Update from AFIA on FSMA Inspections

The following information was provided by AFIA on 3/13/19. Used with permission…

The Food and Drug Administration had a busy year in 2018 conducting inspections for the current good manufacturing practice (CGMP) and the hazard analysis and risk-based preventive controls portions of the Food Safety Modernization Act (FSMA) regulations. In this update, the American Feed Industry Association shares the latest data received through a Freedom of Information Act request.

Current Good Manufacturing Practice Inspections

In 2018, the data indicates that state and/or federal inspectors performed and/or completed 622 CGMP inspections in 47 different states, one U.S. territory (Puerto Rico) and four countries (Canada, Mexico, India and Indonesia). 

The majority of CGMP inspections (58 percent) occurred at feed manufacturers or integrated feed facilities. Ingredient suppliers, renderers, distributors and facilities classified as “other” also received inspections during the same time frame. 

Across the 622 inspections, 28 facilities received a FDA Form 483 (“Notice of Inspectional Observations”). Of the 28 forms issued, 14 were Voluntary Action Indicated (VAI, or minor issues), five were classified as No Action Indicated (NAI) and eight were not classified. One facility failed inspection, receiving an Official Action Indicated (OAI) notice. Issues related to pest control and housekeeping were mentioned on most of the FDA Form 483s, with the most common examples being spilled feed, bird droppings and nests, live and dead rodents, cat excrement and the presence of roaches. Although a facility may consider many of these observations irrelevant, the FDA considers them serious. There are no sanitation standards that specify the number of rodents or droppings that can be present at a feed facility, but AFIA cautions that numerous dead rodents or other sanitary issues may draw FDA’s ire. General sanitation standards apply to animal food establishments under the FSMA CGMPs

Hazard Analysis and Risk-Based Preventive Controls Inspections

Inspections for large-sized animal food facilities (i.e., those firms with more than 500 full-time equivalent employees) on the hazard analysis and risk-based preventive controls regulations began in late 2018. These large-sized firms have been required to be in compliance with the regulations since September 2017, however, the FDA delayed inspections while it trained investigators, allowing firms more time to gather documentation under the system. 

Through the FOIA request, AFIA has learned of seven hazard analysis and risk-based preventive controls inspections that occurred in 2018. The inspections were held in four states at feed manufacturing, integrated feed facilities and pet food facilities. From the seven inspections, six facilities received a FDA Form 483, which is a very high rate. It is believed this high rate of observations can be attributed to the fact that the FDA purposefully sought out these facilities as they may have had recent animal food safety incidents. As industry interprets receiving a FDA Form 483 as very serious, AFIA is in communication with FDA officials regarding this action to help ensure the reasons the agency issued a FDA Form 483 are truly adverse findings versus a simple method of documenting the findings from the inspection.   

Status of FDA Inspections during partial government shutdown

I subscribe to a free publication “FSN – Food Safety News” to keep as up to date as possible with Food Safety issues, incidents and recalls. This article appeared this morning…

FDA food investigations running at less than 50 percent of normal

By Dan Flynn on January 22, 2019

The Food and Drug Administration has “more than 200 food investigators” on the job “not counting support staff and supervisors” out of about 550 total professionals “when the agency is fully operational,” according to Commissioner Scott Gottlieb.

In a “tweet” Monday, the FDA commissioner said he was responding to questions about staffing levels for FDA’s Office of Human and Animal  Food Operations. It was one of the most detailed statements about food safety staffing that Gottlieb has made since the partial government shutdown began on Dec. 22.

Click here to read the entire article…

Environmental Reporting: EPCRA Tier II Reporting for Combustible Dust

The following is the bottom line on methods for reporting combustible dust… It is an excerpt from a longer article published AFIA on 1/15/19
and is used with permission…

“EPA and industry agree on the following approach for combustible
dust reporting:

The EPA agrees that there are two simple, reasonable options to
complete the Tier II form for combustible dust, which ensures
emergency planners have the relevant information they need
about potential combustible concerns at a feed or grain operation.
Depending on the nature or size of your feed or grain operation:

Reporting Option #1 – If combustible dust is likely present at any
level below the 10,000-pound threshold. If a facility has a reasonable
basis to conclude that it has some volume of combustible dust,
but it is below the 10,000-pound threshold, then a facility should:

(1) check the “combustible dust” box in the “physical hazards” column; and
(2) check the “below reporting thresholds” box in the last column
(the “additional reporting information” column) of the Tier II form.

Reporting option #1 is likely most appropriate for most facilities.
EPA has concluded that there is no obligation for a facility to
provide any further information if the “below reporting
thresholds” is checked.

Reporting Option #2 – If combustible dust is likely above the
10,000-pound threshold If a facility has a reasonable basis to
estimate that it may have combustible dust above the 10,000
-pound threshold, then it should:

(1) check the box in the “physical hazards” column;
and
(2) complete the “inventory” column using an estimation
method or calculations based on the facility’s best
professional judgment.

This option may be more applicable for those facilities that
collect and store combustible dust in a bin or container.

Reminder: Certain local or state jurisdictions may require additional
reporting

While the EPA agrees with industry on the two options for reporting
above, facilities may be subject to additional local or state Tier
II reporting requirements for combustible dust. You may need
to check your county or state requirements to determine
whether this may be the case and complete your Tier II
report accordingly.”

Training

Preventive Controls for Animal Food
Penn State Extension will be offering a Preventive Controls for Animal Food workshop at the Penn State Extension Mercer County Office in
Mercer, PA on January 29-31.

Upon completion of the entire 2.5 day course, attendees will met the
requirements to be considered as a preventive controls qualified
individual. Current good manufacturing practices, conducting a hazard
analysis, and preventive controls for animal foods will be covered
during the workshop. The audience for this workshop includes
facilities that process, manufacture, pack, or hold animal feed or pet
food.

Register online with any major credit card (MasterCard, Visa, Discover or American Express) at http://extension.psu.edu/animal-pc.
Registration deadline is January 22.

AFIA Reminds Members of Expectations for HA/PC Inspections, Clarifies Investigator Process with FDA

Most of the feed mills that subscribe to my posts are small facilities and not currently subject to inspections of Feed safety Plans.  This article published by AFIA reminds large facilities what to inspect when FDA knocks to do a Feed Safety Plan inspection. It has valuable information you need to consider as you continue to prepare your Feed safety Plan. In the coming months you may get a CGMP inspection. Remember while the FDA is not inspecting small facility feed safety plans you are required to have one in place. I have bolder the part that i have been preaching for almost 3 years now. Please read this important information…

Continue reading “AFIA Reminds Members of Expectations for HA/PC Inspections, Clarifies Investigator Process with FDA”

All Animal Food Facilities must complete Registration between 10/1 – 12/31/18

All Food Facilities (including animal food) must register as such with the FDA in even years between October 1 and December 31. The FDA has published a small entity compliance guide to assist in this registration process. It is CFD’s opinion that all CFD customers of pet, animal or human food products we sell are required to register.  

Continue reading “All Animal Food Facilities must complete Registration between 10/1 – 12/31/18”

FSMA Compliance is NOW!

It is hard to believe that 3 years has past since the rules for FSMA were finalized. But today is Monday, September 17, 2018 and this date is significant!

  • All food facilities must be in compliance with CGMP’s. If you or someone you know is planning on filing for an exemption based on the size of the facility it is important to understand that there is no exemption from CGMP’s.
  • Small business must have or be actively engaged in performing a Hazard Analysis to identify Known and Reasonably Foreseeable Hazards. They than must make a determination if they require a preventive control to mitigate those hazards to an acceptable hazard.

Continue reading “FSMA Compliance is NOW!”

FDA Announcements

The following was posted on the FDA website today…Caution: Do not be complacent. Keep calm and keep busy. The announcement indicates an intention to delay inspections not compliance.

“Jenny Murphy, a consumer safety officer at FDA’s Center for Veterinary Medicine, explains what animal food producers can anticipate in this next phase in the implementation of the rule entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (PC Animal Food rule). Continue reading “FDA Announcements”