[Federal Register: March 31, 2004 (Volume 69, Number 62)]
[Rules and Regulations]
[Page 16809-16814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr04-20]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0415; FRL-7350-5]
Bacillus Thuringiensis Cry3Bb1; 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 Bacillus thuringiensis Cry3Bb1
protein and the genetic material necessary for its production in corn
on field corn, sweet corn, and popcorn when applied/used as a plant-
incorporated protectant. Monsanto Company, 800 North Lindberg Blvd.,
St. Louis, Missouri 63167 submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act of 1996 (FQPA), requesting an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of Bacillus
thuringiensis Cry3Bb1 protein and the genetic material necessary for
its production in corn.
DATES: This regulation is effective March 31, 2004. Objections and
requests
[[Page 16810]]
for hearings, identified by docket ID number OPP-2003-0415, must be
received on or before June 1, 2004.
ADDRESSES: Written objections and hearing requests may be submitted
electronically, by mail, or through hand delivery/courier. Follow the
detailed instructions as provided in Unit VIII. of the SUPPLEMENTARY
INFORMATION.
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 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-2003-0415. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/ A frequently updated electronic version of 40 CFR part 180 is available at http://.
http://www.gpoaccess.gov/ecfr/, 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 October 22, 2003 (68 FR 60371) (FRL-
7328-4), 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 7F4888) by Monsanto Company, 800 North Lindberg
Blvd., St. Louis, Missouri 63167. This notice included a summary of the
petition prepared by the petitioner Monsanto. There were two comments
received in response to the notice of filing. One comment was from a
private citizen who opposed the granting of the tolerance exemption and
felt the EPA was not fulfilling its duty of protecting public health
and the environment.
The second comment was from Valent BioSciences Corporation, a
producer of microbial Bacillus thuringiensis pesticide products. Valent
maintained that the basis of the safety assessment for the Cry3Bb1
protein is the expression of Cry proteins in Bacillus thuringiensis
microbial pesticides that have been safely used for over 40 years. The
commenter contends that the strain of B. thuringiensis subspecies
kumamotoensis has never been registered as a microbial pesticide and
therefore Cry3Bb1 does not deserve to benefit from the implied 40 years
of safe use argument.
The commenter also states that any new strain of B.thuringiensis,
such as B. thuringiensis subspecies kumamotoensis, would be required to
demonstrate safety through new data on mammalian toxicology and
pathogenicity for non-target organisms.
The commenter also raised questions concerning whether the fact
that the Cry3Bb1 protein subject to the tolerance determination is a
variant of the natural Cry3Bb1 endotoxin that has been engineered
specifically to enhance activity against the corn rootworm larvae means
that the binding characteristics have been altered.
The results of toxicity tests indicate a toxicity category III
designation. The commenter is concerned about these toxicity results
reflecting negatively on the currently registered microbial Bt use.
Finally, the commenter is concerned whether the validated ELISA
method for detecting Cry3Bb1 protein would distinguish the variant from
the natural toxins.
In response to the first commentor, EPA takes seriously its duty to
protect human health and the environment. Specifically, under the
FFDCA, EPA must make a finding that there is a reasonable certainty of
no harm from the granting of the proposed tolerance exemption. EPA is
making such a finding and herein sets forth the bases for this finding.
Regarding the comments from Valent BioScience, the basis of the
Cry3Bb1 tolerance determination is toxicology data that has been
generated separately from any registered microbial B. thuringiensis.
While EPA acknowledges that it has made reference to the safe use of
microbial formulations in both the 2000 reassessment of the B.
thuringiensis-based PIPs and several registered PIPs, all of these PIP
proteins have had extensive mammalian safety data generated for the
expressed protein itself. Therefore, Monsanto's reference in the notice
of filing to the safe use of microbial B. thuringiensis, while cogent
to the safety assessment as useful generic information on previous
exposure to the Cry proteins, is not the basis of the safety finding to
support a tolerance exemption.
The fact that all three variants of Cry3Bb1 protein [see Unit.
III.] have been tested for toxicity and allergenicity indicate that the
safety of these three variants at least, is similar for mammalian
species. The indication of these test results is that minor
modifications due to protein engineering for enhanced target activity
does not necessarily alter non-target toxicity for mammalian species.
This supposition does not mean that all protein engineering
modifications would result in equally benign results for non-target
species. No insecticidal
[[Page 16811]]
activity was seen in specific insect species, including six species of
coleopteran and two species of lepidopteran pests with the variant
Cry3Bb1 protein suggesting that the host range activity is limited.
There are also results from bioassays with two of the variant Cry3Bb1
proteins against two sensitive coleopteran species (Leptinotarsa
decemlineata and Diabrotica virgifera) that indicates that there are
not significant changes in the activity between the two variants.
The category III designation for the results of the acute oral
toxicity test using purified Cry3Bb1 toxin do not represent any change
from the results that would be seen with microbial preparations. The
category classification is due to the limitation of dose volume for the
test animal rather than any sign of toxicity in the test or concern for
possible exposure. The oral tests were done with purified protein doses
that are orders of magnitude higher than would be seen in any microbial
B. thuringiensis products. Actual exposure to Cry proteins in PIP
products are not expected to represent any hazard of oral toxicity
given the results seen in these tests.
Regarding the analytical method, there are features of the assay
procedures that could lessen the likelihood of recognizing a microbial
source of Cry3Bb1 [delta]-endotoxin. The microbial B. thuringiensis
products are known to be rapidly weathered away by environmental
conditions like rain and UV radiation lessening the possibility of a
microbial product being present. In addition, if a positive result was
obtained for the presence of Cry3Bb1 protein in an unexpected source,
the test could be confirmed by washing the suspect crop then retesting.
Any surface contamination by residues from treatment with a B.
thuringiensis product would be removed. Any subsequent positive finding
should be a true Cry3Bb1 detection since it would represent an internal
tissue detection which could be reasonably assumed to result only from
plant expression of the Cry3Bb1 gene.
The petition requested that 40 CFR part 180 be amended by
establishing an temporary exemption from the requirement of a tolerance
for residues of Bacillus thuringiensis Cry3Bb1 protein and the genetic
material necessary for its production in corn.
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.
Data have been submitted demonstrating the lack of mammalian
toxicity at high levels of exposure to the pure Cry3Bb1 proteins. These
data demonstrate the safety of the products at levels well above
maximum possible exposure levels that are reasonably anticipated in the
crops. This is similar to the Agency position regarding toxicity and
the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived (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).
Three acute oral studies were submitted for Cry3Bb1 proteins. These
studies were done with three variants of the Cry3Bb1 protein engineered
with either four or five internal amino acid sequence changes to
enhance activity against the corn rootworm. The acute oral toxicity
data submitted support the prediction that the Cry3Bb1 protein would be
non-toxic to humans. Male and female mice (10 of each) were dosed with
36, 396, or 3,780 milligrams/kilograms bodyweight (mg/kg bwt) of
Cry3Bb1 protein for one variant. The mice were dosed with 38.7, 419, or
2,980 mg/kg bwt of Cry3Bb1 protein for the second variant. The mice
were dosed with 300, 900, or 2,700 mg/kg bwt of Cry3Bb1 protein for the
third variant. In one study, two animals in the high dose group died
within a day of dosing. These animals both had signs of trauma probably
due to dose administration (i.e., lung perforation or severe
discoloration of lung, stomach, brain and small intestine). No clinical
signs were observed in the surviving animals and body weight gains were
recorded throughout the 14-day study for the remaining animals. Gross
necropsies performed at the end of the study indicated no findings of
toxicity attributed to exposure to the test substance in any of the
three studies. No other mortality or clinical signs attributed to the
test substance were noted during either study.
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 plant-
incorporated protectants, even at relatively high dose levels, the
Cry3Bb1 proteins are not considered toxic. Further, amino acid sequence
comparisons showed no similarity between Cry3Bb1 proteins to known
toxic proteins available in public protein data bases.
Since Cry3Bb1 are proteins, allergenic sensitivities were
considered. Current scientific knowledge suggests that common food
allergens tend to be resistant to degradation by heat, acid, and
proteases, may be glycosylated and present at high concentrations in
the food.
Data have been submitted that demonstrate that the Cry3Bb1 protein
is
[[Page 16812]]
rapidly degraded by gastric fluid in vitro. In a solution of simulated
gastric fluid (pH 1.2 - U.S. Pharmacopeia), complete degradation of
detectable Cry3Bb1 protein occurred within 30 seconds. Insect bioassay
data indicated that the protein loss insecticidal activity within 2
minutes of incubation in SGF. Incubation in simulated intestinal fluid
resulted in a 59 kDa protein digestion product. A comparison of amino
acid sequences of known allergens uncovered no evidence of any homology
with Cry3Bb1, even at the level of 8 contiguous amino acids residues.
The potential for the Cry3Bb1 proteins to be food allergens is
minimal. Regarding toxicity to the immune system, the acute oral
toxicity data submitted support the prediction that the Cry3Bb1
proteins 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 plant-incorporated protectants,
even at relatively high dose levels, the Cry3Bb1 proteins are 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) 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 plant-incorporated protectant chemical residue, and exposure
from non-occupational sources. Exposure via the skin or inhalation is
not likely since the plant-incorporated protectant is 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 processed corn products and,
potentially, drinking water. However a lack of mammalian toxicity and
the digestibility of the plant-incorporated protectants have been
demonstrated. The use sites for the Cry3Bb1 proteins are all
agricultural for control of insects. 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 Cry3Bb1 proteins.
V. Cumulative Effects
Pursuant to section 408(b)(2)(D)(v) of FFDCA, EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity to these
plant-incorporated protectants, we conclude that there are no
cumulative effects for the Cry3Bb1 proteins.
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 Cry3Bb1 proteins include the characterization of the expressed
Cry3Bb1 protein in corn, as well as the acute oral toxicity, and in
vitro digestibility of the proteins. 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.
Adequate information was submitted to show that the Cry3Bb1 test
material derived from microbial cultures was biochemically and,
functionally similar to the protein produced by the plant-incorporated
protectant ingredients in corn. Production of microbially produced
protein was chosen in order to obtain sufficient material for testing.
The acute oral toxicity data submitted supports the prediction that
the Cry3Bb1 proteins would be non-toxic to humans. 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)). Since no effects were
shown to be caused by Cry3Bb1, even at relatively high dose levels
(3,780 mg Cry3Bb1/kg bwt), the Cry3Bb1 proteins are not considered
toxic. This is similar to the Agency position regarding toxicity and
the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived. 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).
Cry3Bb1 residue chemistry data were not required for a human health
effects assessment of the subject plant-incorporated protectant
ingredients because of the lack of mammalian toxicity.
Both 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
evaluated. The lack of mammalian toxicity at high levels of exposure to
the Cry3Bb1 proteins demonstrate the safety of the product at levels
well above possible maximum exposure levels anticipated in the crop.
The genetic material necessary for the production of the plant-
incorporated protectant active 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 Cry3Bb1 proteins in corn have been exempted under the
blanket exemption for all nucleic acids (40 CFR 174.175).
B. Infants and Children Risk Conclusions
Section 408(b)(2)(C) of FFDCA provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, section 408(b)(2)(C) of FFDCA also provides that EPA
shall apply an additional ten-fold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the data base unless EPA
determines that a different margin of safety will be safe for infants
and children.
In this instance, based on all the available information, the
Agency concludes that there is a finding of no
[[Page 16813]]
toxicity for the Cry3Bb1 proteins and the genetic material necessary
for their production. Thus, there are no threshold effects of concern
and, as a result, the provision requiring an additional margin of
safety does not apply. Further, the provisions of consumption patterns,
special susceptibility, and cumulative effects do not apply.
C. Overall Safety Conclusion
There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the Cry3Bb1 proteins and the genetic material necessary
for their production. 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 plant-
incorporated protectants.
VII. Other Considerations
A. Endocrine Disruptors
The pesticidal active 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 these plant-incorporated protectants at this time.
B. Analytical Method(s)
Validated methods for extraction and direct ELISA analysis of
Cry3Bb1 in corn grain have been submitted and found acceptable by the
Agency.
C. Codex Maximum Residue Level
No Codex maximum residue levels exists for the plant-incorporated
protectants Bacillus thuringiensis Cry3Bb1 protein and the genetic
material necessary for its production in corn.
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.
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-2003-0415 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 June 1,
2004.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit 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 Unit I.B.1. Mail
your copies, identified by docket ID number OPP-2003-0415, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. In person or by courier, bring a copy to the location of the
PIRIB described in Unit I.B.1. You may also send an electronic copy of
your request via e-mail to: opp-docket@epa.gov. Please use an ASCII
file format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual
[[Page 16814]]
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 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: March 18, 2004.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, 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 180.1214 in subpart D is revised to read as follows:
Sec. 180.1214 Bacillus thuringiensis Cry3Bb1 protein and the genetic
material necessary for its production in corn; exemption from the
requirement of a tolerance.
Bacillus thuringiensis Cry3Bb1 protein and the genetic material
necessary for its production in corn are exempt from the requirement of
a tolerance when used as plant-incorporated protectants in the food and
feed commodities of field corn, sweet corn and popcorn. Genetic
material necessary for its production means the genetic material which
comprise genetic material encoding the Cry3Bb1 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 Cry3Bb1 protein.
[FR Doc. 04-6930 Filed 3-30-04; 8:45 am]
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