[Federal Register Volume 62, Number 70 (Friday, April 11, 1997)]
[Rules and Regulations]
[Pages 17717-17720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9373]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300463; FRL-5597-3]
RIN No. 2070-AB78
Phosphinothricin Acetyltransferase 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-pesticide inert ingredients
Phosphinothricin Acetyltransferase (PAT) and the genetic material
necessary for its production in all plants when used as plant-
pesticides in or on all raw agricultural commodities (RACs). Dekalb
Genetics Corporation submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA) as amended by the Food Quality
Protection Act of l996 (FQPA) 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 RACS.
EFFECTIVE DATE: This regulation becomes effective on April 11, 1997.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300463], 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 Highway., Arlington,
VA. A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically to the OPP by sending
electronic mail (e-mail) to: opp-docket@epamail.epa.gov.
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-300463]. 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, 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 CS, 2800 Crystal Drive, Arlington, VA 22202, (703)-
308-8715); email: mendelsohn.mike@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 24, 1996
(62 FR 3682)(FRL-5380-2), EPA issued a notice pursuant to section
408(d) of FFDCA, 21 U.S.C. 346a(d) announcing the filing of a pesticide
petition for an exemption from the requirement for 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 FQPA (Pub.
L. 104-170). The petition requested that an exemption from the
requirement of a tolerance be established for the plant-pesticides PAT
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 notice 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 PAT
include information on the characterization of the expressed protein in
corn, the acute oral toxicity of PAT, 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 PAT protein
showed no test substance related deaths at a dose of 2,500 milligrams
per kilogram (mg/kg). Residue chemistry data were not required for a
human health effects assessment of the subject plant-pesticide inert
ingredients because of the lack of mammalian toxicity. Both (1)
available information concerning the dietary
[[Page 17718]]
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. [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 PAT 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 levels, the PAT delta-endotoxin protein is not considered toxic.
Adequate information was submitted to show that the PAT test
material derived from microbial cultures was biochemically and,
functionally similar to the proteins produced by the plant-pesticide
inert 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 plant-pesticide
inert ingredient 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 PAT 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 are present at high
concentrations in the food. Data has been submitted which demonstrate
that the PAT protein is rapidly degraded by gastric fluid in vitro and
is non-glycosylated. Thus, the potential for the PAT 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 mode
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. At present, the use sites for PAT are all
agricultural. 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 for
these kinds of 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 PAT 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 PAT and the genetic material necessary for its
production in all plants.
Phosphinothiricin Acetyltransferase (PAT) and the genetic material
necessary for its production in all plants are exempt from the
requirement of a tolerance when used as plant-pesticide inert
ingredients in all plant raw agricultural commodities. ``Genetic
material necessary for its production'' means the genetic material
which comprise (1) genetic material encoding the PAT protein and (2)
its regulatory regions. ``Regulatory regions'' are the genetic material
that control the
[[Page 17719]]
expression of the genetic material encoding the PAT protein, 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. 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. 0
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 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-300463]. 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 Virginia 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 assessed 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 180.1151 is revised to read as follows:
Sec. 180.1151 Phosphinothricin Acetyltransferase (PAT) and the genetic
material necessary for its production all plants; exemption from the
requirement of a tolerance.
Phosphinothricin Acetyltransferase (PAT) and the genetic material
necessary for its production in all plants are exempt from the
requirement of a tolerance when used as plant-pesticide inert
ingredients in all plant raw agricultural commodities. ``Genetic
material necessary for its production'' means the genetic material
which comprise genetic material encoding the PAT protein and its
regulatory regions. ``Regulatory regions'' are the genetic material
that control the expression of the genetic material encoding the PAT
protein, such as promoters, terminators, and enhancers.
[[Page 17720]]
Sec. 180.1175 [Removed]
3. Section 180.1175 is removed.
[FR Doc. 97-9373 Filed 4-10-97; 8:45 am]
BILLING CODE 6560-50-F
