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.
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.
| 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
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;
(2) complete the “inventory” column using an estimation
method or calculations based on the facility’s best
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
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
Last week I attended the 2018 FSPCA Lead Instructor Conference for instructors of FSMA Food Safety Courses. As in last years conference I always learn something new. Here are some highlights for Animal Food. Just a reminder that there are two more dates to remember in terms of compliance: Continue reading “What did I learn at this years FSPCA Instructor Conference?”