by Sanne Kure-Jensen
The Food Safety Modernization Act (FSMA) passed in January 2011. Details are still being finalized. The USDA seeks comments from farmers, producers, handlers, resellers and consumers. The comment period ends Nov. 16.
A webinar called ‘Food Safety Modernization Act (FSMA) — Its Impact on Artisan Cheesemakers’ was hosted by the Washington State Department of Agriculture (WSDA) Office of Compliance and Outreach last month. Dr. Dennis D’Amico, UConn assistant professor of Animal Sciences, described relevant changes within FSMA and their potential impact on artisanal cheesemakers. D’Amico urged those affected to send comments to the USDA before the comment deadline.
Food Safety Modernization Act
One significant change is a shift in the Food & Drug Administration (FDA) from being reactive to preventive. D’Amico explained, “Inspections will focus on documentation review.” He said documentation would become critical to prove hazard risk prevention and use of good food safety practices.
Food businesses will have to register with the FDA every other fall. Registration includes agreeing to allow FDA inspections of your facility. At this time, there are no fees to register or for the first inspection.
Re-inspection rates are set at $237/hr (domestic). There will be a process for small businesses to request a fee reduction.
FDA will have access to all Food Safety Plans, related documents, environmental testing reports and finished product testing. FDA oversight rights include other foods handled in a similar manner to suspect food if a food safety risk is suspected.
Producers must establish and maintain thorough records, make the records and verification available to the FDA, and allow the FDA to copy said documents. The rules vary for farms and do not include distributors. The focus is on producers that must register as defined by law.
The cheese category has been subdivided into four food categories: soft, ripened cheese; semi-soft cheese; hard cheese, other cheeses and cheese products.
FDA will increase inspection frequency. High Risk Facilities are those in industries linked to past food-borne illness like dairy and spinach or individual facilities linked to problems. These facilities will be inspected every three years. Low Risk Facilities will be inspected every five years.
Hazard Analysis and Critical Control Points (HACCP) will be renamed and upgraded to a Hazard Analysis and Risk Based Preventive Controls (HARPC) or Food Safety Plan (FSP). The business owner, operator or facility manager must prepare, or have prepared and implement a FSP. The FSP must be prepared by, or the preparation overseen by, a ‘Qualified Individual.’ That individual must also validate the effectiveness of preventive controls. The qualified individual must also review implementation and effectiveness records, ensure corrective actions are appropriate and reanalyze the FSP as needed.
Plans must be reviewed/updated at least every three years or when practices change, new industry risks are discovered or controls are found to be ineffective. FDA seeks comments on a requirement to verify PCs efficacy and this may include environmental and finished product testing.
A new group, the Food Safety Preventive Controls Alliance (FSPCA) has been created to develop training curriculum and distance training modules. They will develop ‘Train the Trainer’ materials. FSPCA will also create a technical assistance network as well as commodity and industry-sector specific guidelines for Preventive Controls (PCs) to assist small and medium businesses with FSMA compliance.
Food Safety Plan (FSP)
Written FSPs must include Hazard Analysis, Risk-based Preventive Controls (HARPC) and procedures for monitoring PC implementation. Written Corrective Action Procedures, Verification Procedures and a Recall Plan must also be included.
Hazard Analysis should include process flow diagrams and show foreseeable hazards at each step. Ready-to-eat (RTE) producers should include potential environmental pathogens. New considerations include equipment and facility design, condition and function as well as transportation and potential product uses. All “reasonably likely to occur” hazards must be addressed in PCs.
Preventive Controls (PCs)
D’Amico described PCs as “risk-based, reasonably appropriate procedures, practices and processes that a person knowledgeable about the safe manufacturing, processing, packing or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with current scientific understanding of safe food [practices] at the time of the analysis.” This language encompasses more than HACCP Critical Control Points (CCP) and may not include critical limits.
PCs must include what were previously known as prerequisite programs such as supplier management, allergen control, good manufacturing practices, product traceability/recall, food defense, employee training and equipment sanitation, among others.
Cross-contact includes risk of contact with allergens and prevention must be ensured. Proper labeling is also required.
Exemptions — Qualified Facilities
Many small farms and producers may be exempt from HARPC requirements and may not have to submit a FSP. The FDA seeks comments on three “very small business” categories based on annual revenue: under $250,000, under $500,000 and under $1,000,000.
The Tester Amendment tightens requirements for qualified or exempt facilities based on average revenues over the past three years. It also requires qualified facilities to have under $500,000 and more than 50 percent of sales go to qualified end users such as consumers, restaurants or retailers in the same state as the facility, or within 275 miles.
The qualified facility’s owner, operator or manager must certify exemption. Documentation does not have to be submitted to justify exemption, but must be kept and available for FDA inspection. Modified compliance may be possible with state Department of Agriculture requirements. FSPs should still resemble HARPC and may include HACCP.
Be sure to label and/or prominently post the name and complete address of all food sold at your farm stand or website, including that brought in from other facilities.
D’Amico suggested facilities resubmit registration or exemptions if their category changes and always keep your FSP and Operating Plan documentation up to date.
Required Good Manufacturing Practices
No Qualified Facilities are exempt from Good Manufacturing Practices (GMP).
New requirements include controls for cross-contact from allergens with packaging and in the whole manufacturing process. Cleaning and sanitation products must be verified safe for use. All equipment must be installed to allow for adequate cleaning and sanitation of equipment and surrounding spaces.
There are proposals to require that personnel in charge of food safety have training or experience for food processing safety competence as well as mandatory training for all employees and supervisors. Another requirement is frequent cleaning of non-food contact surfaces to protect food-contact surfaces.
By July 2014, the FDA is expected to publish final rules. By July 2015, rules should go into effect for large dairy plants. By July 2016, rules will go into effect for small dairy plants. By July 2017, rules will go into effect for very small dairy plants.
by Sanne Kure-Jensen