PET Food Processing - March 2018 - 38


FDA has
that the agency
is training state
inspectors for a
process as part
of its strategy to
"educate before
they regulate"
while preparing
inspectors for
visits to pet food
newly established authority provided under FSMA, FDA
has begun inspections for CGMP requirements and will
commence enforcement for PCs in fall of 2018.

Know where you stand
As companies and facilities prepare for FDA inspections, it is vital for operators to be aware of compliance
deadlines for the new food safety regulations and how
employees should respond in conversations with regulators. Large pet food processors and small businesses -
defined as those with fewer than 500 employees - can
now expect inspections for compliance with CGMPs.
FDA will commence CGMP inspections for very small
businesses, defined as those with less than $2.5 million
in annual sales, in the fall of 2018.
The inspections for compliance with PCs, including
a written food safety plan, will begin in 2018 for larger
pet food processors, but now is the time for small and
very small businesses to prepare. This is an opportunity
for companies to determine their rights and obligations



under FSMA and identify who in the organization will
be the Preventive Controls Qualified Individual (PCQI)
required to be in place in each facility. This person must
be properly trained to identify and address potential
hazards and may be the appropriate contact to communicate these hazards with ingredient suppliers, who are
also likely subject to FSMA provisions.

What to expect
FDA has communicated that the agency is training its
state inspectors for a conversation-based process as part
of its strategy to "educate before they regulate" while
preparing inspectors for visits to pet food processing facilities. The goal is to create consistent expectations for
FSMA compliance between both the regulator and the
regulated community.
Regardless, facilities may receive requests for documentation not related to FSMA, such as consumer report logs or financial records. Companies are not required to provide business confidential documentation
to the FDA inspector, but it is important for each regulated organization to understand and communicate its
policy and procedure for handling these requests. It may
be appropriate to ask why information is being requested
to ensure understanding or more accurately address an
inspector's questions or concerns. An inspector may request to see records to confirm the number of full-time
employees, and small businesses are required to substantiate the size of the business in relation to compliance
and enforcement dates under the new regulation.
FDA has also noted that for several years the agency
has been asking questions to assess the company's readiness for PCs under FSMA. While a company may be
well underway in preparing and identifying a PCQI and
developing a food safety plan, there may not be an obligation to provide the requested information based on
the company's compliance date. With an advanced plan
in place on how to handle these requests, companies will
be better prepared for FSMA readiness questions.

Readiness starts now
The new inspection process under FSMA offers a unique
opportunity to dialogue with regulators as PFI and processors continue working together to provide safe food
and treats for dogs and cats. PFI encourages companies
to begin preparing now for questions that may be asked
by an inspector and understand their rights and obligations in order to help ensure a smooth and predictable
inspection process.
Together, we can all promote food safety and long and
healthy lives for pets around the world. For more information about PFI, FSMA and pet food safety, visit www. PFP

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