EPA Administrator Lisa Jackson laid out new principles for revising the Toxic Substances Control Act in late September.

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A New Kid on Our Block

Seen by some as OSHA's much bigger brother, EPA waded into several big safety issues this fall.

Some regard EPA as OSHA's much bigger brother. In keeping with that view, EPA waded into several big safety issues this fall. Administrator Lisa Jackson's agency issued a new hearing protector labeling and testing rule; told Congress how to fix the key U.S. chemical management law, the 1976 Toxic Substances Control Act (TSCA); and posted voluntary guidelines for methamphetamine lab cleanups.

The TSCA changes may have the greatest impact among these, but the hearing protector device (HPD) rule has attracted more attention from the safety community, PPE manufacturers in particular. EPA's Oct. 7 public hearing about the HPD rule was sparsely attended, International Safety Equipment Association Public Affairs Director Daniel Glucksman observed.

In testimony filed at the hearing, ISEA urged EPA to use language from ANSI/ASA S12.68-2007, a standard from the Acoustical Society of America that was one of the consensus standards used as the basis for EPA's HPD rulemaking; ISEA is represented on the S12 Committee, President Dan Shipp testified.

HPD manufacturers are saying the final rule from EPA must specify independent testing of the products. "It is inconceivable that a lab owned by a manufacturer could ensure that there will be no influence by the laboratory and/or experimenter on the test subjects many of whom are likely to be employed by the manufacturer. If independent third party testing is not required by EPA, the new regulation will be flawed and may not adequately serve the public," Jeffrey S. Birkner, Ph.D., CIH, vice president of Technical Services for Moldex-Metric, wrote in his comment.

"Testing has to be performed by independent and certified laboratories," Elvex President Roland Westerdal agreed in a comment posted Oct. 20. Westerdal also said enforcement by EPA is vital, and the regulation should not be finalized during this recession.

"The existing EPA regulation has not been enforced by the EPA," he wrote. "There are literally hundreds of products on the market that are sold with either no labeling or bogus labeling. There is no indication that the enforcement will be improved in the new regulation. Consequently legitimate companies will absorb all the expenses of complying, and then end up competing with unauthorized manufacturers/products."

ISEA recommended several changes in EPA's proposal, including:

  • allowing all information (passive, active, and impulsive attenuation) to be listed on a single label, rather than requiring two primary labels for devices that perform impulsive and active noise suppression.
  • using the caution statement from S12.68-2007 instead of the one EPA has proposed to tell users to utilize the Variability of Noise Reduction graph when an HPD is used in primarily low-frequency noise environments and the difference in measured C- and A-weighted sound pressure levels exceeds 3 dB; also, the ANSI/ASA standard specifies using it for a difference of 5 dB, not 3 dB, ISEA pointed out.
  • explaining the two NRR numbers that will be on an HPD's label. ISEA proposed this wording: "The lesser NRR is the protection that is possible for most individually trained users to achieve or exceed. The greater NRR is the protection that is possible for a few motivated proficient users to achieve or exceed."
  • removing a requirement in EPA's proposal that the manufacturer indicate the peak impulsive noise level in which the device may be worn. "This asks the manufacturer to assume risk/damage liability which is the province of the user or hearing conservation regulation. Additionally, this oversteps the bounds of EPA's mandate to provide for labeling of the hearing protector to indicate its ability to attenuate," ISEA's printed testimony states.

ISEA listed several objections to the proposed HPD retesting and relabeling provisions. Requiring manufacturers to retest their products every five years is unnecessary and burdensome, the association said, and EPA should not require relabeling when a retest's results differs by more than 3 dB from labeled value. "Not only is 3 dB arbitrary, but also ISEA believes EPA is wrong in its estimation that relabeling based on the 3 dB threshold will occur less than 12 [percent] of the time," ISEA pointed out.

Glucksman said ISEA, an association of PPE manufacturers, estimates close to 30 percent of retests might necessitate relabeling because of the 3 dB threshold.

The five year retest would be required even if the protector's design, the materials used, or the manufacturer had not changed in the interim, said Glucksman. "We said two things: If you haven't changed any of those factors, they it's pretty burdensome to do this testing," he said in an Oct. 9 interview. "And we kind of disagreed with EPA's use of the 3 dB rule.

"If you've improved your product, made a change -- you'd want to relabel anyway," Glucksman said. "We pretty much stated that the five-year deal doesn't really make sense because the EPA's already capturing in another part of the regulation a relabeling if you've made a change."

The capacity of existing HPD testing labs is another issue. A study done for EPA found approximately 1,000 HPD models are currently on the market, and about 2.1 billion HPDs are bought annually by industry -- including 1.94 billion disposable ear plugs. A 30-month window for testing and relabeling products is not long enough and should be doubled to 60 months, the association stated.

The rulemaking docket will close Nov. 4. Exactly what information manufacturers would have to report to EPA about their new products, and when, is still to be resolved, Glucksman said.

"I am hoping that when this is done, whenever that is, EPA really goes out and hits the health and safety conference circuit" to explain the regulation to the safety and health community, he added.

Meth Lab Cleanup Guidelines, TSCA Changes
EPA posted its 48-page "Voluntary Guidelines for Methamphetamine Laboratory Cleanup" document on Oct. 7, although its cover date is August 2009. The document contains technical guidance for state and local government personnel who remediate methamphetamine lab sites, using best available science and practices. It discusses sampling procedures and provides technical resources.

The Methamphetamine Remediation Research Act of 2007 required EPA to develop the guidelines, and the agency reviewed state guidance and regulations in developing them.

Methamphetamine production "continues to pose considerable challenges," although domestic production has declined in recent years, according to EPA, which said the guidance document "has received extensive review and refinement from a broad array of stakeholders as well as feedback from nationally recognized experts in meth lab remediation." For more information, visit http://www.epa.gov/oem/methlab.htm.

TSCA Changes Coming
Administrator Jackson announced the Obama administration's TSCA goals -- which will require congressional action to be realized -- in a Sept. 29 speech to the Commonwealth Club in San Francisco. She described a major effort to strengthen EPA's current chemical management program and accelerate efforts to address chemicals that pose a health or environmental risk.

"As more and more chemicals are found in our bodies and the environment, the public is understandably anxious and confused," Jackson said. "Many are turning to government for assurance that chemicals have been assessed using the best available science, and that unacceptable risks haven't been ignored. Our oversight of the 21st Century chemical industry is based on the 1976 Toxic Substances Control Act . . . over the years, not only has TSCA fallen behind the industry it's supposed to regulate, it's been proven an inadequate tool for providing the protection against chemical risks that the public rightfully expects.

"Today I'm announcing clear administration principles to guide Congress in writing a new chemical risk management law that will fix the weaknesses in TSCA."

Several members of Congress -- Sens. Frank Lautenberg, D-N.J., and Barbara Boxer, D-Calif., and Reps. Henry Waxman, D-Calif., and Bobby Rush, D-Ill. -- said they'd move legislation quickly. Lautenberg, who chairs the Superfund, Toxics and Environmental Health Subcommittee, said the bill will be modeled on the principles Jackson listed:

  • Chemicals should be reviewed against risk-based safety standards based on sound science and will protect human health and the environment.
  • Manufacturers should provide EPA with the necessary information to conclude that new and existing chemicals do not endanger public health or the environment.
  • EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard.
  • Manufacturers and EPA should assess and act on priority chemicals, both existing and new, in a timely manner.
  • Green chemistry should be encouraged and provisions assuring transparency and public access to information should be strengthened.
  • EPA should be given a sustained source of funding for implementation.

Jackson promised to move faster to gather data from industry that EPA needs to make chemical risk determinations. "This will include filling the current gaps in health and safety data on high production volume chemicals; enhanced, transparent, and more current reporting of use and exposure information; and a number of requirements for increased reporting on nanoscale chemical materials. In addition, EPA is reviewing how nanoscale materials are managed under TSCA. EPA is also reviewing ways to increase the public's access to information about chemicals," according to EPA.

"It's a tremendous step forward. They're very clear that this is about a new law, new rules of the game. It's not about little tweaks. This is a fundamental overhaul," Richard Wiles, who leads the Environmental Working Group in Washington, D.C., said Sept. 29.

"The chorus of voices calling for reform of our nation's chemical regulations now includes the Obama administration, health professionals, environmental advocates, the states, and even industry," said Earthjustice President Trip Van Noppen. "Now, we look to Congress to join the fight to protect our children and our environment from dangerous chemicals.

"We understand that industry has to provide more data and a greater transparency to that data," said Cal Dooley, president of the American Chemistry Council. "Without a comprehensive approach, the American people will be left with minor adjustments to the current federal regime and a patchwork of state and federal laws that will not enable a robust chemical management system that can become the gold standard for the world."

"There's general agreement that we need to reform this law," said Glenn Ruskin of the American Chemical Society, which represents chemists and chemical engineers. "That's very rare that you find such typically disparate groups agreeing."

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