Proposed Rules under the FDA Food Safety Modernization Act

Five Proposed Rules EstablishFood Safety Framework

• Produce Safety Standards - Published Jan. 2013

• Preventive Controls for Human Food - Published Jan. 2013

• Preventive Controls for Animal Food

• Foreign Supplier Verification

• Accredited Third Party Certification

• Confirm industry’s primary role in food safety• Risk-based and flexible• Address small business issues• Extensive government and stakeholder Input

Key Aspects of Proposals

FDA Proposed Rules on Produce Safety

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

• Domesticated and wild animals• Equipment, tools, buildings and sanitation• Worker health and hygiene• Growing, harvesting, packing

and holding activities• Biological soil amendments

of animal origin• Agricultural water• Sprouts have separate

requirements

Standards for Produce SafetyFocuses on identified routes of microbial contamination

• 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

Who Must Be FMSA Compliant?

What Produce Is Required To Be FSMA Compliant?

• “Produce” is defined as fruits and vegetables

• Produce also includes mushrooms, sprouts, herbs and tree nuts

• Produce does not include grains

• Some limitations on covered produce

• Produce that will receive commercial processing

• Farms with sales of <$25,000 /year

• Qualified exemptions/modifications

Exemptions From FSMA Compliance

• Produce for personal or on-farm consumption

• Produce that is not a “Raw Agricultural Commodity”

• Certain produce rarely consumed raw

• Farms may establish alternatives or modifications 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 rules without increasing the risk of contamination or adulteration.

Modifications/Alternatives Permitted

Variances Provide Some 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.

Recordkeeping Required But Not Excessively Burdensome*

The proposed rules would require certain records to document that certain standards are being met– Example: agricultural water testing results

Records already kept for other purposes need not be duplicated (for example, records that are required for organic certification).

*According to the Government

If it was not recorded or logged,it didn’t happen!

Qualitative Assessment of Risk Reflects Science Behind Rule

• Draft qualitative assessment of risk help to inform proposed rules

• 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 rules

Staggered Compliance Dates• Effective Date: 60 days after final rule is published

• Farms with sales ≤$25,000/year are excluded

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

• Food Safety Plan needed with commitment to food safety.

• Someone in charge of food safety.• Policy for Food Safety violations.• Reviewed/renewed at least annually.• Records kept all season and readily

available for auditors.• Records kept for the season.• Train all staff on your policies before they

handle produce.

• Any licensed water lab results are acceptable.

• Use laboratory’s procedure for sampling.

• Documented traceability program advised

Comparison Between GAP and FSMAGAP/GHP

• Food Safety Plan needed with commitment to food safety.

• Someone in charge of food safety 24/7/365• Disciplinary Policy for Food Safety violations.• Reviewed/renewed at least annually.• Records kept all season and readily available

for auditors.• Records kept for at least two years.• Train all staff on your policies before they

handle produce.• Train employees for their specific jobs + one formal food safety course/workshop. • Microbiological lab must have passed a Good Lab Practice Audit and use validated methods.• Utilize written sampling protocol and keep copy of it in your plan.• Documented traceability program required.

FSMA

• Product records enable traceability one step backward and one step forward.

• Written recall procedures advised.• Mock audit suggested within last 6 months.

• Pass/Fail Audit; based on points.

• Land use history and adjacent land use documented and addressed

GAP/GHP FSMA• Product records enable traceability one

step backward and one step forward. Include date of receipt, lot numbers, quantities, source of produce and transporter.

• Written recall procedures required.• Mock audit must achieve accuracy within

4 hrs. and shall show 100% reconciliation and be done at least annually.

• Documented Corrective Action procedures for any non-conformance with food safety. Market determines priorities and minimum standards.

• Self-audit procedures must be established and done annually by knowledgeable person. Record of required corrective action written and kept.

• Evaluation and documentation of possible risks associated with land use history and adjacent land use, including equipment and structures.

• Indoor packing and or storage facilities must be designed, constructed, and maintained so as to prevent contamination of produce.

• Light bulbs, fixtures, windows, mirrors, skylights and other glass and brittle plastic shall be of the safety type or protected to prevent breakage.

• Facilities have pest control programs in place which are monitored on a regular, scheduled basis.

• Written Toilet, Hygiene, and Health policies needed.

GAP/GHP FSMA• Indoor growing and and packing or storage

facilities must be designed, constructed, and maintained so as to prevent contamination of produce.

• Only essential glass and brittle plastic shall be present in a facility, and if it exists, a control policy must also exist. Light bulbs, fixtures, windows, mirrors, skylights and other glass and brittle plastic shall be of the safety type or protected to prevent breakage.

• Operation has procedures in place to prevent pest harborage in any equipment stored near buildings.

• Facilities have pest control programs in place which are monitored on a regular, scheduled basis by a trained or licensed pest control operator.

• Written Toilet, Hygiene, and Health policies needed.

• Employee and Visitor policies needed.• Hand-washing required prior to any

handling of produce.• Signage for hand-washing required.• Clothing shall be clean and appropriate for

operation.• Glove or apron policy if used.

• Policy about personal effects like jewelry, watches not required

• Policy about hair coverings not required.• Smoking, chewing, eating, drinking (other

than H2O) occurs only in designated areas.

• Smoking, chewing, eating, drinking (other than H2O), urinating, defecating or spitting not permitted in growing areas.

GAP/GHP FSMA• Employee and Visitor policies needed.• Hand-washing required prior to any

handling of produce.• Signage for hand-washing required.• Clothing shall be clean and appropriate for

operation.• Glove or apron policy if used.• If Protective clothing worn, policy exists

for when used, how cleaned, replaced, and stored.

• Policy about personal effects like jewelry, watches is required.

• Policy about hair coverings required.• Smoking, chewing, eating, drinking (other

than H2O) occurs only in designated areas.• Employees belongings must have a

designated storage spot.• Smoking, chewing, eating, drinking (other

than H2O), urinating, defecating or spitting not permitted in growing areas.

• Drinking water available to all employees.• Workers with illness are restricted from

direct contact with produce.• Those with exposed cuts, sores, lesions shall

not handle produce.• Need policies on blood and bodily fluids.• First Aid kits necessary and accessible to

employees.

• Agricultural chemicals applied by trained, licensed, or certified application personnel

• All chemicals are stored in a secure separate area and properly labeled.

GAP/GHP FSMA• Drinking water available to all employees• Workers with illness are restricted from

direct contact with produce• Those with exposed cuts, sores, lesions

shall not handle produce.• Need policies on blood and bodily fluids.• First Aid kits necessary and accessible to

employees.• Agricultural chemicals use shall comply

with label directions and regulations, records maintained.

• Agricultural chemicals applied by trained, licensed, or certified application personnel

• All chemicals are stored in a secure separate area and properly labeled.

• Use of agricultural chemicals must meet the MRL entry requirements of country where product is going.

GAP/GHP FSMA• Water System description includes maps,

photos, or drawings that show location of water sources, permanent fixtures, flow of system, and permanent fixtures like wells, gates, reservoirs, valves, returns, backflow prevention…

• Ag. Chemicals applied post-harvest (biocides, waxes, and plant protection products) must be registered for such use and used according to label.

• Annual Water System Description & Risk Assessment exists for all water used. Includes preventive controls, monitoring and verification procedures, corrective actions and documentation. Personnel with oversight need training.

• Documentation of scheduled assessment of water system necessary to show they are not an unsanitary condition themselves.

• Human waste and gray water sewage has sufficient capacity to handle operation’s peak flows and not cause direct or indirect contamination.

• Water testing is part of the plan. Annual testing for wells and municipalities and three times a year for surface water.

• Facilities are monitored for signs of domestic and wildlife.

• Steps are taken to deter animals from production fields.

GAP/GHP FSMA• Water testing is part of the plan, is

directed by the water risk assessment and prevailing regulations for commodities grown.

• Written procedures exist for changing water that is re-used (recirculated, flumes, dump tanks).

• Water antimicrobial treatments monitored to ensure continuous control.

• Written risk assessment on animal activity in and around production area before the growing season. Scheduled monitoring of growing fields and adjacent land based on production factors.

• Risk-appropriate actions to prevent/minimize potential contamination from animal feces. Written records of any mitigation or corrective actions.

• Soil amendments such as manure, biosolids, and compost applied to the soil are processed or applied following food safety guidelines, so as to lessen risk of contamination. Records are kept of applications.

• Vehicles, equipment, tools and silssils are maintained on a regular basis.

GAP/GHP FSMA• Soil amendments such as manure,

biosolids, and compost applied to the soil are processed or applied following food safety guidelines, so as to lessen risk of contamination. Records are kept of applications.

• A list of all soil amendments such as manure, biosolids, and compost applied to the soil are processed or applied following food safety guidelines, so as to lessen risk of contamination. Records are kept of applications that may pose a risk of contamination during normal use.

• Cleaning and sanitizing of containers and implements occurs on a regular basis. Cleaning and sanitizing procedures do not pose a risk of contamination

• Water tanks are cleaned so as not to become a source of contamination.

• Vehicles, equipment, tools and utensils are controlled so as not to be a source of physical hazards.

• Pre-harvest Risk Assessment performed.• Standard Operating Procedures address

quality of water used for ice making that contacts the crop or the food contact surface.

• Water use SOP addresses treatment of water if re-circulated.

• SOP addresses wash water temperature for sensitive commodities.

• SOP exists for storage of harvesting containers.

• SOP exists for inspection of food contact containers.

• SOP for acceptable harvesting containers.• SOP exists prohibiting use of harvest

containers for non-harvest purposes.

GAP/GHP FSMA• Pre-harvest Risk Assessment performed.• Standard Operating Procedures address

quality of water used for ice making that contacts the crop or the food contact surface.

• Iced produce is handled so as not to serve as a source of contamination.

• Water use SOP addresses treatment of water if re-circulated.

• SOP addresses condition and maintenance of water delivery system.

• SOP addresses wash water temperature for sensitive commodities.

• SOP exists for storage of harvesting containers.

• SOP exists for inspection of food contact containers.

• SOP for acceptable harvesting containers.• SOP exists prohibiting use of harvest

containers for non-harvest purposes.

• SOP on what happens to damaged or decayed produce.

• SOP on product that contacts the ground and does not grow on the ground.

• SOP for inspection and removal of physical hazards from harvested product.

• All product is packed in new or sanitized containers.

• Harvested product is stored separately from chemicals.

• SOP addresses cleanliness and functionality of shipping units.

• Loading, unloading procedures and equipment minimizes damage and contamination of product.

GAP/GHP FSMA• SOP on what happens to damaged or

decayed produce.• SOP on product that contacts the ground

and does not grow on the ground.• SOP for inspection and removal of physical

hazards from harvested product.• Cloths, towels or other cleaning materials

that pose a risk of cross- contamination shall not be used to wipe produce.

• Packaging materials are appropriate for intended use. Stored appropriately and SOP exists to address whether they are permitted in direct contact with the soil.

• Pallets are kept clean and in good condition.

• Harvested product is stored separately from chemicals.

• SOP addresses cleanliness and functionality of shipping units.

• Loading, unloading procedures and equipment minimizes damage and contamination of product.

• There is a written preventive maintenance or master cleaning schedule established and followed.

• Food contact surfaces are cleaned, sanitized and maintained according to the Food Safety Plan.

• When temperature control is needed for food safety, facilities shall have suitable temperature monitoring devices which are calibrated and monitored on a scheduled basis.

GAP/GHP FSMA• Maintains and has list of approved raw

material suppliers (including packaging) and procedure for accepting materials from others.

• All raw product suppliers must show evidence of food safety/GAP compliance

• There is a written preventive maintenance or master cleaning schedule established and followed.

• Cleaning agents are approved for their intended use

• Cleaning equipment and tools are clean, in working order, and stored properly away from product handling areas.

• Food contact surfaces are cleaned, sanitized and maintained according to the Food Safety Plan

• Adequate lighting is provided for all areas. • When temperature control is needed for food

safety, facilities shall have suitable temperature monitoring devices which are calibrated and monitored on a scheduled basis.

GAP/GHP FSMA• Cooling equipment is maintained so as not to

contaminate product.• Transportation equipment is maintained so as

not to contaminate product.• Outside garbage receptacles are closed and

located away from entrances and area around is reasonably clean.

• Plant grounds are reasonably free of litter, culls, vegetation, debris, and standing water.

• Non-product storage areas maintained so as not to contaminate products or materials.

• Materials and packing materials are protected from contaminates.

• Adequate space is maintained between rows of stored materials and between stored materials and walls and ceilings, to allow cleaning and inspection.

• Only food grade lubricants are used on food processing and packaging equipment, or any other equipment where incidental food contact may occur. Lubricant leaks are fixed or catch pans are installed to prevent product contamination.

• Cooling equipment is maintained so as not to contaminate product.

• Transportation equipment is maintained so as not to contaminate product.

• Outside garbage receptacles are closed and located away from entrances and area around is reasonably clean.

• Plant grounds are reasonably free of litter, culls, vegetation, debris, and standing water.

• Non-product storage areas maintained so as not to contaminate products or materials.

• Materials and packing materials are protected from contaminates.

• Adequate space is maintained between rows of stored materials and between stored materials and walls and ceilings, to allow cleaning and inspection.

• Only food grade lubricants are used on food processing and packaging equipment, or any other equipment where incidental food contact may occur. Lubricant leaks are fixed or catch pans are installed to prevent product contamination.

GAP/GHP FSMA• All food contact equipment is designed and

made of materials that are easily cleaned and maintained

• Cooling, packing, and other food contact equipment is installed away from walls and otherwise positioned so as not to inhibit access for proper cleaning.

• Catwalks above product flow zones are protected to prevent contamination.

• Temporary repairs on food contact surfaces are constructed of food-grade material and permanent repairs are implemented in a timely manner.

• Clothing & footwear, shall be effectively maintained, stored, laundered and worn to protect product from contamination.

• Protective clothing shall not be left on product, work surfaces, equipment or packaging materials. Will be hung on racks or in designated areas.

• If applicable, operation has a written Allergen Control Program.

• Catwalks above product flow zones are protected to prevent contamination.

GAP/GHP FSMA• Specifications for all packing materials that

impact finished product safety and quality will be available.

• Domestic animals are prohibited from packing house or storage unless procedures are in place for their safe presence. Procedures are in place to exclude wild/feral animals to the degree practicable.

• If produce is washed, an initial risk assessment of the process takes into account the commodity, type of wash system, type of sanitizer, and water quality.

• Operation has procedures to determine how and when debris shall be removed from wash areas/dump tanks.

• Only wash water antimicrobials or systems registered or approved by EPA, FDA may be used in the dump tank water, spray line, or other food contact surfaces.

• Operation records that include minimum limits for antimicrobials in wash water. Must include how to control, monitor and record use and have what corrective actions are needed if criteria are not met.

• Domestic animals are prohibited from packing house or storage.

• If produce is washed, an initial risk assessment of the process takes into account the commodity, type of wash system, type of sanitizer, and water quality.

• Only wash water antimicrobials or systems registered or approved by EPA, FDA may be used in the dump tank water, spray line, or other food contact surfaces.

• Operation records that include minimum limits for antimicrobials in wash water.

GAP/GHP FSMA• All instruments used to measure

temperature, pH, antimicrobial levels and/or other devices used shall be calibrated at a frequency sufficient to assure accuracy.

• Foreign material control devices are inspected and maintained.

• When applicable, there is a written policy for transporters and conveyances to maintain a specified temperature during transit.

• Prior to loading, vehicle shall be pre-cooled.• Refrigerated transport shall have properly

maintained and functional refrigeration equipment.

• When required, temperatures of product are taken and recorded prior to or upon loading.

• There is a written policy and checklist to verify cleanliness and functionality of shipping units.

• Loading/unloading procedures and equipment shall minimize damage to prevent contamination of product.

• All instruments used to measure temperature, pH, antimicrobial levels and/or other devices used shall be calibrated at a frequency sufficient to assure accuracy.

• When applicable, there is a written policy for transporters and conveyances to maintain a specified temperature during transit.

• Refrigerated transport shall have properly maintained and functional refrigeration equipment.

• There is a written policy and checklist to verify cleanliness and functionality of shipping units.

• Loading/unloading procedures and equipment shall minimize damage to prevent contamination of product.

The Harmonized GAP is not a pass/fail audit, nor is it point driven. The bottom line is that individual audit areas will be rated as

either being a) not applicable to this operation; b) acceptable; c) need corrective action; d) or be an immediate food safety risk. The market will decide what items/issues are priorities for them

and determine whether they accept these results.

A Food-Safe CommercialAquaponics System