[Federal Register: May 14, 2004 (Volume 69, Number 94)]
[Rules and Regulations]
[Page 26770-26775]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my04-8]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2004-0135; FRL-7358-9]
Phosphomannose Isomerase and the Genetic Material Necessary for
Its Production in All Plants; 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 in or on plant commodities of
phosphomannose isomerase and the genetic material necessary for its
production in all plants when applied/used as plant-incorporated
protectant inert ingredients. Syngenta Seeds, Inc. submitted a petition
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA), requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues in or on all plant commodities of phosphomannose isomerase and
the genetic material
[[Page 26771]]
necessary for its production in all plants.
DATES: This regulation is effective May 14, 2004. Objections and
requests for hearings must be received on or before July 13, 2004.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
ID number OPP-2004-0135. All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall 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.
FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and
Pollution Prevention Division (7511C), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8715; e-mail address: mendelsohn.mike@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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/), you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
A frequently updated electronic version of 40 CFR part 180
is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
II. Background and Statutory Findings
In the Federal Register of October 22, 2003 (68 FR 60383) (FRL-
7326-1), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 3E6748) by Syngenta Seeds, Inc., P.O. Box 12257,
3054 Cornwallis Road, Research Triangle Park, NC 27709-2257. This
notice included a summary of the petition prepared by the petitioner
Syngenta Seeds, Inc.. 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 in or on all plant commodities of phosphomannose isomerase and
the genetic material necessary for its production in all plants.
Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue....''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
EPA's dietary and human health analysis of proteins expressed as
PIPs and the inert ingredients associated with PIPs as marker proteins
is based on the guidelines for microbial pesticides (See 40 CFR
158.740(b)(2)(i)). EPA recognizes that not all the guidance expressed
in these test guidelines are necessarily appropriate for proteins. For
instance, EPA does not expect a protein alone to exhibit infectivity or
pathogenicity. Nonetheless, EPA believes that the approach used for the
fermentation products of microbial agents applies equally well for
proteins expressed in plants. Therefore, EPA expects acute oral
toxicity with high doses of purified protein and specific criteria on
protein degradation and similarity analyses to provide adequate
information to reach a finding of a reasonable certainity of no harm in
the aggregate for a PIP protein or an inert ingredient associated with
a PIP. Such data have been submitted for pure phosphomannose isomerase
(PMI) protein. These data demonstrate the safety of the products at
levels well above maximum possible exposure levels that are reasonably
anticipated in the crops.
The PMI protein is a new marker gene employing unusual carbohydrate
metabolism to allow for selection of transformants in cell culture. Use
of this
[[Page 26772]]
marker addresses some of the complaints received from the public about
the possible adverse effects of using antibiotic resistance genes as
selection markers. The PMI protein is a ubiquitous enzyme involved in
carbohydrate metabolism and it, or a highly homologous enzymatic
protein, is found expressed in many species including enteric bacteria,
fungi, insects, some species of plants and nematodes, and even mammals
including monkeys, mice and man. The PMI protein for which data was
submitted in support of this tolerance determination was originally
isolated from Escherichia coli, a common intestinal bacterium, which is
considered a non-allergenic source of protein traits. Since the PMI
protein is found in the human intestinal flora and a homologue is
expressed by humans, it is logical to expect that there has always been
a natural background exposure as well as a low quantity found in the
human diet.
An acute oral study was submitted for the PMI protein. The acute
oral toxicity data submitted support the prediction that the PMI
protein would be non-toxic to humans. The mouse oral LD50
for males, females, and combined was greater than 5,050 mg/kg of dosing
solution or 3,080 mg/kg of PMI protein.
When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al. ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no effects were shown to be caused by the PMI protein
inert ingredient, even at relatively high dose levels, the PMI protein
is not considered toxic. Further, amino acid sequence comparisons
showed no similarity between the PMI protein to known toxic proteins
available in public protein data bases.
Since PMI is a protein, allergenic sensitivities were considered.
Current scientific knowledge suggests that common food allergens tend
to be resistant to degradation by heat, acid, and proteases, and may be
glycosylated and present at high concentrations in the food.
Data have been submitted that demonstrate that the PMI protein is
rapidly degraded (2 minutes) by gastric fluid in vitro. Incubation at
65 and 95[deg]C for 30 minutes inactivated PMI. The PMI protein showed
no significant amino acid homology with known or putative allergenic
proteins using either an 8 amino acid sequence stepwise comparison or
an 80 amino acid fragment comparison. The proteins identified as
sharing significant amino acid similarity with the E. coli PMI are
either proteins confirmed as having PMI activity in other organisms or
proteins with inferred PMI enzymatic activity from the close amino acid
sequence similarity with PMI and the organism's ability to mannose. The
source organisms with significant similarity to PMI were identified as
numerous bacteria, fungi, plants, insects, and mammals as well as a
nematode and protist. This wide diversity of source organisms and the
fact that PMI is involved in carbohydrate metabolism indicates that PMI
is an essential enzyme involved with routine functions (i.e.
housekeeping) and already has broad expression and exposure in humans
and many food items.
The potential for the PMI protein to be food allergens is minimal.
Regarding toxicity to the immune system, the acute oral toxicity data
submitted support the prediction that the PMI protein would be non-
toxic to humans. As noted above, toxic proteins typically act as acute
toxins with low dose levels. Therefore, since no effects were shown to
be caused by the PMI protein inert ingredient plant-incorporated
protectants, even at relatively high dose levels, the PMI protein is
not considered toxic.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers, such as infants and children) to the pesticide chemical
residue and to other related substances. These considerations include
dietary exposure under the tolerance exemption and all other tolerances
or exemptions in effect for the PMI inert ingredient plant-incorporated
protectants chemical residue, and exposure from non-occupational
sources. Exposure via the skin or inhalation is not likely since the
PMI protein inert ingredient plant-incorporated protectants are
contained within plant cells, which essentially eliminates these
exposure routes or reduces these exposure routes to negligible. Oral
exposure, at very low levels, may occur from ingestion of food products
and, potentially, drinking water. However, a lack of mammalian toxicity
and the digestibility of the PMI protein inert ingredient plant-
incorporated protectants have been demonstrated. The use sites for the
PMI protein inert ingredient plant-incorporated protectants are all
agricultural associated with the control of plant pests. Therefore,
exposure via residential or lawn use to infants and children is not
expected. Even if negligible exposure should occur, the Agency
concludes that such exposure would present no risk due to the lack of
toxicity demonstrated for the PMI protein.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires the Agency, when
considering whether to establish, modify, or revoke a tolerance, to
consider available information concerning the cumulative effects of a
particular pesticide's residues and other substances that have a common
mechanism of toxicity. These considerations include the possible
cumulative effects of such residues on infants and children. Because of
the lack of toxicity demonstrated for the PMI protein and because there
is no indication of mammalian toxicity to these plant-incorporated
protectant inert ingredients, we conclude that there are no cumulative
effects for the PMI protein.
VI. Determination of Safety for U.S. Population, Infants and Children
A. Toxicity and Allergenicity Conclusions
The data submitted and cited regarding potential health effects for
the PMI protein include the characterization of the expressed PMI
protein in corn, as well as the acute oral toxicity, and in vitro
digestibility of the protein. The results of these studies were
determined applicable to evaluate human risk and the validity,
completeness, and reliability of the available data from the studies
were considered.
Data was submitted that adequately shows that the PMI test material
derived from microbial cultures, which was the material used for
testing purposes, is biochemically and functionally similar to the PMI
protein produced in the plant. Production of microbially produced
protein was chosen in order to obtain sufficient material for testing.
Proteins have a certain predictable metabolic fate: Once ingested,
proteins are broken down by the combination of secreted acid and
digestive enzymes into peptides that are absorbed and
[[Page 26773]]
turned into new molecules by the body's protein synthetic processes.
When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al. ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)). The
acute oral toxicity data submitted supports the prediction that the PMI
protein would be non-toxic to humans. Since no effects were shown to be
caused by PMI, even at relatively high dose levels (greater than 5,050
mg/kg body wt. of dosing solution or 3,080 mg/kg body wt.of PMI protein
), the PMI protein are not considered toxic. This is similar to the
Agency position regarding toxicity and the requirement of residue data
for the microbial pesticide products like Bacillus thuringiensis (Bt).
See 40 CFR 158.740(b)(2)(i). For microbial products, further toxicity
testing and residue data are triggered by significant acute effects in
studies such as the mouse oral toxicity study to verify the observed
effects and clarify the source of these effects (Tiers II and III).
Since no adverse reactions occurred at near limit dose testing with PMI
protein, no further testing of PMI protein is indicated. Thus, residue
chemistry data were not required for a human health effects assessment
of the subject PMI plant-incorporated protectant inert ingredients
because of the lack of mammalian toxicity.
Available information concerning the dietary consumption patterns
of consumers (and major identifiable subgroups of consumers including
infants and children), and safety factors, which in the opinion of
experts qualified by scientific training and experience to evaluate the
safety of food additives are generally recognized as appropriate for
the use of animal experimentation data, were not considered. See
section 408(b)(D) of the FFDCA. Since PMI was tested in an acute oral
toxicity test and found to have no adverse effects, showed no unusual
stability to digestive enzymes or heat, and had no amino acid
similarity to known toxic or allergenic proteins, no mammalian toxicity
was identified. The lack of mammalian toxicity at high levels of
exposure to the PMI protein demonstrate the safety of the product at
levels well above possible maximum exposure levels anticipated in
crops. Given the lack of toxicity at high dose levels, several orders
of magnitude above the expected dietary exposure from submitted
expression data, no additional safety factors to account for the use of
animal data were deemed necessary to provide a reasonable certainty of
no harm to the aggregate exposure to PMI.
The genetic material necessary for the production of the plant-
incorporated protectant inert ingredients are the nucleic acids (DNA,
RNA) which comprise genetic material encoding these proteins and their
regulatory regions. The genetic material (DNA, RNA) necessary for the
production of PMI protein in plant crops have been exempted under the
blanket exemption for all nucleic acids (40 CFR 174.475).
B. Infants and Children Risk Conclusions
Section 408(b)(2)(C) of the FFDCA provides that EPA shall apply an
additional tenfold 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 on toxicity and exposure,
unless EPA determines that a different margin of exposure (safety) will
be safe for infants and children. Margins of exposure (safety), which
often are referred to as uncertainty factors, are incorporated into EPA
risk assessment either directly or through the use of a margin of
exposure analysis or by using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk.
In this instance, based on all the available information, the
Agency concludes that the PMI protein and the genetic material
necessary for its production in all plants are not toxic and,
therefore, that there are no threshold effects of concern. As a result,
the Agency has determined 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.
C. Overall Safety Conclusion
There is a reasonable certainty that no harm to the U.S.
population, including infants and children, will result from aggregate
exposure to residues of the PMI protein and the genetic material
necessary for its production in all plants. This includes all
anticipated dietary exposures and all other exposures for which there
is reliable information. The Agency has arrived at this conclusion
because, as discussed above, no toxicity to mammals has been observed
for the PMI plant-incorporated protectant inert ingredients.
VII. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemical (both
inert and active ingredients), may have an effect in humans that is
similar to an effect produced by naturally occurring estrogen, or such
other endocrine effect... EPA has been working with interested
stakeholders to develop a screening and testing program, as well as a
priority-setting scheme. As the Agency proceeds with implementation of
this program, it is not anticipated that testing of PMI protein for
endocrine effects will be required. The PMI inert ingredients are
proteins, derived from sources that are not known to exert an influence
on the endocrine system. Therefore, the Agency is not requiring
information on the endocrine effects of PMI proteins at this time.
B. Analytical Method(s)
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation. Further, there was a
finding of no toxicity or allergenicity for the PMI plant-incorporated
protectant inert ingredients and they act simply as marker proteins.
C. Codex Maximum Residue Level
No Codex maximum residue levels exists for the plant-incorporated
protectant inert ingredient marker protein phosphomannose isomerase
(PMI) protein and the genetic material necessary for its production in
all plants.
VIII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA, EPA will continue to use those procedures, with
appropriate adjustments, until the necessary modifications can be made.
The new section 408(g) of the FFDCA provides essentially the same
process for persons to ``object'' to a regulation for an exemption from
the requirement of a tolerance issued by EPA under new section 408(d)
of the FFDCA, as was provided in the old sections 408 and 409 of the
FFDCA. However, the period for filing objections is now 60 days, rather
than 30 days.
[[Page 26774]]
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-2004-0135 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 July 13,
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 (1900L),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St. NW,
Washington, DC 2005. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
2. 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 VIII.A.,
you should also send a copy of your request to the PIRIB for its
inclusion in the official record that is described in ADDRESSES. Mail
your copies, identified by docket ID number OPP-2004-0135, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in ADDRESSES. You may also send an electronic copy of
your request via e-mail to: 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).
IX. Statutory and Executive Order Reviews
This final rule establishes an exemption from the tolerance
requirement under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any 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
[[Page 26775]]
defined in the Executive order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.'' This
final rule directly regulates growers, food processors, food handlers
and food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of section 408(n)(4) of the
FFDCA. For these same reasons, the Agency has determined that this rule
does not have any ``tribal implications'' as described in Executive
Order 13175, entitled Consultation and Coordination with Indian Tribal
Governments (65 FR 67249, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: May 6, 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), 346a and 371.
0
2. Section 180.1252 is added to subpart D to read as follows:
Sec. 180.1252 Phosphomannose isomerase and the genetic material
necessary for its production in all plants; exemption from the
requirement of a tolerance.
Phosphomannose isomerase (PMI) protein and the genetic material
necessary for its production in plants are exempt from the requirement
of a tolerance when used as plant-incorporated protectant inert
ingredients in plant commodities. Genetic material necessary for its
production means the genetic material which comprise genetic material
encoding the PMI protein and its regulatory regions. Regulatory regions
are the genetic material, such as promoters, terminators, and
enhancers, that control the expression of the genetic material encoding
the PMI protein.
[FR Doc. 04-10877 Filed 5-13-04; 8:45 am]
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