[Federal Register: March 31, 2004 (Volume 69, Number 62)]
[Rules and Regulations]
[Page 16796-16800]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr04-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0281; FRL-7347-7]
Rhamnolipid Biosurfactant; 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, rhamnolipid
biosurfactant, on all food commodities when applied/used as a
fungicide. Jeneil Biosurfactant Company submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by
the Food Quality Protection Act of 1996 (FQPA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of
rhamnolipid biosurfactant.
DATES: This regulation is effective March 31, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0281,
must be received on or before June 1, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit X. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Denise Greenway, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8263; e-mail address: greenway.denise@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 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
Pesticide manufacturing (NAICS 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 Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0281. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., 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.
2. Electronic access. 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 on E-CFR Beta Site
Two at http://gpoaccess.gov/ecfr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
II. Background and Statutory Findings
In the Federal Register of May 9, 2003 (68 FR 25026) (FRL-7306-3),
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C.
346a(e), as amended by FQPA (Public Law 104-170), announcing the filing
of a pesticide tolerance petition (PP 1F6288) by Jeneil Biosurfactant
Company, 400 N. Dekora Woods Boulevard, Saukville, Wisconsin 53080.
This notice included a summary of the petition prepared by the
petitioner Jeneil Biosurfactant Company. There were no comments
received in response to the notice of filing.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of rhamnolipid biosurfactant.
III. Risk Assessment
New 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. In determining whether an exemption
is safe, the Administrator is directed to take into account the same
factors set forth in section 408(b)(2)(C) and (D) for determining
whether a tolerance is safe. Section 408(b)(2)(C) of the FFDCA requires
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.
IV. 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
[[Page 16797]]
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.
Rhamnolipid biosurfactant (pc code 110029, CAS number 147858-26-2)
has the CAS name decanoic acid, 3-[[6-deoxy-2-O-(6-deoxy-[alpha]-L-
mannopyranosyl)-[alpha]-L-mannopyranosyl]oxy]-, 1-(carboxymethyl)octyl
ester, mixture with 1-(carboxymethyl)octyl 3-[(6-deoxy-[alpha]-L-
mannopyranosyl)oxy]decanoate. The basic composition of the active
ingredient consists of a well-known carbohydrate (rhamnose sugar) and
fatty acid (hydroxydecanoic acid). The active ingredient is a mixture
of two types of rhamnolipid molecules, R1 (RLL) and R2 (RRLL) at a
ratio of R2:R1 = 0.7 - 2.0. Chemical name of the rhamnolipid molecules
is as follows: Molecule 1 (defined as R1 or RLL): Decanoic acid, 3-[(6-
deoxy-[alpha]-L-mannopyranosyl) oxy]-, 1-(carboxymethyl) octyl ester;
and molecule 2 (defined as R2 or RRLL): Decanoic acid, 3-[[6-deoxy-2-O-
(6-deoxy-[alpha]-L-mannopyranosyl)-[alpha]-L-mannopyranosyl] oxy]-, 1-
(carboxymethyl) octyl ester.
Adequate mammalian toxicology data are available and support
registration of the product containing the active ingredient
rhamnolipid biosurfactant. Rhamnolipid molecules are simple glycolipids
consisting of a carbohydrate (rhamnose) ring and a fatty acid
(hydroxydecanoic acid) tail. Individually, these molecules are not
toxic. Rhamnose is a comparatively rare sugar approved by FDA as a food
additive, and fatty acids are ubiquitous in animals and plants and are
a major energy source in the body. Consequently, the breakdown products
of rhamnolipids are of little toxicological concern. The mode of action
of rhamnolipid biosurfactants is a physical action on the plant
pathogen, rather than a toxic action. Rhamnolipid biosurfactant
products are currently in use as emulsifiers, dispersants, wetting
agents, and agricultural adjuvants. There have been no reports of
adverse effects from any uses of rhamnolipid biosurfactants to date.
The information submitted indicates there is already widespread
exposure to rhamnose sugar, fatty acids, and rhamolipid biosurfactants
without any reported adverse effects to human health. The acute
toxicity studies, in conjunction with data or other information
obtained from the open literature and the expected low exposure to
humans, demonstrate that no risks to human health are expected from the
pesticidal use of rhamnolipid biosurfactant.
A. Acute Toxicology
1. Acute oral toxicity (OPPTS Harmonized Guidline 870.1100; 152-10;
MRID 45376702). Male and female rats (5 per sex) were dosed once with
5,000 milligrams/kilograms (mg/kg) and observed for 14 days. The acute
oral lethal dose (LD)50 was >5,000 mg/kg. The study was
acceptable and placed the test material in Toxicity Category IV.
2. Acute dermal toxicity (OPPTS Harmonized Guidline 870.1200; 152-
11; MRID 45376703). Male and female rats (5 per sex) were dosed with
5,000 mg/kg for 24 hours and observed for 14 days The acute dermal
LD50 was >5,000 mg/kg. The study was acceptable and placed
the test material in Toxicity Category IV.
3. Acute inhalation toxicity (OPPTS Harmonized Guidline 870.1300;
152-12, MRID 45376704). Male and female rats (5 per sex) were exposed
whole-body to a gravimetric concentration of 2.05 mg/liter (L) 9.5%
rhamnolipid biosurfactant in water for 4 hours, and observed for 14
days. The lethal concentration (LC)50 was >2.05 mg product/L
(0.20 mg active ingredient (a.i.)/L). The study was acceptable and
placed the test material in Toxicity Category IV.
Other acute toxicology data also reviewed in support of the
rhamnolipd biosurfactant registration include the following.
1. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376705).
2. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376706).
3. Primary eye irritation (OPPTS Harmonized Guidline 870.2400; 152-
13; MRID 45376707).
4. Primary dermal irritation (OPPTS Harmonized Guidline 870.2500;
152-14; MRID 45376708).
A data waiver was requested for the following study, and granted by
the Agency. Although no study was conducted by the registrant,
acceptable information/data was submitted to support the data waiver
request.
Dermal sensitization (OPPTS Harmonized Guidline 870.2600; 152-15).
B. Mutagenicity and Developmental Toxicity
The requested waiver was granted by the Agency based on the fact
that rhamnolipid biosurfactant is not related to any known mutagens and
does not belong to a chemical class of compounds containing known
mutagens. Rhamnolipid biosurfactant consists of rhamnose sugar and
hydroxydecanoic acid, both of which have food-related uses.
C. Subchronic Toxicity, Immunotoxicity
Requested waivers for 90-day oral toxicity and immunotoxicity were
granted by the Agency based on the physical mode of action of the
active ingredient; the lack of acute oral, dermal, and inhalation
toxicity; and the innocuous nature of the potential breakdown products
of rhamnolipid biosurfactants.
D. Chronic Exposure and Oncogenicity Assessment
Repeated-dose studies are conditionally required if the potential
for adverse chronic effects are indicated based on: (1) The subchronic
effect levels established in Tier I subchronic oral, inhalation, or
dermal studies, (2) the pesticide use pattern, or (3) the frequency and
the level of repeated human exposure that is expected. Oncogenicity
studies are required only if the active ingredient or any of its
metabolites, degradation products, or impurities produce in Tier I
studies any morphologic effects in any organ that potentially could
lead to neoplastic changes. None of the results of the submitted
studies triggered the need for chronic exposure or oncogenicity
testing.
V. 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. There is a great likelihood of exposure in the normal
human diet to rhamnolipid biosurfactant's components for most, if not
all individuals, including infants and children. Rhamnolipid
biosurfactant constituents, rhamnose sugar and fatty acid, are normal
parts of the human diet. To date, there have been no known reports of
any hypersensitivity incidents from users of the surfactant. Even if
exposure increased due to pesticidal use of rhamnolipid biosurfactant,
given the low toxicity of the components (or of the surfactant) and the
widespread dietary exposure to the components, the
[[Page 16798]]
Agency believes the risk associated with dietary exposure to the
biosurfactant by the oral route would be low to non-existent.
2. Drinking water exposure. Because rhamnolipid biosurfactant has
low acute mammalian toxicity, the constituent rhamnose sugar is a food
additive, and constituent fatty acids are ubiquitous in plant and
animals, no risk is anticipated should exposure occur through drinking
water.
B. Other Non-Occupational Exposure
The potential for non-dietary exposure to rhamnolipid biosurfactnt
residues for the general population, including infants and children, is
unlikely because potential use sites are horticultural and agricultural
crops. Rhamnolipid biosurfactant's constituent carbohydrate (rhamnose
sugar) and fatty acid (hydroxydecanoic acid) are not considered toxic;
rhamnose sugar is a food additive and fatty acids, ubiquitous in plants
and animals, are a major energy source in the body. Rhamnolipid
biosurfactant's toxicity has been determined to be very low through the
oral, dermal and inhalation routes. Therefore, while there exists a
great likelihood of prior exposure to rhamnolipid biosurfactant's
components, any risk from increased exposure due to the proposed
product would be negligible.
VI. Cumulative Effects from Substances with a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke 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.''
EPA does not have, at this time, available data to determine
whether rhamnolipid biosurfactant has a common mechanism of toxicity
with other substances. Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, EPA has not made a common mechanism of toxicity finding as to
rhamnolipid biosurfactant and any other substances and rhamnolipid
biosurfactant does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that rhamnolipid biosurfactant has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
VII. Determination of Safety for U.S. Population, Infants and Children
1. U.S. population. The Agency has determined that there is
reasonable certainty that no harm will result from aggregate exposure
to residues of rhamnolipid biosurfactant to the U.S. population. This
includes all anticipated dietary exposures and other non-occupational
exposures for which there is reliable information. The Agency arrived
at this conclusion based on the anticipated low exposure estimates from
its pesticidal use; the low mammalian toxicity of rhamnolipid
biosurfactant; and the already widespread human exposure to rhamolipid
biosurfactant constituents, rhamnose sugar and hexadecanoic acid,
without any reported adverse effects to human health.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of exposure for infants and children
in the case of threshold effects unless the Agency determines, based on
reliable data, that a different margin is safe. Margins of exposure are
referred to as uncertainty or safety factors, and are used to account
for potential prenatal and postnatal toxicity and any lack of
completeness of the data base. Based on all the reliable available
information the Agency reviewed on rhamnolipid biosurfactant, including
that showing a lack of threshold effects, the Agency concluded that the
additional margin of safety is not necessary to protect infants and
children and that not adding any additional margin of safety will be
safe for infants and children.
VIII. Other Considerations
A. Analytical Method(s)
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation for the reasons stated
above, including low toxicity and low exposure from the pesticidal use
of rhamnolipid biosurfactant. For the same reasons, the Agency
concludes that an analytical method is not required for enforcement
purposes for rhamnolipid biosurfactant.
B. Codex Maximum Residue Level
There are no CODEX maximum residue levels for rhamnolipid
biosurfactant.
IX. Conclusions
Based on the toxicology information/data submitted and other
information available to the Agency, there is a reasonable certainty
that no harm will result from aggregate exposure of residues of
rhamnolipid biosurfactant to the U.S. population, including infants and
children, under reasonably foreseeable circumstances, when the
biochemical pesticide is used in accordance with good agricultural
practices. This includes all anticipated dietary exposures and all
other non-occupational exposures for which there is reliable
information. The Agency has arrived at this conclusion based on the
information/data submitted (and publically available) demonstrating no
toxicity. As a result, EPA is establishing an exemption from the
tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of
rhamnolipid biosurfactant in or on all food commodities.
X. 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-2003-0281 in the subject line on the
first page of your submission. All requests must be in writing, and
must be
[[Page 16799]]
mailed or delivered to the Hearing Clerk on or before June 1, 2004.
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 (1900C),
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 Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. 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
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit X.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0281, 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 Unit I.B.1. You may also send an electronic copy of
your request via e-mail 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).
XI. 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 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. 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
[[Page 16800]]
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.
XII. 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: March 22, 2004.
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), 346(a) and 371.
0
2. Section 180.1245 is added to subpart D to read as follows:
Sec. 180.1245 Rhamnolipid biosurfactant; exemption from the
requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of rhamnolipid biosurfactant when used in accordance with good
agricultural practices as a fungicide in or on all food commodities.
[FR Doc. 04-6933 Filed 3-30-04; 8:45 am]
BILLING CODE 6560-50-S