Everything You Should Know about
FSMA and Empowering your
Workforce
Jorge Acosta
[email protected] Director, Food Safety Consulting
Alchemy Systems April 17, 2018 San Antonio, TX
Agenda
•
Understand the 5 major elements and 7 rules
of FSMA and how they impact your specific
operation
•
Review lessons learned from previous FDA
audits
•
Discuss how your employees are key to
5 Major Elements
•
Preventive Controls
– Sanitation, Process, Allergen, Supply-Chain – Environmental Monitoring for RTE
– Risk Based
•
Inspection and Compliance
– High Risk sites inspected – within 5 years and 3 years thereafter – FDA must be given access to Food Safety records
– ISO 17025 laboratory testing
•
Imported Food Safety
– FSVP
5 Major Elements
•
Response
–
Mandatory recall authority
–
Suspension of registration
–
Enhanced product traceability
•
Enhanced Partnerships
–
State and local capacity
–
Foreign capacity
7 Rules of FSMA
•
FDA will not enforce certain provisions for 4 rules – Jan 4, 2018
announcement
-https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/UCM5
90667.htm
– facilities that would be farms except for certain factors and activities, – written assurances provisions in all four rules related to the control of
identified hazards or microorganisms that are a potential risk to public health
– the animal food preventive controls requirements for certain
manufacturing/processing activities performed on human food by-products used as animal food, and
7 Rules of FSMA
• Preventive Controls for Human Food - 21 CFR Part 117 Subpart B, C – 9/15/2015
• Very small businesses (averaging less than $1 million per year (adjusted for inflation) in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale): Three years, except for records to support its status as a very small
business (January 1, 2016).
• Businesses subject to the Pasteurized Milk Ordinance (compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule): Three years
• Small businesses (a business with fewer than 500 full-time equivalent employees): Two years
7 Rules of FSMA
7 Rules of FSMA
•
Produce Safety – 21 CFR Part 112 – 11/13/2015
–
Very small businesses, those with more than $25,000
but no more than $250,000 in average annual
produce sales during the previous three year period :
four years
–
Small businesses, those with more than $250,000 but
no more than $500,000 in average annual produce
sales during the previous three year period: three
years
7 Rules of FSMA
•
Sanitary Transportation – 4/6/2016
–
Small Businesses - businesses other than motor
carriers who are not also shippers and/or receivers
employing fewer than 500 persons and motor carriers
having less than $27.5 million in annual receipts
would have to comply two years after the publication
of the final rule.
–
Other Businesses - a business that is not small and is
not otherwise excluded from coverage would have to
comply one year after the publication of the final rule.
7 Rules of FSMA
•
Mitigation Strategies to Protect Food Against Intentional
Adulteration – 21 CFR Part 121 – 5/27/2016
– Very Small Businesses—a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food
manufactured, processed, packed, or held without sale (e.g., held for a fee). These businesses would have to comply with modified
requirements within five years after the publication of the final rule. – Small Businesses—a business employing fewer than 500 persons
would have to comply four years after the publication of the final rule. – Other Businesses—a business that is not small or very small and does not qualify for exemptions would have to comply three years after the publication of the final rule
7 Rules of FSMA
•
Foreign Supplier Verification – 21 CFR Part 1 – 11/13/2015
– 18 months after publication of the final rule;
– For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations;
– For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls
regulations, the date by which it has to comply with those provisions. A range of compliance dates were established in the preventive
controls rules for the supply-chain program provisions, which vary based on the size of the receiving facility and when the receiving facility’s supplier is required to comply with the new FSMA
Top 5 observations on 483’s
•
Specific manufacturer packaging and allergens; cross
contact/some pathogens; may lead into swabs and a
more comprehensive inspection.
•
Personnel practices; not mindful of allergens and cross
contact; hygiene & outer garments; handwashing
practices.
• Sanitary operations.
• Equipment design and maintenance.
•
Plant construction/design and concerns with allergen
Top 5 observations from PC
inspections
•
Deviation from written sanitation procedures, including deviation
from allergen/pathogen procedures – in short, facility is not doing
what its procedures say it should be doing.
•
Hazard analysis is missing information; e.g., a hazard that should
have been identified is not identified.
•
Sanitation verification; ensure sanitation is effective; an
environmental monitoring program is required but it is lacking or
non-existent at the facility.
•
Personnel practices; hygiene & outer garments; handwashing
practices.
•
Sanitary manufacturing to avoid allergen cross contact and/or micro
contamination.
Qualified Individuals 117.4
15
(a) Applicability. (1) The management of an
establishment must ensure that all individuals who manufacture, process, pack, or hold food subject to subparts B and F of this part are qualified to
perform their assigned duties.
(2) The owner, operator, or agent in charge of a facility must ensure that all individuals who manufacture, process, pack, or hold food subject to subpart C, D, E, F, or G of this part are qualified to perform their assigned duties.
Qualified individual means a person who has the education, training, or experience (or a combination thereof)
necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. Definition per 117.3
• Subpart B = GMP’s • Subpart F = Records
• Subpart C = HARPC
• Subpart D = Modified Requirements • Subpart E = Qualified Facilities
• Subpart F = Records
Qualified Individuals 117.4
16
(b) Qualifications of all individuals engaged in manufacturing,
processing, packing, or holding food. Each individual engaged in
manufacturing, processing, packing, or holding food (including temporary and seasonal personnel) or in the supervision thereof must:
(1) Be a qualified individual as that term is defined in § 117.3—
i.e., have the education, training, or experience (or a
combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties; and
(2) Receive training in the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, as appropriate to the food, the facility and the individual’s assigned duties.
Qualified individual means a person who has the education, training, or experience (or a combination thereof)
necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. Definition per 117.3
Qualified Individuals Supervision and
Training Records 117.4
17
(c) Additional qualifications of supervisory
personnel. Responsibility for ensuring compliance
by individuals with the requirements of this part must be clearly assigned to supervisory
personnel who have the education, training, or experience (or a
combination thereof) necessary to supervise the production of clean and safe food.
(d) Records. Records that document training required by paragraph (b)(2) of this section must be established and maintained.
Qualified individual means a person who has the education, training, or experience (or a combination
thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. Definition per 117.3
