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OSHA Hazard Communication Standard
2021 Proposed Rule
July 2021 Client Briefing
7 changes to Safety Data Sheets (SDS) and labels
Changes are coming to SDS and labels
In the USA, requirements for SDS and labels for chemical products are set forth by
OSHA in the Hazard Communication Standard (HCS), which was last updated in
2012 to align with the UN Globally Harmonized System of Classification and
Labelling of Chemicals (GHS).
In February 2021, OSHA issued a new proposed rule to update the HCS. The
changes are intended to improve communication of hazards, align with regulations
in other countries, and to codify previous interpretations of the HCS by OSHA. The
new requirements will necessitate revision of SDS and labels for chemical products.
This brief will help familiarize you with seven of the more significant changes that
are bing proposed.
I’m here to help you navigate the new rule and comply with its requirements, and
will provide additional details once the final rule has issued (late 2021 / early 2022).
Finally, keep in mind that the new requirements also affect your customers, since
they will need to update SDS and labels for their own products. You can expect
that they will start requesting updated SDS as soon as the final rule is effective.
Providing them with updated documentation promptly is one way for you to
differentiate yourself as a supplier. Consider communicating your implementation
plan to them proactively and be open to discussing any concerns they might have.
Registered trademark of the
Occupational Safety and Health
Administration, US Dept. of Labor.
BotkinChemie is not affiliated with or
endorsed by OSHA.
7 proposed changes to SDS and labels
Affects
SDS?
Affects
Label?
1 Alignment with GHS 7th Revised Edition Yes Yes
2 Hazards associated with chemical reactions Yes No
3 Date released for shipment No Yes
4 Ingredients of unknown acute toxicity Yes Yes
5 Prescribed concentration ranges for mixtures Yes No
6 US responsible party Yes Yes
7 Labeling of small containers No Yes
1 Alignment with GHS 7th Revised Edition
A fundamental reason for updating the HCS is realignment with a newer
edition of GHS. At the last update in 2012, the HCS was aligned with the 3rd
revised edition (2009). Since then, GHS has been updated every 2 years,
and in the proposed rule OSHA aligns with the 7th revised edition (2017).
While newer editions exist, this version was selected to provide consistency
with the regulations of our major trading partners.
Practically speaking, the main changes to SDS and labels resulting from
realignment involve changes to the precautionary statements that appear on
the label and in Section 2 of the SDS. In the case of health hazard classes,
almost all types of hazards are affected but most of the changes are minor,
and simply represent better guidance on selection of words and phrases for
clarity. More substantial changes to precautionary statements will be required
for physical hazard classes, such as flammable liquids. Several new hazard
classes (for example Desensitized Explosives, and Aerosols) have also been
added.
Of all the changes, this is the one that was most expected and that will be the
simplest for us to deal with. It will almost certainly be adopted with little or no
change in the final rule.
2 Hazards associated with chemical reactions
OSHA has long required chemical suppliers to classify hazards expected resulting
from normal conditions of use or during foreseeable emergencies.
The proposed rule goes much further, and now requires in Section 2 of the SDS
(but not on the label) disclosure of any hazards identified under normal conditions
of use that result from a chemical reaction. This represents a sharp divergence
from GHS as interpreted by regulators in the rest of the world, and is easily the
most controversial provision of the proposed rule.
This provision potentially applies to a wide range of chemical products that undergo
chemical reactions during use, including some types of stabilizers, foaming agents,
chemical intermediates, and catalysts. Exactly what information OSHA is requiring
chemical suppliers to present in the SDS is not yet clear. If this provision survives
in the final rule, OSHA will need to provide guidance regarding the situations for
which it applies and also specify the exact nature of the information to be presented
in the SDS.
There is significant opposition to this provision from industry stakeholders, and I
expect that this will be a major topic for discussion at OSHA’s public hearing on
September 21. I will keep you posted regarding any new developments, including
whether or not this new provision applies to you.
3 Date released for shipment
OSHA requires that chemical suppliers who become aware of significant new
hazard information must revise labels for affected products within six months, and
ensure that labels on containers shipped after that time include the new
information. In some cases, this means that containers already in stock must be
relabeled, which is inconvenient and time consuming for chemical suppliers and
warehouse managers.
To avoid the need for relabeling, the proposed rule provides that chemicals that
have been released for shipment and are awaiting future distribution need not be
relabeled. “Released for shipment” is defined as “a chemical that has been
packaged and labeled in the manner in which it will be distributed or sold.”
This change is touted by OSHA as a cost saving measure. However, the proposed
rule also requires that the date the chemical was released for shipment appear on
the label. This requirement represents a substantial change to the label format, and
many stakeholders have raised objections regarding the feasibility of changing their
labels in their comments to OSHA.
This is another topic that will no doubt be discussed at the September 21 public
hearing, and I will keep you apprised of new developments.
4 Ingredients of unknown acute toxicity
In the current version of the HCS, OSHA requires a statement on the label and in
Section 2 of the SDS for products containing ingredients of unknown acute toxicity
(for example, “x% of this product consists of ingredients of unknown acute toxicity”).
It has been common practice among SDS and label authors to assume that this
requirement does not apply as long as acute toxicity data is available for at least
one route of exposure (oral, dermal, or inhalation). This data exists for the majority
of chemicals in commerce, and when this is the case it has not been deemed
necessary to add a statement on unknown acute toxicity to labels or SDS.
In the proposed rule, a revision has been made to require the statement to
differentiate by route of exposure. For example, the statements could read
‘‘x% of this product consists of ingredient(s) of unknown acute oral toxicity’’ or
”x% of this product consists of ingredient(s) of unknown acute dermal toxicity.’’
This provision will necessitate changes to SDS and label content for many products
(especially mixtures), because for many chemical substances acute toxicity data is
not available for all three routes of exposure. In these cases, new statements will
be required on both the SDS and the label.
?
5 Prescribed concentration ranges for mixtures
The current HCS allows the exact concentrations of hazardous components of a
mixture to be withheld as trade secrets. In this case, the concentrations are
normally provided in Section 3 of the SDS as ranges. For example, if a mixture
contains 50% of a hazardous ingredient, this may be reported as any range that
covers 50%. The existing HCS does not provide guidance regarding the exact
concentration range to be used.
In the proposed rule, the option to withhold as trade secrets the exact
concentrations of hazardous ingredients of mixtures is maintained, but the use of
one of thirteen prescribed concentration ranges will now be required. It is further
required that the range used must be the narrowest one possible.
In cases where a product has a variable composition, and the range of
concentrations for a given component falls outside one of the prescribed ranges,
OSHA allows for combining of two ranges.
While this approach may be beneficial in that it is aligned with the system used in
Canada under the Hazardous Product Regulations (HPR), it represents yet another
revision that will be required to SDS for products that are mixtures.
Prescribed
ranges:
0.1-1%
0.5-1.5%
1-5%
3-7%
5-10%
7-13%
10-30%
15-40%
30-60%
45-70%
60-80%
65-85%
80-100%
6 US responsible party
The HCS requires the name, address, and telephone number of the “responsible
party” to be listed on product labels and in Section 1 of the SDS. This is normally the
chemical supplier.
In two letters of interpretation, OSHA clarified that the responsible party must be a
US-based entity. For imported chemicals, this is generally the importer, but OSHA
allows that it can be “someone who can provide additional information on the
hazardous chemical and appropriate emergency procedures, if necessary”. It is
acceptable to include the foreign manufacturer’s information on the label (and
presumably in Section 1 of the SDS), although OSHA states that they prefer it to be
omitted to prevent confusion.
The requirement that the responsible party be US-based is incorporated in the
proposed rule. However, unlike the other changes covered in this brief, this
requirement is applicable under the current version of the HCS. Therefore SDS and
labels need to be updated as soon as possible if a US-based responsible party is
not listed.
As part of my practice I can serve as the “responsible party” to help foreign chemical
manufacturers meet this requirement. Please contact me if you need additional
information.
7 Labeling of small containers
Chemical suppliers sometimes make the assumption that labeling requirements do
not apply to small containers, such as small jars used for samples. However, OSHA
makes clear in its letters of interpretation that labeling requirements apply to all
containers, regardless of size. To fit all of the required information on a small label,
OSHA encourages alternative designs for labeling of small containers, such as fold-
back labels, peel-out labels, and tags.
The proposed rule includes a new provision for reduced labeling requirements for
small containers in cases where a standard label or one of the alternative designs is
demonstrated not to be feasible. For containers of 100 mL capacity or less, it is only
required to include, at a minimum, the product identifier, pictogram(s), signal word,
name and phone number of the responsible party, and a statement that the full label
information can be found on the immediate outer package. For very small
containers of 3 mL capacity or less, label requirements (except for the product
identifier) are waived if the supplier can demonstrate that any label would interfere
with the normal use of the container.
In both cases, the outer packaging is required to include the full label information
along with a statement indicating that the small container(s) inside must be stored in
the immediate outer package (bearing the complete label) when not in use.
Please contact me if you need assistance developing labels for small containers.
An example of a label for use on
small containers (100 mL or less
capacity) when it is not feasible to
provide full label information.
Implementation and next steps
Besides the seven changes described herein, the proposed rule includes many other provisions that affect
you as a chemical supplier. For this reason, I recommend that you review the proposed rule, which can be
downloaded at
https://www.federalregister.gov/documents/2021/02/16/2020-28987/hazard-communication-standard
Please consider joining me at OSHA’s informal pubic hearing on the proposed rule, which will be held as a
conference call on September 21, 2021 at 10 AM Eastern Time. For more information, visit
https://www.osha.gov/news/newsreleases/trade/05202021
The final version of the rule is expected to issue in late 2021 or early 2022. It will become effective 60 days
from issue, after which there will be a phase-in period of 1-2 years to allow you to make necessary changes
to your SDS and labels, and train your employees. I will revert with additional details and recommendations
on implementation once the final rule has issued.
On your side, it would be helpful for you to compile a list of active products for which SDS and labels will
need to be updated. With this information I can estimate your cost of compliance and give an indication of
the timing to complete the work.
Please contact me if you have further questions.
Thank You!
DISCLAIMER: Although the information and recommendations set forth herein (hereinafter "information") are presented in good faith and believed to be
correct as of the date hereof, BotkinChemie makes no representation as to the completeness or accuracy thereof. Information is supplied upon the condition
that persons receiving it will make their own determinations as to its suitability for their purpose prior to its use. In no event will BotkinChemie be responsible for
damages of any nature whatsoever resulting from the use of or reliance upon information. No representations or warranties either expressed or implied, or
merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to information for any substance to which information
refers. No statements herein are to be construed as inducements to infringe any valid patent.
© 2021 James H. Botkin dba BotkinChemie
Jim Botkin
www.botkinchemie.com
+1 (732) 309-3476
email

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OSHA Hazard Communication Standard 2021 Proposed Rule

  • 1. OSHA Hazard Communication Standard 2021 Proposed Rule July 2021 Client Briefing 7 changes to Safety Data Sheets (SDS) and labels
  • 2. Changes are coming to SDS and labels In the USA, requirements for SDS and labels for chemical products are set forth by OSHA in the Hazard Communication Standard (HCS), which was last updated in 2012 to align with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). In February 2021, OSHA issued a new proposed rule to update the HCS. The changes are intended to improve communication of hazards, align with regulations in other countries, and to codify previous interpretations of the HCS by OSHA. The new requirements will necessitate revision of SDS and labels for chemical products. This brief will help familiarize you with seven of the more significant changes that are bing proposed. I’m here to help you navigate the new rule and comply with its requirements, and will provide additional details once the final rule has issued (late 2021 / early 2022). Finally, keep in mind that the new requirements also affect your customers, since they will need to update SDS and labels for their own products. You can expect that they will start requesting updated SDS as soon as the final rule is effective. Providing them with updated documentation promptly is one way for you to differentiate yourself as a supplier. Consider communicating your implementation plan to them proactively and be open to discussing any concerns they might have. Registered trademark of the Occupational Safety and Health Administration, US Dept. of Labor. BotkinChemie is not affiliated with or endorsed by OSHA.
  • 3. 7 proposed changes to SDS and labels Affects SDS? Affects Label? 1 Alignment with GHS 7th Revised Edition Yes Yes 2 Hazards associated with chemical reactions Yes No 3 Date released for shipment No Yes 4 Ingredients of unknown acute toxicity Yes Yes 5 Prescribed concentration ranges for mixtures Yes No 6 US responsible party Yes Yes 7 Labeling of small containers No Yes
  • 4. 1 Alignment with GHS 7th Revised Edition A fundamental reason for updating the HCS is realignment with a newer edition of GHS. At the last update in 2012, the HCS was aligned with the 3rd revised edition (2009). Since then, GHS has been updated every 2 years, and in the proposed rule OSHA aligns with the 7th revised edition (2017). While newer editions exist, this version was selected to provide consistency with the regulations of our major trading partners. Practically speaking, the main changes to SDS and labels resulting from realignment involve changes to the precautionary statements that appear on the label and in Section 2 of the SDS. In the case of health hazard classes, almost all types of hazards are affected but most of the changes are minor, and simply represent better guidance on selection of words and phrases for clarity. More substantial changes to precautionary statements will be required for physical hazard classes, such as flammable liquids. Several new hazard classes (for example Desensitized Explosives, and Aerosols) have also been added. Of all the changes, this is the one that was most expected and that will be the simplest for us to deal with. It will almost certainly be adopted with little or no change in the final rule.
  • 5. 2 Hazards associated with chemical reactions OSHA has long required chemical suppliers to classify hazards expected resulting from normal conditions of use or during foreseeable emergencies. The proposed rule goes much further, and now requires in Section 2 of the SDS (but not on the label) disclosure of any hazards identified under normal conditions of use that result from a chemical reaction. This represents a sharp divergence from GHS as interpreted by regulators in the rest of the world, and is easily the most controversial provision of the proposed rule. This provision potentially applies to a wide range of chemical products that undergo chemical reactions during use, including some types of stabilizers, foaming agents, chemical intermediates, and catalysts. Exactly what information OSHA is requiring chemical suppliers to present in the SDS is not yet clear. If this provision survives in the final rule, OSHA will need to provide guidance regarding the situations for which it applies and also specify the exact nature of the information to be presented in the SDS. There is significant opposition to this provision from industry stakeholders, and I expect that this will be a major topic for discussion at OSHA’s public hearing on September 21. I will keep you posted regarding any new developments, including whether or not this new provision applies to you.
  • 6. 3 Date released for shipment OSHA requires that chemical suppliers who become aware of significant new hazard information must revise labels for affected products within six months, and ensure that labels on containers shipped after that time include the new information. In some cases, this means that containers already in stock must be relabeled, which is inconvenient and time consuming for chemical suppliers and warehouse managers. To avoid the need for relabeling, the proposed rule provides that chemicals that have been released for shipment and are awaiting future distribution need not be relabeled. “Released for shipment” is defined as “a chemical that has been packaged and labeled in the manner in which it will be distributed or sold.” This change is touted by OSHA as a cost saving measure. However, the proposed rule also requires that the date the chemical was released for shipment appear on the label. This requirement represents a substantial change to the label format, and many stakeholders have raised objections regarding the feasibility of changing their labels in their comments to OSHA. This is another topic that will no doubt be discussed at the September 21 public hearing, and I will keep you apprised of new developments.
  • 7. 4 Ingredients of unknown acute toxicity In the current version of the HCS, OSHA requires a statement on the label and in Section 2 of the SDS for products containing ingredients of unknown acute toxicity (for example, “x% of this product consists of ingredients of unknown acute toxicity”). It has been common practice among SDS and label authors to assume that this requirement does not apply as long as acute toxicity data is available for at least one route of exposure (oral, dermal, or inhalation). This data exists for the majority of chemicals in commerce, and when this is the case it has not been deemed necessary to add a statement on unknown acute toxicity to labels or SDS. In the proposed rule, a revision has been made to require the statement to differentiate by route of exposure. For example, the statements could read ‘‘x% of this product consists of ingredient(s) of unknown acute oral toxicity’’ or ”x% of this product consists of ingredient(s) of unknown acute dermal toxicity.’’ This provision will necessitate changes to SDS and label content for many products (especially mixtures), because for many chemical substances acute toxicity data is not available for all three routes of exposure. In these cases, new statements will be required on both the SDS and the label. ?
  • 8. 5 Prescribed concentration ranges for mixtures The current HCS allows the exact concentrations of hazardous components of a mixture to be withheld as trade secrets. In this case, the concentrations are normally provided in Section 3 of the SDS as ranges. For example, if a mixture contains 50% of a hazardous ingredient, this may be reported as any range that covers 50%. The existing HCS does not provide guidance regarding the exact concentration range to be used. In the proposed rule, the option to withhold as trade secrets the exact concentrations of hazardous ingredients of mixtures is maintained, but the use of one of thirteen prescribed concentration ranges will now be required. It is further required that the range used must be the narrowest one possible. In cases where a product has a variable composition, and the range of concentrations for a given component falls outside one of the prescribed ranges, OSHA allows for combining of two ranges. While this approach may be beneficial in that it is aligned with the system used in Canada under the Hazardous Product Regulations (HPR), it represents yet another revision that will be required to SDS for products that are mixtures. Prescribed ranges: 0.1-1% 0.5-1.5% 1-5% 3-7% 5-10% 7-13% 10-30% 15-40% 30-60% 45-70% 60-80% 65-85% 80-100%
  • 9. 6 US responsible party The HCS requires the name, address, and telephone number of the “responsible party” to be listed on product labels and in Section 1 of the SDS. This is normally the chemical supplier. In two letters of interpretation, OSHA clarified that the responsible party must be a US-based entity. For imported chemicals, this is generally the importer, but OSHA allows that it can be “someone who can provide additional information on the hazardous chemical and appropriate emergency procedures, if necessary”. It is acceptable to include the foreign manufacturer’s information on the label (and presumably in Section 1 of the SDS), although OSHA states that they prefer it to be omitted to prevent confusion. The requirement that the responsible party be US-based is incorporated in the proposed rule. However, unlike the other changes covered in this brief, this requirement is applicable under the current version of the HCS. Therefore SDS and labels need to be updated as soon as possible if a US-based responsible party is not listed. As part of my practice I can serve as the “responsible party” to help foreign chemical manufacturers meet this requirement. Please contact me if you need additional information.
  • 10. 7 Labeling of small containers Chemical suppliers sometimes make the assumption that labeling requirements do not apply to small containers, such as small jars used for samples. However, OSHA makes clear in its letters of interpretation that labeling requirements apply to all containers, regardless of size. To fit all of the required information on a small label, OSHA encourages alternative designs for labeling of small containers, such as fold- back labels, peel-out labels, and tags. The proposed rule includes a new provision for reduced labeling requirements for small containers in cases where a standard label or one of the alternative designs is demonstrated not to be feasible. For containers of 100 mL capacity or less, it is only required to include, at a minimum, the product identifier, pictogram(s), signal word, name and phone number of the responsible party, and a statement that the full label information can be found on the immediate outer package. For very small containers of 3 mL capacity or less, label requirements (except for the product identifier) are waived if the supplier can demonstrate that any label would interfere with the normal use of the container. In both cases, the outer packaging is required to include the full label information along with a statement indicating that the small container(s) inside must be stored in the immediate outer package (bearing the complete label) when not in use. Please contact me if you need assistance developing labels for small containers. An example of a label for use on small containers (100 mL or less capacity) when it is not feasible to provide full label information.
  • 11. Implementation and next steps Besides the seven changes described herein, the proposed rule includes many other provisions that affect you as a chemical supplier. For this reason, I recommend that you review the proposed rule, which can be downloaded at https://www.federalregister.gov/documents/2021/02/16/2020-28987/hazard-communication-standard Please consider joining me at OSHA’s informal pubic hearing on the proposed rule, which will be held as a conference call on September 21, 2021 at 10 AM Eastern Time. For more information, visit https://www.osha.gov/news/newsreleases/trade/05202021 The final version of the rule is expected to issue in late 2021 or early 2022. It will become effective 60 days from issue, after which there will be a phase-in period of 1-2 years to allow you to make necessary changes to your SDS and labels, and train your employees. I will revert with additional details and recommendations on implementation once the final rule has issued. On your side, it would be helpful for you to compile a list of active products for which SDS and labels will need to be updated. With this information I can estimate your cost of compliance and give an indication of the timing to complete the work. Please contact me if you have further questions.
  • 12. Thank You! DISCLAIMER: Although the information and recommendations set forth herein (hereinafter "information") are presented in good faith and believed to be correct as of the date hereof, BotkinChemie makes no representation as to the completeness or accuracy thereof. Information is supplied upon the condition that persons receiving it will make their own determinations as to its suitability for their purpose prior to its use. In no event will BotkinChemie be responsible for damages of any nature whatsoever resulting from the use of or reliance upon information. No representations or warranties either expressed or implied, or merchantability, fitness for a particular purpose or of any other nature are made hereunder with respect to information for any substance to which information refers. No statements herein are to be construed as inducements to infringe any valid patent. © 2021 James H. Botkin dba BotkinChemie Jim Botkin www.botkinchemie.com +1 (732) 309-3476 email