FSMAWhat You Need To Know An online informational session Module V. - - PowerPoint PPT Presentation

Aurora A. Saulo, Ph.D. Professor and Extension Specialist in Food Technology University of Hawaii at Manoa aurora@hawaii.edu

1

FSMA—What You Need To Know

An online informational session

Module V. Sanitary Transportation

Important Notice

• Because sections were abbreviated for this

presentation, the information provided is only an overview and should not be relied upon as a substitute for reading the final rule, or

• btaining legal advice, or as a summary of all

regulatory requirements.

• Every company must conduct its own detailed

review of the final rule.

MODULE V. SANITARY TRANSPORTATION OF HUMAN AND ANIMAL FOOD

3

Final Rule issued April 6, 2015

Primary Concepts of the Rule

• To prevent practices during food transportation

that create food safety risks, such as:

– Failure to properly refrigerate food (e.g., eggs, milk), including pre-cooling if necessary – Inadequate cleaning of vehicles between loading – Failure to properly protect food

• From allergen cross-contact
• From contamination

– E.g., fresh produce not typically completely enclosed by its container may require a carrier to pick up only other similar fresh produce or good packaged in a sealed container along its route

4

• Three major focus areas defined by FDA to

provide assurance:

• 1. That the vehicles and equipment used are in

appropriate sanitary condition

• 2. That for bulk cargo, a previous cargo does not

make the food unsafe

• 3. That for foods that require refrigeration for

safety, there is adequate temperature control during transport of food.

5

Primary Concepts of the Rule (cont’d)

Other Characteristics of the Rule

• Focus is on food safety
• Covers only motor and rail

vehicles (air and water transportation are not included)

• Does not address

– Food security/Food defense

• Designed to be flexible, non-prescriptive,

more GMP-like

6

Key Provisions

• Vehicles and transportation equipment (includes

shipment and storage equipment that contact food)

• Transportation operations

– Primary responsibility is on the shipper but may assign their responsibilities to other parties through written contractual agreements

• Records
• Training
• Waivers

7

Who Is Covered

• Shipper: arranges for the transportation of the food in the U.S. by a

carrier(s) sequentially

– E.g., Retailers with distribution facilities, wholesalers

• Loader: loads food onto a motor or rail vehicle during

transportation operations

• Carrier: physically moves food by motor or rail vehicle in commerce

in the U.S.; responsible for all functions assigned to a carrier even if performed by others, e.g., driver

– Does not include parcel delivery service

• Receiver: receives food at a point in the U.S. after transportation

whether or not receiver is the final point of receipt for the food (but not a consumer and not distributing food)

• May be one entity
• Does not matter if food is/isn’t in interstate commerce

8

New

What Is Covered

• Bulk food
• Food requiring TCS

(temperature control for safety) even if completely enclosed by container

• Human food byproducts

used as an ingredient in manufactured food or further processed

9

• Food not completely enclosed

by a container

– Food is partially open to the surrounding environment

• Open wooden basket or crate
• Open cardboard box
• Vented cardboard box or plastic

bag

• Food transported in a bulk vehicle (unpackaged food in

direct contact with vehicle) including food additives (except for food contact substances) and GRAS

• E.g., cooking oil, fruit

juices, sugar, seeds, flour

10

What Is Covered (cont’d)

FDA Definition of “Completely Enclosed By Container”

• Container

– Physically separates the food from the environment – Functions to protect the food from environmental contamination during transportation – Examples: cans, bottles, sealed bag,

• r box, including paper bag or box

permeable to moisture

11

FDA Definition of “Completely Enclosed By Container” (cont’d)

• Pallet wrap is not a food container

because it primarily facilitates handling.

• Definition does not include vented

cardboard cartons that are susceptible to environmental contamination

– But if flaps are sealed by tape, may be considered a “completely enclosed container.”

12

Who Is Not Covered

• Farms performing transportation operations on or off

the farm premises

• Non-covered businesses (Shippers, loaders, carriers, or

receivers)

– < $500,000/yr average revenue over a 3-year period – When food is only transshipped through the U.S. to another country – When food is imported for future export but not consumed or distributed in the U.S.

• Is food produced in the U.S. for export covered?

– When engaged in operations of food located in a USDA- regulated facility

• Food is under FDA and USDA oversight as soon as it is transported
• DOT is involved only to notify FDA and USDA if there’s an issue

13

• Food completely enclosed by a

container

– Shelf-stable CPG – Unless TCS is required – Frozen foods – Packaged foods refrigerated for quality

• E.g., cookies completely enclosed in container

– Note: Pallet wrap is not a food container

• Live food animals

(except molluscan shellfish)

• Compressed food gases

(e.g., nitrogen, oxygen, carbon dioxide)

• Food contact substances (FFDCA §409(h)(6),

such as packaging materials

• Packaged alcoholic beverage products

14

What Is Not Covered

• Small parcel deliveries
• UPS, FedEx, etc.

– Full carrier not generally functioning in interactive mechanism, not in dedicated food transport (covered in the preamble section) – Usually in fully enclosed containers – If TCS, are subject to previous regulations

15

What Is Not Covered (cont’d)

• Human food byproducts transported for use

as animal food not subject to further processing (e.g., goes directly to the farm to feed directly to livestock)

– Note: Human food byproducts used as an ingredient in manufactured food or further processed are covered.

16

What Is Not Covered (cont’d)

Are These Covered By the Rule?

17

No No Yes Yes

Are These Covered By the Rule? (cont’d)

18

No Yes

Are These Covered By the Rule? (cont’d)

19

No

Farm carrier hauling grain Non-farm carrier hauling grain

Yes, unless a non-covered business

General Requirements – Vehicle & Transportation Equipment

• Designed and made of materials to be suitable

and adequately cleanable to prevent the food from becoming unsafe

• Maintained in sanitary condition that prevents

food from becoming unsafe during transport (Methods? How often?)

• Stored to prevent harborage of pests or

contamination to render food unsafe

• If for TCS food, designed, maintained, and

equipped to provide adequate temperature control to prevent food from becoming unsafe.

20

General Requirements – Transportation Operations

• Competent supervisory personnel: responsible

for ensuring compliance

• Must take effective measures, such as

segregation, isolation, packaging or other measures (e.g., hand washing)

– To protect food from contamination by raw food and

• n-food items in the same load

– To protect food in bulk vehicles or food not completely enclosed by a container from

• Contamination
• Cross-contact

– To protect food from unsafe temperature fluctuations

21

• If a shipper, loader, carrier, or receiver is aware of

a possible material failure that will render the food unsafe (e.g., temperature deviation), food cannot be sold or distributed in the U.S. unless a qualified individual determines that the condition did not render the food unsafe.

• Qualified Individual (differently defined): qualified

by training or experience and has “…scientific understanding of how temperature deviation could affect the growth of pathogens or production of toxins in the food” (81 FR 20143).

22

General Requirements – Transportation Operations (cont’d)

Requirements -- Shipper

• Shipper has the most responsibility and is expected to

“know whether a food falls within the scope of the exclusion from the definition of ‘transportation

• perations’ applicable to food completely enclosed by a

container and does not require temperature control for safety.”

• Shipper must develop and implement written

procedures to assure meeting the three major focus areas:

– That the appropriate sanitary condition of vehicles and equipment keeps the food safe – That a previous cargo does not make the food unsafe if transported in bulk (and look back ONE cargo load only) – That there is adequate temperature control for food requiring TCS

23

• Shipper must specify in writing to the

carrier(s), and when necessary to loader(s),

– All necessary sanitary specifications for the carrier’s vehicle and transportation equipment, including specific design specifications, cleaning procedures, and maintenance – An operating temperature for the transportation

• peration including, if necessary, the pre-cooling

phase, that is sufficient to keep the food safe, if temperature control for safety is required

24

Requirements – Shipper (cont’d)

• Shipper may

– Issue one-time notification for a particular food product or procedure, unless there are changes in the food or conditions of shipment that may impact food safety.

• Instructions may be communicated in a bill of lading.

– Make alternative arrangements by written contractual agreements to implement these measures

• Must provide information how this communication

process is defined

25

Requirements – Shipper (cont’d)

• For food not completely enclosed

by a container, loader must

– Determine (inspect) that the vehicle or transportation equipment has adequate sanitary condition to maintain food safety, e.g.,

• Equipment is of adequate physical condition
• Free of visible evidence of pest infestation
• Free of previous cargo that could cause food to become

unsafe during transportation

26

Requirements -- Loader

• For food requiring TCS, loader must

– Verify that each mechanically refrigerated cold storage compartment or container is adequately prepared for the transportation of such food, including any pre-cooling

27

Requirements – Loader (cont’d)

• Even under a contractual agreement with

shipper, loaders must continue to

– Determine the appropriate sanitary condition of the vehicle or transportation equipment, if food is not fully packaged – Verify that refrigerated transportation vehicles and equipment are adequately prepared for food requiring refrigeration for safety

28

Requirements – Loader (cont’d)

• For food requiring TCS, carrier must

– Pre-cool, if specified by shipper, each mechanically refrigerated cold storage compartment – Provide, if requested by shipper or receiver, the

• perating temperature specified by the shipper to the

receiver – Demonstrate, if requested of shipper or receiver, that temperature conditions were maintained consistent with the operating temperature specified by shipper

• Through any appropriate means agreeable to carrier and

shipper

29

Requirements – Carrier

• Develop and implement written procedures

that

– Will maintain appropriate sanitary condition by specifying practices for cleaning, sanitizing (if necessary), and inspecting vehicle and transportation equipment – Will demonstrate compliance with temperature control specifications – Will demonstrate compliance with provisions identifying previous cargo and most recent cleaning for bulk vehicles

30

Requirements – Carrier (cont’d)

Training Requirements -- Carrier

• When shipper and carrier agree in writing that

carrier will be responsible for sanitary conditions during transport, carrier must

– Implement a training program for employees (at time of hiring and as needed throughout employment) to cover

• Awareness of potential food safety

problems

• Basic sanitary transportation

practices to address these problems

• Carrier responsibilities

31

• FDA will develop an online training course

(< 1 hrs) and post in on their website

– (Content? Frequency? Length?)

• Recordkeeping (only for carrier because others

are adequately addressed by other rules)

– Date of training – Type of training – Persons trained

32

Training Requirements – Carrier (cont’d)

33

Requirements – Receiver

• For food requiring TCS,

– Receiver must adequately assess that food was not subjected to significant temperature abuse, such as

• Determining food temperature
• Taking ambient vehicle temperature

and its temperature setting

• Conducting sensory inspection

– And if a receiver learns the food may be unsafe, the receiver must ensure that the food is not sold or further distributed pending review by a Qualified Individual.

Allocating Duties by Contract and Establishing Policies

• Intra-company transportation

– Being under the same ownership or operational control of a single entity does not exempt the company

• Common, integrated written transportation procedures

may be used to meet some of the Rule’s requirements.

• Industry practice is to alter, by contract, the tasks assigned

by the Rule to specific parties in the supply chain that actually handle the activity or a rein the best position to handle the activity in question.

– FDA finds this acceptable but such contracts are subject to records requirements. – It is advisable to plan ahead to protect sensitive information that may be subject to a public records request.

34

• FDA would ultimately hold the party who is

covered by the Rule responsible for compliance, regardless of the contractual assignment of duties.

– E.g., A carrier contracts a truck wash station to wash a bulk tanker but the wash station is not covered by the Rule. FDA will hold the carrier responsible for compliance. – Therefore, supplier verification by responsible parties must ensure that service providers are performing their assigned duties adequately.

35

Allocating Duties by Contract and Establishing Policies (cont’d)

• Companies should develop flexible standards

that maintain food safety (which may be different from food quality).

– E.g., A refrigerated food may look better only up to 35F and will be unsafe if >40F. Flexibility means to have shipper’s instructions state “Keep refrigerated below 40F” rather than “Refrigerate at 40F.” Another instruction may be “Do not use if food was held >40F for 4 hrs” rather than “Do not use if food is at 40F.”

36

Allocating Duties by Contract and Establishing Policies (cont’d)

Less Than Load Shipments

• Additional loads added to a partially loaded truck
• Loader is responsible for ensuring vehicle is in

sanitary condition and is appropriate for transporting food, e.g.,

– Adequate physical condition – Free of visible evidence of pest infestation – Free of previous cargo that could cause food to become unsafe during transportation

• FDA expects shipper to instruct loader on vehicle

inspections

37

Transportation of Food With Or Subsequent to Non-Food

• FDA will issue a guidance on what to do when

food is shipped with non-food products

• Segregation, isolation, and packaging can be

effective means of food protection

38

International Shipments

• Rule did not include specific requirements for

food transport before it reaches the U.S.

• Rule starts at point of origination of motor or

rail vehicle in the U.S.

– E.g., food in a enclosed container in an ocean vessel reaches the U.S. It is transferred unopened

• nto a truck at the U.S. port of entry. The

container becomes subject to the rule at the point

• f origination of the truck segment in the U.S.

39

If From An Ocean-going Vessel…

40

If From A Cargo Airplane…

41

Recordkeeping

• Records are generally kept for 12 months after an

agreement’s expiration, or earlier termination, or when a procedure is in use, or their use has been discontinued, or when a person who has undergone training stops performing the duties for which the training was provided.

• Must be made available promptly (i.e., within 24 hrs.) to a

duly authorized individual

– If stored offsite, must be available within 24 hrs. of request – Electronic records are considered onsite if accessible onsite

• “Congress intended recordkeeping to be one of the

requirements for maintaining sanitary food transportation practices.” Thus, if no records are maintained for a food, the food may be deemed adulterated.

42

Recordkeeping (cont’d)

• Shippers must establish and retain records

– That demonstrate they provided sanitary specifications for vehicles and equipment and

• perating temperatures to carriers

– Of any written procedures ensuring

• That vehicles and equipment are maintained in appropriate

sanitary conditions

• That previous cargo does not make food in bulk unsafe
• That adequate temperature controls are achieved

– Of any written agreements to implement procedures – Not required for every shipment; intent is to demonstrate communication

43

• Carriers must establish and retain records of

written procedures

– Of cleaning, sanitizing, and inspecting vehicles and transportation equipment (triggers employee training) – Demonstrating that temperature conditions were maintained, and they conduct required information exchange on operating temperatures with shippers and receivers, if requested – Of identity of previous cargo and most recent cleaning of bulk vehicles

44

Recordkeeping (cont’d)

• Carriers must retain records of

– Employee training (type of training, date, person trained) when carrier has written agreement to assume responsibility for sanitary conditions during transport

• Shippers, loaders, carriers, and receivers must

retain records of agreements assigning tasks

• Shippers, loaders, carriers, and receivers under

the ownership or control of a single legal entity must retain records

– Of written procedures

45

Recordkeeping (cont’d)

Waivers

• As of April 6, 2017, waivers apply to

businesses that have transportation

• perations subject to State-Federal controls,

including

– Business that have valid permits and inspected under the National Conference on Interstate Milk Shipments’ (NCIMS) Grade “A” Milk Safety Program, only when transporting Grade “A” milk and milk products

46

Waivers (cont’d)

– Food establishments that are authorized to operate when engaged as receivers; shippers and carriers in

• perations in which food is delivered directly to

customers; other locations the establishment or its affiliates operate that serve or sell food directly to consumers – Businesses that transport molluscan shellfish that are certified and inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s (ISSC) National Shellfish Sanitation Program (NSSP) and that transport the shellfish in vehicles permitted under ISSC authority.

47

Special Situations

• Fresh Produce and Perishable Agricultural

Commodities Act (PACA)

– If the transportation conditions deviate from the Rule (e.g., failure of temperature control or other conditions that render the food unsafe), the sale or distribution of the food is precluded unless

• A qualified individual determines that the deviation or

condition did not render the food unsafe

• Shelf-stable ingredients (no temperature control

required) completely enclosed by a container (including dedicated, enclosed bulk containers) are not subject to the Rule.

48

Special Situations (cont’d)

• Food Banks and charitable food distribution

centers are subject to the Rule.

• Preemption: If a stricter state law exists, such

state law is not preempted by the Rule

• Conflicts between FSMA Rules: will be addressed

through public meetings or direct questions

• Adulterated Product Intended to be Shipped

Outside the United States: is not allowed. Reconditioning the product or diverting into non- food uses are options.

49

What’s Not Evident

• No requirement for continuous temperature

monitoring, or temperature indicating or recording device

• Information sharing among shippers, carriers,

and receivers will lead to enhanced recordkeeping on

– Type of food product – Proper temperature necessary for food safety, and – Procedures required and performed

50

Summary

• Those with existing best policies, procedures, and

contracts do not have to significantly alter them to adapt to the Rule’s requirements

– But may need to implement new approaches when needed to establish compliance

• Applicability of the rule depends on

– Type of food being transported (animal feed vs. human food) and its production stage (raw vs. finished product) – Type of transportation equipment being used

• Responsibility can be transferred through written

agreements

51

Summary (cont’d)

• Focus is on food safety but general statutory

prohibitions on adulteration apply

• Temperature control requirements are

important but flexible

• FDA goal: to know who is responsible when

things go wrong and to hold them accountable

52

Compliance Dates After April 6, 2016

Food Facility Compliance Date Small business

• <500 Full time equivalent employees
• (Divide total wage/salary hours paid to

employees by 2,080)

• Motor vehicles (not shippers or receivers)

with < $27,500,000 annual receipts 2 years (April 6, 2018) Large business 1 year (April 6, 2017)

53

References

American Frozen Food Institute. April 22, 2016. FDA’s Final Rule on Sanitary Transportation of Human and Animal Food. A webinar.

• FDA. April 25, 106. FDA’s Final Rule on Sanitary Transportation of

Human and Animal Food. A webinar. Food Safety Tech Staff. April 6, 2017. FDA Announces Waivers to FSMA Sanitary Transportation Rule. A news article in FoodSafetyTech https://foodsafetytech.com/news_article/fda-announces- waivers-fsma-sanitary-transportation-rule/ (accessed May 2, 2017).

54

References (cont’d)

Trigg, Suzie. April 29, 2016. Equipping Your Supply Chain for FSMA: Allocating Responsibilities under the FSMA Transportation Rule. A haynesboone FDA Alert online article. http://www.haynesboone.com/~/media/files/alert%20pdfs /2016/equipping_your_supply_chain_for_fsma.ashx (accessed May 5, 2017) Warner Norcross & Judd. April 5, 2016. FDA Releases final Rule for Sanitary Transportation of Human and Animal Food. https://www.wnj.com/Publications/FDA-Releases-Final- Rule-for-Sanitary-Transportatio (accessed May 2, 2017)

55

If You Have A Question, Ask:

• FSPCA Technical Assistance Network

https://fspca.force.com/FSPCA/s/contactsupport ?language=en_US (accessed May 2, 2017)

• FDA Technical Assistance Network

https://www.fda.gov/Food/GuidanceRegulation /FSMA/ucm459719.htm (accessed May 2, 2017)

56

END OF MODULE V

57