Hazard Analysis Critical Control Point

• What is it?
• Where did it come from?
• Is it really a tested new system?
• How do I know if I need/have HACCP?
• How does it affect me right now?

HACCP - the newly mandated program of individual responsibility for the grower, handler and processor

HACCP - What is it? HACCP is a system of quality control management placing responsibility for the result totally in the hands of the manufacturers and handlers of the product. The actual system is created in steps wholly by the enterprise really having "care, custody and control" (the 3 C's) over the raw materials, work in progress or competed product at each step of the way from ocean or farm to dinner plate. This means that each participant's HACCP system must create the accountability needed to enable the next participant in line to pick up responsibility from a known, acceptable status. In other words, each passes the "3 Cs" to the next holder in an adequately documented, accountability-guaranteed, safe condition. Each prior HACCP plan provides data to the next holder's HACCP system, preserving product integrity to that point. Each HACCP system is totally independent of all the others, and applies only to that company's processing/handling. Yet, each must provide the data to mesh with, and validate, the next holder's system input. The integration is guaranteed by guideline rules and the oversight provided by the food processor's HACCP Team and the concerned state/federal government regulatory agency(ies).

Where did it come from? HACCP is generally credited to the Pillsbury Corporation, working in the 1960's for NASA, in seeking a non-destructive safety verification for the manufactured foods fed to the astronauts in space.

Is it really new? The genesis actually goes farther back than that! In fact, it probably goes back, philosophically, to the US Civil War days and the production of arms and ammunition. It was certainly in effect with the advent of W.W.II and the then new War Department's specifications for how to vet goods ordered from the winning (read: LOW) bidder, to prevent cheating on product quality. The quality system had to be trustworthy since there weren't enough experienced government inspectors to go around, nor time to train enough for the new manufacturing base.

How does it affect me? HACCP is the outgrowth of the current Good Manufacturing Practices (cGMP) which are given in the Code of Federal Regulations, Title 21, Part 110 - "current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food." It was first published in the Federal Record on June 19, 1986 as 51 FR 24475. Thirty days later, it was the Law of the Land. By late January of 2000, HACCP was required of all food growers, harvesters, most transporters and all processors. Retail sellers are also affected under the state HACCP programs. The cGMP covers everything from how you maintain your plant and grounds, to the equipment and utensils you use, to the production and process controls you manufacture with. Whether you knew it or not, you've been governed by this set of regulations over the last 13 years; even your favorite government inspector may not have been aware of the cGMP -- they haven't been enforced. They are, however, with the advent of HACCP.  HACCP is being adopted worldwide, on recommendation of the UN's Codex Alimentarius Committee. It is already mandated in many countries. The EU is establishing a HACCP-inclusive food regulatory system to govern all EU members.

For the federal government, the procedure is to publish everything in the FEDERAL REGISTER (or FR), printed daily solely to publicize new regulations and statutes. The public then has 30 days to protest (if someone wants to) the new requirements. Since most people don't know about, or have access to, the Federal Register, few people protest. At the end of the 30 days, if Congress hasn't passed a law "killing" the announcement, the published regulation or statute becomes law. Usually, you'll find that special interest groups are the only people following the Register daily, although the Internet has changed that considerably. The NET is how we found out!.

After becoming law, you'll find a new regulation codified in the Code of Federal Regulations, (or CFR). At the date published in the CFR, the regulation becomes effective. The time until implementation is published in the FR. That's the notice you want to know about. or CFR). At the date published in the CFR, the regulation becomes effective. The time until implementation is published in the FR. That's the notice you want to know about.

Most California agriculture follows FDA regulations, except for meat and poultry, which follows USDA regulations, normally regulated by the FSIS division. The state usually follows FDA regulations.

With this background, you'll now understand the significance of a particular issue of the FR:
FDA HACCP is mandated by the "Procedures for the Safe and Sanitary Processing and Importing of fish and Fishery Products: Final Rule", published in the Federal Register, Volume 60, No. 242 on Monday, December 18, 1995. It specified a two year wait to become effective. Thus, December 18, 1997 was the effective date.
Even though the FR title mentions only seafood, be assured that the HACCP rules cover all FDA-regulated agriculture. The State of California elected to follow the FDA's rules and commencement date.

You may order a copy of the FR, Vol. 60, No. 242 from:

Cost: $8.00 a copy, payable to "Superintendent of Documents", or charge it on your Visa/MasterCard.

Who regulates you, and how you implement HACCP, all depend on what foodstuffs you work with and whether at the wholesale or retail level, are a raw materials supplier, who your processor, or vendor-customer is, and so forth . . . 

RETAILERS Except for "adulteration" and "mislabeling"; you are regulated by state health F and D authorities. For California retailers, this is the Department of Health Services, Food and Drug Branch. The state food code embodies HACCP principles and you can plan on state enforcement at wholesale and retail as the federal FDA has HACCP on-line now. The State inspectors were trained with FDA inspectors, as were Embarcadero personnel. From now on, you are responsible for Good manufacturing Practices (cGMP), and the state health code, as you know. The FDA/CalF&D SSOP and HACCP operations are also mandated now.

SEAFOOD/DAIRY/FIELD CROPS GROWERS You are regulated by FDA, which has mandated that all companies handling products under FDA regulations be "on HACCP". The cGMP is found in the Code of Federal Regulations - Title 21 CFR. HACCP is at 21CFR 123 (et al)

MEAT/POULTRY Regulated by the USDA's Food Safety Inspection Service (FSIS) you went "on" the SSOP January 27, 1997. Mandatory local E-coli testing began then, too.  The latest effective HACCP date came up January 25, 2000 for the smallest of firms. Mandatory local Salmonella testing commenced then. Naturally, CGMP, SSOP and E-coli testing are in effect for all USDA-regulated firms now.

OTHERS From seed suppliers to common carriers; many firms are not yet specifically mandated to operate under HACCP rules. Yet their customers' HACCP demands will require that customers use only those unregulated companies which voluntarily adopt full HACCP for the food product handling areas of their operations. Not to do so would require HACCP-mandated customers to perform additional testing to acquire adequate traceability. Only time and competition will shake out those unregulated firms willing to accommodate their HACCP customers by such voluntary compliance. Current compliance with the CFR's Current Good Manufacturing Practices for Food Manufacturing will ease any transition into a HACCP mode for all ancillary firms making the "paradigm shift", as the USDA puts it.

"WAITING FOR THE LAST MINUTE" We're watching the increasing retail level compliance with CalF&D's HACCP program. The number of "withheld inspections" (lock downs) is appalling! This illustrates the problem with waiting until the first inspection to start. You must set your own rules for your HACCP Plan in advance. They must be documented, even if you've used them for many decades. Documented! This takes time and trial and error. Otherwise the validity of your "local" rules will be challenged. You need a few months of "off-the-record" testing and documentation to write proof of effectiveness into your plan. Otherwise, you can expect a preventable citation or lock down! We're here to help you -- from "do-it-yourself", step-by-step kits, to fully written "turnkey" HACCP Plans. But, HACCP is in effect NOW and documenting the safety of past processing practices unique to your operation takes time! 

In short, every commercial food processor, regardless of size, based in the US or Canada must be on the cGMP/SSOP/HACCP quality assurance program right now! This includes any new "startup" commercial food preservation processing/distribution operations.