Update: Cantaloupe growers sentenced

A federal judge in Denver sentenced Eric and Ryan Jensen each to six months of home detention and five years probation for selling listeria contaminated cantaloupe in 2011 that killed 33 and sickened 147 people in 28 states.

 

The brothers, who owned and operated Jensen Farms, Granada, Colo., each pleaded guilty last year to six federal misdemeanors of introducing an adulterated food into interstate commerce.

 

They could have faced up to six years in prison and each been fined $1.5 million. “No fine is imposed because the defendants have no ability to pay a fine,” according to the sentencing order from Magistrate Judge Michael E. Hegarty. However, the judge ordered each brother to pay restitution of $150,000 — $25,000 for each count. That money will go directly to victims, according to the U.S. Attorney in Denver. The Jensens argued the judge should not order restitution because they may be found liable for damages in civil cases filed by victims.

 

“Accordingly, the court should find that restitution should not be ordered in this case but left to civil actions already in progress,” the brothers’ probation request states.

 

The Jensens are the first growers to face criminal charges in such a case, but other growers could be in similar situations in the future, based on a comment from Spencer Morrison, the Food and Drug Administration’s acting special agent in charge of the agency’s criminal investigation.

 

 

Source: www.thepacker.com, 01/28/2014.

Statement from FDA on Key Provisions of the Proposed FSMA Rules

From FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, 12/19/13. 

 

FDA appreciates and takes very seriously the extensive input we have received from produce farmers and others in the agricultural sector on the proposed FDA Food Safety Modernization Act (FSMA) rules on produce safety and preventive controls for human food, which we published in January 2013. We have made every effort to solicit input on the proposed rules, not only through the standard rule-making process, but also by participating in more than 150 meetings and by traveling to numerous farms of varying types and sizes from Maine to California. To ensure broad input and facilitate constructive dialogue with the produce community, FDA has extended the comment periods on the proposed rules three times.

Based on our discussions with farmers, the research community and other input we have received, we have learned a great deal, and our thinking has evolved. Everyone shares the goal of ensuring produce safety, but, as we said at the beginning of the process, the new safety standards must be flexible enough to accommodate reasonably the great diversity of the produce sector, and they must be practical to implement.

To achieve this goal, we believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

Because the changes to the key provisions would be significant, FDA plans to propose revised rule language and seek comment on it, allowing the public the opportunity to provide input on our new thinking. There may be other revisions to the proposed rules; the scope of the revised proposals, on which we will seek further comment, will be determined after we complete our initial review of written comments. We believe that this additional step to seek further input on revised sections of the proposed rules that need significant adjustment is critical to fulfilling our continuing commitment to getting these rules right.

Our plan is to publish revised proposed rule language by early summer 2014. We will accept additional comments only on those sections of the proposed rules that have been revised. FDA remains under a court order regarding the timelines for finalizing these rules. FDA recognizes that completing these rules is essential to protecting the public health and is committed to completing them as quickly as possible.

It is gratifying to FDA that in our meetings around the country, we have received broad support for moving forward in implementing FSMA in a timely manner in light of its important food safety and public confidence goals. Thanks to all of you who have worked with us. We will continue this collaborative approach as we move down the pathway to final rules and to full implementation of the FDA Food Safety Modernization Act in the years to come.

New FDA Produce Safety Rule Exemptions

The Food Safety Modernization Act signed into law in January 2011 addressed improvements needed to the U.S. food supply. One proposed section to the law addresses the safety of fresh produce by defining new produce standards for foods often consumed in raw form.

“Also identified by the Food and Drug Administration in this section are foods not typically consumed in raw form such as eggplant, lentils or sweet potatoes,” said Catherine Strohbehn, food safety specialist with Iowa State University Extension and Outreach. “These standards are in addition to the Bioterrorism Act of 2002 which continues and requires food facilities to follow preventative control rules and register with FDA.”

New definitions in proposed regulations
Under these new proposed regulations, growers need to be aware of new definitions, said Strohbehn. The proposed rule would define “farm” to mean a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood) or both.

“Farm” includes (i) facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and (ii) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

A broad definition of food is used – thus any item grown or produced on a farm that is ultimately intended for human consumption is considered a food.

“This includes seeds, soybeans and livestock, not just produce sales,” said Angela Shaw, extension food safety specialist. “This also includes prepared foods such as pies and cookies that might be sold with farm-grown produce at a roadside stand.”

Three categories of farm exemptions are defined. These exemptions apply to very small and small businesses. When estimating a farm’s average annual sales, farmers must include ALL defined food sources. Farms with three-year average annual sales for all defined food types going to any vendor of $25,000 or less are exempt as they are considered very small businesses.

Those farms with $300,000 or less with defined food types going to any vendor are exempt also as they are classified as small businesses. For example, a soybean grower for human consumption (annual sales of $300,000) with a small produce road side stand ($10,000) would total all the sales amounts ($310,000) and would no longer be exempt from this proposed ruling.

The third category of exemptions applies to whether a qualified end-user is sold the product during the previous three-year period preceding the applicable calendar year: The average annual monetary value of the food sold directly to qualified end-users during such period exceeded the average annual value of the food sold to all other buyers during that period; AND The average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.

A qualified end user is defined as (a) a consumer of the food or (b) a restaurant or retail food establishment located within the same state as the farm that produced the food or not more than 275 miles from such farm. For example, a farm operation in Iowa selling a three-year average of $300,000 dollars’ worth of food to a restaurant or food establishment less than 275 miles from the farm and which also sold $100,000 at farmers’ markets would be exempt (combined annual monetary value is less than $500,000 and all sales to qualified end user).

It must be noted that such farms exempted under the new Produce Safety Ruling are NOT exempt under the adulteration provisions of the Federal Food, Drug and Cosmetic Act, which requires production of fruits and vegetables that are free of biological, chemical and physical contamination.

Produce Safety Alliance housed at Cornell University has provided additional information on exemptions of the ruling at http://producesafetyalliance.cornell.edu/psa.html. Comments on proposed ruling can be expressed at http://www.regulations.gov/#!docketDetail;D=FDA-2011-N-0921. Specific questions about the proposed ruling can be emailed to amy.berringer@fda.hhs.gov.

 

Do New Food Safety Rules Affect You?

I received a panicked phone call this week from a farmer who was concerned about how the new Food Safety Rules would apply to his farm.  Here is some information I adapted from a recent post by Food Safety News.

Last week, they published an article noting that nearly 80 percent of produce growers will be exempt from the landmark proposed rule that would for the first time require national preventative standards for the produce industry.

The authors note that while it is true that about 8 in 10 growers are exempt from the new rule, the vast majority of produce Americans consume would be covered by the measure.

The proposal is a huge step toward building a more preventive food safety system. The rule focuses on five areas: agricultural water, farm worker hygiene, manure and other additions to the soil, animals in growing areas and equipment, tools, and buildings.

So what is covered and what’s not?

FDA says 90 percent of produce acreage grown and consumed by Americans would either be covered by the rule or be exempt because the product is consumed cooked or sent to food processing plants “designed to address biological hazards associated with produce.”

The remaining 10 percent of acreage presumably comes from farms that would be exempt from the rule because they make less than $500,000 annually and sell more than half their produce directly to consumers (who could be located anywhere) or to restaurants or stores located within 275 miles or within state lines, or they may be exempt because they make less than $25,000 annually.

If you are still confused, the FDA has a helpful flow chart to figure out which farms are covered and which are not.

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