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. “§ 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.