FSMA FACT SHEET- FEBRUARY 24, 2014
- Public outbreaks- 131 between 1996 and 2010. Spinach, peanut butter, cantaloupes, etc.
- 3000 deaths per year from food borne causes
- Death of pets (cats, dogs) from contaminated pet food
- Human illness caused by handling pet food
- Consumer group pressure
- Large amount of imported food: 15%
- Lack of federal regulations for safety of animal and pet food.
- Food regulation strategy has not be significantly updated or “modernized” since 1938
- Risk based- focus on significant issues
- Preventive approach
- SAHCODHA: Serious Adverse Health Consequences Or Death to Humans or Animals
- Best practices for managing food safety in human and animal food manufacturing
- Use of GAP’s, GMP’s, and HACCP principles
- Tiered compliance dates for many of the regulations
- Common process for proposing rules, taking public comment, establishing final regulations, providing outreach to industry, and enforcing regulations.
List of Regulations
- Good Manufacturing Practices: First major overhaul since 1970’s; now includes focus on allergen control.
- Hazard Analysis and Risk Based Preventive Controls-Human Foods (“Preventive Controls”) – Based on HACCP Principles. Training materials and outreach to be coordinated by third party Preventive Controls Alliance (academia and industry partnership). Significant paperwork and recordkeeping. Requires written Food Safety Plan, with a hazard analysis and specific preventive controls.
- Produce Safety- prevent biological hazards on the farm: Control of agricultural water that contacts produce or food contact surfaces-inspection of water system, criteria for water quality, and periodic microbial testing; biological soil amendments of animal origin-measures to reduce risk; handling and storage of animal manure; health and hygiene-GAP’s for employees, hand washing and personal hygiene; domestic and wild animals-control of fecal contamination by wild animal intrusion and from grazing; equipment/tools/buildings-set standards of sanitation for farming operations. Regulation also addresses safety of sprouts and training of farm personnel. Phase in period of 2, 3, or 4 yrs. depending on size of farm. Applies to domestic and foreign farms. Cost to implement in USA is $$459.56 million/year.
- Animal Food: Feed and Pet Food, Ingredients and Raw Materials for Animal Food- GMP’s and HARPC targeted at animal health. Includes Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm- analyses on-farm activities and animal food combinations that would be considered not reasonably likely to introduce hazard that are reasonably likely to cause SAHCHA. Tiered implementation over 1, 2, or 3 years depending on size of facility (less than $500,000 sales; fewer than 500 employees, and larger than 500 employees and over $500,000 in sales. Annualized compliance cost to industry is $128.75 million.
- Foreign Supplier Verification Program: onus put on importer to verify safety of food being imported. Foreign suppliers must grow or process food under the same level of protection that is provided by the Produce Safety rule or Preventive Controls rule. Applies to farms that raise animals or grow food, and foreign manufacturers. Must comply with U.S. allergen labeling requirements. Requirements vary depending on type of food product and who will control identified food hazards, but can include hazard analysis, supplier verification activities, corrective actions, periodic reassessment, compliance review (supplier subject to import alert, warning letter, or a certification requirement?) and record keeping. On-site inspections of foreign supplier may be required if SAHCOCHA hazards present.
- Third Party Auditing
- Food Defense-intentional adulteration of food. Uses similar process as HACCP. Mandatory for companies that receive and store bulk liquids, have a mixing process, and handle secondary ingredients because FDA identified these as vulnerability. Requires written Food Defense Plan.
- Whistle Blower Protection
- Sanitary Food Transportation: Requirements for truck and rail carriers of human and animal food. Requires written procedures, recordkeeping, and training. New design and maintenance requirements; operations requirements; information sharing; and specific shipper and carrier requirements for passing off key information and procedures. Cost to implement estimated at $30.08 million total annual cost.
- Facility Registration: Food processors must re-register with FDA every 2 years.
- Administrative Detention
- Mandatory Recall
- Voluntary Qualified Importer Program
- Produce Safety: Less than $500,000 in sales/yr. (average over 3 yrs.), and sales in same state or within 275 miles exceed sales to other end users during same period. Also produce not consumed raw or thermal processed, such as potatoes, sugar beets, green beans used for canning, corn used for canning. Produce consumed on farm. Farms selling $25,000 or less.
- Preventive Controls: Juice, Seafood, Meat and Poultry, and Canned foods to be exempt. Very small food processors.
- Food defense: All farming, except dairies.
- Animal Food Safety: farms that manufacture animal food for their own animals. Animal foods that are subject to low-acid canned food regulations.
- FSVP: Alcoholic beverages, low-acid canned foods, seafood, juice, food for personal consumption. Also food for research or evaluation.
- Jan. 4, 2011: FSMA signed into law.
- Jan. 27, 2014: Comments due on Foreign Supplier Verification Program
- Jan. 27, 2014: Comments due on Accreditation of Third Party Auditor/Certification Body
- March 31, 2014: Comments due on HARPC for Animal Food
- March 15, 2014: Comments due on the Environmental Impact Statement for the Produce Safety rule.
- May 31, 2014: Comments due on Sanitary Transportation rule.
- March 31, 2016: Deadline for publishing final rule for Sanitary Transportation.
- Aug. 30, 2015: Deadline for publishing final rule for preventive controls for human food and animal food (HARPC).
- October 31, 2015: Deadline for publishing final rules for produce safety, foreign supplier verification program, and third-party accreditation.
- May 31, 2016: Deadline for publishing final rules for intentional adulteration (food defense).
Controversial Areas of FSMA
- Grain elevators to be exempted from Preventive Controls requirements—will be in revision of proposed rule.
- Animal feed industry feels FDA has gone too far by applying human food controls (i.e. HACCP system and GMP’s) to animal food operations.
- FDA is underfunded and will have difficulty in enforcing the regulations.
- There are WTO agreements with other countries that can’t be violated by FSMA.
- Possible retribution by foreign countries which export to USA by imposing similar stringent regulations on food exported by USA.
- Waste by-products from food processing, such as whey, cull potatoes, cull beets, and grain/oilseed/pulse chaff, hull, and other byproducts that are given away or sold to animal feeding operations are subject to animal food regulations.
- Large scale push-back by farming community on produce rule.
- United Fresh, a trade association for corporate farming, has lobbied to prevent exemptions for small farms.
- FDA is rethinking two components of produce rule: the water quality standards and testing, and the standards for using raw manure and compost, based on feedback from the farming community. It is also reconsidering procedures that allow farms to become exempt from regulations.
- There are ten times more people that die annually from road fatalities (about 32,000) than from foodborne illness (3,000).
- Inclusion of “radiological hazards” in the HARPC regulations.
- Consumer groups dissatisfied with the slow pace of FSMA implementation and cite illnesses and deaths that could be prevented if law were in place.
- Most large food processors will easily comply with HARPC rules because they undergo voluntary food safety certification program, but small food processors will find the FSMA regulations onerous and expensive.
- Significant impact on Idaho animal feed industry, due to size of dairy and beef cattle operations, aquaculture, and waste byproducts from potato, beet, and dairy processing operations.
- The FSMA law and intentional adulteration (“food defense”) regulation is basing the need for the new rule on contamination incidents that took place in food service venues and not in food manufacturing. None of these cited intentional adulteration incidents involved terrorists from outside the USA, and none caused “massive public health harm” which FDA seeks to prevent in this proposed food defense rule. The largest incident involved 751 illnesses.
© 2014 Jeff Kronenberg