FDA Commissioner Margaret A.
Hamburg, M.D says
• “Preventing problems before they cause
harm is not only common sense, it is the
key to food safety in the 21st century,”
• “We cannot afford to wait until people
become ill to realize there is a problem.”
The FDA
Food Safety Modernization Act
(FSMA)
• Prevention is the core principle of the FDA Food Safety
Modernization Act that President Obama signed into law in
2011
• The proposed rules will establish requirements for farmers,
food companies and importers to prevent foodborne illness.
• Proposed rules build on existing voluntary industry
guidelines for food safety, which many producers, growers
and others currently follow
Five Proposed Rules
• Produce Safety Standards
• Preventive Controls for Human Food
• Importer Foreign Supplier Verification
• Preventive Controls for Animal Food
• Accreditation of Third-Party Auditors
• The first rules two have been proposed
and published for public comment setting
Science-based standards for the
prevention of foodborne illnesses
Comment Period
• The proposed rules have been published
in the Federal Register, with a 120-day
public-comment period. The rules are filed
in FDA’s official docket at
www.regulations.gov and can also be
accessed at www.fda.gov/fsma
• Comment period has been extended until
September 16, 2013
Compliance Dates under
The New FSMA
• Effective 60 days after final rule is
published
• Very small farms, small farms have up to
2 to 6 years to comply in certain areas
Scope of Coverage Under Produce
Safety Rule
Raw agricultural commodity (RAC) both domestic and imported produce
Exemptions:
• Products that are not a raw agricultural commodity
• Produce for personal or on-farm consumption
• Produce that receives commercial processing that adequately reduces the
presence of microorganisms (e.g. a ‘‘kill step’’) as long as certain
documentation is kept.
• The proposed rule would not cover farms that have an average annual
value of food sold during the previous three year period of $25,000 or less
• The proposed rule would provide a qualified exemption and modified
requirements for 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.
Scope of Preventative Controls Rule
• Applies to facilities that are required to register with FDA
under FDA’s current food facility registration regulations
• Exemption
– (1) During the 3-year period preceding the applicable calendar
year, the average annual monetary value of the food
manufactured, processed, packed or held at such facility that is
sold directly to qualified end-users (as defined in this part) during
such period exceeded the average annual monetary value of the
food sold by such facility to all other purchasers; and
– (2) The average annual monetary value of all food sold during
the 3-year period preceding the applicable calendar year was
less than $500,000, adjusted for inflation.
Exempted Need to Comment!
• This exemption may be withdrawn in the
event of an active investigation of an
outbreak that is directly linked to the farm
Organic
• In the case of production that is certified organic,
not include any requirements that conflict with or
duplicate the requirements of the national
organic program established under the Organic
Foods Production Act of 1990, while providing
the same level of public health protection as the
requirements under guidance documents,
including guidance documents regarding action
levels, and regulations under the FDA Food
Safety Modernization Act” (section 419(a)(3)(E));
Proposed Rule:
Produce Safety
• Proposes requirements that science-based standards
be set for growing, harvesting, packing and holding of
fruits and vegetables on farms, The standards address
major areas specific to agriculture that can be the
conduit for contaminants:
–
–
–
–
–
Irrigation and other agricultural water
Farm worker hygiene
Manure and other additions to the soil
Intrusion of animals in the growing fields.
Sanitation conditions affecting buildings, equipment and
tools
– http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
Your Comments Needed
• Subpart A—General Provisions
– Definition of ‘‘Mixed type facility’’
– How does it pertain to family businesses
• Subpart C—Standards Directed to
Personnel Qualifications and Training
• Subpart D—Standards Directed to Health and
Hygiene
– comments on the notification and other proposed
requirements related to workers health
• Subpart E—Standards Directed to Agricultural
Water
– Comments on testing frequencies
– Alternative approaches
• Subpart F—Standards Directed to Biological
Soil Amendments of Animal Origin and Human
Waste
– treatment processes acceptable for a biological soil
amendment of animal origin
– application requirements, minimum application
intervals that apply to biological soil amendments of
animal origin
• Subpart I—Standards Directed to Domesticated
and Wild Animals
– Working animals
• Subpart K—Standards Directed to Growing,
Harvesting, Packing and Holding Activities
• Subpart L—Standards Directed to Equipment,
Tools, Buildings, and Sanitation
• Subpart O—Requirements Applying to Records
That You Must Establish and Keep
Proposed Rule:
Preventive Controls for Human Food
•
Sets safety requirements for facilities that
process, package or store food for
people. Most human food facilities would
be required to have a written plan
–
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm3341
15.htm
Plan Requirements
– evaluate hazards that are reasonably likely to
occur in food, such as pathogens (diseasecausing organisms) and allergens
– specify the steps that will be put in place to
minimize or prevent those hazards
– specify how these controls will be monitored
– maintain routine records of the monitoring for
verification (is it working)
– specify what actions will be taken to correct
problems that arise
Your Comments Needed
• Facilities that “qualify” for exemption
–
–
–
–
–
–
Are size classifications appropriate?
Should they be more in line with the Produce Rule?
Will there be supporting data to define business size
Requirements for exempted facilities, are they sufficient
Frequency of rechecking for “qualification”
Compliance after rule is published is 2 (very small) & 3 (small)
years, is this timeframe sufficient?
• Minimum requirements for qualified individuals who
prepare, validate, review records, reevaluate a food
safety plan
– Scope of work, standardized curriculum for training, job
experience? Is it sufficient?
• HACCP (critical control point) / HARPC (risk-based
preventative control) shift. Critical limits would not be
required for all preventative controls
• Should requirements for verifying the
monitoring and corrective actions of
preventative controls be specified e.g.:
– Environmental monitoring, should there be
requirements for monitoring Listeria spp,
salmonella spp., when and how? Should
testing specify pathogen or the indicator
organism?
– Product testing is not included in the
proposed rule, FDA seeks comments if it
should be proposed
• Written Recall Plan
– All types of facilities or modified for certain
types
– Should FDA be notified if a recall
–
• Farm mixed-type facility
– Do you agree with the FDA qualitative risk
assessment of activity/food combinations
methodology to determine which is low risk?
(table 5 & pg 3690)
– Should FDA establish submission
requirements to identify above facilities to
exempt or modify inspection frequencies
• Cross Contact (inadvertent incorporation
of an allergen or microorganisms into
food) requirements:
– Current GMPs recommend containers and
carriers of raw materials be inspected on
receipt to ensure that their condition has not
contributed to the cross contact,
contamination or deterioration of food, should
it be required?
• Training and Education of Personnel
– Should this be recommended or required?
Should requirements be more specific?
• Validation Studies
– FDA is seeking comments on decisions to not
require scientific studies on allergen labeling
controls and sanitation controls.
– Is verification activities sufficient?
• Records Review
– Requirement to review records for the
purpose of ensuring preventive controls are
effective
– After reanalysis of food safety plan, it is found
that an identified hazard is reasonably likely to
occur, is six weeks enough time to implement
additional controls?
• Record Retention and Review
– 2 year retention for any facility, records to be
made available for review and copying at a
facility’s place of business at a reasonable
time
– Should this be modified to require a facility to
send records to the FDA and if so,
electronically?
• Supplier Approval and Verification
– Should the above be included in the final
rule? Should it be general and/or based on
risk?
• Customer Complaints
– Should the above be included in the final rule
to verify that preventive controls are
effectively minimizing the occurrence of
hazards?
• Time and Temp controls for safety
– Modifications to the proposed rule for those
solely engaged in the storage of unexposed
packaged food
What are farmers required to do NOW
under the new food safety legislation?
• Currently food safety programs are voluntary
• Any records of food that may be or become
adulterated must be assessable to FDA not
to exceed 24 hours from the time of receipt
of the official request
• Food Facilities are required to register
• http://www.fda.gov/Food/GuidanceRegulatio
n/FoodFacilityRegistration/default.htm
• Must comply with the rules set forth by state and
local health officials
• In some circumstances, must follow commodity
guidelines set forth for products associated with
past food borne illness outbreaks
• Food Safety programs are largely triggered by
buyers who are concerned about consumer
health and well being
Link For More Information
• http://www.fda.gov/Food/FoodSafety/FSM
A/default.htm
Thank You!