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5 Analysis of APHIS Assessments
Pages 167-191

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From page 167...
... The learning process at APHIS has not come without missteps, but the agency seems to use those missteps as opportunities for further improvement. The present analysis is designed to facilitate additional improvements in the APHIS system, which will be necessary to meet future challenges of assessing potential environmental risks of a large number of diverse and novel transgenic products.
From page 168...
... Currently, APHIS policies for public involvement conform to a fairly narrow interpretation of those required by the Federal Administrative Procedures Act. It is useful to summarize involvement at two distinct levels: · First, who is involved or has input into decision making in the notification, permit, and petition processes?
From page 169...
... APHIS generally receives comments on these Federal Register notices for a limited period and is required to issue responses to all comments that express disagreement with intended action. External Input into the Decision-Making Process Table 5.1 summarizes the current range of external participation in APHIS's deliberative process for characterizing and evaluating risks assoTABLE 5.1 APHIS Involvement of Potential Participant Groups in the Process of Commercializing a Transgenic Plant or Its Products External Applicants Experts Critics Consumers Users Petition for Non regulated status Hazard identification I I N N N Risk measurement I I-N N N N Making a decisions F F F F F Risk management I-N N N N N Permit for release Hazard identification I N N N N Risk measurement I N N N N Making a decisions I I I I I Risk management I N N N N Notification Hazard identification I N N N N Risk measurement I N N N N Making a decision I N N N N Risk management I N N N N The process for involving interested or affected parties is designated as F
From page 170...
... . Note that there is essentially no opportunity for either general public comment or external scientific review on notification decisions prior to a decision being made.
From page 171...
... Because the U.S. Coordinated Framework for the Regulation of Biotechnology was developed under statutes put in place before the advent of transgenics, no public debate or congressional testimony specifically relating to the environmental risks or public confidence issues associated with transgenic plants occurred in connection with the creation of APHIS statutory authority.
From page 172...
... Effectiveness of External Input on Specific Decisions APHIS's informal procedures for consulting with outside scientific experts and the record of Federal Register notices, public comments, and APHIS responses to comments suggest that the agency's approach has been useful in some specific cases for assembling technical information needed to exercise its regulatory authority regarding permits and peti
From page 173...
... The effectiveness of the public comment period for this purpose depends on an informal network of people and organizations that monitor the Federal Register and generate or recruit comments from people having relevant expertise. The committee notes that external input through the Federal Register publications, whether from scientists or the public at large, has dwindled over the years.
From page 174...
... For the 1993 decision, the agency used informal mechanisms to solicit public input, which included several public workshops and a scientific review by a subcommittee of ABRAC to evaluate the scientific merits of the 1993 proposal for a notification system. Increased utilization of a system of external scientific review of important policy decisions could help in securing greater public confidence in the regulatory process.
From page 175...
... TECHNICAL ANALYSIS OF APHIS OVERSIGHT There is no question that the APHIS regulatory processes that have evolved to handle transgenic plants have resulted in a system that allows for thousands of field tests and dozens of deregulations of transgenic plants while at the same time allowing for scientific scrutiny of the regulated articles. Nonetheless, there are opportunities for improvement of this system.
From page 176...
... It is noted that the permitting process may become more common as it is the only route to commercialization of products from plants intentionally grown to produce pharmaceutical compounds. General Comments and Concerns Geopolitical Scale The scope of APHIS oversight is limited to whether and how transgenic plants are moved and released in the United States.
From page 177...
... Regardless of the accuracy of either of these interpretations, the extent of CBI in these documents makes public assessment of APHIS decisions extremely difficult. Finding 5.4: The extent of CBI in registrant documents sent to APHIS hampers external review and transparency of the decisionmaking process.
From page 178...
... If a transgenic plant is eligible for oversight through the notification process and the applicant complies with the performance standards, environmental impacts should be minimal (especially if the notification is for a small-scale planting; see below)
From page 179...
... Because many ecological effects are scale dependent and more likely to occur at larger spatial scales, these considerations raise concerns about acreage limitations. Finding 5.5: There is no acreage limit for transgenic plants grown under notification or permit.
From page 180...
... Thus, a transgenic plant producing a toxic compound with pesticidal or pharmaceutical properties may be regulated under APHIS notification if the plant or its seeds do not harm non-target species in the field. Toxins that harm non-targets in storage or toxins in plant parts that harm non
From page 181...
... As indicated above, it is often difficult to ascertain many details about a tested plant from the published notifications. The committee did, however, find one case where enough information was available to result in questioning the rigor with which the restrictions on the notification process are enforced.
From page 182...
... Finding 5.7: It appears that a transgenic plant with toxic properties to non-targets was grown to create a commercial product under the notification process. APHIS personnel must process the notification applications very rapidly (see Chapter 3~.
From page 183...
... Most permit applications, like all notification applications, are not listed in the Federal Register during the process of APHIS assessment unless they include an Environmental Assessment as required under the National Environmental Protection Act. From 1996 to the present, APHIS appears to have conducted environmental assessments for about 6% of the permit applications processed.
From page 184...
... This is a problematic outcome because the U.S. Coordinated Framework for the Regulation of Biotechnology indicates that all regulatory agencies should regulate transgenic plants with similar scrutiny.
From page 185...
... For example, it is important that APHIS be provided with the complete sequence of expressed transgenes in order to provide assurance that only the coding sequences of interest will be expressed in the transgenic plant. Evidence to date indicates that molecular gene transfer techniques often give complicated insertions of the transgene into the genome.
From page 186...
... For example, the document states that: Applicants must report any differences noted between transgenic and nontransgenic plants that are not directly attributed to the expected phenotype. Differences observed could include changes in leaf morphology, pollen viability, seed germination rates, changes in overwintering capabilities, insect susceptibilities, diseases resistance, yield, agronomic performance, etc.
From page 187...
... Furthermore, no single person or small groups of people is likely to have expertise in all of the areas needed to assess the risks of transgenic plants. The heavy workload of APHIS personnel was discussed earlier.
From page 188...
... APHIS's multiple Federal Register announcements and requests for external expert advice created an iterative process of analysis and deliberation. The fact that the process was controversial is, in part, a product of public involvement.
From page 189...
... Finding 5.13: The "toxicology-type" risk assessments used by petitioners are useful but not sufficient to assess the non-target risks of pesticidal crops. In addition to laboratory testing, there have been some short-term, small-scale field tests that have examined the effects of transgenic crops on invertebrate biodiversity.
From page 190...
... This system was implemented in 1993 and is the cornerstone of the APHIS regulatory process. In 1997 they expanded this notification system, which allows many transgenic plants to be planted without any environmental review.
From page 191...
... The committee has identified two interweaving factors that could increase the amount of information available for the regulation of transgenic plants. First, it has identified that the flow of information to and from external scientists during the APHIS decision-making process could be improved if external input were more actively sought by the agency and if the impediments to flow of data by "confidential business information" were reduced.


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