|ASTM Subcommittee D10.31 and Poison Prevention
by Lori Mitchell Dixon, Ph.D.
Last year, nearly 2.25 million calls were placed to the 65 Poison Control Centers in the United States. In more than half of these cases, the call was made because of an incident involving a child under 6 years of age. As a result, poison prevention education is aimed at two goals: teaching heads of households to safeguard their homes against accidental poisonings, and continually developing and improving safety packaging. ASTM Subcommittee D10.31 on Child-Resistant Packaging and Closure Systems, part of Committee D10 on Packaging, is involved in both efforts.
Between 1972 and 1999 (the last year comparable statistics were accumulated), accidental fatal poisonings among children under the age of five were reduced by 87 percent. This translates into nearly 200 fewer poison-related fatalities in 1999 relative to 1972 (see graph).
In an effort to further reduce these fatalities, the American Association of Poison Control Centers, in association with the Centers for Disease Control and Prevention and the Health Resources and Services Administration, instituted a single, national toll-free phone number on Jan. 30, 2002. Regardless of location in the United States, dialing 1-800/222-1222 will connect the caller to the regional Poison Control Center serving the callers geographical area that can provide emergency treatment advice and poison prevention information.
Prior to the announcement of this new number, research showed that, although the public was aware of the existence of Poison Control Centers, few knew the phone number or had it readily available. Implementing a single national phone number appears to have been well received. In the first month, 44,000 Americans used the service. Supporting this move in prevention, Dr. Alan Woolf, former president of the American Association of Poison Control Centers and director of the Regional Center for Poison Control and Prevention serving Massachusetts and Rhode Island, cited a study indicating that every dollar spent on a Poison Control Center results in a seven-dollar savings in otherwise unnecessary medical care. This fact alone clearly shows the value of making Poison Control Centers more easily accessible to those in need.
These encouraging statistics, showing reductions in fatalities and increased use of life-saving information, reflect decades of work on the part of many activists to bring these issues to the forefront.
The first awareness and recognition of accidental ingestion of harmful substances by children occurred in the mid- to late-1940s, following the introduction of flavored aspirin in 1943. The Poison Control Center movement was started in Chicago in 1953. The first documented study of safety closures came out shortly after, around 1955. The first article related to safety closures was published in the Journal of the American Medical Association in 1959. Around this same time, safety closures first appeared on the market on aspirin products.
It became apparent that protecting American children from accidental poisonings would require more than safety packages. The need to create national awareness of the dangers that exist in many homes, and the need to provide information about how to use and store poisons appropriately, were identified.
On Sept. 26, 1961, Public Law 87-319 was approved. This law authorized and requested [the president] to issue annually a proclamation designating the third week of March as National Poison Prevention Week, to aid in encouraging the American people to learn of the dangers of accidental poisoning and to take such preventive measures as are warranted by the seriousness of the danger. Poison Prevention Week was first observed in 1962.
In November 1966, the Food and Drug Administration hosted a conference on childrens aspirin and ingestion. The conclusion and recommendation from this conference was to have a thorough investigation of standards and performances of safety closures carried out by a representative committee of government scientists, pediatricians, and industry experts. The FDA commissioner appointed the committee under the chairmanship of Dr. Edward Press.
The Press Committee, as it became known, worked over a four-year period, conducting tests and studies that led to a recommended performance standard and protocol testing scheme for safety packaging. These recommendations laid the groundwork for the requirements that became public law as the Poison Prevention Packaging Act of 1970. In 1971, the first regulated substance became aspirin-containing preparations for human use.
The work of these leaders continues today. In March 2003, the 42nd observation of National Poison Prevention Week resulted in community events across the nation that reminded the public of the need to take an active role in safeguarding children against accidental poisonings by properly storing and using hazardous products. The 2004 observation, March 21-27, will also be marked with community events aimed at creating awareness of the role everyone plays in keeping homes safe for children.
D10 Subcommittee Involvement
Individual ASTM D10.31 members have been involved in promoting NPPW through their work on the NPPW Council for many years; the 2004 celebration will highlight the active involvement of the entire subcommittee. D10 member Bill Bradley served as the councils chairman for two different terms, 1982-1983 and 2000-2001. Peter Mayberry, also a D10 member, currently serves as council chairman. In 2000, D10.31 chose to become involved in NPPW by appointing Lori Mitchell Dixon, Ph.D., to serve on the NPPW Council and spearhead a task force of the D10.31 subcommittee. This task force is committed to encouraging its members to find ways to bring the messages of NPPW into their own community or workplace.
In the first year of the task forces involvement, several task force members have spearheaded events in recognition of NPPW. Not only is D10.31 helping spread the message of parental diligence, it also has been instrumental in the development of, and providing information about, child-resistant packaging.
The theme for NPPW is Children Act Fast
So Do Poisons. Although the message is simple, it reinforces the true purpose of safety packaging. Safety packaging, required for about 30 different household substances, is technically referred to as child-resistant packaging the focus being on the word resistant not child-proof. The goal of the packaging is to give caregivers a few extra seconds to react to fast-acting children who are inquisitive and exploring the house.
Even though educational campaigns are constantly reminding us to keep hazardous materials away from the quick hands of toddlers, children still get access to these substances. Many accidents happen while visiting homes that might not typically have young visitors. Sometimes products are not closed correctly after use. Regardless of the situation, when children come in contact with these packages, they tend to focus on getting access to the contents. Child-resistant packages are designed to be hard for children to open and easy for adults and seniors to use correctly. Hard to open is defined as taking more than 10 minutes for the majority of children. If the package is not opened in a 10-minute time period by 80 percent of the 42- to 51-month-old children tested, the package is considered to be child-resistant.
Subcommittee D10.31 on child-resistant packaging began work in the early 1970s, to develop the original testing protocol. On Oct. 5, 1990, the Consumer Product Safety Commission issued a proposed rule that would change the original protocol test methodology used to define the performance criteria in order for a package to be considered child-resistant.
The rationale for this proposed change was that some people, especially older adults, find certain types of child-resistant packaging difficult to open and close properly. For this reason, a number of people either purposely purchase products in packages that are not child-resistant or do not properly close the package after the initial opening. The premise was that if these difficult-to-use packages were replaced with packages that were easier to use, more people would purchase and properly use child-resistant packaging, resulting in further reductions of child poisonings. To accomplish this goal, a panel of 100 older adults, aged 60-75 years, would replace the current panel of 18- to 45-year-olds; the time allowed to open and close the package would be reduced from five minutes to one minute.
Subcommittee D10.31 took an active and aggressive role in responding to these proposed changes. Between October 1990 and October 1994, the subcommittee and related task force held nearly 40 meetings to develop a response to the proposed changes. These meetings included several with CPSC technical staff personnel and presentations to the CPSC commissioners.
In order to base the ASTM response on actual test data, D10.31 worked with the ASTM Institute for Standards Research to conduct a research project. For this effort, member companies provided $162,000 in funding that allowed the testing of two different types of child-resistant packages. The testing was completed at four different test agencies with a total of 3,200 senior adults being tested during the course of the research study.
The ASTM test data and official written response to the CPSC laid the groundwork for the compromises that were reached between CPSC and the industry for the senior adult age range. The final regulation, published in the Federal Register on July 21, 1995, stipulated a senior adult panel with an age range of 50-70 years. In addition, an oral comment proposal from a D10.31 member company led to the final senior adult testing scheme of two separate test periods of five minutes and one minute.
D10.31 currently oversees nine test methods for evaluating various physical characteristics of certain child-resistant package types. The subcommittee also maintains and publishes a Classification of Child-Resistant Packages (D 3475) that is a reference for the industry, used by both the CPSC and the Environmental Protection Agency.
Child-resistant packaging is, all factors considered, quite impressive. Consider that, upon first exposure to a new package, seniors are able to read the directions and open the package in an average of 11.7 seconds, across a variety of child-resistant package types. On the second exposure to the same package, the average number of seconds to open the package drops to 6.4 seconds. These same packages confound the busy fingers of most pre-schoolers for more than 10 minutes.
Unit dose packaging, such as pouches or blister cards, typically causes a little more frustration for senior adults, with most (across all child-resistant designs) taking an average of 36.1 seconds upon first exposure to access the first cavity. Once they have become familiar with the design, the number of seconds to open the first cavity drops to 18.2 seconds.
As we continue to see new innovations in package designs and due diligence in spreading the word about safeguarding our children through proper use and storage of hazardous materials, our goal is to involve more people in taking the message of NPPW to their communities. Whether it is through reminding our co-workers to take a few minutes to clean out the products and check the security of the containers stored under the kitchen sink, or taking the Poison Prevention Game to your local preschool, we can all support the mission of our fellow ASTM members who are designing safety packages and trying to remind our friends and neighbors of the important message that children act fast
so do poisons. //
Copyright 2004, ASTM International