > 

2.6 mg/liter (L) 

IV 448219–08 

Primary eye irritation TGAI: Slight irritant 

EP: Moderate irritant 

III 

II 

448219–09 

448219–10 

Primary dermal irritation EP: No dermal irritation symptoms up to 72–hour post-dosing IV 448219–11 

Skin sensitization TGAI: Buehler test was negative 

EP: Buehler test was negative 

Not a sensitizer 

Not a sensitizer 

448219–13 

448219–14 

Additionally, data waivers were 

requested by the applicant for the 

following Tier I toxicology data 

requirements: 

1. Genotoxicity 

2. Teratogenicity 

3. Immune Response 

4. 90–day Feeding 

5. 90–day Dermal 

6. 90–day Inhalation 

The Agency granted these waivers 

based on the widespread and regular 

exposure that humans already have to 

Reynoutria sachalinensis in the 

environment, in food and medicine, and 

as an ornamental plant. As stated 

previously, large numbers of humans 

have been and continue to be regularly 

exposed to the active ingredient via 

physical contact and in their diet with 

no known reports of adverse effects. In 

addition, researchers, manufacturers, 

and others who work with this active 

ingredient have not reported any 

adverse health effects. Thus, the Agency 

does not expect the use of Reynoutria 

sachalinensis extract on food crops to 

result in any harmful effects to humans. 

Reynoutria sachalinensis contains 

anthraquinones, which are widespread 

in plants, including plants used for 

human consumption. Most of the total 

anthraquinone content in plants 

consists of physcion, emodin, and 

chrysophanol. Reynoutria sachalinensis 

contains both emodin and physcion. 

While physcion and chrysophanol have 

shown no genotoxic effects, emodin has 

been shown to have genotoxic potential 

when extracted from edible plant 

substrates (e.g., beans, peas, cabbage, 

lettuce, plaintain, buckwheat). However, 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55275 

whole plant extracts containing these 

anthraquinones have been shown not to 

be genotoxic, and to have properties that 

counteract genotoxic anthraquinones. 

Therefore, because the Reynoutria 

sachalinensis extract is derived from the 

whole plant extract, the Agency has 

concluded that Reynoutria 

sachalinensis extract does not present a 

genotoxicity risk. 

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 

1. Food. The Agency is not concerned 

about dietary exposure to Reynoutria 

sachalinensis because large numbers of 

humans have consumed it regularly 

without any reports of adverse effects. 

In Japan, Reynoutria sachalinensis is 

commonly used as a vegetable and is a 

known source of vitamins A, C, and E. 

Young shoots are edible and are 

harvested to be used in soups, as a deepfried vegetable, a vinegared side dish, 

and sometimes mixed with tobacco or 

used as a substitute for it. Reynoutria 

sachalinensis is sold commercially in 

Japanese supermarkets for use as human 

food. Reynoutria sachalinensis is listed 

among floral nectar sources for 

European honey bees; therefore, humans 

are indirectly exposed to the active 

ingredient via consumption of honey. 

In any event, negligible to no risk is 

expected for the general populations, 

including infants and children, because 

oral toxicity tests on Reynoutria 

sachalinensis indicated that the extract 

is non-toxic (Toxicity Category IV), thus, 

the risks are considered minimal. 

With regard to the emodin content of 

Reynoutria sachalinensis extract, the 

Agency is not concerned about dietary 

exposure because Reynoutria 

sachalinensis extract is derived from the 

whole plant extract, which is not 

genotoxic. 

2. Drinking water exposure. 

Reynoutria sachalinensis commonly 

grows along rivers and streams in much 

of the United States. The leaves of 

Reynoutria sachalinensis are killed off 

in frosts and leaf litter naturally drops 

into nearby bodies of water; therefore, 

those water bodies are already exposed 

to exudates of this plant. In those areas, 

the use of Reynoutria sachalinensis 

extract is unlikely to result in additional 

residues to drinking water that are 

above pre-existing levels. In other areas 

where the Reynoutria sachalinensis 

plant does not already exist, the Agency 

is not concerned about drinking water 

exposure because it is non-toxic and 

studies involving feeding of the active 

ingredient in acute oral rat trials 

indicated no adverse effect. 

B. Other Non-Occupational Exposure 

Reynoutria sachalinensis is a 

naturally-occurring plant currently 

found in 25 U.S. States as an ornamental 

plant, an invasive weed, and a grazing 

crop. Many humans are already 

regularly exposed to the plant in the 

environment. In certain areas of the 

world, i.e., Japan, Germany, and parts of 

Europe, the plant is consumed directly 

and indirectly as human food and is 

used as a pesticide on food. There have 

been no reported adverse effects to 

Reynoutria sachalinensis. 

1. Dermal exposure. There is a long 

history of human dermal exposure to 

Reynoutria sachalinensis as it is a 

widespread, naturally-occurring plant in 

the environment. Humans have had 

direct contact with the plant through its 

use as an ornamental, and greenhouse 

workers have been exposed to 

Reynoutria sachalinensis extract when 

applying the EPA registered product 

Milsana Bioprotectant to ornamentals. 

There have been no reported adverse 

effects to humans from the 

aforementioned forms of exposure. In 

addition, results of the acute dermal 

study indicated low toxicity (Toxicity 

Category III) and no significant dermal 

irritation (Toxicity Category IV). Based 

on these results, the anticipated risks 

from dermal exposure are considered 

minimal. 

2. Inhalation exposure. As stated 

above, there have been no reported 

harmful effects to humans from 

exposure to Reynoutria sachalinensis in 

the environment, from its use as an 

ornamental, or from the application of 

Reynoutria sachalinensis extract to nonfood crops in greenhouses. Furthermore, 

the inhalation toxicity studies showed 

no toxicity (Toxicity Category IV), thus 

the risks anticipated for this route of 

exposure are considered minimal. 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish an exemption from 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. 

Common mechanisms of toxicity are 

not relevant to a consideration of 

cumulative exposure to Reynoutria 

sachalinensis extract because the extract 

is not toxic to mammalian systems. 

Thus, the Agency does not expect any 

cumulative or incremental effects from 

exposure to residues of Reynoutria 

sachalinensis extract when applied/ 

used as directed on the label and in 

accordance with good agricultural 

practices. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

A. U.S. population 

There is reasonable certainty that no 

harm will result from aggregate 

exposure to residues of Reynoutria 

sachalinensis extract to the U.S. 

population, infants, and children. This 

includes all anticipated dietary 

exposures and all other exposures for 

which there is reliable information. The 

Agency has arrived at this conclusion 

based on the fact that the plant is a part 

of the human diet in certain areas of the 

world with no reported adverse effects, 

and that humans have had frequent 

physical contact with Reynoutria 

sachalinensis and plants treated with 

Reynoutria sachalinensis extract with 

no negative health effects. In addition, 

the Toxicity Category IV for acute oral 

toxicity indicates that the extract is nontoxic. Finally, the Agency has 

concluded that there is a reasonable 

certainty of no harm when the 

Reynoutria sachalinensis extract is 

derived from the whole plant extract. 

B. Infants and children 

FFDCA section 408 provides that EPA 

shall apply an additional tenfold margin 

of exposure (also referred to as a margin 

of safety) for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA determines that a different margin 

of exposure will be safe for infants and 

children. Margins of exposure are often 

referred to as uncertainty or safety 

factors. In this instance, based on all 

available information, the Agency 

concludes that Reynoutria sachalinensis 

extract is non-toxic to mammals, 

including infants and children. Because 

there are no threshold effects of concern 

to infants, children and adults when 

Reynoutria sachalinensis extract is used 

as labeled, the provision requiring an 

additional margin of safety does not 

apply. As a result, EPA has not used a 

margin of exposure approach to assess 

55276 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

the safety of Reynoutria sachalinensis 

extract. 

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.’’

Reynoutria sachalinensis extract is 

not a known endocrine disruptor nor is 

it related to any class of known 

endocrine disruptors. Thus, there is no 

impact via endocrine-related effects on 

the Agency’s safety finding set forth in 

this final rule for Reynoutria 

sachalinensis extract. 

B. Analytical Method(s) 

Through this action, the Agency 

proposes to establish an exemption from 

the requirement of a tolerance for the 

extract of Reynoutria sachalinensis 

when used on fruit and vegetable crops. 

For the very same reasons that support 

the granting of this tolerance exemption, 

the Agency has concluded that an 

analytical method is not required for 

enforcement purposes for these 

proposed uses of Reynoutria 

sachalinensis extract. 

C. Codex Maximum Residue Level 

There are no codex maximum residue 

levels established for Reynoutria 

sachalinensis extract. 

VIII. Objections and Hearing Requests 

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. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 

for filing objections is now 60 days, 

rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2005–0221 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 November 21, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit IX.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2005–0221, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) 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 rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). This final rule 

does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA), 44 U.S.C. 3501 et seq., or impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55277 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the exemption in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. The 

Agency hereby certifies that this rule 

will not have significant negative 

economic impact on a substantial 

number of small entities. In addition, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999). Executive Order 

13132 requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ This 

final rule directly regulates growers, 

food processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

X. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 9, 2005. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I 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 180.1259 is added to 

subpart D to read as follows: 

§ 180.1259 Reynoutria sachalinensis 

extract; exemption from the requirement of 

a tolerance. 

Residues of the biochemical pesticide 

Reynoutria sachalinensis extract, when 

derived from the whole plant extract, 

are exempt from the requirement of a 

tolerance in or on all food commodities. 

[FR Doc. 05–18725 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0074; FRL–7736–2] 

Iprovalicarb; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of Iprovalicarb in 

or on tomatoes. Bayer CropScience AG 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0074. All documents in the docket are 

listed in the EDOCKET index athttp:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This 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: 

Mary L. Waller, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail 

address:waller.mary@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