New USDA rule

>                                   Ed Curlett     (301) 734-3256
>                                         ecurlett@aphis.usda.gov
>                                   Jerry Redding  (202) 720-6959
>                                               jredding@usda.gov
>     WASHINGTON, April 23, 1997--The U.S. Department of Agriculture is
>amending its regulations pertaining to genetically engineered plants
>introduced under USDA's notification and petition regulatory processes.
>     "The amendment will simplify procedures for the introduction of
>genetically engineered organisms, expedite review for certain
>of nonregulated status, and adjust procedures for the reporting of field
>conducted under notification to the biology of the test organisms," said
>Payne, director for biotechnology and scientific services with the Animal
>Plant Health Inspection Service, a part of USDA's marketing and regulatory
>programs mission area.
>     Developing and commercializing new genetically engineered plant
>varieties most often involves field testing under APHIS oversight, followed
> by
>submission of a petition for determination of nonregulated status by the
>     APHIS grants nonregulated status to a new plant variety when it
>determines that the new variety has no potential to pose a plant pest risk
>is as safe to grow as any other variety of the same plant.
>     The amended regulations will allow a broader application of existing
>simplified procedures for requests for movement or field testing of
>genetically engineered plants.  They will also streamline the determination
> of
>nonregulated status for plant varieties that closely resemble other
>that have already been through the determination process.  This will enable
>APHIS, when appropriate, to extend the existing determination of
>status for new products that do not raise new risk issues.
>     For plants that are being evaluated in field tests, reporting
>requirements have been made more consistent.  For example, for trees and
>long lived plants field data reports will only need to be provided upon the
>conclusion of the trial.  However, applicants must apply to APHIS for
>renewal to ensure appropriate measures are taken when plants become
>reproductively mature.
>     APHIS will also use appropriate guidelines to provide additional
>information to developers of regulated articles and other interested
>regarding procedures, methods, scientific principles, and other factors
>could be considered for various aspects of its regulations.  The first
>guidelines will provide information to help applicants on requests for
>extension of a determination of nonregulated status.
>     Payne added that USDA has the responsibility to ensure that, in
>releasing any bioengineered plant, no plant pest risk is presented.  APHIS
>                            - more -
>                             - 2 -
>reviewers focus on the biology, propagation, and cultivation of the plant.
>The reviewers also consider the source of the engineered genes, the vector
>used to transfer them, and the stability of the insertion.
>     For further information on the regulatory changes, contact John Payne,
>director, biotechnology and scientific services, 4700 River Road, Unit 98,
>Riverdale, Md. 20737-1237; (301) 734-7602.  For technical information,
>Michael Schechtman, biotechnology and scientific services, plant protection
>and quarantine, Unit 146, Riverdale, Md. 20737-1237, (301) 734-7601.
>     Notice of this action is scheduled for publication in the April 24
>Federal Register.
>                                #
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>[Federal Register: April 24, 1997 (Volume 62, Number 79)]
>[Rules and Regulations]
>[Page 19903-19917]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
>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.
>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.
>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.
>    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.

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