2. FSMA – Past, Present, Future
• Rules impacting the grain and feed industry
• FDA inspection activity
• Sanitary Transportation
• What’s next
• Common questions
3. Food Safety Modernization Act of 2011
• Signed into law on Jan. 4, 2011
• Amended federal Food Drug and Cosmetic Act and
greatly expanded FDA’s authority to regulate the U.S.
food supply
– Mandated that FDA create a new prevention-based
regulatory system to ensure the safety of food products
– Granted new authorities to FDA to ensure food safety
– Directed FDA to implement several new, major food
safety regulations
5. Major FSMA Rules
1. Current Good Manufacturing Practice (CGMP) and Preventive
Controls (PC) for Animal Food
2. CGMP and PC for Human Food
3. Produce Safety
4. Foreign Supplier Verification Programs (FSVP) for Importers
5. Sanitary Transportation of Human and Animal Food
6. Accredited Third-Party Certification
7. Mitigation Strategies to Protect Food Against Intentional
Adulteration
6. FSMA Rules – Who’s Covered
Rules Applicable to Animal Food
Rules NOT Applicable to
Animal Food
Animal Food CGMP and PC Human Food CGMP and PC
Foreign Supplier Verification Program Produce Safety
Accredited Third-Party Certification Intentional Adulteration
Sanitary Transportation
7. FSMA Rules – Who’s Covered
FSMA Rule
Type of Operation(s) Performed at Single Facility
Grain Elevator
(only)
Grain Elevator
and Feed Mill
(co-located)
Feed Mill –
Animal Food
Grain Processor
– Human and
Animal Food
Animal Food
CGMP and PC
XXX XXX XXX
Human Food
CGMP and PC
XXX
Sanitary
Transportation XXX XXX XXX XXX
Intentional
Adulteration
XXX
8. FDA Inspections
• FDA has broad authority to inspect to ensure compliance with
applicable FSMA regulations and other requirements:
– General provisions of federal Food Drug Cosmetic Act
– Adequate sanitation – ensure food is not “adulterated” during manufacturing,
packing or storage
– FDA action, advisory, guidance levels for mycotoxins
– 21 CFR 589.2000-2001 – BSE-Prevention Regulations
– 21 CFR Part 1.361-362 – Records access in the event of food-related serious
adverse health consequence
– FDA Food Facility Registration
– FDA Reportable Food Registry
– FDA Recordkeeping Requirements for Food
– 21 CFR 225 – Medicated Feed CGMPs
9. FDA Inspections
• FDA is authorized to:
– Enter “any factory, warehouse, or establishment in which
food [is] manufactured, processed, packed, or held …” and
“any vehicle….”
– Inspect “at reasonable times and within reasonable limits
and in a reasonable manner”
– Inspect “all pertinent equipment, finished and unfinished
materials, containers, and labeling thereon”
– No warrant necessary for inspection
10. FDA Inspections
• FDA typically does not impose monetary
penalties; instead, agency has authority to:
– Detain product
– Mandate recalls
– Seek consent decrees
– Suspend facility registration
13. FDA Inspection Activity
• Top Citations for Animal Food CGMP and PC Rule
– No written animal food safety plan
– Hazard analysis inadequate
– Failure to identify and/or implement preventive
controls
Inadequate design/implementation of prerequisite
programs
14. FDA Inspection Activity
• General Areas of Concern
– Housekeeping/sanitation practices
– Pest control
– Control of mycotoxins
– Nutrient deficiencies and toxicities
– Pathogens in pet food
15. Sanitary Transportation Rule –
Overview of Shipper Responsibilities
1. Assign responsibility for transportation operations to competent
supervisory personnel.
2. Establish in writing what constitutes suitable design, sanitary and
storage conditions for vehicles and transportation equipment for the
intended use. As appropriate, communicate these in writing to the
carrier, and as necessary the loader and receiver.
3. Develop and implement written procedures to ensure that vehicles
and equipment used in transportation operations are in appropriate
sanitary condition and to ensure that a previous cargo does not
make bulk food unsafe. As appropriate, communicate these in
writing to the carrier, and as necessary the loader.
16. Sanitary Transportation Rule –
Overview of Shipper Responsibilities
4. Before loading food, loaders are to evaluate whether vehicles and
transportation equipment are in appropriate condition.
5. The rule does not require that records be established and
maintained to demonstrate that required procedures are being
followed. Records for the written procedures and/or assignment of
tasks need to be maintained for a period of 12 months beyond
when the procedures/assignments are in use.
17. FSMA – What’s Next
• FDA Proposed Rule - Requirements for Additional Traceability
Records for Certain Foods, Sept. 22, 2020
• Revisions to Food Facility Registration Requirements – NPRM
anticipated during 2021
• Guidance documents for final rules
– Animal Food Hazard Analysis and Preventive Controls
– Animal Food Supply Chain
– Human Food By-Products Used as Animal Food
• Remote Regulatory Assessments
18. Common Questions
1. FDA requires a DUNS number for food facility registration. I can’t get one,
what do I do?
Answer: Keeping trying. FDA is using enforcement discretion for this
requirement and is now providing until the 2022 registration period for facilities
to obtain one.
2. If an FDA investigator arrives at my facility, can I refuse entry or at least
tell them to come back later?
Answer: If a food facility is open for business, FDA has authority to inspect. No
warrant is necessary and refusing entry likely will result in legal action. If the
timing of the inspection is inconvenient, a facility may request the investigator
to postpone the inspection, but the investigator has no obligation to honor the
request.
19. Common Questions
3. Does FSMA require use of only H-1 (food-grade) lubricants in grain and feed facilities?
Answer: No. Food-grade lubricants are to be used when the lubricant will become part of the
food. FDA recommends that food-grade lubricants be used as a precaution when the lubricant
unintentionally could come into contact with food or a food-contact surface. When it is unlikely
that a lubricant will come into contact with food or a food-contact surface, non-food grade
lubricants can be used, but the lubricated equipment is to be designed, constructed, and used to
avoid adulteration of food with the non-food grade lubricant.
4. I operate a grain elevator with a bagged feed warehouse. Am I subject to the FSMA Animal
Food CGMP and PC Rule?
Answer: A facility that is solely engaged in holding and distributing grain is exempt from the
FSMA animal and human food CGMP and PC rules. However, a facility that also includes a bag
feed warehouse is engaged in additional activities, and therefore the entire facility (including the
grain elevator operation is subject to applicable FSMA requirements. In this case, the applicable
requirements include the animal food CGMPs, but not the requirements associated with
preventive controls.
20. Common Questions
5. Are shippers required to know the identity of prior cargoes before
shipping bulk foods?
Answer: The ST Rule does not require shippers (or loaders) to know the
identity of prior cargoes. Instead, the rule requires that effective measures be
implemented to ensure prior cargoes do not make the food unsafe.
6. Do trucks/containers transporting foods under the ST rule need to be
sealed/locked during transportation?
Answer: The ST Rule does not require that trailers hauling food products be
sealed during transit. Additionally, FDA’s intentional adulteration rule does not
require the use of seals on transportation equipment.
21. Common Questions
7. My company operates a transloading station. What FDA requirements
apply?
Answer: FDA excludes from food facility registration facilities that hold food
only because they are part of the process of transporting it from one location to
another.
This type of operation is subject to the general provisions of the federal Food
Drug and Cosmetic Act, FDA’s BSE requirements, Bioterrorism Act’s
Establishment and Maintenance of Records, and the FSMA Sanitary
Transportation Rule.
