1

SAI K . RAMASWAMYDR. GRETCHEN A. MOSHER

NC-213 ,KANSAS CITY

HARPC: Preventive Controls & Food Safety

Implications

NC-213The U.S. Quality Grains Research Consortium

2Food Safety Modernization Act (FSMA)

Most sweeping food safety reform: signed 2011

34 sections already enforced , 7 sections in rulemaking

Wide impact- Farmers to Grain handlers to Processors to Importers

Prevention rather than reaction

3

Good Manufacturing Practices (GMP’s) (Pre-FSMA)

Systematic program to ensure food products meet safety, quality & legal requirements

HACCP (Hazard Analysis and Critical Control Point) one such popular program

Focus on managing critical controls to prevent, eliminate or reduce hazards

Mostly a voluntary program

4

GMP’s - post FSMA

Same goal different approach to handle safety, quality & legal requirements

Identify hazards and controls measures + Risks associated with the hazards

Required to implement Hazard Analysis and Risk-Based Preventive Controls (“Harp sea”)

Mandatory for many of food & grain handling facilities registered with FDA

5

HARPC (“Harp sea”)

Preventive Controls- Section 103 of FSMA For Human Food For Animal food Intentional adulteration ( not addressed by HARPC)

Different from HACCP despite common concepts (HACCP subset of HARPC)

Applies to all facilities that process, pack or hold food and feed E.g.: Grain Elevators

6

HARPC- Key Elements

Identify & evaluate hazards

Create programs/procedures to mitigate or prevent hazards

Develop methods to effectively monitor preventive controls

Maintain records of monitoring

Specify corrective measures in case of issues with preventive controls

Re-analyze

7

HACCP Vs. HARPC

HACCPWorldwide standard

Applies to a wide variety of food products

Focus on control steps

Requires qualifies team

HARPCUS standard

Applies to FDA regulated products

Preventive programs

Needs qualified individual

8

HACCP Vs. HARPC Compliance

HACCPVoluntary across most

food industry

Mandatory for certain foods like seafood, juice, meat and poultry

HARPCMandatory for all

facilities requiring FDA registration

Exemptions for FDA mandatory HACCP programs

9

GMP’s at Grain Elevators

Currently voluntary

Mandatory to maintain proper records & register with FDA for traceability

Implementing quality management to handle globalization and legislation risks

Also using quality management as a tool to handle food safety as well as worker safety risks

10

Business FSMA

Quality Meeting customer requirements Prevent grain spoilage Product safety

Financial Revenue loss Recovering preservation &

storage costs

Safety Personnel safety

BiologicalChemicalPhysicalAllergensRadiological

Potential Risks at Grain Elevators

11

Preventive Controls for Quality Risks

Standardize operation

Improve inventory management

Minimizing variance by monitoring and measuring

Empower employees

12

Quality Management & Preventive Control

QMS processes facilitate:

Documentation of work tasks for control and consistency

Clear statement of decision making responsibilities

Provides statistical targets for quality traits

Improvement of management processes for inventory

Established methods for problem solving and appropriate corrective actions

13

HARPC & Quality Management

Plan• Identify & evaluate hazards

Do• Create programs to mitigate/prevent

hazards and develop preventive controls

Check

• Monitor and maintain records

Act• Apply corrective measures when needed

and re-analyze

14

Recommendations

Grain elevators can manage grain quality and product safety with QMS

QMS can help manage inventory and help decision making related to :

Preservation methods Storage options Blending Shipping details

15

Recommendations cont..

Grain elevators implementing QMS are better suited to handle changes due to new legislation

QMS focus on control, consistency, and reproducibility helpful in hazard management part of HARPC program

QMS could assist in managing risk of intentional adulteration and keeping the facility secure

16

Questions

17

Potential Risks at Grain Elevators

Quality Meeting customer requirements Prevent grain spoilage Product safety

Financial Revenue loss Recovering preservation & storage costs

Safety Personnel safety