[Federal Register Volume 60, Number 162 (Tuesday, August 22, 1995)]
[Proposed Rules]
[Pages 43567-43573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20547]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 340
[Docket No. 95-040-1]
RIN 0579-AA73
Genetically Engineered Organisms and Products; Simplification of
Requirements and Procedures for Genetically Engineered Organisms
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This document proposes to amend the regulations pertaining to
genetically engineered plants introduced under notification and to the
petition process for the determination of nonregulated status. The
proposed notification amendments would allow most genetically
engineered plants that are considered regulated articles to be
introduced under the notification procedure, provided that the
introduction meets certain eligibility criteria and performance
standards. We are also proposing to reduce the field test reporting
requirements for trials conducted under notification for which no
unexpected or adverse effects are observed. The proposed petition
amendments would enable APHIS to extend an existing determination of
nonregulated status to certain additional regulated articles that are
closely related to an organism for which a determination of
nonregulated status has already been made. APHIS also announces its
intention to use guidelines when appropriate to provide additional
information to developers of regulated articles and other interested
persons regarding procedures, methods, scientific principles, and other
factors that could be considered in support of actions under the
regulations pertaining to genetically engineered plants introduced
under notification.
The effect of the proposed amendments would be to simplify
procedures for the introduction of certain genetically engineered
organisms, requirements for certain determinations of nonregulated
status, and procedures for the reporting of field tests conducted under
notification.
DATES: Consideration will be given only to comments received on or
before October 23, 1995.
ADDRESSES: Please send an original and three copies of your comments to
Docket No. 95-040-1, Regulatory Analysis and Development, PPD, APHIS,
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please
state that your comments refer to Docket No. 95-040-1. Comments
received may be inspected at USDA, room 1141, South Building, 14th
Street and Independence Avenue, SW., Washington, DC, between 8:00 a.m.
and 4:30 p.m., Monday through Friday, except holidays. Persons wishing
to inspect comments are requested to call ahead on (202) 690-2817 to
facilitate entry into the comment reading room.
FOR FURTHER INFORMATION CONTACT:
Dr. Michael G. Schechtman, Domestic Programs Leader, Biotechnology
Coordination and Technical Assistance, BBEP, APHIS, 4700 River Road
Unit 146, Riverdale, MD 20737-1237, (301) 734-7601.
[[Page 43568]]
SUPPLEMENTARY INFORMATION:
Background
I. Introduction
The regulations in 7 CFR part 340, referred to below as the
regulations, pertain to the introduction (importation, interstate
movement, and release into the environment) of genetically engineered
organisms and products that are derived from known plant pests
(regulated articles). Before introducing a regulated article, a person
is required under Sec. 340.0 of the regulations to either (1) notify
the Animal and Plant Health Inspection Service (APHIS) in accordance
with Sec. 340.3 or (2) obtain a permit in accordance with Sec. 340.4.
Introductions under notification must meet specified eligibility
criteria and performance standards. Under Sec. 340.4, a permit is
granted for a field trial when APHIS has determined that the conduct of
the trial, under the conditions specified by the applicant or
stipulated by APHIS, does not pose a plant pest risk.
An organism is not subject to the regulations when the organism is
demonstrated not to present a plant pest risk. Section 340.6 of the
regulations, entitled ``Petition for determination of nonregulated
status,'' provides that a person may petition APHIS to evaluate
submitted data to determine that a particular regulated article does
not present a plant pest risk and should no longer be regulated. If
APHIS determines that the regulated article does not present a risk of
introduction or dissemination of a plant pest, the petition will be
granted, thereby allowing unrestricted introduction of the article. A
petition may be granted in whole or in part.
In the preamble to the final regulations published on June 16, 1987
(52 FR 22892-22915, Docket No. 87-021), APHIS stated its intention to
modify or amend the regulations to ensure flexibility and to remove
restrictions when warranted as experience is gained and knowledge is
accrued about safe introductions of particular classes of organisms.
APHIS previously demonstrated its commitment to amend the regulations
by instituting exemptions for the movement, under specified conditions,
of certain microorganisms that contain plant pest sequences (53 FR
12910-12913, Docket No. 88-019, April 20, 1988), and of the plant
Arabidopsis thaliana (55 FR 53275-53276, Docket No. 90-172, December
28, 1990), and by instituting both a notification procedure for the
introduction of certain regulated articles and a petition procedure for
the determination of nonregulated status (58 FR 17044-17059, Docket No.
92-156-02, March 31, 1993).
Under the current regulations, plants from six crop species, i.e.,
corn (Zea mays L.), cotton (Gossypium hirsutum L.), potato (Solanum
tuberosum L.), soybean (Glycine max (L.) Merr.), tobacco (Nicotiana
tabacum L.), and tomato (Lycopersicon esculentum L.), are eligible for
notification, provided that certain eligibility criteria and
performance standards are met. The notification procedure also allows
for additional plant species that Biotechnology, Biologics, and
Environmental Protection (BBEP) determines may be safely introduced in
accordance with the eligibility criteria.
II. Proposed Expansion of Notification
APHIS is proposing to allow the use of the notification procedure
for the introduction of most genetically engineered plants that are
considered regulated articles, provided that the introduction is
conducted in accordance with all other eligibility requirements and
performance standards. APHIS believes that an expansion of the
notification system to new plant species would simplify oversight
procedures for new agricultural biotechnology products, while
continuing to ensure their safe development.
Currently, the regulations require that introductions of most plant
species be done under permit from APHIS. The applications for permits
are evaluated on a case-by-case basis. Since the APHIS permitting
process for regulated articles was established in 1987, we have gained
considerable experience. We have issued over 560 permits for release
into the environment and over 1280 permits for movement. Most of the
regulated articles field tested under permit have been plants. Through
December 31, 1994, permits have been issued for a wide variety of
plants. Thirty-nine different plant species have been field tested
under permit, and 67 species have been moved under permit. The list of
species includes a wide range of transgenic plants from 22 plant
families, including flowering plants, monocots, dicots, gymnosperms,
herbs, shrubs, and trees. These species exhibit a wide variety of
breeding systems, including entomophily, anemophily, cleistogamy, and
sexual and asexual reproduction, and exhibit seed dissemination of many
different kinds. The plants have been grown in virtually all 50 States
and have been moved to facilities with different laboratories, growth
chambers, and greenhouses. One result of our experience with permitting
has been the finding that introductions of many different regulated
articles can be conducted with little or no plant pest or environmental
risk, provided that certain criteria and performance standards are met.
APHIS notes in addition that even at the time that notification
procedures were initially proposed in 1992, several commenters
suggested that APHIS should broaden the list of organisms eligible for
notification beyond the proposed list of six crops in
Sec. 340.3(b)(1)(i). After the notification procedures went into
effect, APHIS has received other inquiries about adding particular
additional crops to the list.
Since the APHIS notification procedure was established in 1993, we
have reviewed and acknowledged over 900 notifications for field tests
involving corn, cotton, potato, soybean, tobacco, and tomato. The
current notification procedure involves a review of the application by
APHIS to confirm that the application falls under notification, i.e.,
that it meets the criteria in Sec. 340.3(b)(2) through
Sec. 340.3(b)(6). Appropriate State regulatory officials are notified.
After acknowledgement of the notification by APHIS, the regulated
article and site(s) of introduction are subject to inspection by APHIS
and State regulatory officials. After field testing, the submission of
a field test report by the applicant to APHIS is required.
One result of our experience with notification has been that such a
notification procedure results in little or no plant pest or
environmental risk, provided that the criteria and performance
standards specified in Sec. 340.3(b)(2) through Sec. 340.3(b)(6) and
Sec. 340.3(c) are met. These criteria and performance standards would
be retained in the proposed amendment, except that eligibility
criterion in Sec. 340.3(b)(5) would be expanded to allow the inclusion
of certain additional plant virus sequences in the regulated article,
as described later in this portion of the preamble.
To establish the notification procedure for additional plant
species, we would revise Sec. 340.3(b)(1), which currently lists
specific crop species eligible for notification. Proposed
Sec. 340.3(b)(1) would allow the introduction under notification
procedures of any plant species that is not listed as a noxious weed
under regulations in 7 CFR part 360, and, for releases in the
environment, is not considered a weed in the area of the proposed
release into the environment.
The Agency's experience with interstate movement, importation, and
release permits indicates that crop plants can be released into the
[[Page 43569]]
environment under notification procedures with little or no plant pest
risk or potential for significant impact on the environment, if the
applicant meets the performance standards given in the regulations.
APHIS intends to continue its practice of consulting with appropriate
State officials or other experts whenever there are questions regarding
impacts on weedy populations of the plant species in question in the
test area. APHIS also notes that the movement and introduction of any
plant species considered a parasitic plant is subject to additional
restrictions under regulations in 7 CFR parts 330 and 360 under the
Federal Plant Pest Act (7 U.S.C. 150aa et seq.) and the Federal Noxious
Weed Act (7 U.S.C. 2809), respectively.
The performance standards in Sec. 340.3(c) of the regulations
provide a description of what APHIS considers effective containment
standards, typically applied on a case-by-case basis in APHIS's reviews
of field trials for organisms under permit. The performance standards
have, APHIS believes, effectively addressed all potential concerns with
respect to nontarget effects, persistence of the regulated article in
the environment, and volunteer plants. The standards also represent an
enumeration of standard good agricultural practice as might be
implemented by researchers and plant breeders in field trials involving
the introduction of new plant material. APHIS believes that the
standards apply equally well when implemented as part of a notification
procedure as when implemented under a permit procedure.
The requirement that plants released into the environment are not
considered weeds in the area of the field trial is not meant to
supersede any State or Federal laws or regulations regarding weeds,
such as the Federal Noxious Weed Act or the various laws of the States.
The requirements of all such laws, acts, and regulations would be
followed as part of APHIS' determination of eligibility under
notification.
APHIS is also proposing to increase the range of virus resistance
modifications that are included under Sec. 340.3(b)(5), which states:
(5) To ensure the introduced genetic sequences do not pose a
significant risk of the creation of any new plant virus, they must be:
(i) Noncoding regulatory sequences of known function, or
(ii) Sense or antisense genetic constructs derived from viral coat
protein genes from plant viruses that are prevalent and endemic in the
area where the introduction will occur and that infect plants of the
same host species, or
(iii) Antisense genetic constructs derived from noncapsid viral
genes from plant viruses that are prevalent and endemic in the area
where the introduction will occur and that infect plants of the same
host species.
This provision does not allow plants expressing sense constructs of
noncapsid viral genes to qualify for introduction under notification.
In its response to comments on notification in the 1993 final rule that
established notification procedures, APHIS stated its commitment to
``seek input from the public on the inclusion under notification of
plants expressing sense constructs from all other noncapsid viral
genes.'' On April 21-22, 1995, APHIS convened a meeting entitled
``Transgenic Virus-resistant Plants and New Plant Viruses,'' which
brought together over 50 plant virologists to elicit information
regarding the safety of virus-resistant plants. The data gathered at
the workshop identified no potential increased risks associated with
the field testing of transgenic plants carrying specific plant virus
genes other than coat protein genes, with the sole exception of genes
encoding functional viral movement proteins. This information, which
will be contained within proceedings to be published later this year,
supports APHIS' position to expand the virus gene eligibility criterion
to include all genes encoding noncapsid viral proteins except for
movement proteins. Movement proteins are virus-encoded proteins that
mediate cell-to-cell spread of virus. After a virus infects and
multiplies in a single plant cell, it must move to adjacent cells and
eventually throughout the plant in order to be a successful pathogen.
Examples of known movement proteins are the 30K protein of
tobamoviruses and the 24K protein of potexviruses.
Information presented at the meeting indicates that there may be
some uncertainty about the effects of an introduced gene encoding a
functional movement protein on viral infections of the plant. However,
genes encoding movement proteins that have been modified so they no
longer produce a functional product should not pose additional
potential unknown risks. APHIS wishes to clarify, however, that the
definition of movement protein is not intended to include the products
of coat (capsid) protein genes, even though coat proteins have some
involvement in long distance movement of virus in a plant in some
instances. These proteins do not have a primary role in cell-to-cell
virus movement.
In accordance with this information, APHIS is proposing to revise
Sec. 340.3(b)(5). Under proposed Sec. 340.3(b)(5), to ensure that the
introduced genetic sequences do not pose a significant risk of the
creation of any new plant virus, plant virus-derived sequences must be
noncoding regulatory sequences of known function; or sense or antisense
genetic constructs derived from viral genes from plant viruses that are
prevalent and endemic in the area where the introduction will occur and
that infect plants of the same host species, and that do not encode any
functional noncapsid gene product responsible for cell-to-cell movement
of the virus.
APHIS is also proposing to amend its administrative procedures in
response to notifications for interstate movement. When a regulated
article is to be moved from another State under notification
procedures, APHIS has requested concurrence from the receiving State
prior to APHIS' acknowledgment of the notification. APHIS would
continue to notify appropriate State regulatory officials of all
interstate movements of regulated articles and provide the States the
opportunity to provide comments or raise concerns if they so wish.
APHIS would continue to ensure that any concerns raised by a State
would be addressed prior to APHIS acknowledgment. Based on the history
of safe interstate movement of regulated articles under notification
and on a desire to lessen administrative burdens imposed on State
cooperators while meeting their information requirements, however,
APHIS proposes to discontinue the requirement that States in every case
provide concurrences for notifications for interstate movement prior to
APHIS acknowledgment. This change would be accomplished by amending
Sec. 340.3(e)(1) to indicate that the Director, BBEP, will notify the
appropriate State regulatory official(s) within 5 business days of
receipt for all notifications. Any additional administrative changes
would only be made in full consultation with State regulatory
officials. Information regarding all notifications will continue to be
available on the APHIS database on the Internet. APHIS invites comment
on whether this proposed change will meet the administrative needs of
its State cooperators.
III. Proposed Changes to Regulations for Petitions for Determination of
Nonregulated Status
APHIS is proposing to amend its regulations in Sec. 340.6 to allow
the extension of a previously issued determination of nonregulated
status to
[[Page 43570]]
certain additional regulated articles that are closely related to an
organism that was determined not to be a regulated article in the
initial determination. The text of the new regulations will be placed
at Sec. 340.6(e), and entitled, ``Extensions of determinations of
nonregulated status.''
To date, APHIS has approved, in whole or in part, eight petitions
for a determination of nonregulated status under its regulations at
Sec. 340.6. Each of those determinations applied only to a specific set
of plant transformation events and all progeny derived from them. In
addition, with regard to one determination, we subsequently extended
nonregulated status to additional transformed lines originally
contained within the initial petition request, following the receipt of
supplementary data (59 FR 50220, Docket No. 94-096-1, October 3, 1994;
59 FR 59746, Docket No. 94-125-1, November 19, 1994; 60 FR 15284,
Docket No. 95-015-1, March 23, 1995). Several other petitions, either
currently under review or being discussed as drafts with potential
applicants, relate to regulated articles that are closely related to
organisms that have already been granted nonregulated status.
Our expectation is that many additional petitions will be received
concerning regulated articles that differ negligibly, from a safety
standpoint, from others that have already been reviewed. APHIS believes
that these petitions can and should be reviewed in a more streamlined
manner than petitions concerning organisms that present potential plant
pest risk issues that have not yet been specifically addressed.
In order to establish the framework under which extensions of
existing determinations to certain additional regulated articles would
be considered, a new term, ``antecedent organism,'' would be added to
part Sec. 340.1, and would be defined as an organism that has already
been the subject of a determination of non-regulated status by APHIS
under Sec. 340.6, and that is used as a reference for comparison to the
regulated article under consideration. This term expresses the agency's
intent to consider the degree of APHIS' familiarity with the types of
modifications in the regulated article and with the behavior in the
environment of organisms similar to the one under consideration. The
antecedent organism would be used as the reference for comparison with
the regulated article. The aim of making such a comparison would be to
ensure that the regulated article in question raises no serious new
issues meriting a separate review under the petition process.
Under this section, requests might be made, for example, that a
determination of nonregulated status be extended to new transformant
lines derived by transformation of a new cultivar of the same crop
species with the plasmid used in constructing the antecedent organism,
or to other lines produced using a related plasmid encoding a protein
of identical amino acid sequence, but in which codon usage has been
modified to improve gene expression. A submitter should provide to
APHIS information that describes the characteristics and identity of
the regulated articles that are the subject of the request, and that
describes the relatedness between the regulated article and its
antecedent organism.
APHIS would publish all extensions of existing determinations of
nonregulated status in the Federal Register. This decision will become
final 30 days after publication unless the agency receives any
significant comments which the agency believes warrants further
consideration. This will allow time for the public to become aware of
our decision and to bring to the agency's attention any additional
information that might be relevant to that decision.
The proposed new provisions also provide that APHIS would inform
any person, whose request for extension of an existing determination
was denied, of the reasons for that denial. Such a person would be
allowed to resubmit without prejudice a modified request or a separate
petition for determination of nonregulated status.
APHIS believes that this approach will streamline regulatory
requirements for organisms that can be straightforwardly demonstrated
not to pose a potential for plant pest risk, while continuing to
provide adequate oversight to assure their safe development.
IV. Guidelines
APHIS is committed to regulations that are adjusted as information
and experience are gained. As indicated earlier, APHIS has amended its
regulations several times to reflect the increasing knowledge with
respect to new products of agricultural biotechnology. APHIS wishes to
continue to provide additional information to developers of regulated
articles and other interested persons regarding procedures, practices,
and protocols that could be considered by the agency in support of
actions under the regulations. A footnote has been added in
Secs. 340.3, 340.4, 340.5, and 340.6 to indicate that APHIS intends to
prepare guidelines detailing procedures, practices, or protocols
related to scientific evaluations, product identity standards, and
other technical or policy considerations. Guidelines will state
procedures, practices, or protocols relevant to matters under this part
that fall under the Federal Plant Pest Act and the Plant Quarantine
Act. A person may follow an APHIS guideline or may follow different
procedures, practices, or protocols. When different procedures
practices, or protocols are followed, a person may, but is not required
to, discuss the matter in advance with APHIS to help ensure that the
procedures, practices, or protocols to be followed will be acceptable
to APHIS.
The first guidelines that will be prepared are intended to help
submitters establish the level of similarity or relatedness between a
regulated article and its antecedent organism, by illustrating
procedures and methods that would be acceptable to the agency to
establish such similarity or relatedness, and principles or issues of
potential concern that might be considered by the agency. APHIS does
not believe it is appropriate to establish rigid rules for determining
similarity or relatedness, in view of the rapid pace of technological
change that is expanding the potential for developing plants with new
types of desirable modifications. However, the agency believes that it
can provide guidance on the types of factors that should be relevant
for a submitter to consider.
V. Simplifications to Reporting Requirements Under Permit or
Notification
APHIS is proposing to simplify the reporting requirements on the
performance characteristics of regulated articles in field trials that
have been conducted under permit or notification, while leaving
unchanged recordkeeping requirements for those trials. The regulations
at Sec. 340.4(f)(9) require that permit holders submit to BBEP
monitoring reports on the performance characteristics of the regulated
article, in accordance with any monitoring reporting requirements that
may be specified in a permit. Starting with field trials in the 1988
growing season, APHIS incorporated into its Supplemental Permit
Conditions for all field trials conducted under permit, a reporting
requirement for data on the fate of the genetically engineered
organisms in the environment. In addition, Sec. 340.4(f)(10) specifies
the time and manner for rapid notification of BBEP in the event of
accidental or unauthorized release of the regulated
[[Page 43571]]
article, or upon finding that the regulated article or associated host
has characteristics substantially different from those listed in the
application, or suffers any unusual occurrence (excessive mortality or
morbidity, or unanticipated effect on non-target organisms).
For field trials conducted under notification procedures,
Sec. 340.3(d)(4) requires that field test reports be submitted to the
Director, BBEP, within 12 months after the start of the field test and
every 12 months through the duration of the field test. It also
requires that final reports for those field tests lasting more than 12
months are due 6 months after the termination of the test. Field test
reports shall include the APHIS reference number and methods of
observation, resulting data, and analysis regarding all deleterious
effects on plants, nontarget organisms, or the environment. In
addition, Sec. 340.3(d)(5) stipulates that the requirements in
Sec. 340.4(f)(10), for reporting of unusual occurrences in field trials
conducted under permit, also apply to field trials conducted under
notification.
The vast majority of data reports received by APHIS for field
trials under either permit or notification have identified no
deleterious effects of the regulated article on plants, nontarget
organisms, or the environment. Less than one percent of all field trial
reports have noted any unusual occurrences of the types indicated in
Sec. 340.3(d)(5). Occasional crop lines have exhibited substandard
agronomic performance, i.e., they were wilted, or were smaller or less
sturdy than controls. No event in any field trial has resulted in any
known unmanaged dissemination of a regulated article.
APHIS proposes to amend the requirements for submission of field
data reports for field trials under notification procedures so that
only reports documenting unusual occurrences would need to be submitted
within the intervals previously specified. Persons submitting petitions
for determination of nonregulated status would, however, be required to
submit all data reports for field trials completed prior to petition
submission and submit appropriate data reports for ongoing field trials
lasting more than one year. This would effect a change in reporting
requirements but not recordkeeping requirements. All records
documenting the safety of field trials would need to be maintained by
persons responsible for the conduct of those trials, but, apart from
instances in which deleterious effects on plants, nontarget organisms,
or the environment are observed, those data would only be needed to be
considered by APHIS at the time of petition. Submission of field trial
reports documenting the absence of deleterious effects on plants,
nontarget organisms, or the environment in completed field trials under
notification procedures would no longer be required prior to submission
of subsequent notifications for the same regulated article(s). The
existing provisions in Sec. 340.4(f)(10) for rapid communication with
BBEP in the event of certain unusual circumstances would remain
unchanged, and the proposed regulation continues to require routine
reporting of other deleterious effects that might be observed.
To implement these changes, Sec. 340.3(d)(4) would be amended. It
would require that responsible persons maintain records of the conduct
and status of all field trials under notification procedures, that
field test records include the APHIS reference number, and methods of
observation, resulting data, and analysis regarding all deleterious
effects on plants, nontarget organisms, or the environment. For field
tests in which deleterious effects on plants, nontarget organisms, or
the environment are observed, proposed Sec. 340.3(d)(4) would also
require that field test reports be submitted to the Director, BBEP,
within 12 months after the start of the field test, and every 12 months
through the duration of the field test. For field tests lasting more
than 12 months, final reports would be due 6 months after the
termination of the field test. Field test reports would have to include
all data required in field test records for the trial.
A new Sec. 340.6(c)(5) would also be added, amending the list of
required data and information in a petition to indicate the requirement
to submit all field test reports at the time of petition submission. We
would require the submission of field test reports for all trials
conducted under permit or notification procedures, involving the
regulated article, that were completed prior to petition submission.
For ongoing trials longer than 12 months in duration, interim field
test reports are required for each year. Field test reports would have
to include the APHIS reference number, and methods of observation,
resulting data, and analysis regarding all deleterious effects on
plants, nontarget organisms, or the environment.
APHIS is also proposing to clarify the requirements for data
reporting for those field trials that remain under permit. These field
trials involve traits that do not meet the eligibility criteria set
forth in Sec. 340.3(b)(2) through Sec. 340.3(b)(6) or field testing
protocols that deviate from the requirements of the performance
standards set forth in Sec. 340.3(c). Submission of data reports for
field trials under permit, which has to date been required via
Supplemental Permit Conditions attached to the APHIS permits for
conduct of the trials, would now be explicitly required in the
regulation. This proposed rule change should not alter the content of
field test reports that are being submitted by permit recipients under
the current regulations. APHIS, however, believes that the formal
requirement for submission of field data reports should be included
within the permit regulations in current Sec. 340.4 to emphasize the
importance of these reports in establishing the safety of field tests
using particular classes of organisms. Under the proposed changes to
our notification procedure, such safety information would be used to
establish that new crop species can be safely field tested under
notification, and could also help establish that crop plants having
other types of modifications can be safely field tested under
notification.
Accordingly, Sec. 340.4(f)(9) would be amended to require that a
person who has been issued a permit submit to the Director, BBEP, field
test reports within 12 months after the start of the field test, and
every 12 months through the duration of the field test. For field tests
lasting more than 12 months, proposed Sec. 340.4(f)(9) would require
final reports 6 months after the termination of the field test. The
field test reports would have to include the APHIS reference number,
and methods of observation, resulting data, and analysis regarding all
deleterious effects on plants, nontarget organisms, or the environment.
VI. Rulemaking Analyses
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been reviewed under Executive Order 12866.
The rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by the Office
of Management and Budget.1
\1\ The agricultural biotechnology industry is still in a
relatively early stage of development. Each year, as the industry
continues to grow, it is anticipated there will be growth in
experimentation, ultimately resulting in an increase in agricultural
production and a broadening of international trade. The potential
benefits could be significant, but are speculative at this time.
APHIS anticipates that this Proposed Rule will be generally welcomed
by public and private researchers, because it is estimated that it
could save the industry as a whole perhaps $50,000 in costs
associated with preparing submissions to APHIS. These savings are
expected to increase as the number of submissions to APHIS continues
to grow.
[[Page 43572]]
The effect of the proposed amendments would be to simplify
procedures: (1) for the introduction of certain genetically engineered
organisms by expanding the scope of organisms that would be included
under notification procedures and lessening certain administrative
requirements for State concurrence on interstate movements under
notification procedures; (2) for determination of nonregulated status
for certain organisms by allowing for extension of determinations of
nonregulated status to other regulated articles closely related to
those for which the initial determination was made; and (3) for
reporting requirements by focusing on reporting only of unusual events
for field tests conducted under notification, while maintaining
recordkeeping requirements.
The expansion of the scope of organisms included under notification
procedures would eliminate the need for a permit to conduct field tests
for many crops that currently fall under the permitting regulations.
This would allow researchers to conduct field tests for most crops with
greatly simplified regulatory requirements. At present, approximately
87 percent of all field trials are conducted under notification
procedures. Based on trials to date, APHIS estimates that less than 0.5
percent of the transgenic plants field tested would not qualify for
notification procedures based on the local weed status of the crop
species. In addition, nearly 99 percent of all introduced genes in
plants field tested to date have qualified under notification
procedures. Most of the donor genes that have not met the eligibility
criteria have been virus-derived genes that could potentially also
qualify for notification under the proposed Sec. 340.3(b)(5). APHIS
therefore estimates that about 99 percent of all field trials would be
conducted under notification procedures under these proposed
modifications. APHIS estimates that the cost savings for preparation of
notification over preparation of a permit application is approximately
95 percent.
APHIS also estimates that extension of existing determinations
would potentially be applicable to perhaps half of all regulated
articles for which a determination of nonregulated status might be
sought. The amount of time required to establish similarity with an
antecedent organism, APHIS estimates, might be about one-fourth of that
required for preparation of a petition for determination of
nonregulated status. In addition, there would be time savings for
applicants for field tests under notification, who would not be
required to submit field data reports on other than adverse events
until the time of petition for determination of nonregulated status.
Much of this data is data that the researcher should already have
acquired while conducting field tests of genetically engineered crops.
This proposed rule is consistent with the risk- and product-based
philosophy underlying the Federal policy for the regulation of the
products of biotechnology, as announced by the Office of Science and
Technology Policy in the Coordinated Framework for the Regulation of
the Products of Biotechnology (51 FR 23303-23350, June 26, 1986). It is
also consistent with the principles of regulation expressed in
Executive Order 12866, specifically that the agency consider the degree
and nature of risks posed by the activities under its jurisdiction, and
tailor its regulations to achieve the least burden on society
consistent with obtaining its regulatory objectives. The proposed
option of allowing applicants to submit protocols for product identity
standards is also consistent with the Presidential Memorandum to heads
of Departments and Agencies of March 4, 1995, on the Regulatory Reform
Initiative which, among other things, directs agencies to consider the
question, ``Could private business, setting its own standards and being
subject to public accountability, do the job as well?''
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action would
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.
3501 et seq.), the information collection or recordkeeping requirements
included in this proposed rule will be submitted for approval to the
Office of Management and Budget. Please send written comments to the
Office of Information and Regulatory Affairs, OMB, Attention: Desk
Officer for APHIS, Washington, DC 20503. Please send a copy of your
comments to: (1) Docket No. 95-040-1, Regulatory Analysis and
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118,
Riverdale, MD 20737-1238, and (2) Clearance Officer, OIRM, USDA, room
404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.
List of Subjects in 7 CFR Part 340
Administrative practice and procedure, Biotechnology, Genetic
engineering, Imports, Packaging and containers, Plant diseases and
pests, Transportation.
Accordingly, we are proposing to amend 7 CFR part 340 as follows:
PART 340--INTRODUCTION OF ORGANISMS AND PRODUCTS ALTERED OR
PRODUCED THROUGH GENETIC ENGINEERING WHICH ARE PLANT PESTS OR WHICH
THERE IS REASON TO BELIEVE ARE PLANT PESTS
1. The authority citation for part 340 would continue to read as
follows:
Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C.
9701; 7 CFR 2.17, 2.51, and 371.2(c).
2. In Sec. 340.1, the following definition would be added in
alphabetical order to read as follows:
Sec. 340.1 Definitions.
* * * * *
Antecedent organism. An organism that has already been the subject
of a determination of nonregulated status by APHIS under Sec. 340.6,
and that is used as a reference for comparison to the regulated article
under consideration under this part.
* * * * *
Footnotes 5 through 7, 8 and 9 [Redesignated as Footnotes 7 through 9,
12 and 13]
3. In part 340, footnotes 5 through 7 and 8 and 9 would be
redesignated as footnotes 7 through 9 and 12 and 13, respectively.
4. In Sec. 340.3, a new footnote 5 would be added at the end of the
section heading and paragraphs (b)(1), (b)(5),
[[Page 43573]]
(d)(4), and (e)(1) would be revised to read as follows:
Sec. 340.3 Notification for the introduction of certain regulated
articles.5
* * * * *
(b) * * *
\5\ APHIS may issue guidelines regarding scientific procedures,
practices, or protocols which it has found acceptable in making
various determinations under the regulations. A person may follow an
APHIS guideline or follow different procedures, practices, or
protocols. When different procedures, practices, or protocols are
followed, a person may, but is not required to, discuss the matter
in advance with APHIS to help ensure that the procedures, practices,
or protocols to be followed will be acceptable to APHIS.
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(1) The regulated article is any plant species that is not listed
as a noxious weed in regulations at 7 CFR part 360 under the Federal
Noxious Weed Act (7 U.S.C. 2809), and, when being considered for
releases into the environment, the regulated article is not considered
by the Administrator to be a weed in the area of release into the
environment.
* * * * *
(5) To ensure that the introduced genetic sequences do not pose a
significant risk of the creation of any new plant virus, plant virus-
derived sequences must be:
(i) Noncoding regulatory sequences of known function; or
(ii) Sense or antisense genetic constructs derived from viral genes
from plant viruses that are prevalent and endemic in the area where the
introduction will occur and that infect plants of the same host
species, and that do not encode a functional noncapsid gene product
responsible for cell-to-cell movement of the virus.
* * * * *
(d) * * *
(4) Responsible persons shall maintain records of the conduct and
status of all field trials under notification procedures. Field test
records shall include the APHIS reference number. Field test records
shall also include methods of observation, resulting data, and analysis
regarding all deleterious effects on plants, nontarget organisms, or
the environment.
(i) For field tests in which deleterious effects on plants,
nontarget organisms, or the environment are observed, field test
reports must be submitted to the Director, BBEP, within 12 months after
the start of the field test, and every 12 months thereafter throughout
the duration of the field test. For field tests lasting more than 12
months, final reports are due 6 months after the termination of the
field test.
(ii) Field test reports shall include all data required in field
test records for the trial.
* * * * *
(e) * * *
(1) The Director, BBEP, will notify the appropriate State
regulatory official(s) within 5 business days of receipt for all
notifications.
* * * * *
5. In Sec. 340.4, a new footnote 6 would be added at the end of the
section heading and paragraph (f)(9) would be revised to read as
follows:
Sec. 340.4 Permits for the introduction of a regulated article.6
* * * * *
(f) * * *
\6\ See footnote 5 at Sec. 340.3.
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(9) A person who has been issued a permit shall submit to the
Director, BBEP, field test reports within 12 months after the start of
the field test, and every 12 months thereafter throughout the duration
of the field test. For field tests lasting more than 12 months, final
reports are due 6 months after the termination of the field test. Field
test reports shall include the APHIS reference number. Field test
reports shall also include methods of observation, resulting data, and
analysis regarding all deleterious effects on plants, nontarget
organisms, or the environment;
* * * * *
6. In Sec. 340.5, a new footnote 10 would be added at the end of
the section heading to read as follows:
Sec. 340.5 Petition to amend the list of organisms.10
* * * * *
7. In Sec. 340.6, a new footnote 11 would be added at the end of
the section heading, a new paragraph (c)(5) would be added, paragraph
(e) would be redesignated as paragraph (f), and a new paragraph (e)
would be added to read as follows:
\10\ See footnote 5 at Sec. 340.3.
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Sec. 340.6 Petition for determination of nonregulated status.11
* * * * *
(c) * * *
\11\ See footnote 5 at Sec. 340.3.
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(5) Field test reports for all trials conducted under permit or
notification procedures, involving the regulated article, that were
completed prior to petition submission. For ongoing trials longer than
12 months in duration, interim field test reports for each year. Field
test reports shall include the APHIS reference number. Field test
reports shall also include methods of observation, resulting data, and
analysis regarding all deleterious effects on plants, nontarget
organisms, or the environment.
* * * * *
(e) Extensions to determinations of nonregulated status. (1) The
Director, BBEP, may determine that a regulated article does not pose a
potential for plant pest risk, and should therefore not be regulated
under this part, based on the similarity of that organism to an
antecedent organism.
(2) A person may request that APHIS extend a determination of
nonregulated status to other organisms. Such a request shall include
information to establish the similarity of the antecedent organism and
the regulated articles in question.
(3) APHIS will announce in the Federal Register all extensions of
determinations of nonregulated status 30 days before their effective
date.
(4) If a request to APHIS to extend a determination of nonregulated
status under this part is denied, APHIS will inform the submitter of
that request of the reasons for denial. The submitter may submit a
modified request or a separate petition for determination of
nonregulated status without prejudice.
* * * * *
Done in Washington, DC, this 15th day of August 1995.
Terry Medley,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 95-20547 Filed 8-21-95; 8:45 am]
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