Monthly Update for November 2018
B&C Launches All Things Chemical™ Podcast: Bergeson & Campbell, P.C. (B&C®) is pleased to announce the launch of All Things Chemical™, a podcast engaging listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space. All Things Chemical is available now on iTunes, Spotify, Stitcher, and Google Play Music. Subscribe so you never miss an episode. All Things Chemical is recorded and produced by Bierfeldt Audio, LLC.
Episode 1, “Animal Testing and New TSCA,” features a roundtable discussion between B&C Managing Partner Lynn L. Bergeson; Director of Chemistry Richard E. Engler, Ph.D.; Director of Toxicology Jane S. Vergnes, Ph.D.; and Senior Regulatory Chemist Oscar Hernandez, Ph.D. about a Strategic Research Plan released by the U.S. Environmental Protection Agency (EPA) earlier this summer, outlining its approach to reduce and replace “vertebrate” testing. In keeping with the commitment outlined in the 2016 amended Toxic Substances Control Act (TSCA), EPA proposes several so-called New Approach Methodologies, or NAMs, which it hopes will be able to replace and reduce animal testing.
Episode 2, “Chemical Regulation in the Middle East,” based on B&C Senior Regulatory Consultant Michael S. Wenk, M.S.’s book of the same name, finds Lynn L. Bergeson and Mr. Wenk offering listeners insight into the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage chemicals in Bahrain, Egypt, Israel, Oman, Pakistan, Saudi Arabia, and other kingdoms and countries of the Middle East.
Future podcasts, available approximately every two weeks, will address a host of fascinating issues, including recent rulemakings under the Food Safety Modernization Act (FSMA), the dis-harmonization of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), and the ever quirky and complicated area of confidential business information (CBI). The issues that B&C pursues in its day-to-day business are unfailingly interesting and we wish to share our knowledge, our insights, and our enthusiasm for these issues with you through our All Things Chemical podcast.
EPA Issues Final TSCA Fees Rule: On October 17, 2018, EPA issued a final fees rule under TSCA. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule. In its press release, EPA states that the fees collected from chemical manufacturers “will go toward developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and making determinations in a timely and transparent manner with respect to the safety of new chemicals before they enter the marketplace.” Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees. EPA hosted a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The final rule was effective on October 18, 2018.
EPA Proposes SNURs That Break New Ground Under Amended TSCA: On October 16, EPA issued a proposed rule that would establish significant new use rules (SNUR) under TSCA for 13 chemical substances that are the subject of premanufacture notices (PMN). 83 Fed. Reg. 52179. The proposed rule is significant. Unlike other recent SNURs (i.e., those acted on since entry into force under amended TSCA, the 13 chemical substances are not also subject to consent orders. For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule. The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification will initiate EPA’s evaluation of the intended use within the applicable review period. Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination. Comments on the proposed SNURs are due November 15, 2018. More information is available in our memorandum.
EPA Extends Dicamba Products Registered For “Over-The-Top” Use: On October 31, 2018, EPA announced that it is extending the registration of dicamba for two years for “over-the-top” use (application to growing plants) to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. EPA states that the registration for these dicamba products will expire on December 20, 2020, unless EPA decides to further extend it. EPA states that the label changes described below were made to ensure that these products can continue to be used effectively while addressing potential concerns to surrounding crops and plants. EPA’s dicamba registration decisions for the 2019-2020 growing season are:
- Two-year registration (until December 20, 2020);
- Only certified applicators may apply dicamba over-the-top (those working under the supervision of a certified applicator may no longer make applications);
- Prohibit over-the-top application of dicamba on soybeans 45 days after planting and cotton 60 days after planting;
- For cotton, limit the number of over-the-top applications from four to two (soybeans remain at two over-the-top applications);
- Applications will be allowed only from one hour after sunrise to two hours before sunset;
- The downwind buffer for all applications will remain at 110 feet, but in those counties where endangered species may exist, there will also be a new 57-foot buffer around the other sides of the field;
- Clarify training period for 2019 and beyond, ensuring consistency across all three products;
- Enhanced tank clean out instructions for the entire system;
- Enhanced label to improve applicator awareness on the impact of low pH’s on the potential volatility of dicamba; and
- Label clean up and consistency to improve compliance and enforceability.
More information is available in our blog.
EPA Proposes Formaldehyde Emission Standards For Composite Wood Products: On November 1, 2018, EPA proposed to amend the regulations promulgated in a final rule that published December 12, 2016, concerning formaldehyde emission standards for composite wood products. 83 Fed. Reg. 54892. EPA published the proposed amendments to address certain technical issues and to further align the final rule requirements with the California Air Resources Board (CARB) Airborne Toxic Control Measures (ATCM) Phase II program. Addressing these technical issues would add clarity for regulated entities. These revisions to the existing rule would also streamline compliance programs and help to ensure continued smooth transitions for supply chains to comply with the requirements associated with regulated composite wood products. Comments must be received on or before December 3, 2018.
EPA Orders Arizona Pool Chemical Company To Stop Sales Of Bacteria And Algae Control Product: On November 7, 2018, EPA announced that it was ordering Pool Water Products Inc. to stop selling an improperly registered pesticide, ALL CLEAR 3” Jumbo Chlorinating Tablets. The announcement states that even though the ALL CLEAR 3” Jumbo Chlorinating Tablets product was registered with EPA, Pool Water Products was selling and distributing an unregistered version of the product made in China that has not been evaluated by EPA. EPA’s action, which it states applies to nationwide distribution, transport, and sales of the product, follows a statewide stop-sale order issued earlier this month by the Arizona Department of Agriculture when state inspectors discovered the unregistered pesticide, which is used to disinfect pools, during an August 30 inspection of the Company’s Phoenix warehouse. This case exemplifies the need for companies to understand Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration and amendment requirements, and the importance that a product’s label, formula, and manufacturing process match exactly with the information submitted to EPA and upon which EPA relied in approving the registration. Many composition and processing changes require an amendment to be approved by EPA; failure to do so could result in an enforcement action such as this one. More information on pesticide registration issues is available in our blog.
DOT And OSHA Hold Public Meetings On Harmonization With International Standards: On November 13, 2018, the Occupational Safety and Health Administration (OSHA) convened a public meeting to discuss proposals in preparation for the 36th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals (UNSCEGHS) to be held December 5 through December 7, 2018, in Geneva, Switzerland. OSHA plans to consider the comments and information gathered at this public meeting when developing the U.S. positions for the UNSCEGHS meeting. OSHA also will give an update on the Regulatory Cooperation Council (RCC). Also on November 13, 2018, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) conducted a public meeting to discuss proposals in preparation for the 54th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCE TDG) to be held November 26 through December 4, 2018, in Geneva, Switzerland. During this meeting, PHMSA is also requesting comments relative to potential new work items that may be considered for inclusion in its international agenda. Both meetings will be held at the DOT Headquarters Conference Center in Washington, D.C. DOT requests that attendees pre-register for these meetings by completing the form at https://www.surveymonkey.com/r/XGN8J7X.
EPA Releases Draft Plan For Ozone NAAQS Review: EPA on November 2, 2018, announced that it is making available for public review the draft Integrated Review Plan for the Ozone National Ambient Air Quality Standards (NAAQS). 83 Fed. Reg. 55163. This document contains the draft plans and the anticipated schedule for the current review of the air quality criteria and NAAQS for photochemical oxidants including ozone. The draft document is available online. EPA is accepting comments on the draft until December 3, 2018.
A Glimpse Of Things To Come: OSHA’s Soon To Be Updated Hazard Communication Standard: In the Trump Administration’s Unified Agenda of Regulatory and Deregulatory Actions (Regulatory Agenda) issued on October 17, 2018, OSHA published a Proposed Rule Stage item titled “Update to the Hazard Communication Standard,” RIN 1218-AC93, and scheduled the Notice of Proposed Rulemaking (NPRM) to be issued by March 2019. The full description of the item is:
OSHA and other U.S. agencies have been involved in a long-term project to negotiate a globally harmonized approach to classifying chemical hazard, and providing labels and safety data sheets for hazardous chemicals. The result is the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The GHS was adopted by the United Nations, with an international goal of as many countries as possible adopting it by 2008. OSHA incorporated the GHS into the Hazard Communication Standard (HCS) in March 2012 to specify requirements for hazard classification and to standardize label components and information on safety data sheets, which will improve employee protection and facilitate international trade. However, the GHS is a living document and has been updated several times since OSHA’s rulemaking. OSHA’s rulemaking was based on the third edition of the GHS and the UN recently completed the seventh. OSHA is conducting rulemaking to harmonize the HCS to the latest edition of the GHS and to codify a number of enforcement policies that have been issued since the 2012 standard.
More information is available in our memorandum.
EPA Announces CASAC Meetings On Ozone And Particulate Matter: EPA on November 6, 2018, announced meetings of its Clean Air Scientific Advisory Committee (CASAC) to discuss background documents related to its review of the NAAQS for ozone and particulate matter (PM). On November 29, 2018, the CASAC will hold a teleconference to discuss the Integrated Review Plan for the Review of the Ozone National Ambient Air Quality Standards (External Review Draft). 83 Fed. Reg. 55528. On December 12-13, 2018, the CASAC will hold a public meeting to review the Integrated Science Assessment (ISA) for Particulate Matter (External Review Draft – October 2018). 83 Fed. Reg. 55529. Both the ozone teleconference and the PM public meeting are open to the public and EPA will accept oral and written statements at both events.
PHMSA Grants 19 Deregulatory Petitions: DOT’s PHMSA on November 7, 2018, issued a final rule granting 19 petitions seeking deregulatory actions under PHMSA’s Hazardous Materials Regulations (HMR). 83 Fed. Reg. 55792. PHMSA states that the revisions will “provide relief from miscellaneous regulatory requirements” and will allow “more efficient and effective ways of transporting hazardous materials in commerce while maintaining an equivalent level of safety.” The final rule addresses almost a score of miscellaneous HMR provisions. Specifically, PHMSA is:
- Incorporating by Reference (IBR) multiple publications from the Compressed Gas Association (CGA), the Chlorine Institute, and the Department of Defense (DoD);
- Revising the table in § 180.407(g)(1)(iv) to make this section consistent with the applicable packaging specification (e.g., § 178.347);
- Addressing inconsistencies with domestic and international labels and placards;
- Revising § 173.150(g) to include the use of the International System of Units (SI);
- Excepting limited quantities of ‘‘UN1942, Ammonium nitrate’’ from requiring permission from the Captain of the Port (COTP) before being loaded or unloaded from a vessel at a waterfront facility;
- Allowing for combination non-bulk packagings that are tested and marked for a liquid hazardous material to be filled with a solid hazardous material;
- Including an additional hazardous material description for transport in roadway striping vehicles;
- Extending the service life of interim compliant toxic inhalation hazard (TIH) tank cars to the full service life of all other tank cars;
- Allowing the use of plastic, metal, or composite pallets to transport materials classed and marked as limited quantities;
- No longer mandating that excepted quantities comply with the emergency response telephone requirement;
- Harmonizing the recordkeeping requirements for portable tanks;
- Allowing for printing tolerances for labels and placards;
- Allowing electronic signatures for EPA manifest forms;
- No longer requiring the service pressure to be marked on DOT 8 and 8L cylinders;
- Acknowledging that the marked date of manufacture on a composite intermediate bulk container (IBC) may differ from the marked date of manufacture on the inner receptacle of that IBC; and
- Revising the basis weight tolerance for fiberboard boxes.
The revisions are effective on December 7, 2018.
EPA Releases Draft Guidance Redefining “Ambient Air” Definition: EPA on November 7, 2018, released draft guidance that redefines the term “ambient air.” The guidance could make it easier for regulated entities to not subject activities to Clean Air Act (CAA) requirements. EPA defines “ambient air” as “that portion of the atmosphere, external to buildings, to which the general public has access.” 40 C.F.R. § 50.1(e). Since 1980, EPA has operated under the presumption that for an area to be excluded from ambient air, public access should be precluded by means of “a fence or other physical barriers.” The guidance states, however, that EPA has long recognized that some areas that are external to buildings are also not covered by the regulatory definition of ambient air. EPA’s revised ambient air policy replaces “a fence or other physical barriers” with “measures, which may include physical barriers, that are effective in deterring or precluding access to the land by the general public.” More specifically, EPA’s revised definition now states that “it is appropriate to exclude the atmosphere over land owned or controlled by the stationary source, where the owner or operator of the source employs measures, which may include physical barriers, that are effective in deterring or precluding access to the land by the general public.” EPA stated that it expects that this change in its ambient air policy will provide greater flexibility in determining where to place modeling receptors for air quality analyses, while maintaining public health protection.
EPA Releases Emergency Release Notification Regulations On Reporting Exemption For Air Emissions From Animal Waste At Farms; Emergency Planning And Community Right-To-Know Act: On November 14, 2018, EPA proposed to amend the release notification regulations under the Emergency Planning and Community Right-to-Know Act (EPCRA) to add the reporting exemption for air emissions from animal waste at farms provided in Section 103(e) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 83 Fed. Reg. 56791. In addition, EPA is proposing to add definitions of “animal waste” and “farm” to the EPCRA regulations to delineate the scope of this reporting exemption. This proposed rulemaking maintains consistency between the emergency release notification requirements of EPCRA and CERCLA in accordance with the statutory text, framework, and legislative history of EPCRA, and is consistent with EPA’s prior regulatory actions. Comments must be received on or before December 14, 2018.
EPA Issues RCRA Rule Exempting Defective Airbag Inflators From Hazardous Waste Regulation: EPA on November 14, 2018, announced that it will issue an interim final rule under the Resource Conservation and Recovery Act (RCRA) that is intended to facilitate the “urgent” removal of defective Takata airbag inflators from vehicles and prevent defective Takata airbag inflators in scrap vehicles from being reused. (Airbag inflators, when disposed, would be considered reactive hazardous waste under RCRA.) EPA estimates the rule will result in a net cost savings of $1.7 to $13 million annually. The Takata airbag recall involves 19 vehicle manufacturers and approximately 65 to 70 million airbag inflators scheduled to be recalled by December 2019. The rule conditionally exempts from the RCRA hazardous waste requirements entities that remove airbag modules and inflators (i.e. airbag waste) from automobiles. Under this rule, the entities that generate the airbag waste are “airbag waste handlers” and include automobile dealerships, automotive salvage and scrap yards, independent repair facilities, and collision centers. EPA is exempting from the RCRA hazardous waste requirements the generation and accumulation of airbag waste at the airbag waste handler location and during transport to an airbag waste collection facility or designated facility, as long as certain conditions are met. Once collected at the airbag waste collection facility, the airbag waste will be managed as RCRA hazardous waste and must be sent to RCRA disposal or recycling facilities. The airbag waste exemption also applies to non-Takata airbag waste. EPA believes that applying the same protective requirements to all airbag waste avoids confusion, increases efficiency, and helps prevent non-Takata airbag waste from being diverted into the municipal waste stream. EPA has determined that the public health risk posed by defective Takata airbags in vehicles provides good cause for EPA to promulgate this as an interim final rule, which will be effective immediately upon publication in the Federal Register. EPA will, nonetheless, accept comments on the interim final rule for 60 days after its publication in the Federal Register. A prepublication of the rule is available online.
In The House, New Bill Introduced To Disclose Ingredients In Beauty And Personal Care Products: On September 26, 2018, Representative Jan Schakowsky (D-IL) introduced H.R. 6903, the “Safe Cosmetics and Personal Care Products Act of 2018.” Ms. Schakowsky’s press release states that the bill “calls for the full disclosure of all ingredients included in beauty and personal care products including fragrances” and “outright bans toxic ingredients, like carcinogens, in those products.” On the day it was introduced, it was referred to the House Committee on Energy and Commerce and to the House Committee on Education and the Workforce where it has remained.
FDA Announces Draft Guidance For Industry To Minimize Food Safety Hazards Of Fresh-Cut Produce: On October 22, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry titled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” 83 Fed. Reg. 53197. FDA states the draft guidance, when prepared in final, will supersede a previous guidance titled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” issued in 2008. The new draft guidance is intended to explain FDA’s current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under FDA’s regulation “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” during the production of fresh-cut produce. Comments are due by April 22, 2019.
FDA Announces Draft Guidance For Industry On FSMA Produce Safety Rule And Four Public Meetings: On October 22, 2018, FDA announced the availability of a draft guidance for industry titled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” 83 Fed. Reg. 53196. FDA states that the draft guidance, when issued in final, will provide its current thinking and recommendations to help covered farms comply with FSMA’s Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption final rule (Produce Safety Rule), which established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce grown for human consumption. Comments on the draft guidance are due by April 22, 2019. On November 1, 2018, FDA announced four public meetings to discuss the draft guidance. 83 Fed. Reg. 54888. FDA states the purpose of the public meetings is to discuss the draft guidance for compliance and implementation of the Produce Safety Rule. The meetings are scheduled for:
- November 27, 2018, from 8:30 a.m. to 5:00 p.m. in Portland, Oregon;
- November 29, 2018, from 8:30 a.m. to 5:00 p.m. in Anaheim, California;
- December 11, 2018, from 8:30 a.m. to 5:00 p.m. in Albany, New York; and
- December 13, 2018, from 8:30 a.m. to 5:00 p.m. in Atlanta, Georgia.
The meetings will be available either in-person or via webinar. More information on the meetings is available on FDA’s website.
FDA Issues Final Guidance On Questions And Answers Regarding Mandatory Food Recalls: On November 6, 2018, FDA announced it was making available a final guidance for industry and FDA staff titled “Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff.” 83 Fed. Reg. 55551. The guidance addresses common questions that may arise during mandatory recalls under the provisions of Section 206 of FSMA. FSMA, enacted January 4, 2011, expanded FDA’s authority to order mandatory recalls when adulterated or misbranded food would result in serious adverse health consequences or death to humans or animals (SAHCODHA) and when the responsible party chooses not to conduct a voluntary recall. Food, under this mandate, includes “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article (section 201(f) of the FD&C Act [21 U.S.C. § 321(f)]).” The term “food” also includes dietary supplements, but excludes infant formula.
FDA notes that, prior to FSMA, recalls were left to the responsible party to remove voluntarily the adulterated and/or misbranded item; the responsible party being the person who submits the food facility registration. This could be an agent, an owner, a partnership, a corporation, an individual, or an association. FDA must provide the responsible party an opportunity to cease voluntarily distribution and recall the item once it has been determined the item could reasonably cause SAHCODHA. If the responsible party does not act, FDA may order a recall and remove the item from commerce. The guidance document states that FDA “will evaluate all applicable evidence, when determining whether there is reasonable probability the article of food … is adulterated … or misbranded … and that the use of or exposure to such article will cause SAHCODHA.” This evidence may include observations during inspections, results from sample analysis, food borne outbreak data, consumer complaints, risk to vulnerable populations, and/or the types of food products. The examples included in the guidance are reminiscent of recent high profile recalls (e.g., Salmonella spp. contaminated peanut butter and alfalfa sprouts), undeclared allergens, and pet food containing elevated levels of melamine and cyanuric acid.
SWA Guidance Includes Advice On Fine Dusts And Nanomaterials: In August 2018, Safe Work Australia (SWA) issued a national guide on classifying hazardous chemicals. SWA intends the guidance for manufacturers and importers of substances, mixtures, and articles who The guidance provides advice on specific situations, including fine dusts and nanomaterials. According to the guidance, if the health hazards of nanoparticles are not fully characterized, it is recommended that an appropriate safety data sheet (SDS) be prepared and the container is labeled:
- Contains engineered/manufactured nanomaterials. Caution: Hazards unknown; or
- Contains engineered/manufactured nanomaterials. Caution: Hazards not fully characterized.
NNI Publishes Key Takeaways And Transcript For Webinar On Technology Pathways Toward Commercializing Nanotechnology: The National Nanotechnology Initiative (NNI) published key takeaways and a transcript for the September 19, 2018, webinar, “Technology Pathways Toward Commercializing Nanotechnology.” The webinar focused on quality control in the manufacturing process and built on NNI’s November 2017 Technology Pathways workshop. The key takeaways from the webinar guests include:
- In nanomanufacturing: fail fast. Have the mindset of fail fast, learn from it, loop back, and fix the problem;
- Expect that anywhere from 25 percent to the entire technical team of a small company will play a role in the quality control process; and
- Take advantage of the ecosystem in your geographic area: companies, research institutions, and government-supported infrastructure. Engage the National Institute for Occupational Safety and Health (NIOSH) for access to environmental, health, and safety resources.
EPA Posts Final Work Plan For Nanosilver Registration Review Process: On October 19, 2018, EPA posted the Final Work Plan (FWP) for the nanosilver registration review process under FIFRA. The FWP explains what the Office of Pesticide Programs (OPP) “knows about nanosilver generally, highlighting anticipated data and assessment needs for each unique nanosilver chemistry, identifying the types of information that would be especially useful to the Agency in conducting the review, and providing an anticipated timeline for completing review of the nanosilver case.” According to the FWP, EPA has identified the following use patterns to date: swimming pool/spa treatments; and material preservative products for coatings, textiles, and plastics. EPA invites any label amendments that could be considered to eliminate the anticipated need to require certain data, reduce the possibility that EPA’s planned risk assessments overestimate risk due to reliance on conservative assumptions, and/or improve label clarity. EPA anticipates issuing in 2018 a data call-in (DCI) requiring the data set out in Table 7 of the FWP, “Studies Anticipated as Needed for Nanosilver Registration Review.” More information is available in our October 23, 2018, blog item.
EC Committee Publishes Final Opinion On Colloidal Silver (Nano): On October 26, 2018, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on colloidal silver (nano). The final opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes and skin care products, with a maximum reported concentration limit of one percent and certain specifications. The EC asked SCCS to produce a safety assessment of the nano form of colloidal silver covered in the notifications, taking into account the reasonably foreseeable exposure conditions. Due to a number of major data gaps, SCCS “is not in the position to draw a conclusion on the safety of colloidal silver in nano form when used in oral and dermal cosmetic products.” The EC also asked SCCS to address any further scientific concerns with regard to the use of colloidal silver in nano form in cosmetic products. SCCS concluded that in addition to the safety assessment of colloidal silver in nano form, consideration should also be given to the likely presence of ionic silver in different types of final products.
JRC Announces New Standardized Nanomaterial Environmental Toxicity Screening Testing Procedure: The EC Joint Research Center (JRC) announced publication of a paper introducing a new standardized testing procedure for nanomaterial environmental toxicity, “Introducing a new standardized nanomaterial environmental toxicity screening testing procedure, ISO/TS 20787: aquatic toxicity assessment of manufactured nanomaterials in saltwater lakes using Artemia sp. nauplii.” The paper reviews the principles behind testing with Artemia sp. and provides an overview of research published between 2009 and 2018 in which manufactured nanomaterials were tested using Artemia sp.
Slides Available From NIOSH Webinar On Revised Draft CIB For Silver Nanomaterials: On October 30, 2018, NIOSH held a webinar on its revised draft document entitled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. The meeting agenda and slide presentation are available in the docket, as well as a list of meeting attendees. As reported in our September 19, 2018, blog item, the revised draft Current Intelligence Bulletin (CIB) provides an updated scientific literature review of information pertaining to occupational exposure to silver nanomaterials. NIOSH developed a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration. The draft REL would apply to processes that produce or use silver nanomaterials. Comments on the draft CIB are due November 30, 2018.
JRC Posts Report On Workshop On Regulatory Preparedness For Innovation In Nanotechnology: The JRC posted a report on the October 5-6, 2017, “NanoReg2 Regulatory Preparedness for Innovation in Nanotechnology Workshop.” Regulatory preparedness was defined at the workshop as the regulators’ timely awareness of innovations and the regulators’ actions to check whether present legislation covers all safety aspects of each innovation, including initiating revision of the legislation as appropriate. Achieving regulatory preparedness for innovations based on nanotechnology requires a continuous proactive combination of interconnected activities: awareness of innovations; dialogue; knowledge building; methodology enhancement and optimization; reflection; and consideration. To implement regulatory preparedness for nanotechnology innovations as a part of the Safe Innovation Approach pursued by NanoReg2, a “road map” of actions of different time scales and levels of formal acceptance was outlined. More information is available in our October 31, 2018, blog item.
JRC Scientists Publish Article On Inventory Of Publicly Available Tools For The Safety Assessment Of Nanomaterials: On November 5, 2018, JRC announced the availability of the NANoREG Toolbox, an inventory of publicly available tools for the safety assessment of nanomaterials. As reported in our October 5, 2017, blog item, JRC first published the inventory as a Microsoft Excel®-based dataset. JRC scientists have now published an article, “An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials,” that presents a “large inventory of published and ready-to-use safety assessment tools.” According to the JRC, the 544 tools in the inventory cover all tasks within a nanomaterial safety assessment, and the tools “are relevant and useful for similar assessments anywhere in the world.”
SCCS Revised Guidance For Testing Of Cosmetic Ingredients And Their Safety Evaluation Addresses Nanomaterials: On November 7, 2018, SCCS published the tenth revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains relevant information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The document states that it is designed to provide guidance to public authorities and to the cosmetic industry to improve harmonized compliance with the current cosmetic European Union (EU) legislation. The guidance includes a section on special consideration for certain cosmetic ingredients that discusses nanomaterials. More information is available in our November 12, 2018, blog item.
EU NanoSafety Cluster Releases EU-U.S. Roadmap Nanoinformatics 2030: The EU released the EU US Roadmap Nanoinformatics 2030 on November 15, 2018. The Roadmap, developed by scientists from the EU, U.S., and a few other countries, is a compilation of state-of-the-art commentaries from multiple interconnecting scientific fields, combined with issues involving nanomaterial risk assessment and governance. The Roadmap expects readers to be experts in specialized fields interested in understanding developments in nanoinformatics, and the authors have written the Roadmap to be understandable by a broad audience. The Roadmap consists of three sections: an administrative section (executive summary, definitions and context, objectives); a technically oriented informatics section (informatics, materials modeling, statistical computation, omics bioinformatics), and a community of practice section (stakeholders, database projects, initiatives, and milestones and pilot projects).
BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
Call For Candidate Chemicals For Equivalency Determinations: Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with EPA.
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under TSCA mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals — restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, BRAG has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and B&C are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
Please contact Ligia Duarte Botelho if your company is interested in submitting a nomination.
Senators Urge House To Reform And Reauthorize CFATS Program: On October 23, 2018, Senator Ron Johnson (R-WI), Chairman of the Senate Committee on Homeland Security and Governmental Affairs, and Senator Shelley Moore Capito (R-WV), Chairman of the Committee on Appropriations’ Homeland Security Subcommittee, sent a letter to the House Committee on Homeland Security and the House Committee on Energy and Commerce, urging them to continue work to pass legislation that reforms and reauthorizes the Chemical Facility Anti-Terrorism Standards (CFATS) program before the end of the 115th Congress. The Department of Homeland Security’s CFATS program currently regulates over 3,000 high-risk chemical facilities. The letter pressed for the House to pass S. 3405, the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2018. The letter is available online.
Senate Subcommittee Holds Field Hearing On PFAS Crisis In Michigan: On November 13, 2018, the Senate Homeland Security and Government Affairs Subcommittee on Federal Spending Oversight and Emergency Management held a “minority field summit” in Grand Rapids, Michigan, on the “Local, State, and Federal Response to the PFAS Crisis in Michigan.” Hosted by Ranking Member Gary C. Peters (D-MI), the hearing examined the responses by government agencies to the issues caused by per- and polyfluoroalkyl substances (PFAS) contamination in Michigan. Testifying at the summit were Patrick Breysse, Ph.D., CIH, Director, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Robert Delaney, Environmental Specialist, Michigan Department of Environmental Quality; Carol Isaacs, Director, Michigan PFAS Action Response Team, Adam London, RS, MPA, Administrative Health Officer, Kent County Health Department; Richard R. Rediske, Ph.D., Senior Program Manager and Professor, Grand Valley State University; Robert B. Annis Water Resources Institute; Sandy Wynn-Stelt Resident of Belmont, Michigan; and Drew YoungeDyke, Communications Coordinator, Great Lakes Regional Center, National Wildlife Federation. Witness testimony is available online.
OIRA Requests Information Soliciting Public Input On Reducing Or Eliminating Unnecessary Regulatory Differences Between The U.S. And Canada: On October 9, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) announced it was issuing a Request for Information (RFI) soliciting public input on how the federal government, under the auspices of the United States-Canada Regulatory Cooperation Council (RCC), may reduce or eliminate unnecessary regulatory differences between the U.S. and Canada. 83 Fed. Reg. 50689. OIRA is also seeking public comment to identify ongoing or emerging areas for which cooperation could reduce the risk of divergence between U.S. and Canadian regulations. OIRA states that the comments submitted “may inform agencies’ development of regulatory reform proposals to modify or repeal existing agency requirements to increase efficiency related to economic activity with Canada, reduce or eliminate unnecessary or unjustified regulatory burdens, or simplify regulatory compliance, while continuing to meet agency missions and statutory requirements.” Comments were due by November 8, 2018. In a separate announcement posted on the International Trade Administration’s U.S. Canada – RCC website,the 2018RCC Stakeholder Forum will be held December 4-5, 2018,at the Walter E. Washington Convention Center in Washington, D.C. The announcement states that this event will “bring together senior regulatory officials, industry, and other interested members of the public from both sides of the border to discuss recent accomplishments and new opportunities for regulatory cooperation.” More information will be made available on the U.S. Canada – RCC website as the date of the Forum draws closer.
California Lists Nickel (Soluble Compounds) On Prop 65 As Known To Cause Reproductive Toxicity: Effective October 26, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) added nickel (soluble compounds) to the list of chemicals known to the state to cause reproductive toxicity for purposes of Proposition 65 (Prop 65). Importantly, “soluble” is not defined in the listing. On October 11, 2018, OEHHA’s Developmental and Reproductive Toxicant Identification Committee (DARTIC), in its official capacity as the “state’s qualified experts” (SQE), determined that soluble nickel compounds were shown to cause reproductive toxicity based on the developmental and male reproductive endpoints. The listing of nickel (soluble compounds) means that warning requirements will apply in one year, or as of October 26, 2019. More information is available in our memorandum.
EPA Inspector General Evaluating Enforcement Results For Past Dozen Years: On November 5, 2018, EPA’s Office of Inspector General (OIG) announced that it has launched an investigation on EPA’s enforcement results from fiscal years (FY) 2006 through 2018. The OIG announcement is available online. OIG hopes to answer two primary questions through this review: (1) What are the trends in enforcement results stemming from EPA enforcement actions (injunctive relief, supplementary environmental projects, and penalties)? (2) What are the key factors explaining differences in enforcement results stemming from EPA enforcement actions over time, among EPA regions and among environmental statutes? In the announcement, OIG asked Susan Bodine, EPA’s Assistant Administrator for the Office of Enforcement and Compliance Assurance (OECA), to provide OIG with OECA’s master list of concluded enforcement cases for FY 2006 through 2018; the official response to Senator Edward Markey’s (D-MA) letter, dated January 19, 2018, to the Administrator, concerning EPA’s enforcement activities; and any other official requests, and responses to congressional requests, for information about EPA’s enforcement activities, received by EPA since October 2016.
EPA OIG Inspecting EPA’s Risk Assessment Process: EPA’s OIG on November 7, 2018, announced that it has launched an audit of EPA’s risk assessment process. The OIG announcement is available online. OIG states that its objective is to determine whether EPA follows federal criteria in preparing risk assessments for EPA programs. When implementing federal programs, federal managers are required to follow OMB Circular A-123, Management’s Responsibility for Enterprise Risk Management and Internal Control; and the U.S. Government Accountability Office’s Standards for Internal Control in the Federal Government. OIG will audit EPA’s risk assessment process to determine if it adheres to these guidelines. OIG has asked for documents related to EPA’s risk assessments on acid rain, the Chesapeake Bay Program, state and local prevention and preparedness, endocrine disruptors, and the sector grant program.
This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.