Gregory A. Jaffe

Gregory Jaffe is the Director of the Biotechnology Project at the Center for Science in the Public Interest (CSPI). He is a lawyer who has focused on regulation of genetically engineered organisms since his undergraduate education.

Previously, Jaffe served on both the USDA's Advisory Committee on Agricultural Biotechnology and 21st Century Agriculture (2003-2008) and the FDA's Veterinary Medicine Advisory Committee (2004-2008). He was also a consumer representative on the Bureau for International Assessment of Agricultural Science and Technology for Development (2004-2008). In 2010, Jaffe served as a temporary voting member on the FDA's Veterinary Medicine Advisory Committee for the hearing on the genetically engineered (GE) AquAdvantage salmon.

Education and Employment

Jaffe has a Bachelor of Arts with High Honors in Biology and Government from Wesleyan University and a J.D. from Harvard Law School (cum laude). At Wesleyan, his Senior Honors Thesis was titled "Recombinant DNA: The Question of Regulation."

Jaffe's early career was in government. He began as a research assistant at the U.S. Congressional Office of Technology Assessment in 1984-1985, where he was assigned to the Biological Applications Program "to research science policy issues, including biotechnology and its regulatory environment." Later, from 1988 to 1989, he served as a Judicial Clerk for The Honorable Alan B. Handler, a justice on the New Jersey Supreme Court. He then left New Jersey for Washington, D.C., where he was a trial attorney at the U.S. Department of Justice in the Environment and Natural Resources Division from 1990 to 1997. In his role there, he advised the Assistant Attorney General on biotechnology and he represented the Department of Justice on "interagency committees concerning the regulatory environment for biotechnology."

Jaffe left the Department of Justice for the EPA, where he worked from 1997 to 2001 as a Senior Counsel in the Air Enforcement Division. He began as a Stationary Source Branch Chief (1997-1998) and later became a Team Leader of the Coal Fired Power Plant Enforcement Initiative (1999-2001).

In 2001, Jaffe left government and returned to his roots in biotechnology, joining CSPI as its Co-Director of its Biotechnology Project. In 2002, he became the sole Director of the Biotechnology Project and continued in that role until present day. He describes his role as follows:

"Areas of expertise include applicable laws and regulations relevant to agricultural biotechnology policy (including both food safety and environmental issues), consumer attitudes regarding biotechnology, the Biosafety Protocol and other international agreements relevant to agricultural biotechnology, and laws and regulations of non-US countries (with special emphasis on developing countries)."

Committee Memberships

Jaffe has served as a member on the following committees:

• Member, US Secretary of Agriculture’s Advisory Committee on Agricultural Biotechnology and 21st Century Agriculture, April, 2003 – 2008.
• Consumer representative on Bureau for International Assessment of Agricultural Science and Technology for Development (IAASTD), August, 2004 – April, 2008.
• Member, Veterinary Medicine Advisory Committee, U.S. Food and Drug Administration, November, 2004 – October, 2008.
• Member, External Advisory Board, Biosafety Institute for Genetically Modified Agricultural Products, Iowa State University, February, 2005 – present.
• Member, Advisory Board, International Society for Biosafety Research, 2004 – 2006.
• Member of Stakeholder Dialogue on Regulation of Agricultural Biotechnology, Pew Initiative on Food and Biotechnology, June, 2001 – May, 2003.

Views on Genetic Engineering

Given Jaffe's role in advising the FDA on the approval of the genetically engineered (GE) AquAdvantage salmon, it is important to examine his record on genetic engineering. In general, he favors the use of genetic engineering for producing food. He comes to this conclusion by overlooking data pointing to problems with currently used genetically engineered crops and even believing positive claims about genetically engineered crops touted by industry that have been proven false.

Benefits

In the spring of 2009, Jaffe summarized his thoughts on commercial biotech saying: "In the past dozen years, genetically engineered crops have become part of mainstream agriculture in developed and developing countries alike. Farmers have planted GE crops on millions of acres and the majority of the risks raised by critics have not been borne out. While not all the advantages touted by the developers have materialized either, significant benefits have been documented. GE crops are here to stay."

Jaffe goes on to state the benefits he believes genetically engineered (GE) crops provide on a crop by crop basis, including a reduction in pesticides by as much as half (for Bt cotton), and substitution of "a herbicide that is believed to be less environmentally harmful" (Roundup) in the case of herbicide tolerant soybeans. He adds that GE soybeans have not increased yields but they allow farmers to use "environmentally beneficial no-till farming" and they make farming less time consuming for the farmer. This analysis ignores the increasingly widespread problem of weeds and pests evolving resistant to Roundup (glyphosate) or Bt, respectively. When that happens, farmers use additional herbicides and insecticides on genetically engineered crops. In fact, scientists found that in the first 13 years of commercialized genetically engineered crops, net pesticide use went up, not down. Jaffe also ignores research by the Rodale Institute in its Farm Systems Trial, in which organic agriculture produced equal or higher yields compared to growing GE crops, and allowed for no-till agriculture (not to mention a dramatic reduction in oil usage).

Throughout the article, he continually sings the praises of genetic engineering. For example: "The fact is, products derived from biotechnology have been consumed by billions of people for more than 15 years without a single documented health problem." However, this ignores the fact that, while acute toxicity does not seem to be a problem associated with genetically engineered crops, GE crops are still new and no one has yet tried eating them for 20 or 50 years to assess their long term safety. Another example from Jaffe is: "Biotech crops help farmers grow heartier and healthier food." This statement is given with no evidence, and it is highly doubtful, as current biotech crops have not been developed to enhance the healthfulness of the food. The sole exception is "golden rice," a type of rice engineered to produce vitamin A. However, a child would need to eat at least 12 pounds of rice each day to meet his or her vitamin A needs.

Jaffe adds: "Biotechnology also benefits the environment. Because biotech crops require less cultivation and fewer pesticide applications, farmers save fuel and reduce carbon dioxide emissions." Again, the claim that biotech crops reduce pesticide usage is false (considering biotech crops and associated pesticide usage in aggregate), and the claim of reduced fuel use and carbon dioxide emissions is provided without evidence, and contradicted by the studies done by the Rodale Institute.

Negative Aspects

In the same 2009 article, Jaffe then lists some of the negative results of GE crops. However, he glosses over these and begins with the caveat that: "agriculture, by its very nature, is usually environmentally detrimental." It is accurate that the form of farming practiced in the United States in the 21st century is usually environmentally detrimental, but it would be wrong to make the same generalization for the entire world or for the whole of human history. Furthermore, it ignores the modern science of agroecology that allows farmers to produce high yields of food while improving the environment. Yet, in providing this assumption, Jaffe lowers the bar for GE crops because they will constitute a success if they result in less harm compared to industrial agriculture, and do not need to prove they cause no harm at all.

Genetically Engineered Animals

In general Jaffe has high hopes for the potential of GE animals. In a 2008 article, he said to concerned eaters: "Before you look askance at your next helping of chevre or curried goat, consider some of the other possible environmental or health benefits that genetically engineered (GE) animals may provide." However, he notes that GE animals could cause animal welfare concerns.

He has specifically referenced the [AquaBounty Technologies]] and the AquAdvantage salmon in his publications more than once. In 2008, he wrote: "AquaBounty has engineered a salmon by adding a gene from another fish species so that it reaches market size in half the time. That may reduce producer costs and generate an environmental benefit by cutting down on the feed that fish-farming operations use and on the waste that the fish produce." He makes roughly the same statement again in a 2009 article. In his 2008 piece, he worries that "such a closed process [as the FDA's regulatory process for New Animal Drugs, which will be used for GE animals] is unlikely to instill consumer confidence that AquaBounty's salmon is safe to eat." He provides one example of a problem with the GE fish: "For instance, might the fast-growing salmon escape from their pens and disrupt native fish populations?"

Regulation

In a 2009 article, Jaffe analyzes whether the current regulatory structure is sufficient for the next generation of genetically engineered (GE) products, including crops engineered for drought tolerance or enhanced nutrition or GE meat and dairy animals and drug-producing biopharming.

At the start of this analysis, Jaffe notes his overall satisfaction with the results (to date) U.S. regulatory approach to genetic engineering, as he feels it has given us "years of experience with the successful and safe deployment of biotechnology." However, he goes on to point out a number of deficiencies in nearly every part of the regulatory system and concludes that "until the deficiencies are eliminated, the federal government will not be adequately ensuring that GE crops are safe to agriculture interests, humans, and the environment."

Regulation on GE Crops

Jaffe has quite a bit of criticism for the FDA's regulatory approach for GE crops. He says: "FDA regulates food under the Food, Drug and Cosmetic Act, which requires pre-market approval only for “food additives.” The agency determined in 1992 that added DNA in crops (and its resulting fruit) generally is not a food additive and does not require mandatory pre-market approval. Instead, FDA set up a voluntary consultation process whereby developers can show the agency their food safety data so it can identify any deficiencies. While such regulation is welcomed by developers (they get to avoid the lengthy food-additive approval process), it puts the burden on the agency to find a product potentially unsafe before it can prevent its introduction into the food supply. It also results in the public relying on the industry’s self-interested safety determination, instead of an FDA independent safety assessment. In contrast, every other country with a functional biosafety regulatory system mandates a government approval before a GE crop is marketed. It is also ironic that GE crops need formal approval to be planted outdoors (see below) but no formal approval to enter the food supply. That result is not a policy decision that GE crops are more dangerous to the environment than they are to eat, but solely because the government is trying to fit products made using a new technology into an old regulatory scheme not designed for such applications."

He is also critical of FDA regulation of "biopharming" (growing GE crops that produce pharmaceuticals), pointing out that the FDA does not regulate the crops because they are not intended for the U.S. food supply, but accidents happen, so they might end up in the U.S. food supply all the same.

He also points out the many deficiencies of the USDA's regulatory system:

• "It does not necessarily capture all GE crops, only those with the potential to be plant pests."
• "It does not conduct a thorough environmental assessment for all GE crops, and when it does, those assessments have been criticized as not analyzing all relevant concerns."
• "When GE crops are deregulated, USDA has no means for enforcement if a problem arises."
• "The department’s enforcement to ensure compliance with issued permits has not been effective. Virtually all violations to date have been identified through industry self-reporting, not agency inspections."

The one area of U.S. regulation he is generally happy with is the EPA's role, regulating plants that are engineered to produce pesticides (referred to as plant-incorporated pesticides, or PIPs). Under the Federal Insecticide, Fungicide, and Rodenticide Act, "A developer must register the GE crop, which requires EPA to determine that the PIP will not cause “unreasonable adverse effects on the environment” and that it does not raise any food-safety concerns for edible portions of the crop." He feels that, while not perfect, "the agency’s procedures are thorough and transparent and the result has generally been protective of both humans and the environment."

Regulation of GE Animals

In assessing the FDA's decision to regulate GE animals as new animal drugs, Jaffe says: "The downside is that new animal drug applications and the approval process are shrouded in secrecy, with no opportunity for public comment before FDA approves the product. Such a closed process will not instill consumer confidence. In addition, GE animals may raise environmental issues, such as potential effects of the fast-growing salmon escaping and mating with wild salmon populations (although the developer says it intends to sterilize the fish). FDA will assess environmental issues in compliance with the National Environmental Policy Act but has no legal authority to deny approval of that animal due to an environmental concern. It also does not have adequate recall authority if a problem arises after commercialization."

In a 2008 article, one focused entirely on GE animals, he concludes that "technology has outpaced our laws" and that the FDA's regulatory framework "by itself won't ensure safety or consumer acceptance" of GE animals. Here, he recommends that Congress should give the FDA the authority to address the "full range of environmental concerns that GE animals might pose," including the authority to recall the animals after commercialization. He also wants confidentiality requirements eliminated so that outside experts can examine safety data and FDA analysis prior to a GE animal's approval. (In 2010, the FDA did release this information to the public two weeks prior to the approval meeting for the AquAdvantage GE salmon. While it did provide the public with the ability to review the data and submit comments, it did not provide enough time to do so adequately.) Last, Jaffe feels that the FDA should be required to consult with other agencies (like the EPA or the U.S. Fish and Wildlife Service) about the potential risks of GE animals.

Publications

Jaffe's publications are as follows:

• Are Current Rules Adequate to Regulate Genetic Engineering?, The Environmental Forum, Volume 26, Number 2, March/April, 2009.
• Questions about Genetically Engineered Animals, Miami Herald.com, October 23, 2008.
• Genetically Modified Crops Need More Oversight, Des Moines Register, March 26, 2007.
• Animal Cloning: FDA Safety Call Not Enough, Business Week.com, January 9, 2007.
• Regulatory Slowdown on GM Crop Decisions, Nature Biotechnology, Volume 24, Number 7, pp. 748-749 (2006).
• Comparative Analysis of National Biosafety Regulatory Systems in East Africa, International Food Policy Research Institute Discussion Paper No. 146 (January, 2006).
• Implementing the Biosafety Protocol Through National Biosafety Regulatory Systems: An Analysis of Key Unresolved Issues, Journal of Public Affairs, 5: 299-311 (2005).
• Creating the Proper Environment for Acceptance of Agricultural Biotechnology, in National Agricultural Biotechnology Council’s Report 17, pp. 221-233 (2006).
• Biosafety Regulation in the North and South, Proceedings of the Eighth International Symposium on the Biosafety of Genetically Modified Organisms, pp. 190-94 (2004).
• Biotech: Keep it, But Regulate it, Sacramento Bee, June 25, 2004.
• Regulating Transgenic Crops: A Comparative Analysis of Different Regulatory Systems, Transgenic Research 13: 5-19 (2004).
• Regulating Transgenic Crops: A Comparative Analysis of Different Regulatory Processes, in Biosafety of Transgenic Rice, pp. 103-117 (2005).
• Who’s Watching What You Eat? St. Louis Post-Dispatch, April 23, 2003.
• How to Approach the Regulatory Condundrum?, National Agricultural Biotechnology Council Report 14 on Foods for Health, pp. 51-60 (2003).
• Coordinated Framework: Structure Needs a Overhaul, The Environmental Forum, May/June, 2002.
• Regulating Agricultural Biotechnology: A Consumer Perspective in Biotechnology and Sustainable Development: Voices of the South and North, pp. 265-278 (2003).
• Getting Consumers the Information They Want About Genetically Engineered Foods: An Interim Solution, Food and Drug Law Institute’s Update Magazine, November/December 2001.
• Lessen the Fear of Genetically Engineered Crops, Christian Science Monitor, August 8, 2001.
• The Inadequacies in the Federal Regulation of Biotechnology, 11 Harvard Environmental Law Review 491 (1987).
• Institutional Ethics Committees: Legitimate and Impartial Review of Ethical Health Care Decisions, 10 Journal of Legal Medicine 393 (1989).

Reports

Jaffe has also written the following reports:

• “Complacency on the Farm,” November, 2009
• “Withering on the Vine: Will Agricultural Biotech’s Promise Bear Fruit?” February, 2005.
• “Sowing Secrecy: The Biotech Industry, USDA, and America’s Secret Pharm Belt,” June, 2004.
• “Planting Trouble: Are Farmers Squandering Bt Corn Technology,” June, 2003.

Articles and resources

Related SourceWatch articles

• AquAdvantage salmon
• Veterinary Medicine Advisory Committee
• Center for Science in the Public Interest

External articles

• Gregory Jaffe, Creating the Proper Environment for Acceptance of Agricultural Biotechnology, in National Agricultural Biotechnology Council’s Report 17, pp. 221-233 (2006).