The Current State of HACCP

  The early food laws also put a great emphasis on chemical adulteration; filth (insects, rodents); the use of rotten or decomposed raw materials; product composition and economic violations (short fills, drained weights).

  To help combat such problems, the FDA has had a program of surprise inspections of food establishments and random sampling of products from the trade since its inception. Why doesn't this approach work? Anyone familiar with sampling plans recognizes that random sampling of a very small portion of a company's production only uncovers problems that are very common to that company. Continuing economic violations and mislabeling would be easy to discover due to the ongoing nature of such problems, but random bacterial contamination and inadvertent adulteration with allergens would be difficult to discover.

  Infrequent inspections of a plant only affect the most blatant operators. For an effective inspection, the inspector needs to know the plant. Even if an inspector visits a plant on a frequent basis, there's opportunity to try and slip something by him or her. Also, with closed records, how can an inspector know if there are problems with process controls and infrequent environmental contamination?

  HACCP puts the burden of control where it belongs - on the people making the food. However, proper use and storage of food by consumers is also a problem. No one can protect consumers from themselves, so there's a need for consumer education on the proper storage and preparation of food, even beyond label statements.

  In some cases, cGMPs have been promulgated for specific industries by the FDA. For example: quality control procedures assuring the nutrient content of infant formulas (21 CFR 106); cGMP regulations for thermally processed low-acid foods in hermetically sealed containers (21 CFR 113) and for acidified foods (21 CFR 114); and cGMP regulations for bottled water (21 CFR 129).

  In other cases, industry associations have used a combination of industry and academic experts to develop industry-specific cGMPs. A recent example of this is the Guidelines for Developing Good Manufacturing Practices and Standard Operating Procedures for Raw Ground Products. These guidelines were coordinated for the National Meat Association by the Institute of Food Science and Engineering at Texas A&M University, College Station.

  The lack of reference, however, by the USDA/FSIS (Food Safety Inspection Service) to the cGMPs has been cited as a problem with that agency's program. (It should be noted that all USDA-inspected meat and poultry plants are required to have a "Standard Sanitation Operating Procedure" in place for all lines prior to implementing HACCP.)

  It is impossible to implement a HACCP program without the prerequisite programs in place, but it is possible to write a HACCP program without them. Lack of prerequisite programs and lack of company understanding of the HACCP principles have proven to be a problem. Another problem, according to Jeffery Brown, consumer safety officer with the FDA, is wrong and false information being dispensed by consultants and other 'experts.'

  Verifying the control points of a HACCP plan - and validating that the plan actually controls the critical control points - is of paramount importance. Bill Smith, assistant deputy administrator, USDA/FSIS, states that there has to be a scientific reason for the control point, and that the control limits must be deliverable every day, and for each step, for the system in question. Consider, for example, that a company writes a cook time of 160°F for 30 seconds as the critical limit for their process. Once in operation, however, the heat distribution and loading of the equipment make it impossible to maintain 160°F in all parts of the product, and worse, the company finds a pathogen in the product after processing. Variation in the system prevents the maintenance of the critical temperature.

  Ken Gall, seafood specialist with the New York Sea Grant Extension Program, says that the major problems encountered by industry are: sanitation programs that are in place, but not being monitored; verification that HACCP plans are being implemented correctly; and knowledge of the HACCP principles. He also observes that, overall, training has eased implementation and that compliance by the industry is good.

  These publications have solved the problem of confusing information by presenting a unified program that all operators and inspectors are required to take. The training is a standardized three-day course, and all trainers have been briefed on how to teach the course outline.

  All participants go through the general training, including FDA inspectors. The FDA inspectors then go through a supplementary training at the agency. This is similar to the Better Process Control schools, which have been in use by the FDA since the 1970s. Everyone covers the same material - from operator to inspector - and the general hazards are pointed out to each person during the course. It should be noted that the DA inspectors carry badges, and are law-enforcement officers, while USDA inspectors cannot make arrests.

  In a follow-up study entitled "Seafood HACCP Implementation Survey Evaluation Report," Gall solicited input on all phases of the implementation process, and reports that "the most frequent changes in equipment to meet HACCP requirements of the FDA regulation were to thermometers, delivery trucks, truck refrigeration units, coolers, other monitoring devices and shipping containers."

  Another striking finding was that "smaller firms invested as much money as medium-sized firms, and the investment made by the largest firms was significantly higher." Ninety percent of the respondents felt that the HACCP training had benefited the industry, but only 47% thought that the benefits of implementing HACCP would outweigh the cost to the company. Only 58% of respondents thought that the program would benefit consumers, and a striking 79% felt that consumers were not aware of the program. Only 70% of respondents reported having had an FDA or state HACCP inspection since the start date of the program.

  There have been snags along the way to implementation in the meat and poultry industry, which is not surprising, given the size of the industry. One of the problems is the nature of the Federal Meat Inspection Act. There are two types of infractions - adulteration and misbranding. Yet, subsection m (8), under adulteration, would appear to belong to misbranding. Also, the USDA has used a command-and-control regulatory approach for a long time, and on-site inspectors are an industry norm. But the USDA chose not to include cGMPs as part of the regulation, and with initial implementation came notice from the USDA that there were regulatory issues that had to be addressed in the HACCP plans. However, while the industry was trained in HACCP plan development, the inspectors were trained in HACCP plan enforcement, and had little training in plan development.

  According to Smith, the USDA has established a technical service center in Omaha. If an inspector has a question, he or she can call the center for a decision on whether the plan in question is compliant. An expert technical team is available to handle the really difficult questions. There's an appeals process in place as well, which is monitored to make sure that appeals do not take too long. All finalized appeals are published in quarterly reports and are available from the USDA and on its website. The findings are recorded in a database, which is reviewed regularly, and all USDA personnel have access to technical support 24 hours a day, 7 days a week.

  To the credit of the USDA, it has chosen to modify its program to address new hazards as they have become known or have become widespread. This has just occurred, in fact, in response to the Listeria monocytogenes problem in packaged RTE meat products. On May 25, 1999, the USDA posted regulations for the control of L. monocytogenes in these types of products in the Federal Register. Says Smith, "as new hazards become known, notices will come out to re-access existing HACCP plans with the new hazards in mind."

  Within the meat and poultry industries, training has taken a different track from that of the fisheries. The poultry industry uses a uniform HACCP training plan that is administered by the U.S. Poultry and Egg Association, according to Steve Knight, director of training for the organization. This includes the basic principles of HACCP and plan development, as well as compliance issues. The people currently going through training are from plants that already have HACCP plans in place; which is helpful, because it gives them a little exposure before they arrive.

  Although there are no poultry plants of which Knight is aware that have not already been included in HACCP, "training is a critical problem in the industry due to the high turnover rate of employees," he says. He would like to see the USDA become more involved in developing the HACCP training programs, and to have each USDA inspector go through the same program in a manner similar to that of the Fish and Fisheries system. Too much emphasis has been placed on teaching USDA inspectors enforcement, and not enough time spent on teaching basic HACCP, he feels.

  The meat side has chosen to use many training programs already being offered, or new courses that meet the criteria of the International HACCP Alliance (formerly the Meat and Poultry HACCP Alliance). The International HACCP Alliance sets up courses, instruction for the trainers, and a curriculum review committee. The review committee approves each HACCP course outline, and each lead instructor has to be approved as well.

  The lack of a single course guide and list of generally recognized hazards accepted by the industry and regulators has led some to believe that there is inconsistency in training and understanding of HACCP. The sheer quantity of people to be trained is a problem, and the last-minute inclusion of regulatory compliance into the HACCP scheme did not help matters.

  An article in the July 5, 1997 Food Chemical News entitled "Congress Seeks Explanation for FSIS regulatory reform delays, Listeria requirements" illustrates the tight scrutiny from Congress under which the USDA operates. There is criticism of USDA sending the Listeria notice to the trade, while the FDA includes a list of hazards in its Fish and Fisheries program and updates this list on a regular basis. Of more concern to the House Agriculture Committee was "the length of time it is taking USDA Food Safety and Inspection Service to review its regulations and remove those that are not HACCP-compatible. While the agency originally promised to remove unnecessary, outdated command-and-control regulations before HACCP was ever implemented, very little progress toward that goal has been made."

  The good news is that according to the USDA, the portion of the meat and poultry industry covered by the program is 90% compliant with the program. The problem is the lack of understanding of the seven HACCP principles, especially validation of the program (see sidebar entitled "HACCP Principles"). As Smith says, "if the design is bad, you cannot fix that with execution."

  At this time, the National Conference of Interstate Milk Shippers (NCIMS) has a committee looking at HACCP as an alternative system for rating and auditing plants operating under the Pasteurized Milk Ordinance (PMO). They may have an easier time using HACCP, since all requirements under the PMO are based upon identified public health concerns. The committee has sent out applications to various states looking for participants in the pilot program. According to Claudia Cole, committee chairperson with the Washington State Department of Agriculture, they want plants from all regions of the country to participate in the pilot program. Once the plants are selected, personnel from the plants and the state agencies involved will train together. The plants will then have to develop HACCP plans and the states will have to create a monitoring scheme to determine how well HACCP is working. The pilot program will start by January 2000, so that it will have been in place for a year before final assessment of the pilot program. A report is to be presented to the NCIMS at the meeting in May 2001.

  Other industries will implement HACCP very soon. On April 24, 1998 the FDA published in the Federal Register (21 CFR part 120) proposed HACCP Procedures for the Safe and Sanitary Processing and Importing of Juice. It was originally set to go into effect for large processors in two years from date of publication, and to go into effect for all parties within four years.

  Like the PMO for the grade-A milk industry, other industry segments have regulations very similar to HACCP - thermally processed low-acid foods in hermetically sealed containers and acidified foods, for example. It would be difficult to see how a change in these programs would benefit public safety.

  We can learn much from those who already have HACCP programs administered by the various governmental agencies. The basic problems that the industry faces are the lack of the prerequisite programs and monitoring systems. Many companies cannot verify at present that their sanitation plans are being followed or that other basic quality-control programs are being followed. And not just small companies - recently a large, well-known company admitted to a lapse in basic quality-control procedures. Again, the key issues are verifying the critical control procedures and validating the processes that control them. Making sure these missions are effectively fulfilled will make HACCP implementation easier for everyone, and will ensure that HACCP works as it is intended - to make the food supply even safer.