[Federal Register Volume 69, Number 94 (Friday, May 14, 2004)]
[Rules and Regulations]
[Pages 26770-26775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10877]


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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: [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:
     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 [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 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: [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).

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]
BILLING CODE 6560-50-S