Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms; Proposed Rule
7 CFR Part 340
In early October, the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) released a proposed rule (Federal Register 73:60008-48) overhauling the agency's biotechnology regulations. The Union of Concerned Scientists is particularly concerned about proposed changes to the agency's oversight of crops that are genetically engineered to produce drugs and industrial chemicals (pharma crops). These crops are not meant to enter the food supply and could be dangerous to humans if consumed, yet they are being grown outdoors in human food staples like corn and rice.
UCS has long called on the agency to ban the outdoor production of pharma crops in crops also used for food, and pointed out the sensible alternatives that would allow employment of this technology without the risks. Yet the agency's proposal—rushed through in the waning days of the current administration—goes in the opposite direction, weakening oversight of these crops.
Below, we have provided a preliminary analysis of the APHIS proposal. UCS will submit final comments to APHIS before the November 24, 2008 deadline.
- Background
- The Proposed Rule Weakens Oversight of Pharma Crops
- The Proposed Rule Fails to Protect the Food Supply
- The Proposed Rule Fails to Take Economic Consequence Fully into Account
- Conclusion
A primary purpose of the agency's rulemaking is to align the regulations with the Plant Protection Act of 2000, which expanded APHIS's authority to control the risks of genetically engineered (GE) crops by consolidating a number of plant health laws including the Noxious Weed Act and the Federal Plant Pest Act (under which GE crops have been regulated since 1987).
In July 2007, APHIS asked for comments on a draft environmental impact statement (EIS) on various options for the regulatory overhaul. NGOs, food companies, the Grocery Manufacturers Association, and thousands of individual citizens responded by calling on the agency to adopt a ban on the outdoor use of pharma food crops.
After review, we have concluded, first, that the proposed rule weakens APHIS's already inadequate pharma crop regulations. Not only has the agency disregarded public comments calling for a ban, it has instead taken the proposed rule in the opposite direction. Second, the proposal does not adequately protect the food supply. Finally, the rule fails to take the economic consequences of the outdoor production of pharma food crops fully into account.
In response to the flawed proposed rule, UCS renews its recommendation for a ban on the outdoor production of pharma food crops.
In addition, from the beginning of its effort to overhaul biotechnology regulations, APHIS has followed an irregular process under the National Environmental Policy Act (NEPA). The draft EIS was published more than a year before the proposed rule, and because its content was more policy than scientific, it did not appear to meet NEPA requirements. Now, APHIS has proposed a new rule and requested public comment in the absence of a final EIS and without responding to comments about the adequacy of the draft statement. According to the proposal, the agency intends to publish a final EIS when it issues the final rule.
As the most significant revision of the department's regulation of GE crops in years, these proposed rules will shape the development of the agricultural biotechnology industry far into the future. Such an important proposal requires careful public review. The USDA's announced 45-day comment period is insufficient to allow UCS scientists, other outside experts, and the interested public to thoroughly evaluate the proposal and provide thoughtful, constructive comments.
If an extension is not granted and a final EIS is not issued in a timely manner, this will be the second time the department has sacrificed public participation to meet arbitrary deadlines in the development of these important rules. Last year, the USDA short-changed the public by offering only 60 days for review and comment on its lengthy draft EIS. We urge the department not to repeat the same mistake this fall. An even more abbreviated comment period and less transparent process will once again limit public participation and deprive the USDA of the thoughtful outside advice it sorely needs and purports to value.
To correct the irregular NEPA process and provide for robust public participation in the rule making process, UCS has asked APHIS to prepare and publish a final EIS on the proposed rule as soon as possible, and extend the current comment period on the proposed rule until the public has had sufficient time (at least 60 days) to consider them in light of their likely environmental impacts.
Below are arguments supporting our conclusion. Page numbers in the text refer to pages in the Federal Register notice.
THE PROPOSED RULE WEAKENS OVERSIGHT OF PHARMA CROPS
The rule, if it were finalized, would eliminate the class status of pharma crops, freeing the agency from the current requirement that all pharma crops be placed in a high-risk category accompanied by more stringent regulatory oversight than that for most other GE crops. Instead, APHIS would be able to place pharma crops in lower-risk categories and issue permits with weaker controls. Below we compare APHIS's current and proposed systems for assessing pharma crop risks and assigning regulatory controls.
Assessing risks
The proposed rule, by abandoning the current requirement to consider all pharma crops as higher risk, gives APHIS considerable discretion to place pharma crops in lower-risk categories.
Current program
Under the existing system, APHIS has no discretion in categorizing pharma crops according to risk. Rather the agency must place all pharma crops in a higher-risk category for which it requires permits before release into the environment. Each year about 10 percent of GE crop applications for field testing fall into the permit category (p 60010). Under the permitting process, the agency can require more stringent regulatory controls than it typically imposes on the other 90 percent, which fall under the notification process. APHIS set up the notification process in 1993 to expedite the review of GE-crop field trials that it categorized as lower risk.
Proposed program
In general—
The proposed rule, pp 60015-16, would establish a new permitting system requiring permits for all releases to the environment, thereby eliminating the notification process. We congratulate the agency for its decision to abandon notifications. The new system would establish four risk or permit categories, ranging, in increasing levels of risk, from A (lowest risk) to D (the highest).
APHIS explains the relationship between the proposed risk categories and the current system as follows (p 60019):
Category A will be associated with a level of regulatory oversight similar to environmental release notifications under the current system, and Categories B and C with a level of regulatory oversight similar to various permits that have been issued under the current system." … Category D was created to acknowledge the possibility that some proposed releases may pose a very high risk of introducing a highly persistent or harmful plant into the environment. To date, APHIS has never been requested to allow releases that would fall into this category. If an applicant were to propose a Category D release, APHIS would only authorize such releases after imposing extremely strict levels of oversight akin to high security quarantine far exceeding that of Category C ….
For pharma crops specifically—
The effect of the proposed rule would be to abandon the class status of pharma crops and give APHIS considerable discretion to place pharma crops in any of the four risk categories. The agency indicates how it might view the risks of pharma crops under the new system on pp 60031 and 60020, respectively:
- "We have not seen evidence suggesting that [pharma crops] present unique or uncontrollable risks, or risks higher than those that may be associated with many other uses for GE plants."
- "Based upon APHIS experience to date, many releases of GE plants producing pharmaceutical or industrial substances would fall in Category C, and would carry the same level of oversight as current permits for [plants making pharmaceutical and industrial compounds]."
The use of the word "many" in the second quote leads us to believe that APHIS intends to downgrade, in at least some instances, its current practice of placing all pharma crops in a class equivalent to category C. Given the relatively benign view of pharma crop risks expressed in the first quote, we would expect that the other categories would be the lower-risk categories A and B.
That expectation is supported by the agency's discussion on pp 60017-20 of how it would place crops into the categories. The examples given there of the types of organisms that would fall into each category suggest to us that APHIS would place some pharma crops in categories A and B, which are lower risk than the category C that the agency says would be equivalent to the pharma class designation in the current system. We would expect that only rarely, if at all, would a pharma crop be placed in category D, which is reserved for "very high risk" organisms.
In summary, under the proposed rule, APHIS would abandon its current policy that all pharma crops belong in a higher-risk category and would have considerable discretion allowing placement of pharma crops in lower-risk categories.
Assigning regulatory controls
Under the proposed rule, APHIS would eliminate the specific regulatory controls currently imposed on pharma crops. Instead, the agency would have considerable leeway to assign regulatory controls commensurate with the level of risks, meaning that pharma crops placed in lower-risk categories would have less stringent controls than currently required.
Current program
The current program overseeing pharma crops is described in "Draft guidance for APHIS permits for field testing or movement of organisms with pharmaceutical or industrial intent," released in spring 2006. That document details:
- the permitting process for pharma crops;
- the information requirements for submitting an application for a pharma crop permit;
- the permit conditions to be imposed on the pharma crop permit holder; and
- APHIS's obligations for inspecting pharma crop field sites.
Specifically, permit conditions refer to practices and procedures that a permit holder must follow, including field test confinement practices, such as spatial separation from other crops, cleaning machinery, post-harvest land use, site security, personnel management, record keeping, and reporting requirements. For example, APHIS currently requires a pharma crop permit holder to submit five separate reports or notices: a pre-planting notice, a planting report, a pre-harvest notice, a field test report, and a volunteer-monitoring report.
Under the existing program, APHIS inspects pharma crop field tests more often than other permitted field tests or tests subject to notification. The Draft Guidance (p 30) states: "a field test may have five inspections during the growing season and two additional inspections postharvest; however APHIS may inspect more frequently in some cases." By contrast, other permitted field tests may be inspected only once a year and tests conducted under notification may not be inspected at all.
Proposed program
By abandoning the class status of pharma crops, the proposed rule would eliminate the specific regulatory controls that are attached to pharma crop permits under the current program as described above. Instead, pharma crops would be subject to the new permitting process where regulatory controls would be set at APHIS's discretion according to risk category. Moreover, the proposed rule, for the most part, would set only minimal basic regulatory requirements for the risk categories and would allow APHIS considerable leeway in determining the stringency of oversight, including information requirements, permit conditions, and frequency of inspections.
Even for pharma crops that might be placed in the higher-risk category C, the proposed rule would not require the same stringency in permit conditions imposed by the current class-based program. (APHIS could use its discretion to impose additional requirements to bring the oversight to today's level.)
In effect, under the proposed rule, APHIS could significantly reduce the stringency of regulatory controls imposed on pharma crops compared with current practices.
THE PROPOSED RULE FAILS TO PROTECT THE FOOD SUPPLY
APHIS turned down opportunities afforded by the expanded authority of the Plant Protection Act (PPA) of 2000, specifically the provisions related to noxious weeds, to strengthen oversight of the food safety risks of pharma and other GE crops.
Under the PPA, APHIS has the authority to evaluate "whether a particular GE plant may be a noxious weed because it poses a public health risk when growing in the environment" (p 60014). However, the agency failed to take advantage of the expanded authority despite acknowledging that noxious weeds could potentially threaten public health if they entered the food supply and despite its assertion that the agency "plays an important supporting role in safeguarding the food supply by protecting the health of plants and animals at the farm level" (p 60014).
Instead the agency offers what appears to be a narrow interpretation of its responsibility for protecting the food supply from noxious weeds by noting that "the noxious weed definition should not be interpreted so broadly as to provide APHIS with the legal responsibility or authority to … prevent GE crops from entering the food supply" (p 60029).
We are left only with vague indications of how APHIS will safeguard the food supply within this narrow interpretation. In terms of risk assessment, the agency merely states, without explanation, that it "would consider available information about toxicity and other food safety information in assessing noxious weed risk posed by the plants growing in the environment" (p 60014) and "it is also likely that existing [Food and Drug Administration (FDA)] food safety evaluations will prove to be useful and relevant to APHIS evaluations…." (p 60029).
In assigning regulatory controls, APHIS says, again without explanation, that food safety concerns would be one of several factors taken into account when considering permit conditions or exemptions from permit requirements (p 60029).
Finally, the agency promises to "contact" the Food and Drug Administration if it is "concerned" about food safety risks of a GE crop (p 60029) but offers no explanation of what would trigger "concern" nor does it propose any interagency process for dealing with these concerns.
THE PROPOSED RULE FAILS TO TAKE ECONOMIC CONSEQUENCES FULLY INTO ACCOUNT
The PPA gives APHIS the authority to consider the economic consequences of harm caused by a noxious weed (pp 60012-60014). However, the proposed rule too narrowly defines the scope of economic harm because it would not "consider significant economic effects alone that are not linked to physical damage to be sufficient to determine a plant is a noxious weed" (p 60014).
In other words, the agency would not consider the economic losses incurred by the food industry, grain elevators, and others if a pharma crop contaminated the food supply but did not cause physical harm. APHIS writes: "the economic loss is never simply the result of marker preference to have commodities free of certain noxious weed seeds in and of itself, in the absence of any potential physical damage or harm" (p 60014).
APHIS should expand the definition of economic harm to include the adverse effects of contamination by unapproved GE traits on customers and markets.
CONCLUSION
UCS urges APHIS to correct its irregular NEPA process by publishing an EIS on the proposed rule before issuing the final rule and to extend the comment period on the proposed rule for 60 days beyond the release of the EIS.
UCS calls on APHIS to reconsider its weakening of pharma crop oversight. The agency should instead adopt a ban on all outdoor production of all pharma food crops.
