Federal Development Update for May 2018


TSCA/FIFRA/TRI

Webinar: TSCA at 2: An Update on Implementation and Hot Topics:

June 25, 2018

11:00 a.m. - 12:00 p.m. (EDT)

Register Today

Presenters:

Nancy B. Beck, Ph.D., D.A.B.T.®

Deputy Assistant Administrator

Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA)

Lynn L. Bergeson

Managing Partner

Bergeson & Campbell, P.C. (B&C®)

Others to be announced soon.

Overview:

Since enactment on June 22, 2016, of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA has implemented a muscular regulatory program expressing Congress’ intent for a new and improved Toxic Substances Control Act (TSCA). The new TSCA framework required significant work and fundamental shifts in regulatory requirements and the conceptual approach, but EPA has hit all of its marks in timely promulgating the rules and fulfilling statutory deadlines. EPA’s prodigious output is compelling, laudatory, and not without controversy as TSCA stakeholders interpret the new law differently.

Join us for a lively, informative, and up-to-the-minute discussion of the very latest with Nancy B. Beck, Ph.D., EPA’s Deputy Assistant Administrator of the Office of Chemical Safety and Pollution Prevention, and other presenters to be announced soon.

EPA Extends Comment Period On TSCA Fees Rules: On April 24, 2018, the U.S. Environmental Protection Agency (EPA) extended by 30 days and has added a supplemental analysis, titled “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,”', to the rulemaking docket for the proposed rule that published on February 26, 2018. 83 Fed. Reg. 17782. EPA has completed supplemental analysis that estimates the impact of setting the small business definition based on an employee-based threshold. EPA estimated the impact when the small business definition is set using the following: a fixed employee-based threshold that defines small businesses as those firms with 500 or fewer employees, and the thresholds set by the Small Business Administration, which vary by industry sector. EPA requests comment on this analysis and whether an employee-based size standard would be more appropriate than a receipts-based size standard and what that employee level should be; whether the size standard, be it receipts-based or employee-based, should vary from industry to industry to reflect differences among the impacted industries; and what other factors and data sources the Agency should consider, besides inflation, when developing the size standard to qualify for reduced fee amounts. The supplemental analysis provides additional estimates for the impact of setting the small business definition based on an employee-based threshold. Comments must be received on or before May 24, 2018.

EPA Updates Pesticide Label Review Manual: On April 24, 2018, EPA announced that it has updated Chapters 3, 7, and 17 of the Pesticide Label Review Manual. The three updated Label Review Manual chapters are: Chapter 3: General Labeling Requirements; Chapter 7: Precautionary Statements; and Chapter 17: Net Contents/Net Weight. More information is available in our blog at http://pesticideblog.lawbc.com/entry/epa-updates-pesticide-label-review-manual.

EPA Seeks Applicants For 2018 Safer Choice Partner Of The Year Awards Program: On April 25, 2018, EPA requested applications for the 2018 Safer Choice Partner of the Year Awards. 83 Fed. Reg. 18051. In 2015, EPA developed the Partner of the Year Awards to recognize Safer Choice stakeholders who have advanced the goals of the Pollution Prevention Act by reducing pollution at its source through safer chemistry. Award winners will be recognized at a ceremony in the fall of 2018. At the 2018 Partner of the Year Awards, Safer Choice will recognize stakeholder organizations from five broad categories: Formulators/Product Manufacturers of both Consumer and Institutional/Industrial products, Purchasers and Distributors, Retailers, Supporters (e.g., non-governmental organizations), and Innovators (e.g., chemical manufacturers). All applications and accompanying materials must be received by June 27, 2018.

EPA Releases Strengthening Transparency In Regulatory Science Proposed Rule: On April 30, 2018, EPA proposed its “Strengthening Transparency in Regulatory Science” (Science Rule) that EPA states is intended to “strengthen the transparency of EPA regulatory science.” 83 Fed. Reg. 18768. EPA states in the preamble that “[t]he proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.” EPA intends the rule to provide this transparency “in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests.” EPA “will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.” EPA states that its “regulatory science” should be “consistent with the Office Management and Budget’s [OMB] Final Information Quality Bulletin for Peer Review,” and that “[r]obust peer review plays a critical role in independently validating key findings and ensuring that the quality of published information meets the standards of the scientific and technical community.” In addition, EPA states, the proposed rule “is designed to increase transparency of the assumptions underlying dose response models,” noting that “[t]he use of default models, without consideration of alternatives or model uncertainty, can obscure the scientific justification for EPA actions.” EPA states: “Across EPA programs much of the science that informs regulatory actions is developed outside the Agency. It is the charge of regulators to ensure that key findings are valid and credible, as required by OMB’s Guidelines.” EPA “believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government,” and “[n]othing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections.” Comments are due by May 30, 2018. More information is available at http://pesticideblog.lawbc.com/entry/epa-releases-strengthening-transparency-in-regulatory-science-proposed-rule. On May 3, 2018, several Democrats on the House Science, Space, and Technology Committee and the Energy and Commerce Environment Subcommittee were joined by 63 Democratic colleagues in sending a letter to Administrator Pruitt calling for a 90-day comment period on the proposed rule. A copy of the letter is available online.

D.C. District Court Provides Reasons For Denying Defendant’s Motion To Dismiss In Glyphosate Case: On April 30, 2018, the U.S. District Court for D.C. issued a memorandum opinion that sets forth the reasons for its denial of defendant Monsanto Company’s (Monsanto) motion to dismiss in a case in which the plaintiffs allege that certain glyphosate label claims violate the District of Columbia Consumer Protection Procedures Act (DCCPPA) (Opinion). The order denying Monsanto’s motion to dismiss was issued on March 31, 2018, but did not provide any substantive discussion as to why it was denied, only that a statement that the reasons would be provided in 30 days. Plaintiffs Beyond Pesticides, et al.’s amended complaint alleges that under the DCCPPA “the claim that Roundup targets an enzyme ‘found in plants but not in people or pets’ is false and misleading because that enzyme ‘is found in people and pets’” (emphasis in original), because, plaintiffs assert, “glyphosate, the active ingredient in Roundup, targets an enzyme that exists in ‘gut bacteria’ found in humans and other mammals.” The amended complaint additionally alleges that Monsanto “is aware that its labels and advertising are false … but continues to repeat this claim because ‘consumers are more likely to buy -- and will pay more for -- weed killer formulations that do not affect people and animals.’” Monsanto’s motion to dismiss, filed on July 10, 2017, stated that plaintiffs’ “claims are time-barred, that Plaintiffs fail to state a claim because the statement at issue is not false or misleading, and that Plaintiffs’ claims are preempted by [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)].” The Opinion outlines the reasons for the court’s conclusion that the claims are not time-barred, at least for purposes of deciding the motion to dismiss. The Opinion states, in response to some of the arguments that the claims were time-barred, that the court has “little trouble concluding that Plaintiffs’ claims are not time-barred in their entirety,” and that Monsanto is “entitled to renew its argument that some portion of Plaintiff’s claims are time-barred at the summary judgment stage.” More information is available at http://pesticideblog.lawbc.com/entry/d.c.-district-court-provides-reasons-for-denying-defendants-motion-to-dismi.

New Electronic Options For Label And CSF Submission To EPA: An Update On The SmartLabel And eCSF Projects: On May 2, 2018, during the EPA’s Pesticide Program Dialogue Committee (PPDC) meeting, EPA announced the progress of its electronic pesticide label data submission project, SmartLabel, and its electronic Confidential Statement of Formula (eCSF) submission project. The SmartLabel and eCSF will be submitted through EPA’s Pesticide Submission Portal (PSP) on the Central Data Exchange (CDX). EPA is developing the SmartLabel program to improve efficiencies in the submission, review, and approval of pesticide label information. EPA believes creation of electronic master labels as structured data will improve the accuracy and clarity of pesticide label information and will allow it to be revised easily and efficiently. EPA indicated that the SmartLabel program will use CDX for the creation of labels in XML format. Once uploaded through CDX’s PSP, the label will undergo an internal validation and move through an internal workflow. EPA anticipates this will aid in faster approvals of labels. The eCSF is an electronic version of EPA’s current paper CSF (EPA Form 8570-4). This eCSF submission option will allow applicants to submit electronically product specification data and will: pre-populate information such as product properties and manufacturing/formulating site addresses from the PSP log in; link the eCSF to previous electronically submitted product information; and link chemical names to EPA information sources. More information is available at http://pesticideblog.lawbc.com/entry/new-electronic-options-for-label-and-csf-submission-to-epa-an-update-on-the.

EPA Will Send Final Methylene Chloride Rule To OMB “Shortly”: On May 10, 2018, EPA announced several upcoming actions on methylene chloride. Under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA is required to perform risk evaluations on the uses of ten specific chemicals, including methylene chloride. According to EPA, it is nearing completion of problem formulations for these first ten chemicals. EPA’s announcement states that it will send a final methylene chloride rule to OMB “shortly.” EPA notes that it is not reevaluating the paint stripping uses of methylene chloride, and instead is relying on its previous risk assessments. More information is available at http://www.lawbc.com/regulatory-developments/entry/epa-will-send-final-methylene-chloride-rule-to-omb-shortly.

ATSDR Announces Availability Of Draft Interaction Profile For Mixtures Of Insecticides: Pyrethroids, Organophosphorus Compounds, And Carbamates: On May, 14, 2018, the Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services, announced the availability of the Draft Interaction Profile for Mixtures of Insecticides: Pyrethroids, Organophosphorus Compounds, and Carbamates for review and comment. 83 Fed. Reg. 22263. This interaction profile evaluates a mixture of chemicals often found in human blood, adipose tissue, and breast milk. The purpose of this interaction profile is to investigate the possible joint actions of these chemicals on endocrine, developmental, and neurobehavioral endpoints in humans. This interaction profile has undergone external peer-review and review by ATSDR's Interagency Workgroup on Mixtures. Comments must be submitted by August 13, 2018.

RCRA/CERCLA/CWA/CAA

EPA Issues Final 2016 Effluent Guidelines Plan: EPA on May 2, 2018, issued its Final 2016 Effluent Guidelines Plan (Final 2016 Plan). 83 Fed. Reg. 19281. Section 304(m) of the Clean Water Act (CWA) requires EPA to publish on a biennial basis a plan for new and revised effluent guidelines. The Final 2016 Plan identifies one new rulemaking for the Steam Electric Power Generating Point Source Category. EPA has concluded that no additional industries warrant new or revised effluent guidelines at this time. The Final 2016 Plan does, however, also announce a new study to look “holistically” at the management of oil and gas extraction wastewater from onshore facilities. The focus of this study is to engage with stakeholders to evaluate approaches to manage oil and gas extraction wastewater from onshore facilities. The Final 2016 Plan also announces that EPA is initiating a study of the Electrical and Electronic Components Point Source Category. The focus of this study will be on changes within the industry since the 1983 rulemaking, particularly as these changes pertain to wastewater characteristics and wastewater treatment technologies. The Plan is available online.

EPA Schedules Workshop On Fuels Regulatory Streamlining: EPA on May 8, 2018, announced that on May 21-23, 2018, it will hold a stakeholder workshop in Chicago on its anticipated rulemaking on Fuels Regulatory Streamlining. 83 Fed. Reg. 20812. EPA is exploring opportunities to streamline and modernize its existing fuels regulations under 40 C.F.R. Part 80. EPA plans to update its gasoline, diesel, and other fuels regulations to help reduce burden for stakeholders while improving overall compliance assurance and maintaining environmental performance. EPA intends to achieve this goal in streamlining the existing fuels regulations by: deleting expired provisions, eliminating redundant compliance provisions, and replacing them with a single set of provisions and definitions that would apply across all gasoline, diesel, and other fuels programs currently under 40 C.F.R. Part 80. The workshop will be held at the Palmer House Hilton Hotel. Additional information is available online.

FDA

FDA To Hold Public Meeting In Preparation For International Cooperation On Cosmetics Regulation (ICCR-12) Meeting: On April 11, 2018, the U.S. Food and Drug Administration (FDA) announced that it will hold a public meeting to receive input on topics pertaining to the regulation of cosmetics on June 7, 2018, from 2:00 p.m. to 4:00 p.m. (EDT) in College Park, Maryland, titled “International Cooperation on Cosmetics Regulation (ICCR) -- Preparation for ICCR-12 Meeting.” 83 Fed. Reg. 15576. Registration is due by May 24, 2018. Registration information is available in the Federal Register notice. FDA states that the purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics and that it may use this input to prepare for the ICCR-12 meeting that will be held July 10-12, 2018, in Tokyo, Japan.

FDA Extends Nutrition Facts Label Compliance Dates: On May 4, 2018, FDA extended the compliance dates for its final rule issued in May 2016 that amended its labeling regulations for conventional foods and dietary supplements, specifically by providing updated nutrition information on the label of food, including dietary supplements; defining a single-serving container; requiring dual-column labeling for certain containers; updating, modifying, and establishing certain reference amounts customarily consumed (RACC); and amending the label serving size for breath mints. 83 Fed. Reg. 19619. The final rule extends the compliance dates by one and a half years, from July 26, 2018, to January 1, 2020, for manufacturers with $10 million or more in annual food sales. Manufacturers with less than $10 million in annual food sales will receive an extra year to comply -- until January 1, 2021. 83 Fed. Reg. 19619. The Federal Register notice states that FDA is taking this action “because, after careful consideration, [it has] determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions [FDA] received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.” A full list of nutrition facts-related guidance documents is available on FDA’s website.

FDA Releases Supplemental Guidance To Help Food Establishments Meet Menu Labeling Requirements: On May 8, 2018, FDA announced the availability of a guidance for industry entitled “Menu Labeling: Supplemental Guidance for Industry.” 83 Fed. Reg. 20731. The Federal Register notice states that the guidance:

  • Addresses stakeholder concerns regarding the implementation of nutrition labeling required for foods sold in covered establishments;
     
  • Includes expanded and new examples of alternatives to aid in compliance;
     
  • Identifies places where FDA intends to be more flexible in its approach; and
     
  • Advises of FDA’s intent to exercise enforcement discretion regarding nutrient declaration for “calories from fat” as part of the additional written nutrition information.
     

The guidance also provides examples of options for implementation and addresses calorie disclosure signage for: self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods, when determining nutrition labeling for such foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer. Interested parties can submit comments via Docket FDA-2011-F-0172-2906 on www.regulations.gov, but there is no deadline to do so.

NANOTECHNOLOGY

EFSA Consumer Survey About Emerging Food Safety Issues Includes Nanoparticles: On April 16, 2018, the European Food Safety Authority (EFSA) published a report entitled “EU Insights -- Consumer perceptions of emerging risks in the food chain.” To understand better the views of European Union (EU) consumers on food-related emerging risks, EFSA surveyed 25 EU countries using three examples of emerging risks: green smoothies, plastic rice, and nanoparticles. The perceptions of the risks posed by nanoparticles used in food were mixed overall, with a similar proportion of participants perceiving high risks (27 percent) and low risks (31 percent). Communicating information about the nature of the risk and the level of uncertainty that surrounds it “may have a significant impact on risk perception, pointing to the malleability of perceptions of emerging risks.”

European Parliament Approves New Law On Organic Production And Labeling Of Organic Products: On April 19, 2018, the European Parliament (EP) approved a regulation on organic production and labeling of organic products. Under the regulation, the production of processed organic food will be based on several specific principles, including the exclusion of food containing or consisting of engineered nanomaterials. According to the EP’s April 19, 2018, press release, one of the features of the regulation is to ensure the high quality of organic food through “strict, risk-based checks” that will take place along the supply chain. In addition, imports will have to comply with EU standards. The Council of the EU must formally approve the text of the regulation before it can enter into force. It applies beginning January 1, 2021.

Germany’s Federal Environment Ministry Holds NanoDialog On Nano-In-Vivo: On April 23-24, 2018, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU) held a NanoDialog to discuss “Nano-In-Vivo,” a long-term research project intended to close existing data gaps concerning the safety of nanomaterials. Using rat organisms, the project is studying the potential long-term effects of nanomaterials on the lungs and other organs. In particular, the tests are examining the impacts that low exposure levels have over a long period of time to identify the chronic effects of nanomaterials in the low-dose range. During the NanoDialog, meeting participants discussed the early study results. The study results are expected to be published at the end of 2018.

NIOSH Seeks Comment On Draft Nanotechnology Research Plan For FYs 2018-2025: The National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice on April 24, 2018, announcing the availability of a draft research plan entitled Continuing to Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025 for public comment. 83 Fed. Reg. 17824. The draft Nanotechnology Research Plan presents the Nanotechnology Research Center (NTRC) strategic plan for fiscal years (FY) 2018-2025, highlighting how the critical research and guidance efforts of NIOSH align with and support the comprehensive Environmental, Health, and Safety Research Strategy needs of the National Nanotechnology Initiative. For the period FY2018-2025, NIOSH states that it will continue to fill information and knowledge gaps that address the five NIOSH NTRC strategic goals first defined in the 2013 strategic plan:

  • Strategic Goal 1: Increase understanding of new hazards and related health risks to nanomaterial workers;
     
  • Strategic Goal 2: Expand understanding of the initial hazard findings of engineered nanomaterials;
     
  • Strategic Goal 3: Support the creation of guidance materials to inform nanomaterial workers, employers, health professionals, regulatory agencies, and decision makers about hazards, risks, and risk management approaches;
     
  • Strategic Goal 4: Support epidemiologic studies for nanomaterial workers, including medical, cross-sectional, prospective cohort, and exposure studies; and
     
  • Strategic Goal 5: Assess and promote national adherence with risk management guidance.
     

NIOSH states that it is seeking stakeholder input on the draft Nanotechnology Research Plan to ensure that the program is meeting the needs of the stakeholders, and to identify ways in which it can be improved to increase its impact on the safety and health of nanomaterial workers across the U.S. Comments are due June 25, 2018. More information is available in our April 24, 2018, blog item, “NIOSH Seeks Comment on Draft Nanotechnology Research Plan for FYs 2018-2025.”

REACH Committee Approves Draft Regulation To Amend The REACH Annexes To Address Nanomaterials: The European Commission (EC) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee voted on April 26, 2018, to amend several REACH Annexes to clarify the registration requirements for nanomaterials. According to the European Chemicals Agency’s (ECHA) press release, the amendments address the knowledge gap regarding which substances registered under REACH are placed on the market as nanomaterials and in what quantities. ECHA states that the amendments will allow both companies and authorities to know more about the characteristics of nanomaterials, how they are used, how they are handled safely, what risks they potentially pose to health and the environment, and how these risks are controlled. The draft regulation is now subject to scrutiny by the EP and Council for a period of three months before being adopted by the EC. ECHA states that it will begin to assess the need to update existing guidance or issue new guidance to support registrants in complying with the new requirements. As soon as the amendments are formally adopted, ECHA encourages registrants of nanoform substances to familiarize themselves with the amendments and assess what actions they need to take to comply. More information on the draft regulation and public consultation is available in our blog items, “EC Proposes to Amend REACH Annexes to Address Nanomaterials” and “EC Posts Comments Received on Draft Regulation to Amend REACH Annexes to Address Nanomaterials.”

EPA Continues To Investigate Engineered Nanomaterials In Industrial Wastewater Discharge: On May 2, 2018, EPA published a Federal Register notice announcing publication of its Final 2016 Effluent Guidelines Program Plan. 83 Fed. Reg. 19281 (see related item above under RCRA/CERCLA/CWA/CAA section). According to the Plan, EPA continued several ongoing investigations, including one on the manufacture and processing of engineered nanomaterials as a potential new source of industrial wastewater discharge. According to the Plan, EPA will continue to look for opportunities to inform current data gaps, including potential sources, quantities, and types of engineered nanomaterials in industrial wastewater discharge; fate, transformation, and treatment of engineered nanomaterials in industrial wastewaters; and the development of analytical methods to detect and quantify engineered nanomaterials.

AIHA® Fact Sheet Addresses National Security Implications Of Export-Import Activities Concerning Nanomaterials: The American Industrial Hygiene Association (AIHA®) announced the availability of a nanomaterial product stewardship fact sheet sponsored by the AIHA® Nanotechnology Working Group. The fact sheet, “Nanomaterial Product Stewardship: National Security Implications of Export-import Activities,” authored by C.R. Knezevich, CIH, provides a thorough and helpful overview of export-import regulations affecting nanomaterials, reviews U.S. export regimes, and includes recommended practices and resources related to export-import activities. The purpose of the fact sheet is to give product safety specialists and industrial hygienists an overview of export-import requirements for nanomaterials and is not intended to be a regulatory compliance guide. The fact sheet states that nanotechnology “is a rapidly changing field with significant health, safety, environmental, and product stewardship considerations” and notes that the export of nanomaterials “presents additional global product stewardship challenges.” According to the fact sheet, these challenges require the cooperation of several departments within a business organization, including industrial hygienists, who “contribute technical, ethical, and critical-thinking skills to global business teams.” The fact sheet is a must read for nano enthusiasts and others engaged in export-import activities.

Nanotech Entrepreneurs Will Share Commercialization Challenges And Successes In NNCO Webinar: The National Nanotechnology Coordination Office (NNCO) will hold the first in its series of free webinars for the nanotechnology entrepreneurship community on May 21, 2018, at 2:00 p.m. (EDT). NNCO states that the webinar will feature stories from entrepreneurs that have transitioned their university-based nanotechnology research through commercialization. Participants will share lessons learned, technological challenges faced, and how their university entrepreneurial ecosystem supported their efforts. Panelists will include:

  • Dr. Angelique C. Johnson, founder and Chief Executive Officer of MEMStim LLC;
     
  • Dr. Christopher Schuh, Chief Scientist of Xtalic Corporation; and
     
  • Dr. Gleb Yushin, co-founder and Chief Technology Officer of Sila Nanotechnologies.
     

Registration is now open.

JRC Extends Call To Access Its Nanobiotechnology Laboratory: As reported in our February 16, 2018, blog item, the EC Joint Research Center (JRC) has opened a call to access its Nanobiotechnology Laboratory. Offering access to the Nanobiotechnology Laboratory is part of JRC’s strategy to enhance dissemination of scientific knowledge; boost competiveness; bridge the gap between research and industry; and provide training and capacity building. To be eligible, the lead user institution and user institutions must be from an EU Member State, candidate country, or country associated with the EU Research Program Horizon 2020. The lead user institution must be from a university, research, or public institution, or from a small- or medium-sized enterprise. The call to access the JRC Nanobiotechnology Laboratory will close May 25, 2018.

Belgium Finds Quality Of Nanoregistrations Can Be Improved: The Belgian Federal Public Service for Public Health, Food Chain Safety and Environment has published the first annual report for nano substances registered for placement on the market in 2016. Although the report is available only in French and Dutch at this time, each contains an executive summary in English. Of the 475 registrations submitted, importers submitted 56 percent of the registrations, distributors 22 percent, and manufacturers 11 percent. Substances registered in quantities greater than 1,000 tons include amorphous silica, calcium carbonate, calcium carbonate treated with stearic acid, carbon black, diiron trioxide, iron hydroxide oxide yellow, and silicon oxide. About half of the submitted registrations reported quantities below one ton. The executive summary states that evaluation of the submitted registrations shows that the quality of the registrations can be further improved. It also suggests the possibility that not all potential registrants are aware of the May 27, 2014, Royal Decree and the obligation to register. The nominative list of the substances registered for 2016 is presented in an annex to the report.

BIOBASED/RENEWABLE PRODUCTS

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.

LEGISLATIVE

Lawmakers Sign Resolutions Seeking Resignation Of EPA Administrator: On April 18, 2018, 170 Democratic and four Republican lawmakers signed resolutions calling on Scott Pruitt to resign as EPA Administrator. The resolutions (S. Res. 473 and H. Res. 834) express no confidence in Mr. Pruitt and call for his immediate resignation. Lawmakers cite his “repeated ethics violations, misuse of taxpayer dollars,” and environmental policy rollbacks. It is unclear if the resolutions will move through the Republican controlled Congress.

House Bill Would Require EPA To Study Effects Of Pharmaceuticals On Drinking Water Sources: On April 18, 2018, Representative Jan Schakowsky (D-IL) introduced the Water, Cosmetics, and Unwanted Pharmaceuticals (WATER CUPS) Act. The bill (H.R. 5548) would amend Section 1442 of the Safe Drinking Water Act to require EPA to carry out a study on the presence of pharmaceuticals and personal care products in sources of drinking water. EPA would be required to identify pharmaceuticals and personal care products that have been detected in sources of drinking water and the levels at which such pharmaceuticals and personal care products have been detected. EPA also would be required to identify the sources of pharmaceuticals and personal care products in sources of drinking water, including point sources and nonpoint sources of pharmaceutical and personal care products and the effects of pharmaceuticals and personal care products on humans, the environment, and the safety of drinking water. The study also must identify methods to control, limit, treat, or prevent the presence of such pharmaceuticals and personal care products.

Bill Would Require EPA To Restore Climate Change To EPA Website: On April 18, 2018, Representative Salud Carbajal (D-CA) introduced the Climate Change is Real Act (H.R. 5552). The bill would require EPA to reinstate information about climate change or global warming that was removed from, or redacted on, the Agency’s website. Congressman Carbajal stated that under Administrator Scott Pruitt, EPA has removed “significant climate change-related information” from its website and since then, “significant information related to climate change remains missing” from the site.

Senate Bill Addresses Hazardous Occupational Exposures: On April 19, 2018,Senators Kamala D. Harris (D-CA) and Catherine Cortez Masto (D-NV) introduced the Environmental Justice Right to Know Act (S. 2722). The bill seeks to address shortcomings in the disclosure of ingredients in pesticides and personal care products. The bill would amend FIFRA to strengthen pesticide labeling requirements. The bill directs EPA to require Spanish translations of all essential safety and environmental information on pesticide products, including: warnings and precautionary statements; information on exposure symptoms, toxicity levels, first aid, personal protective equipment, and Restricted Entry Intervals (REI); general safe handling and usage directions; and storage and disposal instructions and other directions to prevent environmental contamination. The legislation also would require NIOSH to conduct further research on ventilation in nail and hair salons and report on the level of ventilation necessary for health protective ambient air and breathing zone air quality for workers in salons. Under the bill, safety data sheets (SDS) of all cosmetic and personal products used by nail, hair, barber, and other beauty professionals must be available on the manufacturer or product maker website and ensure they be easily accessed via the name of the specific product line. And all SDSs for products used in the professional beauty salon industry would be required to be translated into languages spoken by a significant number of professionals, including Spanish, Vietnamese, Korean, Chinese, and Nepali. The Department of Labor would be required to promulgate rules that ensure that the hazards facing nail and hair salon workers are included as a targeted topic for training in any future announcements of Occupational Safety and Health Administration (OSHA) Susan Harwood Training Grants. The bill also would require the National Institute of Environmental Health Sciences to issue a report to Congress on the long-term negative health effects of endocrine disrupting chemicals, carcinogens, neurotoxicants, and asthmagens in beauty and personal care products on the health of women of color and other highly impacted communities.

Bill Would Prohibit Paper Imports Not Manufactured Under CAA And CWA Equivalent Standards: On April 28, 2018, Representative Peter DeFazio (D-OR) introduced legislation that would prohibit the importation of paper products that are not manufactured in accordance with requirements that are at least as stringent as the requirements under the Clean Air Act (CAA) and the CWA. The bill, H.R. 5611, defines the term “paper product” to mean an article classified under any heading or subheading of chapter 47 or 48 of the Harmonized Tariff Schedule (HTS). The legislation does not specify how importers of paper products could demonstrate that the products were manufactured in a manner at least as stringent as the CAA or CWA.

Top Democrats Push Pruitt For 90-Day Comment Period On New EPA “Selective Science” Policy: On May 3, 2018, the top Democrat on the House Science, Space, and Technology Committee, Eddie Bernice Johnson (D-TX), and on the Energy and Commerce Environment Subcommittee, Paul D. Tonko (D-NY), were joined by 63 Democratic colleagues today to send a letter to EPA Administrator Scott Pruitt calling for a 90-day comment period on a recently proposed rule on the treatment of data in science-based policymaking. “Given the large response from scientists and stakeholders before the rule was officially proposed, a comment period of 30 days will not allow for meaningful engagement from stakeholders,” the letter states. “Regardless of viewpoint, there is agreement that the proposed rule would be a significant change in how the agency considers science in policymaking. Organizations, scientists, industries, and members of the public deserve additional time to understand how this policy shift may impact them.” Administrator Pruitt announced the proposed rule at an event closed to the press late last month. The proposed rule would impose severe restrictions on the use of certain public health data and related research findings, a radical departure from existing and widely-accepted scientific standards. It would also give the Administrator broad discretion to exempt certain studies from the proposal’s requirements on a case-by-case basis. Ranking Member Tonko raised serious concerns about the impartiality of this proposed rule while questioning Administrator Pruitt when he testified before the Energy and Commerce Environment Subcommittee last week. (See related item above, EPA Releases Strengthening Transparency In Regulatory Science Proposed Rule.)

Senators Flake And McCain Introduce Bill On Ozone NAAQS: Senators Jeff Flake (R-AZ) and John McCain (R-AZ) on May 10, 2018, introduced legislation (S. 2825) to amend the CAA to address issues created by “the unattainable air quality burdens placed on rural and international transport areas.” The Air Designation Actions in Areas of Pollutant Transport (ADAAPT) Act would alleviate standards related to background ozone. The Senators state that the current National Ambient Air Quality Standard (NAAQS) for ozone forces states like Arizona to regulate ozone emissions that are beyond its control, especially in international and interstate air pollution transport areas. The ADAAPT Act provides states with assurances of timely approvals or disapprovals of state submittals seeking regulatory relief for nonattainment areas impacted by international transport or that qualify as a rural transport area. It also would allow local air pollution control agencies in nonattainment areas to substitute the best available control technology. The bill also would remove the criteria that limit a rural transport designation from only being available to a nonattainment area that is not included in, and is not adjacent to, a Metropolitan Statistical Area or a Consolidated Metropolitan Statistical Area.

Congressman Veasey Introduces Energy Research Legislation: On May 10, 2018, Representative Marc Veasey (D-TX) introduced H.R. 5475, the Fossil Energy Research and Development Act of 2018. The bill is intended to reauthorize research activities in the Department of Energy’s Office of Fossil Energy and set priorities for clean energy technologies. The legislation is the first comprehensive reauthorization of the Fossil Energy office in more than a decade. The bill would focus research on carbon capture, utilization, and sequestration, along with carbon dioxide removal and methane leak detection.

MISCELLANEOUS

Proposed Substances To Be Evaluated For Toxicological Profile Development: On April 18, 2018, ATSDR requested comment on proposed substances to be evaluated for Toxicological Profile development. 83 Fed. Reg. 17177. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List, as well as any non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the National Priorities List. Nominations from the Substance Priority List and/or additional substances must be submitted by May 18, 2018.

OEHHA Proposes Regulations On Safe Harbor Warning Content As Part Of Clear And Reasonable Warnings: On April 23, 2018, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced it is proposing to amend Article 6 of Title 27 of the California Code of Regulations (C.C.R.), Section 25603, specifically the safe harbor warning content on product warnings for exposures to listed chemicals in pesticides. OEHHA states that this regulation is “intended to provide compliance assistance for businesses that cause pesticide exposures in order to reduce the potential for litigation concerning the sufficiency of warnings, while still allowing them to comply with other federal and state requirements for warnings provided on a label.” It is a part of the new Article 6 Clear and Reasonable Warnings regulations, which OEHHA adopted in August 2016 and which becomes effective on August 30, 2018. These new regulations include safe harbor warning methods and content for consumer product exposures (Sections 25602 and 25603) and occupational exposures (Section 25606) to listed chemicals. The Initial Statement of Reasons (ISOR) is available here and the proposed regulatory text is available here. More information is available at http://pesticideblog.lawbc.com/entry/oehha-proposes-regulations-on-safe-harbor-warning-content-as-part-of-clear.

California DPR Identifies Top Ten Agricultural Pesticide Use Violations Of 2017: On April 23, 2018, the California Department of Pesticide Regulation (DPR) circulated a presentation entitled “Top 10 Agricultural Pesticide Use Violations of 2017” that identifies the top ten agricultural most common pesticide use violations of 2017 in California. The violations are listed from the least common (#10) to the most common (#1):

  1. Handler Training, regulated under Title 3 of the California Code of Regulations (C.C.R.) § 6724 (b-e). Examples of handler training violations listed in the presentation are: not updating employee training on a new pesticide handled; and not training employees prior to them mixing, loading, or applying pesticides.
     
  2. Availability of Labeling, regulated under 3 C.C.R. § 6602. Examples of labeling availability violations listed in the presentation are: not having relevant Special Local Needs (SLN) labeling at the site when mixing, loading, or applying; and not having the labeling booklet on-site when mixing, loading, or applying.
     
  3. Handler Decontamination Facilities, regulated under 3 C.C.R. § 6734. Examples of these types of violations listed in the presentation are: a handler using a backpack sprayer and not carrying a pint of eyewash when the label requires eye protection; and handlers using hand sanitizer instead of soap and water.
     
  4. Service Container Labeling, regulated under 3 C.C.R. § 6678. Examples of service container labeling violations listed in the presentation are: not including the signal word on a service container label; and only putting the name of the pesticide on the service container.
     
  5. Hazard Communication for Fieldworkers, regulated under 3 C.C.R. § 6761. Examples of these types of violations listed in the presentation are: not completing the required fields on the displayed Pesticide Safety Information Series (PSIS) A-9 leaflet; and not providing SDSs for the pesticides listed on the pesticide use records.
     
  6. Annual Registration with County Agricultural Commissioner by Anyone Who Intends to Advertise, Solicit, or Operate as a Pest Control Business in California, regulated under California Food and Agriculture Code (FAC) § 11732. An example of a violation is not registering with the county in which such a business intends to work prior to performing pest control activities.
     
  7. Application-Specific Information (ASI) for Fieldworkers, regulated under 3 C.C.R. § 6761.1. Examples of violations listed in the presentation are: not including the start and stop times, Restricted Entry Interval (REI), or active ingredient in the displayed information; and not displaying the ASI before fieldworkers work in a treated field.
     
  8. Emergency Medical Care Requirements, regulated under 3 C.C.R. § 6726. Examples of violations listed in the presentation are: not taking employees suspected of a pesticide illness to the doctor immediately; and not posting the name, address, and phone number of the medical facility at the worksite or in the work vehicle before employees begin handling pesticides.
     
  9. Personal Protective Equipment (PPE) Requirements, regulated under 3 C.C.R. § 6738. Examples of violations listed in the presentation are: storing PPE in the same place pesticides are stored; and not cleaning PPE and checking for wear after each use.
     
  10. Labeling and Permit Condition Compliance, regulated under FAC § 12973. Examples of violations listed in the presentation are: not following label-required buffer zone, set back distance, or vegetative buffer strip requirements; and applying a pesticide to a site or crop not listed on the labeling.

DPR states that it “recommends and encourages continuing education (CE) course sponsors [to] integrate this information into … future CE courses,” and asks for help “in promoting lawful pesticide use practices by encouraging [CE] attendees to review these agricultural pesticide use violations as they relate to their operations, to assure they are in compliance with federal and California pesticide use requirements.”

FTC Announces Settlement Halting Deceptive Mosquito-Repellent Claims For Aromaflage Perfume And Candles: The Federal Trade Commission (FTC) announced on May 3, 2018, that a New Jersey-based company and its owners have agreed to settle charges that they used deceptive claims to sell purportedly mosquito-repelling perfume sprays and scented candles. The company advertised its Aromaflage products -- marketed as “fragrance with function” -- as effective mosquito repellents and sold them on its website, in retail outlets, and on Amazon.com. Respondents claimed that the sprays were “as effective as 25% Deet over 2.5 hours.” Their website also claimed the sprays and candles were “rigorously tested at one of the world’s leading Universities and found to be as effective at repelling mosquitoes as the leading brand” and “repels mosquitoes that may carry Zika, Dengue, Chikungunya, and Yellow Fever.” The complaint alleges that the respondents made false or unsubstantiated advertising claims: (1) about their products’ efficacy to repel mosquitoes, including those carrying the diseases cited; (2) that the sprays effectively repel mosquitoes for 2.5 hours; and (3) that the sprays and candles repel mosquitoes as effectively as 25 percent DEET. Further, FTC states, the complaint charges the respondents with making false claims that the products are scientifically proven to work as advertised. Finally, the complaint alleges that the respondents deceptively claimed that some of the reviews were by typical, unbiased users, and failed to disclose that those reviewers had a material connection to the respondents and the products being reviewed. Under a proposed order settling the charges, Mikey & Momo, Inc. and its principals Michael Fensterstock and Melissa Matarese Fensterstock would be barred from engaging in such deceptive conduct in the future and must clearly and conspicuously disclose any material connections between a reviewer or endorser and the product being reviewed. FTC will publish a description of the consent agreement in the Federal Register. Comments on the proposed agreement are due June 4, 2018.

OSHA Issues Direct Final Rule Revising Beryllium Standard For General Industry: On May 7, 2018, OSHA issued a direct final rule clarifying aspects of the beryllium standard for general industry as it applies to processes, operations, or areas where workers may be exposed to materials containing less than 0.1 percent beryllium by weight. 83 Fed. Reg. 19936. The direct final rule clarifies the definitions of Beryllium Work Area, emergency, dermal contact, and beryllium contamination. It also clarifies provisions for disposal and recycling, and provisions that apply only where skin can be exposed to materials containing at least 0.1 percent beryllium by weight. The direct final rule will become effective on July 6, 2018, unless OSHA receives significant adverse comments by June 6, 2018.

USDA Issues Proposed Mandatory National Bioengineered Food Disclosure Standard: On May 4, 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service proposed a national mandatory bioengineered (BE) food disclosure standard as required under the Agricultural Marketing Act of 1946, as recently amended. 83 Fed. Reg. 19860. The new rule would require food manufacturers and other entities that label food for retail sale to disclose information about BE food and BE food ingredient content. The Act defines bioengineering with respect to food as a food the contains genetic material; that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature. USDA’s goal is to provide a mandatory and uniform national standard for disclosure of information to consumers about the BE status of foods. USDA seeks comment on many important issues. Non-government organizations have expressed dismay with the use of the term “bioengineered” in lieu of “genetically modified,” claiming it is a deceptive strategy. Comments are due by July 3, 2018.

OSHA Announces Delayed Enforcement Of Certain Provisions Of The Beryllium Standard: OSHA on May 11, 2018, confirmed in a memorandum that it will begin enforcing certain requirements of the final rule on occupational exposure to beryllium in general industry, construction, and shipyards on May 11, 2018. Those requirements include the permissible exposure limits in the general industry, construction, and shipyard standards; and the exposure assessment, respiratory protection, medical surveillance, and medical removal provisions in the general industry standard. Aside from these requirements, other ancillary provisions included in the beryllium standard for general industry will not be enforced until June 25, 2018. Under the terms of settlement agreements with petitioners who challenged the rule, however, OSHA plans to issue a proposal to further extend this compliance date for the ancillary provisions to December 12, 2018. OSHA previously proposed to remove the ancillary requirements from the beryllium standards for the construction and maritime industries. In accordance with that proposal, OSHA will enforce the permissible exposure limits, but will not enforce any other provisions for beryllium exposure in those standards unless it provides notice. Certain compliance dates outlined in the rule remain unchanged. Enforcement of the general industry requirements for change rooms and showers will begin March 11, 2019; and requirements for engineering controls will begin March 10, 2020.

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.

 
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