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The USDA Will Propose Standards for US-Raised Organic Seafood This Year

The USDA Will Propose Standards for US-Raised Organic Seafood This Year


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The aquaculture industry, as seafood farming is known, will need to review how to deal with feeding an organic seafood supply

Seafood like salmon, tilapia, shrimp, oysters, and clams would be addressed under the farming standards.

The United States Department of Agriculture is finally ready to introduce standards for organic seafood raised in the United States, including “salmon, tilapia, catfish, shrimp and mollusks such as mussels, oysters and clams,” reports The Associated Press.

The standards will be proposed later this year, though the earliest that organic seafood would reach grocery stores is two years, if both the USDA and American seafood companies work quickly. The new guidelines would help the United States better compete with cheaper imports, and the higher prices of organic seafood would benefit retailers.

Thus far, organic grocers have imported organic seafood from the European Union and Canada. Organic shoppers “skew to higher income and education which makes them extremely desirable,” Dave Wagner, vice president of seafood merchandizing for Wegmans, told the AP. Currently, Wegmans offers organic seafood imported from Norway and elsewhere.

Marine conservationists and seafood farmers are unsure whether the USDA standards will be successful — and some have argued that while a fish may be sustainably sourced, it cannot be considered organic unless its diet is also 100 percent organic. In that case, farmers may need to breed organic fish to feed organic fish, which could quickly become untenable.

“You can't magically wave a wand and expect an organic supply chain to appear,” Neil Sims, a Hawaiian fish farmer, told the AP.


Hydroponic Produce Can Be Labeled Organic, Says USDA Advisory Board

What does “organic” mean to you? Likely the main component most consumers consider is that no pesticides are used to grow organic produce. But USDA requirements for organic certification go well beyond pest and disease control: Rules also exist for things like the land being used and crop rotation. As a result, hydroponics and other types of high-tech indoor farming raise an interesting question: Can produce be “organic” when the method used to grow it doesn’t really seem natural at all?

The National Organic Standards Board, the 15-person Federal Advisory Board that helps dictate USDA policy on all things organic, has been considering this question for quite some time. In fact, in 2010, the panel recommended that soilless growing not be allowed to earn an organic seal, a recommendation the USDA chose not to follow at that time. But this week, a proposed ban on the use of hydroponic methods in organic farming was voted down by the slimmest of margins, 8 - 7, sending a more unified message on where the USDA and the NOSB stands.

At the heart of the debate isn’t the “health halo” that many consumers worry about when buying organic. Instead, traditional organic farmers are concerned about the broader importance of natural farming practices to the environment. Abby Youngblood, executive director of the National Organic Coalition, told NPR that opening the floodgates to organic hydroponics goes against “the founding principles of organic, which are really about soil health, regenerating the soil.”

But Jessie Gunn, a representative for the company Wholesum Harvest which grows vegetables in high-tech greenhouses, argued that hydroponics has its own benefits. “We can grow our tomatoes organically with 3 to 5 gallons of water, per pound of production, as opposed to growing tomatoes in open fields, which can use anywhere from 26 to 37 gallons of water,” she explained. “I mean, what is the true essence of organic?”

And that, of course, is the big question: Different groups, different companies and different individuals all have different priorities when it comes to their expectations from organic products. And though organic goods have their environmental benefits, they’ve also become big business along the way. A lot is at stake on all sides – over a debate that in some ways comes down to semantics. And at least one organic farmer, Dave Chapman, told the Washington Post that a change of phrasing might be traditional organic farming’s next step. “The question is, do we abandon the National Organic Program and find a new way to identify ourselves?” Chapman asked. “It’s a genuine question. I don’t know.”


New USDA Label Will Clearly Identify 'Organic' Foods

Dec. 20, 2000 (Washington) -- In about 18 months, organic foods will get a "USDA Organic" label similar to the USDA label that now appears on eggs and meat.

Federal regulators Wednesday issued the first national standards for growing, producing, and labeling "organic" foods. The rules cap a decade-long debate over what defines organic vs. non-organic foods. The rules will replace any existing state-based standards regulating organic agriculture.

Now consumers who want to buy organic food "can do so with the confidence of knowing exactly what it is they're buying," Agriculture Secretary Dan Glickman said Wednesday at a press conference.

Under the new federal standards, which will take effect in about 18 months, USDA agents will certify foods that contains at least 95% organically grown ingredients as "organic". Foods whose contents are more than 70% organic will be labeled as "containing organic ingredients."

To be considered organic, the food's ingredients may not be treated with radiation or grown using sewage sludge. The food also must not contain any genetically modified ingredients. And in terms of livestock, the rules forbid the use of antibiotics or of hormones, typically used to promote growth.

Continued

But the standards do permit the use of certain natural pesticides and other manufactured agents. In each case, the USDA explains, the agency tried to rule based on the preference of consumers.

However, the standards were not developed to create a superior product with respect to safety, quality, or nutrition, the agency says. In fact, according to the USDA, the label was created simply to bolster both domestic and foreign confidence in the U.S. organic food industry.

"Let me be clear about one thing. The organic label is a marketing tool. It is not a statement about food safety. Nor is 'organic' a value judgement about nutrition or quality," said Glickman.

Foods that meet the new standards will bear the "USDA Organic" seal.

According to the Organic Trade Association (OTA), the rules will disqualify a certain number of so-called organic products currently trying to capitalize on the almost $8 billion a year market. "Some of those products that are sold as organic will no longer be labeled organic," Katherine DiMatteo, executive director of OTA, told WebMD in an earlier interview.

Continued

"For the first time, there will be consistent standards and labeling for all organic products marketed in the United States. No longer will there be questions concerning what 'organic' stands for, or whether the process has been certified," DiMatteo added Wednesday in a prepared statement.

Still, not everyone will find the new USDA label to be all that appetizing. Traditional food makers and the biotech industry have spent considerable time, money, and effort protesting the creation of this new label because they fear consumers will view the label as a mark of quality.

The USDA label lends support to those seeking to belittle foods derived from other, demonstrably safe production methods such as genetic engineering, explained the Biotechnology Industry Organization in an earlier statement.

Nevertheless, the rules demonstrate that Americans really do have a choice, says the Grocery Manufacturers of America (GMA), the world's largest association of food, beverage, and consumer product makers.

"We just want the USDA to now monitor consumers' response to ensure that the label isn't misleading," GMA spokesman Peter Clearly tells WebMD. "We support the establishment of standards for what qualifies as organic, but are concerned that consumers might see the label as an endorsement," he explains.

Continued

The rules, which the USDA was required to develop by a 1990 congressional law, were first proposed in 1997. The USDA withdrew that proposal after receiving several hundred thousand public comments, mostly criticizing the proposed label and the USDA's definition of organic foods.

The final rules are now one of Glickman's last acts as head of the USDA. Speaking at a recent meeting, Glickman said the final rules represented the end of a heated debate that helped mark his six years in office.


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Path to Success

There are many sections in an organic food restaurant business plan , including the marketing and financial plans, operating plan, and staffing plan. When the document is almost completed, it is time to write the Executive Summary. This is a one or two page summary of what is contained in the rest of the document. Though it is written last, it is the first introduction the reader gets to the entrepreneur’s intentions. It briefly explains many items that are fully developed in the rest of the document.

  • Basic Information – The introduction paragraph presents the name of the eatery and its general location. In one or two sentences, the entrepreneur can explain that it will serve certain foods. If true, it is important to mention that other types of selections will be served, like ethnic recipes, vegetarian, or gluten-free recipes. To entice the reader, add a short description as to why the entrepreneur decided on this type of menu theme and where the ingredients will come from.
  • Atmosphere – In one or two paragraphs, explain the atmosphere or ambiance of the organic food restaurant business plan . Will it be a cheerful, family-style place, a rustic eatery, or an upscale chic eating establishment catering to working professionals? Is the atmosphere casual or formal? What is the decorating theme? What colors were chosen? Are there booths or tables or both? Paint a picture with words so the reader has a clear idea of what the eatery will look like.
  • Staffing – Who is the chef, and what is her or her specialty? Is there a need for wait staff, a cashier, dishwater and busboys or girls? Will the owner primarily manage the organic food restaurant business plan , or will he or she cook, wait tables, or greet guests?
  • Customers – Also draw a picture with words of the type of customers that are expected to frequent the dining location. This is the paragraph where the entrepreneur can describe the market segments targeted, like Baby Boomers interested in a healthy aging process or Millennials who are environmentally conscious. Give specific statistics on the various market segments.
  • Management – Introduce the key managers who are responsible for the restaurant’s success. They include people like the owner, general manager, accountant, chef and assistant chefs, and others. Write a sentence or two about each person, describing responsibilities and years of experience.
  • Additional Information – Add the information that will excite the reader or investor about the dining spot. What will contribute most to financial success of the eatery? For an organic food restaurant business plan, the success factors are likely to include exceptional customer service, delicious and creative recipes, inviting atmosphere, and a wide range of menu options. Many eateries today also offer related and appealing features, such as “green” practices like supporting an environmental cause, installing water and energy saving devices, offering compost material to farmers, and so on.
  • Other revenue sources – To grow any kind of eatery, some restaurants sell packaged goods online or operate a gift shop or mini-market. These are just some of the ways to expand the enterprise outside the eatery’s walls.
  • Financial Information – In one paragraph, give the reader basic financial information like startup expenditures, the first year’s sales and costs, and when the enterprise is expected to be profitable. Also, if the information provided is written to attract investors, the last paragraph will indicate how much money is needed. In some documents, a chart that visually demonstrates the financial information over the first few years is added. The easier it is for readers to understand the financial plan, the easier it will be to attract investors.

Avoiding Failure

A high quality organic restaurant business plan answers in full the questions potential investors will ask. Plan thoroughness is critical because the document is like a set of signposts pointing to success. Approximately 60 percent of restaurants fail within a year according to an Ohio State University study. They fail for many reasons:

  • Inexperienced management
  • Difficulty finding and retaining qualified people able to deliver excellent customer service
  • Lack of accounting skills so does not produce accurate statistics and information for decision-making
  • Poor menu selection or poor ingredient quality

Industry Challenges

Potential investors for business plan are likely to be very aware of the challenges the industry faces, so it is important to address any of them that may impact the startup. For example, the OTA says that there is still a tight supply of appropriate foods. The organic restaurant business plan should include a discussion on how the establishment will ensure it has access to a steady supply of the right ingredients. Patrons do not like choosing items on a menu to hear, “It is not available today.” Word of mouth negative advertising will soon hurt the ability to attract new customers and to steadily grow. It is important to build adaptability into the menu so that a shortage of one or more ingredients does not hurt sales.

Pricing menu items is challenging too because of tight supplies and the frequent need to order fresh fruits and vegetables or other ingredients from a distant supplier. The weather is a factor also. These types of foods also tend to be higher priced than foods with additives or that are processed– sometimes twice as much – because of the specialized farming techniques.

Another challenge is the need to install special equipment that ensures every aspect of the meal is free of chemicals. For example, most public water supply systems produce water filled with chemicals. Therefore, the organic food restaurant business plan needs to install the highest quality commercial water filtration system. That will increase the amount of startup capital needed.


The USDA Will Propose Standards for US-Raised Organic Seafood This Year - Recipes

As of spring 2008, the U.S. Department of Agriculture (USDA) has yet to start certifying fish as organic within the United States. Yet, agencies in other countries (like the Certified Organic Associations of British Columbia in Canada) do certify fish as organic and some of these fish are sold in the U.S. and display a legitimate organic seal. While organic fish farming remains an area of some controversy and confusion, I support these certifying processes and encourage you to consider the potential inclusion of organically farmed fish into your Healthiest Way of Eating. Since approximately 80% of all fish sold in the U.S. have been imported from other countries, there are a number of organic, farmed fish options currently available in different parts of the country (but not yet as widely available as many other organic foods).

Within the near future, I expect the National Organics Standards Board at the USDA to adopt recommendations from its Aquaculture Working Group and start certifying farmed fish as organic within the U.S. if the fish meet the defined organic guidelines. This step will allow for display of the USDA's green organic logo on farmed fish that meet organic standards for health and the environment. I encourage you to purchase those fish when they become available!

Since virtually all fish labeled organic will be farmed fish, what about wild-caught fish? At present, it doesn't look like the USDA will be allowing display of its organic logo on fish that have been wild-caught. Nevertheless, I believe you can purchase wild-caught fish that are both healthy and also safe to consume from the standpoint of the environment.

When it comes to wild-caught fish, what's important is geography. Different fish swim in different native waters, and these waters vary greatly in terms of their contaminants. We've taken a close look at the latest U.S. Environmental Protection Agency (EPA) report on mercury levels in different fish, and on the basis of this report, have identified your best and worst choices when it comes to wild-caught fish. Your best wild-caught choices are Alaskan salmon and West Coast salmon caught in the Pacific Ocean along the coastlines of California, Oregon, and Washington. Pacific scallops, shrimp, oysters, clams, mussels, herring, and anchovies are also good choices based on this EPA data. I recommend that you consider these wild-caught fish for inclusion in your Healthiest Way of Eating on a several-meals-per-week basis.

At the other end of the spectrum are wild-caught fish that we encourage you to avoid due to their high mercury ratings from the EPA. Wild-caught fish on your 'avoid list' should include: swordfish, tilefish, marlin, shark, bluefin tuna, and king mackerel.

For further information about organic standards and aquaculture, I encourage you to visit the following resources:


The Organic Community, the USDA, and the Morning After

Nov 18, 2009. Our previous look at the history behind organic agriculture delved into the grassroots community’s courtship of federal recognition and the consummation of that relationship with the Organic Foods Production Act (OFPA) in 1990. Today’s discussion will pick up in the light of the morning after and the reservations – felt to this day – whether hooking up with Uncle Sam turned out to be as advantageous as hoped. A healthy match between the two has always been a tricky proposition, given the USDA’s top-down approach to decision making and the organic community’s commitment to consensus process. The relationship is further complicated by the fact that though the OFPA affords the organic community considerable influence over the definition and practice of organic agriculture, it also ensures that the USDA ultimately retains the upper hand. Ceding ultimate responsibility for organic agriculture to the USDA has yielded a measure of the consistency, credibility and recognition sought by the organic community. However, these gains have come at the expense of twenty years of turbulence with a partner at times prone to indifference and capriciousness, to say the least.

Let’s not get ahead of ourselves, since the USDA took no meaningful action concerning organic agriculture after OFPA’s passage until December 1997. (I did mention something about indifference, didn’t I?). It’s important to consider the internal changes that organic agriculture underwent during this interval, and especially the significant consolidation in the production, processing and marketing sectors. For the first wave of self-identified and subsequently certified organic products that became commercially available during the 1960’s and 70’s, the reputation behind the name on the label was integral to success. Budding enterprises such as Walnut Acres, Arrowhead Mills and Eden Foods gained a foothold in the markets for whole grains, rice and other staples because the people who ran them were recognized as leading practitioners and advocates of organic management. This process repeated itself during the 1980s for perishable products and canned and frozen foods as start-up ventures such as Pavich Grapes, Organic Valley, Cascadian Farms and Muir Glen garnered valuable consumer confidence. Many of these organic pioneers had been told not long before that they could never grow food without using agricultural chemicals and now they were supplying such food to national markets! The association with grassroots producers and processors who were frontline partners in confronting “the system” was an essential part of the branding that secured a sizable and growing market share for organically produced foods by 1990.

Two reasons why “the system” became (and remains) “the system” are its ability to capitalize on new consumer trends and to respond aggressively to competition. These forces triggered dramatic concentration within the production, processing, distribution and marketing of organic agricultural products even as the overall market grew rapidly during the 1990s. The conventional food establishment didn’t set out to beat or join the organic upstarts during this period subsuming them was a much more practical business strategy. Their tactics included wholesale acquisitions, such as the purchase of Horizon Dairy by Dean Foods in 1998 and Cascadian Farms and Muir Glen by General Mills one year later. In another approach, large conventional producers – particularly in the cut-throat fresh produce market – ventured into organic production and used their deep pockets to eliminate veteran competitors. For example, wholesale produce buyers across the country received a standing offer from a California agribusiness giant to undersell Pavich on organic grapes by one dollar per box, resulting in the latter’s bankruptcy. The increasing control over the organic marketplace exerted by corporate agribusiness coincided with a pronounced increase in sales of highly processed certified convenience foods such as snacks, “heat and eat” meals and a confectionary concoction re-defined as health food called soy milk. Keep in mind that the market growth in these high margin pseudo-foods depended upon overlooking the OFPA’s prohibition on synthetic ingredients in processed foods, something in which the most certifying agents, the NOSB and the USDA were equally complicit.

As a result of this growth and diversification, the organic community of the 1990’s came to epitomize the big tent metaphor. The traditionalist farmers and the back-to-the-land newcomers who had launched the movement were well represented as were the experienced grower-based certifying agents that had grown up to serve them. Senior among these organizations were California Certified Organic Farmers, Oregon Tilth and the state chapters of the Northeast Organic Farming and Gardening Association. However, these present-at-the-creation types found themselves with lots of new company as corporate food processors and marketers (particularly Whole Foods) and both state and private certifying agents emerged as both their peers and competitors. Non-profit consumer and environmental groups including Consumers Union, the Humane Society of the United States and the Environmental Working Group were also active contributors to grassroots organizing and Washington advocacy. With the annual growth in organic products consistently hitting 20 percent by the mid-90’s, the contradictions underlying these alliances – for example, processors and retailers historically stomp on producers and non-profits rarely cozy up with multi-nationals – were easy to overlook. Bonds between these new bedfellows were thoroughly galvanized on December 21, 1997 when the USDA went public with its first proposal for national organic standards and everyone in the organic community hit the roof over what they saw.

Before looking at the USDA’s initial proposal for organic standards, let’s review how they reached their decisions. True to the requirements of the OFPA, Secretary of Agriculture Edward Madigan appointed members to the NOSB in 1992 including several organic stalwarts including Chairman Michael Sligh, Michigan beef producer Merrill Clark and Gene Kahn, founder of Cascadian Farms. The NOSB met regularly, worked assiduously and by late 1995 submitted a detailed outline to the Secretary for setting organic standards and managing the USDA’s accreditation of certifying agents. The draft standards and procedures recommended by the NOSB were a middle-of-the-fairway synthesis of prevailing certification practices. They included basic requirements for crop and livestock production based on natural principles, room for give and take between producers and certifying agents to agree on the specifics and a narrow allowance for synthetic materials in both production and processing. Working with a miniscule budget, the National Organic Program (NOP) within USDA struggled to keep pace with the NOSB, though it wisely hired a veteran expert on organic standards named Grace Gershuny to translate organic speak into federal regulatory language. After the NOSB wrapped up its work, the NOP spent two years working out a comprehensive draft that included a detailed description of the context in which various issues needed to be considered. During this period the NOP also solicited input from federal peers including the EPA and FDA who exercised statutory authority over key elements of the organic standards such as regulating pesticides and food additives.

As mentioned before, it’s hard to overstate how poorly the organic community reacted to USDA’s first proposed rule for national organic standards released on December 21, 1997. “Betrayed”, “A flagrant distortion”, “Written by Monsanto”…there seemed to be no limit to the vehemence of the criticism. Nothing links people like having a common enemy, and there was nobody that the organic community (still largely a bunch of outsiders) could more readily perceive as an enemy than the USDA. Specifically, the organic community saw the crop and livestock production standards as pale imitations of accepted practice and riddled with compromises and loopholes. The community also objected to draconian constraints on certifying agents, the longtime co-stars of organic agriculture who were facing a desultory future completely under the thumb of federal dictate. Think what Rachel Carson would say about that! Perhaps the most incendiary aspect of the proposed rule was the consideration it gave to sanctioning the use of genetic engineering, sewage sludge and irradiation in organic production – this went unthinkably beyond the pale. The groundswell of public rejection to the USDA’s proposal began rolling in about 24 hours after its release and about 275,000 negative comments – more than 100,000 of them unique individual statements and not form letters- were ultimately received. In an interesting historical footnote, the NOP would receive an internal USDA award for its efficiency in receiving this mountain of comment and making it available to the public electronically – it was a groundbreaking success for using the Internet in conducting federal rulemaking.

The most important political commodity in Washington is cover, or the ability to say that you did the right thing regardless of how badly the venture you were engaged in turned out. With 275,000 people calling him out, there would be no cover for Secretary of Agriculture Dan Glickman and to his credit he didn’t try to scamper to find some. Secretary Glickman acknowledged that the USDA had failed badly and he committed the Department to doing the right thing before the Clinton Administration came to an end. In his first move to restore confidence in the Department, he appointed the enormously respected Kathleen Merrigan as Administrator of the Agricultural Marketing Service with a mandate to get the job done right. The NOSB was reconvened and began meeting three times a year and significant new resources flowed into the rejuvenated NOP. (Your author snuck into a position with the NOP under the “new resources” ruse.)

The people’s voices had indeed been heard, and in our next chapter we’ll examine the problematic nature of getting what you ask for from your government!

Mark Keating has worked in the natural, sustainable, organic and local food movements since 1982. His work experience includes stints in commercial food service, farm labor, retail sales and marketing, state and federal civil service, non-profit advocacy and academia. While at the USDA between 1999 and 2004, Mark helped draft the national organic standards for crop and livestock production and spent two years working to develop and promote farmers markets. An inveterate believer that naturally raised and locally distributed food offers the best opportunity for human health and planetary survival, Mark lives in the Kentucky Bluegrass with his wife and their daughter.


A Guide to Buying Organic Food: Reading Food Labels

Why buy organic? The short answer is that organic foods may be a better choice for your health and the environment because they’re not subjected to pesticides, antibiotics and hormones, nor are they made from genetically modified plant or animal species. The issue gets a bit more complicated, however, as you wander through the supermarket aisles and start reading food labels. Let’s take a look.

Vegetables and Fruit

Buying organic vegetables and fruits is the single easiest way to reduce your exposure to pesticides, antibiotic residues and genetically modified food. An Environmental Working Group study found an average of 200 industrial chemicals and pollutants in the umbilical-cord blood of newborns, some of which are pesticides that may have entered the bloodstream through the mother’s diet. Adult levels exceeded 275 contaminants. The good news is that when children eat organic produce, their pesticide exposure levels drop to well below what the Environmental Protection Agency (EPA) considers a negligible health hazard, according to University of Washington researchers.

Fortunately, the United States has a national organic standards program administered by the U.S. Department of Agriculture (USDA). When you buy USDA-certified organic food, you know it’s produced without using most petroleum-derived pesticides, fertilizers made with synthetic ingredients or sewage sludge. Organic regulations also prohibit bioengineered species and irradiation. Before a product is labeled “USDA-certified organic,” a third-party, government-approved certifier inspects the farm for compliance. Companies that handle or process organic food for the supermarket are also certified.

Look for the USDA green-and-white “certified organic” symbol on organic fresh, frozen and canned fruits and vegetables. Also note the fresh-produce stickers: Organic produce always starts with a number 9, followed by the price code. Labels on genetically modified produce, which is not organic, begin with a number 8, followed by the price code.

Poultry and Eggs

The poultry and egg industries have dozens of terms that make their brands appear similar to organic even when they’re not. Words that may appear on labels include “free roaming,” “free range,” “cage free,” “no antibiotics,” “no pesticides,” “vegetarian fed” and “hormone free.” (Hormones are never allowed in the poultry, egg and pork industries—organic or not.)

To be certified organic, poultry or eggs must meet all the above criteria—and be raised using certified organic farming methods. One of the most significant differences between pseudo-organic brands and certified organic is the use of antibiotics on the bird, which may contribute to human antibiotic resistance.

Organic meats are from free-ranging animals that have been raised eating organically grown grass or feed and that have not been treated with antibiotics or hormones that speed up the animal’s growth. Organic livestock rules also prohibit the use of animal byproducts in feed, which has been a primary contributor to bovine spongiform encephalopathy (BSE), or mad cow disease.

The word “natural” on a meat label might mean that hormones, antibiotics, pesticides or other synthetic ingredients never were administered. The USDA definition of “natural” is somewhat diluted it simply means the finished product has been minimally processed and contains no artificial ingredients. The primary difference between “natural” meat (not a USDA classification) and certified organic meat is the feed. Though naturally raised livestock are customarily fed a vegetarian diet, the feed may have been grown with pesticides.

Numerous reports have raised questions regarding fish safety. Elevated levels of such contaminants as dioxins and polychlorinated biphenyls (PCBs) have been found in farmed salmon, and mercury is high in large ocean fish. The USDA has not yet approved organic seafood certification standards, so there’s nothing to prevent a company from selling its product as organic—as long as the official USDA organic seal is not used. (A proposal for organic seafood certification is currently under review.)

Some states, such as Florida, have their own USDA organic seafood certification process, but there’s been resistance to this practice. California recently banned the sale of any organically labeled seafood until state or federal standards are established. For now, remember that U.S. shrimp, wild salmon, crab, tilapia and farmed catfish contain the lowest mercury levels. Also, better aquaculture practices are emerging, such as feeding shrimp and tilapia a vegetarian diet and maintaining clean habitats for farm-raised mollusks.

As many as 30 percent of conventional dairy farmers use hormones (rBGH) to stimulate milk production, according to Monsanto, an rBGH manufacturer. This places extraordinary stress on the cows, causing infections that require more antibiotics. Organic dairy rules prohibit these practices and require that cows receive vegetarian, organic feed and pasture-grazing time. As organic dairy farms try to keep up with high demand, many are under attack for cutting corners on pasturing time. Discussions are under way to address the issue.

Organic Packaged Foods

Packaged foods may be categorized into three organic classifications: 100 percent organic 95 percent organic with the remaining 5 percent from approved foods and substances or 70 percent organic with the remaining ingredients also from an approved list. Only the first two classes may use the USDA’s green and white organic-certification symbol. Packaged foods in the 70 percent–organic category may carry a “made with organic ingredients” label along with a list of those that are organically grown.


HACCP Principles & Application Guidelines

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF) is an advisory committee chartered under the U.S. Department of Agriculture (USDA) and comprised of participants from the USDA (Food Safety and Inspection Service), Department of Health and Human Services (U.S. Food and Drug Administration and the Centers for Disease Control and Prevention) the Department of Commerce (National Marine Fisheries Service), the Department of Defense (Office of the Army Surgeon General), academia, industry and state employees. NACMCF provides guidance and recommendations to the Secretary of Agriculture and the Secretary of Health and Human Services regarding the microbiological safety of foods.

TABLE OF CONTENTS

Describe the food and its distribution

Describe the intended use and consumers of the food

Develop a flow diagram which describes the process

Conduct a hazard analysis (Principle 1)

Determine critical control points (CCPs) (Principle 2)

Establish critical limits (Principle 3)

Establish monitoring procedures (Principle 4)

Establish corrective actions (Principle 5)

Establish verification procedures (Principle 6)

Establish record-keeping and documentation procedures (Principle 7)

EXECUTIVE SUMMARY

The National Advisory Committee on Microbiological Criteria for Foods (Committee) reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in 1995. The primary goal was to review the Committee's November 1992 HACCP document, comparing it to current HACCP guidance prepared by the Codex Committee on Food Hygiene. Based upon its review, the Committee made the HACCP principles more concise revised and added definitions included sections on prerequisite programs, education and training, and implementation and maintenance of the HACCP plan revised and provided a more detailed explanation of the application of HACCP principles and provided an additional decision tree for identifying critical control points (CCPs).

The Committee again endorses HACCP as an effective and rational means of assuring food safety from harvest to consumption. Preventing problems from occurring is the paramount goal underlying any HACCP system. Seven basic principles are employed in the development of HACCP plans that meet the stated goal. These principles include hazard analysis, CCP identification, establishing critical limits, monitoring procedures, corrective actions, verification procedures, and record-keeping and documentation. Under such systems, if a deviation occurs indicating that control has been lost, the deviation is detected and appropriate steps are taken to reestablish control in a timely manner to assure that potentially hazardous products do not reach the consumer.

In the application of HACCP, the use of microbiological testing is seldom an effective means of monitoring CCPs because of the time required to obtain results. In most instances, monitoring of CCPs can best be accomplished through the use of physical and chemical tests, and through visual observations. Microbiological criteria do, however, play a role in verifying that the overall HACCP system is working.

The Committee believes that the HACCP principles should be standardized to provide uniformity in training and applying the HACCP system by industry and government. In accordance with the National Academy of Sciences recommendation, the HACCP system must be developed by each food establishment and tailored to its individual product, processing and distribution conditions.

In keeping with the Committee's charge to provide recommendations to its sponsoring agencies regarding microbiological food safety issues, this document focuses on this area. The Committee recognizes that in order to assure food safety, properly designed HACCP systems must also consider chemical and physical hazards in addition to other biological hazards.

For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems.

The Committee designed this document to guide the food industry and advise its sponsoring agencies in the implementation of HACCP systems.

DEFINITIONS

CCP Decision Tree: A sequence of questions to assist in determining whether a control point is a CCP.

Control: (a) To manage the conditions of an operation to maintain compliance with established criteria. (b) The state where correct procedures are being followed and criteria are being met.

Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard.

Control Point: Any step at which biological, chemical, or physical factors can be controlled.

Corrective Action: Procedures followed when a deviation occurs.

Criterion: A requirement on which a judgement or decision can be based.

Critical Control Point: A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit: A maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard.

Deviation: Failure to meet a critical limit.

HACCP: A systematic approach to the identification, evaluation, and control of food safety hazards.

HACCP Plan: The written document which is based upon the principles of HACCP and which delineates the procedures to be followed.

HACCP System: The result of the implementation of the HACCP Plan.

HACCP Team: The group of people who are responsible for developing, implementing and maintaining the HACCP system.

Hazard: A biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.

Hazard Analysis: The process of collecting and evaluating information on hazards associated with the food under consideration to decide which are significant and must be addressed in the HACCP plan.

Monitor: To conduct a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification.

Prerequisite Programs: Procedures, including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system.

Severity: The seriousness of the effect(s) of a hazard.

Step: A point, procedure, operation or stage in the food system from primary production to final consumption.

Validation: That element of verification focused on collecting and evaluating scientific and technical information to determine if the HACCP plan, when properly implemented, will effectively control the hazards.Verification: Those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.

HACCP PRINCIPLES

HACCP is a systematic approach to the identification, evaluation, and control of food safety hazards based on the following seven principles:

Principle 1: Conduct a hazard analysis.

Principle 2: Determine the critical control points (CCPs).

Principle 3: Establish critical limits.

Principle 4: Establish monitoring procedures.

Principle 5: Establish corrective actions.

Principle 6: Establish verification procedures.

Principle 7: Establish record-keeping and documentation procedures.

GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES

Introduction

HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. For successful implementation of a HACCP plan, management must be strongly committed to the HACCP concept. A firm commitment to HACCP by top management provides company employees with a sense of the importance of producing safe food.

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and food service operations. The seven principles of HACCP have been universally accepted by government agencies, trade associations and the food industry around the world.

The following guidelines will facilitate the development and implementation of effective HACCP plans. While the specific application of HACCP to manufacturing facilities is emphasized here, these guidelines should be applied as appropriate to each segment of the food industry under consideration.

Prerequisite Programs

The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs. Examples of common prerequisite programs are listed in Appendix A. Each segment of the food industry must provide the conditions necessary to protect food while it is under their control. This has traditionally been accomplished through the application of cGMPs. These conditions and practices are now considered to be prerequisite to the development and implementation of effective HACCP plans. Prerequisite programs provide the basic environmental and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in federal, state and local regulations and guidelines (e.g., cGMPs and Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the basic conditions and practices expected for foods intended for international trade. In addition to the requirements specified in regulations, industry often adopts policies and procedures that are specific to their operations. Many of these are proprietary. While prerequisite programs may impact upon the safety of a food, they also are concerned with ensuring that foods are wholesome and suitable for consumption (Appendix A). HACCP plans are narrower in scope, being limited to ensuring food is safe to consume.

The existence and effectiveness of prerequisite programs should be assessed during the design and implementation of each HACCP plan. All prerequisite programs should be documented and regularly audited. Prerequisite programs are established and managed separately from the HACCP plan. Certain aspects, however, of a prerequisite program may be incorporated into a HACCP plan. For example, many establishments have preventive maintenance procedures for processing equipment to avoid unexpected equipment failure and loss of production. During the development of a HACCP plan, the HACCP team may decide that the routine maintenance and calibration of an oven should be included in the plan as an activity of verification. This would further ensure that all the food in the oven is cooked to the minimum internal temperature that is necessary for food safety.

Education and Training

The success of a HACCP system depends on educating and training management and employees in the importance of their role in producing safe foods. This should also include information the control of foodborne hazards related to all stages of the food chain. It is important to recognize that employees must first understand what HACCP is and then learn the skills necessary to make it function properly. Specific training activities should include working instructions and procedures that outline the tasks of employees monitoring each CCP.

Management must provide adequate time for thorough education and training. Personnel must be given the materials and equipment necessary to perform these tasks. Effective training is an important prerequisite to successful implementation of a HACCP plan.

Developing a HACCP Plan

The format of HACCP plans will vary. In many cases the plans will be product and process specific. However, some plans may use a unit operations approach. Generic HACCP plans can serve as useful guides in the development of process and product HACCP plans however, it is essential that the unique conditions within each facility be considered during the development of all components of the HACCP plan.

In the development of a HACCP plan, five preliminary tasks need to be accomplished before the application of the HACCP principles to a specific product and process. The five preliminary tasks are given in Figure 1.

Figure 1. Preliminary Tasks in the Development of the HACCP Plan

Assemble the HACCP Team

The first task in developing a HACCP plan is to assemble a HACCP team consisting of individuals who have specific knowledge and expertise appropriate to the product and process. It is the team's responsibility to develop the HACCP plan. The team should be multi disciplinary and include individuals from areas such as engineering, production, sanitation, quality assurance, and food microbiology. The team should also include local personnel who are involved in the operation as they are more familiar with the variability and limitations of the operation. In addition, this fosters a sense of ownership among those who must implement the plan. The HACCP team may need assistance from outside experts who are knowledgeable in the potential biological, chemical and/or physical hazards associated with the product and the process. However, a plan which is developed totally by outside sources may be erroneous, incomplete, and lacking in support at the local level.

Due to the technical nature of the information required for hazard analysis, it is recommended that experts who are knowledgeable in the food process should either participate in or verify the completeness of the hazard analysis and the HACCP plan. Such individuals should have the knowledge and experience to correctly: (a) conduct a hazard analysis (b) identify potential hazards (c) identify hazards which must be controlled (d) recommend controls, critical limits, and procedures for monitoring and verification (e) recommend appropriate corrective actions when a deviation occurs (f) recommend research related to the HACCP plan if important information is not known and (g) validate the HACCP plan.

Describe the food and its distribution

The HACCP team first describes the food. This consists of a general description of the food, ingredients, and processing methods. The method of distribution should be described along with information on whether the food is to be distributed frozen, refrigerated, or at ambient temperature.

Describe the intended use and consumers of the food

Describe the normal expected use of the food. The intended consumers may be the general public or a particular segment of the population (e.g., infants, immunocompromised individuals, the elderly, etc.).

Develop a flow diagram which describes the process

The purpose of a flow diagram is to provide a clear, simple outline of the steps involved in the process. The scope of the flow diagram must cover all the steps in the process which are directly under the control of the establishment. In addition, the flow diagram can include steps in the food chain which are before and after the processing that occurs in the establishment. The flow diagram need not be as complex as engineering drawings. A block type flow diagram is sufficiently descriptive (see Appendix B). Also, a simple schematic of the facility is often useful in understanding and evaluating product and process flow.

Verify the flow diagram

The HACCP team should perform an on-site review of the operation to verify the accuracy and completeness of the flow diagram. Modifications should be made to the flow diagram as necessary and documented.

After these five preliminary tasks have been completed, the seven principles of HACCP are applied.

Conduct a hazard analysis (Principle 1)

After addressing the preliminary tasks discussed above, the HACCP team conducts a hazard analysis and identifies appropriate control measures. The purpose of the hazard analysis is to develop a list of hazards which are of such significance that they are reasonably likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably likely to occur would not require further consideration within a HACCP plan. It is important to consider in the hazard analysis the ingredients and raw materials, each step in the process, product storage and distribution, and final preparation and use by the consumer. When conducting a hazard analysis, safety concerns must be differentiated from quality concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control. Thus, the word hazard as used in this document is limited to safety.

A thorough hazard analysis is the key to preparing an effective HACCP plan. If the hazard analysis is not done correctly and the hazards warranting control within the HACCP system are not identified, the plan will not be effective regardless of how well it is followed.

The hazard analysis and identification of associated control measures accomplish three objectives: Those hazards and associated control measures are identified. The analysis may identify needed modifications to a process or product so that product safety is further assured or improved. The analysis provides a basis for determining CCPs in Principle 2.

The process of conducting a hazard analysis involves two stages. The first, hazard identification, can be regarded as a brain storming session. During this stage, the HACCP team reviews the ingredients used in the product, the activities conducted at each step in the process and the equipment used, the final product and its method of storage and distribution, and the intended use and consumers of the product. Based on this review, the team develops a list of potential biological, chemical or physical hazards which may be introduced, increased, or controlled at each step in the production process. Appendix C lists examples of questions that may be helpful to consider when identifying potential hazards. Hazard identification focuses on developing a list of potential hazards associated with each process step under direct control of the food operation. A knowledge of any adverse health-related events historically associated with the product will be of value in this exercise.

After the list of potential hazards is assembled, stage two, the hazard evaluation, is conducted. In stage two of the hazard analysis, the HACCP team decides which potential hazards must be addressed in the HACCP plan. During this stage, each potential hazard is evaluated based on the severity of the potential hazard and its likely occurrence. Severity is the seriousness of the consequences of exposure to the hazard. Considerations of severity (e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful in understanding the public health impact of the hazard. Consideration of the likely occurrence is usually based upon a combination of experience, epidemiological data, and information in the technical literature. When conducting the hazard evaluation, it is helpful to consider the likelihood of exposure and severity of the potential consequences if the hazard is not properly controlled. In addition, consideration should be given to the effects of short term as well as long term exposure to the potential hazard. Such considerations do not include common dietary choices which lie outside of HACCP. During the evaluation of each potential hazard, the food, its method of preparation, transportation, storage and persons likely to consume the product should be considered to determine how each of these factors may influence the likely occurrence and severity of the hazard being controlled. The team must consider the influence of likely procedures for food preparation and storage and whether the intended consumers are susceptible to a potential hazard. However, there may be differences of opinion, even among experts, as to the likely occurrence and severity of a hazard. The HACCP team may have to rely upon the opinion of experts who assist in the development of the HACCP plan.

Hazards identified in one operation or facility may not be significant in another operation producing the same or a similar product. For example, due to differences in equipment and/or an effective maintenance program, the probability of metal contamination may be significant in one facility but not in another. A summary of the HACCP team deliberations and the rationale developed during the hazard analysis should be kept for future reference. This information will be useful during future reviews and updates of the hazard analysis and the HACCP plan.

Appendix D gives three examples of using a logic sequence in conducting a hazard analysis. While these examples relate to biological hazards, chemical and physical hazards are equally important to consider. Appendix D is for illustration purposes to further explain the stages of hazard analysis for identifying hazards. Hazard identification and evaluation as outlined in Appendix D may eventually be assisted by biological risk assessments as they become available. While the process and output of a risk assessment (NACMCF, 1997) (1) is significantly different from a hazard analysis, the identification of hazards of concern and the hazard evaluation may be facilitated by information from risk assessments. Thus, as risk assessments addressing specific hazards or control factors become available, the HACCP team should take these into consideration.

Upon completion of the hazard analysis, the hazards associated with each step in the production of the food should be listed along with any measure(s) that are used to control the hazard(s). The term control measure is used because not all hazards can be prevented, but virtually all can be controlled. More than one control measure may be required for a specific hazard. On the other hand, more than one hazard may be addressed by a specific control measure (e.g. pasteurization of milk).

For example, if a HACCP team were to conduct a hazard analysis for the production of frozen cooked beef patties (Appendices B and D), enteric pathogens (e.g., Salmonella and verotoxin-producing Escherichia coli) in the raw meat would be identified as hazards. Cooking is a control measure which can be used to eliminate these hazards. The following is an excerpt from a hazard analysis summary table for this product.

Hazard to be addressed in plan?
Y/N

Enteric pathogens:
e.g., Salmonella,
verotoxigenic-E. coli

enteric pathogens have been associated with outbreaks of foodborne illness from undercooked ground beef

The hazard analysis summary could be presented in several different ways. One format is a table such as the one given above. Another could be a narrative summary of the HACCP team's hazard analysis considerations and a summary table listing only the hazards and associated control measures.

Determine critical control points (CCPs) (Principle 2)

A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The potential hazards that are reasonably likely to cause illness or injury in the absence of their control must be addressed in determining CCPs.

Complete and accurate identification of CCPs is fundamental to controlling food safety hazards. The information developed during the hazard analysis is essential for the HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate the identification of each CCP is the use of a CCP decision tree (Examples of decision trees are given in Appendices E and F). Although application of the CCP decision tree can be useful in determining if a particular step is a CCP for a previously identified hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree is not a substitute for expert knowledge.

Critical control points are located at any step where hazards can be either prevented, eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal processing, chilling, testing ingredients for chemical residues, product formulation control, and testing product for metal contaminants. CCPs must be carefully developed and documented. In addition, they must be used only for purposes of product safety. For example, a specified heat process, at a given time and temperature designed to destroy a specific microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing similar food items can differ in the hazards identified and the steps which are CCPs. This can be due to differences in each facility's layout, equipment, selection of ingredients, processes employed, etc.

Establish critical limits (Principle 3)

A critical limit is a maximum and/or minimum value to which a biological, chemical or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an acceptable level the occurrence of a food safety hazard. A critical limit is used to distinguish between safe and unsafe operating conditions at a CCP. Critical limits should not be confused with operational limits which are established for reasons other than food safety.

Each CCP will have one or more control measures to assure that the identified hazards are prevented, eliminated or reduced to acceptable levels. Each control measure has one or more associated critical limits. Critical limits may be based upon factors such as: temperature, time, physical dimensions, humidity, moisture level, water activity (aw), pH, titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory information such as aroma and visual appearance. Critical limits must be scientifically based. For each CCP, there is at least one criterion for food safety that is to be met. An example of a criterion is a specific lethality of a cooking process such as a 5D reduction in Salmonella. The critical limits and criteria for food safety may be derived from sources such as regulatory standards and guidelines, literature surveys, experimental results, and experts.

An example is the cooking of beef patties (Appendix B). The process should be designed to ensure the production of a safe product. The hazard analysis for cooked meat patties identified enteric pathogens (e.g., verotoxigenic E. coli such as E. coli O157:H7, and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the process at which control can be applied to reduce the enteric pathogens to an acceptable level. To ensure that an acceptable level is consistently achieved, accurate information is needed on the probable number of the pathogens in the raw patties, their heat resistance, the factors that influence the heating of the patties, and the area of the patty which heats the slowest. Collectively, this information forms the scientific basis for the critical limits that are established. Some of the factors that may affect the thermal destruction of enteric pathogens are listed in the following table. In this example, the HACCP team concluded that a thermal process equivalent to 155° F for 16 seconds would be necessary to assure the safety of this product. To ensure that this time and temperature are attained, the HACCP team for one facility determined that it would be necessary to establish critical limits for the oven temperature and humidity, belt speed (time in oven), patty thickness and composition (e.g., all beef, beef and other ingredients). Control of these factors enables the facility to produce a wide variety of cooked patties, all of which will be processed to a minimum internal temperature of 155° F for 16 seconds. In another facility, the HACCP team may conclude that the best approach is to use the internal patty temperature of 155° F and hold for 16 seconds as critical limits. In this second facility the internal temperature and hold time of the patties are monitored at a frequency to ensure that the critical limits are constantly met as they exit the oven. The example given below applies to the first facility.

Oven temperature:___° F
Time rate of heating and cooling (belt speed in ft/min): ____ft/min
Patty thickness: ____in.
Patty composition: e.g. all beef
Oven humidity: ____% RH

Establish monitoring procedures (Principle 4)

Monitoring is a planned sequence of observations or measurements to assess whether a CCP is under control and to produce an accurate record for future use in verification. Monitoring serves three main purposes. First, monitoring is essential to food safety management in that it facilitates tracking of the operation. If monitoring indicates that there is a trend towards loss of control, then action can be taken to bring the process back into control before a deviation from a critical limit occurs. Second, monitoring is used to determine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not meeting a critical limit. When a deviation occurs, an appropriate corrective action must be taken. Third, it provides written documentation for use in verification.

An unsafe food may result if a process is not properly controlled and a deviation occurs. Because of the potentially serious consequences of a critical limit deviation, monitoring procedures must be effective. Ideally, monitoring should be continuous, which is possible with many types of physical and chemical methods. For example, the temperature and time for the scheduled thermal process of low-acid canned foods is recorded continuously on temperature recording charts. If the temperature falls below the scheduled temperature or the time is insufficient, as recorded on the chart, the product from the retort is retained and the disposition determined as in Principle 5. Likewise, pH measurement may be performed continually in fluids or by testing each batch before processing. There are many ways to monitor critical limits on a continuous or batch basis and record the data on charts. Continuous monitoring is always preferred when feasible. Monitoring equipment must be carefully calibrated for accuracy.

Assignment of the responsibility for monitoring is an important consideration for each CCP. Specific assignments will depend on the number of CCPs and control measures and the complexity of monitoring. Personnel who monitor CCPs are often associated with production (e.g., line supervisors, selected line workers and maintenance personnel) and, as required, quality control personnel. Those individuals must be trained in the monitoring technique for which they are responsible, fully understand the purpose and importance of monitoring, be unbiased in monitoring and reporting, and accurately report the results of monitoring. In addition, employees should be trained in procedures to follow when there is a trend towards loss of control so that adjustments can be made in a timely manner to assure that the process remains under control. The person responsible for monitoring must also immediately report a process or product that does not meet critical limits.

All records and documents associated with CCP monitoring should be dated and signed or initialed by the person doing the monitoring.

When it is not possible to monitor a CCP on a continuous basis, it is necessary to establish a monitoring frequency and procedure that will be reliable enough to indicate that the CCP is under control. Statistically designed data collection or sampling systems lend themselves to this purpose.

Most monitoring procedures need to be rapid because they relate to on-line, "real-time" processes and there will not be time for lengthy analytical testing. Examples of monitoring activities include: visual observations and measurement of temperature, time, pH, and moisture level.

Microbiological tests are seldom effective for monitoring due to their time-consuming nature and problems with assuring detection of contaminants. Physical and chemical measurements are often preferred because they are rapid and usually more effective for assuring control of microbiological hazards. For example, the safety of pasteurized milk is based upon measurements of time and temperature of heating rather than testing the heated milk to assure the absence of surviving pathogens.

With certain foods, processes, ingredients, or imports, there may be no alternative to microbiological testing. However, it is important to recognize that a sampling protocol that is adequate to reliably detect low levels of pathogens is seldom possible because of the large number of samples needed. This sampling limitation could result in a false sense of security by those who use an inadequate sampling protocol. In addition, there are technical limitations in many laboratory procedures for detecting and quantitating pathogens and/or their toxins.

Establish corrective actions (Principle 5)

The HACCP system for food safety management is designed to identify health hazards and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal circumstances do not always prevail and deviations from established processes may occur. An important purpose of corrective actions is to prevent foods which may be hazardous from reaching consumers. Where there is a deviation from established critical limits, corrective actions are necessary. Therefore, corrective actions should include the following elements: (a) determine and correct the cause of non-compliance (b) determine the disposition of non-compliant product and (c) record the corrective actions that have been taken. Specific corrective actions should be developed in advance for each CCP and included in the HACCP plan. As a minimum, the HACCP plan should specify what is done when a deviation occurs, who is responsible for implementing the corrective actions, and that a record will be developed and maintained of the actions taken. Individuals who have a thorough understanding of the process, product and HACCP plan should be assigned the responsibility for oversight of corrective actions. As appropriate, experts may be consulted to review the information available and to assist in determining disposition of non-compliant product.

Establish verification procedures (Principle 6)

Verification is defined as those activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan. The NAS (1985) (2) pointed out that the major infusion of science in a HACCP system centers on proper identification of the hazards, critical control points, critical limits, and instituting proper verification procedures. These processes should take place during the development and implementation of the HACCP plans and maintenance of the HACCP system. An example of a verification schedule is given in Figure 2.

One aspect of verification is evaluating whether the facility's HACCP system is functioning according to the HACCP plan. An effective HACCP system requires little end-product testing, since sufficient validated safeguards are built in early in the process. Therefore, rather than relying on end-product testing, firms should rely on frequent reviews of their HACCP plan, verification that the HACCP plan is being correctly followed, and review of CCP monitoring and corrective action records.

Another important aspect of verification is the initial validation of the HACCP plan to determine that the plan is scientifically and technically sound, that all hazards have been identified and that if the HACCP plan is properly implemented these hazards will be effectively controlled. Information needed to validate the HACCP plan often include (1) expert advice and scientific studies and (2) in-plant observations, measurements, and evaluations. For example, validation of the cooking process for beef patties should include the scientific justification of the heating times and temperatures needed to obtain an appropriate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to confirm that the conditions of cooking will deliver the required time and temperature to each beef patty.

Subsequent validations are performed and documented by a HACCP team or an independent expert as needed. For example, validations are conducted when there is an unexplained system failure a significant product, process or packaging change occurs or new hazards are recognized.

In addition, a periodic comprehensive verification of the HACCP system should be conducted by an unbiased, independent authority. Such authorities can be internal or external to the food operation. This should include a technical evaluation of the hazard analysis and each element of the HACCP plan as well as on-site review of all flow diagrams and appropriate records from operation of the plan. A comprehensive verification is independent of other verification procedures and must be performed to ensure that the HACCP plan is resulting in the control of the hazards. If the results of the comprehensive verification identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.

Verification activities are carried out by individuals within a company, third party experts, and regulatory agencies. It is important that individuals doing verification have appropriate technical expertise to perform this function. The role of regulatory and industry in HACCP was further described by the NACMCF (1994) (3) .

Examples of verification activities are included as Appendix G.

Figure 2. Example of a Company Established HACCP Verification Schedule