Food Safety: I Don't Want to Play Referee

by: Jill Richardson

Wed Jul 15, 2009 at 15:40:19 PM PDT

UPDATE: Previously I wrote here that a six year old had recently died from E. coli. I was mistaken. I had misread a post on Bill Marler's blog about a six year old who died many years ago.

So here's what I'm going to do. I'll post arguments from both sides (below). I won't tell you what to think, because to be honest, I don't know what the right solution is. I think there are a few common ideas we can agree on though:

1. The major food processors should be regulated more strongly than they are now. It's not OK for people to die from peanut butter or burgers.

2. Small farmers and small businesses that are not responsible for the majority of food safety problems should not be harmed by regulations. By virtue of their size, they are unable to inflict the damage on our food system that larger businesses are capable of. While they are not guaranteed safe (nobody is), the benefit they provide to our food system is far greater than any food safety problems they pose.

3. Like it or not, farm fields will never be sterile like laboratories.

4. The real source of much of our pathogens are factory farms and we should begin addressing the problems there. It is NOT possible to have a clean, safe, healthy factory farm.

Why the Waxman Bill is Better

This week the San Francisco Chronicle published a front page article describing how in a quest for food safety, environmental havoc is being wreaked upon the Monterey Bay leafy green growing area. It describes how a farmer is ripping out plants because his big customers demand sterile buffers around his crops.

Consumers Union has been campaigning for several years for improvements in our food safety system, but we have been opposed from the start to this "marketing agreement" approach to insuring food safety. Following the deadly outbreak of E. coli in spinach in 2006, the large leafy green processors including Dole and Chiquita/Fresh Express banded together to create a California Marketing Agreement that mandated certain practices for farmers who supplied them. Consumers Union opposed this Agreement because it was created by big processors behind closed doors without any input from the public, consumers, scientists or environmental agencies. The environmental problems we are seeing now, described in the Chronicle, are the result of that closed door process.

The Chronicle was off base however in implying that the Waxman-Dingell FDA reform bill now before the House of Representatives is a vehicle for making this approach "go national." In fact quite the opposite. Do we need new food safety standards and enforcement? Yes. How could anyone look at the three deaths from contaminated spinach two years ago, or the nine deaths this year from contaminated peanut butter, produced in a factory loaded with dirt and dead rats which the FDA had not inspected for eight years, and not think so? But private, closed-door, industry-created standards are not the answer. Though it might seem like an old-fashioned concept, we believe in standards created and enforced by a public agency, for the public good.

Consumers Union supports Waxman's bill because it directs FDA to create on farm regulations, and also, unlike the private marketing agreements, directs the agency to take effects on wildlife habitat, small-scale and diversified farms, watershed protection efforts and organic production methods into account. FDA would have to propose any regulations for public comment and take input from farmers, consumers, scientists, environmentalists, and Congress. We urgently need new standards to keep deadly bacteria out of food. Private industry marketing agreements are not the answer.

Likewise, the Farmer to Consumer Legal Defense Fund has posted an alert, calling out the Waxman bill (HR 2749) as a disaster and asking us to oppose its passage. I'm of the mind that parts of the bill are crucially needed, although the Legal Defense Fund has some good points. Furthermore, I think some of the more necessary parts of the bill are not the same sections as the areas the Legal Defense Fund finds most objectionable. You can read the Legal Defense Fund's arguments here. Another group (the Western Organization of Resource Councils) more or less agrees with them, and Consumers Union Disagrees. Posted below are first WORC's arguments, then Consumers Unions, and THEN the Legal Defense Fund's repsonse to Consumers Union.

From Western Organization of Resource Councils (WORC):

Local foods businesses are not the same
as animal factories or mega-farms that sell products into industrial scale national and international markets.

H.R. 2749 - Food Safety Enhancement Act of 2009
Lead Sponsor: Rep. John Dingell
The House of Representatives is working on H.R. 2749, the Food Safety Enhancement Act of 2009. It's an attempt to address the worst problems in
U.S. agriculture, but as it stands the bill threatens to undermine the best things in U.S. agriculture - small farmers producing for local markets. H.R. 2749 is a well-meaning attempt to address the genuine problems of contamination from
foodborne pathogens and complications in prevention and intervention caused by large, industrialized food distribution systems. All of the well-publicized incidents of contamination in recent years - spinach, peppers, peanuts, hamburger - occurred in industrialized food supply chains that span national and even international boundaries. Food safety is a priority shared by all. It is not compromised by the growing trend toward healthy, fresh, locally sourced vegetables, meats, fruits, and small processing firms reinvigorating local food systems. The following priorities need to be incorporated to make food safety and healthy local food systems complementary. Local food systems are inherently safer and traceable.

Record keeping should not strangle small producers selling into local markets
Record keeping and traceability are essential in long industrialized supply chains. For direct market produce growers, elaborate reporting and record keeping requirements, including mandatory electronic filing, do not make sense, as the buyer knows where the food comes from. For sales to local retailers and restaurants, records should be kept to a minimum, and should be flexible - on file on paper or electronically.

Under the legislation, FDA will develop rules for record-keeping. The bill should add language to ensure that direct market produce growers be consulted and included as a unique category of business in the rulemaking process.

Registration and fee structures should recognize small home-based and farm-based local processing

Farms that sell directly to the consumer or to a retail outlet or restaurant are exempt from registering with the FDA. However, if a farm makes jams and sells them it would need to register with the FDA and pay a $500 annual fee, same as food giants like Del Monte.

FDA oversight of small, local food processors is overreaching and unnecessary

The size and extent of industrial processing (including multiple sourcing, etc.) should play a significant role in determining the level of inspection, record keeping, and traceability requirements mandated and overseen by the federal government. Small local processors selling into local markets do not need federal oversight appropriate for large, industrial, multi-sourced supply chains. The legislation permits delegating some oversight responsibilities to the states. There should be a clear threshold where state and local public health and sanitation laws and authorities are sufficient.

All facilities subject to registration under theAct, including those only engaged in intrastate commerce, are subject to federal inspection. The large recalls during the last several years have all involved facilities that shipped interstate. The Act should set a jurisdictional threshold based on scale and extent of distribution. Since foodsheds often span a state-line, these may be most appropriately defined as a mileage radius.

HACCP undermined local and regional meat packers while failing to increase inspections and
safety of large industrial meat processors
For meat processors, the Hazard Analysis and Critical Control Point (HACCP) system adopted by the U.S. Department of Agriculture in the 1990's effectively reduced the number of small regional packers by creating a maze of paperwork and red tape that many were unable to manage, while failing to reduce the increasing incidence of food borne pathogens in the large industrialized meat packers. The HACCP system all but eliminated the number of independent inspections of the large industrial slaughterhouses. It is critical that Congress not replicate the ineffective systems that failed in the meat industry.

H.R. 2749 extends HACCP type models to produce, with potentially disastrous consequences for small producers.

Imports need sufficient scrutiny to ensure public health is not at risk
Increased scrutiny, inspection and enforcement of safety of food imports is a good idea to protect public health. There needs to be a level playing field between U.S. farmers and global competitors. H.R. 2749 adds some labeling and inspections of imports, but it needs to be stronger to protect public health. Free trade agreements, such as the North American Free Trade Agreement (NAFTA), give carte blanche to agricultural products coming in from trade partners whose standards and systems of inspection may be grossly inferior. H.R. 2749 needs to go further to study imported foods and ensure they are held to the same standards as U.S. products.

FDA will establish standards for safe growing, harvesting, packing, sorting, transporting and holding of raw agricultural commodities
It is over-reaching to establish federal farming standards for produce that is not going into interstate commerce.

Care should be taken not to duplicate systems. Products that are already certified under other rigorous certification standards (e.g. organically certified, etc.) should be exempted.

Consumers Union's response to the Legal Defense Fund's allegations:

The Farm to Consumer Legal Defense Fund (FCLDF), a group primarily devoted to preserving the right to sell raw milk, has mounted a vociferous internet campaign to defeat HR 2749, the Food Safety Enhancement Act (FSEA), alleging that the bill will hurt small farms. The bill was recently received unanimous approval from the House Energy and Commerce Committee and is on its way to a floor vote. Food Freedom has made even more alarming allegations, suggesting that the bill might require a $500 registration fee for every backyard garden and lead to a Monsanto takeover of the food system.

Good grief! Is any of this true? Here we take a close look at some of the more frightening claims.

Food Freedom asks whether the registration fee ($500 on any "facility" that holds, processes, or manufactures food) would apply to every home in the U.S. and every home garden.

CU Responds: No, of course not. In fact the bill applies to no homes or home gardens, nor any farms. The $500 registration fee is only for domestic and foreign manufacturing or processing facilities that sell products in the US, facilities that are in fact already required to register with the FDA. The bill does not expand the scope of who has to register as a facility, but it does make "facilities" as defined in the bill bear their fair share of the cost to inspect them.

Food Freedom claims HR 2749 would empower FDA to regulate how crops are raised and harvested. "It puts the federal government right on the farm, dictating to our farmers." The blog goes on to theorize that FDA would use this purported new power to eliminate most organic farming and force all producers to adopt industrialized farming methods such as pesticides, fertilizer and genetically engineered seeds.

CU Responds: The FSEA does empower FDA to establish safety standards related to use of manure, irrigation water and other farming practices specifically to prevent microbial contamination that causes illness, such as the deadly e. coli 0157:H7 that contaminated bagged spinach and cause three deaths including young children in 2007. However the FSEA in no way calls for elimination of manure or for use of GMOs, chemical fertilizer or pesticides. In fact the bill calls on FDA "to take into consideration, consistent with ensuring enforceable public health protection, the impact on small scale and diversified farms, and on wildlife habitat, conservation practices, watershed protection efforts, and organic production methods."

FCLDF says that the bill will create random, warrantless searches of business records.

CU Responds: H.R. 2749 does not in any way empower FDA to conduct random warrantless searches of business records. The FSEA does provide, importantly, that FDA can have access to business records when it conducts an inspection to check whether plants are safe and complying with the law. It must inspect high risk food processors at least once a year. The need for this provision was highlighted by the behavior of the Peanut Corporation of America (PCA), which hid records of 12 positive test results for Salmonella contamination of its peanut products from state inspectors. Salmonella in PCA products eventually caused more than 700 reported illnesses and nine deaths.

FCLDF says that HR 2749 would give FDA the power to order a quarantine of a geographic area, including "prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area."

CU Responds: H.R. 2749 authorizes quarantine only if there is credible evidence of an imminent threat of serious adverse health consequences or death to humans or animals from a food item originating in a geographic region. The quarantine is limited to the area that FDA can demonstrate must be isolated in order to protect public health, and to the extent practical, it must be of limited duration.

FCLDF notes that HR 2749 charges the Secretary of Health and Human Services with establishing a tracing system for food. Each "person who produces, manufactures, processes, packs, transports, or holds such food" would have to "maintain the full pedigree of the origin and previous distribution history of the food..." Turning up the heat, Food Freedom theorizes that this could apply to every home.

CU Responds: No, it is not every home. H.R. 2749 H.R. 2749 specifically exempts food sold direct to the consumer (e.g. at a farm stand) or to a restaurant or grocery store from the tracing provisions. The bill does require FDA to issue regulations within two years to establish a system for tracing a food sold in interstate commerce back to its point of origin, whether domestic and imported food, with two days. This is needed because of the difficulty FDA currently has in identifying the source of food borne disease outbreaks. In the summer of 2008 it took the FDA months to ultimately identify and trace back Mexican peppers as the source of a salmonella outbreak that was making thousands of people sick. In addition to the specific exemptions noted above, the bill also exempts animal products, which are regulated USDA, from the tracing provisions. Finally, FDA can also exempt other processors if FDA determines that tracing their products is not necessary to protect public health.

Both FCLDF and Food Freedom complain about the creation of criminal penalties and increased fines.

CU Responds: Yes, the bill provides for criminal penalties: prison terms of up to 10 years and fines of up to $100,000 for each violation. People who sell food that they know is likely to kill or sicken people should be severely penalized. They harm the public as well as damage the business of other food producers and processors. The owner of the PCA plant shipped peanut products that he knew were contaminated and which wound up killing nine people. We believe that the penalties for such behaviors should be severe. Criminal penalties are imposed as a result of criminal prosecutions in the courts under the standard rules of federal criminal procedure.

Here's what the Legal Defense Fund says in response:

Consumers Union (CU) recently posted a defense of HR 2749 that casually dismisses concerns the bill would hurt small farms and local food businesses.  The CU avoided addressing the Farm-to-Consumer Legal Defense Fund's detailed analysis, which is posted at http://www.ftcldf.org/news/new... and conflated arguments made by FTCLDF with statements made by anonymous individuals and posted on a blog.

H.R. 2749, the Food Safety Enforcement Act (FSEA), adds over 130 pages to the Food, Drug and Cosmetics Act with myriad new requirements and penalties for violations.  The FTCLDF agrees that the industrial food safety system has serious flaws and needs to be fixed. The country has seen numerous outbreaks of foodborne illnesses caused by imported foods or domestic foods that were processed in huge facilities and shipped throughout the country.  Unfortunately, HR 2749 does not focus FDA's efforts on these very real problems.  Instead, it creates a regulatory framework that will heavily burden the small farms and local food processors, the very people who provide a safe, healthy alternative to the industrial food supply.

Food safety is a priority shared by everyone.  The FTCLDF calls on Consumers Union and the other groups supporting HR 2749 to explain exactly how the bill would address the industrial food supply problems without harming the local food movement.  The fact that massive, industrial food companies, such as Peanut Corporation of America, have killed or sickened people is a strong argument for regulating such companies, and we applaud CU's efforts to improve the industrial food supply.  But the wrongs committed by these companies are not a valid basis for harming the hundreds of thousands of safe, healthy small farms and artisan producers who will be burdened, or even driven out of business, by HR 2749.

Issue 1: Registration fees
FTCLDF agrees with Consumers Union that the registration and fee requirements of HR 2749 do not apply to individuals' home or gardens if those individuals are not selling food to anyone else.  The Fund's website states: "The agency's regulatory power is limited to commerce, so non-commercial activities (such as growing your own vegetables for personal consumption) are not regulated."  (http://www.farmtoconsumer.org/news/news-HR2749-FAQ.htm)

But CU's statement that the registration requirements do not apply to farms depends on one's definition of "farm." While the statute excludes "farms," the FDA's current regulations take a very narrow view of what qualifies.  Under the existing regulations, a place that grows food and does any processing of that food for sale would not be a farm, and thus would be subject to HR 2749.  See 21 CFR § 1.227(3) and (6).   In other words, a farm that washes greens, cut vegetables, or dries fruit before selling it would be forced to register and pay the annual fee under the regulatory definition of "farm."  Currently, FDA has a guidance document that modifies the regulation and allows "farms" to process food so long as the ingredients are grown on the same farm.  Even under the guidance document, many small farms and artisanal producers could be required to register.  FDA has not strictly enforced this requirement so far, but that is no guarantee about future actions by the agency.  And if the agency were to revoke the guidance document and enforce the registration requirement in accordance with the definition of "farm" contained in the regulations, many farms would be required to register and, under the FSEA, pay an annual fee.

Moreover, farms are not the only issue.  There are thousands of individuals who are making artisan foods, such as making jams, breads, fermented vegetables, cheese, or other foods, which they sell to directly to customers at local farmers markets and similar venues. All of these individuals would be forced to pay an annual fee of $500 to the FDA and comply with extensive paperwork burdens.  Notably, the fee is the same regardless of whether it applies to an individual selling a few hundred dollars worth of product or a multi-million dollar company shipping products all over the country.

It is not equitable for a local grandmother making jam from farmers' excess fruit to have to pay the same fee as a Heinz processing plant.  Nor does the FTCLDF believe local artisan food processor should be subject to the same extensive paperwork requirements as the massive industrial processing plants.

Issue 2: the regulation of how farms grow and harvest crops
FTCLDF agrees with Consumers Union that HR 2749 does not call for the elimination of organic practices.  However, the bill's provision directing the agency to set standards for how food is grown and harvested is very troubling.   For example, after the E. coli outbreak linked to spinach that was grown in California and then processed and sent all over the country, the agency developed guidelines that were based entirely on the industrial agriculture model: farms growing thousands of acres of monoculture crops situated next door to huge confined animal feeding operations.  The guidelines were expensive, burdensome, and wholly unnecessary for small, diversified farms.

After FTCLDF issued its first alert, HR 2749 was amended to direct FDA "to take into consideration, consistent with ensuring enforceable public health protection, the impact on small scale and diversified farms..."  While this is an encouraging step, it does not provide sufficient protection.  The FDA has yet to demonstrate that it has any understanding whatsoever of the needs of small scale and diversified farms.  And the new language does not prevent FDA from developing standards that drive such farms out of business under the guise of developing "enforceable standards."

No one has demonstrated any need for FDA to regulate growing practices on small and diversified farms.  No major outbreaks have been traced to such farms.  There is nothing to be gained, and much to be lost, by granting FDA this authority.

Issue 3: Warrantless searches
CU states that HR 2749 does not authorize FDA to conduct random, warrantless searches.  But the bill does empower the agency to obtain all documents relating to "the production, manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location."  See Section 106(a)(1)(B).  These extensive records must be produced whenever FDA decides to do an inspection, even without a warrant.

These requirements may be appropriate for large-scale production facilities, such as the Peanut Corporation of America that CU uses as an example, but consider the implications for small-scale artisan producers, many of whom maintain commercial kitchens within their own homes.  HR 2749 calls for the inspections to be conducted on a random basis.  See Section 105(a).  There is no requirement that the agency suspect any wrongdoing before conducting this burdensome, intrusive search.  A "low-risk facility that manufactures or processes food" - such as a local jam maker or baker - would be subject to such an inspection every 18 months to 3 years.  FTCLDF does not believe that inspecting small, local producers, including demanding all of their records, is the best use of limited resources to protect food safety.

Issue 4: Quarantines
As originally drafted, HR 2749 authorized FDA to quarantine "any geographic area within the" U.S., including "prohibiting or restricting the movement of food or of any vehicle being used or that has been used to transport or hold such food within the geographic area." See Section 133(b)(1) of the Subcommittee's version of HR 2749.  After the FTCLDF issued its first alert, the bill was amended to provide some limits to this power, and it now states that the quarantine "shall be no greater than is appropriate, as determined by the Secretary, to protect the public health." See Sec. 133 of the Committee's version of HR 2749.  While this is a positive change, the bill still sets a low standard for the agency to make to use this extreme power.  Consider the damage that was done to tomato growers in 2008 because of the agency's inaccurate claim that tomatoes were causing a salmonella outbreak.  The FDA's track record does not support giving it such broad power without even the minimal requirement of having to obtain a court order.

Issue 5: Traceability requirements
FTCLDF agrees with Consumers Union that the traceability requirements of HR 2749 will not apply to every single person's home.  The agency's authority is limited to food in commerce, not personal consumption.

However, Consumers Union incorrectly implies that the traceability requirements are limited to interstate commerce by stating that that the bill requires FDA" to establish a system for tracing a food sold in interstate commerce."  HR 2749 contains no such limitation, and simply states that the agency shall "establish a tracing system for food that is located in the United States or is for import into the United States."  See Section 107(c)(1).

HR 2749 exempts direct farm-to-consumer sales, but only when all of the ingredients are grown on the same farm.  For example, a farmer who sells peaches grown on his farm would be exempt from the traceability requirements.  But if that same farmer sells his peaches to a neighbor who makes jam out of it and sells that jam at a local farmers market, the farmer and jam maker would both be subject to the traceability requirements.  These requirements include maintaining a "full pedigree of origin and previous distribution history of the food" in a manner that "is interoperable with the systems established and maintained by other such persons."  See Section 107(c)(2)(A)(i)(I) and (III).  The language of the bill is far from clear, and could easily result in small food makers being required to keep extensive electronic records.

Traceability is of value in long industrialized supply chains, in which large commercial processors ship food all over the country or internationally, such as in the example of the Mexican peppers cited by Consumers Union.  But the same requirements should not apply to small, local producers, where they are unnecessary and overly burdensome.

Issue 6: Penalties
FTCLDF agrees with Consumers Union that people who sell food that they know is likely to kill or sicken people should be severely penalized.  But HR 2749's severe penalties --  including up to 10 years in prison or $100,000 fines for individuals - are not limited to those situations.  These penalties are not appropriate for Amish farmers who have religious objections to electronic registration, local bakers who do not fill out the required paperwork, or the thousands of other individuals who could be jailed or fined for actions that do not create a threat to human health.  Moreover, under the bill, "each day during which [a] violation continues shall be considered a separate offense," meaning farmers can easily rack up large fines for what would be minor offenses.  See Section 135.

Conclusion
HR 2749 is seriously flawed because it does not require FDA to focus on the real threats to food safety: imported foods and industrial domestic foods shipped all over the country.  Instead of ensuring effective, on-the-ground inspection, the bill focuses on paperwork requirements that are ineffective and counter-productive.  At the same time, it imposes extensive, burdensome federal regulation on small, local farms and businesses, which have not been the source of the major food recalls.  It would be best to start over with a new bill that addresses the real problems from the beginning.

The FTCLDF calls on the Consumers Union and other organizations supporting HR 2749 to address the potentially crippling effect the bill would have on the nation's small farms and local food processors rather than dismissing these issues.