Friday, September 27, 2013

FDA Barely Considers Biological, Chemical and Radiological Inputs in Proposed Produce Rule

Violating the explicit language of the Food Safety Modernization Act (FMSA), the Food and Drug Administration’s (FDA) Proposed Produce Rule gives a complete pass to imported vegetables grown with sewage sludge, contaminated to various degrees with heavy metals, polycyclic aromatic hydrocarbons, volatiles, flame retardants, pharmaceuticals, steroids, hormones (1,2) radiologicals (3) and undescribed contaminants. At the same time, the Proposed Rule makes it more difficult for U.S. organic farmers to use compost. It’s amazing.
FSMA states that the regulations are supposed to (4): “minimize the risk of serious health consequences and death… [with regulations to] prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables…”

This sounds eminently reasonable.

In my formal comment to FDA (5), I noted separate examples of radiological, chemical and heavy-metal contaminations that have taken farmland out of production within a few miles of where I live in Davis, CA. I also noted the increasing importance of urban farming.
In cities such as Detroit, Milwaukee, Los Angeles and Boston, and, indeed, around the country, there is increasing use of land for produce production that has been heavily impacted by urban and manufacturing chemical hazards. North Carolina Cooperative Extension, for example, has a guide to avoiding hazards in urban soils (6).

Will Allen of Growing Power, Inc., a Milwaukee-based Midwestern urban farming and community development project with a 20-year history, has the position that (7, and see 8): “…urban gardeners must grow their own soil, and use that soil to grow food.” Existing urban soil, he contends, is far too contaminated to risk growing food in. When you dig in urban areas, he says, ‘All you’re doing is stirring up lead, arsenic, all the bad guys in the soil. And the food takes up the contaminants.’”

FDA’s Proposed Rule rather cavalierly dismisses chemical and radiological contamination issues, including heavy metals, and gives them barely any consideration in the 1,200-odd pages of supporting documents and discussions.

In the prologue to the Rule, FDA states: “While we acknowledge the potential for chemical, physical or radiological contamination of produce, for reasons discussed in this proposed rule, we are not proposing specific standards for these hazards in this rulemaking.”

What are those reasons? “Illnesses attributable to chemical hazards are rare (Ref. 7). In fact, between 1997 and 2011, there have been no Class I recalls of produce associated with a chemical hazard for which there is a reasonable probability of causing serious health problems or death (Ref. 8). Current monitoring, regulations, and industry practice have been sufficient to keep these hazards under control.”

This is the only place in FDA’s Proposed Rule discussions where the lack of a Class I recall record is used to justify non-regulation. Usually FDA only requires that a recall might be possible, sometime in the future perhaps, in order to justify regulation.

The Reference 7, mentioned above, is an FDA “Memo to the File,” a very brief position statement that does not even mention heavy metals. It does note a famous 1985 aldicarb contamination of watermelons (which caused 1,175 illnesses), Three Mile Island and Fukushima, but says that other U.S. monitoring and statistical survey programs are enough protection to consumers against chemical, radiological and physical hazards (9).
FDA appears to use an implicit standard of acute and immediate harm for “serious health consequences,” which I cannot find anywhere in the Food Safety Modernization Act. Cumulative, chronic or slow-acting heath threats are not discussed. Carcinogenic, mutagenic, and teratogenic hazards, among others, would be ignored, if this was applied consistently.

The main assessment of risk is in the “Draft Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Produce,” which still awaits peer review. This states, in a single footnote: “…our qualitative assessment of risk described in this document focuses on biological hazards only; the agency’s considerations related to chemical, physical, and radiological hazards are outside the scope of this assessment.”

And, in Section IV of their introductory discussion of the Proposed Rule, FDA states that it tentatively concludes that the Proposed Rule should be limited to biological hazards. FDA eliminated any consideration of chemical, pesticide, heavy-metal and radiological hazards for the Proposed Rule.

Considering these hazards might have identified a wide range of sources of environmental contamination needing some attention for produce production. These include contamination from mining, manufacturing, oil and gas production and urban wastes, for example. Sewage sludge is our canary in the coal mine on these issues because it can be brought directly to farms.

FDA has no problems even with the biological problems of sewage sludge in vegetable and fruit production and hands over any regulatory concerns to the complex existing Environmental Protection Agency rules.

Ҥ 112.53 What prohibitions apply regarding use of human waste?
“You may not use human waste for growing covered produce, except sewage sludge biosolids used in accordance with the requirements of 40 CFR part 503, subpart D, or equivalent regulatory requirements.”

This refers to the famous (or infamous) EPA Part 503 (10) “Standards for the Use or Disposal of Sewage Sludge.” Subpart D covers a multitude of sins, including Class A sewage sludge, the cream of the crop, and Class B sewage sludge, the bottom of the barrel, so to speak. EPA makes no distinction between “agricultural lands” for, say, grain production and for fresh fruits and vegetables, or between food crop, feed crop, fiber crop, range land or pasture; it is all agricultural land. (Part D 503.11).

FDA does not even mind raw sewage in produce production. In the prologue to the Rule, the agency says:
“For example, if an untreated human waste (i.e., equivalent to domestic septage: “liquid or solid material removed from a septic tank, cesspool, portable toilet” (40 CFR § 503.9(f)), is applied to a field used to produce a food crop, then “Food crops with harvested parts that touch the sewage sludge/soil mixture and are totally above the land surface shall not be harvested for 14 months after application of sewage sludge” (40 CFR § 503.32(c)(1), cross-referencing § (b)(5) of the same section). We agree these standards are appropriate for protecting public health and, therefore, we are not proposing to implement further restrictions.”

Contrast this with how the Organic Farming Production Act (OFPA) treats these issues in general (11):
“The producer must manage plant and animal materials to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances.”

The Organic Farming Production Act has a simple and clear regulation on sewage sludge (12): “The producer must not use sewage sludge (biosolids) as defined in CFR 503.” This would have been a simple and enforceable rule for FDA to adopt for all produce.
Foreign production of fruits and vegetables that are imported into the United States has to meet the same or equivalent standards, as the U.S. rules,. FDA seems to have ignored the consequences for foreign production in its handling of sewage sludge. Since FDA proposes a low bar to use of sludge, one would expect foreign producers and governments to easily hop over that bar. They won’t have to petition for an alternative set of standards that are equivalent in safety. They can just use the U.S. produce regulations to justify sewage sludge in produce production for U.S. consumers, if not for their own consumers.

Finally, there is a major issue of the interactions between chemicals and consequences for human health. Both David Acheson, in his Food Safety News interview (13), and the National Research Council (14), in their 2002 review of EPA’s sludge rules (CFR 503) raise similar concerns. The levels set by EPA and others are done singly for each contaminant and source by source. But the human population is exposed to complex mixes of contaminants from multiple sources over extended periods of time. FDA’s Proposed Rule is silent on these issues as well.

FDA focused on biological contamination. Did they do a good job on human pathogens in soil inputs to farms, at least? Unfortunately, no. They did not.

There seems to be something else going on in the way the Proposed Rule is structured and in its analysis of relative risk and hazards of different inputs and practices.
(1) U.S. Environmental Protection Agency. Biosolids: Targeted National Sewage Sludge Survey. EPA 822-R-08-014.
(2) U.S. Environmental Protection Agency. Final Response to the National Research Council Report: Report on Biosolids Applied to Land and the Results of the Review of Existing Sewage Sludge Regulations. December, 2003; EPA-822-F-03-010.
(3) U.S. Nuclear Regulatory Commission. 10 CFR Part 20. Disposal of Radioactive Material by Release into Sanitary Sewer Systems; Withdrawal of Advance Notice of Rulemaking. Federal Register, Vol. 70, No. 217. Thursday, November 10, 2005.
(4) USC Title 21 — Food and Drugs, Section 350h, Standards for Produce Safety (c) Criteria (1) In general, (A).
(5) Daniel B. Cohen. Comment on: Standards for the Growing, Harvesting, acking and Holding of Produce for Human Consumption. Proposed Rule Document issued by the Food and Drug Administration (FDA). Docket No. FDA-2011-N-0921 Regulatory Information Number RIN 0910-AG35.!documentDetail;D=FDA-2011-N-0921-0196
(6) CR Crozier, M Polizzotto and L Bradley. Soil Facts: Minimizing Risks of Soil Contaminants in Urban Gardens. North Carolina Cooperative Extension Service, AG-439-78_Urban_Soil_Contaminants.pdf
(7) Will Allen: Growing Power and the Future of Food [event announcement and description]. Johns Hopkins Bloomberg School of Public Health. March 09, 2012. future/news_events/events/past_events/2012/will_allen.html
(8) Growing Power, Inc. Website:
(9) Nega Beru. Memo on Chemical, Physical and Radiological Hazards Associated with Produce. Memorandum for the Record. Department of Health and Human Services, Public Health Service, Food and Drug Administration. May 29, 2012.
(10) Code of Federal Regulations, Title 40, Part 503, part503.xml#seqnum503.11
(11) The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. Section 6501, et. seq., as amended, is implemented in 7 CFR Part 205, the NOP Final Rule, which regulates the production, handling, processing, and labeling of all raw or processed agricultural products to be sold, labeled, or represented as organic in the United States. The quote is from § 205.203(c).
(12) 7 CFR § 205.203 (e) (2).
(13) James Andrews. IAFP 2013: Interview with Keynote Speaker Dr. David Acheson. Food Safety News. Aug. 06, 2013. david-acheson/#.Ujnb6ha6hz8
(14) Committee on Toxicants and Pathogens in Biosolids Applied to Land, National Research Council. Biosolids Applied to Land: Advancing Standards and Practices. The National Academies Press, National Academy of Science. 2002.
© Food Safety News

Wednesday, September 25, 2013

FDA to hold first public hearing on GM babies

By Rady Ananda
Food Freedom News
Next month, the US Food and Drug Administration will hold a two-day public meeting to discuss genetic modification within the human egg, which changes will be passed on generationally. The United Kingdom is also moving to allow GM babies.

Human gene therapy has been ongoing since 1990, but most of that involved non-heritable genes, called somatic (non-sex cell) gene therapy. Somatic modifications only affect the individual and are not passed on, and so do not affect the human genome.

The game changed with the successful birth of at least 30 genetically modified babies by 2001. Half of the babies engineered from one clinic developed defects, so the FDA stepped in and asserted jurisdiction over “the use of human cells that receive genetic material by means other than the union of gamete nuclei” (sperm and egg nuclei).

Now the FDA is considering going forward with “oocyte modification” which involves genetic material from a second woman, whereby offspring will carry the DNA from three parents. These kinds of genetic changes (“germline modification”) alter the human genome.

With ooplasmic transfer, the technique injects healthy mitochondrial DNA from a donor into the egg of an infertile woman. Mitochondrial DNA floats outside a cell’s nucleus which contains the regular DNA, and is only inherited from the mother.

This is the first such meeting ever to be held in public by the FDA, reports Biopolitical Times (BPT), speculating that the meeting will likely include discussing a mitochondrial replacement technique developed by Shoukhrat Mitalipov at Oregon Health and Science University (OHSU).

Notes the BPT, “mitochondrial replacement is a form of inheritable genetic modification.” This type of gene therapy is the source of much controversy, because it permanently changes the human genome and risks unforeseeable changes in growth and development, and aging.
As late as 2008, all germline modification therapies and enhancements were banned in 83% of the 30 nations making up the OECD (Organization for Economic Cooperation and Development), including the US and UK, reports the Center for Genetics and Society (CGS).
In June of this year, the United Kingdom reversed its long-standing policy against germline modification, and decided to go ahead with three-parent babies. Regulations on the procedure are now being drafted and Members of Parliament are expected to vote on the issue in 2014.

Testifying before the US House Foreign Affairs Committee, Subcommittee on Terrorism, Nonproliferation and Trade in 2008, CGS Executive Director Richard Hayes advised:
“Most people strongly support therapeutic applications of genetic science, but they also realize that the manipulation of inheritable genetic traits crosses a consequential barrier. In the great majority of instances, couples at risk of passing on a serious genetic disease can ensure that their child is disease-free by means of medically-related trait selection, thus obviating the need for the far more complex and risk-prone intervention that germline modification would entail.”

Making humans better, smarter, stronger has long been the goal of eugenicists. Hayes warns:
“Germline enhancement has also been seriously proposed as a means of creating people with such novel cognitive, psychological, and behavioral traits that they would constitute a new, ‘post-human’ species, incapable of interbreeding with ‘normal’ humans.”

Paul Knoepfler, Associate Professor of Cell Biology and Human Anatomy at the University of California, Davis School of Medicine, commented that:
“Moving one oocyte nucleus into the enucleated oocyte of another person could trigger all kinds of devastating problems (most likely through epigenetic changes) that might not manifest until you try to make a human being out of it. Then it’s too late.”

BPT shares in this opposition:
“If the FDA gives the OHSU researchers a green light to move towards human clinical trials, it will be the first instance of regulatory approval for human germline modification ever, anywhere in the world.

”Given the current regulatory void in the United States and the paucity of safety data, allowing scientists to experiment with creating permanent changes to the human genome is a genie that must be kept in the bottle.”

As with genetically modified crops, a host of unforeseen and deleterious consequences may develop when we begin modifying humans with genes their children will inherit. GM feed is linked with infertility and spontaneous abortions in livestock, and crops modified to be insecticidal are linked to declining pollinator populations, especially bees, moths and bats.
But another argument against germline modification is that it will lead to designer babies and a new class of underdogs – those who cannot afford genetic enhancement.

Eugenicists and futurists like Ray Kurzweil (The Singularity Is Near, 2006) foresee and welcome the convergence of the NBIC fields that can improve human performance: nanotechnology, biotechnology, information technology and cognitive science.
In 2001, over 50 policy makers and scientists from a range of fields contributed to a National Science Foundation-sponsored workshop on converging NBIC technologies. Within the individual, group and societal level discussions, they addressed key areas of human activity: working, learning, aging, group interaction and human evolution. The consensus reached was to focus a national R&D priority on human enhancement.

In re-opening the allowance for GM babies, whose genetic changes will be passed on to future generations, the FDA is taking the next steps toward toeing the line on genetic human enhancement.

In addition to accepting written comments, the FDA, in collaboration with the Office of Cellular Tissue and Gene Therapies Center for Biologics Evaluation and Research, will also provide a free webcast of the two-day discussion. The meeting may be rescheduled without notice, the FDA warns.