EPA Denies Requests for Chemical Confidentiality

Last summer, the Environmental Protection Agency (EPA) stated it would reject confidentiality claims for chemical identity in health and safety studies (see our previous post: EPA to reject confidentiality claims).

EPA says it already notified five companies that the identities of 14 chemicals associated with a number of health and safety studies submitted under the Toxic Substances Control Act (TSCA) and claimed as confidential are not eligible for confidential treatment.  The chemicals were unnamed.

More chemical names connected with health and safety studies will be released in the future.

This newsflash is of particular interest for those that manufacture (defined by statute to include import) and/or process chemical substances and mixtures subject to TSCA (15 U.S.C. 2601 et seq.).

“The public deserves access to critical health and safety information on chemicals, but if the name of the chemical is kept secret in the health and safety report, the information is of no real value to people,” said Steve Owens, EPA’s assistant administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP).

Owens said the agency is committed to increasing the American people’s access to this important information.

And the caveat is…The agency plans to deny confidentiality claims for chemical identity in health and safety studies provided to the agency under TSCA.  The only caveat comes if and when your chemical identity contains process or mixture information that is expressly protected by law.  That will take some convincing.  And some research and legal expertise.

Timeframe: 31 days. So how long do companies have to pursue the caveat or, if not, to watch their data go public?  The last paragraph of the EPA letter sent to companies states:

“EPA will make the information available to the public on the thirty-first (31st) calendar day after the date of your receipt of this determination…”

For more information on chemical transparency initiatives in U.S. manufacturing, go to: http://www.epa.gov/oppt/existingchemicals/pubs/transparency.html

For information on technology to manage chemical transparency initiatives in US manufacturing, try the products page on the Actio  website or try: http://www.materialdisclosure.com.

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REACH’s Complete List of Registered Substances

ECHA announced its list of publishable Phase-In substances under REACH regulation that were registered as of Jan. 24, 2011.

Every product is made from substances, and substances in some articles need to be registered with the European Chemicals Agency or ECHA if the products are intended to be brought to market.  Which products?  Almost any manufactured product that has a chemical in it:  clothing, furniture, plastic cases for electronic devices, motor vehicle parts, printed circuits, as well as process manufacturing products such as pharmaceutical drugs, solder and paint.

EU REACH regulation recognizes three primary deadlines for registering substances, see REACH timeline.  The first deadline was Nov. 30, 2010.  The next two deadlines are May 31, 2013, and May 31, 2018.  The deadline depends on the tonnage band and the hazardous properties of the substance.

About 30,000 substances are expected to be available in the database after expiry of the last registration deadline in 2018.  There are currently about 1/10th of that listed, just over 3000.  It’s expected that the number of substances listed in the database will increase over time, as we’ve said before, as companies will submit more registrations dossiers as we go.

List of REACH publishable Phase-In substances

Below is a preview of the list of publishable Phase-In substances under REACH regulation.  These were substances that were registered as of Jan. 24, 2011. ECHA has published this information on Registered Substances primarily so companies can start to use the data to bolster and gauge their own internal data processes and fortify their REACH software.  The information in the database was provided by companies in registration dossiers.

Please be aware that ECHA does not verify the information before dissemination, so some viewer discretion is advised.

Notice the bottom of the page says there are 62 pages of substances.  We won’t run them all here.  To see the full list, go to the ECHA database.

Please note that the ‘Registered As’ columns in the official ECHA published list (as above) are identified as follows:
•    FULL Indicates registration under REACH Article 10 as a full dossier
•    OSII Indicates registration under REACH Article 17 as an on-site isolated intermediate (OSII)
•   TII Indicates registration under REACH Article 18 as a transported isolated intermediate (TII)
•    ‘Yes’ Indicates the substance registration under REACH is complete
•    ‘In Proccess’ Indicates a dossier on the substance has been successfully submitted to ECHA and is being processed, i.e. the completeness check results are pending

As only publishable substances are listed, the list does not contain phase-in substances where the IUPAC name is claimed confidential under REACH Art 119(2)(g).  The list also doesn’t contain substances which are non-dangerous and not listed in EINECS.

A chemical named John Doe

If you want to keep your chemical name confidential in terms of ECHA registration, you must come up with an alias. As with most things REACH-related, there is a specific methodology for this.  You must provide an adequate public name as a precondition for the acceptance of a confidentiality claim for the chemical IUPAC name.

If ECHA rejects a confidentiality claim for the IUPAC name, the IUPAC name will be published. It’s best to take the time to create a public name the correct way.

The way to derive a public name for a substance are presented in the ECHA manual. There is a process for masking of various structural elements from the IUPAC name in order to derive a public name with just one level of masking. The one level of masking keeps it simple. If you feel your chemical needs additional levels of masking, a special request and allowance can in certain circumstances be made.

The full database contains a variety of information on the substances which companies manufacture or import: their hazardous properties, their classification and labeling and how to use the substances safely.

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ECHA Enhances Enforcement of CLP

On Jan. 25, some 29 countries from the European Economic Area sent 70 participants to ECHA  headquarters in Helsinki to strengthen the national harmonized enforcement of CLP, reports Chris Nowak of Actio, makers of chemical management software.

“The idea is,” Nowak explained, “that if ECHA takes the time to create skilled trainers, they will cascade their knowledge through training events in their own countries.

“We’ll see how it goes.  Both the enforcement of and penalties for REACH are somewhat episodic so far. Certainly well-trained inspectors are the cornerstone for the effective enforcement of CLP and REACH; but consistent legislative parameters would be helpful, too.  Surely we’ll be discussing this in some detail in Houston next month,” Nowak said.

CLP stands for the EU Classification, Labeling and Packaging Regulation.

Look forward to seeing how the “trickle down” enforcement works out for ECHA.  Enforcement has been a tricky aspect as the Agency charges forth in its admirable efforts to manage chemicals in the marketplace.

We’ll see how it goes…”

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CLP Next Steps Include Public Inventory Lists

CLP Regulation passed a major CLP deadline on January 3, 2011.  CLP stands for Classification, Labeling and Packaging of chemicals. It’s a legal obligation affecting manufacturers and distributors doing business in Europe.

The European Chemicals Agency, ECHA, said that 3,114,835 notifications of 24,529 substances for the Classification and Labelling Inventory, either hazardous or subject to REACH registration, were submitted by the midnight Jan. 3 deadline, as reported by Occupational Health & Safety Magazine.

For this January 2011 deadline, the most notifications came from:

  1. Germany: over 800,000.
  2. United Kingdom: over 500,000.
  3. France: nearly 300,000.

Together over 6,600 companies were notified of at least one substance.

“It went extremely well,” said Geert Dancet, Executive Director of ECHA.  “We got over three million submissions of classifications in time by the deadline [midnight, Jan. 3, 2011].  I think it’s a real success.”

Jack de Bruijn, director of risk management, said, “We will put all the information which we have received into a public version of the inventory, which we hope to have available by May of this year.  And the main aim of that inventory is actually for companies to check whether they can better self-classify their chemicals.”

The C&L inventory. The collected data will be held in a central inventory called the C&L inventory. The public version of the inventory will also include substance identifiers and any relevant specific concentration limit or multiplying factor for each substance.

According to the REACH Regulation (Article 119.1), the C&L inventory will contain

  • The classification and labeling information on substances submitted to ECHA through REACH registrations and CLP notifications.
  • A list of substances that have harmonized classification in the EU.

ECHA says that the full database will be accessible to Member State Competent Authorities, and non-confidential information in the inventory will be made public on the ECHA’s website.

“And with that increased transparency,” said de Bruijn, “we hope that we will contribute considerably to the safer use of chemicals in Europe, in particular the chemicals which are used in workplaces and by the general public.”

Again, the classification and labeling inventory will be published in spring/summer 2011.

If a company has flagged the IUPAC name confidential, and where relevant, the Agency will publish an alternative name in the public inventory.

Missed deadline. Companies that missed the deadline and are not sure what to do may contact an advisor such as Chris Nowak at Actio for ideas that are particular for each unique business situation.  To handle the situation directly — use the CLP notification web page, which is what you would use whether you’re late notifying or not.

If you missed the deadline but act quickly, penalties may be minimal or nonexistent.  ECHA wants you to notify.  There is every impetus for ECHA to make CLP notification as reasonable as possible.  Remember: this is a relatively new mind-set as well as project to manage, so no question is too small or naive.  There are few experts, so start where you are, ask questions, and share what you learn with others who are probably wondering, too.

Background on CLP. Classification, Labeling and Packaging regulation relates to chemical substances and mixtures. It introduces into the EU the criteria of the United Nations Globally Harmonised System — also known as GHS conversion — toward classifying and labeling chemicals.

One aim of the CLP regulation is to improve the protection of human health and the environment. One way of protecting human health is by publishing criteria for defining when a substance or mixture displays properties that lead to its classification as “hazardous.”

It’s too bad the CLP Regulation has such a complicated name — the concept is quite simple.

The CLP big picture is that hazardous chemicals and mixtures, when registered under REACH Regulation, require some sort of uniform classification system; this way all participants are using consistent terms, measurement units, and pictographs. Simple.

CLP is a legal obligation, yes, but it’s also common business sense.  Of course we would would want uniform communication standards in terms of classification, labels, and packaging when it comes to hazardous materials. It sounds cost-effective, too.  OSHA estimated last year that GHS, for instance, would result in time-to-market ROI, international trade cost reduction, and savings resulting from greater job safety and less injury.

Also, we should consider cost savings from lean operations resulting from streamlined processes; never mind cost-savings in time, paper and clerical labor, and the priceless ease-of-reporting to stakeholders such as the EPA, REACH agencies, any regulatory bodies, customers, board members, the public at large.

Finally,  in standard communication documents, there are significant risk management returns to consider. No entity is really resisting CLP or GHS because it makes sense from an Environment, Health and Safety or EHS angle, as well as from the business side.

Long live the green!  Both sides of it: for the environmental stewardship folks and for the Finance department.

EPA, ECHA Enter Partnership for Chemical Data Sharing

Arguably the two top environmental acronymn heavyweights, the US Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA) have just announced a partnership that will promote enhanced technical cooperation on chemical management activities.  This is another sign that America’s revamping of chemical regulation known as TSCA reform will likely become more REACH-like and more solidified.  The question is, how soon?

ECHA is the agency that implements the European Union’s chemical management program known as REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).  The REACH regulation has taken the world by storm.  EPA said in a release that the newly-announced partnership is part of EPA’s commitment to “improve chemical safety.”

One of the major anticipated areas of collaboration, say the agencies, will be on the exchange of data and information.

For example, the statement of intent will promote the exchange of non-confidential information on hazards, uses, and substance identification between ECHA and EPA, including data collected under REACH and by REACH software.  The two agencies will also share criteria for managing confidential business information with the goal to increase the availability of chemical information to the public.

Overall this joining of efforts and sharing of best practices is probably a good idea.  We just hope for more efficiency rather than another dimension of beurocracy.  For more on this, see details at the EPA page.

REACH Adds 8 New Chemicals to SVHC List

After unanimous agreement, ECHA, the European Chemicals Agency, has added eight chemical substances to the Candidate List of Substances of Very High Concern (SVHC) for Authorization.  This brings the total number of substances of very highly concern under REACH regulation to 46.

The eight additional Substances of Very High Concern or SVHCs are:

•    Cobalt (II) sulphate
•    Cobalt (II) dinitrate
•    Cobalt (II) carbonate
•    Cobalt (II) diacetate
•    2-Methoxyethanol
•    2-Ethoxyethanol
•    Chromium trioxide
•    Chromic acid, dichromic acid, chromium trioxide, and oligomers of chromic acid and dichromic acid

The eight substances are identified as carcinogenic, mutagenic, and/or reprotoxic in accordance with REACH Articles 57 (a), (b), and (c).

ECHA’s website lists the legal obligations that may apply to companies that manufacture, import, or use these substances on the SVHC list, whether used alone or in mixtures and articles.

Revamped eChemPortal for Access to Over 600,000 Chemicals

The Organisation for Economic Co-operation and Development (OECD), in partnership with ECHA, has launched its newest version of eChemPortal. Also known as the Global Portal to Information on Chemical Substances, eChemPortal provides free public access to over 600,000 records on chemical substances.

The revamped portal, hosted and funded by ECHA, includes the ability to search participating databases by chemical property (i.e., physical chemical properties, environmental fate and behavior, ecotoxicity and toxicity).

The ECHA dissemination database, US Environmental Protection Agency (EPA) Aggregated Computational Toxicology Resource (ACToR), US EPA Integrated Risk Information System (US EPA IRIS), and the United Kingdom Coordinated Chemicals Risk Management Programme Publications (UK CCRMP Outputs) are among 19 participating databases that gather information on existing chemicals, new industrial chemicals, pesticides, and biocides.

New web links provide information according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), including the GHS classification of an estimated 1,500 chemicals stored by the Japanese government.

Visit eChemPortal’s Help page for more information on using eChemPortal.

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RoHS Recast of November 2010

The consolidated text of the Restriction of Hazardous Substances (RoHS) Recast has been adopted by the European Commission.  On Nov. 24, the European Parliament’s environment committee adopted a compromise deal on updating existing legislation on the Restriction of Hazardous Substances (RoHS) in electronic and electrical equipment.  In an overwhelming margin, 640 votes were in favor, three against and 12 abstained.

The RoHS Directive will apply to more types of electronic and electrical equipment, including mechanized toys and lab equipment. This update to EU legislation notes a likely forthcoming review that would consider adding new substances to the current blacklist.

The current RoHS blacklist is as follows:

The RoHS Recast is still subject to further processes prior to final publication in the OJEC, the Official Journal of the European Community.  One aspect of that is confirmation by the European Parliament.

The National Measurement Office of the U.K. is responsible for enforcing the implemented RoHS Regulations only and is not directly involved in this process. They are providing advice and guidance on the future implementation in the meantime until the final version is published.  Advice and guidance is based on the most up to date information available at the time it is given.

Policy questions should be directed to BIS / the European Commission.Commission Decision 2010/571/EU

Exemptions under RoHS recast

Here is what you need to know about exemptions so far.

1.There are no exemptions from RoHS Regulations for products containing either PBB or PBDE.
2.There is one exemption for products containing hexavalent chromium.
3.There are six exemptions for products containing cadmium.
4.There are about 35 exemptions for products containing either mercury or lead.

For a full list of exemptions, click here to go straight to the official site.

Here is some extra help in the form of Guidance from the RoHS site in the UK.  We’ll be sure to post breaking news on this subject as events warrant.

EPA’s ToxCast Screens 1,000 Chemicals for Toxicity

Earlier this week, the US Environmental Protection Agency (EPA) announced that its ToxCast screening program has screened 1000 chemicals, helping determine the way in which exposure to chemicals effect human health. The EPA plans to use the cost-effective tests to screen thousands of chemicals.

The first phase of testing included approximately 300 chemicals, using over 500 automated tests or assays. The assays used human and animal cells and proteins to screen chemicals. The results were compared to animal studies from EPA’s databases, helping to determine which ToxCast assays can predict a chemical’s toxicity and disease-causing potential.

The second phase of testing currently includes 700 chemicals, consisting of consumer and industrial products, food additives, and drugs that failed to make it to market. The drugs and human clinical trial data were donated by pharmaceutical companies, and enable the EPA to compare the ToxCast screening results with actual human clinical data.

ToxCast “allows us to start predicting potential toxicity to human health and the environment instead of just describing the toxic effects that occur after chemical exposure,” said Dr. Paul Anastas (pictured), assistant administrator of EPA’s Office of Research and Development.

ToxCast contributes to Tox 21 — a federal agency collaboration consisting of EPA, US Food and Drug Administration, and the National Institutes of Health — which plans to screen 10,000 chemicals by the end of next year.  ToxRefDB is the database where information and testing results on chemicals is stored.

For more on chemical legislation at the state level, see http://circuitsassembly.com/blog/?p=1416.

Green Chemistry Status in California and All US States

Green Chemistry simply means: using chemistry to reduce or eliminate the use and generation of hazardous materials. Below, we’ve provided a table itemizing which states have stages of green chemistry laws implemented.  Just scroll down.  We all need an overview sometimes.  You can download the Green Chemistry Status pdf version here.

The California Green Chemistry Initiative may be a great idea, but it started an environmental regulatory trend whereby the state regulates chemicals in manufactured products. It applies to goods made or sold in the state. The green chemistry initiatives are similar to, in particular, DfE or Design for Environment and REACH. Often, Green Chemistry focuses on children’s products. This sparks the public interest, makes legislation easier to pass, and let’s face it, it appears children are more vulnerable and susceptible to the maleffects of toxic substances, largely because of toxic attacks on youth in critical developmental stages.

Would it be ideal to have Green Chemistry be some kind of standard at the federal level? Absolutely. Manufacturers, associations, regulatory bodies and the public agree on that. In theory. But then you get the politics, infighting, lobbying, special interest groups on both the left and right — and we’re back to state and local regulations. Of course these are all different, in different stages of implementation. This spells disaster for manufacturers trying to abide by the law.

To solve the problem, we’ve created an up to date Status Table that shows the status of Green Chemistry laws, state by state.

If you have trouble seeing the table below, view and print a high-resolution pdf version. Data are current as of December 2010.

Reuters recently ran an article that pointed out:

“In addition to the health and environmental safety of these greener chemicals, green chemistry brings a competitive advantage to companies:

1. Less risk of product recalls and potential damage to company reputation
2. Cost savings gained when hazardous materials are removed to reduce the costs associated with handling, transportation, disposal and compliance of hazardous materials
3. Improved chances of greater stakeholder engagement from customers, employees, managers, and investors are achieved when a company demonstrates initiatives to reduce their negative impact on the environment
4. Cost savings from greater efficiencies in manufacturing process.”

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