Food Safety Modernization Act

1. FOOD SAFETY MODERNIZATION ACT (FSMA)
WHERE WE ARE NOW.
Presented by: Anne Barker-Smith

2. WHY DO WE NEED RULES? ACCORDING TO THE
CENTERS FOR DISEASE CONTROL AND PREVENTION
Where are our illnesses coming from?
From 1996 to 2010, approximately 131 produce-related
reported outbreaks occurred, resulting in 14,350 outbreak-
related illnesses, 1,382 hospitalizations and 34 deaths.
These outbreaks were associated with approximately 20
different fresh produce commodities.
Allergens – Undeclared allergens make up 36% of all
recalls, and 68% of all Allergen recalls are due to labeling
errors!
Salmonell
a
33%
Undeclare
d
allergens
36%
L. mono-
cytogenes
18%
Other
13%
Reportable Food Registry
Reports 2009-2013
About 48 million people (1 in 6 Americans) get sick,
128,000 are hospitalized, and 3,000 die each year from
foodborne diseases.

3. FSMA -SIGNED INTO LAW ON JANUARY 4, 2011 BY PRESIDENT OBAMA
Sec. 101. Inspections of records.
Sec. 102. Registration of food facilities.
Sec. 103. Hazard analysis and risk-based preventive controls.
Sec. 104. Performance standards.
Sec. 105. Standards for produce safety.
Sec. 106. Protection against intentional adulteration.
Sec. 107. Authority to collect fees.
Sec. 108. National agriculture and food defense strategy.
Sec. 109. Food and Agriculture Coordinating Councils.
Sec. 110. Building domestic capacity.
Sec. 111. Sanitary transportation of food.
Sec. 112. Food allergy and anaphylaxis management.
Sec. 113. New dietary ingredients.
Sec. 114. Requirement for guidance relating to post harvest processing of
raw oysters.
Sec. 115. Port shopping.
Sec. 116. Alcohol-related facilities.

4. A written food safety plan.
Describing how we are going to handle our products to keep it safe while it is under our
control.
We must guard against intentional and unintentional hazards that could be introduced
or occur while products are under our control.
Records of activities demonstrating we followed our food safety plan.
Records must document who, what, when, where, how events were
monitored/controlled.
Records must document corrective actions when deficiencies or failures occurred.
ABS Food &
Distribution
800 Somewhere Drive
Anywhere, VA 23015
POLICY and PROCEDURES
Receiving
(OPER-001.000)
Accepted: 4-1-2018
Supersedes: new
Page: 1 of 4
Approved by:
Susie Responsible
Policy Purpose: Why do you need this and what are you trying to control?
Procedures: Specifics about what you are to do and how. Include recordkeeping documents that are
expected to be filled out, or other related procedures that must also be followed.
Responsibility: Who performs what, when, where, how, and what documents do they use.
Corrective Actions: What to do if the procedure fails or you find out it hasn’t been followed.
Approval/Management signatures: Demonstrates management commitment to process as outlined.
FSMA REQUIRES:

5. PREVENTIVE CONTROLS FOR HUMAN FOODS - 2017
PREVENTIVE CONTROLS FOR ANIMAL FOODS - 2017
REQUIRES a WRITTEN RISK-BASED evaluation of each locations facility, process,
practices, and challenges:
 Current Good Manufacturing Practices (cGMP’s) -- modernized
 Hazard Analysis – must be written even if you decide you don’t need any
controls.
 Allergen Controls – must have written justification for controls
 Sanitation Controls -- must have sanitation – but these are critical sanitation
events that if ineffective would contribute to safety failure. (Maybe critical part
of Allergen Controls)
 Supply-Chain Program -- your sources must be safe – key is “APPROVED
VENDOR”-
 Supplier-Applied-Controls – you are relying on your source to control a hazard
that you cannot control.

6. PREVENTIVE CONTROLS – REQUIREMENT CONTINUED…
 Corrections & Corrective Actions – Corrective Actions must be corrected,
investigated, root cause analyzed, fully documented. Senior Management should
be made aware.
 Verification & Validation– must know the plan works as intended.
 Monitoring, Records & Recordkeeping – proof of activities – defines review (PCQI)
and retention (2 yrs)
 Training – Person writing the plan must be “knowledgeable about food safety”
referred to as PCQI -- FSCPA Preventive Controls Class – PCQI Status – people must
be qualified -- Qualified Individuals (QI)

7. TRAINING REQUIRED – QUALIFIED INDIVIDUAL – PCQI
 Key to food safety is
knowledge…
 Root Cause for most food
safety failures are the
result of poor training.
 FSCPA Preventive Controls
for PCQI and … online
training, or in-house
training – ensure Qualified
Status…
 RECORDS ARE NEED TO
DEMONSTRATE TRAINING
AND DOCUMENT
UNDERSTANDING.

8. You
Supplier A
Supplier C
Supplier B
Custome
r A
Custome
r B
Customer
C
Redistributor
Consume
r
Supplier D
RECALL– TRACEBACK – ONE-UP-ONE-BACK – IS REQUIRED IF
YOU HAVE A PREVENTIVE CONTROL –
Supplier A
Supplier B
Supplier C
Supplier D

9. TWO MORE RULES YOU MAY HAVE TO DEAL WITH …
Produce Rule - 2017
Produce Rules – enforces specific Good Agricultural
Practices to ensure safe production of produce.
 Rules – asks the grower to control
 Irrigation water quality (pathogens, parasites)
 Exclusion or control over wildlife in fields
 Pesticide and chemical hazards controls
 Applies to most farm activities
 Supply-chain-applied controls – for most produce
products – so you are responsible for monitoring
Foreign Supplier Verification Program -
2018
 Foreign Supplier Verification Program – If you
import product – you must ensure what comes
into the country meets the same food safety
standards as product produced in the US.
 Applies to all products that are imported into the US for
use or sale in the US.
 Must have FSVP – review supplier for compliance with
FSMA – ensure products are produced to the same level
as they would be in the US.
 The FSVP is based on who owns the product when it
enters the country – can be assigned by contract to the
importer of import broker – only if that agent is in the
US and is qualified.FSVP Exemptions: Certain juice, fish, and fishery products (because
they are already subject to supplier verification requirements); food
for research or evaluation; food for personal consumption; and
alcoholic beverages and ingredients used in making alcoholic
beverages, are among foods in these categories.
Imported food accounts for about 19 percent of the
U.S. food supply, including about 52 percent of the
fresh fruits and 22 percent of the fresh vegetables
consumed by Americans (2013 statistics, according
to the USDA, Economic Research Service).

10. SANITARY TRANSPORTATION – APRIL 6, 2018
 Responsibility for ensuring that transportation operations are carried out in compliance with all
requirements in this subpart must be assigned to competent supervisory personnel.
 All transportation operations must be conducted under such conditions and controls necessary to
prevent the food from becoming filthy, putrid, decomposed or otherwise unfit for food, or being
rendered injurious to health from any source during transportation operations, including:
 Taking effective measures such as segregation or isolation to protect food from contamination by raw foods
and non-food items in the same load.
 Taking effective measures such as segregation, isolation, or other protective measures such as hand washing, to
protect food transported in bulk vehicles or food not completely enclosed by a container from contamination
and cross-contact during transportation operations.
 For food that can support the rapid growth of undesirable microorganisms in the absence of temperature
control during transportation, ensuring that the food is transported in a manner, including the temperature
conditions, such that the transportation operation meets the requirements of paragraph (a)(3) of this section.
§ 1.908a Requirements apply to transportation operations.

11. §1.908 a-e REQUIREMENTS APPLICABLE TO….
§1.908b Requirements Applicable to Shippers
§1.908e Requirements Applicable to Carriers
 Shippers may contractually require or specify, how you
as the carrier are to schedule and perform specific
practices such as cleaning as well as sanitizing (if
necessary) in order to maintain the equipment in
appropriate sanitary condition.
 Shippers may also require how the carrier will comply
with the temperature control requirements and may as
part of the contractual agreement require specific
methods or continuous monitoring equipment be
installed or used in refrigerated compartments or
containers.
 Shippers needing carriers to provide bulk vehicles may
make additional contractual requirements such as
providing information about previous loads, dedicated
The rule identifies shippers as having the primary
responsibility in determining appropriate transportation
operations. Shippers may rely on contractual agreements to
assign some of the responsibilities to other parties.
§1.908c Requirements Applicable to Loaders
 Ultimately the Loader is the only party that can confirm
the design and maintenance of vehicles and
transportation equipment is suitably sufficient to ensure
that the equipment does not cause the food to become
unsafe.
 Additionally, if the Loader is responsible for food safety,
such as adequate temperature controls, preventing
contamination of ready-to-eat food from touching raw
food, protection of food from contamination by non-
food items in the same load or previous load, and/or
protection of food from cross-contact (defined as the
unintentional incorporation of a food allergen), then the
loader will be expected to have policies and procedures,
as well as, records to support these activities.
§1.908d Requirements Applicable to Receivers
Upon receipt of a food requiring temperature control for
safety, receivers must take steps to adequately assess that the
food was not subjected to significant temperature abuse, such
as determining the food's temperature, the ambient
temperature of the vehicle, or smelling for off odors.

12. SANITARY TRANSPORTATION – APRIL 6, 2018
Requirements defined by Role:
 Shipper -- person who arranges the shipment (has
primary responsibility for food safety of shipment)
 Loader -- person who puts products on truck
 Carrier – person who drives the truck
 Receiver – person who receives the product
Each role must have records documenting
control:
 Shippers must have contracts/written instructions
with Carriers specifying equipment and
temperature requirements.
 Loaders must document suitability conditions and
temperatures at time of loading.
 Carrier must provide temperature records during
transit if required by shipper or receiver.
 Receiver – must agree to vehicle suitability at time
of delivery, may or may not require temperature
records during transit, should determine if
temperatures of product results in a food safety
issue.
New requirement:
If at any time the shipper, loader, carrier, or
receiver becomes aware of a possible material
failure of the temperature control that may
render the food unsafe, food cannot be sold or
otherwise distributed unless a determination is
made by a qualified individual that the
temperature deviation or other condition did
not render the food unsafe.

13. KEY TO FSMA – MONITORING & RECORDKEEPING
If you didn’t
write it down …
you didn’t do it!
It happened just
the way you
wrote it down!

14. SO… RECORDKEEPING – rules…
 You need to take accurate records – with date, time,
signature (ID) of person taking the record.
 PCQI needs to review food safety records within 7
days
 Food Safety Records must be kept for 2 yrs.
 Must be available upon request

15. ROUND TABLE – QUESTION AND ANSWERS
HOW ARE YOU DEALING WITH FSMA REQUIREMENTS?
Instructions -- On your table is a topic question. You have 20 minutes to
discuss the topic and answer key questions. Please select a spokesperson
for your table to summarize & report back what your topic question was
and key things you discovered.