New Concentrations and Concentration Ranges Rules
If you’ve begun switching your MSDSs to SDSs under the new WHMIS 2015 regulations, you likely know this headache all too well.
With the publication and implementation of the Hazardous Products Regulations (HPR or WHMIS 2015), Health Canada removed the old Controlled Products Regulations’ (CPR or WHMIS 1988) list of prescribed concentration ranges that could be used in MSDSs. These concentrations were in place, in part, to allow some Confidential Business Information (CBI) protection when concentrations varied in a product. WHMIS 2015 now requires disclosure of exact concentrations of ingredients, or the actual concentration range of the ingredient. Actual concentration ranges can only be used if the concentration varies in the product due to issues such as batch to batch variability. You cannot list a range if you have an exact concentration, and simply wanted to “protect your formula”.
Suppliers would be required to file a CBI claim under WHMIS 2015 requirements, if even just to protect the exact concentration of one ingredient on a SDS. A whole host of difficulties may face the supplier in obtaining information that would be needed to complete this type of CBI submission, such as obtaining exact concentration information from suppliers outside the country, where CBI or trade secret requirements are different from those in Canada. In the United States, for example, there is no federal requirement Continue Reading…
The Environmental Protection Agency (EPA) issued a final technical amendment to 40 CFR Part 370, in June 2016 which aligns the hazardous chemical reporting regulations to the changes in the Occupational Safety and Health Administration’s (OSHA) Hazcom 2012.
These changes have a compliance date of January 1, 2018, and affect reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA), sections 311 and 312.
Section 311 of EPCRA requires facilities to submit a SDS or a list of hazardous chemicals grouped by categories of physical and health hazards. Section 312 of EPCRA requires facilities to submit an emergency and hazardous chemical inventory form yearly by March 1.
Prior to the change in 2012, the hazard communication regulations (OSHA) were performance oriented, and did not specify the language/description or format that the company had to use. Once the hazard communication regulations were updated, stakeholders requested that EPA align the wording to be consistent with the new OSHA Hazcom 2012 regulations.
Some of the changes in 40 CFR Part 370 include:
- Technical terms have been updated (i.e., Material Safety Data Sheet to Safety Data Sheet)
- The definition of Hazard Category has been updated
- The “Five categories” (Fire/Sudden release of pressure/Reactive/Immediate acute and Delayed-chronic) have been changed to match the physical and health hazards outlined the Hazcom 2012
- The Tier I and Tier II inventory forms are modified
- Tier 2 Submit, the software will be updated, and EPA is Continue Reading…
There are lots of songs out in the world about letters. You remember those things we used to write and send in the mail and have now been replaced by emails? There are some truly classic song regarding letters and the messages they carry. In 1961 The Marvelettes were begging their postman for a letter from a boyfriend indicating he was coming home. Click here for their song. This was followed in 1967 by The Box Tops song “The Letter” (listen here) where the singer is going home “because my baby done wrote me a letter”. This was followed in 1970 by Steve Wonder’s “Signed, Sealed, Delivered” that you can hear here. In this song the “letter” is actually Stevie letting his love know he is still hers.
So how do letters fit in today’s world of hazard communication? You may think they don’t, but actually they do. Think about when and how you receive your Safety Data Sheets (SDS). There are requirements for ensuring all workers know the hazards of the materials with which that work and that is usually accomplished by the SDS. What are the requirements for ensuring that you have an SDS for the hazardous chemicals in your workplace?
First, we will look at what the United States’ OSHA HazCom 2012 says:
“Employers shall maintain copies of any safety data sheets that are received with incoming shipments Continue Reading…
We all have reminders on our calendars for such things as holidays, birthdays, and appointments. As I looked forward to February for some planning purposes, the date of February 4th popped up as World Cancer Day. Is this a day to celebrate cancer? Does that even make sense when most of us upon hearing that word have some pretty strong negative reactions and emotions? This sent me on a path of fact checking. The purpose of World Cancer Day as established by the Union of International Cancer Control (UICC) is to raise awareness of cancer and to encourage its prevention, detection, and treatment. So, this day is similar to Earth Day or World AIDS Day then.
Since I work in the Regulatory World, I thought this would be an opportune time to talk about cancer in the realm of Hazard Communication. For many cancer is part of the acronym CMR which stands for materials that are carcinogenic, mutagenic or toxic to reproduction. In OSHA HazCom 2012, Appendix A Subsection 6 covers the definition, classification criteria, and cut-off values for carcinogens. Are those pieces of information really enough to classify all of your products? Granted the regulation points out in A.220.127.116.11 some factors to consider, but those exact particular factors can be hard to find in many full length cancer studies.
To make things a bit easier, OSHA has allowed for Continue Reading…
Many good jokes have a common setup to them. That setup involves a unique group of individuals and some sort of humorous interaction that ends with a punchline. So here is my setup for this blog. What do a famous scientist, an award-winning actress/comedian and a well-known businessman have in common? Let’s look at a quote from each of them.
- From Werner Heisenberg, the scientist, and his book Physics and Philosophy: The Revolution in Modern Science:
- “Whenever we proceed from the known into the unknown we may hope to understand, but we may have to learn at the same time a new meaning of the word ‘understanding’.”
- From Gilda Radner, the actress/comedian:
- “Life is about not knowing, having to change and making the best of it, without knowing what’s going to happen next.”
- From Warren Buffet, the businessman:
- “Risk comes from not knowing what you’re doing.”
Now, I don’t have the best punchline but there is a common thread in each of these. It is about the unknown.
As authors of Safety Data Sheets (SDS) and labels, when researching ingredients there are times when there are no acute toxicity data in the literature on an ingredient. When this happens, alarm bells should ring. There is a very specific thing that has to happen when ingredients have unknown acute toxicity. When that ingredient is a part of an untested mixture at a relevant concentration, Continue Reading…
As I get older and more wrinkles, crow’s feet and age spots appear on my face, I consider some sort of plastic surgery like a facelift. According to the dictionary, a facelift is a procedure carried out to improve the appearance of someone or something. A little nip and tuck, tightening and smoothing could go a long way in removing some of my signs of aging. So, how does my desire to look younger have anything to do with OSHA? To put it simply, OSHA’s website on Hazard Communication got a facelift.
Click to enlarge
OSHA announced the update to the Hazard Communication website in the November 2nd QuickTakes newsletter under the Educational Resources section. To see the full newsletter, click here.
The new look actually makes the site easier to maneuver through as there are now drop-down tabs that can be used for faster searching for needed information. A quick review of each tab is as follows:
- Safety Data Sheets: This tab includes the Safety Data Sheets QuikCard™ in both HTML and PDF formats along with the OSHA SDS Brief regarding Safety Data Sheets that incorporates Appendix D of the HazCom2012 regulation.
- Labeling: On this tab the setup is very similar to that of the Safety Data Sheets. An additional link is to a QuickCard™ of a comparison between NFPA and OSHA labels.
- Pictograms: Here again are the same features as the Continue Reading…
Why did you use an exact concentration?
Why was an exact concentration used? Health Canada eliminated the allowable ranges (previously allowed with WHMIS 1988) and went to exact concentrations. The only exception is if there is a batch variation. The other option is the customer can apply for an exemption. The blog found here http://www.thecompliancecenter.com/blog/2015/08/10/strictly-confidential-not-sds-ingredient-disclosure-cbi/ provides addition information.
Why is my product a class 9 in Canada when it was not previously?
On December 31, 2014 Transport Canada issued an amendment to the Transportation of Dangerous Goods Regulations (SOR/2014-306). Details on this amendment can be found here http://www.thecompliancecenter.com/blog/2015/01/05/new-year-new-tdg-amendment/ . Essentially, Transport Canada brought in the criteria for classifying marine pollutants that follows the IMDG code. Based on the available aquatic data for fish, invertebrate and algae, the substance or product is given a classification. If that classification falls into Acute Category 1 or Chronic Category 1 or 2, it is regulated for transport and gets the shipping description Environmentally hazardous substance (solids or liquids), n.o.s. The USA still leaves this as an optional classification (you can still use the list or you can harmonize).
Despite the publicity and awareness campaigns around the labels, SDS and classification aspects of WHMIS 2015, there are a few administrative areas that shouldn’t be overlooked.
These elements of the Hazardous Products Act (HPA) and Regulations (HPR) are not related to GHS, but deal with aspects that are important to those with Supplier obligations.
Some of these have become fairly common knowledge (e.g. Canadian supplier, including same supplier on label/SDS, etc.); others have not been widely discussed.
Document Creation/Retention – HPA 14.3
Every Supplier selling (more on this later) or importing a hazardous product for use, handling or storage in a Canadian work place must maintain a “true copy” of both the SDS and label relating to the product at the time of import or sale.
Note the phrase “true copy” does not include the word “certified”- so presumably they don’t need to be notarized – but I’ll leave that for the lawyers in the audience to comment on.
This section also requires the Supplier to create and maintain documented records of the:
- Source (name/address, date and quantity) of the hazardous product obtained from others (e.g. manufacturers);
- location and monthly quantities of sales (“transfer of ownership or possession) of the hazardous product
The Act requires that all of the documents referenced above be kept for 6 years following the end of the year they relate to- unless the Minister prescribes a different period.
Also Continue Reading…
As a new order for classifications and label text is begun, the song “Time Is On My Side” by The Rolling Stones comes to my mind. Take a listen here to remind yourself of the rhythm and lyrics. I and many other SDS and Label authors approach each new request with optimism and the hope that a perfect world exists. Believing all of the information needed is supplied by the client, the data needed is readily available and the time needed for work is plentiful.
For any given order there could be multiple products and each product requires an SDS and Label. Each of the products is probably a mixture. In some cases the products are actually mixtures made up of other mixtures. Some of the products have trade secret claims. Taken together, this means we authors start to question what Mick Jagger is saying. Is time really on my side?
Now, clients are amazing. Any information needed requires a simple email or phone call. If they have it, then within a short period of time it is provided.
Things start to fall apart though when information just is not there. Many companies are still struggling with receiving SDS and Labels that are compliant with HazCom 2012 from their manufacturers and suppliers. When this happens, I am tasked with finding information on my own. This finding of information is the Continue Reading…
The program to harmonize the Canadian WHMIS 2015 regulations and the US HCS2012 extends beyond adopting elements of the UN GHS. Unfortunately not all the differences can be removed, but the effort has led to some changes of which importers and suppliers need to be aware. Since the majority of the differences affect Canadian suppliers and importers (with the implications flowing to US suppliers to Canada), Health Canada has prepared a Guidance document, recently shared with CACD (Canadian Association of Chemical Distributers), on “Disclosure of Ingredient Concentrations and Concentration Ranges on Safety Data Sheets.” The document, dated July 31, 2015, is expected to be available for general distribution soon.
Similar But Different
The GUIDANCE summarizes the WHMIS 2015 requirements and contrasts them with both the previous WHMIS 1988 and current US HCS2012 regulations.
In a nutshell, WHMIS-compliant SDS must disclose “true” – i.e. actual ranges of health-hazard ingredients and cannot optionally use wide ranges as a work-around to avoid the cost/administrative burden of the formal application, under the Hazardous Material Information Review Act/Regulations (HMIRA), for approval to mask trade secrets.
So, in effect, the WHMIS 1988 broad ranges can no longer be used at the Supplier’s discretion (e.g. an ingredient present at 12.5% +/- 0.5% could previously, under WHMIS 1988, have been listed on the msds as “7- 13%;” or as “10-30%”).
Under WHMIS 2015, an SDS must disclose the ingredient Continue Reading…