[Federal Register Volume 69, Number 62 (Wednesday, March 31, 2004)]
[Rules and Regulations]
[Pages 16809-16814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6930]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [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 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://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 [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 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: [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

[[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]
BILLING CODE 6560-50-S