The NSF International Nonfood Compounds Registration Program
By Stan Hazan
Contents
The Prior USDA Program
Termination to the USDA Authorization Program
Industry Reactions to the USDA Program Termination
The NSF Registration Program
The NSF Registration Guidelines
The NSF Registration Program
Summary
In 1998, the United States Department of Agriculture (USDA) discontinued its popular authorization program for Proprietary Substances and Nonfood Compounds that covered more than 6000 companies and 120,000 product names. NSF International responded to requests from stakeholders such as product manufacturers, distributors and product users such as food processors, food service and food marketing companies, as well as the hospitality and institutional industries. NSF polled these stakeholders and their trade associations to determine the level of interest in continuing the USDA program. Based on those discussions, NSF initiated its Nonfood Compounds Registration Program, which retains the scope, terminology and process of the prior USDA program, and includes enhancements that take advantage of the Internet.
The Prior USDA Program
Under the prior USDA authorization program, operated by the Food Safety Inspection Service (FSIS), only compounds on the USDA list were permitted inside meat and poultry processing plants. Food processors retained "authorization letters" for every product they used, or maintained a copy of the USDA listing book. The range of nonfood compounds authorized by the USDA included cleaners, sanitizers, lubricants and products with incidental food contact, such as tripe processing agents, defoamers and tattoo inks. Nonfood compound formulations were required to comply with the U.S. FDA Code of Federal Regulations (CFR) Title 21. In addition, products making a pesticidal claim for sanitization or as a biocide, were required to comply with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as managed by the EPA's Office of Pesticides Program. The FDA was sometimes involved in the approval of hand creams and other over-the-counter products. Therefore, while USDA authorization appeared simple on the surface, complying with all regulations was sometimes difficult for manufacturers and distributors, especially for small companies without the technical or financial resources to perform the function itself.
Termination of the USDA Authorization Program
USDA posted Notices in the Federal Register on August 25, 1997 and on February 13, 1998 that it terminated its authorization program. USDA would no longer provide a product authorization service, but agreed to act in an advisory capacity as long as possible to assist in the transition from the "Command and Control" strategy to a performance based Hazard Analyses and Critical Control Points (HACCP) system. This change in philosophy also resulted in the termination of the FSIS's Food Processing Equipment Approval Program. Under HACCP, the responsibility for food safety is transferred entirely to the plant, which must identify food safety hazards and establish critical control points. Federal inspectors now review a food processor's HACCP plan, confirm its validity, and monitor the plant's documentation verifying adherence to the plan.
The USDA, in its Federal Register Notices, outlined several options to nonfood compound manufacturers and to food processors, including:
- Provide / use products from the final USDA list of July 1998,
- Provide / obtain "Letters of Guaranty" ensuring product is safe and suitable for the proposed end use,
- Provide / obtain product formulation to allow user to determine safety, or
- Rely on third party organizations, such as NSF, for professional evaluations.
In its Federal Register Notices, the USDA provided several options to third party organizations considering development of a replacement program, including:
- Re-introduce a "USDA-type" program with advice and support from the USDA,
- Expand upon the USDA program, by possibly including production facility audits, product evaluations, and or product certifications, or
- Initiate a standards development process, if needed.
Industry Reactions to the USDA Program Termination
Many nonfood compound manufacturers and food processors alike expressed concern to USDA, and to NSF, over the loss of a centralized product approval program. Many companies viewed the USDA program as a technical resource, and loss of that resource was viewed as potentially problematic to several industries. There were also concerns regarding market acceptance of manufacturers' "Letters of Guaranty". Manufacturers and users both expressed concern over smaller companies' ability to provide competent or reliable "Letters of Guaranty".
Additional industry concerns included manufacturers who change formulations under existing USDA authorized trade names, and use of new ingredients not previously reviewed by USDA. Development of entirely new formulations or use of new category codes for previously authorized formulations are activities that stakeholders cited as requiring a competent central body. The use of new chemicals, or use of existing chemicals in new applications, were also cited as potential food safety issues. It is with these USDA options, and industry concerns over USDA program termination, that NSF launched its Nonfood Compounds Registration Program in 1999.
The NSF Registration Program
In 1999, NSF staff met with USDA staff to discuss the possible continuation of the program by NSF. USDA suggested that NSF meet with key organizations in the industry to determine elements of the program. They suggested that NSF meet with the Independent Lubricant Manufacturers Association (ILMA), the International Sanitary Supply Association (ISSA), the Chemical Specialties Manufacturers Association (CSMA), as well as representatives from many of their member companies. These meetings provided valuable input into the current structure of the NSF Registration Program. NSF received strong support for continuing the USDA program.
The recurring themes that NSF heard was that industry did not want a standard, and the user groups did not want to have to absorb additional cost for manufacturers having to comply with a standard. Additionally, nonfood compound manufacturers did not want the elements of a certification program, namely factory audits and product testing. Stakeholders strongly preferred a registration program resembling the USDA program. That is exactly what NSF developed.
Stakeholders also identified several potential issues related to NSF continuation of the program, including:
- Consistency with USDA. The NSF Registration Guidelines for Proprietary Substances and Nonfood Compounds are based on the guidelines used by USDA. The NSF Guidelines document was reviewed by USDA staff, and their comments were incorporated into the final guidelines. As such, there is a very high consistency between the NSF and USDA procedures in terminology, category codes, and even forms.
- Cost. A private sector program will charge for its services whereas the USDA did not. Although industry supports a fee-based system, it wishes to minimize the scope of the service and related fees. As a result, NSF developed a service with a reasonable fee structure.
- Turnaround times for reviews. The prior USDA program performed well and maintained a 6-week turnaround time for product submissions. The NSF Registration Program currently matches this turnaround time, however, electronic formulation submission, as well as proprietary database systems will reduce this to less than 7 days.
- Confidentiality. Several companies expressed interest in knowing more about NSF's confidentiality procedures. Confidentiality is of paramount importance at NSF. In its product certification programs, NSF maintains more than 100, 000 formulations on file, without a single breach of confidence.
- Registration mark. Industry representatives expressed an interest in applying a unique mark or logo to their NSF registered products. The logo, shown below, is the NSF Registration Mark, and will be accompanied by the NSF Registration number on labels
- Grandfathering of previous approvals. NSF has listed all 120,000 products approved by USDA as of their final publication dated July 1998 on the NSF website ‘www.nsf.org'. NSF publishes these products on-line in a black font to differentiate them from the blue-font listings of products registered by NSF. Updated daily, and easily searchable by company name, product name, category code, or by geography, this web listing is extremely useful and easy to use.
- Acceptance and recognition from inspection authorities, food processors, and the international community. With the termination of the regulatory mandate for product approval, any replacement program is required to be benefits and market driven. NSF meetings with users, manufacturers and their trade associations have identified the services and features that will benefit stakeholders most. Current benefits include on-line listings, electronic submission of formulations, downloadable authorization letters, periodic printing of updated listing books, continuous tracking of formulations against changing regulations, and facilitated client notification. One feature that has received considerable positive attention is the hyperlink from NSF listings to the manufacturer's web site to help product purchasing.
It is all of these benefits, combined with NSF's solid reputation, which will drive adoption and use of the voluntary NSF Registration program.
The NSF Registration Guidelines
The foundation of the NSF program is the NSF Registration Guidelines Document that outlines the specific ingredient, label and product use criteria for the Proprietary Substances and Nonfood Compounds covered by the 64 USDA category codes. The NSF Guidelines Document, available for free download from the NSF web site, also contains the necessary forms to submit information to NSF. USDA staff reviewed draft copies of the Guidelines, and their comments and recommendations have been incorporated into the final document.
The NSF Registration Program
The registration program was launched in late 1999, and has received considerable attention in the press, and in industry meetings. NSF held industry forums and regulatory/user forums in 2000 to determine the elements of the Registration program most important to all stakeholders. The greatest needs were seen as remaining current with listings, as well as the Guidelines document. The best mechanism to accomplish this was seen as the NSF Nonfood Compounds Steering Committee, that will provide advice and counsel on the Guidelines, the review process, the listings, and the policies that govern registration.
Summary
In summary, the NSF Nonfood Compounds Registration Program provides many benefits to all stakeholders, at minimal cost, and continues an important and widely respected service by adding the confidence and expertise of a world leading public health organization. The program, which has been operating since 1999, promises to deliver cost effective services from which all stakeholders will benefit.
NSF International is a not-for-profit organization committed to public health safety and protection of the environment by developing standards, by providing education and by providing third-party conformity assessment services while representing the interest of all stakeholders. Its staff includes engineers, chemists, toxicologists, microbiologists, and environmental health professionals with broad experience in both public and private organizations.
Stan Hazan is the General Manager of the NSF Nonfood Compounds Registration Program, and the General Manager of the Drinking Water Additives Certification Program. He joined NSF in 1988 and has additionally held positions in Marketing and Business Development. Stan is a 1978 graduate of the University of Toronto with degrees in chemistry and biochemistry, and an MBA from the University of Michigan in 1987. He worked as an analytical chemist and mass spectroscopist in forensic and environmental laboratories in Toronto and Ann Arbor from 1978 to 1985. He is a member of the American Water Works Association and the American Chemical Society.
For more information contact NSF International, PO Box 130140, 789 N. Dixboro Road, Ann Arbor, MI 48113 -0140, USA. Tel: 734-769-8010; Toll Free (USA): 800-NSF-MARK; Fax: 734-769-0109.