PET Food Processing - March 2020 - 34

"Election years are an important opportunity to
educate candidates and incumbents on important
agricultural issues before they take office."
Constance Cullman, AFIA

Inspection findings for fiscal 2019 and plans for upcoming inspections recently became available. As of late
September, inspectors conducted 626 Current Good
Manufacturing Practices (CGMPs) inspections, with 51
facilities receiving Form 483s - the form used by inspectors to report observed violations. This is also the first
fiscal year the agency has included Hazard Analysis and
Preventive Controls (HA/PC) inspections for large-sized
facilities. The FDA conducted 189 HA/PC inspections,
resulting in 42 Form 483s.
The FDA attributes the high number of Form 483s to
the fact that inspections were carried out at facilities with
recent known food safety issues and shared that Form
483s will likely become less prevalent as more inspections
occur on a broader sample of the industry. Most Form
483s were related to plant sanitation, pest control, not
properly examining incoming raw materials and ingredients for suitability, unlabeled containers, and the prerequisite program used to mitigate a hazard not being in
place, properly implemented, or inadequate to control the
hazard. It is important to note in the last incidence that
the FDA is not stating that a preventive control needs to
take its place, but instead that the pre-requisite program
may just need to be followed or bolstered.
For fiscal 2020, which runs Oct. 1, 2019, through Sept.
30, 2020, the FDA plans 455 HA/PC inspections for
large- and small-sized facilities and another 589 CGMP
inspections across all sized facilities. Inspections at animal food facilities for the Sanitary Transportation (84
inspections) and Foreign Supplier Verification Program
(75 inspections) regulations are also occurring, albeit at
a much lower frequency.

Ingredient review process
As the science of animal nutrition evolves, the animal
food industry works hard to research and bring new ingredients to market to improve the health and productivity of our food-producing and companion animals.
Our members continue to tell us, in recent years, the
lengthy ingredient review processes have hindered many
of these new ingredients with the attributes to improve
the safety, quality and nutrition of feed and pet food
from entering the marketplace.
This slow process and pace for ingredients to gain review and approval at the FDA and Association of American
Feed Control Officials (AAFCO) has led to industry frustration. Speeding up review times has been a top priority for AFIA, and there is hope in sight! On Dec. 20, 2019,

PET FOOD PROCESSING | March 2020 | www.petfoodprocessing.net

Congress passed bipartisan legislation to fund the federal
government for the remainder of the 2020 fiscal year.
The 2020 fiscal year appropriations package allocated
new dollars to the FDA's Center for Veterinary Medicine
(CVM) to hire additional staff specifically for reviewing
new animal food ingredient submissions. The $5 million
allocation from appropriators will allow the CVM to
nearly double ingredient review staff, which will eventually reduce the length of review time by the agency.

Hemp regulations
The US Department of Agriculture (USDA) announced
the publication of rules for hemp production in October
2019. This "interim final rule" will serve as the regulatory
framework for US hemp production until after a public
comment period occurs and the permanent final rule is
published. The interim rule provides licensing of hemp
growers by the USDA, sets testing and sampling guidelines
to protect against misidentified crops and gives hemp producers access to the same loan and risk management programs as other commodities. The rule does not comment
on or approve the use of hemp, CBD or any other hempbased products for use in animal food. Those products will
still need to go through the CVM's ingredient review process before they are legal for use or sale.

2020 elections
I can't finish without addressing the 2020 presidential
election. In addition to electing a president for the next
term, thirty-five Senate seats are also in the 2020 election mix, every House seat will be before voters, and numerous state races will be on ballots.
Per usual during a presidential election year, you
can expect the legislative process to grind to a halt this
spring, with neither party particularly anxious to give
the other a political victory of any kind. As usual, much
of the conversation around the election will surround
gun control, healthcare and other hot button issues,
but we shouldn't discount agriculture as a key issue for
candidates looking to pull more rural voters into their
camps. Election years are an important opportunity to
educate candidates and incumbents on important agricultural issues before they take office. I encourage you to
interact with as many candidates as you can.
2019 brought great success in our mission to engage
on issues affecting the animal food industry. 2020 looks
to be just as busy and exciting as we build on the hardearned successes of last year.
PFP

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PET Food Processing - March 2020

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