In the first use of a framework allowing submission of a single application to the two agencies, U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have worked together to allow drug companies to submit a single application showing the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.
Valero Refining-Texas L.P. has agreed to resolve alleged violations of the Clean Water Act stemming from a spill of 3,400 barrels of oil into the Corpus Christi Ship Channel.
Two repeat violations with penalties of $27,500 are being proposed for violations similar to those noted during earlier inspections in 2007.
The Springfield, Ill.-based facility, which houses an office, warehouse, and woodshop, has been inspected by the agency on two occasions since January 1995.
The U.S. Department of Labor's Mine Safety and Health Administration is distributing its latest version of audio public service announcements aimed at educating miners and mine operators about the hazards typically found in the mining workplace.
"We’re talking about more than just a paper program. It’s the kind of program that can reduce worker’s comp costs and illnesses and injuries, making the companies more productive and more competitive,” said OSHA chief Edwin G. Foulke today.
The Nuclear Regulatory Commission is amending its regulations to reflect the licensing, inspection, and annual fees it will charge its licensees and applicants in fiscal year (FY) 2008.
On only the second official day of the annual event, the society has announced it has broken records for both turnout and exhibition space sold.
OSHA recently renewed its alliance with the Construction Institute (CI) of the American Society of Civil Engineers (ASCE). The alliance will continue encouraging employers in the construction industry to incorporate safety and health information and training resources into their work processes.
States, communities, and organizations across the country are encouraged to make use of these promotional materials, such as the poster shown here, to help in their efforts to prevent drunk driving during the Fourth of July weekend.
OSHA has cited two New York City employers for alleged violations of federal workplace safety standards in connection with a Dec. 7, 2007, scaffold collapse at 265 E. 66th St. in Manhattan. Two window washers fell 47 stories when their scaffold platform detached from the permanent window washing rig attached to the building's roof.
Evaluating the current political landscape at this morning's opening session, Washington insider Jay Carney will be offering his perspective on the presidency (and the ensuing one), Congress, and the press.
Fresh off America's TV screens thanks to last night's "60 Minutes" program, the OSHA chief is a headliner for the event starting today. More than 200 educational sessions and 400 exhibits are scheduled.
The U.S. Food and Drug Administration has filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, and two of its top officers for violating the Federal Food, Drug and Cosmetic Act (FD&C Act).
Correspondent Scott Pelley's segment on the problem of dust explosions will include interviews of former CSB Chair Carolyn Merritt and OSHA chief Edwin Foulke Jr. This CSB photo shows the damaged Imperial Sugar plant.
U.S. Environmental Protection Agency Region 5 has reached an agreement with 3M Co. on alleged clean-air violations at the company's Abrasive Systems Division at 10746 Innovation Road, Cottage Grove, Minn.
The United States has sued Honeywell International Inc. under the False Claims Act in connection with the company's manufacture and sale of defective Zylon Shield (Z Shield), which Honeywell marketed for use as the key ballistic material in bullet-proof vests, the Justice Department announced yesterday.
"This horrible tragedy underscores the need for all employers to implement effective safety and health management systems," said Louis Ricca Jr., acting administrator for OSHA's New York region.
"This case illustrates in the starkest possible terms why effective safeguards are necessary to prevent death and injury on the job," said Christopher Adams, OSHA's area director in Syracuse, N.Y.
Two of the three firms cited are each receiving a willful violation for failing to have a qualified person determine if the structure could support the additional three-quarters of an inch of wet concrete weight that was added to the 20-inch floor slab.