The government and government regulatory agencies impose guidelines upon supply chain service providers such as public refrigerated warehouses because they have significant impact on product quality and safety as they are typically the last to handle and/or process the inventory before reaching consumers. Because of this direct connection to consumers, product safety is a critical element. In many cases, cold storage supply chain service providers must quickly adapt their businesses to meet regulatory guidelines regardless of cost to avoid stiff penalties or shut downs. Some of the most recent regulations impacting temperature controlled facilities include the Food Safety Modernization Act (FSMA), the Sanitary Transport Rule, FDA Title 21 CFR Part 11 and the Drug Quality Security Act (DQSA). Each of these affect operations in a unique way and pose a different set of challenges for each PRW. The FSMA was signed into law by the Obama administration as part of a movement to increase food safety. In this regulation, the FDA is granted additional power through these provisions: expanded administrative detention, records inspection, authority to deny entry, suspension registration and mandatory recall. This was done in hopes of reducing or eliminating the 48 million foodborne illnesses reported each year. The sanitary transport rule, as part of the FSMA, is an additional safeguard added to prevent transportation practices that may negatively impact food safety. This new rule applies to shippers, receivers and carriers transporting both human and animal food products within or into the US. Shippers hired by PRWs now must follow strict vehicle maintenance guidelines, operational procedures, data exchange, training protocols and record maintenance. Another regulation impacting public refrigerated warehouses is FDA Title 21 CFR Part 11. This regulation was initially drafted in 1997 and has been subsequently updated to accommodate new and updated technology. This law regulated what type of electronic signature is acceptable and in what cases electronic signatures are considered valid. This helps to streamline audits, system validations and audit trails required by the FDA. Lastly, for those PRWs handling pharmaceutical inventory, DQSA designates what inventory and transaction data must be saved and available for FDA if requested. This regulation impacts manufacturers, re-packagers, wholesale distributors, 3PLs and dispensers. Under DQSA, businesses must record transaction information, history and statements. To learn more about regulations impacting public refrigerated warehouses contact Datex cold storage experts today at www.datexcorp.com , marketing@datexcorp.com or 800.933.2839 ext 243.

1. REGULATIONS IMPACTING
PUBLIC REFRIGERATED
WAREHOUSES
B Y : A N G E L A C A R V E R

2. Purpose of Regulations
• Governing regulatory bodies are imposing new guidelines upon
supply chain service providers such as cold storage facilities due to
the significant impact their services can have on product quality and
safety.
• Many inventory products handled by public refrigerated warehouses
are directly consumed by the general public. Because of this direct
connection to consumers product safety iscritical.

3. Food Safety Modernization Act (FSMA)
• According to the Center for Disease Control and Prevention about 48
million people get sick, 128,000 are hospitalized and 3,000 die each
year from foodborne illnesses. These significant health burdens
could be prevented with more strict handling requirements.
• The FSMA was signed into law by the President Obama to help
prevent rather than react to food safety concerns.
• To enforce this new regulation, the FDA has added new authorities
responsible for the enforcement and inspection of facilities handling
regulated inventory.

4. Food Safety Modernization Act (FSMA)
• These new provisions have been added by the FoodSafety
Modernization Act:
• Expanded Administrative Detention – this gives the FDA more power to
prevent the release of adulterated and misbranded product into the
marketplace, preventing consumption of potentially harmful food
• Records Inspection – FDA authority to access inventory records about
potentially dangerous food has been expanded

5. Food Safety Modernization Act (FSMA)
• These new provisions have been added by the FoodSafety
Modernization Act:
• Authority to Deny Entry – If facilities outside the US refuse to allow FDA
inspectors to examine their facility, the FDA can refuse to allow food from that
facility to enter into the US.
• Suspension Registration – FDA officials may suspend the registration of any
business if food processing and packaging circumstances are deemed
hazardous.
• Mandatory Recall – Individual businesses no longer reserve the right to
decide to recall product. The FDA can now order recalls and stop distribution
if it is concerned about product safety.

6. Food Safety Modernization Act (FSMA)
• Much of the new regulation created by the Food Safety
Modernization Act falls within these three provisions:
• FSMA § 101 – FDA Enhanced Records Access Authority
• FSMA § 206 – Mandatory FDA Recall Authority
• FSMA § 402 – Whistleblower Protection

7. Sanitary Transport Rule
• A proposed part of the Food Safety Modernization Act, the Sanitary
Transport Rule is an additional safeguard to prevent practices that
may create food safety risk such as:
• Improper refrigeration temperatures
• Inadequate vehicle cleaning between load transport
• Improper food protection during transport
• This rule applies to shippers, receivers and carriers transporting
human and animal food products within the United States and into
the US from other countries via motor, rail or oceangoing vessel.

8. Sanitary Transport Rule
• Under the proposed rule, new requirements would be establishedfor:
• Vehicles and transportation equipment – vehicle maintenance will be
regulated to reduce contamination
• Transportation operations – additional measures must be taken to ensure
food contamination does not occur during transportation (i.e. temperature)
• Information exchange – data exchange requirements about previous cargos
at is relates to cleaning, temperature, etc.
• Training – sanitation training requirements for carrier personnel and
associated training documentation
• Records – maintenance of written procedures and records
• Waivers – procedures by which the FDA will waive any of the above
requirements

9. FDA Title 21 CFR Part 11
• This regulation was initially drafted and issued in March of 1997 and
has been updated and edited in subsequent years to meet increasing
technology adoption including:
• Electronic Records; Electronic Signatures, Validation
• Electronic Records; Electronic Signatures, Glossary of Terms
• Electronic Records; Electronic Signatures, Time Stamps
• Electronic Records; Electronic Signatures, Maintenance of Electronic Records
• Electronic Records; Electronic Signatures, Electronic Copies of Electronic
Records
• Title 21 CFR Part 11 is a regulation established by the Food and Drug
Administration (FDA). This regulation defines what type and under
which conditions electronic signatures are considered an acceptable
equivalent to paper records.

10. FDA Title 21 CFR Part 11
• The rule requires that regulated bodies implement controlsincluding
audits, system validations, audit trails and electronic signatures for
systems involved in the processing of FDA regulated data.
• These audit trail records can be used in cases of FDA inquiry, product
recalls and more.
• Learn more about the scope of the FDA Title 21 CFR Part 11 here.

11. Drug Quality Security Act (DQSA)
• For those refrigerated warehouses handling pharmaceutical
inventory, the recent Drug Quality Security Act will affect your liability
in the handling and processing of regulated pharmaceuticals.
• This regulation went into effect January 1, 2015 and is giving
affected businesses time to implement.
• This regulation affects manufacturers, re-packagers, wholesale
distributors, 3PLs and dispensers.
• DQSA regulations designate what inventory and transaction data
must be stored and easily accessible if requested by FDA
representatives.

12. Drug Quality Security Act (DQSA)
• Under DQSA, affected businesses must exchange and record:
• Transaction information
• Transaction history
• Transaction statement
Learn more about DQSA here.

13. Conclusion
• To help avoid the 3,000 deaths annually from unsafe consumables,
regulatory bodies such as the FDA are introducing new regulation for
supply chain businesses.
• Keep your public refrigerated warehouse compliant by educating your
team about new industry regulations such as DQSA, FSMA and more.
Sources:
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM267486.pdf
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm239907.htm
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm

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