Formulator News December 2, 2014
December 2, 2014
This email is intended to update you on legislative and regulatory subjects of interest to formulator members of ISSA. In this issue, we cover the following:
1. OSHA Denies Petition to Extend GHS HazCom Deadlines
2. EPA Issues Guidance on Ebola Claims to Manufacturers of Disinfectants
3. EPA Lists Disinfectants for Use Against Ebola Virus
4. EPA Proposes SNUR for Nonylphenols and Nonylphenol Ethoxylates
5. Prop 65 Coalition Chimes in on Proposed Regs to Reduce Litigation
In a recent meeting with OSHA representatives, Dr. David Michaels, Assistant Secretary of Labor for Occupational Safety and Health denied industry’s petition to extend the June 1, 2015 deadline for GHS compliant SDSs and labels, much to the frustration and surprise of industry representatives in attendance.
An industry coalition of several prominent trade associations, including ISSA, petitioned OSHA in mid-August 2014 to grant a two year extension of the June 1, 2015 deadline for GHS compliant labels and SDSs for manufacturers and distributors of formulated chemical products such as general purpose cleaners or bathroom cleaners. The industry coalition requested the extension of the deadline to allow formulators sufficient time to gather and review information from raw material suppliers, which in turn is critical to developing accurate and compliant GHS SDSs and labels.
However, OSHA’s denial of industry’s petition means that formulated products (such as cleaning products) must be compliant with the GHS labeling and SDS requirements by the original deadline of June 1, 2015.
Assistant Secretary Michaels on Enforcement. In a twist of irony, Assistant Secretary Michaels noted that OSHA did not have sufficient time to issue a rule extending the current deadline for formulated products. On the other hand, the Assistant Secretary indicated that the Agency could best address industry’s concerns about meeting the June 1, 2015 deadline by being flexible in its enforcement of the Hazard Communication Standard as revised by GHS (i.e., HazCom 2012).
Specifically, Dr. Michaels indicated that OSHA would direct its compliance staff to use its enforcement discretion in considering whether formulators and manufacturers have “…performed their due diligence and made good faith efforts to obtain necessary information to comply with the June 1, 2015 deadline.” If they have exercised due diligence and acted in good faith, OSHA will not penalize the companies for non-compliant GHS SDSs and labels.
Dr. Michaels further noted that OSHA’s policy allows the Agency’s compliance officers to take into consideration “barriers to the downstream flow of information that are beyond their control” in determining whether to cite a formulator for failing to comply with the new SDS and label requirements.
Therefore, Dr. Michaels stressed that it was important for manufacturers and formulators to document their efforts to “alternatively obtain the required information such as: attempts to contact their supplier to obtain the proper information; reasonable efforts to find alternate suppliers who could provide timely and accurate classifications; and reasonable efforts to find relevant data themselves.” OSHA officials indicated that the Agency plans to provide guidance to Regional and Area Offices to ensure such a policy is uniformly applied to individual situations. OSHA intends to apply the same approach to distributors that “can demonstrate that they have received chemicals labeled under this policy.”
Next Steps. While industry representatives were encouraged by OSHA’s reference to a flexible enforcement policy related to GHS compliant SDSs and labels, there was general dissatisfaction about the particulars. Noting that determining whether a company acted in good faith and exercised due diligence is a subjective judgment, industry expects to request OSHA to be more specific regarding its enforcement policy on the GHS revisions. Specifically, the industry coalition (including ISSA) will urge OSHA to issue a formal “directive” to its compliance personnel that creates a better defined “safe harbor” from enforcement for formulators and distributors related to their GHS SDS and label responsibilities.
In the meantime, ISSA members are encouraged to continue to work towards meeting the June 1, 2015 deadline for GHS compliant labels and SDSs. Of equal importance, companies are encouraged to document those efforts to the best of their ability.
ISSA and the industry coalition will continue to work with OSHA to carve out an enforcement policy that gives deference to those companies and organizations that have made reasonable efforts to comply, but were precluded from doing so due to the lack of timely information from raw material suppliers.
ISSA will continue to report on this issue to the members as matters develop.
Industry Coalition. The industry coalition that has come together to petition OSHA for an extension of the GHS deadlines includes ISSA, Adhesives and Sealants Council, American Coatings Association, National Association of Chemical Distributors, National Association of Manufacturers, and other organizations representing formulators of end use products.
Additional Information. Contact Bill Balek, ISSA, 800.225.4772, firstname.lastname@example.org, for more information.
The Environmental Protection Agency, which regulates pesticide products including disinfectants through its pesticides office, said makers of hard surface disinfectants cannot advertise their products as being effective at killing the Ebola virus because the Agency has not established a scientific protocol for testing efficacy against the virus.
On the other hand, the EPA guidance on Ebola claims stated that manufacturers of disinfectants can now advertise on their websites and other non-label advertisements that their products meet the CDC criteria for disinfectants for use against the Ebola virus.
Specifically, the EPA guidance states that if a registrant has an EPA-registered disinfectant that meets the criteria stated in the CDC guidance, they may identify such product(s) on company websites or through other non-label communications as such. These communications should indicate that:
- the product meets the CDC criteria for disinfectant products with label claims for a non-enveloped virus;
- the product is intended for use on hard, non-porous surfaces; and,
- the product’s label use instructions for the non-enveloped virus or viruses should be followed.
CDC Guidance on Disinfectants Against Ebola. The CDC Guidance for Environmental Infection Control in Hospitals for Ebola Virus sets forth their specifications on disinfectants. Specifically, CDC recommends the use of an EPA registered hospital disinfectant with a label claim for a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus) to disinfect environmental surfaces in rooms of patients with suspected or confirmed Ebola virus infection.
Although there are no products with specific label claims against the Ebola virus, enveloped viruses such as Ebola are susceptible to a broad range of hospital disinfectants used to disinfect hard, non-porous surfaces. In contrast, non-enveloped viruses are more resistant to disinfectants. Therefore, as a precaution, selection of a disinfectant product with a higher potency than what is normally required for an enveloped virus is being recommended at this time. EPA-registered hospital disinfectants with label claims against non-enveloped viruses (e.g., norovirus, rotavirus, adenovirus, poliovirus) are broadly antiviral and capable of inactivating both enveloped and non-enveloped viruses, and are recommended by the CDC for use against the Ebola virus.
Additional Information. The EPA guidance to manufacturers on making claims related to a disinfectant’s efficacy against Ebola can be found at: http://epa.gov/oppad001/ebola-efficacy-claims.html.
The U.S. Environmental Protection Agency (EPA) has published a list on its website of well over one hundred registered disinfectants that meet the Center for Disease Control’s (CDC) criteria for use against the Ebola virus on hard, non-porous surfaces.
CDC’s guidance recommends:
- The use of an EPA-registered hospital disinfectant with a label claim for use against a non-enveloped virus (e.g., norovirus, rotavirus, adenovirus, poliovirus); and
- The product label use directions for the non-enveloped virus or viruses should be followed when disinfecting against the Ebola virus.
It is important to note that there are no disinfectants approved as effective against the Ebola virus. As a consequence, manufacturers cannot claim their product is effective against Ebola. On the other hand, manufacturers can advertise that their product meets the aforementioned CDC criteria for the environmental infection control of Ebola virus. Consistent with this guidance, purchasers should look for disinfectants the labels of which indicate the product is effective against a non-enveloped virus such as the norovirus or poliovirus, consistent with CDC guidance.
Ebola Relatively Easy to Kill. As an enveloped virus, Ebola is relatively easy to disinfect on hard surfaces, at least when compared with other viruses such as polio, rotavirus and norovirus, due to differences in cellular structure. However, as a precautionary measure, the CDC is requiring hospitals to use antimicrobial disinfectants that are potent enough to kill the harder-to-kill non-enveloped viruses.
List of Disinfectants. It is important to note that the list of disinfectants for use against Ebola virus is not exhaustive. The list consists primarily of “primary” registered products and omits numerous secondary or “supplemental” registered products. Manufacturers of disinfectant products that would like their products added to the list should follow the guidance provided at: http://www.epa.gov/oppad001/list-l-ebola-virus.html
Additional Information. The CDC Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus is located at: http://www.cdc.gov/vhf/ebola/hcp/environmental-infection-control-in-hospitals.html
EPA’s list of disinfectants that meet CDC criteria for Ebola can be found online at: http://www.epa.gov/oppad001/list-l-ebola-virus.html
On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a “significant new use,” and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a “significant new use.” Persons subject to the SNURs would be required to notify EPA at least 90 days before they manufacture (including import) or process any of these 15 chemical substances for a significant new use. Comments are due December 1, 2014.
For 13 of the NPs and NPEs, EPA is proposing to designate any use as a significant new use. For the two additional NPs, the agency is proposing that any use other than as an intermediate, or as an epoxy cure catalyst, would constitute a significant new use.
For a complete list of the affected substances, please review the proposed rule at: https://www.federalregister.gov/articles/2014/10/01/2014-23253/certain-nonylphenols-and-nonylphenol-ethoxylates-significant-new-use-rule
The proposed SNUR would apply to the uses that are not ongoing at the time of the proposed rule. Uses not ongoing at the time of the proposal would be designated significant new uses in the final SNUR. EPA states that it is specifically requesting comment on whether it has correctly identified the current and ongoing uses of the 15 NPs and NPEs covered by this proposed rule. According to the Federal Register notice, EPA is particularly interested in whether anyone is currently using these chemicals in a manner that is not described in this proposal.
This latest proposal represents yet another regulatory restriction placed upon NPs and NPEs. In 2013, California implemented a ban on alkyphenol ethoxylate (APE) surfactants used in certain cleaning products—APEs include NP and NPEs.
ISSA along with the other members of the Prop 65 Industry Coalition signed on to comments designed to foster regulations that will help reduce frivolous litigation around the California warning requirements established by Prop 65.
Areas under consideration by the California Office of Environmental Health Hazard Assessment (OEHHA), the agency charged with responsibility of implementing Prop 65, include:
- Streamlining the Safe Use Determination process, which allows a business to request a determination from OEHHA that an exposure under a specific set of facts does not require a warning, which
- Clarifying regulatory provisions on averaging exposures
- Prioritizing chemicals for the development or update of safe harbor levels
- Identifying issues that would benefit from interpretive guidelines, similar to OEHHA’s interpretative guidelines on sulfur dioxide in dried fruits (no warning required) and methanol from pectin in fruits and vegetables (methanol is not an exposure when naturally occurring).
- Changes to the use of data on postnatal developmental exposures
These types of changes to the regulations could provide businesses in the California marketplace with a clearer prospective picture of what constitutes compliance with Proposition 65, rather than learning through ever-increasing litigation. In particular, streamlining the Safe Use Determination process may give businesses a better tool to demonstrate their products are safe before a Listed Chemical’s warning anniversary expires. Similarly, OEHHA’s prioritizing of Listed Chemicals for safe harbor levels and more active issuance of interpretative guidelines may prevent litigation from the plaintiff’s bar that can hamper an entire industry without clear indications of public benefit.