[Federal Register Volume 62, Number 79 (Thursday, April 24, 1997)]
[Rules and Regulations]
[Pages 19903-19917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10648]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 340

[Docket No. 95-040-2]
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: Final rule.

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SUMMARY: This document amends the regulations pertaining to genetically 
engineered plants introduced under notification and to the petition 
process for the determination of nonregulated status. The notification 
amendments 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. The petition amendments enable the Animal and 
Plant Health Inspection Service 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. We have prepared guidelines 
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 
certain actions under the regulations, and anticipate developing other 
such guidelines when appropriate for other actions. We are also 
reducing the field test reporting requirements for certain multi-year 
field trials conducted under permit or notification procedures.
    The amendments 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. We are also changing all 
references to ``Biotechnology, Biologics, and Environmental 
Protection'' to ``Animal and Plant Health Inspection Service'' to 
reflect an internal reorganization within the Agency.

DATES: Effective May 27, 1997.

FOR FURTHER INFORMATION CONTACT: Dr. John Payne, Director, 
Biotechnology and Scientific Services, PPQ, APHIS, 4700

[[Page 19904]]

River Road Unit 98, Riverdale, MD 20737-1237; (301) 734-7602. For 
technical information, contact Dr. Michael Schechtman, Domestic 
Programs Leader, Biotechnology and Scientific Services, PPQ, APHIS; 
(301) 734-7601. Guidelines for extensions to determinations of 
nonregulated status are available on the Internet at the APHIS World 
Wide Web site, http://www.aphis.usda.gov/bbep/bp/, or by mail from Ms. 
Kay Peterson at the address listed above.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 7 CFR part 340, referred to 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 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.
    On August 22, 1995, APHIS published in the Federal Register a 
proposed rule on Genetically Engineered Organisms and Products; 
Simplification of Requirements and Procedures for Genetically 
Engineered Organisms and Products (60 FR 43567-43573, Docket No. 95-
040-1). This rule proposed to amend the regulations to 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. In addition, APHIS 
proposed to increase the range of virus resistance modifications 
allowable under notification. APHIS also proposed to amend its 
administrative procedures by discontinuing the requirement that States 
in every case provide concurrences for notifications for interstate 
movement prior to APHIS acknowledgment, and to simplify the reporting 
requirements on the performance characteristics of regulated articles 
in field trials conducted under permit or notification.
    APHIS further proposed to amend the regulations pertaining to 
petitions for determinations for nonregulated status in Sec. 340.6 to 
allow the extension of a previously issued determination of 
nonregulated status to certain additional regulated articles that are 
closely related to an organism that was determined not to be a 
regulated article in the initial determination.
    To provide information regarding procedures, methods, practices, or 
protocols, APHIS indicated its intention to prepare guidelines relating 
to such considerations.
    We solicited comments concerning our proposal for 60 days ending 
October 23, 1995. During the designated comment period, APHIS received 
a total of 50 comments on the proposed amendments from industry, 
universities, State departments of agriculture, science policy 
organizations, environmental groups, industry organizations, 
professional societies, consumer organizations, individuals, and a 
university cooperative extension service office. A general discussion 
of the comments appears below, followed by a section-by-section 
response to comments and an explanation of modifications made.

Summary and Analysis of Comments

    Over 60 percent of the comments expressed support for the proposed 
amendments, while about one-third opposed any change in the current 
level of oversight for genetically engineered organisms. Several 
commenters, expressing support for the proposed amendments, made 
detailed comments and suggestions concerning specific provisions and 
terms used in the proposed amendments. A major concern expressed by 
commenters in opposition to the proposed simplification of requirements 
was the potential for an increased risk to the environment from certain 
transgenic plants, particularly those with wild or weedy relatives. 
APHIS has carefully considered all the comments, suggestions, requests 
for clarification, and concerns. Several modifications have been made 
to the proposed amendments in response to the comments. Before 
providing detailed responses to comments on specific provisions of the 
proposed amendments, and an explanation of the modifications made in 
consideration of these comments, however, APHIS would like to respond 
in a general way to concern about the potential for increased risk for 
field trials conducted under notification for certain new transgenic 
plant species. The comments raising concerns in this regard presuppose 
that the safety standards enforced by APHIS under its notification 
procedures are different from those under its permitting procedures. 
This presupposition is incorrect. The performance standards for field 
trials under notification procedures, as provided in Sec. 340.3(c), 
establish the same standards for confinement of regulated articles that 
have been applied to field trials conducted under permit, except that 
in the latter the Agency receives and evaluates detailed information on 
the methodology used to ensure confinement of the regulated articles 
for each trial. The notification option, which has, to date, been used 
only with respect to field trials involving six crop species, is one 
additional means of meeting those standards. More detailed responses to 
specific comments follow.

Comments on Proposed Changes to Notification Eligibility Criteria 
(Sec. 340.3(b))

    Approximately half of all comments specifically supported the 
proposal to revise Sec. 340.3(b)(1) to extend the notification option 
to any regulated article that is a crop species not listed as a noxious 
weed in regulations at 7 CFR 360 under the Federal Noxious Weed Act (7 
U.S.C. 2801 et seq.) and that meets the other eligibility criteria at 
Secs. 340.3(b)(2) through 340.3(b)(6), provided that the regulated 
article being considered for release into the environment is not 
considered by the Administrator to be a weed in the area of release 
into the environment. A representative comment noted that ``Field 
testing of a wide variety of different types of genetically engineered 
plants over the past decade has confirmed that such tests can be 
carried out safely. The notification system, with the performance 
standards, has worked well since it was established in 1993.''
    Another commenter pointed out the importance of simplified 
procedures to aid the development of improved tree varieties that are 
propagated as rootstocks under conditions in which they cannot 
reproduce, produce pollen, or flower, or that are seriously endangered 
by virulent diseases such as chestnut blight. APHIS agrees with these 
comments. APHIS notes the experience alluded to in field trials to date 
under permit with several tree species whose confinement has been 
assured because the plants were sexually immature, or by physical or 
biological means. This evidence of safe trials indicates that trials 
with these species can be conducted safely under notification 
procedures, and the conduct of such trials should be

[[Page 19905]]

facilitated by the availability of notification procedures.
    About a third of the comments opposed the proposed change to 
Sec. 340.3(b)(1). In general, comments that indicated specific reasons 
for opposition to the proposal focused on some or all of the following 
three issues: The appropriateness of performance standards as 
regulatory tools for certain field trials; the wide range of species 
that would be eligible for notification procedures; and the inadequacy 
of available knowledge about certain aspects of the biology of the 
plant species or its relatives. Comments pertaining to each of these 
general topics will be discussed in greater detail below.
    Several commenters expressed concern that, by largely shifting 
oversight for many organisms from permitting to notification 
procedures, oversight would be inappropriately decreased and compliance 
could be compromised. One comment, which discussed several issues 
related to this topic, asserted:

    Performance standard-based regulations are * * * typically more 
difficult to enforce than traditional design standard-based 
regulations. As a result, performance standards may be inappropriate 
in situations where high levels of compliance are desirable. For 
example, it would be poor policy to rely on performance standards to 
protect the food supply from residues of pesticides or other toxins; 
failure to comply with performance standards could have dire 
consequences for individuals who consumed foods with hazardous 
levels of toxins.

    In response to this comment, we would note that the comment 
recognizes the distinction between performance standards and more 
prescriptive design standards, and recognizes that it might be easier, 
in some instances, to determine whether a design standard, as opposed 
to a more general performance standard, is being followed. We believe, 
however, that the statement that performance standards are 
inappropriate when high levels of compliance are desirable is 
incorrect. High levels of compliance with a performance standard can be 
achieved if procedures exist to enable an applicant to meet the 
standard, and the parameters that determine whether a performance 
standard is or is not met are clear and well understood.
    In the case of implementation of the performance standards under 
Sec. 340.3(c), it has been useful to provide to individuals seeking to 
introduce regulated articles derived from any of the six crops listed 
under Sec. 340.3(b)(1)(i) examples of confinement procedures that would 
enable the performance standards to be met. Such examples are not 
prescribed procedures that must be followed, but rather are indications 
of options that can be used to achieve the required confinement 
standard for each of the crop species. APHIS has provided such examples 
in its User's Guide for Introducing Genetically Engineered Plants and 
Microorganisms (APHIS Technical Bulletin No. 1783) (referred to 
hereinafter as User's Guide), which is provided upon request to any 
interested individual. APHIS believes that the same level of clarity 
can be achieved for other crop species and that providing additional 
information to responsible persons will remove uncertainty about the 
ability to comply with the performance standards in particular cases.
    APHIS intends that there be clear information available to 
responsible persons to aid them in meeting the performance standards. 
To provide additional guidance of this sort, particularly in regard to 
the requirements of performance standards in Secs. 340.3(c)(5) and 
340.3(c)(6), APHIS has developed additional information that 
illustrates the type of reasoning that would apply in designing an 
appropriate protocol for other crop species based on their biology. The 
discussions of biological factors relevant to issues of confinement and 
persistence for several examples of plant species not included in the 
original list of crops at Sec. 340.3(b)(1)(i) will be included in a 
revised User's Guide. The examples will be accompanied by an expanded 
discussion of the biological factors that need to be considered to 
evaluate the adequacy of confinement protocols based on the biology of 
the particular plant species in question.
    APHIS has provided advice to responsible persons in the past on 
whether particular protocols for field tests of the six crops listed at 
Sec. 340.3(b)(1)(i) meet performance standard requirements. The Agency 
anticipates providing similar advice upon request for protocols for any 
other plant species eligible under Sec. 340.3(b)(1). It remains the 
duty of the responsible person to determine the specific procedures 
that will need to be used to meet the performance standards and to 
certify that those standards are being met.
    In further response to the commenter, APHIS would stress that the 
performance standards themselves must not be confused with other 
mechanisms to monitor or document compliance with those standards. 
Since the original publication of 7 CFR 340 (52 FR 22892-22915, June 
16, 1987), APHIS has performed field inspections for many field trials. 
Initially, when only permitting procedures were available, inspections 
were performed exclusively on field trials under permit. Since 1993, 
many inspections have also been performed on trials that have gone 
forward under notification procedures. Inspections have often been 
conducted with the participation of State regulatory officials. These 
inspections have demonstrated to the Agency that applicants have been 
able to comply extremely well with either the performance standards or 
specified permit conditions.
    APHIS considers as erroneous the assumption that oversight under 
permitting procedures provides greater assurance of ``safety'' than 
oversight under notification procedures. Compliance with either 
specified permit conditions or performance standards under notification 
procedures requires the cooperation of all involved in the conduct of 
the field trial. The outcome of either permitting or notification 
procedures is attainment of essentially the same level of confinement. 
No change to the regulations is made in response to this comment.
    Several commenters expressed the view that the proposed expansion 
of eligibility requirements for notification was too broad and that 
permitting procedures should remain in force for a regulated article 
that has wild relatives in the United States with which the plant 
organism can interbreed. The following comment illustrates this point:

    * * * APHIS proposes to ignore what are arguably the most 
troubling and scientifically well-demonstrated ecological risks of 
genetically engineered plants. APHIS will not require permits for 
field tests of genetically engineered sunflowers, radishes, rice, 
and rapeseed, all of which can hybridize with wild relatives growing 
in the United States.
Moreover, while most genetically engineered plants now field tested 
are traditional crops, in the future a much wider variety of 
genetically engineered plants will likely be field tested. Some of 
these plants, such as forest trees, and native perennials intended 
for landscaping, may pose far greater gene transfer risks than most 
crop plants now being field tested. Many crop plants are heavily 
domesticated and thus exhibit relatively low rates of survival and 
reproduction in natural ecosystems * * *. In contrast, forest trees, 
for example, are largely undomesticated. Hybrid offspring of 
genetically engineered trees and wild trees * * * can be expected to 
exhibit relatively high survival and reproductive rates. Genes will 
readily flow from genetically engineered to wild populations.

    This comment recognizes important differences in the biology of 
different crop species that will affect the ability of confinement 
procedures to achieve

[[Page 19906]]

the required performance standard. APHIS acknowledges that there are a 
variety of such biological factors that affect the design of protocols 
intended to meet the standard. These include, for example, the lifespan 
of the plant species in the field, dormancy of its seeds, pollen 
survival and dispersion, the presence of sexually compatible plants 
that are available to receive pollen in the vicinity of the trial, the 
ability of the plant to be vegetatively propagated, and climatic 
conditions. We note, however, that the comment appears to presume that 
all gene transfers pose risks, even those that only result in progeny 
that do not persist in the environment (in accordance with the 
requirements of performance standards in Secs. 340.3(c)(5) and 
340.3(c)(6)). We believe that this is not the case. Indeed, it would be 
inaccurate to assert that any trait that is transferred from a 
transgenic plant to a wild relative, even with the potential of 
persisting in a population of that wild relative, will necessarily pose 
a risk per se. The environmental analysis to address the effect of a 
particular trait on a recipient population, as required in the 
consideration of certain petitions for the determination of 
nonregulated status, would likely involve case-by case analysis based 
on the trait, the characteristics of the recipient population, and 
other factors.
    The previous commenter is clearly correct, however, to suggest that 
field tests with certain plant species will require more stringent 
confinement procedures to comply with the performance standards. 
Certain crop species are not highly domesticated, and some, such as 
strawberries, are sometimes grown in areas where interfertile wild 
relatives are abundant. In some instances these wild relatives are 
routinely found within fields of the cultivated crop. In such 
instances, it may be necessary to prevent flowering or to apply 
physical methods that contain pollen flow. In some instances, the 
responsible person may deem a particular test site unsuitable for a 
particular field trial based on such biological considerations. We 
would, however, note that field trials of many species of trees, which 
were raised as a concern in the comment, can easily be safely performed 
over a period of several years under notification procedures, based on 
the fact that the trees do not become sexually mature for a 
considerable, and well-established, period of years. Other tree species 
can be effectively isolated from wild populations by the appropriate 
choice of test location or by use of physical methods for confinement 
of pollen. APHIS does not believe, therefore, that the biological 
differences discussed in this comment provide adequate justification 
for limiting the application of performance standards to a smaller set 
of host organisms than was in the proposed rule. However, APHIS 
recognizes that there are two features of biology of trees (and, in 
some instances, of other crops grown as perennials) that merit specific 
consideration in a regulatory context. Field tests involving trees may 
be several years in duration, and such trials may result in unexpected 
exposures of nontarget organisms in the environment of the test site if 
continual vigilance as to adherence to performance standards is not 
maintained. Furthermore, the regulated articles may reach sexual 
maturity considerably after initial planting. It may well be, 
therefore, that the procedures utilized to ensure reproductive 
confinement of the regulated articles in the first year of a field 
trial may prove inadequate at a later time in the trial. To emphasize 
the level of continual vigilance that is required to ensure that all 
relevant biological factors are taken into account, APHIS will require 
that all field trials under notification procedures that are to be 
greater than one year in duration be renewed annually. This will be 
accomplished by adding the following sentence at the end of 
Sec. 340.3(e)(4):

    Such acknowledgment will apply to field testing for one year 
from the date of introduction, and may be renewed annually by 
submission of an additional notification to APHIS.

    APHIS stresses that it views the requirement for compliance with a 
performance standard as a stringent one that requires of responsible 
persons a level of care equal to or greater than that under permitting 
procedures. We expect that, if a responsible person has any question 
about whether he or she can comply with the performance standards for 
the introduction of a regulated article, that person must either apply 
for a permit under Sec. 340.4 or consult with APHIS; and that States 
will continue to provide input to APHIS, particularly if they have any 
concern about whether the performance standards can be complied with in 
a given field trial.
    Another commenter that opposed the proposed extension of 
notification procedures asserted that APHIS' 1993 final rule (58 FR 
17044-17059, March 31, 1993) establishing notification procedures for 
field trials of certain regulated articles, particularly the six crop 
species listed in Sec. 340.3(b)(1)(i), was based primarily on a USDA 
finding that the six listed crop species posed negligible risk of gene 
flow to wild relatives in the United States. The commenter argued that: 
``In many cases, scientists do not know the extent to which U.S. crops 
interbreed with wild relatives nor the extent to which wild relatives 
exist in areas where crops are grown.'' The commenter further 
recommended that:

    Until the Department has a comprehensive database of information 
on the location of populations of wild relatives of crops in the 
United States, the sexual compatibility of those relatives with U.S. 
crops, and the impacts of transgenes in wild populations, it should 
require case-by-case risk assessments under its permit procedures of 
all U.S. crops with interbreeding wild relatives in this country.

    In response to these comments, APHIS disagrees with the assertion 
that the primary basis for our final rule establishing the notification 
option was an Agency determination that there was negligible risk of 
gene flow from transgenic derivatives of the six listed crop species to 
wild relatives. Our action was based on accumulated experience showing 
that the six listed crop species, which were those crops for which the 
greatest number of field trials had been performed in the United States 
to that time, could be safely field tested under permit, and on our 
recognition that the conditions imposed under permit formed the basis 
for adequate confinement measures under performance standards. In 
response to a specific request by a commenter, APHIS did provide in its 
final rule additional evidence that the potential for gene flow from 
the six listed crop species to wild relatives in the United States was 
negligible regardless of whether the performance standards were 
applied. Nevertheless, the Agency continues to believe that the 
performance standards themselves adequately address the issue of gene 
flow. APHIS acknowledges that insufficient data with respect to 
interbreeding potential or the locations of populations of wild 
relatives for some plant species could affect the appropriateness of 
design protocols for particular field trials. These considerations 
would be a necessary part of the responsible person's analysis of what 
would be required to comply with the performance requirements under 
Sec. 340.3(c). It may be the case that in some instances, based on the 
realization that existing information is inadequate, adherence to the 
performance standards might require, for example, that flowering of the 
regulated article be prevented or that physical means such as bagging 
be utilized to prevent pollen flow from the

[[Page 19907]]

regulated article. As indicated previously, APHIS will consult with 
responsible persons upon request regarding compliance with the 
standards in individual instances and is also preparing other useful 
information for inclusion in its User's Guide. Nonetheless, APHIS 
believes that the performance standards themselves adequately address 
the concerns raised by the commenters. No change to the regulations is 
made in response to this comment.
    The commenter does raise a point that is relevant to another 
section of the rule, however. Incomplete data regarding compatibility 
with relatives or the presence of interbreeding populations of related 
species may dramatically affect the ability to reach a subsequent 
determination of nonregulated status for certain regulated articles, 
and this should be noted by any persons who may consider submitting 
such petitions. For traits potentially related to plant survival, such 
as disease or stress resistance, information of this kind will often be 
important to an analysis of the potential for plant pest risk under the 
petition process at Sec. 340.6.
    Several commenters disputed APHIS' assertion in the proposed rule 
that the Agency has gained considerable experience with field testing 
under notification and permitting procedures. These comments, in 
general, questioned how much experience had really been gained, in view 
of the fact that most of the permits have been granted in the last few 
years; whether the long-term effects of releases had really been 
determined; and whether the Agency had yet obtained any ``hard data'' 
to assess specific environmental impacts.
    In response to these comments, APHIS believes that its statements 
regarding accumulated experience remain correct. While it is true that 
the majority of field trials of regulated articles have been conducted 
in the last two years, all evidence obtained to date, including that 
from monitoring reports submitted to the Agency by responsible persons 
overseeing the tests, indicates that the trials have been conducted 
safely, and that there has been no reason to believe that any 
hypothetical ``long-term'' impacts have arisen or are likely or 
foreseeable as a consequence of the conduct of any field trial in 
accordance with this final rule. The request for ``hard data,'' which 
APHIS interprets to mean ``data derived from experiments designed 
specifically to address particular safety concerns,'' ignores a great 
deal of highly relevant data, some of which may be empirical in nature, 
on the behavior of the test plants as determined by individuals expert 
in the behavior of the plant species. Moreover, ``hard data'' has been 
requested and obtained by the Agency in some instances, when deemed 
material to consideration of a petition for determination of 
nonregulated status for a regulated article.
    One commenter inquired whether an applicant would be able to 
request a permit for which an environmental assessment is written for a 
regulated article that might qualify for notification procedures. APHIS 
agrees that field trials that would qualify for notification procedures 
could be given permits upon request. However, as indicated in APHIS' 
National Environmental Policy Act (NEPA) Implementing Procedures, which 
were published on February 1, 1995 (60 FR 6000-6005) and codified at 7 
CFR part 372, permitting and acknowledgment of notifications for 
confined field releases of genetically engineered organisms have been 
categorically excluded from the requirement to prepare environmental 
assessments or environmental impact statements. There are two relevant 
exceptions indicated in those procedures. Section 372.5(d)(1) provides 
for preparation of an environmental assessment or environmental impact 
statement ``When any routine measure, the incremental impact of which, 
when added to other past, present, and future actions (regardless of 
what agency or person undertakes such actions), has the potential for 
significant environmental impact.'' Section 372.5(d)(4) provides for 
the preparation of such analyses ``When a confined field release of 
genetically engineered organisms or products involves new species or 
organisms or novel modifications that raise new issues.'' The decision 
as to whether either or both of these exceptions to the categorical 
exclusion applies will be made by the Administrator.
    One commenter asked whether the proposed changes to notification 
procedures would in effect require a responsible person to submit 
requests for notification more than 120 days in advance of a desired 
field trial in order to give the Administrator, APHIS, time to 
determine whether the plant species in question is considered a weed in 
the area of the proposed introduction, and to give the responsible 
person time to submit a permit application if notification procedures 
are deemed not to apply. APHIS believes that the scenario described 
will rarely apply for plant species that are commonly cultivated. In 
most instances, there will not be any uncertainty beforehand as to 
whether a particular species is a weed in the area around the site of a 
proposed introduction. If an applicant has any uncertainty regarding 
the weed status of a particular species around the site of a proposed 
introduction, that applicant should consult with the Agency as early as 
possible to enable the agency to obtain the necessary information early 
enough to prevent undesirable delays. It should be pointed out that 
applicants need to take into consideration the presence of sexually-
compatible populations of the same plant species, even if not weedy, in 
the area of a proposed test site in the development of test protocols 
that would meet the performance standards under Sec. 340.4.
    One commenter suggested that the phrasing of the new eligibility 
criterion under proposed Sec. 340.3(b)(1) would require that 
notification procedures apply for introductions of all non-weed plant 
species. APHIS believes that this comment is incorrect. The eligibility 
criterion, as written, applies only to regulated articles, as defined 
under Sec. 340.1.
    Less than half of all comments specifically addressed the proposed 
revision of eligibility criterion under Sec. 340.3(b)(5), which would 
extend the existing eligibility criterion to allow introductions under 
notification procedures of plants containing genetic sequences from 
plant viruses that are noncoding regulatory sequences of known 
function, or that are 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.
    One comment from a scientific society indicated that the proposal 
was ``clearly based on sound scientific data dealing with the safety of 
virus-resistant plants.'' Another comment supported the proposed 
extension, but recommended in addition that the eligibility criterion 
not require that any viral gene be derived from a plant virus that is 
prevalent and endemic in the area where the introduction will occur. 
This recommendation was based on the following rationale:

    When field trials are performed under controlled circumstances, 
the crop performance standards are sufficient to prevent the 
unintentional dissemination of the virus by the introduced viral 
component, which is not itself capable of plant infection. In 
addition, the opportunity for recombination will be less in an 
isolated field with no homologous viruses than in an area with like 
viruses.


[[Page 19908]]


    APHIS disagrees with the commenter's rationale for further changes 
to the proposal. The performance standards are designed to prevent 
persistence of the regulated article or its progeny, and do not 
specifically address dissemination or persistence of other organisms, 
such as viruses or their vectors.
    Approximately a quarter of the comments opposed the proposed 
revision to the eligibility criterion in Sec. 340.3(b)(5). These 
comments raised some or all of the following four issues: risks of gene 
flow to related plant species; risks of synergistic effects when the 
regulated article is infected with plant viruses other than the one 
from which its viral component was derived; risks that new viral 
strains will be produced; and the supposed paucity of empirical data 
available to support the proposed revision.
    One commenter expressed concern that movement of genes of viral 
origin from regulated articles to related plant species could occur 
when plants containing such genes are introduced under notification, 
which ``could have significant implications for both agroecosystems and 
natural ecosystems, as viral transgenes transferred to wild plant 
populations could result in new or worse weeds in farmers' fields or 
alter the genetic diversity of natural ecosystems * * *''
    APHIS disagrees with these comments. APHIS believes that it has 
addressed the issue of gene flow from regulated articles to other 
plants in its general discussion of the appropriateness of the 
performance standards for confinement of field trials.
    The issues with respect to potential synergistic effects and/or 
recombinational events revolve around potential interactions between 
the regulated article and other viruses in field settings. Before 
discussing these phenomena in detail, however, APHIS notes that during 
field testing of virus resistant plants (whether transgenic or 
conventionally bred), researchers routinely make efforts to exclude 
unwanted viruses to which the test plants are not resistant (unless 
they are specifically investigating an effect such as synergy). This is 
done because infection of plants with other viruses causes additional 
disease symptoms that make comparative evaluation of the desired 
disease resistance phenotypes of the test lines (the transgenic lines) 
with controls (the nontransgenic parent lines) difficult or impossible. 
The need for exclusion of other viruses during field trials with 
vegetatively propagated plants (e.g., potatoes) is even more severe. 
With such plants, infection with other viruses not only contaminates 
the experimental plants but results in infection of all clonal progeny. 
Infected plants then need to be destroyed, or the unwanted virus must 
be eliminated via tissue culture, a time-consuming and expensive 
procedure. For any crop, if an unwanted virus is seed transmitted, 
progeny lines also become infected, which can affect an entire breeding 
program. Thus, researchers have long recognized the importance of 
minimizing the presence of unwanted viruses from field tests of virus 
resistant plants. Minimizing unwanted viruses in a test plot minimizes 
the opportunity for recombination or synergy.
    The concerns raised over the potential for synergistic effects 
between viral genes in the regulated article and other viruses that may 
infect the plant allude to the phenomenon that, when two viruses 
simultaneously infect a plant, disease symptoms can be more severe than 
when either of the viruses alone infects the plant. Such synergistic 
infections can often result in severely diseased, unsalable crops under 
current agricultural production. APHIS believes, however, that such 
synergistic interactions are relatively rare in mixed viral infections. 
APHIS estimates that more than 2000 plant viruses have been identified 
worldwide. Information gathered for APHIS on the occurrence of 
synergistic interactions by Dr. Vicki Vance, University of South 
Carolina, on file in the administrative record, identified no more than 
25 synergistic viral interactions. Moreover, because synergy, unlike 
recombination, is not related to the potential for creation of new 
viruses, the effects of synergy may in effect be considered to be 
agronomic, rather than environmental. Investigation of the potential 
for synergy may be a part of the evaluation of a new crop variety 
undergoing agronomic testing. Were synergistic interactions manifested 
by a transgenic crop during field testing, severe infection would 
result, and the plants or plant lines would likely be destroyed because 
they would have no use in a breeding program. These effects would be 
limited to the test plants.
    Three other independent reports prepared in different countries and 
published in 1995 and on file in the administrative record address the 
subject of synergy and viral resistant transgenic plants:
    1. ``Transgenic virus-resistant plants and new plant viruses,'' a 
report prepared by the American Institute of Biological Sciences 
(AIBS), based on a workshop convened by AIBS and sponsored by the USDA;
    2. ``Risks to the Agricultural Environment Associated with Current 
Strategies to Develop Virus Tolerant Plants Using Genetic 
Modification,'' written by Henry, C. M., Barker, I., Pratt, M., 
Pemberton, A. W., Farmer, M. J., Cotten, J., Ebbels, D., Coates, D., 
and Stratford, R., for the United Kingdom Ministry of Agriculture 
Fisheries and Food; and
    3. ``Transgenic plants expressing viral genes: Issues related to 
field releases,'' written by Rochon, D. M., Ellis, P. E., Martin, R. 
R., and Sanforn, H., for Agriculture and Agri-Food Canada.
    All these reports support APHIS' conclusions that viral synergies 
are rare and would pose only transitory agronomic concerns, but not 
environmental risks. Agronomic characteristics such as disease 
susceptibility are routinely evaluated during agronomic testing. On the 
basis of all the information presented, therefore, APHIS believes that 
the potential for viral synergies when regulated articles are 
introduced under notification will pose no concerns different from 
those arising under traditional agricultural breeding and practice.
    In further response to the commenters, the issue with respect to 
recombination centers around the potential to create new plant viruses 
when transgenic virus resistant plants are infected by other plant 
viruses. The term ``recombination'' is typically defined as an exchange 
of nucleotide sequences between two nucleic acid molecules. Such 
exchanges between genomes result in heritable, permanent change. While 
recombination is a common process, which is responsible in nature for 
much of the observed variation between individual members of the same 
species, a variety of factors affect the appearance and survival of 
recombinant types. In all experiments that have been performed to date 
with plant viruses, recombinant types have been observed only when 
transgenic plants, containing viral sequences and susceptible to the 
virus from which those sequences are derived, are infected with a 
defective but replication-competent parental virus type under a strong 
selection for production of recombinant virus. Recombination between 
two plant viruses under natural field conditions has never been 
reported and may be sufficiently rare that it may only be observed to 
occur on an evolutionary time scale. There are no published reports 
demonstrating recombination between a virus-resistant transgenic plant 
and a nondefective and unrelated plant virus. Resistance to an 
infecting virus would prevent or at least partially inhibit replication 
of that virus and

[[Page 19909]]

replicated progeny viruses might not therefore be available for 
recombination with the resident viral transgene. The reports cited 
above on transgenic plants expressing viral genes provide more detailed 
discussions on the factors affecting recombination, the detection or 
survival of recombinants, and provide additional reference sources.
    The likelihood that a statistically rare recombinational event will 
occur depends on, among other things, sample size. Typically, the first 
field trials of regulated articles containing genes from plant viruses 
that have not yet been demonstrated to confer virus resistance on the 
host plant are small, i.e., with single genotypes representing perhaps 
0.5 acre or less. Lines that are selected for testing on larger plots 
are generally those that have been shown to be resistant to infection 
by the parental virus under field conditions during prior small scale 
field testing. In fact, greater than 95 percent of the individual field 
tests of virus resistant plants that have been conducted to date under 
permit or notification procedures have been small, under 5 acres in 
area. The larger field trials that have been performed to date have 
involved lines that have been subsequently deregulated (e.g., Asgrow's 
ZW-20 squash) or other crop lines that are relatively far along in 
their agronomic testing. All such varieties have already been 
demonstrated to be resistant to viral infection, reducing the 
likelihood of recombination with the related virus.
    As stated above, if an unwanted virus infects the transgenic plant 
and replicates, recombination theoretically could occur. The potential 
for recombination will be limited by efforts to exclude unwanted 
viruses from field tests. Additional constraints in proposed 
eligibility criterion Sec. 340.3(b)(5) for viral sequences that meet 
notification are that the inserted viral sequences come from a viral 
strain that infects the recipient plant and that the virus be widely 
prevalent in the area where the field test is to be performed. If these 
limitations apply, the RNA's of concern that could potentially 
recombine (the viral transgene and the unwanted virus) would be nucleic 
acids that would have already had the potential to interact and 
recombine in nature if the two viruses naturally infected the same 
plant and were located within the same plant tissues.
    APHIS believes that scientific evidence, routine agricultural 
practices, and the other restrictions contained under revised 
Sec. 340.3(b)(5) make it highly unlikely that any new virus will arise 
as a result of field testing of a transgenic virus resistant plant 
under notification procedures. APHIS also believes that in the unlikely 
event that a new virus should arise, standard practices that are used 
to control new viral diseases that are detected in agricultural 
settings would also be adequate to address any new virus. Again, two of 
the above-cited reports that addressed this general subject reached 
conclusions similar to those of APHIS. In a report to Agriculture and 
Agri-Food Canada, Rochon et al. (1995) conclude, ``It is likely that 
current means of detecting and controlling new diseases in this country 
would be adequate to control any new virus resulting from recombination 
between a transgene and another virus.'' The AIBS report concludes by 
stating, ``With or without the use of transgenic plants, new plant 
virus diseases will develop that will require attention.'' No changes 
to the regulations are made in response to these comments.
    Several commenters expressing opposition to the proposed revision 
to Sec. 340.3(b)(5) asserted that there is insufficient empirical data 
for its justification. In response to these comments, we understand the 
desire for additional experiments specifically designed to increase 
understanding of the mechanisms involved in virus resistance, to 
measure the frequency at which certain interactions between regulated 
articles and infecting viruses occur, and to examine the effects of 
those interactions on virus populations. We agree that such information 
will probably be scientifically interesting. It may also be potentially 
useful for resolving uncertainties that may arise for specific crop-
gene combinations when, eventually, approval is sought to grow the 
regulated articles under routine agricultural conditions as opposed to 
under performance standards (i.e., when a petition is submitted to 
APHIS for a determination of nonregulated status). A statement in the 
AIBS report (1995) previously cited recognizes this fact: ``More 
research is needed to explain these mechanisms and to assess the 
environmental and agricultural risks that might be presented by the 
commercialization of transgenic virus-resistant crops.''
    We do not agree with the comment that additional data of these 
types are needed to justify the proposed modification to 
Sec. 340.3(b)(5) for field trials under notification procedures. Such 
arguments, APHIS believes, ignore the weight of experience with 
conventionally bred and conventionally cross-protected crop varieties 
(a cross-protected variety being one made immune or resistant to a 
severe strain of a virus by infecting the variety with a mild strain of 
the virus), and take note of neither the performance standards under 
Sec. 340.3(b) nor the agricultural practices routinely used to minimize 
infection of test crops or to control infections.
    One commenter suggested that APHIS mischaracterized the results of 
the AIBS Workshop on Transgenic Virus-Resistant Plants and New Plant 
Viruses. The comment asserted that a discrepancy exists between the 
proposed regulations (which would extend eligibility to all viral genes 
derived from certain viruses, apart from those genes encoding noncapsid 
movement proteins) and the written proceedings, which in the view of 
the commenter indicated that any as yet undiscovered viral genes would 
pose novel risks, with the implicit implication that such genes should 
not be eligible for APHIS' notification procedures.
    APHIS disagrees with this commenter's interpretation of the 
workshop proceedings. The relevant phrase in the AIBS report, which 
contains the only mention of ``known'' genes, is, ``The participants 
agreed that the risk considerations for coat protein (currently on the 
list for notification) are the same as those for other known viral 
genes * * *.'' APHIS believes that the report does not attempt to 
indicate that other genes would pose new risks, but rather that the 
participants at the workshop only discussed the potential risks of 
genes for which scientific information was at hand. APHIS believes that 
enough information has been established to date about the function of 
plant virus genes so that whole new categories of genes that would 
raise new concerns other than those addressed at the workshop are 
unlikely to appear. However, should any information arise that would 
suggest that notification procedures are not appropriate for a 
specific, as yet undiscovered class of viral genes, APHIS would of 
course act to ensure that appropriate safety requirements for field 
testing applied to such trials.
    The comment also noted that the proposal would extend notification 
procedures to field trials of any size, while the report only discussed 
risk considerations for small-scale trials, i.e., those under 10 acres. 
APHIS agrees that the workshop participants, in discussing specific 
categories of genes in accordance with questions distributed to 
participants to help focus discussions, specifically addressed small 
scale field trials. However, in their discussions of the various types 
of viral interactions (such as recombination and synergy) that formed 
the broader issues

[[Page 19910]]

at the heart of the workshop, no specific size-related concerns were 
raised. Moreover, as was discussed previously, preliminary field trials 
with new crop lines carrying virus-derived genes are generally 
conducted on a very small scale until it can be demonstrated that the 
new lines exhibit the desired virus-resistant phenotype. When this 
phenotype is manifested, the likelihood that the viral transgene could 
recombine with a related infecting virus is further limited. Again, 
however, the general concerns raised are concerns that may become 
relevant on a case-by-case basis when the Agency considers petitions 
for determination of nonregulated status for specific virus-resistant 
regulated articles. No change is made to the regulations in response to 
this comment.

Comments on Proposed Simplifications to Paperwork Requirements by State 
Regulatory Officials (Sec. 340.3(e)(1))

    About one-fifth of all comments specifically addressed the proposal 
to eliminate the requirement that States actively provide to APHIS 
concurrence on interstate movements of regulated articles under 
notification. All but one of the comments were in favor of the rule as 
proposed. Each of those, however, suggested that the proposal needed 
some additional clarification: either that States' roles in oversight 
over other aspects of the notification process should be lessened, or 
that the notification process for interstate movement should be made 
``generic'' by indicating a master list of potential terminal 
destinations to which transgenic seed might be shipped. Several 
comments indicated that State involvement should be eliminated 
entirely.
    In response to these comments, APHIS believes that the notification 
process for interstate movement is not burdensome, that State 
notification and involvement in that process has been, and continues to 
be, useful, and that it is appropriate that States be made aware that 
shipments of specific regulated articles may be destined to enter. 
States should be offered the opportunity to consider any notifications 
in view of local requirements. APHIS further believes that a system for 
generic identification of sites to which transgenic seed may be shipped 
might not provide States with adequate opportunities to address these 
considerations.
    One State commenter indicated strong opposition to removal of the 
requirement for review and concurrence by affected States. The comment 
asserted, ``Notification without the review opportunity is not 
acceptable.'' APHIS believes that this comment reinforces the view of 
other comments, in favor of the proposed rule, that indicated the need 
for additional clarification. APHIS believes that the proposed 
regulation was not sufficiently clear in indicating that States would 
be notified and that those States that wish to continue to review 
notifications for interstate movement would be free to do so. 
Furthermore, the important role that States have played in considering 
local factors with respect to field trials will remain unchanged. 
(These field test factors, as indicated by one State Department of 
Agriculture, include review of proposed uses of challenge organisms, 
the planting of species in areas in which host-free periods exist for 
the crop, the planting of crops in protection districts where specific 
state regulations restrict planting, and the planting of plant material 
for which there are established specific quarantines.) In response to 
comments, APHIS is revising Sec. 340.3(e)(1) of the regulations to 
clarify its intent as follows:

    APHIS will provide copies of all notifications to appropriate 
State regulatory official(s) for review within 5 business days of 
receipt. Comments to APHIS from appropriate State regulatory 
officials in response to notifications for interstate movement of 
regulated articles will not be required by APHIS prior to 
acknowledgment, although States may provide their reviews to APHIS 
at their discretion.

Comments on Proposed Changes to Regulations for Petitions for 
Determination of Nonregulated Status and on Proposed Use of Guidelines 
to Provide Information to the Public (Sec. 340.6(e) and Footnotes Added 
to the Ends of the Headings of Secs. 340.3, 340.4, 340.5, and 340.6)

    Two related portions of the proposed rule, i.e., the proposed 
changes to regulations for petitions for determination of nonregulated 
status and the proposed use of guidelines to provide information to the 
public on various issues, were frequently discussed together in 
comments. APHIS will discuss the comments received on these two topics 
together.
    A majority of comments that specifically addressed the expansion of 
determinations of nonregulated status supported the concept of relating 
the extension of a determination of nonregulated status to a 
determination of nonregulated status for a closely related antecedent 
organism. One comment stated: ``The slight differences in closely 
related varieties are no more significant than the differences that 
occur between the products of traditional plant breeding.''
    Several commenters also noted the value of the increased 
flexibility provided by the proposed changes, in allowing for desirable 
outcomes such as greater innovation, reduced paperwork, less redundant 
experimentation, and promoting the rapid development of the best new 
crop varieties. One commenter, in pointing out that progress through 
the development of new transformants would be encouraged under the 
proposed changes, noted: ``The current system encourages the 
development of genetically engineered crops using a trait from a single 
progenitor line. Such crops are genetically more narrow and less 
adaptable than crops developed from several lines derived from various 
insertions of the same trait.'' APHIS agrees with these comments.
    The comments opposed to the proposed extension of determinations of 
nonregulated status to plants closely related to antecedent organisms 
generally expressed the view that a ``huge loophole'' would be opened 
up under which risk assessments of potentially dangerous new varieties 
would not be made. One comment suggested that companies would be able 
to reengineer particular plants to contain genes that pose ecological 
concerns and then claim that the new plants are, indeed, ``closely 
related.''
    APHIS disagrees with these comments. The basis for extending a 
determination of nonregulated status to additional closely related 
regulated articles will be a demonstration by the applicant that the 
risk assessment that was developed for the antecedent organism is in 
fact adequate to address any potential plant pest risk issues for the 
regulated article. While the guidelines developed by APHIS will provide 
examples of types of differences between regulated article and 
antecedent organism that the Agency believes are unlikely to raise such 
new issues, it will be the burden of the applicant to provide data, 
including data from field tests, to demonstrate this contention. 
Moreover, in the proposal, any action by the Agency to extend a 
determination of nonregulated status would not take effect for 30 days. 
This interval was deliberately incorporated into the proposed rule to 
allow an opportunity for any new plant pest risk issues that might have 
been overlooked in APHIS' review of the applicant's requests to be 
identified. No change to the regulations is made in response to these 
comments.
    Another commenter, expressing the desire that APHIS proceed 
cautiously

[[Page 19911]]

with respect to this proposed action, stated: ``Differences in gene 
insertion sites, copy number, and genetic background have the potential 
to make two very similar sounding varieties significantly different in 
phenotype.'' APHIS agrees that phenotypic differences may arise in 
these ways. However, the Agency believes that the differences that may 
result would likely be of the magnitude observed through traditional 
crop breeding. In any event, the phenotype of the regulated article 
will need to be specifically described in any request for an extension 
of an existing determination of nonregulated status. On a case-by-case 
basis, APHIS will consider whether observed phenotypic changes raise 
any issues that were not adequately addressed in the determination of 
nonregulated status for the antecedent organism, and the Agency's 
decision will be announced to the public 30 days before it takes 
effect.
    One commenter objected to this portion of the proposed rule on the 
grounds that commercialization of genetically engineered plants raises 
large-scale issues not addressed by small-scale field testing, and, 
implicitly, that these issues would not be adequately addressed when 
requests for extension to existing determinations of nonregulated 
status are considered. APHIS disagrees. We reiterate, as was indicated 
in response to comments in the final rule establishing the notification 
and petition options, that we believe that all relevant issues are 
carefully considered in APHIS analyses of petitions for determination 
of nonregulated status. It should further be noted that other agencies 
outside USDA, notably the Environmental Protection Agency and the Food 
and Drug Administration, also exercise regulatory responsibilities for 
assuring the safety of certain agricultural products developed using 
biotechnological techniques. The framework of agency authorities and 
responsibilities, under which more than one agency often has a 
designated regulatory role in assuring the safety of a particular 
product, was set forth by the White House Office of Science and 
Technology Policy as the Coordinated Framework for the Regulation of 
the Products of Biotechnology (51 FR 23303-23350, June 26, 1986).
    Two commenters addressed APHIS' discussion of the use of guidelines 
as part of regulatory oversight. One comment stated: ``* * * guidelines 
should not be used as a substitute for rulemaking. The practice of 
issuing guidelines should be codified in the regulation not relegated 
to the status of a footnote in the preamble of the proposed 
regulation.''
    Both commenters requested that APHIS codify the use of guidelines 
to establish the policy that data developed in compliance with those 
guidelines will be accepted by the Agency for purposes of review. In 
response to these comments, APHIS notes that its guidelines are 
intended to provide guidance to applicants and not as rules of general 
applicability. They are not intended to be requirements for submission 
of requests under this part and accordingly they have not been placed 
in the regulations. Should APHIS at a later date decide to adopt the 
guidelines as requirements, it would do so after notice and comment 
rulemaking. In addition, APHIS anticipates that data and information 
submitted in accordance with the guidelines would generally be 
acceptable to the Agency, unless additional information becomes 
available to the Agency that raises specific new plant pest risk issues 
regarding a particular request for an extension of a determination of 
nonregulated status. No change to the regulations is made in response 
to these comments.
    Several comments were received regarding the use of guidelines to 
help applicants establish the similarity of a regulated article to an 
antecedent organism. Many of the comments suggested that APHIS needed 
to provide clear definitions for ``closely related'' and ``negligibly 
different,'' two terms used in the discussion of the relation of 
antecedent organism to regulated article in the proposed rule. Two 
comments indicated that a standard for ``closely related'' should be 
put directly in the text of the regulations. Several commenters also 
expressed the desire to comment directly on precise definitions for 
these terms or on any guidelines APHIS might develop. Several comments 
suggested that it was not possible, given the information in the 
proposed rule, to provide informed comments on this portion of the 
proposed rule.
    In response to these comments, APHIS continues to believe, as 
indicated in the proposed rule, that it is not appropriate to establish 
rigid rules or definitions for determining similarity. A wide range of 
minor differences might be exhibited by a regulated article and its 
antecedent organism that would not affect any characteristics related 
to the potential for plant pest risk of the regulated article. 
Moreover, the relevant plant pest risk issues discussed in any 
determination of nonregulated status will vary depending on the biology 
of the regulated article in question. When an applicant requests an 
extension of a determination of nonregulated status, it will be 
necessary that the applicant demonstrate that the Agency's analysis of 
the identified relevant issues for the antecedent organism, in fact 
adequately addresses all relevant issues relating to the regulated 
article as well. APHIS wishes to announce, however, that it has 
developed guidelines for extensions to determinations of nonregulated 
status. The Agency believes that these guidelines will provide useful 
examples of some types of modifications that are unlikely to raise new 
plant pest risk issues, and the types of information that an applicant 
may use in support of such a request. APHIS believes that this 
information is adequate to address any confusion about the use or 
intent of guidelines. The guidelines are available on the Internet or 
by mail as indicated under FOR FURTHER INFORMATION CONTACT. APHIS 
welcomes suggestions on the guidelines themselves. These guidelines 
will be updated periodically as extensions are granted.
    Several comments indicated general preferences for either stringent 
or flexible requirements. Four other comments provided specific 
suggestions as to the types of similarities between antecedent 
organisms and regulated articles that the commenters believe would be 
unlikely to raise new plant pest risk issues. APHIS does not believe 
that it would be informative to attempt to categorize guidance 
information provided to potential applicants as either ``stringent'' or 
``flexible,'' inasmuch as these are subjective terms. We would note 
that independent of the specific content of the guidelines, the 
Agency's responsibilities to prevent the introduction and dissemination 
of plant pests are no less stringent under the regulations in 7 CFR 
part 340 than under other of its regulations. However, the use of 
guidelines can provide flexibility for applicants while allowing for 
the Agency's exercise of these responsibilities. To address the 
specific recommendations, the comments as a whole suggested that the 
following types of changes between antecedent organisms and regulated 
articles would raise no new plant pest risk issues: The regulated 
article and the antecedent organism contain genes from different donor 
organisms when the two genes perform the same molecular function; and 
the antecedent organism and the regulated article differ only in the 
use of a different selectable marker gene; the antecedent organism and 
the regulated article differ only in structural modifications of the 
same functional gene, or in the use of different noncoding regulatory 
sequences to drive

[[Page 19912]]

the expression of the gene. APHIS agrees that it is likely that most 
organisms in the proposed classes would raise no new plant pest risk 
issues. As an illustration, a new ``selectable marker gene'' could 
potentially be a gene of any function, providing that a useful assay 
has been developed for it in the context in which the gene is to be 
expressed. However, evaluation of the potential for plant pest risk 
posed by a new selectable marker gene would, APHIS believes, require 
consideration of the specific function of that gene.
    For any specific request for an extension of a determination of 
nonregulated status, a requester will need to provide justification as 
to why the analysis put forth in the determination of nonregulated 
status for the antecedent organism is adequate to address any potential 
plant pest issues that may be posed by the regulated article. With 
respect to any suggestions that APHIS may receive on the contents of 
its guidelines, the Agency will carefully consider all suggestions, 
both those that identify specific new plant pest risk issues that may 
be posed by classes of modifications as well as any of those 
identifying additional types of similarities that would be unlikely to 
raise any new risk issues. No changes to the regulations are made in 
response to these comments.
    One State cooperator expressed the view that States need the 
opportunity to review guidelines to verify that any specific conditions 
in the State are addressed. The comment also inquired: how States can 
make known any difference of opinion on any judgment by APHIS to extend 
a determination of nonregulated status; whether the particular 
guideline on which a requester based a request for extension of a 
determination would be identified in that request; and if a different 
guideline were followed by a person requesting an extension of a 
determination of nonregulated status, whether States would have the 
opportunity to comment on that guideline.
    In response to these comments, APHIS notes, first, that it welcomes 
any comments from its State cooperators at any time, whether in 
response to any guidelines or in response to a particular action to 
extend a determination of nonregulated status. With respect to the 
identification of specific guidelines on which an applicant bases his 
or her request to extend a determination of nonregulated status, APHIS 
presumes that the applicant will describe in any request, the 
justification for the proposed extension. An applicant may choose 
whether or not to rely on the guidelines as a basis for the proposed 
extension, inasmuch as adherence to the guidelines is not mandatory. 
APHIS believes that it is most appropriate that States focus 
specifically on the justification provided by an applicant and the 
documentation developed by the Agency that demonstrates that the 
existing analysis is adequate to address the new regulated article as 
well.
    One commenter in favor of the proposal to allow the extension of 
determinations of nonregulated status to closely related organisms 
requested that APHIS change the term ``antecedent organism'' to either 
``antecedent deregulated article'' or ``substantially equivalent 
organism,'' to avoid implying that new genetic transformation events 
result in ``new organisms.'' APHIS does not believe that the term 
``antecedent organism'' carries with it the implication that the 
commenter inferred. No change to the regulations is made in response to 
this comment.
    Two commenters requested that individuals who seek extensions of 
determinations of nonregulated status and who did not submit the 
initial petition for determination of nonregulated status be required 
by APHIS to provide written proof of permission for use of any 
information in the initial petition. One of those comments further 
suggested that APHIS should provide petitioners with a means of 
deriving compensation for information from their petition that is used 
by another person who requests an extension of the original 
determination of nonregulated status. If such a compensation provision 
is not included, then, the comment asserted, extensions of 
determinations of nonregulated status should only be available to the 
submitters of the initial petition for the antecedent organism.
    APHIS understands the concern that competitors may derive a 
competitive advantage from utilizing information developed by others 
without equivalent expenditure of time and money. However, the Agency 
disagrees that an individual who requests an extension of a 
determination of nonregulated status will necessarily utilize to any 
great extent the data contained in the petition for the antecedent 
organism. Rather, a person who requests an extension to a determination 
of nonregulated status is likely, in large part, to make reference to 
APHIS' analysis of the potential for plant pest risk posed by the 
antecedent organism, providing additional evidence for the new 
regulated article that the existing analysis is adequate to address 
that organism as well. Requesters do need, however, to attest to the 
validity of any data they provide to the agency that is material to the 
safety of the regulated article that is the subject of the extension 
request.
    Two commenters requested clarification on the content of requests 
to extend determinations of nonregulated status, specifically on the 
format of such requests and on information requirements. APHIS does not 
believe a specific format for requests for extension of determinations 
of nonregulated status needs to be specified, but believes that the 
request itself could simply be provided to the Agency in the form of a 
letter. Similarly, the guidelines, as guidelines rather than 
regulations, do not specify data requirements in great detail, but 
indicate the general rationale of the analyses that need to be 
presented to the Agency and the general areas that need to be 
addressed, including a description of the genetic modifications in the 
regulated articles under consideration and a comparison of the 
modifications in those regulated articles with those in the antecedent 
organism, information on the phenotypic expression of the genetic 
modifications in the regulated articles and any known differences in 
phenotype between the regulated article and its antecedent organism in 
support of the contention that the regulated articles in question do 
not pose new risk issues meriting separate consideration.
    One commenter requested that APHIS clarify whether field data 
reports need to be submitted along with a request to extend 
determinations of nonregulated status. APHIS believes that submission 
of such data is material to any determination of nonregulated status, 
whether the determination is made in response to a separate petition or 
in response to a request for extension of a determination. (The 
guidelines mentioned previously do indicate that data from at least one 
field trial should be included for any new regulated articles for which 
an extension of a determination of nonregulated status is requested.) 
APHIS intended in its proposed rule that requirements for submission of 
field data reports for petitions for the determination of nonregulated 
status under proposed Sec. 340.6(c)(5) would also apply to extensions 
of such determinations. In response to comments, proposed 
Sec. 340.6(c)(5) is revised to indicate that field test reports for all 
completed field trials need to be submitted prior to submission of 
either a petition for determination of nonregulated status or a request 
for extension of a determination of nonregulated status.
    Two commenters recommended that APHIS eliminate the 30-day interval

[[Page 19913]]

between the announcement of an extension of a determination of 
nonregulated status and its effective date, based on the fact that the 
Agency had already conducted a thorough safety review, with public 
comment, on the antecedent organism. APHIS believes that it is 
necessary to retain the 30-day interval to allow State officials and 
PPQ officers to receive and process the information concerning the 
extension of an existing determination to new lines. Moreover, 
Sec. 340.6(e)(3) ensures that the public has adequate notice of all 
preliminary decisions to extend determinations of nonregulated status 
by announcing such decisions in the Federal Register 30 days before the 
decisions become final and effective. This section provides that APHIS 
may modify its preliminary decision should APHIS receive additional 
information that it determines warrants a change in the decision. In 
such cases, APHIS will issue a revised decision and publish it in the 
Federal Register. In the absence of additional information that the 
Agency believes warrants such a change, the preliminary decision will 
automatically become final and effective after 30 days.

Comments on Proposed Simplifications to Reporting Requirements Under 
Permit or Notification (Secs. 340.3(d)(4), 340.4(f)(9), and 
340.6(c)(5))

    About 40 percent of the comments specifically addressed the 
proposals to simplify the reporting requirements under permit and 
notification procedures in Secs. 340.3(d)(4), 340.4(f)(9), and 
340.6(c)(5). Less than half of the comments on this section supported 
the proposal. These supportive commenters recognized the intent of the 
proposed regulations to preserve reporting of all significant 
occurrences, in that the proposed regulations would still require: 
reporting of deleterious effects observed in trials under either permit 
or notification procedures; and submission of all field test reports 
for completed trials prior to, or as part of, a petition for 
determination of nonregulated status.
    A majority of those who commented on this section opposed the 
proposed simplification of reporting requirements, although a few of 
those commenters indicated that other, more limited streamlining 
measures would be appropriate. Several commenters suggested that field 
reporting requirements should be strengthened, although no evidence in 
support of such a view was provided.
    Commenters opposed to the proposed regulations and in favor of 
retaining existing reporting requirements or of implementing other, 
more limited measures, provided justification for their disapproval of 
the proposed changes to the regulations. Representative examples of 
their justification are provided as follows:

    APHIS asserts that regular reporting is unnecessary because so 
far, there have been no unmanaged disseminations of regulated 
articles. * * * there are several flaws with this justification. 
First, almost all of the environmental release permits have involved 
only a small variety of selected articles. Although there may have 
been no unfavorable incidences with these few articles, this does 
not indicate that other types of releases will be as safe. Second, 
even if the information gathered by these previous releases 
identified no harmful occurrences, this fact does not carry much 
significance because there has been little long term analysis of the 
potential environmental effects caused by such releases. Most of the 
deliberate releases have occurred within the last few years. In this 
respect, it is too early to conclude that these releases have not 
caused any unanticipated effects on nontarget organisms or the 
environment.

    A second commenter said: ``USDA has created a loophole which 
apparently allows companies to decide for themselves what constitutes 
deleterious effects. Under this arrangement, USDA and the public could 
be kept in the dark about unsafe field trials.'' A third commenter 
said: ``Reporting requirements provide an important incentive for 
companies to comply with APHIS's record-keeping requirement. In 
addition, field trial reports gives (sic) the public an important 
window on the results of field trials. Especially under a notification-
based regulatory system, the availability of field trial reports helps 
generate public confidence in the conduct of field trials.''
    In response to these comments, APHIS agrees in part with the first 
comment that it is inappropriate to base judgments on the safety of 
future introductions of specific regulated articles solely on the 
behavior of other regulated articles in previous introductions. 
However, we have never intended that reports of field trial results 
submitted to APHIS be broadly used to affirm the safety of individual 
future trials with other organisms. Each report is used in more limited 
and appropriate contexts that refer specifically to the trial itself, 
i.e., to verify that specific introduction did not result in unmanaged 
dissemination of a regulated article, and to document any unusual 
occurrences during the trial or any deleterious effects of the 
regulated article on plants, nontarget organisms, or the environment. 
The reports do support the broad conclusion that it has been possible 
to conduct field trials with a variety of plant species under a variety 
of experimental protocols without unmanaged dissemination of regulated 
articles, and the reports indicate that to date, observed unusual 
occurrences and deleterious effects have been minimal. Further, APHIS 
believes that the suggestion that the Agency should consider potential 
long term environmental effects that differ from any effects that have 
yet been observed is outside the scope of the requirements of the NEPA 
and would be an exercise in speculation. NEPA does require, however, 
that Agencies have a continuing duty to gather and evaluate new 
information relevant to the environmental impact of their actions (See 
Association Concerned About Tomorrow v. Dole, 610 F.Supp. 1101 (D.C. 
Texas 1985)).
    APHIS also disagrees with the second comment that the proposed 
simplifications of reporting requirements create a ``loophole'' for the 
reporting of deleterious effects. The proposed regulation neither 
alters in any way the legal requirement that deleterious effects be 
reported to the agency, nor alters either the classes of effects that 
are to be reported to the agency or the time schedules for reporting 
those effects. The proposed rule would only have eliminated the 
requirement for submission of field data reports for field trials 
conducted under notification procedures if those trials exhibited no 
deleterious effects, unusual occurrences, or accidental releases. Any 
events or observations of deleterious effects, unusual occurrences, or 
accidental releases would have been reported to APHIS and the reports 
would have been available for public scrutiny. If a responsible person 
had any uncertainty regarding whether a particular event or observation 
constituted a deleterious effect, unusual occurrence, or accidental 
release, it was their responsibility to contact APHIS to ascertain 
whether that event or observation required reporting under the proposed 
regulations.
    In response to the third comment, APHIS disagrees that the 
requirement to submit field data reports for trials under notification 
procedures in which no deleterious effect, unusual occurrence, or 
accidental release is observed, in fact provides any additional 
incentive to maintain complete and accurate records. However, the 
Agency agrees that the availability of field trial reports, including 
the vast majority not reporting unexpected events, may help to increase 
public confidence about the conduct of field trials. For this reason, 
we believe that there is significant benefit in maintaining reporting 
requirements for

[[Page 19914]]

all field trials under notification or permit procedures at the present 
time. The Agency will accordingly continue to require submission of 
field data reports for all field trials. The regulations at 
Sec. 340.3(d)(4)(i) are changed in response to these comments.
    Inasmuch as the proposal did not affect recordkeeping requirements, 
we believe that a continued requirement for submission of field data 
reports is not a great burden on responsible persons. APHIS received 
two identical comments that opposed the original proposal for 
streamlining reporting requirements. Both comments requested that, for 
field trials of longer than one year duration, the requirement for 
yearly submission of field data reports be eliminated and that only a 
single report be submitted within 6 months of completion of the field 
trial. APHIS believes that this is a reasonable request. In response to 
these comments, the regulations at Secs. 340.3(d)(4)(i) and 340.4(f)(9) 
are changed accordingly. Additionally, the regulations at 
Sec. 340.6(c)(5) for the submission of yearly field data reports in 
multi-year field trials in support of petitions for determination of 
nonregulated status are changed to be consistent with the previous 
sections.
    Another commenter suggested that when APHIS receives field test 
reports that demonstrate deleterious effects or other unexpected field 
observations, the agency should be required to notify the affected 
State of those observations. APHIS agrees that affected States should 
be informed when such events are observed. Such provision of 
information is in keeping with our existing coordination with States. 
APHIS currently provides such information to States on a routine basis, 
and will continue to inform affected States in the future whenever the 
Agency receives either a report of deleterious effects or directly 
notify States under Sec. 340.4(f)(10) that there has been an accidental 
or unplanned release.

Miscellaneous

    We are deleting all references to ``Biotechnology, Biologics, and 
Environmental Protection'' and replacing them with ``Animal and Plant 
Health Inspection Service'' in order to reflect an internal 
reorganization within APHIS; we are also adding a definition of 
Administrator as part of that change. The authority citation has also 
been amended to reflect number changes in Title 7 of the Code of 
Federal Regulations that address delegations of authority to the 
Assistant Secretary, Marketing and Regulatory Programs, and the 
Administrator, APHIS.
    Therefore, based on the rationale set forth in the proposed rule 
and in this document, we are adopting the provisions of the proposal as 
a final rule with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This 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 final 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.
---------------------------------------------------------------------------

    The effect of the amendments is to simplify procedures: (1) for the 
introduction of certain genetically engineered organisms by expanding 
the scope of organisms that will 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 during 
multi-year field trials.
    The expansion of the scope of organisms included under notification 
procedures will eliminate the need for a permit to conduct field tests 
for many crops that currently fall under the permitting regulations. 
This will 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 revised Sec. 340.3(b)(5). APHIS 
therefore estimates that about 99 percent of all field trials will be 
conducted under notification procedures under these 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 will 
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. 
Much of this data is data that the researcher should already have 
acquired while conducting field tests of genetically engineered crops.
    This rule is consistent with the risk-based 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 option of 
allowing applicants to submit requests to extend existing 
determinations of nonregulated status to one or more related organisms 
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?''
    In response to the comments received, APHIS has changed the 
proposed regulations to simplify field test reporting for 
notifications, permits, and petitions, and to clarify the requirement 
for State concurrence on interstate movements under notification 
procedures.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

[[Page 19915]]

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 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This final rule contains an information collection requirement that 
was not included in the proposed rule. Specifically, this final rule 
adds an additional 288 annual burden hours required for the field test 
reports submission to APHIS. In accordance with section 3507(d) of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this 
information collection requirement has been submitted for approval to 
the Office of Management and Budget (OMB). When OMB notifies us of its 
decision, we will publish a document in the Federal Register providing 
notice of the assigned OMB control number or, if approval is denied, 
providing notice of what action we plan to take.

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 amending 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 is revised to read as 
follows:

    Authority: 7 U.S.C. 150aa-150jj, 151-167, and 1622n; 31 U.S.C. 
9701; 7 CFR 2.22, 2.80, and 371.2(c).


Sec. 340.0  [Amended]

    2. In Sec. 340.0(a) introuctory text, the words ``Director, BBEP,'' 
are removed and the word ``Administrator'' added in their place.
    3. Section 340.1 is amended as follows:
    a. In the definitions of courtesy permit, inspector, permit, and 
regulated article, the words ``Director, BBEP,'' are removed and the 
word ``Administrator'' added in their place.
    b. The definition of Director, BBEP is removed, and definitions for 
Administrator and antecedent organism are added, in alphabetical order, 
to read as set forth below:


Sec. 340.1  Definitions.

* * * * *
    Administrator. The Administrator of the Animal and Plant Health 
Inspection Service (APHIS) or any other employee of APHIS to whom 
authority has been or may be delegated to act in the Administrator's 
stead.
* * * * *
    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 these regulations.
* * * * *


Secs. 340.4, 340.8, and 340.9  [Amended]

    4. In Sec. 340.4, footnotes 5 through 7 are redesignated as 
footnotes 7 through 9; in Sec. 340.8, footnote 8 is redesignated as 
footnote 12; and in Sec. 340.9, footnote 9 is redesignated as footnote 
13.
    5. Section 340.3 is amended as follows:
    a. A new footnote 5 is added at the end of the section heading and 
paragraphs (b)(1), (b)(5), (d)(4), (e)(1) and (e)(4) are revised to 
read as set forth below.
    b. In paragraph (d)(1), the words ``Biotechnology, Biologics, and 
Environmental Protection'' are removed and the words ``Plant Protection 
and Quarantine, Biotechnology and Scientific Services'' are added in 
their place.
    c. In paragraph (d)(3), introductory text, the word ``BBEP'' is 
removed and the word ``APHIS'' is added in its place.
    d. In paragraphs (d)(5), (e)(2), and (e)(3), the words ``Director, 
BBEP,'' are removed and the word ``Administrator'' is added in their 
place.


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 
release 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) Field test reports must be submitted to APHIS within 6 months 
after termination of the field test. Field test reports shall include 
the APHIS reference number, methods of observation, resulting data, and 
analysis regarding all deleterious effects on plants, nontarget 
organisms, or the environment.
* * * * *
    (e) * * *
    (1) APHIS will provide copies of all notifications to appropriate 
State regulatory official(s) for review within 5 business days of 
receipt. Comments to APHIS from appropriate State regulatory officials 
in response to notifications for interstate movement of regulated 
articles will not be required by APHIS prior to acknowledgment, 
although States may provide their reviews to APHIS at their discretion.
* * * * *
    (4) APHIS will provide acknowledgment within 30 days of receipt 
that the environmental release is appropriate under notification. Such 
acknowledgment will apply to field testing for 1 year from the date of 
introduction, and may be renewed annually by submission of an 
additional notification to APHIS.
* * * * *

[[Page 19916]]

    6. Section 340.4 is amended as follows:
    a. A new footnote 6 is added at the end of the section heading.
    b. In paragraph (a), the first complete sentence after the 
paragraph heading is revised to read as set forth below.
    c. Paragraph (f)(9) is revised to read as set forth below.
    d. The words ``Director, BBEP'' are removed and the word 
``Administrator'' is added in their place in the following places:
    i. Paragraph (f), introductory text;
    ii. Paragraph (f)(7);
    iii. Paragraph (f)(8);
    iv. Paragraph (g), each time they appear;
    v. Paragraph (h)(1).
    e. The words ``Biotechnology, Biologics, and Environmental 
Protection'' are removed and the word ``APHIS'' added in their place in 
the following places:
    i. Paragraph (b), introductory text, each time they appear.
    ii. Paragraph (c), introductory text, each time they appear.
    iii. Paragraph (c)(1), both times they appear;
    iv. Paragraph (c)(2);
    v. Paragraph (f)(10);
    vi. Paragraph (f)(11)(ii);
    vii. Paragraph (h)(2);
    viii. Paragraph (h)(3), both times they appear.
    f. In paragraph (b), in newly redesignated footnote 8, the words 
``Biotechnology, Biologics, and Environmental Protection'' are removed 
and the words ``Plant Protection and Quarantine, Biotechnology and 
Scientific Services'' added in their place.
    g. In paragraph (e), the words ``Biotechnology, Biologics, and 
Environmental Protection, of the'' are removed and the word ``APHIS of 
the'' added in their place, and the words ``Biotechnology, Biologics, 
and Environmental Protection, a permit'' are removed and the words 
``APHIS, a permit'' added in their place.


Sec. 340.4  Permits for the introduction of a regulated 
article.6

    (a) * * * Two copies of a written application for a permit to 
introduce a regulated article, which may be obtained from APHIS, shall 
be submitted by the responsible person to the Animal and Plant Health 
Inspection Service, Plant Protection and Quarantine, Biotechnology and 
Scientific Services, Biotechnology Permits, 4700 River Road, Unit 147, 
Riverdale, Maryland 20737-1237. * * *
---------------------------------------------------------------------------

    \6\ See footnote 5 in Sec. 340.3.
---------------------------------------------------------------------------

* * * * *
    (f) * * *
    (9) A person who has been issued a permit shall submit to APHIS a 
field test report within 6 months after the termination of the field 
test. A field test report shall include the APHIS reference number, 
methods of observation, resulting data, and analysis regarding all 
deleterious effects on plants, nontarget organisms, or the environment.
* * * * *
    7. Section 340.5 is amended as follows:
    a. In Sec. 340.5, a new footnote 10 is added at the end of the 
section heading to read as set forth below.
    b. The words ``Director, BBEP'' are removed and the word 
``Administrator'' added in their place in the following places:
    i. In paragraph (a), each time it appears.
    ii. In paragraph (c)(3), both times it appears.
    c. In paragraph (b), introductory text, the words ``Biotechnology, 
Biologics, and Environmental Protection'' are removed and the words 
``Biotechnology and Scientific Services, PPQ'' added in their place.
    d. In paragraph (b), under subheading ``PETITION TO AMEND 7 CFR 
340.2,'' the words ``the Director, BBEP of Biotechnology, Biologics, 
and Environmental Protection, to'' are removed and the words ``that the 
Administrator'' added in their place.
    e. In paragraph (c)(1), in the third sentence, and in paragraph 
(c)(3), the words ``Biotechnology, Biologics, and Environmental 
Protection'' are removed and the word ``APHIS'' added in their place.
    f. In paragraph (c)(1), in the first sentence, and in paragraph 
(c)(2), the words ``Director of Biotechnology, Biologics, and 
Environmental Protection'' are removed and the word ``APHIS'' added in 
their place.
    g. In paragraph (c)(3)(ii), the words ``Director, BBEP's'' are 
removed and the word ``Administrator's'' added in their place.


Sec. 340.5  Petition to amend the list of organisms.10

* * * * *
    8. Section 340.6 is amended as follows:
---------------------------------------------------------------------------

    \10\ See footnote 5 in Sec. 340.3.
---------------------------------------------------------------------------

    a. A new footnote 11 is added at the end of the section heading, a 
new paragraph (c)(5) is added, paragraph (e) is redesignated as 
paragraph (f), and a new paragraph (e) is added to read as set forth 
below.
    b. The words ``Director, BBEP,'' are removed and the word 
``Administrator'' added in their place in the following places:
    i. Paragraph (a), both times they appear;
    ii. Paragraph (b), under subheading ``PETITION FOR DETERMINATION OF 
NONREGULATED STATUS'';
    iii. Paragraphs (d)(1), (d)(2), and (d)(3).
    c. In paragraph (a), remove the words ``Director, Biotechnology, 
Biologics, and Environmental Protection (BBEP),'' and add in their 
place the word ``Administrator''.
    d. In paragraph (b), remove the words ``Biotechnology, Biologics, 
and Environmental Protection'' and add in their place the words ``Plant 
Protection and Quarantine, Biotechnology and Scientific Services''.
    e. In paragraph (c)(4), remove the word ``Director'' and add the 
word ``Administrator'' in its place.
    f. In paragraph (d)(1), remove the words ``The BBEP'' and add in 
their place the word ``APHIS''.
    g. In the undesignated paragraph following paragraph (d)(3)(ii), 
remove the word ``Director's'' and add the word ``Administrator's'' in 
its place, and remove the word ``BBEP'' and add the word ``APHIS'' in 
its place.
    h. In newly redesignated paragraph (f)(1), remove the word 
``Director's'' and add the word ``Administrator's'' in its place.
---------------------------------------------------------------------------

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


Sec. 340.6  Petition the determination of nonregulated 
status.11

* * * * *
    (c) * * *
    (5) Field test reports for all trials conducted under permit or 
notification procedures, involving the regulated article, that were 
submitted prior to submission of a petition for determination of 
nonregulated status or prior to submission of a request for extension 
of a determination of nonregulated status under paragraph (e) of this 
part. Field test reports shall include the APHIS reference number, 
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 
Administrator 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

[[Page 19917]]

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 preliminary 
decisions to extend determinations of nonregulated status 30 days 
before the decisions become final and effective. If additional 
information becomes available that APHIS believes justifies changing 
its decision, it will issue a revised decision.
    (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.
* * * * *


Sec. 340.7  [Amended]

    9. In Sec. 340.7, paragraph (b) introductory text, remove the words 
``Biotechnology, Biologics, and Environmental Protection'' and add in 
their place the word ``APHIS''.

    Done in Washington, DC, this 21st day of April 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-10648 Filed 4-22-97; 9:12 am]
BILLING CODE 3410-34-P