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55272 Federal Register / Vol. 70, No.

182 / Wednesday, September 21, 2005 / Rules and Regulations

Distribution, or Use (66 FR 28355, May Executive Order 13132, entitled required information to the U.S. Senate,
22, 2001). This final rule does not Federalism (64 FR 43255, August 10, the U.S. House of Representatives, and
contain any information collections 1999). Executive Order 13132 requires the Comptroller General of the United
subject to OMB approval under the EPA to develop an accountable process States prior to publication of this final
Paperwork Reduction Act (PRA), 44 to ensure ‘‘meaningful and timely input rule in the Federal Register. This final
U.S.C. 3501 et seq., or impose any by State and local officials in the rule is not a ‘‘major rule’’ as defined by
enforceable duty or contain any development of regulatory policies that 5 U.S.C. 804(2).
unfunded mandate as described under have federalism implications.’’ ‘‘Policies
that have federalism implications’’ is List of Subjects in 40 CFR Part 180
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public defined in the Executive Order to Environmental protection,
Law 104–4). Nor does it require any include regulations that have Administrative practice and procedure,
special considerations as required by ‘‘substantial direct effects on the States, Agricultural commodities, Pesticides
Executive Order 12898, entitled Federal on the relationship between the national and pests, Reporting and recordkeeping
Actions to Address Environmental government and the States, or on the requirements.
Justice in Minority Populations and distribution of power and Dated: September 9, 2005.
Low-Income Populations (59 FR 7629, responsibilities among the various
James Jones,
February 16, 1994); or OMB review or levels of government.’’ This final rule
Director, Office of Pesticide Programs.
any other Agency action under directly regulates growers, food
processors, food handlers and food ■Therefore, 40 CFR chapter I is
Executive Order 13045, entitled
retailers, not States. This action does not amended as follows:
Protection of Children from
Environmental Health Risks and Safety alter the relationships or distribution of
power and responsibilities established PART 180—AMENDED
Risks (62 FR 19885, April 23, 1997).
This action does not involve any by Congress in the preemption ■ 1. The authority citation for part 180
technical standards that would require provisions of section 408(n)(4) of continues to read as follows:
Agency consideration of voluntary FFDCA. For these same reasons, the
Agency has determined that this rule Authority: 21 U.S.C. 321(q), 346a and 371.
consensus standards pursuant to section ■ 2. Section 180.144 is amended by
does not have any ‘‘tribal implications’’
12(d) of the National Technology revising the table under paragraph (a) to
as described in Executive Order 13175,
Transfer and Advancement Act of 1995 read as follows:
entitled Consultation and Coordination
(NTTAA), Public Law 104–13, section
with Indian Tribal Governments (65 FR
12(d) (15 U.S.C. 272 note). Pursuant to § 180.144 Cyhexatin; tolerances for
67249, November 6, 2000). Executive residues.
the Regulatory Flexibility Act (RFA) (5
Order 13175, requires EPA to develop
U.S.C. 601 et seq.), the Agency (a) General. * * *
an accountable process to ensure
previously assessed whether revocations
‘‘meaningful and timely input by tribal
of tolerances might significantly impact Expiration/
officials in the development of Commodity Parts per Revocation
a substantial number of small entities regulatory policies that have tribal million Date
and concluded that, as a general matter, implications.’’ ‘‘Policies that have tribal
these actions do not impose a significant implications’’ is defined in the Orange, juice 0.1 6/13/09
economic impact on a substantial Executive Order to include regulations
number of small entities. This analysis that have ‘‘substantial direct effects on * * * * *
was published on December 17, 1997 one or more Indian tribes, on the [FR Doc. 05–18581 Filed 9–20–05; 8:45 am]
(62 FR 66020), and was provided to the relationship between the Federal BILLING CODE 6560–50–S
Chief Counsel for Advocacy of the Small Government and the Indian tribes, or on
Business Administration. Taking into the distribution of power and
account this analysis, and available responsibilities between the Federal ENVIRONMENTAL PROTECTION
information concerning the pesticides Government and Indian tribes.’’ This AGENCY
listed in this rule, the Agency hereby rule will not have substantial direct
certifies that this final rule will not have effects on tribal governments, on the 40 CFR Part 180
a significant economic impact on a relationship between the Federal
substantial number of small entities. [OPP–2005–0221; FRL–7730–3]
Government and Indian tribes, or on the
Specifically, as per the 1997 notice, EPA distribution of power and Reynoutria Sachalinensis Extract;
has reviewed its available data on responsibilities between the Federal Exemption from the Requirement of a
imports and foreign pesticide usage and Government and Indian tribes, as Tolerance
concludes that there is a reasonable specified in Executive Order 13175.
international supply of food not treated Thus, Executive Order 13175 does not AGENCY: Environmental Protection
with canceled pesticides. Furthermore, apply to this rule. Agency (EPA).
for the pesticides named in this final ACTION: Final rule.
rule, the Agency knows of no VI. Congressional Review Act
extraordinary circumstances that exist The Congressional Review Act, 5 SUMMARY: This regulation establishes an
as to the present revocations that would U.S.C. 801 et seq., as added by the Small exemption from the requirement of a
change EPA’s previous analysis. In Business Regulatory Enforcement tolerance for residues of the biochemical
addition, the Agency has determined Fairness Act of 1996, generally provides pesticide Reynoutria sachalinensis
that this action will not have a that before a rule may take effect, the extract on all food commodities. The
substantial direct effect on States, on the agency promulgating the rule must Interregional Research Project Number 4
relationship between the national submit a rule report, which includes a (IR-4), on behalf of KHH Bioscience,
government and the States, or on the copy of the rule, to each House of the Inc., submitted a petition to EPA under
distribution of power and Congress and to the Comptroller General the Federal Food, Drug, and Cosmetic
responsibilities among the various of the United States. EPA will submit a Act (FFDCA), as amended by the Food
levels of government, as specified in report containing this rule and other Quality Protection Act of 1996 (FQPA),

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

requesting an exemption from the entities not listed in this unit could also maintaining in effect an exemption from
requirement of a tolerance. This be affected. The North American the requirement of a tolerance, EPA
regulation eliminates the need to Industrial Classification System must take into account the factors set
establish a maximum permissible level (NAICS) codes have been provided to forth in section 408(b)(2)(C), which
for residues of Reynoutria sachalinensis assist you and others in determining require EPA to give special
extract. whether this action might apply to consideration to exposure of infants and
DATES: This regulation is effective certain entities. If you have any children to the pesticide chemical
September 21, 2005. Objections and questions regarding the applicability of residue in establishing a tolerance and
requests for hearings must be received this action to a particular entity, consult to ‘‘ensure that there is a reasonable
on or before November 21, 2005. the person listed under FOR FURTHER certainty that no harm will result to
INFORMATION CONTACT. infants and children from aggregate
ADDRESSES: To submit a written
exposure to the pesticide chemical
objection or hearing request follow the B. How Can I Access Electronic Copies
residue....’’ Additionally, section
detailed instructions as provided in of this Document and Other Related
408(b)(2)(D) of the FFDCA requires that
Unit VIII. of the SUPPLEMENTARY Information?
the Agency consider ‘‘available
INFORMATION. EPA has established a In addition to using EDOCKET (http:// information concerning the cumulative
docket for this action under Docket www.epa.gov/edocket/), you may access effects of a particular pesticide’s
identification (ID) number OPP–2005– this Federal Register document residues’’ and ‘‘other substances that
0221. All documents in the docket are electronically through the EPA Internet have a common mechanism of toxicity.’’
listed in the EDOCKET index at http:// under the ‘‘Federal Register’’ listings at EPA performs a number of analyses to
www.epa.gov/edocket. Although listed http://www.epa.gov/fedrgstr/. A determine the risks from aggregate
in the index, some information is not frequently updated electronic version of exposure to pesticide residues. First,
publicly available, i.e., CBI or other 40 CFR part 180 is available at E-CFR EPA determines the toxicity of
information whose disclosure is Beta Site Two at http:// pesticides. Second, EPA examines
restricted by statute. Certain other www.gpoaccess.gov/ecfr/. exposure to the pesticide through food,
material, such as copyrighted material, drinking water, and through other
is not placed on the Internet and will be II. Background and Statutory Findings
exposures that occur as a result of
publicly available only in hard copy In the Federal Register of March 31, pesticide use in residential settings.
form. Publicly available docket 2004 (69 FR 16925) (FRL–7342–4), EPA
materials are available either issued a notice pursuant to section III. Toxicological Profile
electronically in EDOCKET or in hard 408(d)(3) of the FFDCA, 21 U.S.C. Consistent with section 408(b)(2)(D)
copy at the Public Information and 346a(d)(3), announcing the filing of a of the FFDCA, EPA has reviewed the
Records Integrity Branch (PIRIB), Rm. pesticide tolerance petition (PP 3E6751) available scientific data and other
119, Crystal Mall #2, 1801 S. Bell St., by Interregional Research Project relevant information in support of this
Arlington, VA. This docket facility is Number 4 (IR-4), New Jersey action and considered its validity,
open from 8:30 a.m. to 4 p.m., Monday Agricultural Experiment Station, completeness, and reliability and the
through Friday, excluding legal Technology Center of New Jersey, 681 relationship of this information to
holidays. The docket telephone number U.S. Highway 1 South, North human risk. EPA has also considered
is (703) 305–5805. Brunswick, NJ 08902–3390, on behalf of available information concerning the
FOR FURTHER INFORMATION CONTACT: KHH BioScience Inc., 920 Campus variability of the sensitivities of major
Driss Benmhend, Biopesticides and Drive, Suite 101, Raleigh, NC 27606. identifiable subgroups of consumers,
Pollution Prevention Division (7511C), The petition requested that 40 CFR part including infants and children.
Environmental Protection Agency, 1200 180 be amended by establishing an Reynoutria sachalinensis is a
Pennsylvania Ave., NW., Washington, exemption from the requirement of a naturally-occurring plant in the
DC 20460–0001; telephone number: tolerance for residues of Reynoutria environment, commonly known as
(703) 308–9525; e-mail address: sachalinensis extract. This notice Giant knotweed. It is a rhizomatous,
benmhend.driss@epa.gov. included a summary of the petition herbaceous, perennial, terrestrial plant
prepared by the petitioner IR-4, on belonging to the Polygonaceae family.
SUPPLEMENTARY INFORMATION: behalf of KHH BioScience Inc. There The plant is a native of East Asia, but
I. General Information were no comments received in response was introduced into Europe and North
to the notice of filing. America in the 19th century as a fodder
A. Does this Action Apply to Me? Section 408(c)(2)(A)(i) of the FFDCA plant for cattle and as an ornamental.
You may be potentially affected by allows EPA to establish an exemption Reynoutria sachalinensis has a wide
this action if you are an agricultural from the requirement for a tolerance (the geographic distribution throughout the
producer, food manufacturer, or legal limit for a pesticide chemical United States, Europe, and Asia. The
pesticide manufacturer. Potentially residue in or on a food) only if EPA plant is currently present in 25 U.S.
affected entities may include, but are determines that the exemption is ‘‘safe.’’ States (Alaska, California, Connecticut,
not limited to: Section 408(c)(2)(A)(ii) of the FFDCA Idaho, Illinois, Kentucky, Louisiana,
• Crop production (NAICS code 111) defines ‘‘safe’’ to mean that ‘‘there is a Maine, Maryland, Massachusetts,
• Animal production (NAICS code reasonable certainty that no harm will Michigan, Montana, New Jersey, New
112) result from aggregate exposure to the York, North Carolina, Ohio, Oregon,
• Food manufacturing (NAICS code pesticide chemical residue, including Pennsylvania, Rhode Island, Tennessee,
311) all anticipated dietary exposures and all Vermont, Virginia, Washington, West
• Pesticide manufacturing (NAICS other exposures for which there is Virginia and Wisconsin). It is found in
code 32532) reliable information.’’ This includes diverse habitats including riparian
This listing is not intended to be exposure through drinking water and in areas, wet meadows, floodplain forests,
exhaustive, but rather provides a guide residential settings, but does not include forest edges, roadsides, railroad and
for readers regarding entities likely to be occupational exposure. Pursuant to utility rights-of way, and open areas.
affected by this action. Other types of section 408(c)(2)(B), in establishing or The plant has become invasive in

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

certain regions. According to the diuretic, and for the treatment of the manufacturing-use product,
Invasive Plant Atlas of New England, dermatitis and athlete’s foot. Reynoutria Reynoutria sachalinensis Bioprotectant,
this weed is present in all of the sachalinensis has been consumed in the and the greenhouse, non-food-use end-
northeast U.S., with the exception of human diet in Japan for generations use product, Milsana Bioprotectant
New Hampshire, as far south as North without any known negative effects. The Concentrate. Submitted data for the
Carolina and Tennessee. It has also been plant is sold commercially in Japanese technical grade active ingredient (TGAI)
reported in Louisiana, Montana, Idaho, supermarkets for use in soups, as a and the end-use product, indicate
Alaska, and three west coast States. deep-fried vegetable, and as a vinegared Toxicity Category IV for acute oral and
Reynoutria sachalinensis extract is an side dish. Reynoutria sachalinensis is acute inhalation toxicity. Acute dermal
ethanolic extract of dried, ground also a floral nectar source for European
toxicity data indicated a Toxicity
Reynoutria sachalinensis plants, and is honey bees, and thus many more
already approved as an active ingredient Category III. The data reported for
humans are already indirectly exposed
by EPA for use as a spray on non-food, to the active ingredient via consumption primary eye irritation studies showed
ornamental plants grown in of honey. The active ingredient has been that the test substance was moderately
greenhouses. The active ingredient has registered and used in two end use irritating, and was given a Toxicity
been used in this manner for over 4 products in Germany (Milsana fluessig Category III when the TGAI was used,
years with no reports of harmful health and Milsana Pulver) as a resistance and Toxicity Category II when the end-
effects to greenhouse workers. In enhancer on fruit and vegetables since use product Milsana is used as a test
addition, there is a long history of November 2000. To date, there have material. Exposure to Milsana
human dermal and oral exposure to been no reports of adverse health effects produced very slight erythema in
Reynoutria sachalinensis through its use resulting from the use of Reynoutria animal tests; as a result, a Toxicity
as an ornamental plant, as a human sachalinensis on food. Category IV was given for dermal
medicinal agent, and as human food. This final rule supports the use of irritation.
Humans are regularly, physically Reynoutria sachalinensis extract as the
The Agency deemed the submitted
exposed to the plant when handling it active ingredient in an end-use product
acute toxicity studies acceptable and
as an ornamental and there have been that will be used on food crops to
no known reports of any adverse health approved the bridging of these studies
enhance the resistance to fungal and
effects to humans via physical contact bacterial diseases. to support this tolerance exemption. A
with the plant. In Asian folk medicine, Acute toxicity studies were summary of these acute toxicity studies
the rhizomes, leaves, and stems of the previously submitted and reviewed by is presented in the table below.
plant have been used as a laxative, EPA in support of the registrations of

ACUTE TOXICITY DATA FOR REYNOUTRIA SACHALINENSIS


Data Requirement Results Toxicity Category MRID No.

Acute oral toxicity TGAI: Lethal dose (LD)50 > 5,000 IV 448219–04
milligrams/kilogram (mg/kg)
EP: LD50 > 5,000 mg/kg IV 448219–05

Acute dermal toxicity TGAI: LD50 > 2,000 mg/kg III 448219–06
EP: LD50 > 5,000 mg/kg III 448219–07

Acute inhalation toxicity EP: Lethal concentration (LC)50 > IV 448219–08


2.6 mg/liter (L)

Primary eye irritation TGAI: Slight irritant III 448219–09


EP: Moderate irritant II 448219–10

Primary dermal irritation EP: No dermal irritation symp- IV 448219–11


toms up to 72–hour post-dos-
ing

Skin sensitization TGAI: Buehler test was negative Not a sensitizer 448219–13
EP: Buehler test was negative Not a sensitizer 448219–14

Additionally, data waivers were environment, in food and medicine, and Reynoutria sachalinensis contains
requested by the applicant for the as an ornamental plant. As stated anthraquinones, which are widespread
following Tier I toxicology data previously, large numbers of humans in plants, including plants used for
requirements: have been and continue to be regularly human consumption. Most of the total
1. Genotoxicity exposed to the active ingredient via anthraquinone content in plants
2. Teratogenicity physical contact and in their diet with consists of physcion, emodin, and
3. Immune Response no known reports of adverse effects. In chrysophanol. Reynoutria sachalinensis
4. 90–day Feeding addition, researchers, manufacturers, contains both emodin and physcion.
5. 90–day Dermal and others who work with this active While physcion and chrysophanol have
6. 90–day Inhalation ingredient have not reported any shown no genotoxic effects, emodin has
The Agency granted these waivers adverse health effects. Thus, the Agency been shown to have genotoxic potential
based on the widespread and regular does not expect the use of Reynoutria when extracted from edible plant
exposure that humans already have to sachalinensis extract on food crops to substrates (e.g., beans, peas, cabbage,
Reynoutria sachalinensis in the result in any harmful effects to humans. lettuce, plaintain, buckwheat). However,

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whole plant extracts containing these extract is unlikely to result in additional considerations include the possible
anthraquinones have been shown not to residues to drinking water that are cumulative effects of such residues on
be genotoxic, and to have properties that above pre-existing levels. In other areas infants and children.
counteract genotoxic anthraquinones. where the Reynoutria sachalinensis Common mechanisms of toxicity are
Therefore, because the Reynoutria plant does not already exist, the Agency not relevant to a consideration of
sachalinensis extract is derived from the is not concerned about drinking water cumulative exposure to Reynoutria
whole plant extract, the Agency has exposure because it is non-toxic and sachalinensis extract because the extract
concluded that Reynoutria studies involving feeding of the active is not toxic to mammalian systems.
sachalinensis extract does not present a ingredient in acute oral rat trials Thus, the Agency does not expect any
genotoxicity risk. indicated no adverse effect. cumulative or incremental effects from
IV. Aggregate Exposures B. Other Non-Occupational Exposure exposure to residues of Reynoutria
sachalinensis extract when applied/
In examining aggregate exposure, Reynoutria sachalinensis is a used as directed on the label and in
section 408 of the FFDCA directs EPA naturally-occurring plant currently accordance with good agricultural
to consider available information found in 25 U.S. States as an ornamental practices.
concerning exposures from the pesticide plant, an invasive weed, and a grazing
residue in food and all other non- crop. Many humans are already VI. Determination of Safety for U.S.
occupational exposures, including regularly exposed to the plant in the Population, Infants and Children
drinking water from ground water or environment. In certain areas of the A. U.S. population
surface water and exposure through world, i.e., Japan, Germany, and parts of
pesticide use in gardens, lawns, or Europe, the plant is consumed directly There is reasonable certainty that no
buildings (residential and other indoor and indirectly as human food and is harm will result from aggregate
uses). used as a pesticide on food. There have exposure to residues of Reynoutria
been no reported adverse effects to sachalinensis extract to the U.S.
A. Dietary Exposure population, infants, and children. This
Reynoutria sachalinensis.
1. Food. The Agency is not concerned 1. Dermal exposure. There is a long includes all anticipated dietary
about dietary exposure to Reynoutria history of human dermal exposure to exposures and all other exposures for
sachalinensis because large numbers of Reynoutria sachalinensis as it is a which there is reliable information. The
humans have consumed it regularly widespread, naturally-occurring plant in Agency has arrived at this conclusion
without any reports of adverse effects. the environment. Humans have had based on the fact that the plant is a part
In Japan, Reynoutria sachalinensis is direct contact with the plant through its of the human diet in certain areas of the
commonly used as a vegetable and is a use as an ornamental, and greenhouse world with no reported adverse effects,
known source of vitamins A, C, and E. workers have been exposed to and that humans have had frequent
Young shoots are edible and are Reynoutria sachalinensis extract when physical contact with Reynoutria
harvested to be used in soups, as a deep- applying the EPA registered product sachalinensis and plants treated with
fried vegetable, a vinegared side dish, Milsana Bioprotectant to ornamentals. Reynoutria sachalinensis extract with
and sometimes mixed with tobacco or There have been no reported adverse no negative health effects. In addition,
used as a substitute for it. Reynoutria effects to humans from the the Toxicity Category IV for acute oral
sachalinensis is sold commercially in aforementioned forms of exposure. In toxicity indicates that the extract is non-
Japanese supermarkets for use as human addition, results of the acute dermal toxic. Finally, the Agency has
food. Reynoutria sachalinensis is listed study indicated low toxicity (Toxicity concluded that there is a reasonable
among floral nectar sources for Category III) and no significant dermal certainty of no harm when the
European honey bees; therefore, humans irritation (Toxicity Category IV). Based Reynoutria sachalinensis extract is
are indirectly exposed to the active on these results, the anticipated risks derived from the whole plant extract.
ingredient via consumption of honey. from dermal exposure are considered B. Infants and children
In any event, negligible to no risk is minimal.
expected for the general populations, 2. Inhalation exposure. As stated FFDCA section 408 provides that EPA
including infants and children, because above, there have been no reported shall apply an additional tenfold margin
oral toxicity tests on Reynoutria harmful effects to humans from of exposure (also referred to as a margin
sachalinensis indicated that the extract exposure to Reynoutria sachalinensis in of safety) for infants and children in the
is non-toxic (Toxicity Category IV), thus, the environment, from its use as an case of threshold effects to account for
the risks are considered minimal. ornamental, or from the application of prenatal and postnatal toxicity and the
With regard to the emodin content of Reynoutria sachalinensis extract to non- completeness of the database unless
Reynoutria sachalinensis extract, the food crops in greenhouses. Furthermore, EPA determines that a different margin
Agency is not concerned about dietary the inhalation toxicity studies showed of exposure will be safe for infants and
exposure because Reynoutria no toxicity (Toxicity Category IV), thus children. Margins of exposure are often
sachalinensis extract is derived from the the risks anticipated for this route of referred to as uncertainty or safety
whole plant extract, which is not exposure are considered minimal. factors. In this instance, based on all
genotoxic. available information, the Agency
2. Drinking water exposure. V. Cumulative Effects concludes that Reynoutria sachalinensis
Reynoutria sachalinensis commonly Section 408(b)(2)(D)(v) of the FFDCA extract is non-toxic to mammals,
grows along rivers and streams in much requires that, when considering whether including infants and children. Because
of the United States. The leaves of to establish an exemption from a there are no threshold effects of concern
Reynoutria sachalinensis are killed off tolerance, the Agency consider to infants, children and adults when
in frosts and leaf litter naturally drops ‘‘available information concerning the Reynoutria sachalinensis extract is used
into nearby bodies of water; therefore, cumulative effects of a particular as labeled, the provision requiring an
those water bodies are already exposed pesticide’s residues and other additional margin of safety does not
to exudates of this plant. In those areas, substances that have a common apply. As a result, EPA has not used a
the use of Reynoutria sachalinensis mechanism of toxicity.’’ These margin of exposure approach to assess

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

the safety of Reynoutria sachalinensis A. What Do I Need to Do to File an mail to: opp-docket@epa.gov. Please use
extract. Objection or Request a Hearing? an ASCII file format and avoid the use
You must file your objection or of special characters and any form of
VII. Other Considerations
request a hearing on this regulation in encryption. Copies of electronic
A. Endocrine Disruptors accordance with the instructions objections and hearing requests will also
EPA is required under section 408(p) provided in this unit and in 40 CFR part be accepted on disks in WordPerfect
of the FFDCA, as amended by FQPA, to 178. To ensure proper receipt by EPA, 6.1/8.0 or ASCII file format. Do not
develop a screening program to you must identify docket ID number include any CBI in your electronic copy.
determine whether certain substances OPP–2005–0221 in the subject line on You may also submit an electronic copy
(including all pesticide active and other the first page of your submission. All of your request at many Federal
ingredients) ‘‘may have an effect in requests must be in writing, and must be Depository Libraries.
humans that is similar to an effect mailed or delivered to the Hearing Clerk B. When Will the Agency Grant a
produced by a naturally-occurring on or before November 21, 2005. Request for a Hearing?
estrogen, or other such endocrine effects 1. Filing the request. Your objection A request for a hearing will be granted
as the Administrator may designate.’’ must specify the specific provisions in
Reynoutria sachalinensis extract is if the Administrator determines that the
the regulation that you object to, and the material submitted shows the following:
not a known endocrine disruptor nor is grounds for the objections (40 CFR
it related to any class of known There is a genuine and substantial issue
178.25). If a hearing is requested, the of fact; there is a reasonable possibility
endocrine disruptors. Thus, there is no objections must include a statement of
impact via endocrine-related effects on that available evidence identified by the
the factual issues(s) on which a hearing requestor would, if established resolve
the Agency’s safety finding set forth in is requested, the requestor’s contentions
this final rule for Reynoutria one or more of such issues in favor of
on such issues, and a summary of any the requestor, taking into account
sachalinensis extract. evidence relied upon by the objector (40 uncontested claims or facts to the
B. Analytical Method(s) CFR 178.27). Information submitted in contrary; and resolution of the factual
connection with an objection or hearing issues(s) in the manner sought by the
Through this action, the Agency
request may be claimed confidential by requestor would be adequate to justify
proposes to establish an exemption from
marking any part or all of that the action requested (40 CFR 178.32).
the requirement of a tolerance for the
information as CBI. Information so
extract of Reynoutria sachalinensis IX. Statutory and Executive Order
marked will not be disclosed except in
when used on fruit and vegetable crops. Reviews
accordance with procedures set forth in
For the very same reasons that support
40 CFR part 2. A copy of the This final rule establishes an
the granting of this tolerance exemption,
information that does not contain CBI exemption from the tolerance
the Agency has concluded that an
must be submitted for inclusion in the requirement under section 408(d) of the
analytical method is not required for
enforcement purposes for these public record. Information not marked FFDCA in response to a petition
proposed uses of Reynoutria confidential may be disclosed publicly submitted to the Agency. The Office of
sachalinensis extract. by EPA without prior notice. Management and Budget (OMB) has
Mail your written request to: Office of exempted these types of actions from
C. Codex Maximum Residue Level the Hearing Clerk (1900L), review under Executive Order 12866,
There are no codex maximum residue Environmental Protection Agency, 1200 entitled Regulatory Planning and
levels established for Reynoutria Pennsylvania Ave., NW., Washington, Review (58 FR 51735, October 4, 1993).
sachalinensis extract. DC 20460–0001. You may also deliver Because this rule has been exempted
your request to the Office of the Hearing from review under Executive Order
VIII. Objections and Hearing Requests Clerk in Suite 350, 1099 14th St., NW., 12866 due to its lack of significance,
Under section 408(g) of the FFDCA, as Washington, DC 20005. The Office of this rule is not subject to Executive
amended by the FQPA, any person may the Hearing Clerk is open from 8 a.m. Order 13211, Actions Concerning
file an objection to any aspect of this to 4 p.m., Monday through Friday, Regulations That Significantly Affect
regulation and may also request a excluding legal holidays. The telephone Energy Supply, Distribution, or Use (66
hearing on those objections. The EPA number for the Office of the Hearing FR 28355, May 22, 2001). This final rule
procedural regulations which govern the Clerk is (202) 564–6255. does not contain any information
submission of objections and requests 2. Copies for the Docket. In addition collections subject to OMB approval
for hearings appear in 40 CFR part 178. to filing an objection or hearing request under the Paperwork Reduction Act
Although the procedures in those with the Hearing Clerk as described in (PRA), 44 U.S.C. 3501 et seq., or impose
regulations require some modification to Unit IX.A., you should also send a copy any enforceable duty or contain any
reflect the amendments made to the of your request to the PIRIB for its unfunded mandate as described under
FFDCA by the FQPA, EPA will continue inclusion in the official record that is Title II of the Unfunded Mandates
to use those procedures, with described in ADDRESSES. Mail your Reform Act of 1995 (UMRA) (Public
appropriate adjustments, until the copies, identified by docket ID number Law 104–4). Nor does it require any
necessary modifications can be made. OPP–2005–0221, to: Public Information special considerations under Executive
The new section 408(g) of the FFDCA and Records Integrity Branch, Order 12898, entitled Federal Actions to
provides essentially the same process Information Resources and Services Address Environmental Justice in
for persons to ‘‘object’’ to a regulation Division (7502C), Office of Pesticide Minority Populations and Low-Income
for an exemption from the requirement Programs, Environmental Protection Populations (59 FR 7629, February 16,
of a tolerance issued by EPA under new Agency, 1200 Pennsylvania Ave., NW., 1994); or OMB review or any Agency
section 408(d) of the FFDCA, as was Washington, DC 20460–0001. In person action under Executive Order 13045,
provided in the old sections 408 and or by courier, bring a copy to the entitled Protection of Children from
409 of the FFDCA. However, the period location of the PIRIB described in Environmental Health Risks and Safety
for filing objections is now 60 days, ADDRESSES. You may also send an Risks (62 FR 19885, April 23, 1997).
rather than 30 days. electronic copy of your request via e- This action does not involve any

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

technical standards that would require Government and the Indian tribes, or on ENVIRONMENTAL PROTECTION
Agency consideration of voluntary the distribution of power and AGENCY
consensus standards pursuant to section responsibilities between the Federal
12(d) of the National Technology Government and Indian tribes.’’ This 40 CFR Part 180
Transfer and Advancement Act of 1995 rule will not have substantial direct
[OPP–2005–0074; FRL–7736–2]
(NTTAA), Public Law 104–113, section effects on tribal governments, on the
12(d) (15 U.S.C. 272 note). Since relationship between the Federal Iprovalicarb; Pesticide Tolerance
tolerances and exemptions that are Government and Indian tribes, or on the
established on the basis of a petition distribution of power and AGENCY: Environmental Protection
under section 408(d) of the FFDCA, responsibilities between the Federal Agency (EPA).
such as the exemption in this final rule, Government and Indian tribes, as ACTION: Final rule.
do not require the issuance of a specified in Executive Order 13175.
proposed rule, the requirements of the Thus, Executive Order 13175 does not SUMMARY: This regulation establishes a
Regulatory Flexibility Act (RFA) (5 apply to this rule. tolerance for residues of Iprovalicarb in
U.S.C. 601 et seq.) do not apply. The or on tomatoes. Bayer CropScience AG
X. Congressional Review Act requested this tolerance under the
Agency hereby certifies that this rule
will not have significant negative The Congressional Review Act, 5 Federal Food, Drug, and Cosmetic Act
economic impact on a substantial U.S.C. 801 et seq., as added by the Small (FFDCA), as amended by the Food
number of small entities. In addition, Business Regulatory Enforcement Quality Protection Act of 1996 (FQPA).
the Agency has determined that this Fairness Act of 1996, generally provides DATES: This regulation is effective
action will not have a substantial direct that before a rule may take effect, the September 21, 2005. Objections and
effect on States, on the relationship agency promulgating the rule must requests for hearings must be received
between the national government and submit a rule report, which includes a on or before November 21, 2005.
the States, or on the distribution of copy of the rule, to each House of the ADDRESSES: To submit a written
power and responsibilities among the Congress and to the Comptroller General objection or hearing request follow the
various levels of government, as of the United States. EPA will submit a detailed instructions as provided in
specified in Executive Order 13132, report containing this rule and other Unit VI. of the SUPPLEMENTARY
entitled Federalism (64 FR 43255, required information to the U.S. Senate, INFORMATION. EPA has established a
August 10, 1999). Executive Order the U.S. House of Representatives, and docket for this action under Docket
13132 requires EPA to develop an the Comptroller General of the United identification (ID) number OPP–2005–
accountable process to ensure States prior to publication of this final 0074. All documents in the docket are
‘‘meaningful and timely input by State rule in the Federal Register. This final listed in the EDOCKET index athttp://
and local officials in the development of rule is not a ‘‘major rule’’ as defined by www.epa.gov/edocket. Although listed
regulatory policies that have federalism 5 U.S.C. 804(2). in the index, some information is not
implications.’’ ‘‘Policies that have List of Subjects in 40 CFR Part 180 publicly available, i.e., CBI or other
federalism implications’’ is defined in information whose disclosure is
the Executive order to include Environmental protection, restricted by statute. Certain other
regulations that have ‘‘substantial direct Administrative practice and procedure, material, such as copyrighted material,
effects on the States, on the relationship Agricultural commodities, Pesticides is not placed on the Internet and will be
between the national government and and pests, Reporting and recordkeeping publicly available only in hard copy
the States, or on the distribution of requirements. form. Publicly available docket
power and responsibilities among the materials are available either
various levels of government.’’ This Dated: September 9, 2005. electronically in EDOCKET or in hard
final rule directly regulates growers, James Jones, copy at the Public Information and
food processors, food handlers and food Director, Office of Pesticide Programs. Records Integrity Branch (PIRIB), Rm.
retailers, not States. This action does not 119, Crystal Mall #2, 1801 S. Bell St.,
alter the relationships or distribution of ■Therefore, 40 CFR chapter I is Arlington, VA. This docket facility is
power and responsibilities established amended as follows: open from 8:30 a.m. to 4 p.m., Monday
by Congress in the preemption through Friday, excluding legal
provisions of section 408(n)(4) of the PART 180—[AMENDED] holidays. The docket telephone number
FFDCA. For these same reasons, the is (703) 305–5805.
■ 1. The authority citation for part 180
Agency has determined that this rule FOR FURTHER INFORMATION CONTACT:
continues to read as follows:
does not have any ‘‘tribal implications’’ Mary L. Waller, Registration Division
as described in Executive Order 13175, Authority: 21 U.S.C. 321(q), 346a and 371. (7505C), Office of Pesticide Programs,
entitled Consultation and Coordination Environmental Protection Agency, 1200
with Indian Tribal Governments (65 FR ■ 2. Section 180.1259 is added to
Pennsylvania Ave., NW., Washington,
67249, November 6, 2000). Executive subpart D to read as follows:
DC 20460–0001; telephone number:
Order 13175, requires EPA to develop § 180.1259 Reynoutria sachalinensis (703) 308–9354; e-mail
an accountable process to ensure extract; exemption from the requirement of address:waller.mary@epa.gov.
‘‘meaningful and timely input by tribal a tolerance.
SUPPLEMENTARY INFORMATION:
officials in the development of
Residues of the biochemical pesticide
regulatory policies that have tribal I. General Information
Reynoutria sachalinensis extract, when
implications.’’ ‘‘Policies that have tribal
derived from the whole plant extract, A. Does this Action Apply to Me?
implications’’ is defined in the
are exempt from the requirement of a
Executive order to include regulations You may be potentially affected by
tolerance in or on all food commodities.
that have ‘‘substantial direct effects on this action if you are an agricultural
one or more Indian tribes, on the [FR Doc. 05–18725 Filed 9–20–05; 8:45 am] producer, food manufacturer, or
relationship between the Federal BILLING CODE 6560–50–S pesticide manufacturer. Potentially

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