[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17720-17722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9376]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300462; FRL-5596-7]
RIN 2070-AB78


Bacillus Thuringiensis Subspecies Kurstaki CryIA(c) and the 
Genetic Material Necessary for Its Production in All Plants; Exemption 
From the Requirement of a Tolerance on All Raw Agricultural Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document establishes an exemption from the requirement of 
a tolerance for residues of the plant-pesticides CryIA(c) and the 
genetic material necessary for its production in all plants when used 
as plant-pesticides in or on all raw agricultural commodities. Dekalb 
Genetics Corporation submitted a petition to EPA under the Federal 
Food, Drug and Cosmetic Act as amended by the Food Quality Protection 
Act of l996 requesting the exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of this plant-pesticides in or on all 
raw agricultural commodities.

EFFECTIVE DATE: This regulation becomes effective on April 11, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300462], may be submitted to: Hearing Clerk 
(1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
Washington, DC 20460. Fees accompanying objections and hearing requests 
shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
requests filed with the Hearing Clerk should be identified by the 
docket control number and submitted to: Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. In person, bring copy of objections and hearing 
requests to: Rm. 1132, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect in 5.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300462]. No Confidential Business Information (CBI) should 
be submitted through e- mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries. Additional information on electronic submissions 
can be found in Unit VIII. of this preamble.

FOR FURTHER INFORMATION CONTACT: By mail: Mike Mendelsohn, 
Biopesticides and Pollution Prevention Division (7501W), Office of 
Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., 
SW., Washington, DC 20460. Office location, telephone number, and e-
mail address: 5th Floor Crystal Station, 2800 Crystal Drive, Arlington, 
VA 22202, (703)-308-8715); email: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1997 
(62 FR 3682)(FRL-5380-2), EPA issued a notice pursuant to section 
408(d) of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d) announcing the filing of a pesticide petition for an exemption 
from the requirement of a tolerance by Dekalb Genetics Corporation 
(Dekalb), 3100 Sycamore Road, Dekalb, IL 60115. The notice contained a 
summary of the petition prepared by the petitioner and this summary 
contained conclusions and arguments to support its conclusion that the 
petition complied with the Food Quality Protection Act (Pub. L. 104-
170). The petition requested that an exemption from the requirement of 
a tolerance be established for the plant-pesticides Bacillus 
thuringiensis subspecies kurstaki CryIA(c) [CryIA(c)] and the genetic 
material necessary for its production in plants in or on all raw 
agricultural commodities (RACS). There were no comments or requests for 
referral to an advisory committee received in response to the notices 
of filing. The data submitted in the petition and other relevant 
material have been evaluated. The toxicology and other data listed 
below were considered in support of this exemption from the requirement 
of a tolerance.

I. Toxicological Profile

    The data submitted regarding potential health effects of CryIA(c) 
include information on the characterization of the expressed protein in 
corn, the acute oral toxicity of CryIA(c), and in vitro digestibility 
studies 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. The 
acute oral toxicity test of bacterially-derived CryIA(c) protein showed 
no test substance related deaths at a dose of 5,000 mg/kg. Although 
CryIA(c) expression level data were required for an environmental fate 
and effects assessment, residue chemistry data were not required for a 
human health effects assessment of the subject plant-pesticides 
ingredients because of the lack of mammalian toxicity. Both (1) 
available information concerning the dietary consumption patterns of 
consumers (and major identifiable subgroups of consumers including 
infants and children) and (2) 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 because the 
lack of mammalian toxicity at high levels of exposure demonstrate the 
safety of the product at levels above possible maximum exposure levels. 
This is similar to the Agency position regarding toxicity and the 
requirement of residue data for the microbial Bacillus thuringiensis 
products from which these plant-pesticides are derived. [See 40 CFR 
158.740(b).] For microbial products, further toxicity testing to verify 
the observed effects and clarify the source of the effects (Tiers II 
and III) and residue data are triggered by significant acute effects in 
studies such as the mouse oral toxicity study.
    The acute oral toxicity data submitted support the prediction that 
the CryIA(c) protein 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)]. Therefore, since no 
effects were shown to be caused by the plant-pesticides, even at 
relatively high dose

[[Page 17721]]

levels, the CryIA(c) delta-endotoxin protein is not considered toxic.
    Adequate information was submitted to show that the CryIA(c) test 
material derived from microbial cultures was biochemically and, 
functionally similar to the protein produced by the plant-pesticide 
ingredient in corn. Production of microbially produced protein was 
chosen in order to obtain sufficient material for testing. In addition, 
the in vitro digestibility studies indicate the proteins would be 
rapidly degraded following ingestion.
    The genetic material necessary for the production of the plant-
pesticides active and inert ingredients are the nucleic acids (DNA) 
which comprise (1) genetic material encoding these proteins and (2) 
their regulatory regions. ``Regulatory regions'' are the genetic 
material that control the expression of the genetic material encoding 
the proteins, such as promoters, terminators, and enhancers. DNA is 
common to all forms of plant and animal life and the Agency knows of no 
instance where these nucleic acids have been associated with toxic 
effects related to their consumption as a component of food. These 
ubiquitous nucleic acids as they appear in the subject active 
ingredients has been adequately characterized by the applicant. 
Therefore, no mammalian toxicity is anticipated from dietary exposure 
to the genetic material necessary for the production of the subject 
active and inert plant pesticidal ingredients.

II. Sensitivity of Subgroups

    The Agency has considered available information on the variability 
of the sensitivities of major identifiable subgroups of consumers 
including infants and children and the physiological differences 
between infants and children and adults and effects of in utero 
exposure to the plant-pesticides. Since CryIA(c) 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, are glycosylated and present at high 
concentrations in the food. Data has been submitted which demonstrate 
that the CryIA(c) delta-endotoxin is rapidly degraded by gastric fluid 
in vitro and is non-glycosylated. Studies submitted to EPA done in 
laboratory animals have not indicated any potential for allergic 
reactions to Bacillus thuringiensis or its components, including the 
delta-endotoxin in the crystal protein. Despite decades of widespread 
use of Bacillus thuringiensis as a pesticide (it has been registered 
since 1961), there have been no confirmed reports of immediate or 
delayed allergic reactions to the delta-endotoxin itself despite 
significant oral, dermal and inhalation exposure to the microbial 
product. Several reports under FIFRA section 6(a)2 have been made for 
various Bacillus thuringiensis products claiming allergic reactions. 
However, the Agency determined these reactions were not due to Bacillus 
thuringiensis itself or any of the Cry toxins. Thus, the potential for 
the CryIA(c) protein to be a food allergen is minimal.

III. Cumulative Effects

    The Agency 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-pesticides, there are no cumulative 
effects.

IV. Aggregate Exposures

    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-pesticides chemical residue, and exposure from non-
occupational sources. Exposure via the skin or inhalation is not likely 
since the plant-pesticides 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 processed corn products and drinking water. However a lack 
of mammalian toxicity and the digestibility of the plant-pesticides has 
been demonstrated. The use sites for CryIA(c) delta endotoxin are all 
agricultural for control of lepidopteran 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.
    FFDCA section 408 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 pre- and post-natal toxicity 
and the completeness of the database unless EPA determines that a 
different margin of exposure (safety) will be safe for infants and 
children. In this instance, EPA believes there is reliable data to 
support the conclusion that the plant-pesticides are not toxic to 
mammals, including infants and children and thus there are no threshold 
effects of concern. As a result, the provision requiring an additional 
margin of exposure does not apply.

V. Endocrine Effects

    EPA does not have any information regarding endocrine effects on 
these pesticides at this time. The Agency is not requiring information 
on the endocrine effects of these plant-pesticides at this time; and 
Congress allowed 3 years after August 3, 1996, for the Agency to 
implement a screening and testing program with respect to endocrine 
effects.

VI. 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 CryIA(c) protein and the genetic material necessary 
for its 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-
pesticides. As a result, EPA establishes an exemption from tolerance 
requirements pursuant to FFDCA section 408(j)(3) for Bacillus 
thuringiensis CryIA(c) delta-endotoxin and the genetic material 
necessary for its production in all plants.
    Bacillus thuringiensis subspecies kurstaki CryIA(c) delta-endotoxin 
and the genetic material necessary for its production in all plants are 
exempt from the requirement of a tolerance when used as plant-
pesticides in all plant raw agricultural commodities. ``Genetic 
material necessary for its production'' means the genetic material 
which comprise (1) genetic material encoding the CryIA(c) delta-
endotoxin and (2) its regulatory regions. ``Regulatory regions'' are 
the genetic material that control the expression of the genetic 
material encoding the CryIA(c) delta-endotoxin, such as promoters, 
terminators, and enhancers.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) 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) as 
was provided in the old section 408 and in section 409.

[[Page 17722]]

However, the period for filing objections is 60 days, rather than 30 
days. EPA currently has procedural regulations which governs the 
submission of objections and hearing requests. These regulations will 
require some modification to reflect the new law. However, until those 
modifications can be made, EPA will continue to use those procedural 
regulations with appropriate adjustments to reflect the new law.
    Any person may, by June 10, 1997 file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the Virginia address given under the ADDRESSES 
section (40 CFR 178.20). A copy of the objections and/or hearing 
requests filed with the Hearing Clerk should be submitted to the OPP 
docket for this rulemaking. The objections submitted must specify the 
provisions of the regulation deemed objectionable and the grounds for 
the objections (40 CFR 178.25). Each objection must be accompanied by 
the fee prescribed by 40 CFR 180.33(i). If a hearing is requested, the 
objections must include a statement of the factual issue(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). 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 issue(s) in the manner sought by the 
requestor would be adequate to justify the action requested (40 CFR 
178.32). 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.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
control number [OPP-300462]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Response and Program Resources Branch, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the address in ADDRESSES at 
the beginning of this document.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and since this action 
does not impose any information collection requirements subject to 
approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it 
is not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any ``unfunded mandates'' as described in Title II of the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior 
consultation as specified by Executive Order 12875 (58 FR 58093, 
October 28, l993), or special considerations as required by Executive 
Order 12898 (59 FR 7629, February 16, l994).
    Because exemptions from the requirement of a tolerance established 
on the basis of a petition under section 408(d) of FFDCA do not require 
issuance of a proposed rule, the regulatory flexibility analysis 
requirements of the Regulatory Flexibility Act (RFA), 5 U.S.C. 604(a), 
do not apply. Prior to the recent amendment of the FFDCA, EPA had 
treated such rulemakings as subject to the RFA; however, the amendments 
to the FFDCA clarify that no proposal is required for such rulemakings 
and hence that the RFA is inapplicable. Nonetheless, the Agency has 
previously assesssed whether establishing tolerances or exemptions from 
tolerance, raising tolerance levels, or expanding exemptions adversely 
impact small entities and concluded as a generic matter, that there is 
no adverse impact (46 FR 24950, May 4, 1981).
    Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted 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 
General Accounting Office prior to publication of the rule in today's 
Federal Register. This 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 25, 1997.

Daniel M. Barolo,
Director, Office of Pesticide Programs.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. Section 180.1155 is revised to read as follows:


Sec. 180.1155  Bacillus thuringiensis subspecies Kurstaki CryIA(c) and 
the genetic material necessary for its production in all plants; 
exemption from the requirement of a tolerance.

    Bacillus thuringiensis subspecies kurstaki CryIA(c) delta-endotoxin 
and the genetic material necessary for its production in all plants are 
exempt from the requirement of a tolerance when used as plant-
pesticides in all plant raw agricultural commodities. ``Genetic 
material necessary for its production'' means the genetic material 
which comprise genetic material encoding the CryIA(c) delta-endotoxin 
and its regulatory regions. ``Regulatory regions'' are the genetic 
material that control the expression of the genetic material encoding 
the CryIA(c) delta-endotoxin, such as promoters, terminators, and 
enhancers.

[FR Doc. 97-9376 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F