Q: Are the 2009 H1N1 influenza vaccines safe?
A: The 2009 H1N1 vaccines have undergone all the safety testing and quality checks that are usually done for other vaccines. We expect the 2009 H1N1 influenza vaccine to have a similar safety profile as seasonal flu vaccines, which have a very good safety track record. Over the years, hundreds of millions of Americans have received seasonal flu vaccines. The most common side effects following flu vaccinations are mild such as soreness, redness, tenderness, or swelling where the shot was given.
The CDC and the Food and Drug Administration (FDA) will be closely monitoring for any signs that the 2009 H1N1 vaccine is causing unexpected adverse events, and will work with state and local health officials to investigate any unusual events.
Q: How will the 2009 H1N1 influenza vaccines be monitored for safety?
A: CDC and FDA closely monitor the safety of all vaccines licensed for use in the United States in cooperation with state and local health departments, healthcare providers, manufacturers, and other partners.
The purpose of vaccine safety monitoring is to quickly identify significant adverse events following immunization that may be worrisome enough to consider changing vaccine recommendations. Adverse events, or health problems, following immunization may be coincidental to (meaning occurring around the same time but not related to vaccination) or caused by vaccination. CDC and its partners are using multiple systems to monitor the safety of 2009 H1N1 influenza vaccine.
CDC also is collaborating with partners through the Emerging Infections Program to enhance monitoring of Guillain-Barre' syndrome (GBS) during the 2009-10 flu season.
Q: How can adverse events following vaccine administration be reported?
A: Clinically significant adverse events that follow vaccination should be reported to VAERS, which is a U.S. vaccine safety surveillance system co-managed by CDC and the FDA. Reporting forms are available online. In addition, reporting forms or other assistance can be obtained by calling 1-800-822-7967.
Q: Is the 2009 H1N1 influenza vaccine safe for pregnant women?
A: Flu vaccines have not been shown to cause harm to pregnant women or their babies. The seasonal flu shot has been recommended for pregnant women for many years. The 2009 H1N1 flu vaccine is being made the same way as the seasonal flu vaccine. Studies that test the 2009 H1N1 flu vaccine in pregnant women began in September.
Q: Can pregnant women receive the nasal spray vaccine?
A: The nasal spray vaccine is not recommended for use in pregnant women. Pregnant women should not receive nasal spray vaccine for either seasonal flu or 2009 H1N1 flu. After delivery, women can receive the nasal spray vaccine, even if they are breastfeeding.
Q: What is thimerosal and does the 2009 H1N1 influenza vaccine contain thimerosal?
A: Thimerosal is a mercury-based preservative that has been used for decades in the United States and internationally in multi-dose vials (vials containing more than one dose) of some vaccines to prevent the growth of microorganisms, such as bacteria and fungi, which may contaminate them.
The 2009 H1N1 influenza vaccines that FDA licensed are manufactured in several formulations. Some are produced in multi-dose vials and contain thimerosal as a preservative. Some 2009 H1N1 influenza vaccines are also produced in single-dose units and do not contain thimerosal. Nasal spray is produced in single-dose units and does not contain thimerosal.
Q: What is a vaccine adjuvant and will the 2009 H1N1 influenza vaccines that are currently recommended contain adjuvants?
A: A vaccine adjuvant is a substance that is added to the vaccine to increase the body’s immune response to the vaccine.
Vaccine adjuvants will not be used in the United States during the 2009-10 flu season. This includes all of the 2009 H1N1 and seasonal influenza vaccines that will be available for children and adults in both the injectable and nasal spray formulations.
Q: How will the federal government determine whether people who receive the 2009 H1N1 vaccine have an increased risk for Guillain-Barre' syndrome (GBS)?
A: CDC, FDA, and other federal agencies are tracking GBS through VAERS and several other safety monitoring other systems. In VAERS, scientists will assess whether reports of GBS are more common among reports received for H1N1 vaccine compared to seasonal flu vaccine or other vaccines. At the same time, CDC and others are working with neurologists, the medical specialists who see most GBS cases, to encourage reporting of GBS cases through VAERS.
Another system tracking GBS is the Vaccine Safety Datalink project, or VSD. Analysis of VSD information will determine if GBS is more common among people who have received H1N1 vaccine than among people that have not received it. CDC, in collaboration with neurologists, academic centers and state health departments, is also tracking GBS disease among persons in 10 states who are part of CDC's Emerging Infections Program.
If there is an increase in the number of reported cases, public health officials will conduct intensive investigations. If any problems are detected with this 2009 H1N1 vaccine, they will be reported to health officials, healthcare providers, and the public, and health officials will take needed action to ensure the public’s health and safety.
Q: Are there some people who should not receive 2009 H1N1 vaccine?
A: There are some people who should not get a flu vaccine without first consulting a physician. These include:
- People who have a severe allergy to chicken eggs.
- People who have had a severe reaction to an influenza vaccination.
- Children less than 6 months of age (influenza vaccine is not approved for this age group).
- People who have a moderate-to-severe illness with a fever (they should wait until they recover to get vaccinated).
Q: I am allergic to eggs. Can I get the 2009 H1N1 influenza vaccine?
A: People who have a severe allergy to chicken eggs are among certain groups of people who should not get any flu vaccine (regular seasonal flu vaccine or 2009 H1N1 flu vaccine) without first consulting a physician. This is because both regular seasonal flu vaccine and 2009 H1N1 flu vaccine are made using eggs and each type of vaccine contains tiny amounts of egg protein. Your doctor can best decide if the potential risks of receiving the flu vaccine outweigh the benefits of protection against the flu.
Nearly $1 Million in Fines During Statewide Enforcement of California Carwash Industry
Investigators from the California Labor Commissioner’s Office issued over $900,000 in fines to businesses in the car wash industry in a two-day statewide enforcement sweep which began on October 28. The enforcement sweep involved 42 investigators who conducted 230 car wash inspections and issued 141 citations against 103 car wash businesses with citations issued totaling $916,711. Included in the penalties was a total of $600,900 issued to 76 unlicensed carwash businesses that were cited for not having a registration.
“Requiring carwash businesses to register with the state allows us to focus on those businesses that undercut their competition, which makes it difficult for legitimate carwash businesses to stay in operation,” said California Labor Commissioner Angela Bradstreet. “As part of the underground economy, these illegal businesses often do not pay state taxes, and take advantage of employees by not providing workers’ compensation coverage or paying proper wages.”
Investigators found 49 businesses that failed to provide workers’ compensation coverage for their employees. Citations issued totaled $240,000 and businesses without workers’ compensation coverage were issued stop work orders, which prevents them from operating with employee labor.
Also found during the investigations were 12 cases where the employer did not provide employees a wage deduction statement, one case of improper payment of minimum wage, and one case of improper payment of overtime. Two businesses were found to have hired minors without having the required work permits on file.
The statewide enforcement action included the counties of Alameda, Butte, Contra Costa, Fresno, Humboldt, Imperial, Kern, Los Angeles, Monterey, Napa, Orange, Riverside, Sacramento, San Bernardino, San Diego, San Francisco, San Joaquin, San Mateo, Santa Clara, Shasta, Solano, Sonoma, Stanislaus, Sutter, Tehama, and Yolo.
“Recently, AB 236 was signed by the governor, extending the law to 2014, to protect those workers in the carwash industry and to provide businesses the opportunity to come into compliance with labor laws,” added Bradstreet. “This registration allows us to better monitor situations where we have traditionally seen labor violations.”
NIOSH Pocket Guide Available for the iPhone
The NIOSH Pocket Guide to Chemical Hazards (NPG) is now available as an application for the iPhone and iPod touch. The information found in the NPG helps users recognize and control chemical hazards. All 667 chemicals in the NPG, including resources, are now immediately accessible for safety professionals in the $9.99 application.
NIOSH’s NPPTL Makes Respirator Trusted-Source Information Page Available
NPPTL has developed a Respirator Trusted-Source Information Page. The information on the page should be regarded as a reliable source to identify NIOSH-approved respirators, how to obtain products, and how to use them. The page will be dynamic and information will be added as it becomes available.
Content of the Respirator Trusted-Source Page will address each of the sections listed below:
- Section 1: NIOSH-Approved Respirators – Answers to questions such as What are they, How can they be identified, Where can I get them; Understanding the types of respirators; Identifying NIOSH-approved products; and Outlets for purchasing products
- Section 2: Use of NIOSH-Approved Respirators – How to implement the use of respirators in the workplace and use them appropriately.
- Section 3: Ancillary Respirator Information – Commonly asked Questions and Answers (Fact Sheets), Respirator Myths, Science of Respirator Function and Performance, Respiratory Protective Devices Not Approved by NIOSH
NIOSH Proposing Total Inward Leakage Requirements for Half-mask Air-purifying Particulate Respirators
The National Institute for Occupational Safety and Health (NIOSH) has proposed the establishment of total inward leakage (TIL) requirements under 42 CFR Part 84 for half-mask air-purifying particulate respirators, including both elastomeric facepiece and filtering facepiece types. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g., influenza A which is H5N1, severe acute respiratory syndrome (SARS) corona virus, and Mycobacterium tuberculosis).
This docket collects the public comments related to the Notice of Proposed Rulemaking. Information submitted to the docket will be considered in the context of developing a Final Rule to establish TIL requirements for half-mask respirators approved under Subpart K of 42 CFR Part 84.
NIOSH Extends Comment Period for Respirator Standards Development
NIOSH is extending the stakeholder comment period through November 19 for the following topics.
New NIOSH HHE Report Available on Hospital Employee Exposure to Enzymatic Cleaner and Sterilant
Investigators found that air samples did not contain detectable concentrations of acetic acid and that concentrations of peracetic acid were thought to be low but could not be measured.
Investigators recommended increased ventilation in the sterilization room and use of appropriate PPE to prevent eye, face, hand, arm, and body contact with concentrated peracetic acid and contaminated equipment.
Material Handling Guide Wins CICMHE Award
The award recognizes informational products that make a strong contribution to the material handling and logistics industry.
NIOSH and Partners Sign Roadway Work Zone Safety Agreement
NIOSH and partners have renewed an alliance to improve the safety of workers and motorists in roadway construction zones. The alliance will develop hazard awareness training and education programs for Spanish-speaking and other vulnerable highway construction workers about safe practices in roadway work zones. The Alliance focus will be on flagger safety, safer deployment of traffic control devices, positive protection, night work, work zone speeding, and runovers/backovers.
Kentucky’s Worker Safety Program Makes Information Available to Small Businesses
The University of Kentucky, the Kentucky Department for Public Health’s Occupational Safety and Health Surveillance (KOSHS) Program, and partners have developed a presentation on worker safety programs geared toward small businesses. The presentation contains information on workers’ compensation, the basic elements of a worker safety plan, and how workers’ compensation premiums are impacted by the variation in the quality or absence of a worker safety plan.
CSB Investigative Team Deployed to Silver Eagle Refinery Explosion and Fire near Salt Lake City
According to local officials, the explosion in the diesel hydrotreater unit caused damage to homes in the surrounding area and was felt several miles away from the facility.
OSHA Fines Northern Wind Inc. $66,800 Following Worker Death in Ice Machine
OSHA has cited Northern Wind Inc., a New Bedford, Massachusetts, seafood processor, for 23 alleged violations of workplace safety standards after a worker was killed on May 4 when he became caught in the moving parts of a large industrial ice-making machine that activated while he was performing maintenance work inside it.
OSHA found that the plant lacked specific steps and procedures to power down and lock out the ice machine’s power source before employees entered it. The agency’s investigation also found that workers were not trained to recognize and address the hazard of the machine operating without warning. In addition, the plant lacked a program and employee training for working in confined spaces, such as the ice machine, and ladders were not available to ensure safe entry and exit from the ice machine.
“This is exactly the type of grave accident that OSHA’s hazardous energy control, or ‘lockout/tagout’ standard, is designed to prevent,” said Brenda Gordon, OSHA’s area director for southeastern Massachusetts. “For the safety of their workers, employers must always ensure that machinery is powered down and its power sources locked out before workers perform maintenance. Employers must also ensure that workers are properly trained for work in confined spaces.”
Additionally, OSHA’s inspection identified unmarked exit doors and a lack of emergency exit route lighting, no eyewash or drenching facilities for employees working with corrosive chemicals, a lack of MSDSs and chemical hazard communication training, unguarded open-sided floors, a missing safety latch on a hoisting hook and several electrical-related hazards.
All told, these conditions resulted in the issuance of 19 serious citations, with $62,800 in proposed fines. The company also has been fined $4,000 for four other-than-serious hazards, including incomplete recording of injuries and illnesses. The combined penalties total $66,800.
New Place Carpentry Faces $308,500 in OSHA Fines for Fall Hazards at Massachusetts Worksites
New Place Carpentry, a New Haven, Connecticut, contractor with a long history of fall protection violations, faces a total of $308,500 in new OSHA fines for willful and repeat fall hazards following the agency’s inspections at worksites in Plymouth and Methuen, Massachusetts.
The contractor, which primarily performs residential framing work, has been cited by OSHA eight times since July 2003. Fines from earlier investigations total $171,700 for failing to provide fall protection and other required safeguards for workers at jobsites in Connecticut, Massachusetts, and Rhode Island.
“The sizable fines proposed here reflect the gravity of these hazards and this employer’s ongoing refusal to comply with basic, commonsense and legally required protections for its workers,” said Marthe Kent, OSHA’s New England regional administrator. “Falls remain the number one killer in construction work. Employers who repeatedly fail to provide and ensure fall protection continue to place their workers’ lives at needless risk.”
Both of the latest inspections found workers engaged in residential construction work at heights greater than six feet without any form of fall protection. In addition, workers at the Plymouth site were working on unguarded, inadequately constructed and uninspected scaffolds, and were not trained to recognize scaffold hazards. Workers at the Methuen site were installing roof trusses without fall protection, lacked fall protection training, and accessed an upper work surface via a ladder that did not extend above the surface for required stability.
Additional hazards identified at the jobsites include gasoline-powered equipment left running while being refueled, power tools lowered to the ground by their cords, untrained fork truck operators, no fire extinguishers, debris with protruding nails in work areas, no hardhats where overhead hazards were present, and no eye protection for workers using nail guns.
New Place Carpentry has been issued one willful, six repeat and 13 serious citations. OSHA defines a willful violation as one committed with plain indifference to or intentional disregard for employee safety and health.
OSHA Fines Total $109,000 Against Veolia ES Technical Solutions Following Second Investigation into May 3 Explosion at Chemical Plant
OSHA has concluded the second of two investigations into a May 3 explosion at Veolia ES Technical Solutions in West Carrollton, Ohio, and has issued an additional $64,000 in fines against the chemical processing company, bringing the total fines to $109,000.
The $64,000 in proposed penalties are based on 16 serious violations of federal regulations governing process safety management. These regulations are intended to prevent or minimize the consequences of a catastrophic release of toxic, reactive, flammable, or explosive chemicals. OSHA’s first inspection, focusing on other workplace health issues at the facility, resulted in $45,000 in fines issued on October 22. That inspection found 11 serious violations.
OSHA initiated two inspections at this facility after powerful explosions occurred shortly before midnight on May 3. The explosions were the result of a large cloud of flammable and solvent vapor ignited by boilers at the worksite. Two employees were seriously injured in the blasts and several onsite buildings were destroyed. Veolia ES Technical Solutions distills and purifies contaminated organic solvent solutions at the West Carrollton facility.
This second set of serious citations allege that the company failed to conduct compliance audits every three years to ensure that policies and procedures were in place for the handling of flammable liquids. They also relate to worker training deficiencies, inadequate testing and inspections of piping and processes, a lack of written standards for operating procedures, maintaining the mechanical integrity of equipment, and other items involving process safety.
“The May 3 explosion underscores how vital it is that employers keep continuous watch on the handling of dangerous chemicals throughout the process,” said OSHA Area Director Richard Gilgrist. “It is also critical that employees are thoroughly trained and familiar with these processes.”
OSHA Levies more than $100,000 in Penalties against Columbus Steel Castings Co.
OSHA has cited Columbus Steel Castings Co., in Columbus, Ohio, with proposed penalties totaling $102,000 for alleged serious and repeat violations of federal workplace safety and health standards.
Columbus Steel Castings has been cited with four repeat violations, with proposed penalties of $62,500, for failure to enforce hazardous energy control, failure to apply a lock on an energy isolation device, failure to guard the point of operation on a jag press, having inadequate protection against welding rays, allowing airborne overexposures to silica, and failure to implement engineering or administrative controls for silica overexposures. OSHA issues a repeat violation when an employer has been cited in the past and the agency finds a substantially similar violation of any of the company’s facilities in federal enforcement states.
The company has also received citations for 12 serious violations, with proposed fines of $39,500. Some of the violations address the company’s failure to provide adequate training on hazardous energy control; failure to provide flashback protection on fuel-gas torches; failure to have procedures for selection of respirators; failure to provide inspection, maintenance, and cleaning procedures for respirators; failure to prevent overexposure to hexavalent chromium; and lack of proper training for airborne exposures to cadmium and lead.
“It is extremely important that companies ensure safety and health procedures are initiated and enforced, especially while working with hazardous materials such as hexavalent chromium or when working around high energy equipment,” said Deborah Zubaty, OSHA’s area director in Columbus. “OSHA’s goal is to make sure workers return home, safe and healthy, at the end of every shift.”
OSHA’s comprehensive safety and health inspection was conducted as a follow-up to a 2006 inspection in which Columbus Steel Castings Co., was cited by OSHA for 60 violations of federal workplace safety and health standards resulting in the issuance of $257,000 in penalties. The company has been inspected 12 times since 2003, including the 2006 inspection. The company was inspected 71 times between 1972 and 2003 under its former name, Buckeye Steel Castings Co.
OSHA Fines for Four Miami Companies $318,900 after Fatality at Bernuth Marine Terminal
OSHA is proposing penalties against four Miami, Florida, companies for safety violations following a fatality at the Bernuth Marine Terminal. In May, an investigation was initiated following notification to OSHA of a possible occupational death when a longshoreman was missing for two days. The employee of Miami Stevedoring Services (MSS) apparently fell overboard from the top of a container that was onboard a cargo vessel.
Miami Stevedoring is receiving willful citations related to the fatality for exposing workers to fall hazards while working from the ship’s intermodal containers and failing to provide workers with personal floatation devices while working onboard ships. The company is also receiving a willful citation for operating powered industrial trucks that had broken and missing equipment, along with two repeat, six serious, and one other-than-serious violation.
Inspections of the other three companies—Island Stevedoring LLC, Bernuth Agencies Inc., and Marine Diesel Inc.—were started during the fatality investigation based on violations observed by the OSHA compliance officer. Bernuth Agencies owns the marine terminal where MSS was contracted to provide stevedoring services. Marine Diesel provides equipment repair at the terminal. Island Stevedoring currently provides the stevedoring services, replacing MSS after the fatality.
Island Stevedoring is being cited with two willful and nine serious violations. Bernuth Agencies is being cited with four serious and one other-than-serious violation. Marine Diesel is receiving five serious violations.
“Working around containers is dangerous. However, it can be done safely if employees are provided the required equipment to perform their duties, and management enforces the OSHA standards,” said Darlene Fossum, OSHA’s area director in Fort Lauderdale. “The cost of human life is far too great a price to pay for anyone to ignore these hazards. All of us want to see working men and women go home safe at the end of every work shift.”
OSHA is proposing $318,900 in penalties against the four companies. The penalties for Miami Stevedoring Services total $196,600, Island Stevedoring $90,000, Bernuth Agencies $24,800, and Marine Diesel $7,500.
ANSI Z359 Fall Protection Standards Committee Meeting
Dr. Hongwei Hsiao will represent NIOSH at the ANSI Z359 Fall Protection and Related Systems Standards Committee meetings to be held November 10–12 in Chicago, Illinois. The committee is charged with developing recommended standards for the design and test of fall protection equipment and systems for fall hazard operations that are related to recent NIOSH research. Participation on this committee provides NIOSH with the opportunity to further partnerships with the fall protection professional community. The meetings are open to the public.
Living with Nanotechology Workshop
Experts at the meeting will include Dr. Paul Schulte, manager of the NIOSH Nanotechnology Research Center, and Dr. Charles Geraci, coordinator for NIOSH’s nanotechnology cross-sector research program.
NIOSH Calls for Abstracts for Upcoming Events and Conferences
NIOSH is calling for abstracts of papers for the following upcoming events:
11th Biennial Kentucky Conference on Health Communication—Call for papers, posters, and panel proposals related to issues in health communication.
International Conference on Fall Prevention and Protection—Call for abstracts for presentations related to falls from elevation; slips, trips, and falls; the practical application of prevention and intervention tools and methods; and global strategic goals on fall prevention.
American Society for Testing and Materials (ASTM), International Symposium on Surface and Dermal Sampling—Call for papers for the ASTM International Symposium on Surface and Dermal Sampling.
NIOSH and International Journal of Occupational and Environmental Health—Call for papers on nanotechnology exposure assessment.
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