GM Free Cymru

Key issues in GM regulation

from the Center for Food Safety, USA

[Note: This document was written in response to attempts in the USA to loosen regulatory controls over GM crops and foods. In spite of the strong US emphasis in the piece, it is an excellent summary of the key issues which confront GM regulators -- and the public -- everywhere in the world.] Examiner~y2009m6d9-Sign-up-USDA-June-29th-deadline-to-halt-GE-drug-and- industrial-chemicals-in-food-crops?#comments

Many social welfare, health and environmental organizations are asking Americans to sign up before June 29 to halt the United States Department of Agriculture's (USDA) proposed rule which will significantly weaken the regulation of Genetically Engineered (GE) crops. This well written consumer call-to-action is largely taken from the Center for Food Safety. The USDA’s Animal and Plant Health Inspection Service (APHIS) proposed new rules governing the introduction of GE crops to implement the agency’s authority under the Plant Protection Act (“PPA”). Providing substantive comments to the Obama Administration at this juncture is crucial. The USDA released a proposed rule on the regulatory oversight of GE crops just before Bush left office. The proposed rule significantly weakens the regulation of GE crops. The rule virtually ensures that contamination of organic and conventional crops will become even more frequent and further excuses USDA from taking any action to remedy such contamination. Moreover, the rule continues to allow the dangerous practice of producing drugs and industrial chemicals in food crops and crops grown in the open environment. Finally, the proposed rule would open the door to deregulation of agricultural biotechnology by giving industry discretion to decide whether many of their new GE crops are even subject to regulation in the first place. Over four years ago, USDA started this process by promising stricter oversight of GE crops. Unfortunately, improvements considered early-on have vanished and the regulations have instead become weaker. The proposed rule now has even more gaping holes than the regulations it is replacing, and creates a few new ones as well, resulting in more public exposure to untested and unlabeled GE foods. Instead of tightening controls to protect the public and the environment from contamination and harm, what USDA has offered further endangers the public’s right to choose the foods their families eat and farmers’ right to their livelihoods.

Meaningful regulations can make the difference

1. APHIS must rely upon independent, sound scientific evidence and analysis for its decision-making APHIS must rely first and foremost on “sound science,” as required under the PPA and President Obama’s Memorandum concerning “Scientific Integrity.” [1] The Memorandum stipulates that “[s]cience and the scientific process must inform and guide decisions of my Administration,” with the “highest level of integrity in all aspects of the executive branch’s involvement with scientific and technological issues.” APHIS has frequently violated the tenants of sound science in its decision-making documents on GM crops in numerous ways: excessive reliance on applicants’ analysis and data; frequent citation of dubious, industry-sponsored white papers with little or no scientific merit or review; egregious factual errors biasing decisions in favor of the applicant; among other unscientific practices. In contrast, sound science requires APHIS to: undertake its own independent and holistic analysis of the impacts of GE crops; base its decision-making on peer-reviewed scientific literature whenever possible; critically examine applicant claims and analysis rather than uncritically accept them; and call on independent experts from outside the agency for external peer review. In addition, unduly narrow assessments – for example, not assessing impacts from pesticides used in conjunction with herbicide-tolerant GE crops – cannot be considered sound science. Sound assessments must also apply the social sciences, for instance, to analyze the economic impacts of transgenic contamination of non-GE crops.

2. APHIS must regulate all GE crops and not allow them to be self- regulated by industry Left unaltered, the proposed rules would allow industry to determine, based on a broad set of vague criteria, when APHIS regulations would apply to a new GE crop, opening the door to the unregulated cultivation of experimental GE crops. It is critical that the scope of regulation cover all GE crops. Using the process of genetic engineering as the trigger for regulatory oversight remedies this problem by giving regulatory authority to APHIS over all GE crops, and provides clarity and consistency to the regulatory process. Moreover, a National Academy of Sciences committee that reviewed APHIS’s performance of GE crop regulation explicitly stated that genetic engineering can and should be used as the “trigger” for regulation. [2]

3. APHIS should actively prevent harm to public health, the environment, and farm economies by fully implementing its noxious weed authority to address risks posed by GE crops APHIS should fully implement its PPA noxious weed authority to address the potential adverse effects of GE crops on “the interests of agriculture,” the environment, and public health. Under the Bush Administration’s proposed rules and the agency’s “current thinking” as communicated at the April 2009 public meeting, APHIS has backtracked from initial plans to make broad use of its noxious weed authority. APHIS now plans to apply the noxious weed authority in the narrowest possible terms, according to its historical view of noxious weeds. This interpretation is outdated and inadequate to regulate noxious weeds, let alone GE crops. APHIS should properly interpret and apply its robust PPA noxious weed authority to prevent or mitigate economic harms to the interests of agriculture, environmental harms, and threats to public health based on the unique issues related to GE crops. Three areas where APHIS should apply it noxious weed authority are:

A. Economic Harms from GE Crop Contamination: A primary purpose of the PPA is to protect the agricultural economy, yet APHIS has explicitly disavowed authority to regulate the economic impacts of GE crop introduction (such as market rejection) not directly related to “physical harm.” Since transgenic contamination of commercial food/ feed supplies is both a physical fact and often entails substantial economic losses in GE-sensitive agricultural markets, particularly organic and foreign markets, APHIS’s rules must address the economic harms associated with transgenic contamination of non-GE crops. APHIS cannot simply disregard these impacts as “marketing” problems. Moreover, the noxious weed authority includes “indirect” harm to agriculture as its own form of potential harm. This means that APHIS must analyze economic harms from GE crops even when not limited to, or related to, transgenic contamination, including for example harms from pesticide use and drift or the promotion of weed resistance.

B. Herbicide-Tolerant Crops, Pesticide Use and Resistant Weeds: The PPA requires APHIS to protect the environment and gives APHIS authority to prevent/mitigate “noxious weed risks.” Yet APHIS’s current proposal may narrowly apply its noxious weed authority only to GE plants that closely resemble a limited list of federally designated “noxious weeds,” a list that predates the introduction of GE plants. The most widely planted class of GE plants – herbicide-tolerant (HT) crops – are specifically designed to withstand application of one or more herbicides (one form of pesticide). HT crop systems – defined as the HT crop and use of the associated herbicide(s) – require regulation as noxious weed risks for their propensity to: 1) Foster the rapid evolution and spread of herbicide-resistant weeds, which can: (a) increase pollution of the environment with toxic herbicides, with attendant harms such as adverse impacts on farmworkers and wildlife; (b) increase soil erosion through greater use of tillage to control resistant weeds; and c) increase weed control costs for growers of all crops; 2) Lower agricultural productivity through the adverse impacts of excessive pesticide use on soil life; and 3) Reduce the availability of weed control options by undermining the efficacy of the HT crop-associated herbicide(s), among other harms.

C. Threats to Public Health: The PPA’s noxious weed authority requires APHIS to protect public health, yet APHIS explicitly disavows its responsibility to ensure the safety of GE crops. Three compelling reasons for APHIS to assume this responsibility are: 1) The lack of any mandatory FDA review of GE crops for food or feed safety; 2) The use of GE food crops as “biofactories” for production of potentially harmful experimental pharmaceutical and industrial compounds; and 3) A policy permitting the low level presence of unapproved GE traits in commercial food and feed. For these reasons, APHIS must properly interpret and apply its noxious weed authority to assess and ensure the safety of GE crops for human and animal consumption.

4. APHIS should oversee and regulate all GE crops throughout their life cycle APHIS should end its practice of unconditionally removing GE crops and their progeny from its oversight through a “determination of non- regulated status.” This deregulation decision is normally sought by companies prior to commercial use of the GE crops. In the new rules APHIS should clarify that it retains authority to monitor and regulate GE crops for issues not detected in field trials and for threats that emerge or manifest only after commercial cultivation begins. For instance, herbicide-tolerant crop systems should be monitored for their potential to foster resistant weed populations, with appropriate control measures imposed if monitoring reveals a problem. All GE crops require monitoring and control measures to mitigate transgenic contamination of crops grown for GE-sensitive markets. These recommendations comport with recommendations made by the Government Accountability Office (GAO) in a recent report. [3] To this end, APHIS should implement a two-tiered permitting process, one tier for experimental permits for field trials and a second tier for commercial permits allowing GE crops to be sold in commerce with continued APHIS jurisdiction to monitor, collect data to confirm risk assessments and detect unanticipated harms, and impose protective measures when necessary to manage GE crops systems and emerging risks.

5. APHIS should eliminate the proposed low level presence policy which ensures and sanctions GE contamination While APHIS says it advocates “co-existence” of biotech, conventional and organic agriculture, its “Low Level Presence” (LLP) policy would make co-existence impossible. The LLP policy would allow APHIS to take no recall or similar action when experimental GE crops grown in field trials are found contaminating commercial food, feed or seed. Exposure to experimental GM crops contaminating food may pose health risks, yet the LLP policy contains no protocols for assessing such potential harms. Despite its appellation, the LLP policy proposes no quantitative, maximum threshold for contamination, so “low level” essentially means unlimited contamination. The LLP policy could easily cause non-GE growers to lose markets for their goods, and organic growers could lose their organic certification. With the LLP policy, biotech companies testing new GE crops (sometimes on thousands of acres) will have little incentive to assume the expense of adequately isolating their experimental plots to prevent transgenic contamination in the first place. Further, companies may be able to use the LLP policy’s “non-actionable” (i.e no recall) status to help avoid liability for their irresponsible practices. APHIS should eliminate this unscientific policy, and instead make “zero tolerance” its management goal by mandating recalls whenever experimental GM crops contaminate the food, feed or seed supply. For coexistence to be feasible, the regulations must “establish scientifically valid and proven isolation and containment distances” as mandated in the 2008 Farm Bill (Sec. 10204(C)(1)(c)) and clarify that it is the responsibility of the developer and the grower of GE crops to establish and maintain appropriate isolation distances to minimize the potential for contamination.

6. APHIS should prohibit the outdoor cultivation of plants engineered as biofactories for experimental drug production, and all cultivation of any such food crops Biopharm crops produce experimental pharmaceuticals that in some cases may pose risks to human health in the event of inadvertent exposure, yet no risk assessment is required before they are grown out of doors. Public interest groups, the food industry, many scientists and even some in the biotech industry advocate an end to outdoor cultivation of biopharm crops, especially food crops, due to the inevitable contamination of food. The proposed rules inappropriately lump biopharm crops into the same subjective risk assessment scheme with all other GE crops. Under the PPA, APHIS has broad authority to restrict the introduction of such plants to protect public health and the economy. In its programmatic EIS, APHIS proposed (and rejected) alternatives that would either bar outdoor cultivation of ALL biopharm crops, or of all biopharm food crops. [4] Ignoring sound science, APHIS’s “current thinking” is that concerns about biopharm crops are nothing more than “marketing” or “public perception” issues. Tell APHIS that experimental drugs have no place in the food supply or environment, and to prohibit the outdoor cultivation of plants for drug production and the cultivation of ANY such food crops (indoors or outdoors).

7. APHIS must implement congressional mandates to improve GE crop oversight and management With the adoption of the 2008 Farm Bill, Congress mandated that APHIS “improve the management and oversight” of GE crop field trials (§ 10204), implement measures outlined in the agency’s “Lessons Learned” document prepared in the wake of the 2006 ‘Liberty Link’ rice contamination debacle, and adopt a series of other new measures to mitigate transgenic contamination. The proposed rules, however, fail to comply with many of the Farm Bill mandates, such as requiring representative samples of GE crops to be retained by GE crop field trial permit holders, submission of contingency and corrective action plans to address contamination episodes, and use of cutting edge science and technology to ensure effective isolation of GE crops grown in field trials from commercial supplies, among several others. APHIS must revise its proposed rules so as to comply with these Congressional mandates.