Proposed Rule for Preventive Controls for

Animal Food

1

Why FSMA is Important

• Too many preventable foodborne illnesses

• Too many costly disruptions in the marketplace

• Loss of public confidence

• Global pressures on food safety and oversight system

2

Key FSMA Principles

• Primary industry responsibility for food safety

• Focus on farm-to-table prevention• Science- and risk-based• Focus on enhanced domestic inspection

and modern import oversight• Partnerships key to success

3

Who is Covered?

• Facilities that manufacture, process, pack or hold animal food

• In general, facilities required to register with FDA under sec. 415 of the FD&C Act

• Applies to domestic and imported food

• Some exemptions and modified requirements are being proposed

Farm-Related Exemptions• Activities within the definition of “farm,” including

farm activities that are covered by the proposed produce rule

• Certain low-risk manufacturing/processing, packing and holding activities conducted by small/very small businesses on farms for specific foods

Farm Definition (21 CFR 1.227)

Farm means a facility in one general physical location

devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term "farm" would include:

(1) Facilities that pack or hold food, provided that all

food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership and

(2) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.

6

Exemptions and Modified Requirements -1

• “Qualified” facilities:– Very small businesses (3 definitions being proposed

—less than $500,000, less than $1millon and less than $2.5 million in total annual sales)

OR– Food sales averaging less than $500,000 per year

during the last three years AND– Sales to qualified end users must exceed sales to

others

Exemptions and Modified Requirements - 2

• Certain storage facilities such as grain elevators and warehouses that only store raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing are exempt from hazard analysis and risk-based preventive controls.– Also exempt with respect to CGMPs

Summary of Requirements

• Establish, for the first time, Good Manufacturing Practices for animal food

• Hazard Analysis and Risk-Based Preventive Controls– Each facility would be required to implement a written

food safety plan that focuses on preventing hazards in foods

New Current Good Manufacturing Practices

• Personnel

• Plant and grounds

• Sanitary operations

• Sanitary facilities and controls

• Processes and controls

• Equipment and utensils

• Warehousing and distribution

10

CGMP Elements cont’d• Personnel

– follow good hygiene practices– protection of food from contamination from personal

effects

• Plant and grounds– including proper cleaning, maintenance, and pest

control

.

CGMP Elements cont’d• Sanitary operations

– includes maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests

• Sanitary facilities and controls– such as the plant's water supply, plumbing, and

toilet and hand-washing facilities

CGMP Elements cont’d

• Processes and controls includes:– following adequate sanitation principles– proper labeling of ingredients and finished

animal food– ensuring the safety of raw materials – prevention of contamination of animal food

during processing

CGMP Elements cont’d

• Equipment and utensils– includes the cleaning and maintenance of

such items and protecting animal food from contamination

• Warehousing and distribution– Includes protecting animal food against

contamination and deterioration

CGMP Elements cont’d• Spectrum of animal food producers and production

facilities, and hazards and risks can vary greatly• Requesting comment whether CGMPs related to

human food are appropriate for animal food• Requesting comment on CGMP requirements by

types of animal food– Appropriate for some but not for others?– How can/should FDA distinguish between animal food

types?

15

Specific Provisions

21 CFR 507 Subpart C

Hazard Analysis and Risk-based Preventive Controls

Hazard Analysis and Risk-Based Preventive Controls

Hazard Analysis• Identify known or reasonably foreseeable hazards

for each food type to determine whether there are hazards that are reasonably likely to occur – Including an assessment of the severity of the

illness or injury if the hazard were to occur• Must consider hazards that may occur naturally or

may be unintentionally introduced• Must include biological, chemical, physical and

radiological

Measures Under Consideration: Additional Verification

• We are seeking comment on

– Finished product testing

– Environmental testing

– Supplier verification

Finished Product Testing• Should FDA require finished product

testing? • “(3) Performance of scientifically valid finished

product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards that are reasonably likely to occur”

• When and how is finished product testing an appropriate means of verifying that hazards are being effectively controlled?

Environmental Testing

• “(4) Performance of environmental monitoring for any environmental pathogens that are reasonably likely to occur, or for appropriate indicator organisms for such pathogens, at a frequency of not less than monthly, to assess whether the preventive controls significantly minimize or prevent the environmental pathogens that are reasonably likely to occur. Environmental monitoring must be scientifically valid and must include:

• Collecting and testing

• When and how is environmental testing an appropriate means of verifying that hazards are being effectively controlled?

Supplier Approval and Verification

• Should FDA require supplier approval and verification?– requirements for supplier verification are

primarily based on who is to control the hazards that are reasonably likely to occur.

• When and how is a supplier approval and verification program an appropriate preventive control measure?

Effective and Compliance Dates

Effective date:

60 days after the final rule is published

Compliance Dates

• Small Businesses—a business employing fewer than 500 persons would have two years after publication of final rule

Compliance Dates cont’d• Very Small Businesses—a business having

less than $500,000 (or alternatively $1 million or $2.5 million) in total annual sales of food would have three years after publication to comply. - Very small businesses are considered “qualified”

facilities and subject to modified requirements

• Other Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply.

How to Comment onthe Proposed Rules

• www.regulations.gov• Link to rules on www.fda.gov/fsma• Comment period is 120 days• Comment periods on other major FSMA

proposals will be coordinated to enable comment on how the rules can best work together

More Information Available• Web site:

http://www.fda.gov/fsma • Subscription feature available• Send questions to FSMA@fda.hhs.gov• Comments on regulation:

– www. regulations.gov