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. 16. You can get to the rules from our FSMA page at www.fda.gov/fsma. The 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

Five Proposed Rules Establish Food Safety Framework Produce Safety Standards - Published Jan. 2013 Preventive Controls for Human Food - Published Jan. 2013 Foreign Supplier Verification Program Preventive Controls for Animal Food Accredited Third Party Certification These 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.

Key Aspects of Proposals Confirm industry’s primary role on food safety Risk-based and flexible Address small business issues Extensive government, stakeholder Input All of the proposed rules will share key aspects. They: Confirm industry’s primary role on food safety Proposals are based in part on industry-developed practices and FDA guidance documents that many in the industry are following Risk-based and flexible Not one size fits all Controls are tailored to operations Burden is commensurate with risk Address small business issues Exemptions in proposals Additional compliance time for smaller operations Extensive government and stakeholder input sought Learn from community – 500 meetings w industry leaders, farmers, consumers, states and academics Produce safety – consulted w USDA and 14 farm tours Global outreach – meetings included global regulatory partners on international issues

FDA Proposed Rule on Produce Safety Let me give you a brief overview of the produce safety rule.

Key Principles Considers risk posed by practices, commodities Science- and Risk-based Focus on identified routes of microbial contamination Excludes certain produce rarely consumed raw Excludes produce to be commercially processed (documentation required) Flexible Additional time for small farms to comply Variances Alternatives for some provisions The 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-based Focuses on identified routes of microbial contamination Sets 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 ways Feasible 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.

Standards for Produce Safety Focus on identified routes of microbial contamination Domesticated and wild animals Equipment, tools, buildings and sanitation Worker health and hygiene Agricultural water Growing, harvesting, packing and holding activities Biological soil amendments of animal origin Specific requirements for sprouts As I indicated, the proposed rule focuses on identified routes of microbial contamination of produce. They are: Domesticated and wild animals Equipment, tools, buildings and sanitation Worker health and hygiene Agricultural water Growing, harvesting, packing and holding activities Biological soil amendments of animal origin Also, there are specific requirements for sprouts

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 facilities Domestic and imported produce Farms with annual sales > $25,000 per year Limitations on coverage are proposed In 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.

Covered Produce “Produce” defined as fruits and vegetables Produce includes mushrooms, sprouts, herbs and tree nuts Produce does not include grains Some limitations on covered produce In 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.

Limitations on Coverage Produce for personal or on-farm consumption Produce not a Raw Agricultural Commodity Certain produce rarely consumed raw Produce that will receive commercial processing Farms with sales of $25,000 or less per year Qualified exemption and modified requirements The 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 ownership Produce that is not a raw agricultural commodity An example is fresh-cut bagged salads Produce 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)

Alternatives Permitted Farms may establish alternatives to certain requirements related to water and biological soil amendments of animal origin Alternatives must be scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration One 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.

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 rule The 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.

Recordkeeping Required But Not Burdensome The proposed rule would require certain records, for example, to document that certain standards are being met Example: agricultural water testing results Records already kept for other purposes need not be duplicated The 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.

Qualitative Assessment of Risk Reflects Science Behind Rule Draft qualitative assessment of risk helps to inform proposed rule Provides a scientific evaluation of potential adverse health effects resulting from human exposure to hazards in produce Available for public comment as part of the proposed rule FDA 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.

Compliance Dates Staggered Effective Date: 60 days after final rule is published Not covered: Farms with sales ≤$25,000/year Compliance Dates Very small farms Average annual value of food sold >$25,000 and ≤$250,000 Four years after the effective date to comply For some water requirements, six years Compliance 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 date FDA is proposing staggered compliance dates for farms that would be covered based on size. Very Small Farms Very 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.

Compliance Dates Small farms Average annual value of food sold > $250,000 and ≤ $500,000 Would have three years after the effective date to comply Would have five years for some water requirements Other covered farms Other covered businesses would have to comply two years after the effective date Would have four years for some water requirements Small Farms Small 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 Farms Other 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.

Preventive Controls for Human Food Let me now give you an overview of the Proposed Rule on Preventive Controls for Human food.

Key Principles Confirms industry’s primary role on food safety Prevention of hazards Risk-based The 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 based because 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.

Summary of Requirements Hazard Analysis and Risk-Based Preventive Controls Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods Updated Good Manufacturing Practices The rule has two major features: Hazard analysis and risk-based preventive controls are required Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods. Updated Good Manufacturing Practices

Who is Covered? Facilities that manufacture, process, pack or hold human food In general, facilities required to register with FDA under sec. 415 of the FD&C Act Applies to domestic and imported food Some exemptions and modified requirements are being proposed Facilities that would be covered by the proposed rule are those that manufacture, process, pack or hold human food In general, facilities required to register with FDA under current regulations are covered. The proposed rule would apply to domestic and imported food Some exemptions and modified requirements are being proposed.

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 hazards Preventive 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 required Corrective actions that would be used if preventive controls are not properly implemented Verification Recordkeeping

Preventive Controls Required Process controls Food allergen controls Sanitation controls Recall plan In addition, seeking comment on supplier approval and verification program The preventive controls required would depend on which, if any, hazards are reasonably likely to occur. They are: Process controls Food allergen controls Sanitation controls Recall plan We 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.

Verification Required Validation Calibration Review of records In addition, seeking comment on review of complaints, finished product and environmental testing Verification activities are required to ensure that preventive controls are consistently implemented and effective. They include: Validation Calibration Review of records We are seeking comment on the following as verification activities: review of complaints finished product and environmental testing

Updated Good Manufacturing Practices Protection against allergen cross-contact Updated language; certain provisions containing recommendations would be deleted Comments requested on mandating training and whether rule should require, rather than recommend, certain provisions Updated 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 supervisors whether 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.

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) OR Food sales averaging less than $500,000 per year during the last three years AND Sales to qualified end users must exceed sales to others A 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 AND Sales 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.

Exemptions and Modified Requirements Foods subject to low-acid canned food regulations (microbiological hazards only) Foods subject to HACCP (seafood and juice) Dietary supplements Alcoholic beverages Foods subject to low-acid canned food regulations (microbiological hazards only) Foods subject to HACCP (seafood and juice) Dietary supplements Alcoholic beverages The types of businesses listed would be exempt from food safety plan requirements but are not exempt from GMP requirements

Exemptions and Modified Requirements Facilities, such as warehouses, that only store packaged foods that are not exposed to the environment Certain storage facilities such as grain elevators that store only raw agricultural commodities intended for further distribution or processing Facilities, 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 records Certain storage facilities such as grain elevators that store only raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing

Farm-Related Exemptions Activities within the definition of “farm,” including farm activities that are covered by the proposed produce rule Certain low-risk manufacturing/processing, packing and holding activities conducted by small/very small businesses on farms for specific foods Farm-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, and Certain low-risk manufacturing/processing activities conducted by small/very small businesses on farms for specific foods

Effective and Compliance Dates Effective date: 60 days after the final rule is published Compliance Dates Small 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 size Small businesses Small businesses, defined as employing fewer than 500 persons and not qualifying for an exemption, would have two years after publication

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 requirements Other Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply. Very small businesses Very 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 businesses Other Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply.

Risk Assessment Draft qualitative risk assessment announced in a separate notice of availability Addresses activities outside the farm definition conducted in a facility co-located on a farm. Comments being accepted separate from the proposed rule FDA 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.

How to Comment on the Proposed Rules http://www.regulations.gov Link to rules on http://www.fda.gov/fsma Comment period is 120 days; exact due date will be in the Federal Register Comment 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 http://www.regulations.gov and also can be accessed at www.fda.gov/fsma. The 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.

Outreach and Technical Assistance Will Continue Public meetings Presentations Listening sessions Alliances Produce Safety Preventive Controls Sprouts Safety Guidance documents Outreach FDA conducted extensive outreach before the proposed rules were issued and that outreach will continue We 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 assistance Will 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 University The Food Safety Preventive Controls and Sprouts Safety Alliances were established in partnership with the Illinois Institute of Technology FDA 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

More Information Available Web site: http://www.fda.gov/fsma Subscription feature available Send questions to FSMA@fda.hhs.gov The 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 news Stakeholders can send questions to FSMA@fda.hhs.gov. We 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.