Where is FSMA in terms of implementation? What requirements must be satisfied now? These are questions that many manufacturers, processors, and packers have. The following prevention overview aims to provide insight into what is required now, based on effective dates for statutory requirements and subsequent rules that have been finalized. Please note that this overview should not be used as a substitute for seeking the advice of an attorney.
SEC 102. REGISTRATION OF FOOD FACILITIES
Prior to FSMA, the FDA did not have a clear standard and process for suspending a food facility’s registration. Now, under § 102, the FDA may suspend a registration upon finding a “reasonable probability of causing serious adverse health consequences or death to humans or animals.”
Overview of Current Requirements
A food facility must:
- Register the facility as required by § 415 of the Food, Drug and Cosmetic Act (“FD&C Act”) as added by § 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (“Bioterrorism Act”).
- Determine relevant “general categories” and “other categories” of food processed, packed or held at such facility.
- Provide information on the general food category (or any other food categories, as determined by FDA, including by guidance) of a food processed, packed or held at such facility.
- Complete a biennial registration renewal as required under § 415 of the FD&C Act during the period beginning October 1 and ending on December 31 of each even-numbered year.
- Determine if the abbreviated registration renewal (APR) process would be available to the registrant.
Rules and Guidance
- Draft Guidance for Industry: Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories. (August 2012)Summary of Effective Dates for FSMA § 102
- Registration requirements under § 102 became effective on 180 days after the date of enactment of FSMA, which was July 3, 2011. The Secretary has not promulgated regulations under § 102.
- Suspension of registration provisions became effective on July 3, 2011.
- Electronic registration requirements may not take effect until a date that is 5 years after the date of enactment, which would be no sooner than January 4, 2016.
- Small Business Compliance Guide is due within 180 after the issuance of the registration regulations promulgated under section 415(b)(5) of the FD& C Act (as added by this section 102 of FSMA). At this time no regulations have been promulgated.SEC 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS
Overview of Current Requirements
The owner, operator, or agent in charge of a facility shall:
– Determine whether the facility meets the definition of a “qualified facility”
– Conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards that could affect food manufactured, processed, packed, or held by such facility,
– Identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that food is not adulterated under section 402 (§342) or misbranded under section 403(w) (§343(w)).
– Preventive controls may include (a) sanitation procedures, (b) employee hygiene training, (c) an environmental monitoring program, (d) a food allergen control program, (e) a recall plan, (f) Current Good Manufacturing Practices (cGMPs), and supplier verification activities.
– Develop a written plan of the analysis
– Monitor the performance of those controls, and
– Maintain records of this monitoring as a matter of routine practice
Rules and Guidance
- Future guidance will be released on Preventive Controls for Registered Human Food and Animal Food/Feed Facilities. FDA has stated that three updated food facility registration guidance documents will be released later this year to further clarify the process.Summary of Effective Dates for FSMA § 103
- Preventive controls requirements of § 103 became effective on July 4, 2012 (18 months after the FSMA date of enactment).SEC 105. STANDARDS FOR PRODUCE SAFETY
Overview of Current Requirements
The FSMA standards for produce safety are applicable to raw agricultural commodity (RAC) is any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. FDA is required to establish science-based, minimum standards for safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities (RACs) for which the FDA has determined that such standards minimize the risk of serious adverse health consequences or death, by preventing hazards that either occur naturally or may be introduced during growing, harvesting, sorting, packing and storage operations. These standards do not cover produce destined for “kill step” processing and agronomic crops such as grain, canola, cocoa, cottonseed, flaxseed, rice, soybean, and sugar beets.
A food facility should:
- Determine whether the farm qualifies for the direct farm marketing exemption from § 105.
- Comply with upcoming science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water.
Rules and Guidance
- No new draft or final guidance documents have been issued.
- Relevant guidance documents currently in effect include the following:
Produce
- Letter to Firms that Grow, Harvest, Sort, Pack, Process, or Ship Fresh Cantaloupe (November 2011)
- Letter to Firms that Grow, Harvest, Sort, Pack, or Ship Fresh Cilantro (March 2011)
- Guide to Minimize Microbial Food Safety Hazards of Tomatoes (July 2009)
- Guide to Minimize Microbial Food Safety Hazards of Melons (July 2009)
- Guide to Minimize Microbial Food Safety Hazards of Leafy Greens (July 2009)
- Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (October 26, 1998)
- Final Guidance: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables (February 2008)
- Reducing Microbial Food Safety Hazards For Sprouted Seeds (October 1999)
- Sampling And Microbial Testing Of Spent Irrigation Water During Sprout Production (October 1999)
Nuts
- Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Pistachio-Derived Product As An Ingredient (June 2009)
- Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient (March 2009)
Summary of Effective Dates for FSMA § 105
- At this time no regulations have been promulgated.
- The proposed regulations were due on January 1, 2012 for comment, but have yet to be proposed. This delay in proposed regulations alters the subsequent deadline for adopting a final regulation, which is to be not later than 1 year after the close of the comment period for the proposed rulemaking.
SEC 106. PROTECTION AGAINST INTENTIONAL ADULTERATION
Overview of Current Requirements
Regulations promulgated under FSMA § 106 (21 U.S.C. 341) will only apply to food with a high risk of intentional contamination, as determined by collaborative efforts between the FDA, USDA and the Department of Homeland Security (“DHS”). The FDA and DHS will identify clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points).
Future regulations, once promulgated, will provide science-based mitigations strategies and measures that are deemed necessary to protect the food supply.
Rules and Guidance
- No draft or final guidance documents are currently available
Summary of Effective Dates for FSMA § 106
- At this time no regulations have been promulgated.
- Regulations were required to be promulgated under FSMA § 106 (21 U.S.C. 341) by July 4, 2012 (not later than 18 months after the date of enactment for FSMA).
SEC 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY
Overview of Current Requirements
The National Agriculture and Food Defense Strategy will provide goals on preparedness, detection, emergency response, and recovery. The strategy will entail a coordinated implementation plan and research agenda for use by the Secretary of Health and Human Services, Secretary of Agriculture and Secretary of Homeland Security which should be submitted to the relevant committees of Congress and made publicly available in a manner and format that take into account national security.
Summary of Effective Dates for FSMA § 108 (22 U.S.C. 2202)
Under FSMA, the National Agriculture and Food Defense Strategy was to be available not later than January 4, 2012 (one year after the date of enactment FSMA).
SEC 109. FOOD AND AGRICULTURE COORDINATING COUNCILS
Overview of Current Requirements
Secretary of Health and Human Services, Secretary of Agriculture and Secretary of Homeland Security will coordinate to create a report on the activities and progress of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council. This report will be submitted to the relevant committees of Congress and made publicly available.
Summary of Effective Dates for FSMA § 109
This report was due by July 3, 2011 (within 180 days of enactment of FSMA), and annually thereafter.
SEC 110. BUILDING DOMESTIC CAPACITY
Overview of Current Requirements
Section 110 requires a comprehensive report identifying programs and practice that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities.
Summary of Effective Dates for FSMA § 110
This report is due not later than January 4, 2013 (2 years after the date of enactment of FSMA).
SEC 111. SANITARY TRANSPORTATION OF FOOD
Overview of Current Requirements
Section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)) requires the Secretary to promulgate regulations that require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.
The regulations will set forth practices relating to (a) sanitation, (b) packaging, isolation, and other protective measures (c) limitations on the use of vehicles, information to be disclosed to certain parties involved with transportation, and (d) recordkeeping.
Summary of Effective Dates for FSMA § 111
Not later than July 4, 2012 (18 months after the date of enactment of this Act [Jan. 4, 2011]), the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)).
SEC 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT
Overview of Current Requirements
Section 112 requires the Secretary of Health and Human Services in consultation with the Secretary of Education to develop guidelines to be used on a voluntary basis by interested entities and individuals, to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs.
Rules and Guidance
- No draft or final guidance documents are currently availableSummary of Effective Dates for FSMA § 112
These voluntary guidelines were due by January 4, 2012 (not later than 1 year after the date of enactment of FSMA)
SEC 113. NEW DIETARY INGREDIENTS
Overview of Current Requirements
FSMA § 112 added a notification requirement to § 413 of the Federal, Food, Drug and Cosmetic Act (21 U.S.C. 350b). Under the new notification requirements, the Secretary is required to notify the Drug Enforcement Agency (“DEA”), if the Secretary determines that information provided in a new dietary ingredient premarket notification submitted for an article purported to be a new dietary ingredient is inadequate to establish that dietary supplement containing such article will reasonably be expected to be safe.
In order to provide adequate information, the responsible parties should consider:
- What qualifies as a new dietary ingredient (“NDI”)?
- Is a NDI notification necessary?
- What are the procedures for submitting a NDI notification?
- What information should manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI?
- What to include in a NDI notification?
Summary of Effective Dates for FSMA §113
- Guidance clarifying the new dietary ingredient notification process was required not later than July 3, 2011 (180 days after the enactment of FSMA). The draft guidance was issued July 2011.
Rules and Guidance
- Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues (July 2011)