Tag Archives: environmental compliance

Canadian Chemical Regulations: An View From Above

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Quality professionals focus on Europe, the US and even China — as with China REACH and China RoHS for example — when we speak of chemical regulations.  Sometimes we overlook Canada when we say “global.”

This is a mistake. Many supply chains go through Canada, and Canadian substance-level regulations are not shrinking violets at the regulatory compliance dance.

One really good way to stay on top of Canadian environmental law is to read the annual Blake’s Guide to Environmental Law in Canada. The document is an effective introduction to the principal laws and regulations in Canada and the provinces of British Columbia, Alberta, Quebec and Ontario, concerning environmental protection and conservation.

Specific advice should be sought in connection with particular matters or transactions — questions can be routed to the authors of this blog or to the environmental lawyers listed in the guide.

Key subjects include:

  1. Canadian Environmental Protection Act, 1999 (CEPA)
  2. Canadian Environmental Assessment Act (CEAA)
  3. Transportation of Dangerous Goods Act, 1992 (TDGA)
  4. Hazardous Products Act (HPA) and Canada Consumer Product Safety Act (CCPSA)
  5. Pest Control Products Act, 2002 (PCPA)
  6. Fisheries Act
  7. Canada Shipping Act
  8. Marine Liability Act
  9. Navigable Waters Protection Act (NWPA)
  10. Oceans Act
  11. Canada National Marine Conservation Areas Act
  12. Species at Risk Act (SARA)
  13. Migratory Birds Convention Act, 1994 (MBCA)
  14. Canada National Parks Act
  15. Criminal Law
  16. Energy Efficiency Act

The Canadian law firm Blake, Cassels & Graydon LLP has issued Blake’s Guide to Environmental Law in Canada.

The guide also provides an overview of environmental law in Ontario, Quebec, Alberta, and British Columbia.

Canadian law and toxic substances. CEPA, the Canadian EPA, provides the federal government with “cradle to grave” regulatory authority over substances considered toxic. CEPA provides for assessment of “new” substances not included on the Domestic Substances List, a national inventory of chemical and biotechnical substances.

It’s required that an importer or manufacturer must notify the federal government of a new substance before manufacture or importation can take place in Canada. Consequently, businesses must build in a sufficient lead-time for the introduction of new chemicals or biotechnology products into the Canadian marketplace. In certain circumstances, manufacturers and importers must also report new activities involving approved new substances so they can be re-evaluated.

All existing substances included on the Domestic Substances List are in the process of being
assessed by Environment Canada for bioaccumulation, persistence and inherent toxicity
(BPIT). Currently, Environment Canada is in the process of collecting information and
conducting risk assessments with respect to a series of “Batches” as part of the “Challenge to Industry” program.

Under the Canadian Environmental Protection Act, a substance is “toxic” if it is entering or may enter the environment in a quantity or concentration or under conditions that;

  1. have or may have an immediate or long-term harmful effect on the environment or its biological diversity
  2. constitute or may constitute a danger to the environment on which life depends or
  3. constitute or may constitute a danger in Canada to human life or health

Substances that are persistent, bioaccumulative, and result primarily from human activity
must be placed on the Virtual Elimination List. Listed toxic substances include:

  1. PCBs
  2. CFCs
  3. chlorinated solvents

You can contact us or contact the Blakes, a law firm that regularly produces reports and special publications on Canadian legal developments. For further information about these reports and publications, please visit blakes.com.

TSCA Update: New Chemical Reporting for 2012

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Last week the US Environmental Protection Agency held a training session to further explain the amendments to the Toxic Substances Control Act (TSCA), scheduled for 3 hours this afternoon.  For those who couldn’t make it, here’s the distilled version:

For starters, there is a section 8(a) Inventory Update Reporting (IUR) rule change in name, to the Chemical Data Reporting (CDR) rule.  The new name is more precise, we appreciate that.   “Inventory” is a softer word than “chemical” but it has also far too broad an implication in the industrial world.

EPA is promulgating several amendments to the IUR / CDR rule, taking into consideration comments received on the proposed rule.  The amendments were proposed in the Federal Register issue of August 13, 2010.

In short, the way Production Volumes are reported will change:

*

Who is affected? Businesses are affected by this action if they manufacture (including manufacture as a byproduct or import) for commercial purposes chemical substances listed on the TSCA Inventory and produced in volumes of 25,000 lb or more during the principal reporting year (i.e., calendar year 2011).

Potentially affected entities likely include but are not limited to:

  1. Chemical substance manufacturers and importers (North American Industry Classification System (NAICS) code 325 and 324110; e.g., chemical substance manufacturing and processing and petroleum refineries)
  2. Chemical substance users and processors who may manufacture a byproduct chemical substance (NAICS codes 22, 322, 331, and 3344; e.g., utilities, paper manufacturing, primary metal manufacturing, and semiconductor and other electronic component manufacturing)

In short:  manufacturers — including importers — of TSCA Inventory-listed chemical substances with a 2011 production volume of 25,000 lb or greater at a site, unless otherwise exempted.

The 2012 submission period is Feb. 1 to June 30, 2012. You need to know:

  • Reporting is site-specific
  • Reporting standard is “known to or reasonably ascertainable by” for all data
  • CBI – upfront substantiation required for:
    • Site and chemical identity claims
    • Processing and use information claims [new requirement]

Manufacturing-related data includes:

  1. Chemical identity
    1. CAS RN and chemical name
    2. Accession number and generic chemical name for CBI substances
  2. Production volume (PV)
  3. Number of workers that are reasonably likely to be exposed (in ranges)
  4. Maximum concentration
  5. Indication of whether a manufactured chemical substance is being recycled, remanufactured, reprocessed or reused
  6. Physical form and percent production volume in the form
  7. Processing and use-related data are required for production volumes of 100,000 lb. or more, at a site, unless otherwise exempted

Online web based software can help with the new reporting requirements.  EPA has offered up a web based portal of similar nature.

*chart courtesy EPA CDR training info

 

15 Bad Intentions Under REACH

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Three new restriction proposals for NPs and NPEs have been announced under REACH.  Specifically, the three are:

  1. 4-nonylphenol, branched
  2. nonylphenol
  3. nonylphenol ethoxylates

NPs and NPEs are grouped under alkyl phenols and their ethoxylates.  Sweden has proposed intentions to restrict the three substances.

Notification of intention: September 2, 2011
Expected date of submission: August 3, 2012

Currently, most substances under intention for restriction are mercury compounds and phthalates.  To view or download the list of 12 substances with intention for restriction under REACH see below or download REACH’s12 intentions.

The Swedish Chemicals Agency understands that the proposed restriction is a new restriction, not an amendment of an existing one.  (The amendment of an existing restriction requires first a decision according to REACH article 69(5) to amend the restriction and then a decision according to the normal procedure amending the restriction.)

Justification for the three new proposed market restrictions for 4-nonylphenol, branched and nonylphenol and nonylphenol ethoxylates is reportedly based on Sweden’s understanding that:

  1. NP (e.g., nonylphenol) and NPEs (e.g., nonylphenol ethoxylates) have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota
  2. NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents
  3. NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms
  4. NP has also been shown to exhibit estrogenic properties in vitro and in vivo assays. NP’s main use is in the manufacture of NPEs
  5. NPEs are nonionic surfactants that have been used in a wide variety of industrial applications and consumer products. They can be found in textile (including leather) articles
  6. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP
  7. Levels of NP in waters above the environmental quality standards in the Water Framework Directive (WFD) is found in several waters despite the strict restriction on the use of Nonylphenol (NP) and Nonylphenoletoxilates (NPEO) under the limitations directive 76/769/EEC (now in Reach Annex XVII, entry 46) having been in force since January 2005
  8. NP and NPEO in textiles have been identified as a significant source of NP in the environment

Based on these data, the Swedish Chemicals Agency is investigating the possibility to propose a restriction on the placing of the market of textile and leather articles containing NP or NPEO.

RoHS Recast — Regulatory Update Made Official

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The Council of the European Union (“the Council“) officially revised the RoHS directive on hazardous substances in electrical and electronic equipment.  The chemical restrictions will now apply to all electrical and electronic equipment, as well as to cables and spare parts, and to medical devices, medical equipment, control and monitoring equipment – which were previously exempt from RoHS compliance but are not exempt now.

Further, this recast will harmonize the directive across the European Union.

The product categories affected by RoHS include large household appliances, computer equipment, TVs, lighting, toys and video games, and vending and ATM machines – as well as the categories listed at the top of this article.  You can imagine then that almost all discrete manufacturing sectors are affected – as most use computer equipment in parts, components or assemblies.  RoHS creates a notable data management challenge in terms of supplied parts and compliance certification.

RoHS Recast provisions. Provisions are included in the recast to allow time for the market to adjust.

A three-year transitional period is allowed for some devices:

  • monitoring
  • control
  • medical

A five-year transitional period is allowed for:

  • in vitro medical devices

A six-year transitional period is allowed for:

  • industrial control appliances

Nanomaterials under RoHS. Everyone wants to know how nanomaterials will be regulated.  It’s a grey area.  Rightly, the European Commission says that work towards a common definition of nanomaterials is necessary (yes!) and ongoing. The EC intends to adopt a Commission Recommendation on a common definition “in the near future.”

The Commission considers that the RoHS provisions cover different forms (including nanoforms) of the substances which are currently banned. The Commission also considers that these RoHS provisions cover forms subject to a priority review under RoHS in the future.

RoHS Recast next steps. Next steps include:

  • Signatures and Journal publication
  • Transposition into EU member state laws
  • Industry implementation

There are a few good resources for more information. Design Chain Associates (DCA) has a good article and some (reasonably priced) on-demand webinars for more in depth review.

Would you accept this RoHS? It may be a good idea to review why we are gathered here today. While the ins and outs of regulations can be like jungle hacking – a look from the air is a good idea from time to time.

There are measurable environmental benefits to a well-executed and enforced RoHS program. Reported environmental benefits include:
•    reduction of lead (Pb) use in products by 82,700 tons in the EU
•    reduction of cadmium (Cd) use in products by 14,200 tons
•    reduction of mercury (Hg) use in products by 9,500 tons due to changes in copiers and fluorescent light bulbs
•    reduction of mercury in waste streams by 6,900 tons

RoHS restricted substances. RoHS focuses on six hazardous substances: lead, mercury, cadmium, hexavalent chromium and two types of flame retardants in plastics (PBB and PBDE). The restrictions have not changed since last November, but additional hazardous substances are now expected, whereas the list of substances of concern under the previous version of RoHS was considered more stable. Click here for the current list/threshold amounts.

To wit, RoHS is a directive, not a regulation. The difference is that a directive cares only about the result. With RoHS, for example, the required result is the restricted use of certain toxic metals in electronics manufacturing. A regulation, on the other hand, delineates to each entity under the umbrella of the regulation how to get the result.  A good example is the REACH regulation, which has a detailed process for substance registration, use, and data sharing.

REACH Penalties: Belgium Found Guilty

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Belgium is the first EU Member State to be condemned by European Court of Justice for breach of REACH.  This is the result of a May 5 judgment in Case 265/10 Commission vs. Belgium.

REACH has been very clear from the beginning that Member States have their own responsibilities and their own penalty structures.  For instance, the chart (above) shows comparative REACH compliance fines between countries across Europe.  Belgium has among the highest penalties in the EU.  Moreover, the chart shows the incredible discrepancies between how Member States choose to implement and moderate REACH compliance.  (The chart is from the EC December report on penalties, from a study conducted by Milieu Ltd. for the European Commission.)

Brussels fails to comply. REACH Article 126 imposes the obligation on EU Member States to adopt whatever measures necessary to ensure sufficient and correct enforcement of REACH.  Crucially, EU Member States were obligated to notify their enforcement/sanctions-systems to the Commission by Dec. 1, 2008.

Brussels-based Peter Kugel, Partner at Kugel Legal, a firm specializing in EU Law & Litigation, reports that “Belgium evidently failed to comply with that obligation because the Regions of Wallonia and Brussels-capital had not yet adopted any measures to comply with Article 126 REACH.”

REACH “cooperation agreement.” The Commission argued that Belgium failed to comply with Article 126 because there was no “cooperation agreement” in place between the Federal Government and the Regional governments.  A “cooperation agreement” would be an agreement that paves the way for cooperation between the different inspection services in a Member State, largely by implementing modalities of cooperation and information exchange pathways.

The Court dismissed the argument that lack of such an agreement would necessarily lead to lack of compliance.

The court found that, yes, such an agreement could certainly be an appropriate instrument towards the implementation of an effective sanctions-system in connection with violations of REACH (as foreseen by Article 126).

“However,” points out Kugel, “the Court ruled that neither Article 126 REACH nor any other provision of REACH oblige Member States to engage in such domestic ‘cooperation agreements’ for a correct implementation of Article 126 REACH.”

In other words:  it’s each country’s responsibility to figure out its compliance infrastructrue.  It is not up to any outside (federal) agent to coordinate or install procedures to ensure clear compliance processes for a Member State.

REACH breach ruling insight. Many were surprised that Belgium was the first to receive a judgement against their REACH compliance efforts.

Politically, in the longer term, to crack down on Belgium first could be a smart decision.  It shows lack of favoritism when it comes to compliance breach judgements.  In the short term, though, Belgium comes away with a bruised ego and a bruised Public Relations team.  Overall?  It’s nothing a month or two and a few more condemnations in other directions won’t fix.

In saying that, however, we must not be glib.  Businesses in America are watching compliance rulings on REACH like hawks.  Rightly so.  As court action heats up, so will fines, and then all import/export companies will really begin take REACH compliance risk management more seriously.

Apparently, and refreshingly perhaps, the “we didn’t know how to do it; we didn’t know what was going on” argument isn’t flying far in European courts.