On January 5, 2013, the U.S. Food and Drug Administration (FDA), as part of a continuing overhaul of the United States’ food safety laws under the Food Safety Modernization Act (FSMA), published proposed rules regarding the minimum standards for the safe production and harvesting of raw fruits and vegetables on farms, whether grown within the United States or abroad for consumption within the United States. The main goal of these rules is to reduce the occurrence of microbial contamination of produce resulting in foodborne diseases, which currently causes illness in 1 out of 6 Americans each year, including 128,000 hospitalizations and approximately 3,000 deaths.

Accordingly, these rules focus more on “preventing food safety problems rather than primarily reacting to problems after they occur” and provide enhanced enforcement mechanisms to “achieve higher rates of compliance with prevention- and risk-based safety standards.” While significant cost will attend to the implementation of the new rules, the overall net savings anticipated by the FDA is $406.22 million in annual potential benefits. New standards have been proposed in the following areas: (1) Worker Training, Health and Hygiene; (2) Agricultural Water; (3) Biological Soil Amendments; (4) Domesticated and Wild Animals; (5) Equipment, Tools and Buildings; and (6) Sprouts. In nearly every case, the rules impose not only guidelines and standards, but also record-keeping requirements with regard to compliance with such rules.

The proposed rules were released in conjunction with a separate set of rules regarding the Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, representing a comprehensive overhaul to the FSMA in order to increase the safety of food consumed by humans in the United States. The proposed new rules would require manufacturers of processed foods sold in the United States to develop methods to reduce the risk of their products causing foodborne illness. Food companies would be required to have a written plan for monitoring and correcting problems (including recalls) and for keeping records that government inspectors can audit.

The FDA proposal also includes provisions that allow the FDA to withdraw the exemptions or modifications if necessary, based on the facts at a particular facility. Flexibility can be both good and bad news. Some segments of the food industry may argue for a simpler, less costly process during the public comment period on the rulemaking. However, public advocacy groups may argue that exemptions or modifications should be narrowly applied, so the contours of the final rule are not certain at this point. Once implementation of the final regulations begins, companies will need to determine whether, given the nature of their particular operations and food products, a company- or facility-specific control plan is necessary to provide the level of protection required by the regulations in a cost-effective manner. As a result, whether during the public commenting process or during the implementation of the regulations, going forward companies in the food industry are likely to need to develop their factual and scientific “case” and advocate their positions to the FDA (whether using in-house resources or with the assistance of consultants and outside legal counsel).

The FDA has promised to coordinate comments to all of these proposed rules in order to better integrate their implementation. In addition, new rules for importers to verify that food products grown or processed overseas are as safe as domestically produced food and accreditation standards to strengthen the quality of third-party food safety audits overseas are soon to follow. These rules demonstrate a changing role for the FDA in food safety; from an agency that merely tracked down contamination outbreaks after the fact, to one that is focused on prevention, imbued with strong enforcement and punishment powers to drive that message home.

Parties interested in commenting on the proposed rules should submit their comments at http://www.regulations.gov. The commentary period is open for 120 days. A summary of the major changes in the proposed rules is set forth in the Appendix below.

APPENDIX

The following sets forth the major new requirements in the six areas of: (1) Worker Training, Health and Hygiene; (2) Agricultural Water; (3) Biological Soil Amendments; (4) Domesticated and Wild Animals; (5) Equipment, Tools and Buildings; and (6) Sprouts.

• Worker Training, Health and Hygiene:
  • establish qualification and training requirements for all personnel who handle (contact) covered produce or food-contact surfaces and their supervisors (proposed §§ 112.21, 112.22, and 112.23)
  • require documentation of required training (proposed § 112.30), and
  • establish hygienic practices and other measures needed to prevent persons, including visitors, from contaminating produce with microorganisms of public health significance (proposed §§ 112.31, 112.32, and 112.33).
• Agricultural Water:
  • require that all agricultural water must be of safe and sanitary quality for its intended use (proposed § 112.41). Agricultural water is defined in part as water that is intended to, or likely to, contact the harvestable portion of covered produce or food-contact surfaces (proposed § 112.3(c))
  • establish requirements for inspection, maintenance, and follow-up actions related to the use of agricultural water, water sources, and water distribution systems associated with growing, harvesting, packing, and holding of covered produce (proposed §§ 112.42 and 112.46)
  • require treatment of agricultural water if you know or have reason to believe that the water is not safe and of adequate sanitary quality for its intended use, including requirements for treating such water and monitoring its treatment (proposed § 112.43)
  • establish specific requirements for the quality of agricultural water that is used for certain specified purposes, including provisions requiring periodic analytical testing of such water (with exemptions provided for use of public water supplies under certain specified conditions or treated water), and requiring certain actions to be taken when such water does not meet the quality standards (proposed §§ 112.44 and 112.45); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12), and
  • require certain records, including documentation of inspection findings, scientific data or information relied on to support the adequacy of water treatment methods, treatment monitoring results, water testing results, and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.50).
• Biological Soil Amendments:
  • establish requirements for determining the status of a biological soil amendment of animal origin as treated or untreated, and for their handling, conveying, and storing (proposed §§ 112.51, 112.52)
  • prohibit the use of human waste for growing covered produce except in compliance with EPA regulations for such uses or equivalent regulatory requirements (proposed § 112.53)
  • establish requirements for treatment of biological soil amendments of animal origin with scientifically valid, controlled, physical and/or chemical processes or composting processes that satisfy certain specific microbial standards (proposed §§ 112.54 and 112.55); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12)
  • establish application requirements and minimum application intervals for untreated and treated biological soil amendments of animal origin (proposed § 112.56); and provide for alternative requirements for certain provisions under certain conditions (proposed § 112.12), and
  • require certain records, including: documentation of application and harvest dates relevant to application intervals; documentation from suppliers of treated biological soil amendments of animal origin; periodic test results; and scientific data or information relied on to support any permitted alternatives to requirements (proposed § 112.60).
• Domesticated and Wild Animals:
  • if animals are allowed to graze or are used as working animals in fields where covered produce is grown and under the circumstances there is a reasonable probability that grazing or working animals will contaminate covered produce, require, at a minimum, an adequate waiting period between grazing and harvesting for covered produce in any growing area that was grazed, and measures to prevent the introduction of known or reasonably foreseeable hazards into or onto covered produce (proposed § 112.82), and
  • if under the circumstances there is a reasonable probability that animal intrusion will contaminate covered produce, require monitoring of those areas that are used for a covered activity for evidence of animal intrusion immediately prior to harvest and, as needed, during the growing season (proposed § 112.83).
• Equipment, Tools, and Buildings:
  • establish requirements related to equipment and tools that contact covered produce and instruments and controls (including equipment used in transport), buildings, domesticated animals in and around fully-enclosed buildings, pest control, hand-washing and toilet facilities, sewage, trash, plumbing, and animal excreta (proposed §§ 112.121-134), and
  • require certain records related to the date and method of cleaning and sanitizing equipment used in growing operations for sprouts, and in covered harvesting, packing, or holding activities (proposed § 112.140).
• Sprouts:
  • establish measures that must be taken related to seeds or beans for sprouting (proposed § 112.141)
  • establish measures that must be taken for the growing, harvesting, packing, and holding of sprouts (proposed § 112.142)
  • require testing of the growing environment for Listeria spp. or L. monocytogenes and testing of each production batch of spent irrigation water or sprouts for E. coli O157:H7 and Salmonella species and take appropriate follow-up actions (proposed §§ 112.143, 112.144, 112.145, 112.146), and
  • require certain records, including documentation of treatment of seeds or beans for sprouting, a written environmental monitoring plan and sampling plan, test results, and certain methods used (proposed § 112.150).

Implementation

The usual effective date of the new rules is 60 days after the final rule is published; however the FDA is allowing for longer timelines for farms to comply. Except for those farms that fall into the following two categories, farms will have two years after the effective date to comply with the new rules, and for some of the water requirements, four years. Small businesses (those entities subject to proposed Part 112, and on a rolling annual basis, with average monetary value of food sold during the previous three-year period being no more than $500,000) have three years after the effective date to comply, but with certain water requirements, that period is extended to five years. Very small businesses (those entities subject to proposed Part 112, and on a rolling annual basis, with average monetary value of food sold during the previous three-year period being no more than $250,000) have four years to comply, but again, with certain water requirements, the period is extended to six years.

Exemptions

While the above new rules apply to both domestic and foreign produce, there are several categories of produce and/or farms that are exempt from the new rules. The proposed new rules would not apply to or cover:

• certain specified produce commodities that are rarely consumed raw
• produce that is used for personal or on-farm consumption, or that is not a raw agricultural commodity
• produce that receives commercial processing that adequately reduces the presence of microorganisms (e.g., a “kill step”) as long as certain documentation is kept
• farms that have an average annual value of food sold during the previous three-year period of $25,000 or less
• farms that meet two requirements: (1) the farm must have food sales averaging less than $500,000 per year during the last three years; and (2) the farm’s sales to qualified end-users must exceed sales to others. A “qualified end-user” is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state as the farm or not more than 275 miles away. Instead, these farms would be required to include their name and complete business address either on the label of the produce that would otherwise be covered (if a label is required under the federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations) or at the point-of-purchase. This exemption may be withdrawn in the event of an active investigation of an outbreak that is directly linked to the farm, or if it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions on the farm that are material to the safety of the produce. These entities are either exempt from all the requirements of the rules or are subject to a narrower set of requirements.

The following sets forth the proposed changes to the current FDA rules on the manufacturing, processing, packing or holding of human food.

Overview of Rule Changes

The proposed rule would revise the FDA’s current regulations in Part 110 regarding the manufacturing, processing, packing, or holding of human food in two fundamental ways: First, it would add new provisions to implement Section 103 of FSMA. Second, it would update, revise, or otherwise clarify certain requirements of current regulations in Part 110. The new provisions and revisions to the current requirements of Current Good Manufacturing Practices (CGMP) would be established in Part 117. Under the proposed rule, new Part 117 would be divided into the following subparts:

• Subpart A—General Provisions
• Subpart B—Current Good Manufacturing Practice
• Subpart C—Hazard Analysis and Risk-Based Preventive Controls
• Subpart D—Modified Requirements
• Subpart E—Withdrawal of an Exemption Applicable to a Qualified Facility
• Subpart F—Requirements Applying to Records That Must Be Established and Maintained, and
• Subpart G would be reserved.

Proposed Revisions to 21 CFR Part 1. Subparts H. I. and J

To implement Section 103(c) of FSMA, the proposed rule would revise certain definitions in the FDA’s current Section 415 registration regulations. These revisions would clarify the types of activities that are included as part of the definition of the term “facility” under Section 415 of the FD&C Act and the scope of the exemption for “farms” provided by Section 415 of the FD&C Act. The proposed rule also would make corresponding changes in Part 1, Subpart I (Prior Notice of Imported Food) and in Part 1, Subpart J (Establishment, Maintenance, and Availability of Records).

Proposed Revisions to General Provisions of 21 CFR Part 110 (Part 110)
(Proposed Part 117. Subpart A)

The proposed rule would both revise current provisions of Subpart A of Part 110 and add new provisions to Subpart A as it would be established in proposed Part 117. The new provisions would include specified exemptions for certain facilities, or for certain activities conducted by facilities, from the proposed requirements for hazard analysis and preventive controls in proposed Part 117, Subpart C. The proposed exemptions would be consistent with requirements established by FSMA or discretion provided by FSMA. The subjects of the specified exemptions relate to:

• a “qualified” facility
• activities subject to the FDA’s existing Hazard Analysis and Critical Control Point (HACCP) system regulations for seafood and juice, regulations governing microbiological hazards in low-acid canned foods, and dietary supplement CGMP regulations
• activities of a facility that are subject to the Standards for Produce Safety in Section 419 of the FD&C Act
• certain low-risk packing or holding activity/food combinations conducted on a farm by a small or very small business
• certain low-risk manufacturing/processing activity/food combinations conducted on a farm by a small or very small business
• the receipt, manufacturing, processing, packing, holding, and distribution of alcoholic beverages and other prepackaged food sold in conjunction with alcoholic beverages (e.g., gift baskets)
• facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, and
• facilities solely engaged in the storage of packaged food that is not exposed to the environment, although the storage of such food that requires time/temperature control to prevent the growth of, or toxin formation by, pathogenic microorganisms would be subject to modified requirements that would be established in proposed Subpart D.

Proposed Revisions to Current Good Manufacturing Practice Requirements of Part 110
(Proposed Part 117. Subpart B)

In order to modernize current CGMP requirements, the proposed rule would make revisions including:

• modernizing and updating the language throughout (e.g., by replacing the word “shall” with the word “must” and by using certain terms consistently throughout proposed Part 117)
• deleting certain provisions containing recommendations, including the specific temperatures for maintaining refrigerated, frozen or hot foods
• clarifying that certain CGMP provisions requiring protection against contamination require protection against cross-contact of food as well to address allergens, and
• proposing that provisions directed to preventing contamination of food and food- contact substances be directed to preventing contamination of food-packaging materials as well.

Proposed New Requirements for Hazard Analysis and Risk-Based Preventive Controls
(Proposed Part 117. Subpart C1)

Written Food Safety Plan

This proposal would require that the owner, operator, or agent in charge of a facility have and implement a written food safety plan that includes as applicable:

• a hazard analysis
• preventive controls
• monitoring procedures
• corrective action procedures
• verification procedures, and
• a recall plan.

Written Hazard Analysis

As proposed, the written hazard analysis must identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at the facility to determine whether there are hazards that are reasonably likely to occur, including biological, chemical, physical, and radiological hazards. The hazard analysis would include an evaluation of the identified hazards to determine whether the hazards are reasonably likely to occur, including an assessment of the severity of the illness or injury if the hazard were to occur.

Written Preventive Controls

The owner, operator, or agent in charge of a facility must identify and implement preventive controls (including at critical control points, if any) to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented and that the food manufactured, processed, packed or held by such facility will not be adulterated under Section 402 of the FD&C Act or misbranded under Section 403(w) of the FD&C Act. The preventive controls would include, as appropriate:

• parameters associated with the control of the hazard and the maximum or minimum value, or combination of values, to which any biological, chemical, physical, or radiological parameter must be controlled to significantly minimize or prevent a hazard that is reasonably likely to occur
• process controls
• food allergen controls
• sanitation controls
• a recall plan, and
• any other necessary controls.

Written Recall Plan

The new rules, as proposed, would require that the written recall plan be developed for food with hazards that are reasonably likely to occur.

Monitoring

Monitoring of the preventive controls to provide assurance that they are consistently performed, including requirements to establish and implement written monitoring procedures and establish and maintain records documenting the implementation of the monitoring procedures.

Corrective Actions

Facilities must establish and implement written corrective action procedures that would be used if preventive controls are not properly implemented and take corrective actions in the event of an unanticipated problem.

Verification

The new rules would require that facilities conduct certain verification activities, including:

• validation of a subset of the preventive controls
• verification that monitoring is being conducted
• verification that appropriate decisions about corrective actions are being made, and
• verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards that are reasonably likely to occur.

Last, the food safety plan must be reanalyzed at least once every three years and more often when circumstances warrant.

Qualified Individual

Qualification requirements for a “qualified individual” will be established to determine who would be required to do or oversee the: 1) preparation of the food safety plan; 2) validation of preventive controls; 3) review of records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions; and 4) reanalysis of a food safety plan. A “qualified individual” would be required to successfully complete training with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.

List of Required Records

A list of records that would be required under proposed Subpart C are proposed, including the written food safety plan and records documenting monitoring of preventive controls, corrective actions, verification, and applicable training for the qualified individual.

Proposed New Provisions for Modified Requirements
(Proposed Part 117, Subpart D)

Proposed Subpart D would implement certain provisions in Sections 418(1) and (m) of the FD&C Act for modified requirements with respect to:

• Qualified facilities: Implementing the modified requirements specified in Section 418(1) of the FD&C Act for facilities that satisfy the statutory criteria for a “qualified facility,” the FDA proposes to establish requirements that include:
  • submission to the FDA of documentation that the facility is a qualified facility, and
  • submission to the FDA of documentation demonstrating that the owner, operator, or agent in charge of the facility has identified the potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the performance of the preventive controls to ensure that such controls are effective, or
  • submission to the FDA of documentation that the facility is in compliance with state, local, county, or other applicable non-federal food safety law, including relevant laws and regulations of foreign countries.
• Facilities solely engaged in the storage of packaged food that is not exposed to the environment: Acting on the discretion provided to the FDA by Section 418(m) of the FD&C Act, the owner, operator, or agent in charge of a facility solely engaged in the storage of packaged food that is not exposed to the environment would be required to conduct certain activities for any such refrigerated packaged food that requires time/temperature control to significantly minimize or prevent the growth of, or toxin production by, microorganisms of public health significance, including:
  • establishing and implementing temperature controls
  • monitoring the temperature controls
  • taking appropriate corrective actions when there is a problem with temperature controls
  • verifying that temperature controls are consistently implemented, and
  • establishing and maintaining the following records:
    • records documenting the monitoring of temperature controls
    • records of corrective actions, and
    • records documenting verification activities.

Proposed New Provisions for Withdrawal of an Exemption Applicable to a Qualified Facility
(Proposed Part 117. Subpart E)

Proposed Subpart E would implement the provisions of Section 418(1)(3) of the FD&C Act and establish the conditions under which an exemption granted to a “qualified facility” could be withdrawn, and the procedures that would be followed to withdraw such an exemption.

Proposed New Recordkeeping Requirements
(Proposed Part 117. Subpart F)

Proposed Subpart F would establish requirements that would apply to all records that would be required by the various proposed provisions of proposed Part 117, including:

• additional requirements specific to the food safety plan
• general requirements related to the content and form of records
• requirements for record retention
• requirements for official review of records by the FDA, and
• public disclosure.

Compliance Dates

Section 103(i)(l) of FSMA, General Rule, provides that “[t]he amendments made by this Section shall take effect 18 months after the date of enactment” (i.e., by July 4, 2012). Section 103(i)(2) of FSMA, Flexibility for Small Businesses, provides that “notwithstanding paragraph (1),” the amendments made by this section “shall apply” to a small business and very small business beginning on the dates that are six months and 18 months, respectively, “after the effective date” of the FDA’s final regulation.

The FDA is implementing the amendments made by Section 103 to the FD&C Act through this rulemaking (except as relates to animal food and intentional contamination). The FDA tentatively concludes that it is appropriate to provide a sufficient time period following publication of the final regulation for facilities to come into compliance. The final regulation will contain provisions that affect which facilities are subject to Section 418 and which provisions apply to particular facilities. Without these provisions of the regulation in effect, facilities would be uncertain as to the applicability of certain requirements to them. Further, the FDA tentatively concludes that compliance with Section 418 will be facilitated greatly by the detail and explanation that will be provided by the final regulation.