Blog Archives

Frozen farm-raised catfish recalled for potential chemical contamination

Recall 060-2016 labels

Haring Catfish Inc. of Wisner, LA, is recalling approximately 21,521 pounds of siluriformes fish (catfish) products that may be adulterated with a residue of public health concern, specifically gentian (crystal) violet, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced Thursday, July 14, 2016.

The products subject to recall bear establishment number “EST. 51217” inside the USDA mark of inspection. These items were shipped to retail locations and hotels, restaurants, and institutions in Arkansas, California, Louisiana, Mississippi, Oklahoma, and Texas.

The problem was discovered on July 11, 2016, after routine FSIS sampling results revealed a violative level of the chemical gentian (crystal) violet in the product.

The siluriformes (catfish) products items were produced on June 28 and 29, 2016. The following products are subject to recall:

  • 11-lb. Cardboard boxes of IQF (Individually Quick Frozen) “catfish” tails in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.
  • 15-lb. Cardboard boxes of IQF “catfish” steaks, irregular filets, whole fish, strips, nuggets, and partially gutted fish in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.
  • 30-lb. Cardboard boxes of IQF “catfish” steaks, irregular filets, whole fish, strips, nuggets, and partially gutted fish in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.

There have been no confirmed reports of adverse reactions, injury, or illness due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

Consumers who have purchased these products are urged not to consume them but instead to throw them away or return them to the place of purchase.

Consumers with questions about this recall can contact Dottie Walker at (318) 724-6133, ext. 119.

(To sign up for a free subscription to Food Safety News, click here.)

Food Safety News

Whole Foods Raw Almonds Recalled for High Levels of Natural Chemical

Marin Food Specialties, Inc. of Byron, CA, is voluntarily recalling Organic Raw Almonds (bitter almonds) sold at Whole Foods Markets due to potentially elevated levels of the natural chemical hydrogen cyanide, according to laboratory test results.

The almonds were labeled as “Whole Foods Market Organic Raw Almonds Imported from Italy” and “Whole Foods Organic raw Almonds Imported from Spain” and packaged in 13.5 oz. plastic tubes.

Recalled almonds have sell-by dates from 4/8/15 to 6/7/15 with a UPC code of 9-99482-00071-7.

The recalled almonds were sold in Northern California, Oregon, Washington, Reno, Nevada and Idaho. A complete list of Whole Foods stores where the product was sold can be found in the recall notification.

Eating foods that contain high amounts of hydrogen cyanide (also known as prussic acid) may result in some of the following symptoms within minutes: dizziness, headache, nausea and vomiting, rapid breathing, rapid heart rate, restlessness and weakness.

Exposure to even higher quantities of hydrogen cyanide may cause even more serious health effects, including convulsions, loss of consciousness, low blood pressure, lung injury, slow heart rate, and respiratory failure leading to death.

No illnesses have been reported in association with this product. However, due to the time involved in tracing an illness back to a food source, it is impossible to say whether or not any illnesses have occurred.

All recalled almonds have reportedly been pulled from Whole Foods stores.

Food Safety News

New species of spider wasp may use chemical signals from dead ants to protect nest

A new species of spider wasp, the ‘Bone-house Wasp,’ may use chemical cues from dead ants as a nest protection strategy, according to a recent study published July 2, 2014 in the open-access journal PLOS ONE by Michael Staab from University of Freiburg, Germany, and his colleagues from China and Germany.

Wasps use a wide variety of nest protection strategies, including digging holes or occupying pre-existing cavities such as in wood. Previous studies showed that the nests of cavity-nesting wasps contain several brood cells separated by thin walls of plant debris, resin, or soil. Once the females have finished constructing the nest, laying eggs, and providing food, they construct an outermost vestibular cell to close the nest. After construction, female wasps abandon the brood and do not care for their offspring anymore. Nest protection strategies play a central role in brood survival, and in this study, scientists interested in better understanding these strategies collected ~800 nests of cavity-nesting wasps with ~1900 brood cells belonging to 18 species in South-East China.

The scientists found a nesting behavior previously unknown in the entire animal kingdom: in over 70 nests they found an outer vestibular cell filled with dead ants. The species constructing these ant-filled vestibular cell was so far unknown to science and was described in the same study as the ‘Bone-house Wasp’ (Deuteragenia ossarium), after graveyard bone-houses or ossuaries. The scientists also found lower parasitism rates in “Bone-house” nests than in nests of similar cavity-nesting wasps. The authors suggest that D. ossarium nests are less vulnerable to natural enemies, potentially supporting the outer cell’s role in defense, which most likely involves chemical cues emanating from the dead ants used as nest-building material.

Dr. Staab added, “Our discovery demonstrates in an impressive way, what fascinating strategies of offspring-protection have evolved in the animal kingdom.”

Story Source:

The above story is based on materials provided by PLOS. Note: Materials may be edited for content and length.

Agriculture and Food News — ScienceDaily

Scientist with Chemical Industry Ties Quits EU Advisory Panel

This report was originally published Oct. 15 by Environmental Health NewsIt is a follow-up to a Sept. 23 article entitled, “Scientists Critical of EU’s Draft Chemical Regulation Policy Have Industry Ties”.

A German scientist who is critical of the European Union’s plan to regulate chemicals and has extensive financial ties to regulated companies has resigned from a key scientific committee of the European Commission.

Wolfgang Dekant was one of 18 scientists who authored a controversial editorial that criticized Europe’s plans to regulate hormone-disrupting chemicals. A September investigation by Environmental Health News revealed that Dekant and 16 others had collaborations with the chemical, pharmaceutical, cosmetic, tobacco, pesticide and biotechnology industries.

A professor of toxicology at the University of Würzburg, Dekant resigned last month from the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks. The committee provides scientific opinions to EU decisionmakers on various topics such as antimicrobial resistance and fertility reduction and new technologies such as nanomaterials.

Dekant, who has served as an expert for the European Commission since 2000, said he resigned on his own initiative. His resignation letter was dated Sept. 6, after he signed the editorial that sparked a firestorm among scientists.

“Due to a number of recent developments which have severely restricted my time availability, I am not able to devote sufficient time to contribute to the work,” he wrote to the Commission. “I therefore resign from the committee effective immediately.”

Dekant said in an email that he had been considering resigning since “March 2013 onwards” because serving on the panel required traveling to Luxembourg and that the “very long opinions/large number of meetings require more time.” Also, he said, the “topics seem to move away from my expertise.”

“Members (and Commission) wanted me to stay,” he said.

Frédéric Vincent, a spokesperson for the European Commission, declined to comment other than to confirm that Dekant resigned last month. Dekant’s name, however, was not removed from the Commission’s list of advisors until a few days after the EHN article was published.

“I don’t know why Mr. Dekant resigned,” said Michèle Rivasi, a French member of the European Parliament and vice ­president of the Green/EFA group. “But I know that the criteria of excellence that are required for members of the scientific committees imply that scientists are as independent as possible and respect the most basic rules of science ethics, like disclosing their interests.”

EHN’s investigation shows that Dekant has a long history of ties to companies that would be regulated by a policy that Europe is developing for endocrine disruptors – chemicals that can interfere with hormones such as estrogen, testosterone and thyroid hormones.

Included are bisphenol A, a controversial compound in hard plastics and food can liners, phthalates found in vinyl and fragrances, furniture flame retardants and pesticides. Lab animal studies and some human studies have linked these chemicals to reproductive problems, cancers, neurological effects and other diseases.

Europe would be the first region in the world to adopt a specific policy that could lead to bans of some of these chemicals, which are used in everyday consumer products. The stakes are high since companies worldwide that sell products in Europe would have to comply.

Earlier this year, Dekant and the 17 other scientists, all editors of scientific journals, signed an editorial published in 14 journals. They criticized a precautionary approach to regulating the chemicals outlined in a leaked draft proposal by Europe’s Environment Directorate-General. They called the proposal “scientifically unfounded” and “defying common sense, well-established science and risk assessment principles.”

The editorial sparked outrage from other scientists with no declared industry ties, including 41 who wrote in a rebuttal that it ”appears to be intended as an intervention designed to impact imminent decisions by the European Commission.” Another 104 scientists and journal editors wrote a second rebuttal calling the editorial ”a profound disservice” to public health.

This debate focuses largely on two issues for the Commission: determining whether there are safe concentrations for endocrine-disrupting compounds and defining criteria to identify pesticides that would be removed from the market.

Of the scientists who signed the editorial, Dekant appears to have the most ties to industries that would be regulated by the new strategy.

Dekant, editor in chief of the journal Toxicology Letters, reported in an April 2013 online declaration of interest to the Commission’s scientific committee that he had 18 consultancy contracts with companies. He did not disclose the company names, however.

Another document shows that Dekant received money from the Polycarbonate/BPA Global Group – part of the American Chemistry Council, which represents manufacturers of bisphenol A. He was paid for a 2008 review, which concluded that “exposure to bisphenol A does not result in a health risk to the general population.” During that same period, from 2006 through 2008, he served on the European Food Safety Authority’sscientific panel, which reported that the EU’s acceptable daily intake for BPA was safe.

Dekant also wrote a review on phthalates for a European group representing phthalates manufacturers, ECPI, in 2012 and a review on TBBPA, a flame retardant, for the global association of the brominated flame retardant industry, EBFRIP, in 2010.

He also co-authored a 2010 article on degradation products of pesticides with an employee from chemical and pesticide manufacturer BASF and a private consultant and two studies on 3-(4-methylbenzylidene)camphor, a UV filter, with employees from this chemical’s manufacturer, Merck, in 2006.

BPA, phthalates, TBBPA, 3-(4-methylbenzylidene)camphor, and some pesticides are endocrine disruptors that could be regulated under the new EU policy.

Since 2011, Dekant also has been a member of the scientific advisory panel of the Research Institute for Fragrance Material, an organization for the fragrance, detergents and cosmetics industry, whose members include BASF, L’Oréal and Unilever. In 2007, he was an advisor for the German Association of the Automotive Industry.

Some of Dekant’s research activities have been supported by private benefactors such as Honeywell since 2006. For a 2013 study, he received funding from the Tetrahydrofuran Task Force, a consortium of U.S. manufacturers of tetrahydrofuran, European Chemical Industry Council (CEFIC) and The Toxicology Forum.

Dekant collaborated with an industry lobby group, International Life Sciences Institute (ILSI Europe), in 2005.

When asked about his industry ties, Dekant replied, “I don’t consider conflict of interest as a measure tool to judge scientific debate.”

Getting money from a mix of sources, including industry, is “the normal way” to do research nowadays, Dekant said.

“You can’t do research anymore if you don’t go for money from all sources,” he said.

Food Safety News

Scientists Find Meth-Like Chemical in ‘Craze’ Bodybuilding Supplement

Late Monday, you could still buy the body-building diet supplement Craze online from Amazon in candy grape, berry lemonade and piña colada flavors, but it was “currently unavailable” at Driven Sports, Inc., the company that markets the product.

Earlier in the day, an international panel of scientists disclosed that one of the ingredients in the dietary supplement peddled to body builders is a chemical compound similar to the illegal drug methamphetamine.

The substance – not disclosed on the label – is called N,alphadiethylphenylethylamine or N,a-DEPEA.

It has never been the subject of studies with humans and was probably created by a “criminal chemist” only about three years ago.

Driven Sports, Inc., markets Craze to body builders who want to train “BEYOND YOUR LIMITS” and by promising “endless energy.”

Writing in the journal Drug Testing and Analysis, researchers from the global public health organization NSF International, the Harvard Medical School, and the National Institute for Public Health and the Environment in the Netherlands said that Craze contains a meth-like chemical that may be harmful to human health. Craze is widely sold online and in retail stores.

“The health risk of using supplements adulterated with a drug should not be underestimated,” said Dr. Pieter Cohen, an assistant professor at Harvard who has conducted extensive research on supplements.

The researchers tested Craze samples from three different suppliers, finding the meth-like chemical in all of them in amounts ranging from 20 to 35 milligrams per the recommended serving size for the supplement. Such a dose represents more than might be blamed on contamination in the manufacturing process.

Driven Sports did issue a statement saying that Craze does not contain any illegal stimulants. Manufacturers and distributors of dietary supplements are not required to obtain U.S. Food and Drug Administration approval before putting a product on the market. Craze won BodyBuilding.com’s new supplement of the year award for 2012.

FDA did not comment on the report.

Food Safety News

Scientists Find Meth-Like Chemical in ‘Craze’ Bodybuilding Supplement

Late Monday, you could still buy the body-building diet supplement Craze online from Amazon in candy grape, berry lemonade and piña colada flavors, but it was “currently unavailable” at Driven Sports, Inc., the company that markets the product.

Earlier in the day, an international panel of scientists disclosed that one of the ingredients in the dietary supplement peddled to body builders is a chemical compound similar to the illegal drug methamphetamine.

The substance – not disclosed on the label – is called N,alphadiethylphenylethylamine or N,a-DEPEA.

It has never been the subject of studies with humans and was probably created by a “criminal chemist” only about three years ago.

Driven Sports, Inc., markets Craze to body builders who want to train “BEYOND YOUR LIMITS” and by promising “endless energy.”

Writing in the journal Drug Testing and Analysis, researchers from the global public health organization NSF International, the Harvard Medical School, and the National Institute for Public Health and the Environment in the Netherlands said that Craze contains a meth-like chemical that may be harmful to human health. Craze is widely sold online and in retail stores.

“The health risk of using supplements adulterated with a drug should not be underestimated,” said Dr. Pieter Cohen, an assistant professor at Harvard who has conducted extensive research on supplements.

The researchers tested Craze samples from three different suppliers, finding the meth-like chemical in all of them in amounts ranging from 20 to 35 milligrams per the recommended serving size for the supplement. Such a dose represents more than might be blamed on contamination in the manufacturing process.

Driven Sports did issue a statement saying that Craze does not contain any illegal stimulants. Manufacturers and distributors of dietary supplements are not required to obtain U.S. Food and Drug Administration approval before putting a product on the market. Craze won BodyBuilding.com’s new supplement of the year award for 2012.

FDA did not comment on the report.

Food Safety News

Scientists Critical of EU’s Draft Chemical Regulation Policy Have Industry Ties

This special report by Stéphane Horel and Brian Bienkowski was originally published Sept. 23 by Environmental Health News.

Seventeen scientists who have criticized plans in Europe to regulate endocrine-disrupting chemicals have past or current ties to regulated industries.

An investigation by Environmental Health News reveals that of 18 toxicology journal editors who signed a controversial editorial, 17 have collaborated with the chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries. Some have received research funds from industry associations, while some have served as industry consultants or advisors. [Read about the scientists here.]

The editorial – published in 14 scientific journals from July to September – has created a firestorm in Europe among many scientists and regulators. It criticized a leaked draft proposal by Europe’s Environment Directorate-General that recommends a precautionary approach, which could lead to the ban of some commonly used chemicals. The stakes are high in the controversy because it involves the European Union’s strategy to regulate hormone-altering chemicals – the first attempt in the world to do so. The new rules would have sweeping, global ramifications because all companies that sell a variety of products in Europe would have to comply.

The signees, including many toxicology professors at universities in Europe, wrote that the European Commission plan is “scientifically unfounded” and is “defying common sense, well-established science and risk assessment principles.”

The proposed rules have “worrisome ramifications” for “science, the economy, and human welfare the world over” and “lack the required scientific robustness needed for such an important piece of legislation,” they wrote.

All of the scientists who responded to questions from Environmental Health News denied they were influenced by industry.

Daniel Dietrich, a toxicologist who was the editorial’s lead author, is a former advisor for an industry organization funded by chemical, pesticide and oil companies that lobbies the European Commission on endocrine disruptors.

“We do not believe the discussion on the conflicts of interests will serve anybody because it takes away the focus from the real issue,” Dietrich said in an interview.

‘Worrying’ conflicts of interest

But other scientists question the writers’ motives and undisclosed ties to industry, calling the editorial criticizing a policy proposal an “unusual initiative” for science journal editors.

“I was very surprised by the editorial. I thought it was emotional and non-specific, a mixture of science and policy, and with too many errors,” said Åke Bergman, an environmental chemistry researcher at Stockholm University.

When Bergman learned of the conflicts of interest of the editors, he called it “worrying.”

rebuttal, published in the journal Environmental Health, was signed by Bergman and 40 other scientists with no declared conflicts of interest. They wrote that they were “concerned that the Dietrich editorial appears to be intended as an intervention designed to impact imminent decisions by the European Commission.” The editorial “ignores scientific evidence and well-established principles of chemical risk assessment” related to endocrine-disrupting chemicals, they wrote.

Another rebuttal signed by 104 scientists and editors of journals was published last week. “The letter by Dietrich, et al does the European Commission, science – including the field of toxicology – and most importantly, public health – a profound disservice,” they wrote in the journal Endocrinology. One of the signees was Pete Myers, founder of EHN, chief scientist of Environmental Health Sciences and associate editor of the journal Endocrine Disruptors.

Some authors of the first rebuttal, including Bergman, are widely considered leading scientific experts in endocrine disruption; 14 of them wrote a recent report by the World Health Organization and the United Nations Environment Programme that called endocrine disruptors a “a global threat that needs to be resolved.”

Endocrine disruptors are chemicals that can interfere with hormones, including estrogen, testosterone and thyroid hormones. They are found in everyday consumer products such as food, cosmetics, pesticides and plastics. Included are bisphenol A, found in hard plastics, some receipts and food can liners; phthalates used in fragrances and vinyl; and some pesticides and flame retardants.

Their effects on human health are uncertain, but many lab animal studies and some human studies have linked them to reproductive problems, cancers and other diseases.

The European Commission’s strategy

The European Commission is planning to regulate the chemicals by updating three of its existing regulations. Two controversial issues are critical to the efforts.

First, the commission is trying to decide whether these chemicals are safe under certain threshold concentrations. If no safe threshold can be determined, industry would then have to demonstrate that the economic benefits outweigh human health risks or that there are no alternatives. Otherwise, they would be banned under Europe’s REACH, a sweeping regulation adopted in 2006 that controls industrial chemicals.

Second, pesticides and biocides are regulated under new regulations that already require that endocrine disruptors must be removed from the market. The commission still needs to formulate precise identification criteria for those.

The commission’s final proposal was expected this year. But now the commission is considering launching an “impact assessment,” a procedure that is likely to postpone the decisions until the end of next year.

The chemical, pesticides, cosmetics and plastics industries have been lobbying the commission against any regulation. They claim that thresholds do exist for endocrine disruptors, and they contest the precautionary approach in setting the identification criteria.

The journal editors admonished the commission for a framework “based on virtually complete ignorance of all well-established and taught principles of pharmacology and toxicology.” They said that a threshold can be set for endocrine disruptors, and that toxicologists should distinguish between the effects the hormonal system can adapt to and actual adverse effects.

But other scientists disagree.

Hormone disruption during development can have irreversible impacts, Bergman and the other scientists replied in their rebuttal. The “existence of a threshold for endocrine disruptors,” they wrote, “cannot be demonstrated experimentally.” Some scientists maintain that animal experiments indicate that low doses of BPA and other hormone-like compounds can harm fetuses as they develop, while high doses have no effect or different effects.

“The most worrying aspect of the editorial by Dietrich et al. is the blurring of the border between what constitutes science and what belongs to the realm of political, societal and democratic choice,” the 41 scientists wrote.

In addition to the editorial, a letter was signed by 71 scientists – including some who signed the original editorial – urging the Chief Scientific Advisor of the President of the European Commission to step into the debate. At least 40 of the 71 have ties to various industries. The European Crop Protection Association, the lobby organization for the pesticides industry, recently backed the letter.

Scientist Philippe Grandjean, editor-in-chief of the journal Environmental Healthurged Dietrich and colleagues to correct their “lapse” of disclosure of competing interests in their editorial.

“It is important that academics share their information with stakeholders. But when there is a financial interest, it is also important that this information is made available,” Grandjean said in an interview. He is a professor and chair of environmental medicine at the University of Southern Denmark and an adjunct professor of environmental health at the Harvard School of Public Health.

Dietrich, however, said there was no disclosure because it was an editorial, “not a dataset that would influence any particular chemical.” He dismissed as irrelevant industry’s support of the letter to the Chief Scientific Advisor.

“There are things you cannot control. If someone comes – whether it is the chemical industry or the European Commission or who else – and says ‘that’s a good idea,’ that does not necessarily mean that I have an affiliation with them,” said Dietrich, who is editor-in-chief of the journal Chemico-Biological Interactions and head of the Environmental Toxicology Research Group at the University of Konstanz in Germany.

Dietrich is a former advisor for the European Centre for Ecotoxicology and Toxicology of Chemicals, or ECETOC, funded by chemical, pesticide and oil companies. He also has co-authored research with Dow Europe and some pharmaceutical companies.

When asked if his industry involvement influenced his opinion about the proposed regulations, Bas Blaauboer, editor of the Toxicology in Vitro journal, said, “This is a very stupid question.”

“Working in a university, we have collaborations with people all over the world, including people who work in the industry, but we always have the freedom to say whatever we want,” Blaauboer said. “If you can trace any comment made by me back to the fact that it is influenced by this type of conflict of interest, just let me know, but you cannot find it.”

Blaauboer, a toxicology professor at Utrecht University in the Netherlands, received $ 529,370 in research funding from the European Chemical Industry Council, or CEFIC, between April 2008 and March 2010. He also is a member of a technical committee on risk assessment within the International Life Sciences Institute, or ILSI, an industry-funded institute.

Getting money from a mix of sources – including industry – is “the normal way” to do research nowadays, said Wolfgang Dekant, editor-in-chief of the Toxicology Letters journal and a toxicology professor at University of Würzburg in Germany. “You can’t do research anymore if you don’t go for money from all sources,” he said.

Dekant received chemical industry funds for a 2008 study of BPA and has signed 18 consultancy contracts in the past five years. He denied any industry influence.

Jan Hengstler, editor-in-chief of the Archives of Toxicology journal, wrote a 2011 review on BPA with an employee of a division of Bayer AG, the leading BPA producer, and a scientist who had been commissioned by the American Chemistry Council for another BPA review. The review concluded that “exposure represents no noteworthy risk to the health of the human population, including newborns and babies.”

Hengstler said in an interview that he has no current ties to industry. “I am only interested in scientific things,” he said. Hengslter is director of the Leibniz Research Centre for Working Environment and Human Factors at the Technical University of Dortmund in Germany.

Nigel Gooderham, editor-in-chief of the Toxicology Research journal, has current or past collaborations with the food, pesticide and pharmaceutical industries.

“I have nothing to gain from any company by signing that document. It was purely based on my scientific thinking and analysis,” said Gooderham, who is a professor of molecular toxicology at Imperial College London.

Sonja von Aulock, editor-in-chief of the ALTEX journal, has no known ties to industry. But she said that collaborating with industry “does not mean that the scientists are biased to the industry’s possible financial interests or that they are not making a statement they believe is in the best interest of public health.”

Olavi Pelkonen, Kerstin Stemmer, Hans Marquardt and Albert Li also acknowledged past or current collaborations but denied having any conflicts of interest. Abby Collier, Gio Batta Gori, Alan Harvey, A. Wallace Hayes, James Kehrer, Florian Lang, Frans Nijkamp and Kai Savolainen did not respond to requests for comment.

Officials from the European Commission stressed that the best available science will guide their endocrine-disruptor regulations.

“We all want our decisions to be based on science,” wrote Joseph Hennon, European Commission spokesperson for the environment, in an email response. “And we count on the scientific community to play its role and inform policy and decision-makers with facts and figures.

“The relationship between science and politics should be based on trust,” he added. “And we trust scientists to act independently for the benefit of all.”

Stéphane Horel, based in Paris, France, is a freelance journalist and documentarian who investigates conflicts of interest and influence on public health issues. She is working on a documentary about the regulation of endocrine disruptors in Europe.

Brian Bienkowski is senior editor and staff writer at Environmental Health News.

Food Safety News

Send Lawyers, Guns, and Money… Biological, Chemical and Radiological Inputs to Produce

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 EPA 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. The 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).

The FDA does not even mind raw sewage in produce production. In the prologue to the Rule the FDA 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 the 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,. The FDA seems to have ignored the consequences for foreign production in its handling of sewage sludge. Since the 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 the 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. The FDA’s Proposed Rule is silent on these issues as well.

The 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. http://water.epa.gov/scitech/wastetech/biosolids/tnsss-overview.cfm

(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.

http://www.regulations.gov/#!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

http://www.soil.ncsu.edu/publications/Soilfacts/ 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.

http://www.jhsph.edu/research/centers-and-institutes/johns-hopkins-center-for-a-livable- future/news_events/events/past_events/2012/will_allen.html

(8) Growing Power, Inc. Website:

http://www.growingpower.org

(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

http://www.gpo.gov/fdsys/pkg/CFR-2012-title40-vol31/xml/CFR-2012-title40-vol31- 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. August 06, 2013.

http://www.foodsafetynews.com/2013/08/iafp-2013-interview-with-keynote-speaker-dr- 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