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The idea of protecting the safety and health of consumers isn’t new. From the beginnings of civilization, people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848, although the first federal biologics law, which addressed the provision of reliable smallpox vaccine to citizens, was passed in 1813.
The revolting condition of the meat-packing industry that Upton Sinclair captured in The Jungle (right) led to a meat inspection law and a comprehensive food and drug law, now known as the Food Drug and Cosmetic Act (FDCA) of 1906. In this chapter, we will examine some of the most significant regulations, explore how regulations come to pass, and discuss the role of the Food and Drug Administration (FDA) in regulations of consumer products.
The FDA's authority to regulate products has changed over time significantly. The agency has inherited new product areas and lost others. New laws and court rulings have reshaped the FDA's powers over these product areas. Transformations in the marketplace have created new regulatory challenges. At times, public health crises have compelled urgent changes, and at other times, reform has taken place slowly through a length and controlled administrative process. Through it all, FDA's steadfast commitment to protecting the public health has remained at the core of all regulatory action.
History of Regulation in the Pharmaceutical Industry
The aim of pharmaceutical regulation is to ensure objective characteristics such as safety, effectiveness, honesty in labeling, accurate reporting of side effects (if any). Regulations do not apply to subjective characteristics such as taste, color, or texture. There are no regulations, for example, that dictate all aspirin tablets to be blue in color. Most of us take quality for granted these days. It was not so long ago that substances such as cocaine could be used as ingredients in soda (Coca-Cola) or over-the-counter tonics (Wikipedia, 2016).
The FDA outlines major milestones of product regulation: www.fda.gov/about-fda/fdas-evolvingregulatory-powers/milestones-us-food-and-drug-law-history
Some of the better-known incidences and the regulations that arose, as a result, are as follows:
- The original Food Drug and Cosmetic Act (FDCA) of 1906. The FDCA is intended to prevent the sale of unacceptable foods and drugs rather than regulate safety or effectiveness.
- The Durham-Humphrey Amendment, passed in 1951, was the first federal law requiring a physician’s prescription for drugs “unsafe for self-medication.”
- The requirement that drugs are proven to be both safe and effective and is supported by "substantial evidence" is the mandate of the Kefauver-Harris Amendments.
- The Orphan Drug Act amended the FDCA as of January 4, 1983, is an act calling for incentives to companies producing orphan drugs (which may benefit only a small number).
- The Drug Price Competition and Patent Term Restoration Act, passed in 1984, made generic drugs more readily available at the same time as providing a way for manufacturers to recoup some amount of pre-patent research costs by factoring research time into the patent life of the drug
- ClinicalTrials.gov was founded in 1999 to provide the public with updated information on enrollment in federally and privately supported clinical research.
Go here to explore more FDA law milestones. List any laws put in place after 2005. Why do you think they were put into law? Are there any unusual laws?
What Causes the Enactment of Regulations?
There are two major influences which trigger the enactment of regulations:
- Consumer tragedy (serious injury, death) resulting from the use of a product
- Advancements in science and technology
Once alerted to either of the above conditions, our lawmakers respond through legislation, and enforcement is assigned to the appropriate government agency. The issue of enforcement is not always clear-cut. Several agencies may enforce regulations in certain sectors – for example, GMOs, which we will discuss in a later chapter. Authority for oversight and regulation of the pharmaceutical industry, however, is quite clear - the primary agency is the Food and Drug Administration (FDA).
Go here to learn how consumers can report problems with FDA-regulated products. Look to the Q&A on the left-hand panel - what kinds of products *doesn’t* the FDA handle?
Welcome to Consumer Safety Guide
Consumer Safety Guide is here to help inform our readers of risks some products, devices, and drugs have on American consumers.
Bottled water manufactured by Whole Foods and sold under the name brand Starkey Spring
The COVID-19 outbreak has brought changes to all aspects of our lives and how
After years of controversy over its popular baby and adult hygiene products, Johnson &
California Occupational Safety and Health Standards Board Receives Update on California Department of Public Health Guidance
Sacramento — The Occupational Safety and Health Standards Board (Standards Board) this evening voted to withdraw the revisions to Cal/OSHA's COVID-19 prevention emergency temporary standards that they had voted to approve on June 3, and that were sent to the Office of Administrative Law (OAL) for review.
The vote was held during a special meeting on June 9 to consider the latest guidance regarding masking from the Centers for Disease Control (CDC) and California Department of Public Health (CDPH). The meeting, attended by members of the public including workers, industry leaders, employers and other stakeholders shared their views on the matter in more than two and a half hours of public comment.
Last November, the Board adopted emergency temporary health and safety standards to protect workers from COVID-19 that went into effect that month. On June 3, the Standards Board voted to adopt revisions due to the changing nature of the COVID-19 pandemic.
Those revised emergency standards were expected to go into effect no later than June 15 pending approval by the OAL within 10 calendar days after the Standards Board rulemaking package submission. At today's meeting, the Standards Board voted unanimously to withdraw the revisions approved on June 3 that are currently at OAL for review but have not yet become effective. Cal/OSHA will review the new mask guidance and bring any recommended revisions to the board. The Board could consider new revisions at a future meeting, perhaps as early as the regular meeting on June 17. In the meantime, the protections adopted in November of 2020 will remain in effect.
The Occupational Safety and Health Standards Board, a seven-member body appointed by the Governor, is the standards-setting agency within the Cal/OSHA program. The Standards Board's objective is to adopt reasonable and enforceable standards at least as effective as federal standards. The Standards Board also has the responsibility to grant or deny applications for permanent variances from adopted standards and respond to petitions for new or revised standards.
The California Division of Occupational Safety and Health, or Cal/OSHA, is the division within the Department of Industrial Relations that helps protect California's workers from health and safety hazards on the job in almost every workplace. Cal/OSHA's Consultation Services Branch provides free and voluntary assistance to employers to improve their health and safety programs. Employers should call (800) 963-9424 for assistance from Cal/OSHA Consultation Services.
Media Contact: [email protected], (510) 286-1161
Employers with Questions on Requirements May Contact: [email protected], or call your local Cal/OSHA Consultation Office
Stakeholders Who Wish to Comment on the Rulemaking Process May Contact: [email protected]
The California Department of Industrial Relations, established in 1927, protects and improves the health, safety, and economic well-being of over 18 million wage earners, and helps their employers comply with state labor laws. DIR is housed within the Labor & Workforce Development Agency
3. Providing a Safe Workplace
Stanford's program for providing a safe workplace for faculty, staff and students includes: facility design hazard identification, workplace inspection and corrective action shutdown of dangerous activities medical surveillance: and emergency preparedness. In addition to this general institutional health and safety policy, additional hazard specific policies and requirements may apply to different work and learning environments at Stanford and will be found in the Research Policy Handbook and at the EH&S Website.
A. Facility Design
Facilities will be designed in a manner consistent with health and safety regulations and standards of good design. Those University departments charged with primary responsibility for the design, construction, and/or renovation of facilities, together with EH&S shall ensure that there is appropriate health and safety review of facility concepts, designs, and plans.
In case of disagreement between EH&S and the cognizant facilities department, the conflict shall be resolved by the Vice Provost and Dean of Research in consultation with the cognizant vice president or dean and the Provost (or designate). The determination of the Vice Provost and Dean of Research may be stayed by the Associate Vice Provost for EH&S pending a prompt appeal to the President.
B. Hazard Identification and Correction
Stanford University encourages employees and students to report health and safety hazards to their supervisors, managers, or EH&S. Employees and students shall not be discriminated against in any manner for bona fide reporting of health and safety hazards to Stanford or to appropriate governmental agencies. Supervisors shall inform students and employees of this policy and encourage reporting of workplace hazards.
Supervisors, both faculty and staff, shall assure that regular, periodic inspections of workplaces are conducted to identify and evaluate workplace hazards and unsafe work practices.
- The frequency of inspections should be proportional to the magnitude of risk posed in the particular workplace.
- Means of correcting discovered hazards and/or protecting individuals from the hazards shall be determined and implemented appropriately.
- Unsafe conditions which cannot be corrected by the supervisor or manager must be reported to the next higher level of management. Any individual, supervisor or manager who becomes aware of a serious concealed danger to the health or safety of individuals shall report this danger promptly to the Department of EH&S and to the faculty, staff and students who may be affected.
C. Shutdown of Dangerous Activities
The Associate Vice Provost for EH&S has the authority to curtail or shut down any University activity considered to constitute a clear and imminent danger to health or safety. In the event of such curtailment or shutdown, the cognizant dean, director or vice president and the Provost (or designate) shall be immediately notified.
In cases of dispute, an order to curtail or shutdown will remain in effect until the Provost or the Vice Provost and Dean of Research (or their respective designates) determine in writing that the danger has passed or been mitigated or that the order should be rescinded for other reasons.
Should the Associate Vice Provost for EH&S disagree with a determination to restore a curtailed or shutdown activity, the Associate Vice Provost for EH&S may promptly appeal the matter to the President. In the event of an appeal, the order to curtail or shutdown shall be in effect until the President determines otherwise.
D. Providing Medical Surveillance
Stanford University shall evaluate and monitor, through a program of medical surveillance, the health of Stanford University faculty, staff and students who are exposed to certain hazardous materials and situations as defined by law or University policy. Each supervisor is responsible for ensuring that employees and students under their supervision participate in the medical surveillance program as required by University policy. EH&S will monitor medical surveillance program participation. Each University department/school shall administer the program for faculty, staff and students covered by University policy.
E. Emergency Response and Preparedness
EH&S coordinates overall emergency response planning for the institution and provides guidelines for departmental emergency response plans. Every department shall have an individual emergency response plan and shall develop business continuity and contingency plans and implement appropriate mitigation programs to reduce the impact of emergency events.
Schools and departments shall maintain local departmental emergency operations centers and communications capabilities according to guidelines in the campus emergency plan. Multiple departments located within individual buildings will jointly develop comprehensive building-based life safety response plans.
Emergency plans shall include evacuation and assembly procedures, posted evacuation maps, reporting and communication practices, training, and drills.
Food safety risks and consumer health
The major food safety risks are not eating a healthy diet, and failure to avoid foodborne illness. Over one billion people in the world suffer from food insecurity and malnutrition. Nutritionally enhanced transgenic crops such as Golden Rice are one potential strategy for reducing malnutrition in the world. Transgenic crops are subjected to a rigorous pre-market safety assessment. The safety of novel proteins and other products is established, and through compositional analysis and animal studies, the safety of any observed changes is evaluated. These studies provide evidence that the new product is as safe as, or safer than, comparable varieties. It must be asked, however, if this rigorous analysis is necessary, because unregulated crops produced by other breeding methods also undergo genetic changes and contain unintended effects. Golden Rice poses infinitesimally small, if any, risk to consumers whilst it has the potential to spare millions of lives each year. However, because it is a transgenic crop, it cannot be deployed without years of expensive pre-market safety review. Paradoxically, if Golden Rice had been produced by less precise conventional methods of breeding, it would already be in the hands of poor farmers. It is concluded that the hyper-precautionary regulatory process applied to transgenic crops works to the extreme disadvantage of the hungry and the poor.
International Consumer Product Health and Safety Organization Conference Keynote Address - Thursday, March 1, 2012, Orlando, Florida
Good afternoon everyone. Michelle, for the second straight year, I want to thank you for that kind introduction.
This outstanding organization is well served by having you on their Board, and CPSC is well served by having your support in the Wisconsin Department of Consumer Protection.
So let's give Michelle a round of applause for all of her efforts to improve the health and safety of consumers.
This is my sixth ICPHSO conference.
Six conferences in less than three years.
I'm doing all I can to keep pace with Marc and Carol and Ross. Also, I want to recognize my colleague, Commissioner Bob Adler, who has attended this conference in Orlando for the past three years.
I have supported ICPHSO throughout my tenure because I believe this is a great forum for CPSC - a great forum for us to engage in a forward-looking conversation with all of our stakeholders.
And with today being CPSC Day, I am especially proud to be here. I am proud of the direction - the forward-leaning direction - that the CPSC is headed.
Since more stringent rules were established in 2008, recalls of toys and recalls of toys due to lead violations have declined 80 percent. This is progress, and it is the result of hard work by CPSC and the toy industry.
Since the Pool and Spa Safety Act went into effect in December of 2008, no child has died from the horrific hazard of a pool drain entrapment. The CPSC staff and I are working hard to maintain a zero death rate from this danger.
Since the strongest standards in the world for cribs went into effect in June of 2011, the sleep environment for babies and toddlers is safer than ever.
Infant walkers, toddler beds, and bed rails now have stronger, mandatory safety requirements, which is another win for children, parents, and caregivers.
Independent, third party testing of children's products is taking place in North Carolina, New Jersey, Illinois, and Tennessee. It is happening in Beijing, Milan, Guangdong, and Jakarta.
Independent testing of children's products is the capstone of CPSC's implementation of the Consumer Product Safety Improvement Act, and it is one of the most important safeguards sought by parents and consumers.
Farther upstream, Chinese companies are starting to incorporate best practices in manufacturing. I have seen it firsthand. I have seen how strollers, toys, ATVs, and fireworks are made in China, and there are signs of progress.
My philosophy is to "take safety to the source." And that philosophy is driving CPSC's efforts to work with Chinese manufacturers to adhere to U.S. standards and build safety into product design.
Back on the home front, unprecedented cooperation with Customs and Border Protection is leading to success at the ports. Toys, teddy bears, hair dryers, Christmas lights, extension cords, jewelry, and fireworks are being caught by CBP inspectors and CPSC investigators.
Products with small parts, missing shock- protection devices, undersized wiring, counterfeit UL labels, high levels of cadmium, and too much flash powder are being caught by our inspectors.
So, what do all of these products have in common?
They never reached store shelves and never reached the hands of consumers.
By being proactive at the ports, CPSC and CBP staff has stopped 6.5 million units of about 1,700 different children's products in 2010 and 2011.
I predict that our import surveillance program will continue to succeed. This is because for the first time we have gained real-time access to a special commercial targeting system operated by CBP.
This is a database that tracks the manifests of shipments headed from ports of call around the world to our shores.
Now we can anticipate when and where a shipment of interest will arrive.
And we have implemented a pilot risk assessment methodology aimed at early detection and targeting of high risk products and repeat offenders. I believe this will make CPSC even more effective in using our limited resources.
Our work at the ports is another win for the consumer and another sign that CPSC is willing and able to stand and protect.
Because of all of these accomplishments, I come before you today and say with confidence that the state of product safety is strong - and it is built to last.
CPSC is the strongest it has been in decades, and I believe we are making a strong contribution to the state of product safety around the world.
We are using our strength not for short-term gains, but to create a sustainable product safety system.
A system built to last through compliance with the stringent safety and testing requirements established by the CPSIA.
A system built to last by creating a regulatory approach that strives for injury prevention rather than reaction.
A system built to last for which future generations will thank us.
What drives me to ensure that CPSC leads at home and on the world stage is my commitment to consumer protection.
Consumer protection is ingrained in the mission and history of the agency. Having a single agency with the authority to protect consumers from flammable fabrics, defective products, and dangerous poisons is at the heart of CPSC's founding.
Through a progressive approach, acting on behalf of the consumer, the CPSC of today is staying true to our roots and to our core values.
Consumer protection has always been ingrained in my years of service to children, and it has been deepened by the people I have met during my time as Chairman.
I have met with countless stakeholders in industry who have expressed that a strong CPSC does a better job at keeping a level playing field for American businesses in the global economy.
I have met apparel makers down South and toy companies from Minnesota and California who are playing by the rules and thriving. But they want foreign manufacturers to be held accountable if they do not play by the same safety rules.
I agree, and I have made this point to our counterparts in the Chinese government.
I have met parents who lost their children due to defective juvenile products, who want the nursery to once again be the safest place in the home. And I heard from more than 12,000 consumers in all 50 states who called for the Commission to approve continuous testing for children's products.
I heard their calls for action, and we responded by strengthening the product safety net.
As President Obama stated earlier this year about the role government should play in consumer protection: "We shouldn't be weakening oversight. We shouldn't be weakening accountability. We should be strengthening it."
I agree with the President.
Some of the cable news shows may offer up sound bites that consumer protection is an approach that invariably hurts the business community. I disagree.
Under my watch, the CPSC has given all stakeholders a voice and a role in the process. The track record of the Commission shows that we have expanded the ways in which the business community can contribute to the setting of standards and the recalls process.
Sometimes the rules are the rules and the outcomes cause concern to the business community but, we try our best to strike the right balance.
Another reason why the President's remarks about the role of the regulator are so important is that we face a disparity in this country.
There is an economic disparity in consumerism and a digital divide across the social strata - a divide that this Administration has been dedicated to closing.
I believe that when it comes to consumer protection, no one, no one, should be left unprotected.
Everyone deserves to be safe in their home by knowing how to make their home safe.
Now, we still have work to do.
CPSC is a global leader in product safety, but we have not perfected our system or accomplished everything that I want to accomplish. So, I would like to speak about three areas of focus during the remainder of my time with you today:
First, I want to talk about CPSC's safety agenda for 2012.
Second, I want to talk about the standards development process, the recalls process, and how they can be strengthened.
And third, I will share my assessment of SaferProducts.gov, because next week marks the one year anniversary.
Many of the talented employees at CPSC - and there are truly many - are working on safety initiatives aimed at making our agency even more proactive in 2012.
The safety agenda I would like share with all of you will guide CPSC in the months and years ahead. It is an agenda that advances consumer protection.
High on the agenda are a series of projects that, once completed, have the potential to save hundreds of lives and prevent thousands of injuries each year.
Continued federal rulemaking for juvenile products. Last month, the Commission voted unanimously to approve a brand new standard for bed rails. Next up to be approved is a final rule for play yards. And also this year, standards are in the works for bassinets and cradles, strollers, and infant carriers. Our dedicated professional staff will continue to work closely with ASTM, so that we can stay on track and start two new rulemakings every six months, which is required by the CPSIA. During my tenure, the CPSC has approved new rules on baby cribs, toddler beds, infant walker, baby bath seats, bed rails, and product registration cards.
We are also continuing to work on portable gas generators, which were involved in 676 carbon monoxide related deaths in the United States between 1999 and 2010. Our mechanical engineers are working with college engineers to develop a cut-off switch that will shut down a generator if oxygen levels are depleted in a contained space. We have required a danger label that says, "Using a generator indoors can kill you in minutes." But, the fact that we are still seeing a high number of deaths and injuries associated with portable generators means that we need to explore technical solutions that can save lives.
Recreational off-highway vehicles are a popular off-road product in the United States, but they come with risks - risks compounded by the fact that these vehicles allow for passengers. There have been more than 170 deaths over the past nine years related to the use of these off-road vehicles. We started rulemaking in December 2009, and we are moving toward a proposed rule to make these vehicles safer - safer in terms of occupant protection, stability, and steering performance.
All-terrain vehicles also remain a serious concern to the agency and to me. With more than 700 deaths per year, ATVs are the second most deadly product we oversee. We have been doing grassroots education and technical research for years. And this summer, we will consider a final rule aimed at providing young riders with greater protections.
Upholstered furniture is involved in tens of thousands of fires and hundreds of deaths each year in the United States. And, we know that 90 percent of the addressable deaths are related to smoldering fires, such as those caused by cigarettes. CPSC staff has proposed a rule that would limit the fire spread in upholstered furniture without the need for manufacturers to use flame retardant chemicals. This rule has the potential to be one of the top lifesaving rules in CPSC's history. After 16 years of the agency trying, I am committed to pursuing the approval of a final rule while I am Chairman.
There are two fairly new rulemakings that I also want to share with you, because they address very serious risks.
First, is table saws. Would you believe that 11 people suffer amputations every day in the United States from using power saws that cut wood? It's true. We are exploring solutions at CPSC to save people from these life-altering injuries, and we are still seeking comments from our stakeholders on how the safety of these products can be improved.
The other is gel fuels and firepots. In December, the Commission voted unanimously to publish an advance notice of proposed rulemaking, just months after nearly all bottles of pourable gel fuel used in firepots were recalled. The ANPR was prompted by the number of serious injuries and deaths. We are aware of 65 incidents that have resulted in two deaths and at least 34 victims who were hospitalized. The victims had second- and third-degree burns of the face, chest, hands, arms or legs, after ignited gel fuel splattered on them. The ANPR is exploring the question of whether it is even possible to make gel fuel safe for consumers to use.
A common attribute that runs through all of the product hazards I just discussed is that we have team leaders and technical staff at CPSC who are experts in their field.
I'm proud of the work they are doing, and I know they want to bring closure to their projects, in order to advance consumer safety in these areas.
I know they want to prevent injuries and deaths from defective juvenile products, rollovers, crashes, CO poisonings, fires, and finger amputations.
I just focused on the mandatory standards work we are doing at CPSC. Now, I want to focus on the voluntary standards and voluntary recalls processes.
Let's start with voluntary standards.
As exemplified by the Chairman's Circle of Commendation Award that I presented to Kathie Morgan and Len Morrissey, the ASTM F15.18 subcommittee has set the bar very high for how an SDO can work in partnership with CPSC.
This subcommittee has been instrumental in adopting tough, new voluntary standards for children's nursery products, especially cribs.
Nothing is more important than the safety of babies in these products. And the standards that this subcommittee helps create are intended to ensure that babies are safe when placed to sleep.
We have the strongest crib safety standard in the world, not just because of the CPSIA, not just because of CPSC, but because CPSC worked side by side with ASTM.
When I met with the subcommittee members to lay out my vision for the scope and timing of achieving a mandatory rule, they got it.
They understood how important their work would be in the process. They understood how important their work would be in preventing child fatalities.
The standard that CPSC approved in December 2010 was based to a large extent on the great work done by this ASTM subcommittee.
And their mandate extends beyond cribs. Their work on toddler beds was vital to the new rule we just approved, and we are working with their standard to finalize the upcoming play yard rule.
We have years of work ahead of us to turn all of the voluntary juvenile product standards into mandatory standards, pursuant to the CPSIA.
Our experience with cribs is still a shining example of how CPSC and the standards community can form a successful partnership.
Turning from juvenile products to jewelry and toys, ASTM - once again - delivered new, child-protective standards.
I am thankful that the Fashion Jewelry and Accessories Trade Association and the Toy Industry Association were all supportive of new ASTM voluntary standards for cadmium and other toxic metals in both surface coatings and substrates of children's jewelry and toys.
At my urging, the ASTM children's jewelry and F963 subcommittees approved these voluntary standards in December of last year.
Brent Cleveland from FJATA and Joan Lawrence from TIA did a very good job of leading these two subcommittees and incorporating the viewpoints of a variety of stakeholders.
I appreciate the determination that both subcommittees displayed in carrying out their work.
For the past two years, I have been warning manufacturers about substituting cadmium or other toxic metals in place of lead.
And I believe that the proactive steps we have taken in China, at the ports, and in the standards environment have stopped cadmium from being the next lead.
Now, we have standards for both toys and children's metal jewelry, reinforcing my warning to manufacturers about the hazards of cadmium and other toxic metals.
Strong standards are the pathway to safer products, and children's jewelry and toys will be safer thanks to these efforts.
And, more importantly, children using and playing with them will be safer thanks to these efforts.
To me, that is forward progress.
An example of a standard that is in the works, and that I believe is on the right track, is the ANSI standard on gas fireplaces.
During the past decade, there have been hundreds of burn injuries, many involving second and third degree burns, to children who touched the unprotected glass of a gas fireplace.
The glass can reach temperatures between 400 and 1,000 degrees. Can you imagine the pain that those children experienced?
Well, in January, the Hearth, Patio, and Barbeque Association visited with the Commissioners and me to announce that they would support a revision of the ANSI standard to include a protective barrier.
And, the Association said they would push for the barrier to be available as a retrofit for existing gas fireplaces.
This was great news and a sign of an association that gets it.
As I shared with the association, I want to see the revised standard apply to vented and unvented fireplaces. And it is critical that installers attach the shield if it comes unassembled with new products.
But overall, I am encouraged that we will see a standard this year that will prevent horrible burn injuries to children.
So, I have shared examples of the good now, let's talk about where advancements in safety could be made in the voluntary standards world.
During my tenure, TV and furniture tip-over incidents have been a special concern to CPSC. One child dies every two weeks from a TV or furniture tip-over incident.
And more than 22,000 children younger than 8 end up in emergency rooms from tip-over incidents each year.
Through our "Anchor it and Protect a Child" campaign, we are trying to use education to prevent this hidden hazard.
But, I believe that education alone is not the solution.
Both UL and ASTM have standards for furniture stability.
But I urge both SDOs to look for ways to:
strengthen the stability standards for children's and adult furniture
explore a stability standard for televisions and
evaluate whether manufacturers and retailers are doing all they can to provide consumers with safety straps and anchors.
I know that this is a challenging issue that involves old and new TVs, and old and new furniture, but let's try to work together to tackle the problem from all angles.
Our children deserve no less.
Next, I want to talk about window coverings.
After more than 500 strangulation deaths of children and the recall of tens of millions of blinds and shades over the past three decades, window blind safety is in great need of improvement.
The Window Covering Manufacturers Association, working through the ANSI process, spent last year working to come up with a set of revised standards.
There was optimism that after years and years of prior revisions that fell short of eliminating the risk of exposed looped cords, this new push might get the job done.
At this moment, WCMA is evaluating the votes and comments to see whether their ballot can be approved. I call upon WCMA to give serious consideration to all of the comments they received - especially those from CPSC's window covering expects, and even those tied to a negative vote.
Unfortunately, the revised ANSI standard does not go far enough to support cordless solutions or shrouded lift cords. And it does not adequately address the problems with tension devices.
As I told the industry just days ago, we still need to work together to "design out" the strangulation hazard in future work on the standard. And I appreciate the industry's willingness to keep an open dialogue.
The CPSC's work on window blind safety will continue at an aggressive pace, so that the agency and the industry can reach consensus on how to design out the risk of strangulation.
I am encouraged that the industry has new, innovative designs that can meet this challenge.
I want to make an appeal to the innovators of cordless blinds and shades with hidden lift cords, I say, keep on pushing, keep on working to bring your products to the market.
You can do it. You represent the best of American ingenuity.
Parents with young children deserve the right to a home free from this hidden hazard, and your products can make that a reality.
There are other examples where CPSC has stepped up and taken the lead, where we believe the voluntary standards process is not getting the job done.
With table saws and recreational off-highway vehicles, we stepped in and started federal rulemaking. There is ongoing voluntary standards work with both of these products, but CPSC staff believes that we have ability to come up with federal standards that will create even safer products.
Now let's turn know to the voluntary recall process.
I believe that the majority of recalls we announce are well done. They are done cooperatively, and they provide important safety information to consumers.
But, we know that recall effectiveness is still a challenge for both the CPSC and industry.
If we reach affected consumers with information about a recall one time, they may feel informed but if we reach consumers two or three times, then they may respond.
So, I commend those who are using Facebook, who are tweeting, or who are producing YouTube videos to reach consumers. And, I commend those who work cooperatively with CPSC as we try to use blogs and our social media tools to spread the word.
My promise to you is that we will be fair and we will be accurate.
If you accuse us of violating 6(b), when we have not been unfair or inaccurate, then we will stand our ground.
The old notion of alerting consumers just through the four corners of the recall press release does not reflect current thinking.
We need to keep pace with the evolving ways consumers receive and process information.
Recalls can be more effective if we communicate better, and to a broader audience. Recalls are done for a point - a very important safety point.
I believe we can adhere to 6(b), give proper consideration to the interests of your company or your clients, and still do a better job of generating higher response rates.
About 400 times a year, we work together to announce corrective action programs. Let's get the best results possible from all of the work both sides put into the process.
Finally, I would like to update you on the progress we have made with the SaferProducts.gov website. Next week, we will celebrate the one year anniversary of the site.
During the past year, we have posted more than 6,300 reports of harm or potential reports of harm and 3,800 comments from manufacturers.
We have processed about 675 material inaccuracy claims, with the majority involving the consumer naming the wrong manufacturer. We can handle those claims easily.
Kitchen, home maintenance, furniture, and baby products are the top four product areas that consumers reported on via the website.
To answer the question of who is visiting the site and who is filing reports?
The answer is consumers overwhelmingly - just as I expected.
And even prior to the passage of the CPSIA amendment bill by the Congress, we were seeing that 80 percent of the reports included specific product information, such as the model number.
Our most recent data indicates that we are now up to 86 percent of reports contain the model number.
I appreciate that many companies are using their right to comment as a means to educate consumers.
Some of the comments inform consumers that their product has been subject to a recall, and other comments provide information about why a company believes its product is safe.
What is key - and I said this before the database was launched, and I want to restate it again today - if you work for a company that CPSC regulates, and you have not registered on the SaferProducts.gov Business Portal, you should do so right away.
Every regulated business deserves the full due process that our database rule affords you. But, if you are not registered to receive electronic notification of a report of harm, then it will take away from the amount of time you have to respond to CPSC.
Now, there are other benefits to registering in the Business Portal that I hope you know about.
You can use the site for Section 15 reporting.
You can use the site for retailer reporting.
And qualified small batch manufacturers can use the site to register to receive relief from certain third party testing requirements.
I believe SaferProducts.gov is doing the job of informing consumers in a way that is empowering them. I also believe the site is helping to make CPSC be more accessible to the public and letting the sun shine in.
We will continue to make improvements so that the site serves the business community and consumers even better.
And we will continue to work on integrating the data from SaferProducts.gov with all of our other systems, so that we can connect the dots faster in finding emerging hazards.
In closing, I believe that prevention must win out over reaction - from manufacturing to distribution, industry, consumer advocates, and CPSC should continue to work cooperatively to prevent injuries.
I predict that the year 2012 will be another successful year, especially if everyone rallies around this approach of being "Proactive for Prevention."
I know that each of you is up to the challenge, because many of you already have a corporate or organizational mission that is committed to the well-being of consumers.
At CPSC, we are proud that this is a time when parents and grandparents can stand in toy stores and know that the products they see have been independently tested.
This is a time when consumers have unprecedented access to safety information at the tips of their fingers.
This is a time when foreign regulators and foreign manufacturers understand the requirements established in the United States, and know that there are consequences for not following our rules.
This is a time when the American consumer is being well represented by their government and is being better protected by a global system of safety that is getting stronger.
Together, we are building a product safety system that is built to last - built to last so that future generations of children and other consumers have an even greater level of safety.
Thank you all for you time, and congratulations to ICPHSO for organizing another great conference.
This review identified a number of gaps in the research evidence. First and foremost, as interventions are developed to improve the organizational climate, rigorous research and evaluation studies need to be conducted. It is important to note, however, that this type of research will not often lend itself to randomized controlled trials. Other epidemiological designs that control for confounding variables and ensure comparability between groups will most likely be needed. Second, future research aimed at understanding the impact of human capital variables (i.e., stability of the workforce, education, etc.) on patient outcomes and system efficiencies is warranted. Furthermore, consistency in measurement tools would help advance the field and assure that study results are more consistent and comparable.
Lastly, more cost analyses need to be conducted to make the business case for improving the organizational climate in nurses’ work environment and improving patient, employee, and organizational outcomes. The model provided presents various aspects of organizational climate that may be measured in different research projects, across a research portfolio, and in various settings. It is doubtful that any one study would include all aspects presented in this model. Rather, the researcher may use this model to select the organizational aspects and outcomes most appropriate to their research aims.
Organizational climate is one of the overarching aspects found in the work environment. However, it is not the only aspect related to patient safety and worker satisfaction and turnover. Other environmental aspects include actual workload, such as nurse-to-patient ratios in acute and long-term care and caseloads in outpatient settings scheduled work hours (e.g., shift length, nights versus days) mandatory overtime information systems for decision support to prevent errors of commission and omission and human factor engineering solutions. The impact of these other aspects of the work environment is discussed elsewhere in this volume.
There are both strengths and limitations to this review. In our search for evidence we attempted to be comprehensive. However, we may have missed some studies. Additionally, only primary studies published in English after the year 2000 were audited.
Washington, D.C. -- The U.S. Consumer Product Safety Commission (CPSC) and Fisher-Price are announcing the recalls of the Fisher-Price 4-in-1 Rock ‘n Glide Soothers and 2-in-1 Soothe ‘n Play Gliders. There have been reports of four infant deaths in the 4-in-1 Rock ‘n Glide Soother. The infants were reportedly placed on their backs unrestrained in the product and later found on their stomachs. These incidents occurred between April 2019 and February 2020. The fatalities were a 4-month old from Missouri, a 2-month old from Nevada, a 2-month old from Michigan and an 11-week old from Colorado. There have been no fatalities in the 2-in-1 Soothe ‘n Play Gliders.
“These types of incidents are heart-breaking,” said Acting Chairman Robert Adler. “Loving parents put their babies in these products never expecting a tragedy. Inclined products, such as gliders, soothers, rockers and swings are not safe for infant sleep, due to the risk of suffocation.”
“There is nothing more important to Fisher-Price than the safety of our products and the trust that families put in us,” said Chuck Scothon, General Manager of Fisher-Price. “These incidents are indeed heart-breaking. We are committed to educating parents and caregivers on the safe use of all of our products, including the importance of following all warnings and instructions to ensure the health and safety of babies and children.”
This recall involves CHP56, CHP55 and CBT81 4-in-1 Rock ‘n Glide Soothers. This recall also involves the GDD28, GDD39, GDD41, GGW85, GNX43, GVG43, HBD26 and HBD27 of the 2-in-1 Soothe ‘n Play Gliders. HBT17 is sold in Canada only. The products have two use modes: A powered glider seat and an infant rocker. In both modes, the product can move in a head-to-toe or side-to-side motion. The model number is located on the underside of the base.
Approximately 120,000 4-in-1 Rock ‘n Glide Soothers and 55,000 2-in-1 Soothe ‘n Play Gliders were sold at juvenile product stores and mass merchandisers nationwide and online, including Walmart and Target stores and Amazon.com. The 4-in-1 Rock ‘n Glide Soothers were sold from January 2014 through December 2020, for about $108. The 2-in-1 Soothe ‘n Play Gliders were sold from November 2018 through May 2021, for about $125.
Approximately 25,000 4-in-1 Rock ‘n Glide Soothers and approximately 27,000 2-in-1 Soothe ‘n Play Gliders were also distributed in Canada.
Consumers should immediately stop using the recalled products and contact Fisher-Price for a refund. To obtain a refund, consumers should visit Fisher-Price online at www.service.mattel.com, and click on “Recall & Safety Alerts,” or call toll-free at 855-853-6224 from 9 a.m. to 6 p.m. ET Monday through Friday.
CPSC continues to emphasize that the best place for a baby to sleep is on a firm, flat surface in a crib, bassinet or play yard. Parents and caregivers should never add blankets, pillows or other items to an infant’s sleeping environment. Babies should always be placed to sleep on their backs.
The Cancer Prevention and Control Program
We here at the Cancer Prevention and Control Program are very interested in how normal and disrupted circadian rhythms affect a person's general health and whether disrupted or altered sleep patterns are a risk factor for various types of cancer. Our researchers are currently performing novel research in this area, which has received growing attention in the public health research community recently.
Ongoing and Completed Studies
Funding Source: US Department of Veterans Affairs, Office of Research and Development, Clinical Science Research and Development Program
This randomized, sham-controlled, pilot intervention trial will examine whether heart rate variability biofeedback improves parasympathetic tone and ameliorates pain, stress and insomnia among Veteran patients with chronic, neuromusculoskeletal pain.
Funding Source: Greenville Health System Cancer Institute
This study will test the hypothesis that heart rate variability biofeedback (HRV-B) restores autonomic balance and has the effect of reducing pain and related symptoms among cancer survivors. The specific aims are to: (1) conduct a randomized, controlled, pilot intervention trial to determine whether HRV-B increases HRV coherence among cancer survivors (minimum N of 20 [10 per group], up to 100 total [50 per group]) (2) determine whether HRV-B reduces pain, stress, fatigue, depression or insomnia among cancer survivors and (3) determine whether an increase in HRV coherence reduces pain, stress, fatigue, depression or insomnia in the study population.
Funding Source: Department of Veterans Affairs, Health Services Research and Development
This retrospective cohort study utilizde pre-existing, de-identified data to test the hypothesis that sleep disorder diagnoses among Veterans are associated with an increased incidence of prostate, breast, colorectal or total cancer.
Co-Principal Investigators: Susan Steck and Jim Burch
Funding Source: National Cancer Institute
This case-control study examined whether circadian disruption or dietary factors influence methylation of specific cancer-related genes, including clock genes, among individuals with adenomatous polyps and controls.
Carnivorous Plants – Producers or Consumers?
Are carnivorous plants, such as the Venus fly-trap and pitcher plant, producers or consumers?
Carnivorous plants are found predominantly in heavily forested regions, notorious for low levels of nutrients. These plant types are the perfect example for showing how the different levels and categories of a food chain are in constant motion and never absolute.
Evolution has produced plants which can collect additional nutrients (mainly nitrogen) through the slow digestion of insects caught via ingenious traps. However, carnivorous plants are able to survive without catching prey, although their rates of growth will be negatively affected. This shows that carnivorous plants are predominantly producers, but able to step outside of this box and simultaneously act as consumers.