The debates over the Food Safety Modernization Act (FSMA) started back in 2009 and appear nowhere near a conclusion. While one chapter of the story closed with the passage of the Act in 2010, the implementation process through agency rulemaking has been a hot topic ever since, and will continue to be so for a long time to come.
There have been some encouraging developments in the last few months, however. Both FDA and Congress have taken steps that will provide important opportunities for more scrutiny of the problematic regulations under FSMA.
First, in December, just a few weeks after the public comment period closed on the proposed regulations, the FDA announced that it will issue revised proposals on four of the areas that received the most criticism: water quality standards and testing, the standards for using raw manure and compost, provisions governing farms that do value-added products, and due process issues under the Tester-Hagan exemption for small-scale, direct-marketing farms and producers. The FDA plans to issue new proposed regulations on these issues in the summer of 2014 and seek a second round of public comments. (See sidebar for highlights of the original proposed regulations.)
It is not common for an agency to issue a second set of proposed regulations; and announcing the intention to do so within weeks of the public comment period closing on the first set is very unusual. FDA’s actions show that it heard that its first proposal was simply not acceptable and would not be allowed to stand.
Of course, while FDA got the message that the first proposal was unacceptable, it remains to be seen what FDA will do in the second round. Given just how bad the first set of proposed regulations were, even significant improvements could still mean a bad second proposal as well. But, regardless of their content, having a second round of proposed regulations at least provides another opportunity for farmers and consumer to weigh in and influence the process.
The second recent development is also unusual in the political world. As mentioned in the last couple of Wise Traditions articles, Representative Benishek of Michigan had introduced an amendment to the Farm Bill to rein in the FDA’s rulemaking under FSMA. While Congress typically would wait to see what the final rules looked like before taking action, this time they decided to act earlier—the final Farm Bill includes the Benishek amendment in a somewhat weakened form.
As passed, the Farm Bill requires the FDA, when it publishes a final produce safety rule, to also publish an economic analysis as well as an analysis of the scientific information used to develop the final rule, “taking into consideration any information about farming and ranching operations of a variety of sizes, with regional differences, and that have a diversity of production practices and methods.” Even more importantly, the Farm Bill requires the FDA to publish a plan to systematically evaluate the impact of the final rule on farming and ranching operations. The agency must further develop an ongoing process to evaluate and respond to business concerns. The Farm Bill also calls on the Comptroller to report on an annual basis to the House and Senate Ag Committees about how the evaluation and response process is going.
While this is not as strong as the original Benishek amendment, it is still a step forward and sends a signal to the agency that Congress will continue to be involved, and not just leave food safety regulations in the bureaucrats’ hands. The required process for evaluating and reporting the impacts of the rule will also provide opportunities for change in the future, if FDA’s final rules prove unworkable.
At the same time, public awareness of the issues continues to increase. In February, the L.A. Times published an article focusing on the FDA’s visit to an organic farm and the threat posed by the regulations to organic farmers. The Center for Science in the Public Interest (CSPI) showed its ignorance and bias, claiming that the regulations would only cost a “few cents” to “tweak” farming practices. Rather than acknowledge the excellent safety record of sustainable farms, CSPI’s view is that manure should not be allowed on the farm; instead, it should be trucked off the farm to compost at a commercial facility under the FDA’s proposed regulations, and then be trucked back to the farm. Sadly, CSPI and groups like it simply don’t understand, and don’t seem to want to understand, the realities of farming healthy food. CSPI is opposing the changes to the proposed regulations and pushing for FDA to move forward with the original version.
CSPI is not the only group that claims to speak for consumers and is pushing for the FDA to move forward. The Center for Food Safety (CFS) sued the FDA in 2012 to try to force it to issue the FSMA regulations quickly. Last summer, the district court ruled against FDA and set deadlines for issuing the regulations. FDA appealed, but recently reached a settlement with CFS, creating a new time line for finishing the food safety law rules. The settlement allows the FDA to extend the deadlines for food safety regulations only if CFS and the other plaintiff (the Center for Environmental Health) agree. Under the settlement, the FDA has agreed to issue a final rule for facilities by August 30, 2015, and a final rule for on-farm produce safety standards by October 31, 2015.
While the facilities and on-farm proposed rules have deservedly drawn the most attention, other aspects of implementing FSMA also require comment. In response to the comments on the produce safety rule, FDA has acknowledged that the rule will have a significant impact on the environment, which means that the agency must perform an Environmental Impact Statement. WAPF weighed in at the first stage of the process, submitting comments on the sorts of issues and impact FDA should consider. As the agency takes its next steps, public input will become more and more important.
WAPF also submitted comments on yet another proposed FSMA rule, this one dealing with intentional adulteration. FSMA directed FDA to address the threat that the U.S. food supply is vulnerable to intentional actions, whether by terrorists or economic interests seeking to disrupt the food supply. Sadly, both Congress and the FDA continue to ignore the true solution to this problem: decentralizing and re-localizing our food system. Instead, FDA’s proposed rule involved yet more paperwork for companies to analyze and address the risks. Most WAPF-friendly producers will be exempt, since the proposed rule exempts facilities with less than ten million dollars in annual revenues, as well as most farms. But the agency is looking at setting a different threshold for dairy farms, which was the focus of WAPF’s comments.
At the risk of stating the obvious, the situation with FDA and the implementation of FSMA poses many dangers to our farmers and food producers. Through the work that WAPF, its members, and many other organizations have done in the last four years, we have won important victories that limit the damage FSMA will do and have had a significant impact on the implementation of the law. But like so much in the political arena, we could easily lose those victories if we do not stay involved and active. As I’ve written many times before, stay tuned!
UPDATE ON GMOS
While the FDA focuses on the supposed threat of foodborne illness from compost, it continues to ignore the health threats posed by genetically engineered foods or GMOs. But as more and more Americans learn about GMOs, the issue is heating up at an increasing pace.
In the world of scientific research, the fight against GMOs suffered an unexpected and unwarranted setback. In November, the journal of Food and Chemical Toxicology retracted the paper by Professor Séralini, which found severe toxic effects (including liver and kidney damage), increased tumor rates and higher mortality in rats fed Monsanto’s genetically modified NK603 maize and/or the associated herbicide Roundup. The journal’s editor admitted that none of the usual criteria for retraction applied (there was no fraud, etc.), but claimed that the “inconclusive” nature of the results was the basis. Using that reasoning, however, large numbers of scientific studies should be retracted. The appropriate course of action would be for critics to conduct studies to prove or disprove the hypotheses, not to retract the study.
Fortunately, another study, the Carman study, is still available for citation. This long-term study on the effects of feeding genetically engineered grains to livestock was published in the Journal of Organic Systems last summer. The researchers found statistically significant increases in severe stomach inflammation in the pigs fed GMOs, as well as an increase in the size of the uterus in female pigs fed GMOs. The results are deeply concerning for anyone who suffers from or has a loved one who suffers from digestive problems, food allergies or fertility challenges. Both studies remain available at www.farmandranchfreedom.org/gmo/ gmo-studies-research/
One just-published study goes to the underlying issue of GMO labeling: are GMO crops “substantially equivalent” to non-GMO crops? The common-sense answer is “no,” and the study substantiates that. The study analyzed three groups of soybean samples: 1) GMO soybeans, 2) non-GMO soybeans grown conventionally (with chemicals), and 3) non-GMO soybeans grown organically. Results showed that the organic soybeans had the healthiest nutritional profile (although they had less saturated fat) than the conventional and GMO soybeans. In addition to being less nutritious, the GMO soybeans also contained significant levels of glyphosate (the herbicide used on Roundup Ready crops) and aminomethyphosphonicacid (AMPA). AMPA, the chemical compound that glyphosate breaks down to, is even more toxic than glyphosate. While the residue levels are below the EPA’s tolerance levels, they are dramatically higher than levels shown to cause severe harm to beneficial microorganisms that are needed in the digestive tracks of both livestock and humans.1
On the political side, bills to label or otherwise limit GMOs are being considered in twenty states this year. Two states, Colorado and New Hampshire, have already rejected legislation, and some others will inevitably fail—it is an uphill battle to pass any bill, and GMO labeling bills face extremely well-funded and well-connected opposition. But there are several that look particularly promising.
Vermont may be the first state in the nation to require GMO labeling with no strings attached (remember that Connecticut’s and Maine’s bills include “trigger clauses” that require other states to adopt the laws before they go into effect). The House passed the bill by an overwhelming majority last year, and the bill, H. 112, has been cleared by the Senate Agriculture Committee. Currently the Judiciary Committee is considering it and is likely to hold hearings early in March.
Hawaii is another hotbed of citizen action on GMOs. Last year, several individual islands passed measures restricting the cultivation of GMO crops and the use of pesticides. This local pressure has led to the state legislature weighing in. SB 2454 seeks to establish a task force to assess what actions, if any, the state should take on the cultivation of GMOs. The group would have to issue a report with recommendations to the legislature in 2016. The bill has been approved by Senate committees on agriculture, ways and means, education and the judiciary and labor, and appears poised to soon head for a full vote. A second measure, SB 2521, would require the labeling of GMO foods, and has cleared Senate committees on health, the judiciary and labor.
California is back on the GMO legislative scene also. Although Prop 37 was narrowly defeated in the 2012 ballot initiative, it seems that lawmakers in Sacramento are ready to tackle the GMO labeling issue themselves. SB 1381 was introduced by Senator Noreen Evans, who has described the bill as a “cleaned up” version of the ballot initiative, placing the burden for labeling on food manufacturers and closing loopholes that opponents of the 2012 measure said would result in frivolous litigation.
The other states considering measures are Alaska, Arizona, Florida, Maryland, Michigan, Missouri, New Jersey, New York, Oklahoma, Oregon, Rhode Island, Tennessee, Utah and West Virginia.
At the federal level, the long-awaited and dreaded approval of crops engineered to be resistant to the herbicide 2,4-D is getting closer. The USDA released its environmental impact statement in January and acknowledged that approval of the crops would significantly increase the amount of 2,4-D used in agriculture; by some estimates, the increase would be twenty-five-fold. Yet the USDA completely failed to address the impacts this increase would have. As this article goes to print, the public comment period is drawing to a close, and it remains to be seen how USDA will respond to the outrage generated by its plans to approve these “Agent Orange” crops.
In an overlapping comment period, USDA also sought public input on the issue of co-existence, namely the “concurrent cultivation” of GMO and non-GMO crops. As WAPF states in its comments: “The track record from the last twenty years of coexistence of genetically engineered and non-genetically engineered crops shows that our existing system is not workable and not equitable.” WAPF submitted extensive organizational comments that concluded with several recommendations, including urging the agency to:
1. Establish mandatory measures that prevent GE contamination. Our country has used voluntary measures for the last twenty years, and they have failed. Furthermore, education alone cannot prevent contamination. USDA must mandate best practices to prevent GE contamination by all farmers who use GE seed and require concrete contamination prevention measures on their farms, such as requiring farmers planting GE crops to use buffer zones, rather than placing that burden on non-GE farmers. Included in these measures should be a halt in the planting of GE crops whose pollen is easily spread long distances, such as alfalfa, canola and sugar beets.
2. Adopt a fair compensation proposal. The patent holder should be responsible for segregation and traceability, from seed to plate. They should be held responsible for the economic and market harms their products cause. Those who promote, profit from and use GE products must be responsible for preventing contamination and for covering the financial risks associated with contamination.
The free market can only work if certain conditions are met. One of the conditions is that the price of the item reflect its true cost—something that the biotech companies have avoided so far. Another condition is that buyers have the information they need to make informed choices, another missing item in our current system. It’s time for our food system to address these basic issues.
FDA’S PROPOSED FOOD SAFETY REGULATIONS
In 2013, the FDA proposed regulations to implement two key provisions of the Food Safety Modernization Act (FSMA): a produce safety rule for farms and a hazard analysis and risk-based preventive controls (HARPC) rule for facilities. The twelve hundred pages of proposed regulations contained numerous problems, of which several stood out as major issues for sustainable farmers and food producers. Specifically, the proposed regulations:
1. Required a nine-month waiting period between applying manure and harvesting a crop;
2. Treated compost tea with additives (such as molasses or kelp), static compost, vermicompost, and many other types of biological inoculants the same as raw manure, with the same nine-month waiting period;
3. Required weekly testing of the water by farmers who use surface water sources, such as ponds or creeks, for irrigating;
4. Applied recreational standards to water sources, so that the presence of relatively low levels of generic E. coli— which is not pathogenic—would require the farmer to either treat the water source with antimicrobial compounds or stop using it;
5. Treated many farmers as processing “facilities” simply for making common value-added products;
6. Empowered FDA officials to revoke a food producer’s Tester-Hagan exemption (which protects small, direct-marketing farms and processors from the imposition of the new on-farm produce safety standards and HARPC rules) without any due process or effective recourse for the producer.
WAPF, its members, and many others objected to these unnecessary and costly provisions in the proposed rules. In its December announcement, the FDA acknowledged the outcry and stated that it would issue revised proposed regulations on these topics in the summer of 2014.
1. T. Bohn et al, Compositional differences in soybeans on the market: glyphosate accumulates in Roundup Ready GM soybeans, Food Chemistry 153: 207-215 (2014).
This article appeared in Wise Traditions in Food, Farming and the Healing Arts, the quarterly journal of the Weston A. Price Foundation, Spring 2014.