Sweeping Regulatory Changes Aimed at Manufacturers: Are You Ready?

Sweeping Regulatory Changes Aimed at Manufacturers: Are You Ready?

man and woman inspecting blueprints


On January 4th, 2011 President Obama signed the Food Safety Modernization Act (FSMA) into law as an amendment to the Food, Drug & Cosmetics Act of 1938. As a result, facilities that process human or animal food must now have a “Qualified Individual” to oversee preparation of the Food Safety Plan, validation of Preventative Controls, Records Review, and the reanalysis of the Food Safety Plan. The enacting of this law, one of the largest of its kind in 70 years, comes in response to major recalls and outbreaks as well as increased risks of food allergens, and more resilient organisms.

Why FSMA is a good thing:
According to the Centers for Disease Control and Prevention, about 48 million people get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases each year nationwide. Illnesses like this are preventable and exactly why FSMA was created. Proper use of preventative controls during food manufacturing and careful oversight can lead to fewer outbreaks and a healthier society. By requiring safety plans that set forth how companies will identify and minimize hazards, FSMA is bringing a new level of accountability to food manufacturers. Beyond the social responsibility aspect of increasing preventative safety measures, FSMA also benefits manufacturers by elevating the standard of their product. By safeguarding against potential outbreaks, manufacturers are protecting against the negative perception that accompanies them. Lowering the risk of a product recall makes good business sense and helps maintain a company’s reputation with customers.

How this affects your business:
In order to be compliant with FSMA companies manufacturing food must either hire or contract a Qualified Individual by the following dates:

  • September 17, 2016 – Large Businesses
  • September 17, 2017 – Small Businesses (fewer than 500 full-time employees) 
  • September 17, 2018 – Very Small Business (average less than $1 million in yearly sales of human food plus the value of such food manufactured, processed, packed or held without sale) 

As a result of this amendment, the Food Safety Preventative Controls Alliance (FSPCA), was formed to develop training courses and technical information on preventing contamination for both human and animal food during production. FSPCA is comprised of members from the U.S. Food and Drug Administration (FDA), state regulatory agencies, and leaders in the food industry as well as academia.

Completion of the standardized course developed by the FSPCA is required to be considered a Qualified Individual.

How you can prepare a Qualified Individual:
A FSPCA course is being offered by The Food Processing Center at the University of Nebraska- Lincoln on June 14-16, 2016. Additional dates will likely be offered in the future. Employees of FDA regulated food manufacturers such as Production Supervisors, Quality Assurance Managers, company owners and other members of the food safety team would all benefit from attending this course. Registration for this course ends May 31, 2016.

For more information about this course and instruction on how to register, please visit http://go.unl.edu/u4qb

Who can assist in Food Safety Plan development:
Trained Nebraska Manufacturing Extension Partnership (MEP) specialists can provide assistance to your business in its development of a Food Safety Plan, validation of Preventative Controls, Records Review, and the reanalysis of the Food Safety Plan. For more information about assistance, please contact a Nebraska MEP specialist at 402-472-5993 or ne.mep@unl.edu .

You may also visit http://go.unl.edu/2sgu

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Thursday, May 26, 2016