The Food Safety Modernization Act (FSMA) passed in January 2011. Details are still being finalized. The United States Department of Agriculture (USDA) seeks comments from farmers, producers, handlers, resellers and consumers. The comment period ends this November 15.
In a webinar called “Food Safety Modernization Act (FSMA) - Its Impact on Artisan Cheesemakers,” Dr. Dennis D’Amico, UConn Assistant Professor of Animal Sciences, described relevant changes within the FSMA and their potential impact on artisanal cheesemakers. D’Amico urged those affected to send comments to the USDA before the comment deadline of November 15, 2013. The Washington State Department of Agriculture (WSDA) Office of Compliance & Outreach hosted the webinar.
One significant change is a shift in the Food & Drug Administration (FDA) from 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. FDA has been posting more inspection reports online recently.
Food businesses will have to register with the FDA every other fall (October to December in even years). Registration includes agreeing to allow FDA inspections of your facility. There are no fees to register or for the first inspection now.
Re-inspection rates are set at $237/hour (domestic) and $302/hour (foreign). Fees will not be charged until guidance documents are published. There will be a process for small businesses to request a fee reduction.
The FDA has the right to suspend any food-processing facility’s registration and/or issue a food recall. 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.
D’Amico described “Swab-a-thons”. Soft and semi-soft cheese manufacturing facilities of all sizes were inspected and swabbed; inspectors were checking for Listeria monocytogenes. Current inspections at aged cheese producers seek L. monocytogenes and E. coli with environmental and finished goods sampling.
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. (D’Amico urged comment on this.) 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. Be sure to comment on this.
A qualified individual is defined as someone trained in the development and application of Risk-based Preventive Controls in a training program approved by the FDA. Their training must be documented. Alternately, their on-the-job training could have allowed them to develop and apply a Food Safety System.
A new group, the Food Safety Preventive Controls Alliance (FSPCA) was 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.
The FDA will issue guidance documents to clarify the requirements. See samples here.
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 (21 CFR 110 (117)), 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 American Cheese Society says 65% of survey respondents fit in the first category and 17% of respondents fell into the other two categories. D’Amico urged comment on this definition.
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% 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.
The FDA can withdraw your exemption if they think your facility or products pose a food safety threat.
Required Good Manufacturing Practices
No Qualified Facilities are exempt from Good Manufacturing Practices (cGMP). (Look up the new 21 CFR 117 that replaces rule 21 CFR 110). The language will use “must” instead of “shall” and “facility” will be replaced with “establishments or “plants.”
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.
D’Amico recommended comments on proposals to require that personnel in charge of food safety to have training or experience for food processing safety competence as well as mandatory (documented) training for all employees and supervisors. Another requirement is frequent (how defined?) cleaning of non-food contact surfaces to protect food-contact surfaces. Other optional rules may regulate storage of portable equipment and utensils to prevent cross contact and cross contamination. Incoming materials may require immediate inspections for potential contamination. Protect all foods from liquid drips, spills or absorbable contaminants. Please send in your comments on all these potential rules.
Implementation for Cheese and Dairy Operations
Draft HARPC and GMP requirements of FSMA were published and opened for public comment in January 2013. Comments will be accepted through November 16, 2013. 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
Recommendations - Be Proactive
At a minimum, learn the basics and comment on the FSMA and HARPC provisions that could affect your operation, recommended D’Amico. Create a plan for your facility. Use a trained consultant to help you develop a Food Safety Plan until training is widely available. Set up basic environmental testing procedures and keep records. D’Amico urged everyone to be ready when FSMA rolls out. Shore up your practices to ensure full traceability and verify the raw materials in your supply chain are all safe ingredients. Review your records maintenance and make sure they are inspection-ready. Be sure to review Guidance Documents as they become available. D’Amico said, “Everyone should be able to get ready in time.”
View the one-hour, FSMA webinar and find links for dozens of other informative agricultural webinars at AgInUncertainTimes.FarmManagement.org.
Send questions to Dr. Dennis D’Amico, Assistant Professor of Animal Sciences at UConn or call (860) 486-0567.
A similar story ran in the October 21, 2013 New England edition of Country Folks.