Friday, January 04, 2013

At Last: FDA Releases Two Proposed Rules For Food Safety Modernization Act

One size doesn't fit all:  FDA's draft regulations offer different rules based on size of food production operations and farms, many exemptions, and a long time frame for implementation...
Two years to the day after President Obama signed into the law the sweeping FDA Food Safety Modernization Act, the Food and Drug Administration on Friday released two proposed rules required by the measure, which cover produce safety and requirements for implementing food safety procedures and recall protocols for domestic and foreign-produced food, at farms and food producing facilities of all sizes.  These are now open for public comment for 120 days.  

In the wake of repeat foodborne disease outbreaks that have sickened millions of Americans and killed thousands, such as the deadly outbreak of listeria in cantaloupe that killed 33 people in 2011, the long-awaited draft regulations--buried at the Office of Management and Budget since late 2011--offer 'science based' reforms, and call for more vigilance from farmers and food producers to guard against microbial contamination.

"The rules go very directly to preventing the types of outbreaks we have seen," said Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, at a noon press conference. 

In the last decade, contamination of peanut butter, spinach, sprouts, leafy green vegetables, peppers, tomatoes, melons, mango, and spinach have been responsible for large foodborne disease outbreaks and deaths, from bacteria, parasites, and pathogens, including the deadly E. coli O157:H7, E. coli O157, Salmonella, Listeria monocytogenes, Cyclospora, Shigella sonnei, and Hepatitis A. 
The first proposed rule, Standards for Produce Safety, covers operations at fruit and vegetable farms, calling for things like worker training, clean water, and monitoring the presence of animal waste in crop rows.  In an effort to block protests from farmers, it applies only to certain fruits and vegetables that pose the greatest risk, like leafy greens, berries, melons, and other foods that are typically eaten raw.  For example, a farm that produces green beans that will be canned and cooked won't be regulated. Pumpkins and sweet potatoes, typically consumed cooked, are exempt.

The FDA estimated that the produce regulations would cost a large farm close to $30,000 annually.  But qualifying farms that sell less than $25,000 annually in their own states or within 275 miles are exempt from the produce rules.

The second proposed rule, Preventive Control for Human Food, requires food processors to develop and follow detailed plans for preventing contamination of their products when being handled, packaged, stored, and transported.  Among other things, it calls for worker training, and proposes that things like hot water, soap, and toilet facilities be made available to workers.  It also has exemptions based on size of the operation.  Specific foods are also exempt, such as jams and jellies and honey and maple syrup.

Still, the rules offer modest direct enforcement from FDA, which has a limited budget that could grow smaller in the coming months, as well as a limited number of inspectors.  FDA monitors about 166,000 food production facilities that account for about 80% of the food that is consumed in the USThe pricetag for the original legislation was estimated at $1.5 billion by the Congressional Budget Office. 

There are no criminal penalties for those who fail to comply with the proposed regulations once these are finalized, and FDA has not yet leased strict guidance on implementation.

"It's all well and good to set the rules and expect companies to comply without enforcement," said Bill Marler, a preeminent food safety expert and advocate and partner in Seattles' Marler Clark law firm, who has won some of the biggest lawsuits in history following deadly foodborne disease outbreaks.

"Recent history shows the need for both rules and enforcement, Marler said.  "Having consumers protected through lawsuits as the enforcement mechanism is a blunt instrument for changing behavior.  I think there also needs to be more inspections and more criminal prosecutions."

A long time frame...
The legislation became law after a pitched battle that lasted more than 18 months during the 111th Congress.  Last August, in a suit filed by food safety advocates, the Obama Administration was sued in Federal court for missing by more than a year the deadline for issuing the rules required by the measure.

But after the final rules are issued there will be further waiting for a better food safety landscape, because there is a long time frame for implementation, based on size of farms and production facilities. The preventive controls rule will go into effect in part one year after the final rule is approved, while the produce safety rule will go into effect in part more than two years after a final rule is released.  

Small and "very small" facilities and small and "very small" farms will have even more time to act on the rules.  They are also exempt from many of the requirements in both proposed rules. 

"We know one-size-fits-all rules won’t work," said FDA's Taylor.  "We’ve worked to develop proposed regulations that can be both effective and practical across today’s diverse food system." 

Each year, about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases, according to estimates from the Centers for Disease Control and Prevention, though the actual numbers are probably far higher, and difficult to calculate.   FDA said the proposed produce regulation alone will not only reduce foodborne illness, but also reduce the burden of healthcare costs. 

"We estimate the number of foodborne illness prevented by this regulation to be 1.75 million, with an associated benefit of $1.04 billion, annually," FDA said. 

To develop the long-awaited rules, FDA said it "conducted extensive outreach that included five federal public meetings and regional, state, and local meetings in 14 states across the country as well as making hundreds of presentations to ensure that the rules would be flexible enough to cover the diverse industries to be affected."  Representatives also visited farms and facilities of varying sizes.

“The FDA knows that food safety, from farm to fork, requires partnership with industry, consumers, local, state and tribal governments, and our international trading partners,” said FDA Commissioner Margaret A. Hamburg, M.D. in a statement.  

“Our proposed rules reflect the input we have received from these stakeholders and we look forward to working with the public as they review the proposed rules.”

Erik Olson, director of food programs at The Pew Charitable Trusts, today congratulated President Obama and FDA for the draft regulations.

"President Obama today has taken an important step forward in the fight to save lives, prevent foodborne illnesses and lower health-care costs," Olsen said in a statement. "...Once it is in full effect, FSMA will, for the first time, empower the Food and Drug Administration to take sweeping measures to prevent foodborne illnesses."

Other advocates and industry groups are reviewing the rules before offering congratulations.

United Fresh Produce Association, an industry group whose members are in every part of the produce supply chain, said Friday that it has already launched "a rigorous and deliberate review process, involving the expertise of food safety experts and industry stakeholders."

“United Fresh is pleased that FDA has published the draft rules and look forward to working with all stakeholders to conduct a thorough review,” said Dr. David Gombas, senior vice president, food safety & technology. 

“We will work closely with members across the produce industry, leading food safety scientists, other stakeholders and the FDA to ensure the proposed rules are practical and effective for enhancing produce food safety.”

The proposed rules are only one part of the Food Safety Modernization Act. The legislation also authorized more surprise inspections by the FDA, and gave the agency additional powers to shut down food facilities. It also required stricter standards on imported foods. Taylor said the agency will soon propose other overdue rules to ensure that importers verify the safety of imported food, and to improve food safety audits overseas, but did not give a date for release.

The proposed Preventive Control for Human Food rule...
The first rule, "Preventive Control for Human Food," requires those who manufacture, process, pack or hold human food to develop a formal written plan for preventing their food products from causing foodborne illness, whether the food is produced in a domestic or foreign facility.  It also requires "monitoring procedures" and having plans for "correcting any problems that arise," FDA said, as well as record keeping.  

The proposed hazard analysis and risk-based preventive control requirements "are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood," the agency said.

FDA proposed that many--but not all--food manufacturers be in compliance with the new preventive controls rules one year after the final rules are published in the Federal Register, but the implementation time frames differ by size.  "Small and very small businesses would be given additional time," the agency said.

FDA defines a "Small Business" as one "that employs fewer than 500 persons and that does not qualify for an exemption." The agency has proposed three options for "Very Small Businesses," by level of total annual sales of food, adjusted for inflation: Less than $250,000, less than $500,000, and less than $1,000,000.

Some of the exemptions in the proposal offer some risky loopholes.  

FDA defines certain food makers as "low-risk manufacturing/processing activities," and that includes "packing or holding activities that are conducted by small or very small businesses on farms for specific foods."  It cited those making jams and jellies and manufacturing honey and maple syrup as one example of those who would be exempt.  

It's a questionable premise that just because you're a small operation, you're producing safe food.  The economics of implementation are dictating this rule:  Monitoring and record keeping are expensive propositions for anyone, but especially for smaller producers.

Activities within the definition of “farm” are also exempt.  Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment are exempt, as is "packaged food for which refrigeration is not required for safety."  This suggests that foods cannot be contaminated after production, a ridiculous notion.

The proposed Standards for Produce Safety rule...
The second rule, "Standards for Produce Safety," proposes enforceable "science- and risk-based standards" for the safe growing, harvesting, packing, and holding of produce that is grown for human consumption. The proposed rule focuses on identified routes of microbial contamination of produce, and excludes any kind of contamination with chemicals or radiation.  

It includes standards for Agricultural Water, Biological Soil Amendments, Health and Hygiene,  Domesticated and Wild Animals, and Equipment, tools and buildings, designed to prevent foodborne illness from bacteria, parasites, and pathogens, including the deadly E. coli O157:H7, E. coli O157, Salmonella, Listeria monocytogenes (L. monocytogenes), Cyclospora, Shigella sonnei, and Hepatitis A.  

America has had repeat foodborne disease outbreaks from all of these in the last few decades, and scientists have battled to figure out how, for instance, E.Coli gets into things such as sprouts and spinach.

But again, there are exemptions based on size of the farm, as well as other exemptions. The proposed rule would not apply "to certain specified produce commodities that are rarely consumed raw." If a food is eaten on-farm, it is exempt.  Produce that receives a "kill step"--commercial processing that "adequately reduces the presence of microorgnaisms" using things like bleach baths, is exempt, "if adequate records are kept."

The proposed rule for Agricultural Water requires that "at the beginning of the growing season, the agricultural water system components under a farm’s control be inspected to identify conditions that are reasonably likely to introduce pathogens to produce or food-contact surfaces." With growing seasons lasting for months, the FDA is asking that water sources be reinspected.

The rule for Biological Amendments--that would be things like manure and other compost--  proposes "reasonable time intervals between the application of a biological soil amendment of animal original (sic) and crop harvest." The rule also has provisions for the handling and storage of biological soil amendments.  In theory, things like uncovered manure pits would be off limits.

The Health and Hygiene rule proposes "basic hygienic practices to prevent bacteria, viruses, and parasites that are frequently transmitted from person to person and from person to food."  It calls for training and education for farm workers about things like hand washing, and not defecating directly in the crop fields.  It thus would require farms to have hot water and soap available, as well as toilet facilities.

The Domesticated and Wild Animal Rule proposes "farms be required to take reasonable measures to prevent pathogens from being introduced onto the produce" from wild or domestic animals, and calls for not harvesting produce "that is visibly contaminated with animal excreta."  It is essentially a call for fencing, covering crop rows, or patrolling the fields with a shotgun or traps to keep animals at bay, among other interventions that hard-working farmers employ, since excreta can be dropped from air, or deposited by animals running through the crops.  It calls for keeping working and grazing animals away from the crops rows, and harvesting when these animals have been held at bay for a certain time period.

The Equipment, tools and buildings proposal calls for "standards for sanitation" that include the availability of hot running water and toilet facilities, among other things.

Farms that have an average annual value of food sold during the previous three-year period of $25,000 or less are completely exempt.  The rule proposes modified requirements or exemptions for farms that average sales of $500,000 or less per year during the last three years, which have sales to "qualified end-users" that exceed sales to others.

A farm of this size that sells produce to individuals, restaurants or retail establishments, that is either located in the same state or "not more than 275 miles away" is exempt from most of the requirements, and instead would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the FD&C Act and its implementing regulations) or at the point-of-purchase.

The agency is proposing that larger farms be in compliance with most of the requirements 26 months after the final rule is published in the Federal Register.  "Small and very small farms would have additional time to comply, and all farms would have additional time to comply with certain requirements related to water quality," FDA said.  


*Details on how to offer comment on the proposed rules are here.

*All documents for the Proposed Rule for Preventive Controls for Human Food are available here.

Download: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Controls for Human Food Proposed Rule [PDF]

*All documents for the Proposed Rule for Produce Safety are available here.

Download: Standards for the Growing, Harvesting, and Packing of Produce for Human Consumption Proposed Rule [PDF]

*Photo by Pete Souza/White House