Voluntary, Third-Party Certification and Registration Programs Fill Void for Meat and Poultry Processors
For many years, the U.S. Department of Agriculture's meat and poultry inspection program was based on intensive command and control oversight of plant operations, including prior-approval systems for facility, blueprints, equipment, in-plant chemicals, ingredients, process changes, and labels.
Under USDA's regulatory scheme, the agency's Food Safety and Inspection Service was given the task of approving virtually everything used during the slaughter and processing of meat and poultry that might affect the safety, quality, or wholesomeness of the food. FSIS also conducted a prior-approval program for the labeling of federally inspected meat and poultry products and imported products to ensure compliance with the requirements of the inspection laws.
These prior-approval systems consumed significant public and private resources–resources that many thought could be better used in reducing the risk to the public of foodborne illnesses. In reforming these systems, USDA sought to clarify the proper roles of government and industry in ensuring food safety.
In 1995, USDA's comprehensive review of its regulatory procedures culminated in the creation of the Pathogen Reduction and Hazard Analysis and Critical Control Points (HACCP) system, which was designed to reduce the regulatory burden associated with the agency's demanding oversight of federally inspected facilities. The proposal reflected a fundamental shift in how USDA regulates the meat and poultry industries to ensure the safety of the products they produce. FSIS shifted away from its traditional reliance on "command-and-control" regulations toward the use of performance standards. In keeping with this change, USDA eliminated many of the prior-approval programs, including those applicable to the approval of nonfood compounds and proprietary substances, as well as the prior approval of equipment used in federally inspected plants.
With the elimination of the prior-approval programs, regulated meat and poultry facilities were left without a readily available list of products that were deemed acceptable for use in their facilities. Consequently, two nationally recognized certification bodies, NSF International and Underwriters Laboratory, initiated programs to provide facility operators with a list of certified products acceptable for use in meat and poultry facilities.
In addition, Congress stepped in, demanding that USDA's Agriculture Marketing Service develop a voluntary certification program for equipment and utensils used to process livestock and poultry products. The transition from the prior-approval system to a voluntary, third-party review of products used in federally inspected meat and poultry facilities is discussed below.
Nonfood Compounds and Proprietary Substances
During processing, meat and poultry products can come into contact with a variety of chemical agents used in and around processing plants. For many years, FSIS conducted a mandatory prior review and approval program for these so-called "proprietary" substances and nonfood compounds. Substances authorized by USDA under this program were listed in a USDA publication titled List of Nonfood Compounds and Proprietary Substances.
Proprietary substances are chemicals used in the preparation of meat and poultry products. They are considered "proprietary" because not all of their ingredients may be identified by common chemical names. These substances include branding inks, poultry and hog scald agents, tenderizers, defoamers, and substances used for cleaning or treating edible parts.
Nonfood compounds are chemicals used in meat and poultry establishments that are not intended to become components of food. Such compounds include sanitizers, cleaning compounds, boiler and water treatments, compounds for use in the laundry, paint removers, hand-washing compounds, lubricants, solvents, drain cleaners, and pesticides.
On Feb. 13, 1998, FSIS announced that it intended to terminate the prior-approval program for proprietary substances and nonfood compounds (see 63 Fed. Reg. 7,319 (Feb. 13, 1998)), after USDA determined that the program was inconsistent with the agency's HACCP regulation. Under HACCP, meat and poultry establishments must identify and manage critical control points–areas where chemical, physical, and microbial contamination may occur. Once these points are identified, the processor must reduce contamination risk and maintain documentation describing any corrective actions taken. USDA officially terminated the prior-approval program on Oct. 20, 1999, with the publication of the final rule on Sanitation Requirements for Official Meat and Poultry Establishments (see 64 Fed. Reg. 56,400 (Oct. 20, 1999)).
Almost immediately, companies such as Underwriters Laboratory and NSF International began to promote programs that were intended to take the place of the former USDA program. UL formed a technical committee and initiated plans to develop a consensus standard under which such products could be certified. The standard, identified as UL 2362, was to be drafted by representatives from UL, industry, and government, and was to be balloted at the American National Standards Institute. In parallel, NSF began implementing a registration program for nonfood compounds and proprietary substances as the ultimate replacement for the USDA program. Most of the industry now supports the NSF registration program.
The NSF registration program purports to be a continuation of the former USDA program. NSF uses the same product categories and has incorporated the same review criteria that USDA used to evaluate products. In addition, NSF "grandfathered" substances that were authorized by USDA and included these substances in its list of acceptable nonfood compounds. To convert a USDA listing to an NSF registration, a manufacturer must submit the product formulation and label to NSF for review.
The NSF program is a listing service rather than a true certification program. The NSF registration program does not have an associated certification standard and NSF does not conduct testing or plant audits to verify compliance with its requirements. As such, manufacturers are not authorized to use the round, blue NSF Certification mark on registered products. However, NSF authorizes, and in fact requires, manufacturers to include the NSF registration mark, NSF registration number, and category code on the label of registered products.
It is important to note that neither registration nor certification is legally required. The only USDA requirement for nonfood and proprietary compounds is that the products be safe for the intended use. In this regard, USDA requires that meat and poultry establishments have documentation on file establishing the safety of the use of these substances used in the facilities of interest. Such documentation need not be in the form of a third-party letter (although this type of documentation is acceptable); the documentation may equally be in the form of a "letter of assurance" from the supplier of the product.
Indeed, in an April 17, 2000, FSIS Constituent Update, USDA stated that third-party certification programs are one means of documenting compliance with regulatory requirements. However, the agency refused to sanction any particular organization's certification as definitive evidence of compliance with FSIS requirements.
The UL certification program, once a potential option for manufacturers of nonfood and proprietary compounds, has been suspended. Industry response to the two programs indicates that the less rigorous NSF product registration program is all that is needed at the present time. NSF has suggested that if, and when, stakeholders desire a certification standard for these products, it is prepared to develop the standard and will certify to it. If a significant portion of the industry believes that a certification is appropriate, UL will undoubtedly rekindle its certification program or otherwise become involved in the standard development process.
Equipment and Utensils Used in Meat and Poultry Facilities
From 1975 to 1997, USDA also carried out a mandatory prior-approval program for equipment used in federally inspected meat and poultry packaging and processing establishments.
This program, also managed by FSIS, evaluated equipment and utensils proposed by manufacturers or suppliers before they could be used in official establishments to assure that they could be maintained in a sanitary condition and were otherwise safe for use with food. Once approved, the equipment was authorized for use in federally inspected facilities and was listed in a FSIS publication titled Accepted Meat and Poultry Equipment.
Because the "command and control" requirements of the prior-approval program were contrary to the HACCP approach to federal meat inspection, USDA discontinued the mandatory prior- approval program on Sept. 24, 1997 (see 62 Fed. Reg. 45,016 (Sept. 24, 1997)). Left without an official means of qualifying equipment for use in their plants, equipment manufacturers and livestock and poultry processors sought a continuation of the FSIS program or the development of a voluntary third-party certification program for equipment.
In response to pressure from industry and congressional mandates under the 1999 Agriculture Appropriations Bill, USDA's Agriculture Marketing Service (AMS) developed a voluntary certification program for equipment and utensils used to process livestock and poultry products. Specifically, in July 1999, AMS sought information regarding those industry initiatives underway in which voluntary, consensus-based standards were being developed applicable to the design and manufacture of equipment. At that time, both UL and NSF were developing such standards.
AMS held public meetings and discussed its proposed program with equipment manufacturers and the regulated industry. Ultimately, AMS selected the consensus standard proposed by NSF/3-A Joint Committee on Food Processing Equipment, a group jointly administered by NSF and the 3-A Sanitary Standards Committee, a standards development group supported by the International Association of Food Industry Suppliers. Since that time, the NSF/3-A standard has become accredited by the American National Standards Institute (ANSI).
The USDA user-fee-based, voluntary certification program became effective on Jan. 8, 2001. When a manufacturer files an application for certification under this program, USDA specialists will review the design, inspect the equipment, and determine if the equipment complies with the performance criteria in the ANSI/NSF/3-A standard. Upon completion of the review, the product may be marked with an official identification symbol to indicate that the equipment has been "accepted" by USDA. In addition, USDA will include the product on its Internet listing of accepted products. To date, only three products have completed this process.
Currently, both NSF and UL have active certification programs for equipment used in federally inspected meat and poultry facilities; however products certified by third parties may not include the USDA "accepted equipment" mark nor will they be included in USDA's list of accepted products. The NSF program certifies products to the ANSI/NSF/3-A Standard 14159-1-2000. Additional information about the NSF program is available at http://www.nsf.org. Despite USDA's selection of the competing NSF standard for its AMS certification program, UL has decided to continue to certify equipment used in meat and poultry facilities to its ANSI/UL 2128 standard. However, if a manufacturer prefers, UL will certify equipment to the ANSI/NSF/3-A standard. Information about the UL certification program can be obtained at http://www.ul.com.
The Food and Drug Administration's Food Code Section 4-205.10 states that "food equipment that is certified or classified for sanitation by an ANSI-accredited certification program will be deemed to comply [with the Food Code]." Because both UL and NSF standards require manufactures to demonstrate that equipment can be maintained in a sanitary condition, and because both companies are ANSI accredited, certification by either NSF or UL should provide sufficient assurance to facility operators that the equipment is suitable for use in meat and poultry facilities, and should be adequate to demonstrate compliance with the facility's HACCP plan.