[Federal Register Volume 69, Number 42 (Wednesday, March 3, 2004)]
[Rules and Regulations]
[Pages 9954-9958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-4706]


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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: [email protected].

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 [email protected], 
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: [email protected]. 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