The FDA Food Safety Modernization Act

http://www.fda.gov/fsma

Devin Koontz, Team Lead Health Communications Specialist Office of Regulatory Affairs/Office of Communications and Quality Program Management/Public Affairs and Editorial Services Branch

Foundational Rules

• Preventive Controls for Human Food • Preventive Controls for Animal Food • Produce Safety • Foreign Supplier Verification Programs • Accredited Third-Party Certification • Sanitary Transportation • Intentional Adulteration

Preventive Controls for Human Food: Background

• Originally proposed: January 16, 2013 • Supplemental proposal: September 29,

2014 • Public comments: More than 8,000 for the

original proposal; more than 1,300 for the supplemental proposal

• Final rule issued: September 10, 2015

Preventive Controls for Human Food: Provisions

• Facilities that manufacture, process, pack or hold human food must have a written food safety plan that outlines: o Hazard analysis o Preventive controls o Supply-chain program o Recall plan o Procedures for monitoring o Corrective action procedures o Verification procedures

Supply-Chain Program • The preventive controls rules for both

human and animal food require that: oManufacturing/processing facilities have a

risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients.

o Suppliers are approved after a consideration of factors that include a hazard analysis of the food, the entity that will control that hazard and supplier performance.

Definition of Farm • The final PC-Human Rule clarifies and

expands the definition of a farm, which is not subject to preventive controls requirements. Depending on certain factors, it may be subject to the Produce Safety rule.

• The Produce Safety rule includes this new definition.

Definition of Farm Covers two kinds of farming operations: • Primary production farm: Under one management in one

general, but not necessarily contiguous location. o Devoted to the growing of crops, harvesting of crops, raising of

animals, or any combination of these activities. o Can also pack or hold raw agricultural commodities (RACs)

regardless of who grew them and can manufacture, process, pack or hold processed foods under certain limited conditions

• Secondary activities farm: Not located on primary production farm; devoted to harvesting, packing, and/or holding raw agricultural commodities (RACs). o The primary farm must own or jointly own a majority interest.

Preventive Controls for Human Food: Compliance Dates

• Very small businesses (less than $1 million in annual food sales): Three years

• Businesses subject to the Pasteurized Milk Ordinance: Three years

• Small businesses (a business with fewer than 500 full-time equivalent employees): Two years

• All other businesses: One year

• (Separate compliance dates have been established for the supply-chain program.)

Preventive Controls for Animal Food: Background

• Originally proposed: October 29, 2013 • Supplemental proposal: September 29,

2014 • Public comments: More than 2,400 for the

original proposal; more than 140 for the supplemental proposal

• Final rule issued: September 10, 2015

Preventive Controls for Animal Food: Provisions

• Establish Current Good Manufacturing Practices (CGMPs)

• Hazard Analysis and Risk-Based Preventive Controls o Each facility is required to implement a written

food safety plan that focuses on preventing hazards in animal foods

Feed Mills • Feed mills associated with fully vertically integrated farming

operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) generally meet the definition of a farm.

• The FDA remains concerned that not having these operations subject to the Preventive Controls for Animal Food final rule leaves a gap in the protection of human and animal health because these feed mill operations manufacture significant amounts of animal food.

• The FDA intends to publish a proposed rule in the future that would require some feed mill operations that currently are part of a farm to implement the current good manufacturing practices established by the Preventive Controls for Animal Food rule.

Preventive Controls for Animal Food: Compliance Dates

• Very small businesses (less than $2.5 million in annual food sales): Three years (CGMP); four years (PC rule)

• Small businesses (a business with fewer than 500 full-time equivalent employees): Two years (CGMP); three years (PC)

• All other businesses: One year (CGMP); two years (PC)

• (Separate compliance dates have been established for the supply-chain program.)

Produce Safety Rule: Background

• First proposed: January 16, 2013 • Supplemental proposal: September 29,

2014 • Number of comments: About 36,000

submissions representing about 15,000 unique comments

• Final rule issued: November 13, 2015

Produce Safety Rule: Provisions The focus is on conditions and practices identified as potential contributing factors for microbial contamination: • Agricultural water • Biological soil amendments of animal origin • Worker health and hygiene • Equipment, tools, buildings and sanitation • Domesticated and wild animals • Sprouts requirements

Agricultural Water Quality • The stringency of the microbial water quality

criteria depends on use: • For activities e.g. post-harvest wash, sprout irrigation

– No detectable generic E. coli • For growing activities such as non-sprout irrigation

– GM of 126 CFU/100 mL or less generic E. coli and STV of 410 CFU/100 mL or less generic E. coli

• Allows for microbial die-off in-field, between last irrigation and harvest, of up to 4 consecutive days

• Allows for microbial reduction or removal post-harvest, including through commercial practices or storage

Agricultural Water Testing • Untreated surface water: Initial survey with a minimum

of 20 samples collected over two to four years. Updates annually with five new samples which, added to the most recent 15 samples, creates a rolling dataset of 20 samples.

• Untreated ground water: Initial survey with a minimum of four samples during growing season or over a one-year period. Updates annually with one new sample which, added to the most recent three samples, creates a rolling dataset of four samples.

Produce Safety Rule: Compliance Dates

• Very small businesses (less than $250,000 in annual produce sales): Four years (three for sprout growers)

• Small businesses (less than $500,000 in annual produce sales): Three years (two for sprout growers)

• All other businesses: Two years (one for sprout growers)

• (An extra two years is allowed to comply with

specific agricultural water requirements.)

Foreign Supplier Verification Programs (FSVP): Background

• First proposed: July 29, 2013 • Supplemental proposal: September 29,

2014 • Number of comments: More than 300 for

the original proposal; more than 100 for the supplemental

• Final rule issued: November 13, 2015

FSVP: Provisions • Importers covered by the rule must have a

program to verify that foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

•

FSVP: Provisions • Importers are responsible for:

o Determining known or reasonably foreseeable hazards with each food

o Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

o Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

o Conducting supplier verification activities o Conducting corrective actions

FSVP: Compliance Dates

• Required to comply with FSVP no earlier than 18 months after issuance of final rule

• If foreign supplier is subject to preventive controls or produce safety regulations, importer required to comply with FSVP 6 months after supplier must comply with relevant regulations (varies based on size of supplier).

Accredited Third-Party Certification: Background

• First proposed: July 26, 2013 • Number of comments: More than 150 • Final rule issued: November 13, 2015

Accredited Third-Party Certification: Provisions

• This rule establishes a voluntary program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications for foreign facilities and/or the human or animal foods they produce.

• Contains requirements for accreditation bodies, which FDA must recognize, and certification bodies, which accreditation bodies must accredit

When Are Certifications Needed? • Certifications will be used for two

purposes: o Facility certifications will be used by importers

to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food.

• Food or facility certifications will be used for admissibility of a food that FDA considers a potential risk to public health.

Accredited Third-Party Certification: Compliance Dates • Program will launch on the effective date

of the final user fee rule. • Accreditation bodies could begin to apply

when the program goes into effect. − Third-party auditors could seek accreditation

after one or more FDA-recognized accreditation bodies begin accepting applications.

Two Remaining Rules • Sanitary Transportation: Would require

those who transport foods to use sanitary practices. Deadline for final rule: March 31, 2016

• Intentional Adulteration: Would require domestic and foreign facilities to implement controls against acts of terrorism. Deadline for final rule: May 31, 2016

For More Information • Web site: www.fda.gov/fsma • Subscription feature available • To submit a question about FSMA, visit

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