[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.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------


Sec. 340.6  Petition for determination of nonregulated status.11

* * * * *
    (c) * * *

    \11\  See footnote 5 at Sec. 340.3.
---------------------------------------------------------------------------

    (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]
BILLING CODE 3410-34-P