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
- How does it affect me right
HACCP - the newly mandated
program of individual responsibility for the grower, handler
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
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.
How do I know if I need HACCP?
How do I know if I have to have an HACCP Plan?
We are asked many times
how we know about HACCP when people in a particular branch of
agriculture, transport, storage, etc. have heard nothing about
it? The answer lies in knowing where the government publishes
its announcements about new legislation and new regulations.
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
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
You may order a copy of the FR,
Vol. 60, No. 242 from:
Superintendent of Documents
P. O. Box 37154
Pittsburgh, Pennsylvania 15250-7154
Cost: $8.00 a
copy, payable to "Superintendent of Documents", or
charge it on your Visa/MasterCard.
Phone orders to: (202) 783-3238
How does HACCP affect Me?
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