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.
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