COMMENT from Debbie Ruben: You might want to let your readers know the number of this docket in case they want to comment before end of day Tuesday, March 17. It looks like the docket will close then until after the April meeting when it will be reopened.

Docket ID APHIS-2008-0023 
Docket Title Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms 

I wanted to send you this comment by David Gould. It is one of the best I have ever read -- and how can anyone deny his points? 

http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023 <http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0023>

Comment 

Dear Secretary Vilsack and staff of USDA and APHIS,

We hereby offer our comments on Docket ID APHIS-2008-0023, entitled "Importation, Interstate Movement, and Release into the Environment of Certain Genetically Engineered Organisms."

Our company has experience in the analysis, detection, risk assessment, and supply chain management of genetically engineered organisms since their release into the environment first occurred in 1996. We have worked with producers, handlers, manufacturers, marketers, researchers, and governmental and non-governmental regulatory agents over the course of that time and continue to do so as a core competency of our daily work.

We find that the proposed rules in the docket fall well short of USDA's and APHIS' fulfillment of their responsibility to safeguard the public welfare of the citizens of the United States as mandated in the US Code that details the creation and responsibilities of these agencies. In fact, the proposed rules actually further weaken the government's oversight, acknowledge and allow for cross-contamination of traditional varieties by genetically engineered varieties, and create loopholes for companies who trespass to continue operations essentially unchecked, uncorrected, and not accountable for economic consequences.

It is incumbent upon your agencies to change the approach being taken with respect to these novel organisms. Contamination events have cost farmers billions of dollars in lost profits, yet the proposed rules fail to adopt the corrective measures recommended by an Inspector General Audit (2005) and mandated by Congress in the 2008 Farm Bill to improve the oversight, administration and management of genetically engineered crops that could significantly minimize contamination and the resulting economic harm.

The deregulation process that has been the subject of significant critique in the federal courts for its failure to adequately assess environmental and inter-related economic impacts is not addressed in the proposed rules. Witness the injunction handed down by the US Courts with regard to genetically engineered alfalfa, a precedent decision that was sustained upon appeal. Despite precedent, existing statutory authority under the Plant Protection Act, and the recommendations contained in a recent November 2008 GAO Study conducted at the request of Senators Harkin and Chambliss, the proposed rules also fail to account for the economic impact that deregulation of new genetically engineered crops will have on farmers' livelihoods and the economic health of rural communities.

The assumptions made by APHIS and USDA and the practices used to date, as expressed in the docket and evidenced thus far in the world, reflect a profound lack of understanding and appreciation of the impacts - already experienced and potential - of genetically engineered organisms on the environment, human health, and the economic well being of producers.

We respectfully elaborate here on some key faults we see within the docket, which we believe USDA and APHIS need to take into consideration when considering the topic of genetically engineered organisms and their release and movement in the environment. Our recounting below of examples in the docket is not exhaustive, but hopefully adequately illustrative of our points. We group our analysis of the document under the following general positions:
     
1. The technology involved in the creation of genetically engineered organisms is inexact and leaves much in question regarding their safety and functionality.

On page 60012 of the Docket as published in the Federal Register, you state:

"Unknown risks might lead to a determination by the Administrator that a GE organism should be subjected to regulatory oversight if APHIS lacks familiarity with the non-transformed recipient organism or the introduced trait."

Why, if your offices' mandate is to first and foremost protect and serve the public welfare - and not the interests of commercial entities who manufacture and sell these novel organisms - would an unknown risk not be subject to regulatory oversight? What if the risk was large and significant? How could USDA or APHIS justify such an abdication of its primary responsibility?

The next paragraph on page 60012 is an example of the agencies' misguided policy with regard to regulating genetically engineered organisms:

"The proposed scope makes it clear that the mere act of genetic engineering does not trigger regulatory oversight or mean that a GE organism will pose risks as a plant pest or noxious weed. Instead, it clarifies that APHIS would subject a GE organism to regulatory oversight based upon known plant pest and noxious weed risks of the parent organisms, or based upon the traits of the GE organism, or based upon the possibility of unknown risks as a plant pest or noxious weed when insufficient information is available."

We disagree with the approach from a fundamental standpoint. The inexact nature of genetic engineering technology does not guarantee safety or freedom from risk (or even a minimization of risk). There are already well-documented cases of genetically engineered organisms creating noxious weeds, such as glyphosate resistant wild mustards, which obtained the trait from outcrossing of engineered canola. Furthermore, there is clear evidence that the engineering of herbicide resistant varieties results in far more widespread use of herbicides on those crops, which, through basic mechanisms of survival and evolution, causes certain weed species evolve to resist these herbicides. This makes a need for stronger, more toxic herbicides, causing greater ecological damage and greater threats to human safety. That this phenomenon occurs is easy to understand according to basic principles of biology, one of which is that species do everything they can to ensure their survival; in that sense, it is
not surprising that some specimens of any given species might somehow end up surviving continuous exposure to large quantities of herbicides. In summary, the appearance of plant pests as a result of genetic engineering have been shown to happen not only as a direct effect of the engineering, but as an indirect effect of the increased use of herbicides on the genetically engineered crop lands. We emphasize that these effects all happened after (sometimes years after) the novel organisms were approved for release into the environment.

Later on page 60012 you state:

"Specifically excluded from the proposed regulatory scope are GE microorganisms that are regulated as biological control organisms by the EPA under provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). APHIS concludes that there is no need for such GE organisms to be evaluated by both agencies. EPA is already evaluating the environmental safety of such organisms with respect to their impact on the entire environment, including plants. We also propose to retain an exclusion from the current regulations for GE microorganisms where the recipient microorganism is not a plant pest and which have resulted from the addition of genetic material from a donor organism where the material is well characterized and contains only non-coding regulatory regions."

This proposal and reasoning is not scientifically sound. Insertion of genetic material into recipient DNA may have unintended effects even if the donor DNA consists of non-coding regulatory regions. The fact that they are regulatory regions means they could potentially regulate regions of recipient DNA in unintended ways, i.e. recipient DNA-binding proteins could bind to donor regulatory regions. In fact, there are several well-documented examples where unintended effects of the insertion cause problems relevant to safety and/or other negative consequences. This principle applies to all species, not just to microorganisms.

Regarding your categorization of risk, we strongly believe that overall the approach being taken is imprudent. From the comments we are submitting here, we hope it becomes a clear position of your agencies that all genetically engineered organisms carry risk until proven otherwise, and this has not actually occurred for any crop developed thus far.

On page 60018 of the docket you state, when categorizing the potential risk of an engineered trait:

"Low: Any new proteins or substances produced are unlikely to be toxic or otherwise cause serious harm to humans, vertebrate animals, or invertebrate organisms upon consumption of or contact with the plant or plant parts;"

Without extensive, substantive investigation and peer review, it is unlikely that any determination as stated above could be rationally made. There is simply not enough known to adequately assess such risks. New studies are published all the time - and have been published for over a decade - showing how supposedly innocuous genetically engineered organisms actually have significant deleterious effects on soil, plants, invertebrates, animals, and humans.

In a similar vein, you state on page 60030:

"Some commenters against process-based approach stated that this approach is illogical, on the one hand, to regulate a plant species with no known risks only because GE techniques were used to modify it, whereas on the other hand the same plant species modified by other techniques faces no additional regulatory requirements from APHIS. Those supporting a product-based regulatory approach stated that it would be aligned with the preponderance of scientific opinion on the issue, that the characteristics of the organism should take precedence over the technique of genetic modification in the APHIS assessment of the organism. APHIS agrees that any evaluation of risk should be based on the biology of the product."

This is not a valid argument, as genetic engineering does not allow controlled insertion of the transgene(s). Each plant grown from a gene insertion is unique because where the transgene ends up integrating itself into the host DNA is uncontrolled and cannot be reproduced. For this reason, the possible consequences to the plant's DNA are different with each insertion. Such effects are not seen using traditional plant breeding therefore the suggestion that assessment of each individual GE organism would better protect the environment and human health vs. a trait-based approach is a valid and logical argument.

Later on page 60030 you state:

"APHIS agrees that any evaluation of risk should be based on the biology of the product."

We agree. But the problem is that the "biology" of the product is not known. Please see our comments below related to selected sections of the proposed rule (on section 340.2(c)).

On page 60031 you state (and similarly do so in other places in the docket):

"A permit for an environmental release would not be approved if APHIS concluded there was a likelihood of such events causing any of the types of harm as described in the noxious weed definition."

Basing a decision on "likelihood" as opposed to actual "possibility" is to de facto acknowledge that certain escapes of potentially harmful genetically engineered organisms will be expected and tolerated. This is an unacceptable approach to take when regulating potentially damaging introductions to the environment and food stream, and is certainly not with the public welfare as a priority.

With respect to the proposed rule itself we note the following clauses have inadequate thought behind them:

"340.2 (c)(1) (iii) (D) The anticipated phenotype of the GE organism"

and

"340.2 (c) (3) (i) A description of how the phenotype of the GE organism differs from the phenotype of the recipient organism, particularly with respect to potential interactions with and its likelihood of persistence in the environment."

and

"340.6 (b) (iii) Detailed description of the phenotype of the GE organism, including known and potential differences from the recipient organism that could change the likelihood that the GE organism is unlikely to be a plant pest or noxious weed."

To think that the petitioner (or any other party for that matter) will be able to adequately anticipate the phenotype of the organism is to incompletely understand the nature of the technology and genomic structures. Not only is the inserted trait of concern. Perhaps of even greater concern is the unknown effect the insertion will have on the organism - turning on or off other genes in ways that are not yet possible to understand.

Another fundamental concept of biology that is not reflected in the proposed rules and the rationale behind them is that of homeostasis, i.e., that an organism, when disrupted, makes an attempt to re-achieve equilibrium. This is a characteristic of all living things (perhaps so that they can thus survive long enough to reproduce). Given humans' understanding of genetic interactions, the approach taken in the proposed rule is akin to having a jigsaw puzzle of 50000 pieces, putting a few hundred on the table, and thinking you know what the whole picture looks like. Even if we knew every gene in the organism, knowing how they interact with each other is a quantum level of even greater complexity and yet even less known.

Section 340.2 (d)(2)(iii) addresses: "Whether the gene function is known and based upon empirical observation of the added trait in the same species."

Again, it is not just the target gene that is being inserted, it is the disruption of the genome by its insertion and the unknown effects that may have. Sometimes it takes several crop years for the problems to become obvious; in other cases, bad effects have become known more quickly. The petitioner, pressured by their own desire for approval, cannot and will not wait for such evidence to be borne out. It is incumbent upon the government to exercise the necessary precaution and oversight.

2. Contamination occurs. Coexistence is not really possible without far stricter controls.

The goal of coexistence should be to preserve the survival and purity of non-genetically engineered varieties. These varieties are our evolutionary heritage and the basis of our food supply, and must not be sacrificed or replaced by novel varieties that have not withstood the test of time (not even close!). The weakness of regulations and oversight to date is evidenced by the widespread contamination of seed stocks with both approved and unapproved varieties of genetically engineered organisms. Without stricter controls in place, the level of contamination is likely to increase. Part of the answer to the problem is to have stricter isolation requirements and separation distances between genetically engineered varieties and non-engineered varieties ˆ as trials and as field crops. Furthermore, harvest, post-harvest, and related handling and transport practices should be monitored by the entities using the genetically engineered organisms, and these practices should be overseen by
diligent government surveillance.

In the proposed rules, section 340.3(c)(5) requires that

"The field trial must be conducted such that (i) The regulated article will not persist in the environment, and (ii) No offspring can be produced that could persist in the environment.'' The responsible person might meet this standard in a field trial by isolating the regulated GE plants at a sufficient distance to preclude gene flow from the GE plant to sexually compatible plants in the vicinity."

What has APHIS determined to be a "sufficient distance" and how, in the face of the evidence of GMO drift, was it determined? This determination cannot be left up to the "responsible person." APHIS and USDA must make the determination, based on sound evidence accumulated to date, scientific peer review, and ongoing monitoring with corrections made as needed to safeguard the objective. We suggest that in order to truly serve the idea of coexistence and to prevent unnecessary escape of genes, that the minimum separation distance should be greater than the greatest known travel of pollen.

On page 60015, regarding Regulation of Whole Organisms, Parts, and Nonliving Products, you state:

"APHIS does not consider most GE organisms or parts of GE organisms which cannot reproduce to present a risk as plant pests or noxious weeds."

We wish to have APHIS reaffirm that pollen from a genetically engineered plant would pose a risk.

On page 60020 of the docket, you state:

"APHIS considered whether to continue to issue environmental release permits for GE plants engineered to produce pharmaceutical and industrial compounds if the GE plant species is the same as, or sexually compatible with, a species commonly used for food or feed. APHIS concludes that the proposed permitting procedure and the use of stringent permit conditions can continue to effectively minimize the risks that may be associated with the environmental release of such GE plants. APHIS will continue to impose permit conditions that take into account the issues related to the safety of proteins or other substances that these plants have been engineered to produce."

We disagree with APHIS' assessment that oversight has been stringent enough.  History has shown that food and feed can be contaminated with unauthorized or uncommercialized GM varieties of the same crop. Placement of plants engineered to produce pharmaceutical and industrial compounds into Category C does not fully appreciate the catastrophe that would occur should the food supply be contaminated with such engineered plants. There should be a ban on environmental release of GE plants intended to produce compounds for pharmaceutical or industrial use.

Later on page 60020 of the docket, one of the aspects the petitioner is supposed to supply to the government is stated thusly:

"This information would also address the capability of the organism to persist or spread in the environment, or include details about how the engineered traits might be harmful."

It is unrealistic to expect that the petitioner will, without monitored and controlled experimentation, and the support substantial peer review acceptance and extensive, be able to make such an assessment, either in terms of safety or environmental persistence. For USDA and APHIS to expect this reflects an approach that is too simplistic and destined for problems.

Furthermore, on page 60025 of the docket, you state:

"We are proposing to amend the current regulations to explicitly incorporate APHIS' low level presence policy."

We object to the idea that low level presence should be tolerated and go unchecked. Any escape needs to be met with serious corrective actions on the part of the transgressor, and these measures need to be reported to and followed up by APHIS and/or USDA to ensure that they are not repeated.

The proposed rules, section 340.2 (d)(5), on page 60042 of the docket, states:

"(5) Site inspection. Prior to and after permit issuance, an inspector may inspect the sites or the means of conveyance associated with the proposed importation, interstate movement, or release into the environment."

We believe that inspections must be carried out by APHIS of all such operations. When put into the context of other programs administered by the USDA, it seems strange to us that APHIS and USDA would not impose such diligence. For example, for operators in the National Organic Program, inspections are mandatory. There are regulatory structures and certification and related frameworks that the government can employ to enforce its regulations without breaking its budget.

3. Petitioners seeking approval from APHIS or USDA cannot be relied upon as the sole source of information for making a responsible decision regarding the allowance to develop, release, or movement of genetically engineered organisms.

On page 60012, you state:

"Because the Administrator may make such a determination at any time the Administrator receives information that a GE organism is within the scope, APHIS expects that developers will seek early consultation with APHIS on whether the
regulatory scope covers their GE organism. Since it is generally necessary for research or business plans to include, as early as possible, elements addressing regulatory processing, approval, and compliance, it will be in the interest of the developers to determine the regulatory status of their GE organism prior to contemplating its movement or environmental release."

We respectfully caution APHIS and USDA not to assume such foresight or consideration on the part of petitioners. Their intent is (perhaps understandably) biased toward their desire to have their products approved and released. The US government's record of oversight of genetically engineered organisms to date is not good and must be improved by a change of attitude and policy about the need for precaution. Several "accidental" releases of unapproved varieties have occurred, causing problems in the market and posing public safety threats. Examples are unapproved Liberty Link rice and Prodigene soybeans.

Later on page 60012 you state:

"We welcome suggestions from the public on the most appropriate ways to provide administrative guidance to the public on the issue of which GE organisms are within the scope of the regulations. The Agency is especially interested in ways which will balance transparency with the efficient use of Agency resources in conducting consultations and communicating information to the public regarding which GE organisms are within the scope of the regulations."

We repeat that all genetically engineered organisms should fall within the scope of regulatory oversight, be it as part of an APHIS concern regarding noxious weeds or plant pests or another issue of environmental impact or food or feed safety. We appreciate the practicality of APHIS' need to use its resources wisely, but this should not influence the transparency of the regulatory process. The obvious solution is to put more of the burden of proof of safety and minimization of risk on the developer of the novel organism, with very strict controls by the government to assure that appropriate technical peer reviews have been done. APHIS and USDA should draw up guidelines for such review so that developers and the public at large will better understand what is involved with a diligent and transparent review process.

Our conclusions and recommendations:

As a way forward, we believe the proposed rules as expressed in the docket must be fully withdrawn and a more responsible regulatory framework drafted, one which heeds the recommendations and warnings of relevant, peer-reviewed environmental impact studies and health-related investigations regarding the safety of genetically engineered organisms. Until such a revised program is established, we advocate for a complete freeze on the approval and release of any new genetically engineered organism.

We recommend the following be included in the new approach:

1. Ensure that objective scientific peer review occurs under the relevant US agency before its approval of an entity's placing on the market any new genetically engineered organism. For such products already in the market, check that the approval processes for them included environmental, economic, and social impact studies that adequately addressed public comments and heeded the US Code's mandate to prioritize the welfare of the general public over the interests of private entities. Mandate remediation as necessary. We also note that in January of 2004, the USDA initiated an Environmental Impact Statement (EIS) scoping process to a new regulatory framework for agricultural biotechnology to cure serious deficiencies in the existing regulatory programs and to meet the new challenges of novel biotechnologies that the current system was not designed to address. We request that final EIS be published immediately in any case and, failing your complete withdrawal of the proposed rules in
the Docket APHIS-2008-0023, that the comment period be further extended to afford adequate consideration of the EIS' contents and its impact on the proposed rules.

2. Require that all test sites for new genetically engineered organisms be subject to strict control criteria. Strong penalties for escape or unauthorized release of genetically engineered organisms should be put into law. All test sites for genetically engineered organisms should be public information, so that monitoring can be done responsibly and thoroughly. Transparency will foster public trust.

The government must establish strict requirements for monitoring programs for all entities developing, handling, or otherwise moving genetically engineered organisms. Such monitoring programs should include risk assessments and critical control point analyses, segregation and traceability procedures, internal monitoring of people and practices, and analytical testing for unwanted presence of the engineered material based on regular and surveillance-based regimens. Analytical testing should be used as a tool both by the entity who develops, trials, handles, or transports the genetically engineered organism, as well as by the government. Testing opportunities - especially those done by the government - should be opened to all laboratories that hold a valid ISO 17025 accreditation for the analysis in question.

3. "Pharm" crops - crops designed to contain drugs - should categorically be excluded from species historically used as food or feed. Likewise, crops that are specifically engineered with a new trait to make them more suitable for biofuel use must be strictly regulated so that the new trait does not escape and compromise the integrity of a food crop. A clear example is currently at hand, namely Syngenta's petition for approval of a variety of corn that is engineered to express an enzyme that facilitates the breakdown of starches in the grain to simple sugars, thereby facilitating ethanol production. What will happen when that gene escapes into corn crops and seed stocks that are typically used for animal feed or human food? That the gene will escape should be clear by now - so many cases of escaped or otherwise transferred genetically engineered corn pollen to traditional varieties are known - all of which happened under APHIS and USDA's watch and regulatory framework to date - that
it would be an illusion to think the same would not happen again in this
case.

4. "Terminator" or "Technology Protection" genes should be illegal even under controlled conditions, no exceptions. These genes can prevent a species from being able to reproduce. Genocide is a crime against humanity - be it against part of the human species or another species we hold as valuable.

We thank you for your attention to this important matter and for considering our comments. We stay available should we be able to be of additional service.

End of comments.

Respectfully submitted,

David Gould
Director of Technical Services
Global ID Group