[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
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\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.
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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) * * *
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\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. * * *
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\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
