July 2011, Vol. 66 No. 7


Styrene Designation Disputed By Industry

Jeff Griffin, Senior Editor

The sanitary sewer rehabilitation industry — especially organizations involved in cured-in-place-pipe (CIPP) lining — are evaluating potential ramifications, if any, of the designation last month of styrene as a “reasonably anticipated carcinogen.”

On June 10, the U.S. Department of Health and Human Services (HHS) added styrene and seven other substances to its latest Report on Carcinogens (RoC) which the department says is a science-based document that identifies chemicals and biological agents that put people at risk for cancer.

The reasonably anticipated carcinogen designation does not mean that styrene has been found to cause cancer, but that it is “reasonable” to think that it may put people at risk for cancer. That alone, many fear, may severely constrain the use of styrene.

Styrene is a primary ingredient used to manufacture the thermoset resins used in cured-in-place-pipe sewer rehabilitation. On a wider scale, styrene is a synthetic chemical used worldwide in the manufacture of products such as rubber, plastic, insulation, fiberglass, pipes, automobile parts, and carpet backing.

Exposure to styrene can occur by breathing indoor air that has styrene vapors from building materials, tobacco smoke and from other everyday products. The HHS designation ultimately could impact hundreds of consumer products ranging from ubiquitous styrofoam cups and take-out food containers to sophisticated sports equipment.

The designation was immediately condemned by organizations representing industries using styrene.

NASSCO (National Association of Sewer Service Companies) has opposed the designation of styrene as a reasonably anticipate carcinogen for lack of solid evidence linking styrene with cancer in humans or animals.

Now that the designation has been made, NASSCO Executive Director Ted DeBoda said the industry should avoid unfounded concerns that the styrene classification would adversely affect businesses.

“For now,” said DeBoda, “we do not see any immediate changes in the use of styrenated resins in cured-in-place pipe.

“The organizations involved in identifying substances as reasonably anticipated to be a carcinogen are extremely conservative. By definition, substances can be listed as such with less than sufficient evidence of carcinogenicity in humans or laboratory animals, and with no potential exposure levels identified that would put people at risk above normal background exposure levels. The International Agency for Research on Cancer (IARC) includes styrene with a long list of everyday substances that have been classified as possibly carcinogenic to humans, which include electromagnetic fields from cell phones, talc-based body powder and coffee.”

Cured-in-place pipe technology was introduced 40-years ago and has developed into a billion dollar industry that provides municipalities and private companies an environmentally sound means to rehabilitate failing underground pipeline infrastructure at a fraction of the cost of traditional replacement techniques. CIPP is also considered a cost-effective rehabilitation solution.

Although CIPP consumes millions of pounds of styrene per year, it is a relatively small user of styrene — estimates are that CIPP consumes about 5 percent of the styrene used for composite manufacturing which is about 0.5 percent of the total styrene used in North America.

NASSCO’s position is that there appears to be no evidence that styrene, as it is currently used in the CIPP process, poses any health hazards to the workers installing the CIPP or to the general public and cites independent studies in North America and Europe that concluded a styrene exposure health hazard does not exist.

However, the HHS has emphasized the “science” used in conducting carcinogen studies to justify designations of substances added to the RoC.

“The strength of this report lies in the rigorous scientific review process,” said Ruth Lunn, Dr. P.H., director of the National Toxicology Program (NTP) Office of the Report on Carcinogens. “We could not have completed this report without the significant input we received from the public, industry, academia and other government agencies.”

Disputed research, science
Yet, the quality of that science is the primary objection raised by styrene proponents who question styrene’s designation as a reasonably anticipated carcinogen.

Immediately after the release of the RoC report, Styrene Information and Research Center (SIRC) Executive Director Jack Snyder said the U.S. styrene industry will contest vigorously the HSS listing of styrene in its 12th Report on Carcinogens.

“The designation,” he said, “is completely unjustified by the latest science and resulted from a flawed process that focuses on only those data that support a cancer concern, and in the case of styrene, ignored the preponderance of data that failed to suggest a cancer concern for this substance.”

Snyder noted that the HHS included styrene in the document despite the fact that European Union (EU) regulators have determined that styrene does not represent a human cancer concern. To reach that conclusion, EU scientists reviewed the full styrene database, weighing all of the available data.

Moreover, he continued, NTP’s own language acknowledges how weaknesses in its approach could lead to public misinterpretation of the meaning of the RoC listing, including this statement:

“It is important to note that the reports do not present quantitative assessments of carcinogenic risk . . . Listing in the report does not establish that such substances present a risk to persons in their daily lives [emphasis added],” says the report.

Commented Snyder: “In plain language, this statement means that NTP has not concluded that styrene presents an actual human cancer risk, or a risk from any of the thousands of products made with styrene.”

In addition, said Snyder, new science that has emerged since the EU’s 2007 Risk Assessment Report, points even further away from a cancer concern. In 2009, the peer-reviewed Journal of Occupational and Environmental Medicine published a comprehensive review showing that the “…available evidence does not support a causal relationship between styrene exposure and any type of human cancer.”

The same day as HHS announced the additions to the RoC, SIRC filed a motion in the U.S. District Court for the District of Columbia seeking invalidation of the RoC styrene listing. The next week, a motion was filed requesting expedited handling based on SIRC’s science and process and evidence of irreparable injury to the styrene industry.

With the release of the new RoC list, Snyder said industry advocacy efforts have changed direction to focus on seeking a Congressional oversight review of the RoC and NTP’s process. A detailed white paper that outlines the scientific, procedural and administrative problems encountered during the styrene assessment will be shared with the House Committee on Oversight and Government Reform. Plans are to approach the House Appropriations, Small Business and Energy and Commerce committees.

NASSCO plans
NASSCO’s DeBoda continues to emphasize that the use of styrenated resin in CIPP has not posed any documented health issues for workers or the public, and studies have proven that health risks from styrene exposure in the cured-in-place pipe industry are extremely low.

In fact, he added, association research has found exposure levels to styrene of workers during CIPP field installations are significantly lower than standards set by NIOSH (National Institute for Occupational Safety and Health) and the Environmental Protection Agency (EPA) for a typical manufacturing or plant facility. Once the installed product is cured, he added, CIPP becomes essentially inert with no long-term associated styrene issues.

“NASSCO,” concluded DeBoda, “plans to support ongoing research on the effects of styrene in the workplace through the efforts of the Styrene Information and Research Center and the American Composites Manufacturers Association efforts to overturn the ROC’s premature decision to include styrene in its report.”

NASSCO, (410) 486-3500, www.nassco.org

Reactions From Industry Groups, National Media

Warnings about cancer risks always make the news, and the U.S. Department of Health and Human Services (HHS) announcement that eight substances had been added to its Report on Carcinogens (RoC) received coverage from national television news networks and major daily newspapers, with follow-up reports on local news channels and metropolitan newspapers.

The industrial chemical formaldehyde and botanical aristolochic acids were designated “known” human carcinogens and six other substances, including styrene, were listed as “reasonably anticipated carcinogens.” The RoC is a congressionally mandated document that is prepared for the HHS by the National Toxicology Program (NTP).

The primary source of information in most press reports was John Bucher, PhD, NTP associate director. Bucher said the RoC report “underscores the critical connection between our nation’s health and what’s in our environment.”

Regarding the designations, the official press release from the NTP contains this qualification: “A listing in the Report on Carcinogens does not by itself mean that a substance will cause cancer. Many factors, including the amount and duration of exposure, and an individual’s susceptibility to a substance, affect whether a person will develop cancer.”

During a NTP-called teleconference for the press following the announcement on June 10, Bucher was asked if he would alter his use of products based on the new RoC listings, and he indicated that it was unlikely he would do so.

Formaldehyde and styrene are the most recognizable names of the new RoC listings, and styrene received heavy attention from reporters who invariably mentioned styrofoam cups and food containers. No reference was made to styrene’s use in the manufacture of resins for cured-in-place-pipe (CIPP) liners.

The number news reports in the consumer press about the additions to the RoC dramatically dropped in the days immediately following the NTP announcement.

Following are excerpts from various news reports, all dated June 10, the day of the announcement, about styrene’s designation as a reasonably anticipated carcinogen:

New York Times: “Styrene is mostly a concern for workers who build boats, car parts, bathtubs and shower stalls. Studies of workers exposed to high levels of styrene have found increased risks of leukemia and lymphoma and genetic damage to white blood cells. . . Consumers can be exposed to styrene from the fumes of building materials, photocopiers and tobacco smoke.

“As for styrene’s presence in plastic utensils and other consumer products, Dr. Brawley [Dr. Otis Brawley, chief medical officer at the American Cancer Society] likened the risk from such products to that of coffee and cell phones — uncertain and slight.”

“An industry spokesman said the action will hurt small businesses.

“‘It will unfairly scare workers, plant neighbors and could have a chilling effect on the development of new products,’ said Tom Dobbins of the American Composites Manufacturers Association. ‘And our companies are primarily small businesses, and this could hurt jobs and local economies.’

“Cal Dooley, president and chief executive of the American Chemistry Council, a trade association that represents companies that make and use polystyrene and formaldehyde, rejected the report’s conclusions. ‘We are extremely concerned that politics may have hijacked the scientific process,’ he said.

msnbc.com: “In light of the recent inclusion of the substance styrene in the National Toxicology Program’s (NTP) 12th Report on Carcinogens, some people may wonder whether federal regulators have changed their view on the safety of plastic foodservice packaging made with styrene. The answer is no.

“Polystyrene plastic has been used in foodservice products – foam coffee cups, salad bar takeout containers, cutlery – for more than five decades. Polystyrene has been reviewed by regulatory agencies (including the U.S. FDA) that have deemed it safe for use in contact with food.

“In addition to its use in making polystyrene, styrene is naturally present in foods such as strawberries, beef, beer, and cinnamon and is naturally produced in the processing of foods such as wine and cheese.

“To put its recent report in perspective, NTP states: ‘It is important to note that the reports do not present quantitative assessments of carcinogenic risk… Listing in the report does not establish that such substances present a risk to persons in their daily lives. Such formal risk assessments are the purview of the appropriate federal, state, and local health regulatory and research agencies.’

“NTP has not concluded that styrene or plastic foodservice packaging made with styrene present any risk to human health.”

Washington Post: “Styrene, which is used to make those ubiquitous white foam coffee cups, food containers and many other products, is probably a human carcinogen, the federal government declared Friday.

“Officials stressed that the listings do not mean that any exposure to the substances will cause cancer. Instead, it means that the latest scientific evidence indicates that the agents can cause cancer in some people exposed to enough of the compounds under the right circumstances. Most of the evidence for a cancer risk came from people exposed to relatively high levels in industrial settings.

“‘The listings do not trigger any immediate new restrictions on the substances, but other government agencies may use the information in the future as part of their regulatory decisions,’ Bucher [John Bucher, NTP associate director] said. ‘In the meantime, individuals can use the list to make personal choices,’ he said.

ABC News: “The U.S. Department of Health and Human Services added eight more substances to its ‘known human carcinogen’ or ‘reasonably anticipated to be carcinogen’ lists today, one week after a World Health Organization study concluded that cell phones may cause cancer.
“Among the substances is styrene, a synthetic chemical found in Styrofoam and used in the manufacturing process for products such as pipes, fiberglass, automobile parts and other materials.

“’As a pediatrician, I’m in the business of urging caution and I think this is a case where it’s reasonable to urge caution even while the data are incomplete,’ said Dr. Phillip Landrigan of Mount Sinai School of Medicine.”

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