[Federal Register: March 3, 2004 (Volume 69, Number 42)]
[Rules and Regulations]
[Page 9954-9958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr04-15]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0403; FRL-7343-9]
Yeast Extract Hydrolysate from Saccharomyces cerevisiae;
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 Yeast Extract
Hydrolysate from Saccharomyces cerevisiae on all food commodities when
applied/used for the management of plant diseases. Morse Enterprises,
Limited, Inc. submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
(FQPA) of 1996, requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Yeast Extract Hydrolysate from
Saccharomyces cerevisiae.
DATES: This regulation is effective March 3, 2004. Objections and
requests for hearings, identified by docket ID number OPP-2003-0403,
must be received on or before May 3, 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 IX. of the SUPPLEMENTARY
INFORMATION.
FOR FURTHER INFORMATION CONTACT: Diana M. Horne, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8367; e-mail address: horne.diana@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:
[sbull] Crop production (NAICS 111)
[sbull] Animal production (NAICS 112)
[sbull] Food manufacturing (NAICS 311)
[sbull] 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-2003-0403. 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 numberis (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 at http://.
ecfr.gpoaccess.gov/ cgi/t/text/text-idx?sid=
694b82a50366afdfc121f3c76cc00405& c=ecfr&tpl=/ecfrbrowse/ Title40/
40cfrv21--02.tpl, a beta site currently under development.
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 August 6, 2003 (68 FR 46613) (FRL-7316-
8), 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 (2E6383) by Morse Enterprises,
Limited, Inc., Brickell East Floor Ten, 151 South East 15 Road, Miami,
Florida. This notice included a summary of the petition prepared by the
petitioner Morse Enterprises. One commenter requested information on
the identity and mechanism of action of the active ingredient, which is
provided and/or addressed in this rule.
The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Yeast Extract Hydrolysate from Saccharomyces cerevisiae.
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 tolerance 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
[[Page 9955]]
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Section of the FFDCA (b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishinga 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 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.
An acute oral study was conducted with the end use product KeyPlex
350 at the limit value of 5 g/kg, a single high dose required by the
Agency's testing guidelines to determine whether any adverse effects
are noted at this extremely elevated exposure level. No deaths or
adverse effects occurred during this test, placing this product in
Toxicity Category IV (the least toxic) via the oral route of exposure.
A primary dermal irritation study has shown KeyPlex 350 to be very
slightly irritating to non-irritating, placing the product in Toxicity
Category IV (again, the least toxic) for skin irritation. An eye
irritation study indicated that the product is slightly irritating to
rabbit eyes, placing the product in Toxicity Category III for primary
eye irritation. There have been no reported incidents of
hypersensitivity to Yeast Extract Hydrolysate from Saccharomyces
cerevisiae in individuals exposed during the manufacture or use of this
product, which has been used as a plant micronutrient product for over
20 years. Nevertheless, to comply with the Agency's requirements under
FIFRA section 6(a)(2), any incident of hypersensitivity associated with
the use of this pesticide must be reported to the Agency.
All other acute and subchronic toxicity studies were waived based
upon all or some combination of the following rationales: First, no
effects were observed in an acute oral study on the end use product,
KeyPlex 350 containing 0.063% Yeast Extract Hydrolysate from
Saccharomyces cerevisiae, at the limit value of 5 g/kg. Yeast Extract
Hydrolysate from Saccharomyces cerevisiae is made from Brewer's
(Baker's) yeast extract, which is the water soluble portion of
autolyzed yeast (Saccharomyces cerevisiae), and contains protein,
peptides, free amino acids, vitamins, minerals and trace elements.
Brewer's yeast extract is already widely used as a flavor enhancer for
soups, soy sauce, sausage, fruits, etc., and is also used as a
nutritional supplement, since it is rich in B-vitamins. Brewer's yeast
extracts are used in hundreds of food products at levels up to 2.0%, as
consumed, which is approximately 32 times higher than levels of Yeast
Extract Hydrolysate from Saccharomyces cerevisiae found in the end use
product (0.063%). Third, Brewer's yeast extract is affirmed as
``generally recognized as safe'', or GRAS (21 CFR 184.1983), which
means that it may be applied to food as a direct additive. Fourth, all
inerts used in the end use product KeyPlex 350 are either already
exempted from the requirement of a tolerance under 40 CFR 180.1001 (c)
or (d), or common fertilizer ingredients cleared by FDA as direct food
additives (GRAS). Fifth, KeyPlex 350 containing 0.063% Yeast Extract
Hydrolysate from Saccharomyces cerevisiae has been sold as a plant
micronutrient product for over 20 years, with no adverse effects ever
reported. Sixth, label directions allow a minuscule amount (a maximum
of 7.1 milliliters) of Yeast Extract Hydrolysate from Saccharomyces
cerevisiae to be applied per acre per year, and the literature
indicates that the components of yeast hydrolysate degrade rapidly in
the environment. Finally, Yeast Extract Hydrolysate from Saccharomyces
cerevisiae has a non-toxic mode of action by eliciting a systemic
acquired resistance response in plants, and has no direct antimicrobial
effect on plant disease organisms.
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
Yeast Extract Hydrolysate from Saccharomyces cerevisiae is already
cleared for use in food products at concentrations greater than that
found in the end use product KeyPlex 350. Additional dietary exposure
to Yeast Extract Hydrolysate from Saccharomyces cerevisiae resulting
from labeled uses is unlikely to occur because of extremely low use
rates and rapid degradation in the field. Further, the lack of
demonstrable toxicity in acute studies and the long history of safe use
as a component of food products support the establishment of an
exemption from the requirement of a tolerance for Yeast Extract
Hydrolysate from Saccharomyces cerevisiae.
1. Food. The use of KeyPlex 350 is not expected to result in any
increase in dietary exposure to Yeast Extract Hydrolysate from
Saccharomyces cerevisiae against the background of Brewer's yeast
extract normally consumed in the diet. Yeast Extract Hydrolysate from
Saccharomyces cerevisiae is made by hydrolyzing Brewer's yeast extract,
which is the water soluble portion of autolyzed yeast (Saccharomyces
cerevisiae) and contains protein, peptides, free amino acids, vitamins,
minerals and trace elements. Brewer's yeast extract is classified as
Generally Recognized as Safe (GRAS) under 21 CFR 184.1983 and is used
as a flavor enhancer for soups, soy sauce, sausage, fruits, and other
food products at concentrations in the range of 0.1%-2.0%, as consumed,
which is significantly higher than the levels found in the end use
product KeyPlex 350 (0.063%). Brewer's yeast is also used as a human
nutritional supplement since it is rich in B-vitamins. Further, all
inerts in the formulation of KeyPlex 350 are either already exempted
from the requirement of a tolerance under 40 CFR 180.1001 (c) or (d),
or common fertilizer ingredients cleared by FDA as direct food
additives (GRAS). Finally, when used according to label directions, an
extremely small amount (a total of 7.1 milliliters) of Yeast Extract
Hydrolysate from Saccharomyces cerevisiae may be applied per acre per
year, and the literature indicates that the components
[[Page 9956]]
of yeast hydrolysate are rapidly degraded in the environment.
2. Drinking water exposure. Brewer's yeast extract, the starting
material for the manufacture of Yeast Extract Hydrolysate from
Saccharomyces cerevisiae, is classified as GRAS under 21 CFR 184.1983.
Further, the other ingredients used in the production of Yeast Extract
Hydrolysate from Saccharomyces cerevisiae are either already exempted
from the requirement of a tolerance under 40 CFR 180.1001 (c) or (d),
or common fertilizer ingredients cleared by FDA as direct food
additives (GRAS). The concentration of Yeast Extract Hydrolysate from
Saccharomyces cerevisiae allowable in food products is significantly
higher than that found in the end use product KeyPlex 350. Finally,
because KeyPlex 350 is applied at extremely low rates and rapidly
degrades in the environment, it poses no concern as a drinking water
contaminant.
B. Other Non-Occupational Exposure
With the sole exception of turf uses, the label use sites are
commercial agricultural and horticultural, as opposed to domestic
settings. In addition, KeyPlex 350 is applied at extremely low rates
and rapidly degrades after application. As a result, the approved uses
of KeyPlex 350 for field crops and commercial application to turf and
ornamentals will not likely result in exposures in residences, schools
or day care institutions to Yeast Extract Hydrolysate from
Saccharomyces cerevisiae. Thus non-occupational exposure to the general
population is expected to be minimal to non-existent.
1. Dermal exposure. KeyPlex 350 is classified as a Toxicity
Category IV product, the least toxic category,with regard to dermal
irritation. This combined with the lack of toxicity via the oral route,
suggests that risks due to dermal exposure are of no concern.
2. Inhalation exposure. KeyPlex 350 is classified as a Toxicity
Category IV product, the least toxic category, via the oral route, and
will not likely pose any risk via inhalation.
VI. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency to
consider the cumulative effect of exposure to Yeast Extract Hydrolysate
from Saccharomyces cerevisiae and to other substances that have a
common mode of toxicity. These considerations include the possible
cumulative effects of such residues on infants and children. Because of
the lack of toxicity, lack of information indicating that any toxic
effects, if they existed, would be cumulative with any other compounds,
extremely low use rates, and common occurrence in hundreds of food
products, the Agency does not expect any cumulative or incremental
effects from exposure to residues of this product when used as directed
on the label.
VII. Determination of Safety for U.S. Population, Infants and Children
Key Plex 350 has an oral LD50 greater than 5 g/kg,
placing the product in Toxicity Category IV, the least toxic category.
Further, Brewer's yeast extract, from which Yeast Extract Hydrolysate
from Saccharomyces cerevisiae is derived, is a common component of
hundreds of food products and is used as a human nutritional supplement
because of its high B-vitamin content. Therefore, EPA concludes that
there is a reasonable certainty that no harm to the United States
population in general, and to infants and children, specifically, will
result from aggregate exposure to residues of Yeast Extract Hydrolysate
from Saccharomyces cerevisiae. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. Accordingly, exempting Yeast Extract Hydrolysate from
Saccharomyces cerevisiae from the requirement of a tolerance is
considered safe and pose no risk. FFDCA section 408(b)(2)(C) provides
that EPA shall apply an additional ten-fold margin of exposure (safety)
for infants and children in the case of threshold effects to account
for prenatal and postnatal toxicity and the completeness of the
database unless EPA determines that a different margin of exposure
(safety) will be safe for infants and children. Margins of exposure
(safety) are often referred to as uncertainty (safety) factors. Here,
based on all the available information and for all the reasons already
set forth above in this final rule, the Agency finds that there are no
threshold effects of concern to infants, children, and adults when
Yeast Extract Hydrolysate from Saccharomyces cerevisiae is used as
labeled, and that the provision requiring an additional margin of
safety is not necessary to protect infants and children. As a result,
EPA has not used a margin of exposure (safety) approach to assess the
safety of Yeast Extract Hydrolysate from Saccharomyces cerevisiae.
VIII. Other Considerations
A. Endocrine Disruptors
EPA is required under 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.'' Following the recommendations of its Endocrine Disruptor
Screening and Testing Advisory Committee (EDSTAC), EPA determined that
there is no scientific basis for including, as part of the program, the
androgen and thyroid hormone systems in addition to the estrogen
hormone system. EPA also adopted EDSTAC's recommendation that the
program include evaluations of potential effects in wildlife. For
pesticide chemicals, EPA will use FIFRA and, to the extent that effects
in wildlife may help determine whether a substance may have an effect
in humans, FFDCA authority to require wildlife evaluations. As the
science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disruptor Screening Program
(EDSP). When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed, Yeast Extract
Hydrolysate from Saccharomyces cerevisiae may be subjected to
additional screening and/or testing to better characterize effects
related to endocrine disruption. Based on available data, no endocrine
system-related effects have been identified with consumption of Yeast
Extract Hydrolysate from Saccharomyces cerevisiae. To date, there is no
evidence to suggest that Yeast Extract Hydrolysate from Saccharomyces
cerevisiae affects the immune system, functions in a manner similar to
any known hormone, or that it acts as an endocrine disruptor.
B. Analytical Method(s)
The Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation for the reasons enumerated
in this preamble, including Yeast Extract Hydrolysate from
Saccharomyces cerevisiae's lack of toxicity. Accordingly, the Agency
has concluded that an analytical method is not needed for enforcement
purposes for Yeast Extract Hydrolysate from Saccharomyces cerevisiae
residues.
C. Codex Maximum Residue Level
There is currently no CODEX Maximum Residue Limit set for food use
of this active ingredient.
[[Page 9957]]
IX. 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-2003-0403 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 May 3,
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 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 Unit I.B.1. Mail your
copies, identified by docket ID number OPP-2003-0403, 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).
X. 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
[[Page 9958]]
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 foodretailers, 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 theFFDCA. 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 policiesthat 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.
XI. 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: February 18, 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 is revised to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1246 is added to subpart D to read as follows:
Sec. 180.1246 Yeast Extract Hydrolysate from Saccharomyces
cerevisiae: exemption from the requirement of a tolerance.
This regulation establishes an exemption from the requirement of a
tolerance for residues of the biochemical pesticide Yeast Extract
Hydrolysate from Saccharomyces cerevisiae on all food commodities when
applied/used for the management of plant diseases.
[FR Doc. 04-4706 Filed 3-2-04; 8:45am]
BILLING CODE 6560-50-S