U.S. Science Policy Outlook 2016

“The issue is no longer a scientific issue. It’s a political issue.”—Andrea Widener

Chances are better than ever this year that Congress will pass legislation to modernize the U.S. law that governs commercial chemicals, the 1976 Toxic Substances Control Act (TSCA). Both the Senate and House of Representatives passed TSCA reform bills last year, but significant differences between the two bills still need to be worked out before Congress can finish the job.

The Senate’s version of the legislation (S. 697), introduced by Sen. Tom Udall (D-N.M.), builds on a previous bipartisan bill introduced by the late Sen. Frank R. Lautenberg (D-N.J.) just weeks before his death in 2013. S. 697 represents years of negotiations and comprehensively overhauls TSCA. In contrast, the House version (H.R. 2576), introduced by Rep. John Shimkus (R-Ill.), attempts to fix only a few sections of the law, which virtually everyone agrees is broken.

Both bills have widespread support from the chemical industry and some environmental and public health organizations. But each group has different preferences about what should be included in the final legislation.

One big difference between the two bills is how they address the safety of new commercial chemicals. A key sticking point is that S. 697 does not protect the identity of new substances in health and safety studies that firms must submit to the Environmental Protection Agency before putting such substances on the market. Chemical companies oppose this.

Disclosure of a new chemical’s identity could impede innovation, points out William E. Allmond IV, vice president of government relations at the Society of Chemical Manufacturers & Affiliates, a trade group for specialty chemical companies. In general, the chemical industry prefers the slimmer H.R. 2576, which leaves untouched the existing TSCA provisions on EPA review of new commercial substances. TSCA allows chemical manufacturers to claim the identities of new chemicals as trade secrets.

Another area of contention involves who would decide which of the tens of thousands of chemicals already in commerce need to be evaluated for safety by EPA. Both bills contain provisions that allow industry to pick specific chemicals for evaluation by the federal agency. But S. 697 would set a cap of 30% selected by manufacturers, meaning EPA would decide on at least 70% of the chemicals, says Richard Denison, a senior scientist at the environmental group Environmental Defense Fund. H.R. 2576 has no such caps, so industry could essentially set EPA’s agenda, Denison argues.

As C&EN went to press, it was unclear whether lawmakers will convene a formal conference committee made up of members from both the Senate and House, or whether they will try to reach an agreement informally. There is much to negotiate, but observers are optimistic that the process will move quickly. “We will see the President sign a TSCA reform bill of some sort in the first couple months of the year,” Allmond predicts.—Britt Erickson

The Department of Energy will spend the next year cultivating support for a community engagement strategy that it hopes will help move the nation’s nuclear waste more quickly into storage and disposal.

DOE is taking this action because work remains stalled on Yucca Mountain, the only proposed nuclear waste repository in the U.S.

Last year, Energy Secretary Ernest Moniz announced that the department intends to expedite the movement of defense nuclear waste into permanent storage and disposal by separating it from civilian waste. To help meet this goal, the Energy Department late last month began the search for new sites and unveiled its community engagement program, called consent-based siting.

Franklin Orr, DOE’s undersecretary for science and energy, explains in a blog post that consent-based siting is “a way to ensure that communities, tribes, and states, as partners, are comfortable with the location of future storage and disposal facilities before they are constructed.” DOE is trying to build trust and cultivate support with U.S. communities for new storage and disposal sites for nuclear waste.

“We will be developing a detailed plan for this process in the coming year, and we need your help,” Orr says.

Through mid-June, DOE is soliciting public comments on the consent-based siting initiative. The Administration is seeking responses about the fairness of the site selection process, the stakeholders who should be involved, and the accessibility of information that would increase community involvement in the siting process.

Completion of Yucca Mountain, the decades-old proposed repository in the Nevada desert, has faced continuous opposition from Senate Minority Leader Harry M. Reid (D-Nev.). Among other obstacles, DOE has been unable to obtain the necessary permissions to finish the facility from Nevada and Congress.

DOE says that its consent-based siting effort could lead to facilities ranging from a pilot interim storage facility to a permanent geologic repository for the disposal of defense high-level waste.—Jessica Morrison

In a 2015 draft of its long-awaited hydraulic fracturing study, the Environmental Protection Agency said fracking has had no “widespread, systemic impact” on water resources. But the agency’s outside science advisers have urged EPA to include more data to better reflect the risks of fracking to drinking water resources. The panel, which is expected to finish its evaluation by mid-2016, has suggested that EPA revise its key statement and more clearly explain the limitations of the study.—Jessica Morrison

Consumer activists are likely to keep pressing lawmakers in the Senate to move a bill (S. 1014) that would strengthen the Food & Drug Administration’s oversight of cosmetics and require manufacturers to test the safety of chemicals in shampoos, lotions, makeup, and other personal care products before they hit the market. S. 1014, which was introduced in April by Sen. Dianne Feinstein (D-Calif.), has garnered bipartisan support as well as the support of the personal care products industry.

The Personal Care Products Council and its member companies have worked for more than five years with Congress seeking to reform federal oversight of cosmetics and personal care products, Lezlee Westine, president and chief executive officer of the industry group said when S. 1014 was introduced in April. “We support the creation of a national standard that maintains the continued safety of our products while providing FDA with additional regulatory authority over our industry.”

The Environmental Working Group, an advocacy group that has been pushing for stronger federal oversight of cosmetics for years, also supports the more stringent requirements found in S. 1014. The group estimates that women in the U.S. use a dozen personal care products each day, exposing themselves to more than 150 chemicals. Men use about half of the number of products used by women, the group says.

The current patchwork of state laws is prompting cosmetics companies to push for federal standards. To that end, Rep. Pete Sessions (R-Texas) introduced the Safe Cosmetics Modernization Act (H.R. 4075) in the House of Representatives in November. Like the Senate bill, the House bill would create uniform federal standards. But unlike the Senate bill, the House bill would also stop states from enacting labeling or registration requirements for cosmetics.

H.R. 4075 is supported by the Independent Cosmetic Manufacturers & Distributors (ICMAD), a group that represents small cosmetics businesses. “This legislation increases consumer protections on cosmetics while allowing continued growth of small and entrepreneurial cosmetics enterprises in the U.S.,” Pam Busiek, president and CEO of ICMAD, said when the bill was introduced. The group is concerned that additional testing requirements in S. 1014 would put too large a burden on small businesses and stifle innovation.—Britt Erickson

Long-awaited changes in the rules governing clinical trials could come out in 2016.

Last September, the Department of Health & Human Services, which includes the National Institutes of Health, and 15 other federal agencies, proposed the first major revision in decades to the so-called Common Rule, which governs all research involving human subjects.

The biggest change that could affect chemists is tighter informed consent requirements for study participants. Consent would be required for researchers to use blood or tissue samples that were originally collected for another purpose—even if the donor is anonymous.

In addition, informed consent forms would have to immediately address the most likely consequences of the research and be shorter so they are easier to understand than the current version. The forms would also be publicly released so that they would be open to more scrutiny.

Another change would alter ethics reviews conducted by institutional review boards (IRBs), with the goal of bringing the greatest scrutiny to research with the greatest risk.

The proposal would narrow the scope of IRB reviews to the most potentially harmful studies while exempting some nonharmful studies that currently require review. The proposed modifications would also compel only one IRB review for multisite research studies.

HHS and its partners accepted comments on the proposal until Jan. 6. They are now reviewing the comments.—Andrea Widener

This year, Obama Administration officials will be defending both the President’s cornerstone policy to reduce U.S. greenhouse gas emissions and the global climate change pact clinched last month in Paris.

High-ranking Republican lawmakers are leading congressional attacks on the Administration’s emissions policy, the Clean Power Plan. It consists of two 2015 Environmental Protection Agency rules that require fossil-fuel-fired power plants to control emissions of CO₂. Those leading the charge against the policy include Rep. Lamar Smith (R-Texas), who chairs the House of Representatives’ Science, Space & Technology Committee, and Sen. James Inhofe (R-Okla.), chairman of the Senate Environment & Public Works Committee.

Smith, who plans to hold hearings on the Clean Power Plan, says the regulations “would cost billions of dollars and risk thousands of jobs.”

The Administration is defending the Clean Power Plan in court as well as before Congress. A federal appeals court will decide in the coming weeks whether to suspend the Clean Power Plan while 27 states plus industries and labor groups present their legal case against it, says EPA Administrator Gina McCarthy. Regardless of that determination, the court battle over the Clean Power Plan is expected to drag on for years.

Meanwhile, an aide to Smith tells C&EN that hearings on the Paris accord “are a strong possibility.” According to Smith, the Paris agreement “will increase the control of the federal government over the lives of Americans, all for little environmental benefit.”

Inhofe says he will hold hearings this year to probe the details of the Paris deal and President Barack Obama’s pledge to provide $3 billion to help developing countries control emissions and adapt to climate change.

Congress might cut this funding in appropriations legislation. But any effort to overturn the Clean Power Plan is likely to be stopped with a veto.

International climate change negotiations continue this year to iron out details related to the new agreement. U.S. officials want the international community to establish clear methods for verifying emission control actions that were pledged by countries in the Paris accord.—Cheryl Hogue

A controversial, long-delayed proposal that could toughen chemical industry and refinery safety regulations is undergoing final White House review and is expected to be released as soon as February. That Environmental Protection Agency proposal would modify a 25-year-old chemical accident prevention program.

Called the Risk Management Plan (RMP), this program requires companies that make, use, or store quantities of specific extremely hazardous chemicals above certain thresholds to develop plans to prevent or minimize the impact of accidental releases. Other provisions of the regulation help local emergency responders avoid hazards and address chemical emergencies.

EPA has been developing the proposal since August 2013. It follows an executive order by President Barack Obama in response to a string of chemical accidents, including the 2013 explosion of a fertilizer distribution facility in West, Texas. That accident killed 15 people. Most of those killed were unprepared emergency responders.

Labor and community groups have sought an expansion of the number of chemicals covered and tougher and more modern safety requirements as well as more public access to the information that companies report to EPA. Industry representatives, however, say a new RMP regulation is unneeded. But they concede that better enforcement of the existing ones may be called for.

One sticky issue is whether the proposal would require companies to shift to inherently safer technologies. Such approaches include use of simpler manufacturing processes and substitution of dangerous and reactive chemicals with less hazardous ones.

Labor and community groups have long sought more requirements for inherently safer technologies, but the chemical industry says they are unnecessary and infringe on its ability to make products. Both sides predict the final proposal is likely to include consideration of inherently safer approaches but will not make them mandatory.

The agency appears to be on track to finalize the regulation in 2017. This means the fate and form of the final RMP regulation will be left up to the next President, who will take office next January.—Jeff Johnson

The Environmental Protection Agency is expected to finalize a regulation this year that would ban the common organophosphate insecticide chlorpyrifos from all agricultural uses.

The agency proposed the ban last October, saying it cannot ensure that combined exposure to chlorpyrifos in food and drinking water in certain watersheds is safe.

Prompting EPA’s actions was a court order that required the agency to respond by the end of October 2015 to a 2007 petition from environmental groups to ban all uses of chlorpyrifos. The groups claim that the insecticide is linked to nervous system damage.

EPA received tens of thousands of comments in support of the proposed ban from farmworkers, environmental organizations, and labor groups.

“Chlorpyrifos causes brain damage to children and poisons workers and bystanders. It is imperative that EPA move quickly to protect workers and children by issuing a final and total ban to this widely used pesticide,” says Patti Goldman, an attorney with the environmental group Earthjustice who is handling the case.

The National Cotton Council of America and other farm groups are opposed to the ban, saying the insecticide is needed to control multiple pests on cotton. The agriculture groups question the accuracy of the data that EPA is considering. Chlorpyrifos manufacturer Dow AgroSciences has said it is confident that all issues relating to the continued use of the pesticide “can be readily resolved with a more refined analysis.”—Britt Erickson

Hookah, electronic cigarettes (e-cigarettes), cigars, pipe tobacco, and other novel tobacco items would be regulated like tobacco products under a Food & Drug Administration regulation expected this year. E-cigarette companies oppose the rule, fearing that FDA regulation will wipe out their quickly growing industry. They are particularly concerned about a proposed provision that would require companies to apply retroactively for FDA approval for all nicotine delivery devices marketed after Feb. 15, 2007. The rule is currently under review at the White House.—Britt Erickson

NANOMATERIAL MANUFACTURERS will be required to file a one time report with EPA under a proposed rule expected to be finalized by October. Companies would report information including chemical identity, production volume, exposure and release information, and existing data on environmental and health effects, the agency says.

PHTHALATES could be further restricted this year by the Consumer Product Safety Commission. The agency plans to finalize a regulation that would ban diisononyl phthalate, diisobutyl phthalate, di-n-pentyl phthalate, di-n-hexyl phthalate, and dicyclohexyl phthalate in children’s products.

LABELING OF SALMON that have been genetically modified to grow faster than nonmodified salmon would be voluntary under guidance expected to be finalized by FDA this year. Although the agency approved the sale of such salmon in 2015, it currently does not require it be labeled as genetically modified.

TERRORISM PREVENTION rules for chemical facilities might be finalized in 2016. The Department of Homeland Security released an interim final rule last year as part of the Chemical Facility Anti-Terrorism Standards program. The proposal identifies chemicals of interest to terrorists and instructs chemical facility operators to assess their vulnerabilities and develop a security plan.

UNUSED DRUGS are the target of a hazardous waste proposal that EPA expects to finalize later this year. Under the proposal, health care facilities would be banned from flushing certain pharmaceuticals that can pass through wastewater treatment plants and contaminate waterways.

FOOD ADULTERATION, such as the substitution of melamine for milk, is likely to decrease under a rule expected by FDA this year on protecting the U.S. food supply from intentional adulteration. The rule could drive demand for more testing of foods.

ORGANOHALOGEN FLAME RETARDANTS in children’s products, furniture, mattresses, and electronic casings would be banned if the Consumer Product Safety Commission grants a petition from consumer activist groups. The agency is expected to respond to the petition this year.

CLEAN WATER RULE opponents in Congress are likely to continue efforts to nullify the controversial regulation. Introduced last summer, it defines which waterways fall under the federal Clean Water Act. President Barack Obama has said that he will veto any attempts by lawmakers to block the rule-making.

TETRACHLOROETHYLENE,N-methyl-2-pyrrolidone, and methylene chloride would be subject to new restrictions under proposed rules expected to be released by EPA in March. The agency is using its authority under the Toxic Substances Control Act to manage the risks posed by the three chemicals.