# Presentation: 533162

## The Impact of Pathogen Reduction/HACCP on Food Animal Production Systems

**Food Safety and Inspection Service**
**U. S. Department of Agriculture**

## Overview of Presentation

**New USDA Pathogen Reduction and HACCP Systems Rule for Plants**
**In-Plant Residue Control Options**
**Impact of Rule on Food Animal****Production Systems**
**Importance of HACCP-Compatible Production Practices**

**Notes:**
Today, I will:

Provide key information on the new USDA’s rule and its regulations that’s important for producers and veterinarians to be aware of;
Describe in-plant residue controls, which consider options for incoming animals;
Provide some insight on how implementation of the rule may impact food animal producers; and
Help you understand why producer Quality Assurance Programs are HACCP-compatible and are important for marketing to plants with HACCP systems,

## Why Has FSIS Changed Its Inspection Rules?

**Focus on Foodborne Illnesses**
***Salmonella***
***E. coli O157:H7***
***Campylobacter***
***Listeria***

**Notes:**
As you know, there have been many reports of deaths and illnesses due to these and other foodborne illnesses.
Almost everyday the media is covering news stories about these organisms.
The public’s concerns about the safety of the food supply have been heightened.
Public Health Agencies have raised concerns that more adequate controls form farm to table are needed.

## Why Has FSIS ChangedIts Regulations

**First major change in almost 100 years**
**Need to reduce risks of foodborne****illnesses from meat, poultry and****egg products**
**HACCP accepted as science-based****preventive risk reduction system**

**Notes:**
USDA’s Food Safety and Inspection Service recognized it needed to modernize its 90-year-old system.
A critical gap in the inspection program was that it did not adequately prevent or control harmful pathogens on raw meat and poultry.
Changes in FSIS’ total approach to food safety were needed.
HACCP is accepted nationally and internationally as a science-based, preventive risk reduction system.

## Pathogen Reduction:Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule

**Published**
**July 25, 1996**

**Notes:**
On July 25, 1996, after much public input, the final rule was published.  The rule clarifies that:

Industry’s role is to produce safe meat and poultry products.
FSIS’ role is also to set appropriate food safety standards, to make sure those standards are being met through regulatory oversight, and to take enforcement action when these standards are not met.

## Pathogen Reduction/HACCPFinal Rule

**Meat and poultry slaughter and****processing establishments must:**
**Implement Standard Operating****Procedures for Sanitation**
**Test certain products for generic *****E. coli***
**Implement HACCP systems**
**Meet USDA-FSIS *****Salmonella*****performance standards**

**Notes:**
According to the rule:
As of January 27, 1997, plants are required to have SOPs in place to address sanitation
Each plant must describe all procedures it conducts daily, before and during operations
Plants are responsible for detecting, documenting and correcting sanitation deficiencies
Inspectors will continue to look for and require the correction of problems
FSIS will verify SOPs are maintained and effective, and take appropriate action if a plant fails to comply with SOP requirements
Since January 1997, plants have also been required to test carcasses for generic E. coli as an indicator of the adequacy of the plant’s ability to control fecal contamination.
FSIS has adopted performance criteria for E. coli.. FSIS is using the term “criteria” because they are guidelines, not regulatory standards.
The original baseline surveys and performance criteria published in the final rule were based on the excision method of removing meat from carcasses for testing.
FSIS is now conducting new baseline surveys using a nondestructive sponge sampling technique for swine, cattle, and turkeys.
Plants must evaluate their own results using statistical process control.
FSIS will make available interim criteria for use in evaluating sponge samples until final criteria can be set.
Meat and poultry slaughter and processing plants must implement HACCP systems to prevent hazards in meat and poultry products:
Chemical (illegal drug, antibiotic, pesticide and other) residues
Physical hazards (metal, needles, .....)
Microbial pathogens
USDA has set performance standards for Salmonella contamination levels on raw meat and poultry, and plants must meet or be below these levels.

## Pathogen Reduction/HACCP Final Rule

**      ****Slaughter and processing plants must assume more practical responsibility for food safety**

**Notes:**
The rule makes it clear that:

Slaughter and processing plants are responsible for food safety and must assume more practical responsibility for control of these hazards in their products.

## Pathogen Reduction/HACCP Final Rule

**    “****Those in control of each segment must bear the responsibility**
**for identifying and preventing or reducing food safety hazards.”**
**1996 Rule, Background**

**Notes:**
The rule also makes it clear that:

Those in control of each segment of the food industry must bear the responsibility for identifying and preventing or reducing food safety hazards.

Although FSIS has regulatory authority primarily in the meat, poultry, and egg processing plants, it has the responsibility to work with all parts of the food production and marketing chain to help ensure we are all doing our best to improve food safety.

## Farm to Table Food Safety

**Animal Production (farm to slaughter)**
**Slaughter and Processing Plants**
**Post-Processing Transportation**
**Wholesale and Retail Stores**
**Food Service**
**Consumer Education**

**Notes:**
FSIS supports efforts at all levels of the Farm to Table Food Safety Chain:
Promotes voluntary adoption of producer quality assurance programs
Is working with FDA to address safe transportation of products
Through the Food Code, works with local and State authorities to improve wholesale, retail and food service food safety practices
Has helped develop the FIGHT BAC! Consumer education campaign.  Provides extensive consumer information and Hotline services.

## Pathogen Reduction/HACCP Final Rule

**Foreign Systems must be ****“equivalent to”**
**State Systems must be “equal to”**

**Notes:**
We often are asked “What about imports?”
We are currently working with our trading partners to ensure their systems are equivalent to our HACCP rule.
Our State meat and poultry inspection programs must be “equal to” the federal system.

## Pre-HACCP ImplementationIn Plants

**On January 27, 1997 plants:**
**implemented Standard Operating Procedures for Sanitation**
**began generic *****E. coli***** testing for fecal contamination; and**
**began devising pathogen reduction and HACCP plans**

**Notes:**
Plants were required, on January 27, 1997, to:
Implement SSOPs
Begin generic E.coli testing for fecal contamination
Begin preparations, including educating themselves, about how they are going to develop PR/HACCP plans.  FSIS provided extensive guidance to plants to facilitate implementation.

## Pathogen Reduction/HACCP Final Rule Implementation

**January 26, 1998**
***Large establishments***
**January 25, 1999**
***Small establishments***
**January 25, 2000**
***Very small establishments***

**Notes:**
Plants will need to implement HACCP systems and meet Salmonella performance standards in a phased-in manner according to their size.

Large establishments - 500 or more employees
Small establishments - 10 or more but fewer than 500 employees
Very small establishments - Fewer than 10 employees or annual sales of less that $2.5 million.

## Pathogen Reduction/HACCP Rule and Animal Production

**January 26, 1998**
**75-80% of food animals marketed**
**January 25, 1999**
**90-95% of food animals marketed**
**January 25, 2000**
**100% of food animals marketed**

**Notes:**
In terms of percentage of animals whose products end up in interstate or internationally shipped meat and poultry products:

In 1998, about 75-80% of all animals were being marketed to plants implementing HACCP;
This year, when the small plants come on-board, about 90%; and
Starting the year 2000, every animal will be marketed to plants with HACCP systems.

## Pathogen Reduction/HACCP Rule and Animal Production

**There is no regulatory requirement to test live animals for hazards**
**Rule describes non-regulatory approach for animal production food safety**
**Part 417.2 requires plans to evaluate hazards in animals**

**Notes:**
FSIS does not have, and does not seek regulatory authority over live animals from the farm to the slaughter house gate, and the rule does not have regulatory requirement to test live animals for hazards.
The rule clearly describes our role as promoting voluntary producer efforts to implement food safety preventive practices.
The potential impact on animals marketed to HACCP plants is found in Part 417.2.  This section of the PR/HACCP regulations does require plants to evaluate hazards from live animals.

## Pathogen Reduction/HACCP Rule Part 417.2(a)

**Plants must conduct a hazard**
**analysis “to determine the food**
**safety hazards reasonably likely to**
**occur before, during and after entry**
**into the establishment”**

**Notes:**
Part 417.2 states the plants must conduct a hazard analysis “to determine the food safety hazards reasonably likely to occur before, during and after entry into the establishment.:

The key words for you are “reasonably likely to occur” and “before...entry.”

## Pathogen Reduction/HACCP Final Rule Part 417.2 Hazards

**Physical hazards (foreign objects)**
**Natural toxins (aflatoxins, etc.)**
**Zoonotic diseases (bacterial, parasitic)**
**Other microbial contaminants**
**Chemical contaminants (pesticides and drug residues)**
**Food additives and decomposition**

**Notes:**
The rule also describes what hazards must be considered in a hazard analysis.

All of these, except the last ones, food additives and food decomposition, can apply to incoming animals.

## Slaughter Plant ResidueControl Process

**Evaluate significant residue hazards****of incoming animals purchased**
**Develop HACCP plan for****residue control**
**Determine information needed****from animal suppliers**

**Notes:**
Although the focus and the biggest challenge for plants is meeting microbial performance standards, plants are responsible for preventing illegal, or violative, residues from adulterating their meat and poultry products.

Therefore, plants are responsible for residue control:
They must evaluate significant residue hazards of incoming animals;
develop a HACCP plan for controlling residues; and
determine information needed to help develop the residue control plan.

## Slaughter Plant Residue Control Options for Incoming Animals

**Reject animals with a high risk of violative residues**
**Clearly define purchase criteria**
**Buy only from suppliers quality assurance certified**

**Notes:**
When considering how to control residues, plants have many options.  They can:
Reject animals with a high risk of violative residues;
develop specifications for high-risk classes of animals for residue violations. 
Buy only for suppliers on a QAP.  As of January 1999, Hormel will only purchase pigs from producers certified on the Pork quality Assurance Level 3 program.

## Slaughter Plant Residue Control Options for Incoming Animals

**Refuse to purchase from suppliers****with past residue violations**
**Require written assurances or letters****of guarantee of no adulteration**
**Have drug or pesticide use****records available**

**Notes:**
Plants can:
refuse to purchase from suppliers with past residue violations that caused adulteration of meat;
require written assurances or letters of guarantee of no adulteration; or
ask for sufficient history of production practices to determine whether or not significant residue hazards are likely.  Plants need to use residue tests appropriate for the treatment history of the animals slaughtered.

## Slaughter Plant Residue Control Options for Incoming Animals

**Periodically test animals or carcasses for residues**
**Obtain verification of proper drug or pesticide use**

**Notes:**
Plants can also:
periodically test animals or carcasses for residues; and
To convince suppliers of the importance of preventing violative residues, plants could periodically visit suppliers or obtain independent third party verification that good production practices are being implemented

## Higher Risk Classes for Violative (Illegal) Drug Residues

**Bob veal (3 weeks, 150 lbs.)**
**Culled cows and bulls**
**Culled boars and sows**
**Roaster pigs**
**Hospital pen clean-outs**

**Notes:**
There are sufficient historical data that show these classes of animals are more likely to have violative residues than others.
It is imperative proper withdrawal times prior to slaughter are observed.
These are the primary classes of animals on which both plants and FSIS will need to focus residue testing efforts to protect the public’s health.

## Impact of PR/HACCP Rule on Animal Production Systems

**Packers may need more**
**information on incoming**
**animals for their HACCP plan.**

**Notes:**
With the advent of HACCP systems, packers may need more information on incoming animals to develop their HACCP plan and prevent residue adulteration of their products.

## Impact of PR/HACCP Rule on Animal Production Systems

**HACCP-compatible practices provide food safety and market assurances**
**Quality Assurance Program****(QAP)  Certification**
**Animal/premise identification**

**Notes:**
Producer practices which will provide packers with the information and assurances they need are called “HACCP-compatible.”
They include four key industry standards for good production practices:

1.  Being a certified producer on a QAP
2.  Identifying treated animals and enabling packers to know the source of animals	

## Impact of PR/HACCP Rule on Animal Production Systems

**HACCP-compatible practices (con’d)**
**Record keeping**
**Third party verified****(audited) processes**

**Notes:**
HACCP-compatible practices (con’d):

3.  Keeping herd health and treatment records, which could supply purchasers with information and improves management, and
4.  Another process which may become more important for branded and international markets will be third party verification of food production practices by auditors.

## Importance of QualityAssurance Certification

**Promotes animal health and welfare**
**Ensures proper drug and antibiotic use**
**Provides records to assure purchasers of good production practices**

**Notes:**
By now, I hope you see how important the practices embodied in the QAPS are.
Being a certified producer will not only promote excellence in animal health and welfare, but will also ensure safety of meats by ensuring proper drug and antibiotic use.
Certified producers are more likely to have the proper records which assure purchasers of good production practices.

## Importance of QualityAssurance Certification

**Proven to reduce residue violations**
**Potentially reduces pathogens through ****good hygiene and animal health**
**Improves production efficiency and****quality of animals**

**Notes:**
It has been shown that when producers follow QAPs, they have fewer residue violations, especially repeat violations.
Following the good production practices also potentially reduces contamination with pathogens through good hygiene and animal health.
Quality assurance also increases production efficiency and animal quality.

## Importance of Verified Quality Assurance Programs

**Provides added assurances****to purchasers**
**Provides documentation to****support branded products****and international markets**

**Notes:**
National and international marketing systems are moving toward branded products with quality and safety assurances from suppliers along the chain.
Verified programs that have been audited by a third party, such as an accredited veterinarian or other trained expert, may provide added value to purchasers because of the additional assurances and documentation of certain practices being followed.

## Milk and Dairy Beef Quality Assurance Program

**Food Safety Control Points**
**Valid veterinary/client/patient****relationship for drug use****and health**
**Storing and administering drugs**
**Milk drug screening tests**

**Notes:**
The Dairy QAP has taken a HACCP-like approach to looking at specific food safety control points for residue avoidance.
Ten control points are clearly described.
Although the QAP focuses on residue avoidance in mil,, critical control points for preventing residues in beef are stressed.
Producers who follow the practices in the Milk and Dairy Beef QAP will be able to provide slaughter plants the assurances needed for their residue control plans for culled cows and bob veal calves.

## Milk and Dairy Beef Quality Assurance Program

**Certification by veterinarians is an educational process**

**Notes:**
Although the Milk & Dairy QAP certification is primarily an educational process for residue food safety and milk quality, the practices of record-keeping, animal identification, maintaining good herd health and hygiene, educating all on handling drugs properly, and working with a veterinarian are keys to success when marketing culled cows and bob veal calves to slaughter plants implementing HACCP systems.
Plants will have more trust when buying culled cows and bob veal calves.from producers with QA programs.
Recently, this Program has also incorporated Best management Practices for Biosecurity to control infectious diseases and hopefully reduce risk of foodborne pathogens by good sanitation and herd health management.

## Pork Quality Assurance Certification Program

**Level I**
**Food safety and HACCP awareness**
**FDA animal drug use compliance policy guide explained**
**Current regulatory systems****included**
**Level II:  Educational self test**

## Pork Quality Assurance Certification Program

**Level III:  Veterinarian Assisted**
**10 Good Production Practices Defined**
**1 to 6:  Residue avoidance practices**
**7 to 9:  Animal health, care and feeding**
**     ****10:  Complete checklist annually**
**Recertify every two years**

**Notes:**
The Level 3 PQA contains industry standards for good production practices.
It requires producers to go to educational meeting and recertify every two years with a veterinarian or swine expert.
According to a recent article in the National Hog Farmer, up to now, pork packers have borne the brunt of the responsibility for food safety.  Starting in January 1999, Hormel will buy only from producers certified on the Level 3 QAP.
This will provide them with added assurances that producers are educated about industry standards.

## Beef Quality Assurance Certification Program

**Beef Quality Assurance Certification Program**

**Guidelines for proper animal****health product use**
**Awareness of feed ingredients****and potential residues**
**Total Quality Manage-****ment education**
**Tailored State by State**

**Notes:**
The Beef QAP is often tailored by States.
In the Northeast, there has been a focus on culled dairy cattle and how best to work with dairy producers to avoid violative residues in beef.
The BQA stresses total quality management practices for improved beef quality and residue safety

## Animal Production andPathogen Reduction

**Research needed to determine food safety control points from farm to slaughter**
**What practices will reduce pathogens in live animals and result in reducing contamination on carcasses?**

**Notes:**
We’ve talked a lot about residue avoidance, but what about foodborne pathogens?
Although plants will be testing for generic E. coli and some will be checking for pathogens, there are no requirements to test live animals or to traceback to the farm.  Some integrated poultry plants are working closely with their suppliers on ways to practically reduce contamination of birds with Salmonella and Campylobacter.
Research is needed to know what will reliably reduce pathogens in live animals and carcasses.

## Animal Production andPathogen Reduction

**Research needed for food safety control points from farm to slaughter (con’d)**
**Can animals be sorted pre-slaughter to reduce contamination on carcasses?**

**Notes:**
Plants may also be interested in knowing if animals someday can be sorted based on their risk of carrying pathogens.
Plants could process high-risk animals at the end of the day or make other decisions based on food safety.
Much research is needed to determine if sorting of animals pre-slaughter could consistently reduce contamination of carcasses.

## Salmonella in National Culled Dairy Cattle Survey 1996-1997

**FSIS/University collaborative project**
**5,000 cecal-colon samples at slaughter**
**Winter and summer seasons**
**Good *****and***** poor conditioned cows****had no significant difference****in *****Salmonella***** shedding**

**Notes:**
To look at the possibility of sorting culled dairy cattle prior to slaughter, FSIS and the Food Animal Production Medicine Consortium conducted a pilot survey of over 5,000 cows at slaughter across the country during both winter and summer seasons.
The hypothesis was that cows in poor body condition would shed Salmonella more than cows in good body condition.
We could not prove this.
The shedding of Salmonella at slaughter is much more complex that body condition.  Another survey is on-going looking at livestock markets and transportation distances.

## Summary of Presentation

**New USDA Pathogen Reduction and HACCP Systems for Plants**
**In-Plant Residue Control Options**
**Impact of Role on Food Animal Production Systems**
**Importance of HACCP-Compatible Production Practices**

**Notes:**
In summary, I have discussed:
the new PR/HACCP Systems rule for meat and poultry plants and the farm-to-table concepts for food safety;
the options plants have for addressing residue control and incoming animals;
the potential effect this rule may have on food animal producers; and
the importance of being on Quality Assurance Programs.  These programs all are HACCP-compatible; in other words, they are the types of practices plants need for reducing risks of chemical, physical and microbial hazards in the animals they purchase.

## Summary

**New Pathogen Reduction/HACCP Systems Rule implemented in plants requires physical, chemical and microbial hazard controls**
**Food animal producers are being affected**

**Notes:**
Producers are being affected because the new rule covers physical, chemical and microbial hazard control in meat and poultry slaughter plants.
An example is that Hormel and most large pork packers now require suppliers to be on the Pork Level 3 QAP and have their certification card.
However, plants have many options on how to address these hazards when considering the live animals supplied to them.

## Summary

**Packers may need more information on animals supplied**
**Quality Assurance Program Certification**
**Animal/premise supplier identification**
**Treatment and disease records**

**Notes:**
Packers may need more information on the animal supplied.
The information can best be supplied by producers who:
are on QAPs and are certified;
have animal or premise identification systems place; and
keep good treatment and disease records which improves productivity, herd health, and helps prevent food safety problems.

## Good Management

**Good Management**

**Quality Assurance Program**
**Animal Identification**
**Production Treatment Records**
**Proper Drug Use**

**Feed Quality & Safety**
**Culling Practices**
**General Sanitation**
**Waste Management**

**Productivity**
**    ****(Value)**

** ****Food Safety**

**Animal**** Health**

**Notes:**
Good Management Practices provide a solid basis for producing food animals which are safe, wholesome and profitable.  The foundation of good management encompasses animal health, food safety and sustainable productivity.

## Summary

**     ****Food animal producers who follow****good production practices and are Quality Assurance Program Certified****will be able to meet food safety****demands in the HACCP era.**

**Notes:**
As we address consumer concerns about food safety, meet the demands of the HACCP era, and seek international markets, those producers who follow industry standards for good production practices, and who are certified on a QAP, will best be able to turn these challenges into opportunities.
Working together, we will build consumer confidence in the safety of our food supply from farm to table.