Canada Confirms Order Designating Four Chemicals as CEPA Toxic

Canada has published an "Order Adding Toxic Substances to Schedule 1 of the Canadian Environmental Protection Act, 1999." The order confirms the CEPA toxic designation of four chemicals, thus allowing for Canada to regulate them.  The four chemicals are:

• Propane, 2-nitro- (Chemical Abstracts Service [CAS] (see footnote 2) Registry No. 79-46-9), hereafter referred to as “2-nitropropane”; 

• Benzene, 1-methyl-2-nitro- (CAS No. 88-72-2), hereafter referred to as “2-nitrotoluene”;

• Phenol, 2,6-bis(1,1-dimethylethyl)-4-(1-methylpropyl)- (CAS No. 17540-75-9), hereafter referred to as “DTBSBP”; and

• Methylium, [4-(dimethylamino)phenyl]bis[4-(ethylamino)-3-methylphenyl]-, acetate (CAS No. 72102-55-7), hereafter referred to as “MAPBAP acetate.”

Draft regulations have been proposed for at least one of the chemicals.  According to the Canada Gazette:

The Order adds the four above-mentioned substances to Schedule 1 to CEPA 1999, thereby allowing the Ministers to meet their obligation to publish proposed regulations or other instruments no later than July 31, 2012, and finalize them no later than January 31, 2014. Developing an implementation plan or a compliance strategy or establishing service standards are not considered necessary if no specific risk management proposals are made. An appropriate assessment of implementation, compliance and enforcement will be undertaken during the development of proposed regulations or control instrument(s) respecting preventive or control actions for these substances.  

More information can be found in the Canada Gazette notice.

Canada Moves Into Next Phase of Chemical Management Plan

Canada has issued a news release indicating that it will move into the next phase of its ongoing Chemical Management Plan.  This is an extension of the plan first launched in 2006.   The CMP was designed to apply the rigorous assessment used for new chemicals to 'legacy chemicals' that were introduced in Canada between January 1, 1984, and December 31, 1986.  The new phase is seen "as a continuation of Canada's world-leading initiatives in this area and it will ensure the protection of Canadians' health and safety, and their environment," according to Shannon Coombs, President, Canadian Consumer Specialty Products Association, who promised to "continue to work proactively with the government as the plan is implemented."

According to the announcement, new funding is being provided for this next phase of the Plan, "which will focus on:"

• Further improving product safety in Canada;
• Completing assessments of 500 substances across nine categories including phthalates, primarily used in plastics; and,
• Investing in additional research for substances like Bisphenol A, flame retardants, substances that affect hormone function and substances that affect the environment.

Canada anticipates that "approximately 1,000 additional substances will also be addressed in the next five years through other initiatives, including rapid screening of substances which pose little or no risk." Canada recently banned four chemicals as harmful to the environment.

More information on Canada's Chemical Management Plan can be found here.

Canada's Chemical Substance main page is here.

Canada to Ban Four Categories of Chemicals

Canada issued a proposed regulation in the Canada Gazette on July 23, 2011 designed to essentially ban four groups of chemicals.  According to the proposal, the four chemicals are Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene (BNST), short-chain chlorinated alkanes, polychlorinated naphthalenes (PCNs) and tributyltins (TBTs) for non-pesticidal uses.  All four were assessed in accordance with the Canadian Environmental Protection Act of 1999 (CEPA), which concluded that all four may be harmful to the environment.  Health Canada determined that short-chain chlorinated alkanes also constitute a danger in Canada to human life or health. 

Interestingly, three of the chemical classes are already no longer manufactured or used in Canada.  So the main impact will be on the ban of BNST, which is an antioxidant additive in vehicle engine oils and industrial lubricants.  Under the regulations, there would be a two-year transition period in which BNST could still be used for specific uses so that industry has time to conduct research to find alternatives.  The transition period would also allow manufacturers to gain product performance certification for any product modifications using BNST subsitutes.

For all four chemical classes Environment Canada and Health Canada believe risk management measures are necessary to prevent harm to the environment and human health.  Also, they determined that all four "meet the criteria for persistence and bioaccumulation potential as set out in the Persistence and Bioaccumulation Regulations."

The regulations as proposed would also modify existing restrictions on hexachlorobenezene (HCB), which is commonly found as an impurity in chlorinated solvents and other manufactured products.  HCB would be moved from Part 2 to Part 1 of the schedule of toxic substances, which would put it on a track for full banning.

The public may provide comment on the draft regulations until October 6, 2011.  More information is available in the Canada Gazette online.

Canada Lists 4 Chemicals to its Schedule 1 List of Toxic Substances

While the US struggles with what to do to modernize the Toxic Substances Control Act (TSCA), Europe has been busy with the first registration phase of it's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and Canada is well into its Chemical Management Plan evaluating their Inventory of existing chemicals.  As part of that process Canada recently proposed to add four additional chemicals its Schedule 1 "list of toxic substances" under CEPA (the Canadian Environmental Protection Act of 1999).   

The four substances are:

Vanadium pentoxide: A naturally occurring substance in the environment, "used primarily in Canada in the manufacture of ferrovanadium and as a catalyst in the production of sulphuric acid." According to Environment Canada, "vanadium pentoxide is released to air, to water and to land, mainly through combustion of fossil fuels and wood fuels from industrial activities."  It "was identified as a high priority for assessment because of its classification as a carcinogen by national and international agencies."

Potassium bromate: A man-made substance "used primarily in Canada in industrial and commercial applications," including "as an oxidizing reagent in laboratories, in the dying of textiles, and in permanent wave neutralizing solutions in the cosmetics industry."  While it appears there is limited current reporting of use in Canada, and no reported consumer uses, the substance was listed "based principally on the weight-of-evidence assessment or classification from international or other national agencies..., the critical effect of exposure...is carcinogenicity," as well as reports of genotoxicity and "a variety of non-cancer effects."

TGOPE: A thankfully brief acronym for a long chemical name, TGOPE "is a man-made component of epoxy resin used as an adhesive or binding agent" used primarily "in the manufacture of paints, coatings designed for industrial use and certain consumer epoxy-patch adhesives." Exposure is expected to be minimal because it is it seems to have limited current manufacture in Canada (but is imported) and has limited consumer uses (mostly epoxy adhesives).  Health effects assessments have not been identified, but "in vitro experiments and weight-of-evidence assessment or classification from several other analogues...show that TGOPE may cause cancer."

Methyl eugenol: Mainly "a naturally occurring organic substance in the essential oils of several plant species," used primarily "as flavour ingredients in food and beverages and as fragrance ingredients and emollients in personal care, cosmetics and other household products." According to the Canadian assessment, "the substance may also be produced synthetically."  Exposure is "mainly from its naturally occurring presence in food and beverages with smaller contributions from the use of personal care products and citronella-based personal insect repellents."  Canada has determined "that methyl eugenol may cause cancer," and may also "be genotoxic in a range of experimental studies...Therefore, it cannot be precluded that the substance may have interacted with the genetic material."

More information on these four substances can be found here.  In addition to these four listed, there were 13 substances from "Batch 9" that were not found to meet the criteria for listing.  These can be seen here.

Does Canada's Declaration that BPA is Toxic Make Sense?

I noted last week that the Canadian government formally labeled Bisphenol A (BPA) as "toxic," and added it to Schedule I of the Canadian Environmental Protection Act of 1999. But does their action make any sense?  After all, the European Food Safety Authority (EFSA) had only days before stated their belief that BPA is safe for use in food-contact items.  The USEPA isn't basing any of its proposed actions on human health effects.  The USFDA seems to think BPA is okay to use.

The American Chemistry Council (ACC), which represents major chemical manufacturers and plastics chemical manufacturers (including BPA), notes that:

"...Environment Canada’s announcement is contrary to the weight of worldwide scientific evidence, unwarranted and will unnecessarily confuse and alarm the public."

According to ACC, Enviroment Canada's "decision also appears to contradict the very recent opinion of Health Canada, which stated in August that ‘the current dietary exposure to BPA through food packaging is not expected to pose a health risk to the general population, including newborns and infants.’"

Canada has issued a series of risk management action milestones that include such actions as prohibiting the importation of baby bottles containing BPA, reviewing all medical devices and notifications for substances used in the packaging of baby formulas, and facilitating the assessment of proposed industry alternatives to bisphenol A used in can linings.

While there seems to be quite a difference of opinion on the hazards of BPA, or lack of hazard, the primary concern of Canada is that "the neurodevelopmental and behavioural dataset in rodents, though highly uncertain, is suggestive of potential effects at doses at the same order of magnitude to 1-2 orders of magnitude higher than exposures."  So the potential for hazard is still contentious, but Canada feels that the the "potential sensitivity to the pregnant woman/fetus and infant," and the suggestion from rodent studies that there is "heightened susceptibility during stages of development in rodents."  As such they have determined that "it is considered appropriate to apply a precautionary approach when characterizing risk."

Canada Declares Bisphenol A (BPA) Toxic...Will the US Follow Suit?

The Canadian government has formally labeled Bisphenol A, commonly called BPA, as "toxic," and added it to Schedule I of the Canadian Environmental Protection Act of 1999.  They now will propose mechanisms to protect human health and the environment from the risks of BPA exposure.  They have already banned the use of polycarbonate baby bottles that contain BPA.   The assessment also offers additional recommedations for removing or restricting BPA use in food contact materials and cosmetics, as well as provisions for recycling and limiting discharges in industrial effluents. Ironically, this announcement comes only days after the European Food Safety Authority (EFSA) reaffirmed its belief that BPA is safe for use in food-contact items.

 More information can be found on the assessment web page.

The question now turns to what will happen in the United States.  The USEPA had already issued an "action plan" for BPA under their current TSCA authority.  In that plan the EPA noted that it was considering a 5(b)(4) rulemaking to "identify BPA on the Concern List as a substance that may present an unreasonable risk of injury to the environment on the basis of its potential for long-term adverse effects on growth, reproduction and development in aquatic species at concentrations similar to those found in the environment."  They also were considering initiating a section 4 rulemaking to obtain more data and work on a collaboration with industry to find alternatives under EPA's "Design for the Environment" program.

Interestingly, EPA was not initiating any action based on concerns for human health, as they felt that particular area was too uncertain to take action at that time.  It seems Canada has disagreed.

So it remains to be seen whether the Canadian action will spawn similar action in the US.  Whether or not this happens it seems clear that state and local jurisdictions are not waiting for EPA and/or FDA; they are initiating their own restrictions and bans.

A PDF of the EPA action plan can be found here.

Joint USA/Canada Great Lakes Strategy Could Help or Hinder TSCA Chemical Reform

Last month the Great Lakes Binational Toxics Strategy (GLBTS) issued a report stating that they had achieved 12 of the 17 goals it set out to accomplish when the agreement was signed by the US and Canada in 1997. The report sets the stage for a not unsurprising face off between industry (who wants to scuttle any future agreements) and environmentalists (who want to expand future agreements to include new chemicals). How this plays out could both help and hinder the prospects for reform of the Toxic Substances Control Act.

The GLBTS was added in 1997 to the Great Lakes Water Quality Agreement, which was originally signed in 1972 and has been updated periodically. EPA and Environment Canada are now working to renegotiate the agreement, which they hold will allow them to build on the successes of the past to identify and address new chemicals of particular interest to the Great Lakes, over which both Canada and the US cooperate to protect. The GLBTS set milestones for reducing the levels of toxics in the Lakes.

Industry is opposed to the renegotiation, arguing that they should wait until the US decides how it will reform TSCA before expanding the GLBTS. They argue that the achievements have been largely accomplished through voluntary efforts by industry working with the binational regulators. Environmental groups counter that it took 12 years to reach what they say are modest goals, and then not even all of them. They prefer to see the voluntary actions made mandatory, with much more aggressive timelines for completion. They also argue that the initial goals were based on the "low-hanging fruit," that is, the easy ones - chemicals that had already been identified as of concern.

It seems likeley that the effort to renegotiate and expand the GLBTS will add to the pressure to reform TSCA. Industry is currently faced with a multitude of state-initiated actions, and the GLBTS would add yet another set of standards by which industry must comply. They would prefer a single national standard in the US (i.e., TSCA reform) and preferably one that coordinates with Canada, the EU and other regulatory bodies to maximize the cross-jurisdiction acceptability of data packages and assessments. Environmental and health advocacy groups would also like to see a national standard, albeit a much more prescriptive and data intensive one than industry envisions.

All of this plays out as the anticipation grows for Senator Lautenberg to reintroduce an updated version of his Kid Safe Chemical Act. At this point, I think all stakeholders want to see something on the table that can be debated.