[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Rules and Regulations]
[Pages 55272-55277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18725]


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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.

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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),

[[Page 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 <greek-i>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: <a href="/cdn-cgi/l/email-protection#adcfc8c3c0c5c8c3c983c9dfc4dedeedc8ddcc83cac2db"><span class="__cf_email__" data-cfemail="f092959e9d98959e94de9482998383b0958091de979f86">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111)
    <bullet> Animal production (NAICS code 112)
    <bullet> Food manufacturing (NAICS code 311)
    <bullet> 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

[[Page 55274]]

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 end-use product, Milsana[reg] 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 end-use product Milsana[reg] is used as a test material. 
Exposure to Milsana[reg] 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
------------------------------------------------------------------------
                                          Toxicity
 Data Requirement       Results           Category          MRID No.
------------------------------------------------------------------------
Acute oral         TGAI: Lethal dose  IV                448219-04
 toxicity           (LD)50 > 5,000
                    milligrams/
                    kilogram (mg/kg)
                   EP: LD50 > 5,000   IV                448219-05
                    mg/kg
--------------------------------------
Acute dermal       TGAI: LD50 >       III               448219-06
 toxicity           2,000 mg/kg       III               448219-07
                   EP: LD50 > 5,000
                    mg/kg
--------------------------------------
Acute inhalation   EP: Lethal         IV                448219-08
 toxicity           concentration
                    (LC)50 > 2.6 mg/
                    liter (L)
--------------------------------------
Primary eye        TGAI: Slight       III               448219-09
 irritation         irritant          II                448219-10
                   EP: Moderate
                    irritant
--------------------------------------
Primary dermal     EP: No dermal      IV                448219-11
 irritation         irritation
                    symptoms up to
                    72-hour post-
                    dosing
--------------------------------------
Skin               TGAI: Buehler      Not a sensitizer  448219-13
 sensitization      test was          Not a sensitizer  448219-14
                    negative
                   EP: Buehler test
                    was negative
------------------------------------------------------------------------

    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,

[[Page 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 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

    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 deep-fried 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[reg] 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 non-food 
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 non-toxic. 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

[[Page 55276]]

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 e-mail to: <a href="/cdn-cgi/l/email-protection#38574848155c575b535d4c785d4859165f574e"><span class="__cf_email__" data-cfemail="d4bba4a4f9b0bbb7bfb1a094b1a4b5fab3bba2">[email protected]</span></a>. 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

[[Page 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.1259 is added to subpart D to read as follows:


Sec.  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


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