Safety Data Sheets (SDSs), formerly known as Material Safety Data Sheets (MSDSs), are a critical component, required by law, of safe manufacturing operations as they contain basic information about a chemical or product which helps to ensure the safety and health of the user at all stages of its manufacture, storage, use, and disposal. But are they really needed in food production?
As explained in the Guidance for Hazard Determination For Compliance with OSHA Hazard Communication Standard (29CFR1910.1200), manufacturers and importers are responsible for performing a hazard determination on the chemicals they produce to determine if, under normal conditions of use, their product could result in a hazardous exposure situation for downstream employees who will be working with or otherwise handling that product. “Chemical” is broadly defined in the Harmonized Communication Standard as “any element, chemical compound, or mixture of elements or compounds.” Chemicals, therefore, include food and food additives.
SDSs in the Food Facility
Food products, like any other chemical product, must be evaluated for their downstream hazardous exposure potential. As an example, employees who work with flour may be exposed to the potential hazards of explosion or combustion that may occur if flour becomes airborne in sufficient concentrations. Chemicals added to the food, such as sodium nitrate and sodium nitrite in processed foods, that could be hazardous must also be identified on an SDS.
Both of these cases represent potential physical hazards that would have to be noted on an accompanying SDS for that food product. In these cases, in addition to preparing an SDS, employers must also train employees about operating safely with those chemical hazards in the workplace. SDSs for all chemicals must located at or near the point where the chemical in question will be introduced so that the information is readily accessible. They must be updated at a minimum every five years. SDSs are an important component of food safety plans. Facilities without them, or without all that are required, will be found in violation during an FDA inspection or third-party certification audit.
Interestingly, SDSs have a long and involved history, extending back into time as far back as 4,000 years ago when MSDS-like records described pharmaceutical use in Egypt. A thousand year later, the Greeks recorded not only their own observations, but also some of their early experimental work on similar documents. Skipping ahead another millennium, chemical data sheets were continuously being developed by chemists at avante garde chemical companies as a way of transmitting various data to fellow chemists, including melting/freezing/flash points, viscosity, density, with additional items such as reactions and fire hazards. While health, safety and toxicological data had been in development over thousands of years, it is only recently that this information has been included on data sheets for an all-inclusive document.
The U.S. federal government got involved in the mid-1960s, developing its original Form LSB-00S-4 to meet the needs of maritime workers and adding safety and hazard information for the first time to a chemical safety sheet. With the passage of Public Law 91-596, on Dec. 29, 1970, OSHA was established within the Department of Labor and Form LSB-OOS-4 became Form OSHA-20, issued as “revised May 1972.”
On Nov. 25, 1983, OSHA issued its final regulation requiring MSDSs for all shipments of hazardous chemicals leaving a manufacturer’s workplace and from all importers of such on all shipments, to be implemented by November 1985. Distributors and employers were to comply as of that same date. All employers were to follow all provisions of this section, including initial training requirements for all current employees, by May 25, 1986. At that time, the formatting for MSDSs was fluid and varied considerably from company to company and from country to country. The European Union standardized the format into what is now the 16-section document, and the U.S. government created the Hazard Communication Standard (HCS) (29 CFR 1910.1200(g)), revised in 2012, requiring that the chemical manufacturer, distributor, or importer provide an SDS for each hazardous chemical to downstream users, with a standardized and more effective format to communicate chemical hazards than the MSDS. Additionally, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) was set up with core elements that included standardized hazard testing criteria, universal warning pictograms, and harmonized safety data sheets that provide users of dangerous goods with a host of information on toxicity and safety protocols. The system also acts as a complement to the United Nations’ system of regulated hazardous material transport.
As of 2017, the system has been enacted to a significant extent in most major countries around the world. This includes the European Union, which has implemented the United Nations’ GHS into EU law as the CLP Regulation, and OSHA standards. When creating an SDS it is important to be aware that the proper labeling and warnings are included for the country where the product will be sold—the place that regulates the product.
The 16 sections of an SDS are in a strict order. Sections 1 through 8 contain general information about the chemical, identification, hazards, composition, safe handling practices, and emergency control measures (e.g., firefighting). This information should be easily available to those who need to get the information quickly.
Sections 9 through 11 and 16 contain other technical and scientific information, such as physical and chemical properties, stability and reactivity information, toxicological information, exposure control information, and other information including the date of preparation or last revision.
Basic toxicological information is placed methodically in Section 11. While the specific format is not set, the acute data is a generally good place to start. Toxicological data such as the oral and dermal LD50s (the dose at which 50 percent of the specified animal exposed would be expected to die–this is a calculated formulaic number from a limited number of animals) as well as the inhalation LC50s (the concentration of a chemical in the air at which 50 percent of animals exposed would be expected to die). Basic information on skin, mucous membrane, respiratory and eye irritation as well as any repeated dose information also would be inserted in this section, as well as cancer listings from the International Agency for Research on Cancer, the Environmental Protection Agency, the National Toxicology Program, the American Conference of Governmental Industrial Hygienists, and the National Institute for Occupational Safety and Health, or OSHA. Any repeated dose studies that generate the no observed adverse effect level (NOAEL) should be briefly included here. Some companies insist on a full toxicological profile of the chemical in this section, while others put only minimal information.
There are other sections that depend on the information found in the toxicology section. For instance, Section 3, the Hazard Identification, applies the toxicological data to direct how the user must handle the product. This includes things other than toxicity (e.g., flammability, volatility, etc.). Any serious issues in handling the product must be pointed out here. Sometimes potential health effects also are detailed in this section. If the sheet is for global/EU use, then warning pictograms must go in this section (See Figure 1).
Section 4 is about first aid. There are stock phrases that appear in this section based upon the toxicological profile of the material. Section 5 covers firefighting measures and also can relate back to the toxicology section if the product has the potential for serious chemical reactions.
Section 12 is ecological information. This information is very important in the EU, which puts more emphasis on this than the U.S. historically has. EU regulators want to know the potential ecotoxicity to fish, daphnia, and algae, and if the product biodegrades or bio-accumulates, which can produce long-term harm to the environment.
The relevant regulatory information including exemptions, what agency takes precedence, rules to follow in the country that product is in, Toxic Substances Control Act (TSCA)–1976 Public Law 94-469) listing, etc., should be in Section 15.
Even for all its storied history and seemingly strict rules, the health and safety information found on current SDSs is still sometimes less than optimal. If no data is available for a particular product, then that can be stated and the SDS is in compliance with OSHA regulations. Interestingly, the regulations do not require that a preparer actually test a product/chemical. The preparer often makes their best-educated guesses or uses component toxicology data from the literature. To clarify some readings, such as skin or eye irritation, sometimes in vitro or other studies are run on the products, but this is the manufacturer’s prerogative.
An SDS preparer cannot underestimate or misrepresent the toxicity of the product. Therefore, if there are components that can cause irritation or other issues, they must be called out on the SDS. If the in vitro or other test data on the actual product show that not to be the case, then the preparer can put the results of the actual product test data on the sheet. This can help manufacturers if they think their product is less toxic than the chemistry appears (fewer warnings/less hazardous = good marketing). But the data must be available to support such claims.
Who Really Needs SDSs?
The powers that be determined that the individual consumer should have access to this information only on a “need to know” basis. Therefore, SDSs would not normally be found at the store on the shelves where food products are sold. SDSs are meant for:
- Employees who may be occupationally exposed to a hazard.
- Employers who need to know the proper methods for storage, safe use, etc.
- Emergency responders such as firefighters, hazardous material crews, emergency medical technicians, and emergency room personnel.
At first blush, the fact that consumers do not have access to this information seems counterintuitive; however, the real purpose of the SDS is to protect occupationally exposed individuals and not the occasional home consumer. For instance, most paints contain some rather harsh and toxic materials. If they didn’t, they wouldn’t work well. If painting were your profession and you were exposed to paint fumes for 40 hours a week, week after week, that SDS data might be considerably more important than it would be for someone who painted a room once a year. It all goes back to the age-old toxicology statement: “The dose makes the poison.”
Some companies put a considerable amount of information on their SDSs while others, not so much. As a rule of thumb, the data should be as complete as possible with the information at hand, with toxicological statements evaluated by a certified toxicologist. One should never speculate or overstate the effect of the product–as in all things scientific, be truthful and accurate.
Dr. Kapp, an independent consultant for EAS Consulting Group, has over 30 years of experience as a toxicologist involved with the management, development, and safety of new and existing products. Reach him at firstname.lastname@example.org.