An Economic Assessment of Food Safety Regulations

The Hazard Analysis and Critical Control Points

Regulatory System

The new rules represent a comprehensive strategy on

the part of FSIS to modernize the 90-year-old inspection

program.  There are four essential elements of this new

food-safety system:

·

All State and federally inspected meat and poultry

slaughter and processing plants must have a

Hazard Analysis and Critical Control Points

(HACCP) plan.

·

Federally  inspected meat and poultry plants must

develop written sanitation SOP’s to show how they

will meet daily sanitation requirements.

·

FSIS will test for 

Salmonella on raw meat and

poultry products to verify that pathogen-reduction

standards for 

Salmonella are being met.

·

Slaughter plants will test for generic 

E. coli (all types

of 

E. coli) on carcasses to verify the process is

under control with respect to preventing and remov-

ing fecal contamination.

HACCP Plans

USDA now requires that all meat and poultry plants

develop HACCP plans to monitor and control production

operations.  These plants must first identify food-safety

hazards and critical control points in their particular

production, processing, and marketing activities.  In

addition to biological hazards such as pathogens, food-

safety hazards include chemical and physical hazards

such as chemical residues and metal fragments that may

cause a food to be unsafe for human consumption.  A

critical control point is a point, step, or procedure where

controls can be used to prevent, reduce to an acceptable

level, or eliminate food-safety hazards.

As part of the HACCP plan, these plants must then

establish critical limits, or maximum or minimum levels,

of a hazard for each critical control point.  For example,

water or steam used for cleaning carcasses must be

maintained at a minimum temperature of 180

o

F or higher.

Monitoring activities are necessary to ensure that the

critical limits are met.  In the HACCP plan, each plant is

required to list the monitoring procedures and frequen-

cies.  HACCP also includes steps for recordkeeping and

verification, including some microbial testing of product to

ensure that the HACCP system is meeting the target

level of safety.  Plants and FSIS share responsibility for

verifying the effectiveness of the HACCP system.

HACCP will be implemented first in plants with more than

500 employees. Seventy-five percent of meat slaugh-

tered occurs in large plants. The effective date is January

26, 1998, 18 months after the July 1996 rule was pub-

lished.  In plants with 10-500 employees, the effective

date will be January 25, 1999.  In very small establish-

ments, those having fewer than 10 employees or annual

sales of less than $2.5 million, the effective date will be

January 25, 2000.

Sanitation Standard Operating Procedures

The Pathogen Reduction/HACCP final rule requires that

all federally inspected meat and poultry plants must

develop written SOP’s by January 26, 1998, to show how

they will meet daily sanitation requirements.  This ele-

ment is important in reducing pathogens on meat and

poultry because unsanitary practices increase the

likelihood of product contamination.  Plants must docu-

ment and maintain daily records of completed sanitation

SOP’s, and any corrective and preventive actions taken.

Plant managers must make these records available for

USDA inspectors to review and verify.

Testing for Salmonella

FSIS testing for 

Salmonella on raw meat and poultry

products will be used to verify that plants are controlling

pathogen levels.  All plants that slaughter and grind meat

and poultry must achieve at least the current baseline

level of 

Salmonella control for the product classes

produced.  

Salmonella was selected for testing because

it is the most well-known cause of U.S. foodborne

illnesses associated with meat and poultry.  Plants must

meet the 

Salmonella standard on the same timetables as

they meet the HACCP requirement.

Testing for E. coli

Slaughter plants will be required to test for generic 

E. coli

on carcasses to verify that they are preventing and

removing fecal contamination.  Generic 

E. coli was

selected because of the scientific consensus that it is an

excellent indicator of fecal contamination, because the

analysis is relatively easy and inexpensive to perform,

and because levels of 

E. coli contamination can be

quantified.  

E. coli contamination is not directly correlated

with 

Salmonella contamination, which is affected by other

factors as well, including the health and condition of

incoming animals.  Therefore, the pathogen reduction

standards for 

Salmonella and the E. coli testing comple-

ment one another.

---

8

Economic Research Service/USDA

An Economic Assessment of Food Safety Regulations

Microbiological performance criteria will be used to help

plants verify that their process controls are effectively

preventing fecal contamination.  These performance

criteria are based on FSIS survey data on the prevalence

of 

Salmonella and E. coli in raw products.  Inspectors will

also use these criteria to help assess the effectiveness of

the plant’s controls.  These criteria are not enforceable

regulatory standards, but they are intended to provide an

objective point of reference that will help slaughter plants

and FSIS ensure that plants are preventing and reducing

fecal contamination of meat and poultry products.  Plants

were required to begin 

E. coli testing on January 27,

1997, regardless of plant size.  Plants will be given an

additional 6 months to gain experience in conducting

these tests before FSIS personnel begin reviewing the

test results as part of their inspection routine.

Enforcement Strategies

Implementation of the four essential elements of FSIS’s

new food-safety system follows a schedule.  In general,

larger establishments are expected to comply sooner

than smaller establishments.  If FSIS inspectors find

violations of these new requirements, enforcement action

will vary, depending on the seriousness of the problem.

USDA’s first concern will continue to be preventing

potentially unsafe or adulterated product from reaching

consumers, which could mean detaining product at the

plant or requesting that the company recall the product.

Minor violations of an establishment’s HACCP and

SOP’s will be noted by inspection personnel.  A pattern

of minor violations may result in intensified inspection to

ensure that there is no systematic problem of noncompli-

ance or underlying food-safety concern.  For more

serious violations involving adulterated or contaminated

products, inspectors can stop production lines until

failures in HACCP and sanitation SOP’s are corrected.

Inspectors can also identify specific equipment, produc-

tion lines, or facilities that are causing the violations and

remove them from use until sanitation or other problems

are corrected.

Repeated or flagrant violations will result in other admin-

istrative, civil, or criminal penalties, after due process.

For example, improper maintenance or falsification of

records would have potentially serious implications

because accurate recordkeeping is essential to the

functioning of sanitation and HACCP systems and to the

production of foods safe for human consumption.  USDA

will continually monitor and adjust its enforcement

approach during this program transition to ensure that

enforcement activities are effective, fair, and consistent.