Comments of Consumers Union on Docket No. 03-031-1: Field Testing of Plants Engineered to Produce Pharmaceutical and Industrial Compounds
Overview
Consumers Union* welcomes the opportunity to comment on the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) proposed rules on ways to improve the requirements (called permits) for field testing of plants that have been genetically engineered to produce drugs by increasing permit confinement measures, procedures to verify compliance with these new measures, and ways to enhance the transparency of the permitting system.
We support USDA’s ultimate goal of insuring that plants, or the engineered traits they contain, from such field tests do not get into human food or animal feed. We also commend APHIS for requiring permits for field tests of plants genetically engineered to produce industrial compounds. Previously, field tests involving plants engineered to produce industrial compounds could be conducted under the far weaker notification system. The APHIS proposed rule is a significant strengthening in this regard. However even with the proposed strengthening, we do not believe that the proposed rule will achieve USDA’s important goal. In fact, for the reasons we outline, we think that if industry follows the strengthened permit systems for field testing as laid out in this proposed rule, but takes no other measures, significant contamination of the food supply is inevitable.
We believe USDA should indicate that drugs and industrial compounds should not be genetically engineered into food crops. Rather, to achieve the potential benefits of using this technology USDA should guide companies to investigate engineering of such substances into non-food crops, if they can be grown indoors under controlled conditions.
APHIS should learn from the two Prodi-Gene problems in Nebraska and Iowa discovered in 2002. The permit conditions for those field tests were such that they were supposed to ensure no violations. Yet, in the Nebraska case, soybeans, which may have been contaminated with pharmaceutical corn, had made it all the way to a grain silo, necessitating the quarantining of some 500,000 bushels of soybeans. APHIS must make the conditions stringent to ensure that such a problem never happens again.
In sum, we think that the confinement measures laid out in the Guidance, and listed above, will not guarantee that the goal of zero tolerance-a proper goal in our view-will be reached. A zero tolerance is needed because acceptable risk levels simply cannot be established based on current scientific knowledge. We believe that the only way to achieve the goal of zero tolerance is to ban the use of food crop species as a source plant material for pharmaceutical production. This means that food crop plants should not be permitted to be engineered for pharmaceutical production, regardless of whether they are grown outdoors or indoors. Even if the crops were grown indoors, there is the strong possibility of a mistake which could mix up the seeds of food crop engineered with pharmaceuticals with seeds of the same food crop destined for human consumption, or a natural disaster, which would disseminate pollen.
However, we also recognize that there may be advantages to producing pharmaceuticals in plants. We therefore believe that companies should explore the use of non-food and non-feed plants in controlled conditions indoors-such as in greenhouses or phytotrons.
Detailed Comments
II. Changes in the Permit Conditions for 2003
In general, we commend APHIS for the changes it proposes in the permit conditions for field tests for all plants engineered to produce pharmaceutical and/or industrial compounds. These changes-to increase the size of the perimeter fallow zone (where no non food or feed plants are allowed); to restrict the production of food and feed crops at the field test site and perimeter fallow zone in following year; to require the use of planter, harvesters, and storage facilities for such equipment to be dedicated for that purpose for the duration of the field tests; to require stricter cleaning procedures for the equipment and seed collected from the field test sites; and to require an approved training program for all personnel to ensure that they can implement and comply with all the required permit conditions-are stricter than those in the present permits. We believe they will reduce the likelihood that the food supply will be contaminated
While the proposed changes for the permit conditions do represent a strengthening, there is, however, a significant loophole in the proposed rule: the proposed restriction will not be considered mandatory for all field tests involving plants engineered to produce pharmaceutical and/or industrial compounds. Instead, APHIS is proposing to allow exemptions from these requirements: “For all of the conditions described below, APHIS will consider variances proposed by applicants if they are appropriate for the specific case.” We urge APHIS to delete this statement. Allowing variances for any or all of the conditions that APHIS is proposing strengthening, without specifying the specific conditions under which any such variances may be granted or indeed, nor even mentioning any circumstance that may lead to such a variance, does not engender confidence in the agency’s proposed actions. Indeed, the complete lack of any discussion of the conditions for such variances-which are mentioned in a single sentence-may lead a cynical person to wonder if variances may be granted for all of the proposed field tests.
In earlier discussion with representatives of consumer and environmental groups, the head of BRS (Biotechnology Regulatory Service)/APHIS, clearly stated that there would be a prohibition on the planting of food and feed crops at the field test site and the perimeter fallow zone in the year after a field test and briefed us on the other things that would be “required” in the new strengthening of the permits. On the surface, this meeting lead to the impression among NGO attendees that APHIS was beginning to seriously consider the problems with the field test permit system. With the issuing of this proposed rule, we now see that there is no such prohibition; rather APHIS simply says that they will not allow planting of food and/or feed crops unless the company has a variance from APHIS. Furthermore, the specific language on the variances says that APHIS will consider them “For all of the conditions described below.” Just a few sentences later, the document states that “APHIS currently prohibits the use of the field test site and its perimeter fallow zone to be used to produce food or feed crops during the tests.” Thus, a literal reading of APHIS’ variance proposal says that, under some unspecified condition, APHIS could allow food or feed crops to be grown on a perimeter fallow zone during a field test. Consequently, CU believes that if the agency is to have any credibility with the public and with NGOs, they should delete the sentence on variances and make all their suggested changes mandatory, with no exceptions allowed.
II. 1.B.
In light of the ProdiGene cases, we also have a concern about possible contamination of the food supply via the inadvertent harvesting of volunteer plants. We therefore believe that APHIS should prohibit the planting of food and field crops at the field test site and perimeter fallow zone in the following season where the potential for such inadvertent harvesting could occur. APHIS’ proposed rule would simply “restrict” the planting of food and feed crops in the following season. By not out-right prohibiting the planting of food and feed crops at a field test site in the following season, but simply “restricting” such planting, APHIS leaves the door open to human error and other problems that could lead to contamination. APHIS needs to set a clear and high bar-no planting of food or feed crops in a field test site or perimeter fallow zone in the following season where there is a potential for volunteer plants to be inadvertently harvested with the following crop-and not permit any exceptions.
II. 2. Changes to field test permit conditions for pharmaceutical corn.
The proposed changes in the field test permits for pharmaceutical corn-requiring that no corn be grown within one mile or one-half mile of the field test site, for open-pollinated corn and controlled pollination corn, respectively, for the duration of the field test; and disallowing use of border rows/buffer strips to decrease these isolation distances-are a significant improvement over present permit conditions. However, we do not believe that these new restrictions can guarantee achieving a zero tolerance of drugs and industrial compounds in food or feed. Even a one mile buffer zone of no corn does not mean there is a zero percent chance that there could be pollen flow. This distance is useless against major acts of nature such as tornadoes or huge wind gusts, which could carry pollen such long distances. In at least one incident, a tornado destroyed a plot of tobacco containing transgenic proteins in Kentucky in the mid-1990s. This Kentucky case, which involved the transgenic tobacco mosaic virus (TMV), could have resulted in the spread of the virus. Birds or insects could also carry pollen for a mile.
IV. Information to the Public-Transparency
We strongly agree with APHIS that “Transparency of the regulatory system and information about its effectiveness are essential ingredients for informed dialogue with the public,” and commend the agency for believing “that effective communication and dialogue with interested parties and the public are necessary to enable continued refinement of its [APHIS’] regulatory system and help instill confidence in the safety of field testing.” In addition, we commend the agency for putting information on its website about the field tests that have been authorized and are also pending authorization. However, there are a number of steps that the agency could make to improve transparency and improve the utility of the information put up on the website.
One significant step APHIS could take would be to make each individual permit more restrictive. At present, a company can get a single permit number that covers a number of genes, phenotypes and test locations. For example, a search of the APHIS field test database for all field tests of Pioneer that were done under the permit system reveals a fair number of permits. The most recent permit listed in Permit # 03-022-03R, issued on April 15, 2003 to Pioneer for genetically engineered soybeans. This one permit covers 42 different genes comprised of 10 phenotype categories, with field test occurring in 13 states plus Puerto Rico. Such a permit is so broad that it provides little in the way of useful public information. Looking at this, one has no idea how many field tests, involving which combinations of traits and phenotypes are occurring.
At the least, a separate permit should be required for each particular combination of genetic trait and particular crop variety. Since each transformation event is unique, ideally APHIS should require a different permit for each separate transformation event. We note that the Food and Drug Administration (FDA), in their proposal to require a premarket biotechnology notification for each genetically engineered food, proposes requiring a notice for foods from each separate transformational event: “[B]ecause some rDNA-induced unintended changes are specific to a transformational event (e.g. those resulting from insertional mutagenesis), FDA believes that it needs to be provided with information about foods from all separate transformational events, even when the agency has been provided with information about foods from rDNA-modified plants with the same intended trait and has had no questions about such foods” (FR 66(12), pg. 4711). This is a scientifically sound approach to the issue. Given that different transformational events can effect food safety, we believe that they could also effect ecological traits or other characteristics of plants engineered to produce drugs or industrial compounds. Thus, APHIS should take the same position as FDA and require separate notice for each transformation event and assign a unique permit number to each separate transformation event. This unique permit number would allow the specific transformation event to be field tested in a number of locations.
A second way to improve transparency of information on the website and in the database would be to either require a new permit number for each year of a field test or to put information in the database that would let one know if a given transformational event was been tested in more than one year. As it stands now, it appears that a single permit could be good for a number of years. Somehow this information should be inputted into the database so that the public could determine how many transformation events were being field tested each year.
A third way to improve the database would be to include more information about the phenotypes within the phenotype category other (OO). At present, there is one phenotype category-other (OO)-that is overly broad. More information should be given about the traits in this phenotype category. In the example given above-a permit # 03-022-03R-one of the descriptions of the OO category is “novel protein.” It is unclear what this means. If the novel protein is to be used as an industrial compound or as a research chemical, then that should be stated-call it “research compound” or “industrial compound” or “pharmaceutical protein.” The category “novel protein” is too broad and too vague. Also, it is unclear whether all “novel proteins” would be required to be tested under the permit system. In addition, in one case, an industrial compound, laccase, was tested in as a “novel protein;” in another case, a pharmaceutical compound, aprotinin, was initially tested as a “novel protein.” In sum, USDA/APHIS shouildabolish the phenotype of “novel protein” and be more specific about the specific phenotype.
*Consumers Union is a nonprofit membership organization chartered in 1936 under the laws of the State of New York to provide consumers with information, education and counsel about goods, services, health, and personal finances; and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers. Consumers Union’s income is derived solely from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees. In addition to reports on Consumers Union’s own product testing, Consumer Reports, with approximately 4.5 million paid circulation, regularly carries articles on health, product safety, marketplace economics and legislative, judicial and regulatory actions which affect consumer welfare. Consumers Union’s publications carry no advertising and receive no commercial support.
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*Consumers Union is a nonprofit membership organization chartered in 1936 under the laws of the State of New York to provide consumers with information, education and counsel about goods, services, health, and personal finances; and to initiate and cooperate with individual and group efforts to maintain and enhance the quality of life for consumers. Consumers Union’s income is derived solely from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees. In addition to reports on Consumers Union’s own product testing, Consumer Reports, with approximately 4.5 million paid circulation, regularly carries articles on health, product safety, marketplace economics and legislative, judicial and regulatory actions which affect consumer welfare. Consumers Union’s publications carry no advertising and receive no commercial support.