REGULATORY HISTORY. On July 20, 1976 Waste Discharge Requirements were adopted for the site in Board Order No. 76-77. In that Order Parkwood 101, Limited (the previous landfill owner), was required to place “a final cover of at least four-feet of compacted inert fill material” over the waste disposal areas. Board Order No. 76-77 was subsequently revised on October 18, 1977 by Order No. 77-134, wherein a revised time schedule was adopted for compliance with site closure specifications. Closure activities at the site included placement of additional cover material over the waste disposal areas and grading to eliminate ponding.
REGULATORY HISTORY. Beginning in the late 1970's and early 1980's, regulatory agencies in the U.S. and abroad frequently adopted a cancer risk criteria of one in a million (1 x 10-6) as a negligible (i.e., of no concern) risk when fairly large populations might be exposed to a suspect carcinogen. Unfortunately, theoretical increased cancer risks of one in a million are often incorrectly portrayed as serious public health risks. As discussed by Dr. Franx Xxxxx (0087), the commissioner of the FDA, this was not the intent of such estimates: 304 In applying the de minimis concept and in setting other safety standards, FDA has been guided by the figure of "one in a million." Other Federal agencies have also used a one in a million level, such as the Occupational Safety and Health Administration and the Environmental Protection Agency. Both agencies rely on the one in one million increased risk over a lifetime as a reasonable criterion for separating high-risk problems warranting agency attention from negligible risk problems that do not. The risk level of one in one million is often misunderstood by the public and the media. It is not an actual risk - i.e., we do not expect one out of every million people to get cancer if they drink decaffeinated coffee. Rather, it is a mathematical risk based on scientific assumptions used in risk assessment. FDA uses a conservative estimate to ensure that the risk is not understated. We interpret animal test results conservatively and we are extremely careful when we extrapolate risks to humans. When FDA uses the risk level of one in one million, it is confident that the risk to humans is virtually nonexistent. In short, a 'one in a million' cancer risk estimate, which is often tacitly assumed by some policy-makers to represent a trigger level for regulatory action, actually represents a level of risk that is so small as to be of negligible concern. Another misperception within the risk assessment arena is that all occupational and environmental regulations have as their goal a theoretical maximum cancer risk of 1 in 1,000,000. Travxx xx al. (1987) recently conducted a retrospective examination of the level of risk which triggered regulatory action in 132 decisions. Three variables were considered: 1) individual risk (an upper-limit estimate of the probability 305 that the most highly exposed individual in a population will develop cancer as a result of a lifetime exposure), 2) population risk (an upper-limit estimate of the number of additional...
REGULATORY HISTORY. Describe all permits (including waste discharge requirements) requested or received, any enforcement actions taken by the Department or designated agencies and any closure activities that are planned or underway.
REGULATORY HISTORY. Describe all permits requested or received, any enforcement actions taken by regulatory agencies and any closure activities that are planned or underway.
REGULATORY HISTORY. A copy of all documents pertaining to the Rondec Products' and CCA Products' regulatory history including any existing correspondence with the FDA.
REGULATORY HISTORY. CuraGen has currently held two End-of-Phase 2 meetings with the FDA in conjunction with PXD101 (belinostat) for the treatment of Peripheral T-Cell Lymphoma (PTCL) and Cancer of Unknown Primary (CUP). Both meetings have yielded input into our clinical development plan and protocol designs. The following documentation and meetings should be referenced in association with the clinical development of belinostat.
REGULATORY HISTORY. On December 27, 2004, the NTSB published a notice of proposed rulemaking (NPRM) titled, ‘‘Notification and Reporting of Aircraft Accidents or Incidents and Overdue Aircraft, and Preservation of Aircraft Wreckage, Mail, Cargo, and Records,’’ in the Federal Register (69 FR 77150). The December 2004 NPRM proposed various changes to 49 CFR Part 830, all of which affected is delayed in the performance of the work under this contract and if the types of accidents and incidents that individuals and entities must report additional funds are allotted, an equitable adjustment will be made in the price or prices (including appropriate target, billing, and ceiling prices where applicable) of the item(s), or in the time of delivery, or both. Failure to agree to any such equitable adjustment hereunder will be a dispute concerning a question of fact within the meaning of the clause entitled ‘‘Disputes.’’
REGULATORY HISTORY. 6.1 Historical regulatory confirmation attached: Yes Not relevant for this individual No (provide reasons):
REGULATORY HISTORY. 6.1 Historical regulatory confirmation attached: Yes Not relevant for this applicant No (provide reasons):
REGULATORY HISTORY. During the PA DEQ reviewed the following regulatory databases for the facilities listed above: DEQ’s underground storage tank (UST) and leaking underground storage tank (LUST) database, DEQ’s spills database, and the state fire marshal’s hazardous substance information survey (HSIS). The Oil Can Henry’s facility has an above ground storage tank (AST) for waste oil. It is listed in HSIS and spills databases. According to the HSIS, Oil Can Xxxxx uses antifreeze, transmission fluid, gear oil, motor oil, and waste oil. According to DEQ’s spills database, Oil Can Xxxxx’x had a small oil release (less than 20 gallons), in January 2004. There are active UST Cleanups at the Younger Oil station at 0000 Xxxxx Xxxx (DEQ USTC ID 24-03-0558) and Keizer Exxon at 0000 Xxxxx Xxxx (XXX XXXX ID 24-91-4141); low levels of TCE and decay products have been detected at or near both of these sites, but no PCE.
