Presentation on theme: "Proposed Rules under the FDA Food Safety Modernization Act"— Presentation transcript:
1 Proposed Rules under the FDA Food Safety Modernization Act Welcome, everyone. Thank you for taking the time for this overview on proposed rules under the FDA Food Safety Modernization Act.FDA has announced an important step that lays the foundation for a prevention-based food safety system for domestic and imported food.The first two proposed rules are on view at the Federal Register and publish(ed) Jan You can get to the rules from our FSMA page atThe first, the produce safety rule, proposes enforceable standards for the growing, harvesting, packing and holding of produce on farms.The second, preventive controls for human food, would require food companies to develop a formal plan for preventing food at their facilities from causing illness. The plan would identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise.Version 1/8/2013
2 Five Proposed Rules Establish Food Safety Framework Produce Safety Standards - Published Jan. 2013Preventive Controls for Human Food - Published Jan. 2013Foreign Supplier Verification ProgramPreventive Controls for Animal FoodAccredited Third Party CertificationThese two proposed rules are the first among five rules that would lay the cornerstone of a prevention-based, modern food safety system.These proposed rules work together to address hazards in the commodities FDA regulates and to address food safety both in domestically produced and imported foods.We expect to soon propose the Foreign Supplier Verification Program, Preventive Controls for Animal Food and Accredited Third Party Certification.
3 Key Aspects of Proposals Confirm industry’s primary role on food safetyRisk-based and flexibleAddress small business issuesExtensive government, stakeholder InputAll of the proposed rules will share key aspects. They:Confirm industry’s primary role on food safetyProposals are based in part on industry-developed practices and FDA guidance documents that many in the industry are followingRisk-based and flexibleNot one size fits allControls are tailored to operationsBurden is commensurate with riskAddress small business issuesExemptions in proposalsAdditional compliance time for smaller operationsExtensive government and stakeholder input soughtLearn from community – 500 meetings w industry leaders, farmers, consumers, states and academicsProduce safety – consulted w USDA and 14 farm toursGlobal outreach – meetings included global regulatory partners on international issues
4 FDA Proposed Rule on Produce Safety Let me give you a brief overview of the produce safety rule.
5 Key Principles Considers risk posed by practices, commodities Science- and Risk-basedFocus on identified routes of microbial contaminationExcludes certain produce rarely consumed rawExcludes produce to be commercially processed (documentation required)FlexibleAdditional time for small farms to complyVariancesAlternatives for some provisionsThe proposed rule follows three key principles:It considers the risk posed by practices and commodities associated with growing, harvesting, packing and holding produce as well as how produce will be used and consumed after it leaves the farm.It is science- and risk-basedFocuses on identified routes of microbial contaminationSets only those standards reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards.Does not apply to certain specified produce rarely consumed raw. (example-potatoes)Produce destined for processing that includes a kill step would not be covered as long as certain documentation is provided (example-green beans sent for canning)It is flexible in many waysFeasible and effective across the diversity of crops, hazards, practices and growing conditions.It provides additional time for small operations to comply.A state or foreign country may request a variance from some or all of the provisions of the proposed rule if it can be demonstrated that the variance provides a comparable level of public health protection.Farmers may use alternative means for some provisions to achieve a comparable level of public health protections other than those specified in the proposed rule.
6 Standards for Produce Safety Focus on identified routes of microbial contamination Domesticated and wild animalsEquipment, tools, buildings and sanitationWorker health and hygieneAgricultural waterGrowing, harvesting, packing and holding activitiesBiological soil amendments of animal originSpecific requirements for sproutsAs I indicated, the proposed rule focuses on identified routes of microbial contamination of produce. They are:Domesticated and wild animalsEquipment, tools, buildings and sanitationWorker health and hygieneAgricultural waterGrowing, harvesting, packing and holding activitiesBiological soil amendments of animal originAlso, there are specific requirements for sprouts
7 Who Would be Covered?Farms that grow, harvest, pack or hold most produce in raw or natural state (raw agricultural commodities)Farms and “farm” portions of mixed-type facilitiesDomestic and imported produceFarms with annual sales > $25,000 per yearLimitations on coverage are proposedIn terms of coverage, the proposed rule would cover farms that grow, harvest, pack or hold most produce in their raw or natural state. These produce are referred to as raw agricultural commodities.It also covers farm portions of mixed-type facilities. These are farms that are also engaged in activities outside the definition of “farm” that require food facility registration.An example is an establishment that grows and harvests produce but also conducts activities such as processing fresh-cut produce that requires the establishment to be registered.In such cases, only the establishment’s farm activities would be subject to the proposed produce rule. Other activities may be subject to the preventive controls proposed rule.The proposed rule would cover both domestic and imported produce.The proposed rule would cover farms with an average annual value of food sold during the previous three-year period of more than $25,000. Farms below the monetary threshold are not covered by the proposed rule.There are proposed limitations on coverage that I will explain in a moment.
8 Covered Produce “Produce” defined as fruits and vegetables Produce includes mushrooms, sprouts, herbs and tree nutsProduce does not include grainsSome limitations on covered produceIn terms of what produce is covered, produce is defined as fruits and vegetables.Produce includes mushroom, sprouts, herbs and tree nuts.Produce does not include grains,Some limitations on covered produce are proposed, which I will now go over in more detail.
9 Limitations on Coverage Produce for personal or on-farm consumptionProduce not a Raw Agricultural CommodityCertain produce rarely consumed rawProduce that will receive commercial processingFarms with sales of $25,000 or less per yearQualified exemption and modified requirementsThe proposed rule includes a number of limitations on coverage. The following are NOT covered:Produce that is produced by an individual for personal consumption or produced for consumption on the farm or another farm under the same ownershipProduce that is not a raw agricultural commodityAn example is fresh-cut bagged saladsProduce identified in the rule that is rarely consumed raw. A few examples are: artichokes, beets, Brussels sprouts, cranberries, eggplant, okra, peanuts, potatoes and sweet potatoes. Additional commodities are listed in the rule.Produce that will receive commercial processing that adequately reduces the presence of microorganisms of public health significance provided that certain documentation is kept.Farms with sales of $25,000 or less per year are not covered because they represent less than one percent of all produce in commerce.The rule also contains a qualified exemption and modified requirements for farms with sales of less than $500,000 per year, using a 3-year average, whose sales to qualified end users make up the majority of sales.This exemption can be withdrawn in certain circumstances (see rule for more detail)
10 Alternatives Permitted Farms may establish alternatives to certain requirements related to water and biological soil amendments of animal originAlternatives must be scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulterationOne way the proposed rule is flexible is that it permits alternatives to certain requirements.The proposed rule would provide that farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin if the alternative is scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration.
11 Variances Provide Flexibility A state or foreign country may petition FDA for a variance from some or all provisions if deemed necessary in light of local growing conditions.Practices under the variance would need to provide the same level of public health protection as the proposed rule without increasing the risk of adulteration.The proposed rule also is flexible in that the proposed rule also would allow a state or foreign country to request a variance from some or all provisions of the proposed ruleThe state or country would need to determine that it is necessary in light of local growing conditions.Practices under the proposed variance provide the same level of public health protection as the requirements of the proposed rule without increasing the risk of adulteration.The proposed rule provides a process by which FDA would consider such requests and approve or deny them.
12 Recordkeeping Required But Not Burdensome The proposed rule would require certain records, for example, to document that certain standards are being metExample: agricultural water testing resultsRecords already kept for other purposes need not be duplicatedThe proposed rule would require certain records, for example, to document that certain of the standards are being met. Agricultural water testing results are an example.However, it would not require duplication of records already being kept for other purposes.
13 Qualitative Assessment of Risk Reflects Science Behind Rule Draft qualitative assessment of risk helps to inform proposed ruleProvides a scientific evaluation of potential adverse health effects resulting from human exposure to hazards in produceAvailable for public comment as part of the proposed ruleFDA has issued a draft Qualitative Assessment of Risk as part of the rule.It provides a scientific evaluation of potential adverse health effects resulting from human exposure to hazards in produce, with a focus on public health risk associated with on-farm microbial contamination of produce.The draft qualitative assessment of risk specifically addresses the following questions:What are the biological hazards of concern in produce that can lead to serious adverse health consequences or death?How does produce become contaminated (i.e., routes of contamination) during on-farm growth, harvesting, and postharvest operation?Does the likelihood of contamination vary among produce commodity types?Does the likelihood of illness attributable to produce consumption vary among produce commodity types?What is the impact of postharvest practices on the level of contamination at consumption?What on-farm interventions are available to reduce the likelihood of contamination?Comments on the draft qualitative assessment of risk can be submitted along with comments on the proposed rule.
14 Compliance Dates Staggered Effective Date: 60 days after final rule is publishedNot covered: Farms with sales ≤$25,000/yearCompliance DatesVery small farmsAverage annual value of food sold >$25,000 and ≤$250,000Four years after the effective date to complyFor some water requirements, six yearsCompliance dates for the produce safety rule are staggered based on size.FDA is proposing 60 days as the effective date, but farms do not have to meet the requirements on this dateFDA is proposing staggered compliance dates for farms that would be covered based on size.Very Small FarmsVery small farms have an average annual value of food sold of more than $25,000 and no more than $250,000.These farms would have four years after the effective date to comply.For some water requirements, they would have six years to comply.
15 Compliance Dates Small farms Average annual value of food sold > $250,000 and ≤ $500,000Would have three years after the effective date to complyWould have five years for some water requirementsOther covered farmsOther covered businesses would have to comply two years after the effective dateWould have four years for some water requirementsSmall FarmsSmall farms have an average annual value of food sold of more than $250,000 and no more than $500,000.They would have three years after the effective date to comply.For some water requirements, they would have five years to comply.Other Covered FarmsOther farms that do not meet the definition of “very small” or “small” would have two years after the effective date to comply.For some water requirements, they would have four years to comply.
16 Preventive Controls for Human Food Let me now give you an overview of the Proposed Rule on Preventive Controls for Human food.
17 Key Principles Confirms industry’s primary role on food safety Prevention of hazardsRisk-basedThe proposed rule follows three key principles:First, it confirms industry’s primary role on food safety.Second, prevention of hazards is the foundation of a modern food safety system.Third, it is risk basedbecause the nature and extent of preventive controls would depend on which, if any, hazards are likely to occur.establishes a set of exemptions and modified requirements from the requirements for hazard analysis and risk-based preventive controls.
18 Summary of Requirements Hazard Analysis and Risk-Based Preventive ControlsEach facility would be required to implement a written food safety plan that focuses on preventing hazards in foodsUpdated Good Manufacturing PracticesThe rule has two major features:Hazard analysis and risk-based preventive controls are requiredEach facility would be required to implement a written food safety plan that focuses on preventing hazards in foods.Updated Good Manufacturing Practices
19 Who is Covered?Facilities that manufacture, process, pack or hold human foodIn general, facilities required to register with FDA under sec. 415 of the FD&C ActApplies to domestic and imported foodSome exemptions and modified requirements are being proposedFacilities that would be covered by the proposed rule are those that manufacture, process, pack or hold human foodIn general, facilities required to register with FDA under current regulations are covered.The proposed rule would apply to domestic and imported foodSome exemptions and modified requirements are being proposed.
20 Hazard Analysis and Risk-Based Preventive Controls Covered facilities will be required to prepare and implement a written food safety plan, which would include the following:Hazard analysis – identifies or evaluates known or reasonably foreseeable hazardsPreventive controls – would depend on which, if any, hazards are reasonably likely to occur:Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring requiredCorrective actions that would be used if preventive controls are not properly implementedVerificationRecordkeeping
21 Preventive Controls Required Process controlsFood allergen controlsSanitation controlsRecall planIn addition, seeking comment on supplier approval and verification programThe preventive controls required would depend on which, if any, hazards are reasonably likely to occur. They are:Process controlsFood allergen controlsSanitation controlsRecall planWe do not expect that all possible prevention measures and verification procedures would be applied to all foods at all facilities.FDA believes that a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients and that such a program is consistent with current scientific understanding of food safety practices.We are seeking comments on such a program.
22 Verification Required ValidationCalibrationReview of recordsIn addition, seeking comment on review of complaints, finished product and environmental testingVerification activities are required to ensure that preventive controls are consistently implemented and effective. They include:ValidationCalibrationReview of recordsWe are seeking comment on the following as verification activities:review of complaintsfinished product and environmental testing
23 Updated Good Manufacturing Practices Protection against allergen cross-contactUpdated language; certain provisions containing recommendations would be deletedComments requested on mandating training and whether rule should require, rather than recommend, certain provisionsUpdated Good Manufacturing Practices also are part of the proposed rule.The CGMPs would be modified to clarify that certain existing provisions requiring protection against contamination of food also require protection against cross-contact of food by allergens.Further, language in the regulation would be updated and certain provisions containing recommendations would be deleted and may be added to guidance.In addition, FDA is requesting comment on:whether it should mandate training for employees and supervisorswhether it should require, rather than recommend, certain provisions, such as cleaning non-food-contact surfaces of equipment as frequently as necessary to protect against contamination of food and food-contact surfaces.
24 Exemptions and Modified Requirements “Qualified” facilities:Very small businesses (3 definitions being proposed—less than $250,000, less than $500,000 and less than $1 million in total annual sales)ORFood sales averaging less than $500,000 per year during the last three years ANDSales to qualified end users must exceed sales to othersA number of exemptions and modified requirements are being proposed:“Qualified” facilities:Very small businesses (3 definitions being proposed—less than $250,000, less than $500,000 and less than $1 million in total annual sales)Food sales averaging less than $500,000 per year during the last three years ANDSales to qualified end users must exceed sales to others.Qualified end users are consumers (in any location), and restaurants and retail food establishments in the same state or within 275 miles of the facility that purchase the food for sale directly to consumers.
25 Exemptions and Modified Requirements Foods subject to low-acid canned food regulations (microbiological hazards only)Foods subject to HACCP (seafood and juice)Dietary supplementsAlcoholic beveragesFoods subject to low-acid canned food regulations (microbiological hazards only)Foods subject to HACCP (seafood and juice)Dietary supplementsAlcoholic beveragesThe types of businesses listed would be exempt from food safety plan requirements but are not exempt from GMP requirements
26 Exemptions and Modified Requirements Facilities, such as warehouses, that only store packaged foods that are not exposed to the environmentCertain storage facilities such as grain elevators that store only raw agricultural commodities intended for further distribution or processingFacilities, such as warehouses, that only store packaged foods that are not exposed to the environment, except:Certain packaged food for which refrigeration is required for safety must have temperature controls, monitoring, verification and recordsCertain storage facilities such as grain elevators that store only raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing
27 Farm-Related Exemptions Activities within the definition of “farm,” including farm activities that are covered by the proposed produce ruleCertain low-risk manufacturing/processing, packing and holding activities conducted by small/very small businesses on farms for specific foodsFarm-related exemptions also are being proposed. They are:Activities within the definition of “farm,” including farm activities that are covered by the proposed produce rule, andCertain low-risk manufacturing/processing activities conducted by small/very small businesses on farms for specific foods
28 Effective and Compliance Dates Effective date:60 days after the final rule is publishedCompliance DatesSmall Businesses—a business employing fewer than 500 persons would have two years after publication.Compliance dates for the preventive controls rule also are staggered depending on facility sizeSmall businessesSmall businesses, defined as employing fewer than 500 persons and not qualifying for an exemption, would have two years after publication
29 Compliance Dates (cont.) Very Small Businesses—a business having less than $250,000 (or alternatively $500,000 or $1 million) in total annual sales of food would have three years after publication to comply.Very small businesses are considered “qualified” facilities and subject to modified requirementsOther Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply.Very small businessesVery Small Businesses—Three options are being proposed for the definition of a very small business: less than $250,000, less than $500,000 or less than $1,000,000 in total annual sales of food, adjusted for inflation. Very small businesses would have three years after publication of the final rule to comply.Very small businesses are considered “qualified facilities” and subject to modified requirements for preventive controls.Other businessesOther Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply.
30 Risk AssessmentDraft qualitative risk assessment announced in a separate notice of availabilityAddresses activities outside the farm definition conducted in a facility co-located on a farm.Comments being accepted separate from the proposed ruleFDA is announcing the availability of a draft qualitative risk assessment in a notice of availability, separate from the rule.Addresses activities outside the farm definition conducted in a facility co-located on a farm.Comments being accepted separate from the proposed rule.
31 How to Comment on the Proposed Rules Link to rules onComment period is 120 days; exact due date will be in the Federal RegisterComment periods on major FSMA proposals will be coordinated to enable comment on how the rules can best work together.We encourage comments on the proposed rule from a wide variety of stakeholders.The proposed and final rules and supporting documents will be filed in FDA’s official docket on and also can be accessed atThe comment period is 120 days and the exact date will be set in the Federal Register. However, we plan to coordinate the comment periods on the major FSMA proposals as fully as possible to enable public comment on how the rules can best work together to create an integrated and effective food safety system.
32 Outreach and Technical Assistance Will Continue Public meetingsPresentationsListening sessionsAlliancesProduce Safety Preventive Controls Sprouts SafetyGuidance documentsOutreachFDA conducted extensive outreach before the proposed rules were issued and that outreach will continueWe will work closely with our government partners at the state and federal levels and with stakeholders.We will hold public meetings across the country, give presentations and hold listening sessions to explain the proposed rules and get comments.Technical assistanceWill help farms comply with produce safety requirements and facilities comply with the preventive control requirements once the final rules are issued.We are working with stakeholders through three public-private partnerships known as alliances.The alliances are developing training materials and will disseminate information to industry, particularly small and very small businesses.The Produce Safety Alliance was established in partnership with Cornell UniversityThe Food Safety Preventive Controls and Sprouts Safety Alliances were established in partnership with the Illinois Institute of TechnologyFDA also intends to issue a number of guidance documents to help industry comply with requirements.A national network to provide technical assistance is under development.Partnerships will be essential
33 More Information Available Web site:Subscription feature availableSend questions toThe FSMA web site, at fda.gov/fsma, has a number of materials on the proposed rules that you can download.They also are available in several languages.We have a subscription feature to get the latest newsStakeholders can send questions toWe will continue to update the frequently-asked-questions on our web site.I hope this overview has been helpful and we look forward to continuing our discussions on the rules during the comment period.