Chapter 22. Uses and Limitations of Product Labeling for Public Safety

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2 Chapter 22 Uses and Limitations of Product Labeling for Public Safety

3 Purpose of Product Labeling Labeling is the main method of communication between a manufacturer and the user of the product. The information attached to the product package is what most consumers look at.

4 Product Labeling Labeling includes: all other information received from the manufacturer about the product when it is purchased pamphlets or brochures package inserts

5 Purpose of Product Labeling Labeling for the manufacturer is a way to advertise and sell the product. To the user, it provides directions on how to use the product safely and effectively. To medical personnel, it is a source to identify toxicants for treatment in the case of poisoning. To the federal government, it is a means for control and assurance that standards are met and adequate information is provided to safeguard the public.

6 Purpose of Product Labeling If a product is found to pose an unacceptable risk to people or the environment, it can be restricted in its use or removed from the market. For example, the use of dichlorodiphenyltrichloroethane (DDT), chlordane, and other pesticides has been banned in the United States.

7 Use of Product Labels by Consumers Consumers generally assume that chemical products are safe if used according to the label directions.

8 Use of Product Labels by Consumers Consumers generally read product labels for the following reasons: If the product is new to them To understand the directions for safe and effective use If there are children or pets in the household If there is a concern for a potential hazard if used incorrectly An accidental exposure has occurred

9 Limitations of Product Labels Difficult to read Fold-out Failure to provide comprehensive ingredient information: full chemical names Chemical Abstracting Service (CAS) numbers proprietary formulations Misinterpreted or non-standard warnings

10 Federal Requirements A product or substance is hazardous when it contains one or more of the following properties: Flammable Explosive/reactive Corrosive/caustic Toxic/poisonous/sensitizer Radioactive

11 Federal Hazardous Substance Act Brand or trade name. (FHSA) Common and/or chemical name: common names of the chemical ingredients; chemical name if there is no common name; both chemical and common names may appear on the label (e.g., bleach and sodium hypochlorite). Amount of contents (e.g., weight or volume).

12 FHSA, cont. Description of hazard and precautionary statements: description of the principal hazard involved in using the product, such as Do not eat, drink, or smoke while using this product, and wash hands thoroughly when finished; may be harmful if swallowed. Harmful vapor work in a well-ventilated area. (A shortcoming of labels is that they do not specify how much ventilation is adequate or (in many cases) what personal protective equipment should be used.)

13 FHSA Description of hazard and precautionary statements, cont: Flammable avoid excessive heat and open flames. Avoid skin contact can be absorbed through the skin wear long sleeves and gloves Avoid eye contact product is an irritant to the eyes; avoid splashing and wear protective goggles. Avoid use if pregnant (indicates a concern that the product could injure the developing fetus). Keep out of the reach of children.

14 Signal Word Informs the consumer about the level of the hazard. The signal word danger appears on products that are extremely flammable, corrosive, or highly toxic (additionally the word poison will appear on these products). The signal words warning (moderately hazardous) or caution (slightly hazardous) appear on all other hazardous substances.

15 Signal Word The word nontoxic lacks a regulatory definition, but it is often used by the manufacturer as a marketing tool. The absence of a signal word implies a nonhazardous product.

16 FHSA, cont. Name and address of manufacturer, distributor. Instructions for safe handling and use (e.g., warnings about where to avoid the use of the product; the amount to be mixed with water; what not to mix with the product). First aid instructions (e.g., do not induce vomiting; if redness persists see a physician; seek medical help immediately).

17 Caution, Warning and Danger The labeling of pesticides, even for household use, falls under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Here, signal words associated with the level of toxicity (based on laboratory studies and oral consumption) include slightly toxic (caution), moderately toxic (warning), and highly toxic (danger)

18 Caution, Warning, and Danger Caution: slightly toxic, more than 1 ounce can be fatal. Any product marketed as a pesticide must at least bear the word caution on the label. Warning: moderately toxic, 1 teaspoon to 1 ounce can be fatal. Danger or poison: Highly toxic, a few drops to 1 teaspoon can be fatal.

19 FIFRA and Pesticides Pesticides are an important public health intervention to control vectors of disease and increase the yields of agricultural products on a global scale. Pesticide use protects the public and our property from species that can produce physical injury to both.

20 FIFRA and Pesticides Concerns exist regarding the potential health risks to the public and the environment because of the extent of pesticide use. Special concern exists about exposures in more susceptible individuals, including pregnant women, the very young or elderly, and those with certain disease states.

21 FIFRA and Pesticides, cont. This concern is reflected by the level of product label detail for these chemicals. The EPA under FIFRA regulates pesticide sale and use in the United States. Pesticides must be registered with the EPA for use, whether that use is residential or commercial and no matter who is applying the pesticide.

22 FIFRA and Pesticides, cont. To obtain a registration number, a pesticide must undergo extensive testing and characterization of its chemical, physical, and toxicological properties. Manufacturing production aspects, toxicology test results, and information on environmental fate are examples of the necessary data requirements to apply for registration.

23 FIFRA and Pesticides, cont. The EPA also conducts risk assessments for pesticides. FIFRA was amended in 1996 by the Food Quality Protection Act (FQPA) to take into account prenatal, infant, and child exposures to pesticides, recognizing that they require additional margins of safety (10-fold) for exposures because of their unique potential health risks and vulnerabilities associated with toxicant insults.

24 Pesticide Product Labeling To comply with EPA guidelines, mandatory statements must appear on pesticide product labels. These mandatory statements include the actions that are necessary to ensure the proper use of the product and to help prevent adverse effects on the applicator, bystanders, and the environment.

25 Pesticide Product Labeling Examples of mandatory statements include directions for the use of the pesticide and precautions needed for the user to take or to avoid specific actions. Wear chemical-resistant gloves when applying this product. Do not apply in windy conditions. Keep away from open flames, sparks, and heat. Do not induce vomiting. Do not use indoors.

26 Pesticide Product Labeling In addition to mandatory statements, advisory statements must be provided on the labeling as well. The statements must not conflict with the mandatory statements and must not be misleading or false or violate any regulatory provisions.

27 Pesticide Product Labeling Advisory statements include the following: This product is best applied within 2 hours of mixing. Spray around the baseboards for optimum coverage. For best results, apply the granules at the base of the ant mound. Common household latex gloves provide adequate protection. This product may discolor carpet.

28 Pesticide Product Labeling: Required Information The name and address of the manufacturer or registrant must appear on the label A restricted use statement (not applicable to the consumer) must appear where a product should only be applied commercially or has a high level of restrictions on its use. The product name, brand, or trademark must be plainly visible on the front label of the product container.

29 Pesticide Product Labeling: Required Information, cont A statement of ingredients must be on the product label and include the percentage of active and inert ingredients. The EPA registration number and EPA establishment number appear on the front of the label.

30 Pesticide Product Labeling: Required Information, cont An appropriate signal word must appear on the front label of the pesticide container. All pesticide labels must have a misuse statement on the label that generally reads use of this product in any manner inconsistent with its labeling is a violation of federal law. A statement for the storage and disposal of pesticides is a labeling requirement as well.

31 Product Labels Are Not Material Safety Data Sheets The product label is not a MSDS. The manufacturers of pesticides and other consumer products can provide an MSDS upon request. MSDSs are not generic and may vary with respect to the accuracy and amount of information contained within them. They should essentially be viewed as documents that contain additional product information that could not be contained within the confines of a typical container label.

32 An MSDS contains information on: Product identification Composition information and/or ingredients Hazardous identifications First aid Fire-fighting measures Accidental release measures Handling and storage Exposure controls and personal protection

33 An MSDS contains information on: (cont.) Physical and chemical properties Stability/reactivity Toxicological information Ecological information Disposal Transport Regulatory information Other

34 Federal Drug Administration Requirements for Labeling We have seen a great increase in use of both prescription and over-the-counter (OTC) drugs in the United States and worldwide, due in part to an aging population. People frequently rely on OTC preparations to self-medicate themselves or their children.

35 Federal Drug Administration Requirements for Labeling Many OTC preparations were once available by prescription only and thus today are relied on to treat many conditions (e.g., pain, allergy, acid reflux, colds, and bronchial asthma). Thousands of generic preparations are available.

36 Federal Drug Administration Requirements for Labeling The enormous market of OTC drugs has been associated with medicine misuse, in part because of failure to recognize the potential risks associated with their use. Part of the blame attributed to: Difficulty associated with reading and understanding product labels Failing eyesight accompanying old age Language barriers

37 Federal Drug Administration Requirements for Labeling In its review of the readability of OTC drug labels, the Food and Drug Administration (FDA) found studies in which a significant number of people 60 and older could not read the print on some labels and some labels even required eyesight much better than normal.

38 Label Enclosures Ingredient name Common uses Things to do before using this medicine Instructions on how to use this medicine Cautions Possible side effects Overdose Additional information

39 Americans are overwhelmed with the complexity of health information. We have hit a point of information overload and the public health message is being diluted, says former Surgeon General Richard H. Carmona, MD, This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively. This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information.

40 Websites American National Standards Institute: California Department of Health Services Food and Drug Branch: LABEL2_CRL_ PDF Clinical Data Interchange Standards Consortium: Gateway to Government Food Safety Information:

41 Websites HL7: U.S. EPA Regulating Pesticides: U.S. FDA: U.S. FDA Center for Drug Evaluation and Research: U.S. FDA Center for Food Safety and Applied Nutrition:

42 Websites U.S. FDA Data Standards Council: U.S. FDA Structured Product Labeling Resources: U.S. HHS Office of the National Coordinator for Health Information Technology (ONC): U.S. NLM, NIH, Environmental Health, and Toxicology Specialized Information Services (SIS). (2005). Toxicology tutorial I.