1

Understanding FSMA: Preventive Controls for Food for Animals

(Proposed Rule)

Jennifer McEntire, PhDAnne Sherod, MS

Sept 3, 2014

2Overview

Today’s Challenges & Changing Risks

FSMAPreventive Controls for Animal

FoodOther applicable rules

3Today’s Challenges

Complex supply chainsConsumer demandsEmerging threats Improving epidemiologyDisrespect for science Influence of mediaLitigationNew regulations

4Changing Science of Food Safety

13 Foods Linked to New Outbreaks of Foodborne Illness  in the United StatesSince 2006

Bagged spinach  Carrot juice   Peanut butter  Canned chili sauce  

Broccoli powder on snacks       Hazelnuts Pot pies Dog food

Hot peppers Papayas  White pepper Raw cookie dough     Pine Nuts

New risks identified with foods (peanut butter, cookie dough)

Greater capacity to link food with illness

Ability to measure lower levels of chemicals

Improvements in genetic testing Whole genome sequencing

5Changing Landscape

Risk

Science & Epi

Media

Consumer Expectations

6Product Risks

Geographic risk Inherent risk

MicrobiologicalChemical

History of product Mitigations Consumer susceptibilities

7Supplier Risk

Country – regulatory/food safety infrastructure Audit status (who/when/what type) Internal preventive controls—by facility

Environmental

HACCP and GMPs

Prior regulatory actions Testing strategy Food safety corporate culture

8

Regulatory Requirements: Assessing and Controlling Risk

Preventive Controls (and GMPs)FSVP

Sanitary Transport

9Food Safety Modernization Act

Signed into law on January 4, 2011Most sweeping overhaul of the food

safety system since 1938Law reflects risk-based integrated

global systems approachCongress made the law…

FDA must implement itNUMEROUS regulations

10FSMA: What does it do?

10

Stronger enforcement authorityMandatory recalls (effective immediately)Enhanced records access (effective

immediately)

On-farm produce safetyHACCP (and more) for everyone Increased inspections Intentional adulteration addressedMore stringent import requirementsRegistration/Fees

11

Prevention

Inspections, Compliance, and Response

Import Safety

Enhanced Partnerships

Food Safety Modernization Act

12Rule Making Process

12

Congress gives FDA the

authority

FDA drafts new

regulation

Health and Human Services

approves the draft

Draft reviewed by the Office of

Management and Budget

Draft released for

public comment

Cycle Repeats

13

FSMA Status Summary: “The 7 Pillars”

Proposed Rule Final DeadlinePC- Human Food August 30, 2015

PC- Animal Food August 30, 2015

Produce Safety October 31, 2015

FSVP October 31, 2015

Third Party Accreditation October 31, 2015

Sanitary Transport March 31, 2016

Food Defense May 31, 2016

14 Rules for the Pet Food and Animal Feed Industries

1. Preventive Control Rule for Animal Food*2. Foreign Supplier Verification Program3. Sanitary Transportation

15

Preventive Controls Rule –Animal Food

16Animal Food

“Food for animals other than man, and includes pet food, feed, and raw materials and ingredients. When used in this part, the phrase ‘animal food’ does not refer to food derived from animals that is intended for human consumption.”

17Key Principles

GMP requirements (controversial)

Develop a Food Safety PlanIncludes having a recall plan

Focus on three key elementsThe safety of animal food and in turn the

health of animalsHealth of humans who are exposed to

animal foodAnimal derived products for human

consumption

18Who is Covered?

Manufacturing, processing, packing, and holding of finished products that are intended to be fed to animals, including livestock, pets, and other captive animals

Manufacturing, processing, packing, and holding of ingredients that may be used in animal foods.

Includes: Renderers

Grain and oilseed processors

biofuel manufacturing (suppliers of distillers grain for animal food)

19Exemptions Activities within the definition of “farm” Facilities such as grain elevators and

warehouses that store only raw agricultural products intended for further distribution or processing

Qualified facilities – limited exemptions Less than $500,000 of animal food sales, <275 miles etc.

Very small (3 options - $0.5m, 1m, 2.5m)

Facility must certify that it is qualified

Still needs to comply with GMPs

LACF (micro only) – but all must comply with GMPs

20ExemptionsLow Risk “manufacturing/processing”

activities conducted on a farmConveyingWeighingSortingCullingGrading grain, oilseed, grain and oilseed by-

products, and forage (hay and ensiled material)

Must comply with GMPs

21Exemptions

Solely engaged in the storage of packaged animal food that are not exposed to the environment and do not require refrigerationMust comply with GMPs

Solely engaged in the storage of packaged animal food that are not exposed to the environment and dorequire refrigerationModified requirements concerning temperature

controls (monitoring, verification, records)Must comply with GMPs

22What is Required?

GMP Provisions- pet food and animal feed (for now)Establish procedures in buildings and

facilitiesHygienic personnel practices and trainingFacility operations, maintenance, and

sanitationEquipment and utensil design and useMaintenanceProcesses and controlsWarehousing and distribution

23GMP: Personnel

Hygienic practicesPersonal cleanlinessHandwashingNo jewelryStorage of personal effects

Education/experience/training for those involved in sanitation, food handling

24GMP: plants and grounds

PestsWeeds and grassscreens

DrainageWaste disposalSuitable construction, size, designAdequate lighting and ventilation

25GMP: sanitary operations

Safe cleaning compoundsPesticidesFrequent cleaning

Wet and dry cleaning

Cleaning non food contact surfaces

26GMP: sanitary facilities and controlsSafe waterAppropriate plumbing, drains, etcToiletsHandwashing stationsTrash removal

27GMP: Equip and Utensils

Designed to be cleanableResist corrosion, nontoxic, smooth

seamsTemp monitoring on freezersAppropriate measuring/monitoring

devicesCompressed air and gas

28GMP: processes and controls

Label containers to ID contentsLabel bulk and rework

Safe packagingTesting to ID sanitation failuresSafe raw materialsTemperature controlsExclude foreign objects

29GMP: warehouse and distribution

Storage under conditions that will protect against biological, chemical, physical, and radiological contamination of animal food as well as against deterioration of the animal food and the container.

30Preventive Controls

30

Hazard Analysis

Preventive Controls

Monitoring

Corrective Actions

Verification

Reanalysis

Documentation

Food Safety Plan by a qualified individual

31Animal Rule Vs Human Rule

The exclusion of the need to control allergens

The requirement to consider animal species when evaluating hazards

The need to evaluate nutrient imbalances as a potential chemical hazard

32Oct 9 Workshop www.jointconference.orgWhat is a “Qualified Individual”?How do you do a hazard analysis?

What is “known and reasonably foreseeable”

What is “reasonably likely to occur”What level of scientific justification is

needed to make decisions?Does it matter if it’s pet food vs animal

feed?Does the animal species matter?

33Oct 9 workshop

Once we know hazards RLTO, what are options for preventive controls?Process controlsSanitation controlsSupplier controls

How do you establish parameters? How do you select and justify PCs?

34Oct 9 workshop

What is validation? What is verification?

What kind of monitoring is required and how do you set it up?

How do you develop and implement corrective actions?

What needs to be in the recall plan?What is “reanalysis” and what would

make me do it?

35What Does it Mean to You?

Don’t wait

GMP

Qualified Individual

Food safety plan

36Next Steps

Come to the Oct 9 workshopwww.jointconference.orgGet in depth on Animal PC ruleAsk about other rules (there or here,

during Q&A)FSVP

Sanitary Transport

Get ready to comment on reproposals

37

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jennifer@achesongroup.comanne@achesongroup.com