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August 1, 2016

Monthly Update for August 2016

Bergeson & Campbell, P.C.


EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI) preliminary dataset for calendar year 2015. This dataset contains the most current TRI data on toxic chemical releases and pollution prevention activities at U.S. industrial facilities. EPA intends to update the dataset several times during the summer and early fall based on information from facilities. The TRI Program provides this dataset each July to give you an opportunity to find TRI data for facilities in your community prior to the publication of the TRI National Analysis report in January. The dataset reveals what TRI-covered chemicals a particular industrial facility is using, how much is being released into the environment, whether the TRI facility is recycling or treating any of its toxic chemical waste, or burning any of it for energy recovery, and whether a TRI facility initiated any source reduction activities in the most recent calendar year. The data are available at Envirofacts or data files on the TRI website.

EPA Issues Stop-Sale Order: On July 18, 2016, EPA announced that PuriCore Inc. paid a $550,000 penalty for the unauthorized distribution of two of its pesticide products, ProduceFresh and FloraFresh, that were used in supermarkets nationwide. Along with the penalty, EPA issued a stop-sale order to PuriCore prohibiting the sale of ProduceFresh. PuriCore’s unauthorized distribution and sale of pesticide products violates the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). ProduceFresh is used as part of a crisping process in the produce section of stores, and FloraFresh is used in floral departments. EPA states that PuriCore had submitted an application to EPA to register ProduceFresh as a pesticide, however, EPA has not completed its review of the risks associated with the product. FloraFresh was registered as a pesticide as of February 12, 2016, but PuriCore had been distributing FloraFresh to supermarkets for at a least a year prior to it being registered. The recent enforcement action offers a use reminder to FIFRA stakeholders not to market products before they are registered by EPA relevant state agencies. More information on FIFRA requirements and pesticide registration issues can be found on our FIFRA Frequently Asked Questions (FAQ) web page.

Flubendiamide Registrants And EPA File Post-Oral Argument Briefs: On July 1, 2016, in an administrative appeal of the June 1, 2016, Administrative Law Judge (ALJ) Initial Decision and an earlier order denying Bayer CropScience LP and Nichino America, Inc.’s (BCS/NAI) Motion for Accelerated Decision that held that EPA was authorized to cancel the conditional flubendiamide registrations under FIFRA Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process, the parties in the case filed post-oral argument briefs. The briefs were ordered by the Environmental Appeals Board (EAB or Board) following oral arguments held on June 22, 2016, by BCS/NAI and EPA. Additional information regarding this case is available in our EPA ALJ Issues Initial Decision in Bayer Flubendiamide Cancellation Proceeding and EPA ALJ Denies Bayer’s Motion for Accelerated Decision blogs. The EAB requested that the parties submit post-order briefs responding to questions raised by the Board during oral argument, and the responses filed by the parties demonstrate their divergent views on issues related to this conditional registration and the process by which EPA sought to cancel such registration. More information on the specific questions asked by the Board and BCS/NAI’s and EPA’s responses may be found in our Flubendiamide Registrants and EPA File Post-Oral Argument Briefs blog. The questions posed by the EAB, and the respective responses by BCS/NAI and EPA, indicate fundamental differences regarding the facts and application of the law to this case. Although the resolution of this case has potential implications for current and future registrations, EPA has acknowledged the unique circumstances of this case, and indicates that it is unlikely that a conditional registration like that issued for flubendiamide will be issued again. EPA states: “[T]he structure of the flubendiamide cancellation condition was unprecedented, and the flubendiamide experience shows that a condition requiring a registrant to request cancellation pursuant to section 6(f) is significantly less reliable than a condition that would allow a registration to simply expire. EPA is unlikely to grant in the future a registration with conditions that depend on a registrant requesting cancellation pursuant to section 6(f).” The statement by EPA that it is more likely in the future to impose a condition that would allow affected registrations “to simply expire” leaves unresolved the question of the rights a registrant would have to contest cancellation based on such an expiration date.

EPA Reopens Docket On ICR For SNURs: On July 26, 2016, EPA reopened the docket on an Information Collection Request (ICR) for approval of an existing ICR for Toxic Substances Control Act (TSCA) Section 5(a)(2) Significant New Use Rules (SNUR) for existing chemicals. 81 Fed. Reg. 48788. Several commenters had expressed the view that the burden on industry created by SNURs was too low in the ICR and additional comment was needed. Comment on the ICR may now be submitted until August 25, 2016.

EPA Schedules Public Meetings On TSCA Implementation: On July 26, 2016, EPA announced its intention to hold two public meetings on August 9, 2016, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. 81 Fed. Reg. 48789. The August 9 public meeting provided an opportunity to discuss EPA’s proposed rule on conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment. The August 10, 2016, meeting provided an opportunity to discuss EPA’s proposed rule to establish a risk-based process for chemical prioritization. More information concerning EPA’s implementation of the amended TSCA is available in our memorandum EPA Publishes First Year Implementation Plan, as well as on the Bergeson & Campbell, P.C. (B&C®) website under Regulatory Developments: TSCA.

EPA Issues Final Rule To Protect The Public From Exposure To Formaldehyde: On July 27, 2016, EPA signed off on final regulations to reduce exposure to formaldehyde vapors from certain wood products produced domestically or imported into the United States. EPA worked with the California Air Resources Board (CARB) to ensure the final national rule is consistent with California requirements for composite wood products. The new rule will, according to EPA, level the playing field for domestic manufacturers who have a high rate of compliance with the California standard and non-California based entities that are not subject to the CARB standard. The Formaldehyde Emission Standards for Composite Wood Products Act of 2010 established emission standards for formaldehyde from composite wood products and directed EPA to issue a final rule on implementing and enforcing a number of provisions covering composite wood products. One year after the rule is published, composite wood products that are sold, supplied, offered for sale, manufactured, or imported in the United States will need to be labeled as TSCA Title VI compliant. These products include: hardwood plywood, medium-density fiberboard, and particleboard, as well as household and other finished goods containing these products. EPA is also setting testing requirements to ensure that products comply with those standards, establishing eligibility requirements for third-party certifiers, and establishing eligibility requirements for accreditation bodies to be recognized by EPA that will accredit the third-party certifiers. The new rule includes exemptions for products made with ultra-low formaldehyde or no-added formaldehyde resins and new requirements for product labeling, recordkeeping, and enforcement provisions. Formaldehyde is used as an adhesive in a wide range of wood products, such as some furniture, flooring, cabinets, bookcases, and building materials, including plywood and wood panels. Exposure to formaldehyde can cause adverse health effects, including eye, nose, and throat irritation, other respiratory symptoms, and cancer. For more information, visit online. A prepublication of the rule is available online.

EPA Issues SAP Minutes On Use Of Biomonitoring Data To Derive PoD: On July 20, 2016, EPA issued a memorandum attaching minutes from the April 19-21, 2016, FIFRA Scientific Advisory Panel (SAP) meeting, Transmittal of Meeting Minutes of the April 19-21, 2016 Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP or Panel) Meeting Held to Consider and Review Scientific Issues Associated with “Chlorpyrifos: Analysis of Biomonitoring Data.” This SAP was convened to advise EPA regarding the evaluation of biomonitoring chlorpyrifos data from epidemiology studies conducted by the Columbia Center for Children’s Environmental Health (CCCEH). The minutes reflect the SAP’s significant concerns with EPA’s proposal to use the biomonitoring chlorpyrifos data from the CCCEH epidemiology studies to establish a point of departure (PoD) for chlorpyrifos risk assessment. The minutes state a major source of uncertainty cited by the FIFRA SAP is “the lack of verification and replication of the analytical chemistry results that reported very low levels of chlorpyrifos (pg/g),” because EPA had to impute a finite quantitative value to “a large fraction of cord blood samples included in the analyses presented with levels below LOD.” Moreover, some SAP members “thought the quality of the CCCEH data is hard to assess when raw analytical data have not been made available, and the study has not been reproduced.” The SAP also, however, stated that “both epidemiology and toxicology studies suggest there is evidence for adverse health outcomes associated with chlorpyrifos exposures below levels that result in 10% red blood cell (RBC) acetylcholinesterase (AChE) inhibition (i.e., toxicity at lower doses).” Nevertheless, it agreed with EPA that “applying additional safety factors to the AChE PoDs to account for a possible noncholinergic mode of action (MOA) would be problematic because of challenges in justifying any particular value for such an adjustment.” Of note, the SAP concluded that it would be appropriate to use a “10X intra-species extrapolation factor” in any analysis based on the cord blood data. It also identified other sources of uncertainty that should be considered in such an analysis, including “the inability of single measures of chlorpyrifos concentration in blood to provide information regarding source, frequency, duration and magnitude of exposure, and how these exposures are linked to specific outcomes measured in the CCCEH study participants.” Although EPA suggested in a Status Report filed in the chlorpyrifos litigation pending in the Ninth Circuit Court of Appeals on June 29, 2016, that the FIFRA SAP might recommend a “hybrid approach” that EPA could use in lieu of a PoD based on AChE inhibition, thereby altering the prior EPA analysis for chlorpyrifos, the SAP minutes do not include a recommendation for such a hybrid methodology. For more information, see our EPA Issues FIFRA SAP Minutes on EPA Proposal to Use Biomonitoring Data to Derive a PoD for Chlorpyrifos blog.

EAB Upholds EPA Cancellation Of Flubendiamide Registrations: On July 29, 2016, the EAB issued its Final Decision and Order (Order) upholding the ALJ Initial Decision and an earlier order denying BCS/NAI’s Motion for Accelerated Decision that held that EPA was authorized to cancel the conditional flubendiamide registrations under FIFRA Section 6(e) and did not need to provide BCS/NAI the full Section 6(b) cancellation process. The Board also upheld EPA’s determination prohibiting BCS/NAI from the continued sale, distribution, and use of existing stocks of flubendiamide products, but found that EPA’s determination to prohibit the continued sale and distribution of existing stocks of flubendiamide end-use products by distributors and retailers other than BCS/NAI was not supported by the record. See the related item earlier in the update for more information regarding this case.


EPA Propose User Fee System For Waste Manifests: On July 26, 2016, EPA proposed its user fee methodology applicable to electronic and paper manifests submitted to the national electronic manifest system (or e-Manifest system) that is being established by EPA under the Hazardous Waste Electronic Manifest Establishment Act. 81 Fed. Reg. 49072. After the implementation date for the e-Manifest system, certain users of the hazardous waste manifest would be required to pay a prescribed fee for each electronic and paper manifest they use and submit to the system in order for EPA to recover its costs of developing and operating the national e-Manifest system. The final rule that EPA develops in response to public comments on this action’s proposed fee methodology will include the final fee methodology. In addition, EPA intends to include the initial fee schedule and the implementation date for the e-Manifest system in the preamble to the final rule. The proposal also suggests several amendments to the regulations governing the use of electronic hazardous waste manifests and the completion of manifests. These amendments propose: to change EPA’s longstanding regulations regarding transporter changes to shipment routing information on the manifest during transportation, to specify a process by which receiving facilities may submit manifest data corrections to the e-Manifest system, and to modify a provision of the current electronic manifest use requirements that precludes the use of mixed electronic and paper manifests by those users desiring to make use of electronic manifests in settings where not all users are able to participate electronically. Comments must be received on or before September 26, 2016.

EPA Issues Direct Final Rule Adding To List Of Excluded VOCs: On August 1, 2016, EPA issued a direct final rule revising the definition of volatile organic compound (VOC) under the Clean Air Act (CAA) and adding 1,1,2,2-tetrafluoro-1-(2,2,2-trifluoroethoxy) ethane to the list of compounds excluded from the definition of VOCs. 81 Fed. Reg. 50330. EPA has concluded that the compound makes a negligible contribution to tropospheric ozone (03) and that there is a low likelihood of risk to human health or the environment. The rule is effective on September 30, 2016, unless EPA receives adverse comment by August 31, 2016. EPA also published a proposed rule on the same day proposing to revise the definition of VOC as noted above. 81 Fed. Reg. 50408. Comment is due August 31, 2016.

EPA Issues Guidance On Drinking Water: In July 2016, EPA released guidance for drinking water professionals on how to use public health data to detect and respond to drinking water contamination. The guidance offers recommendations on how utilities can identify and collaborate with public health partners and others to generate and monitor data for disease clusters, and outlines how to investigate clusters, once identified, to identify whether and what drinking water issues may be linked. The EPA guidance is available online.


FDA Issues Final Environmental Assessment For Genetically Engineered Mosquitoes: On August 5, 2016, the U.S. Food and Drug Administration (FDA) completed and issued the final environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, FDA released a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment. FDA’s final issuance of the EA and FONSI does not mean that Oxitec’s GE mosquitoes are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, determining whether and when to begin the proposed field trial in Key Haven, Florida. For more information, see online.

FDA Issues Final Rule On Amendments To Registration Of Food Facilities: On July 14, 2016, the FDA Center for Food Safety and Applied Nutrition (CFSAN) issued a final rule as part of the Food Safety Modernization Act, Amendments to Registration of Food Facilities, that updates FDA’s food facility registration requirements to better protect public health by requiring additional registration information that will improve the accuracy of the food facility registration database for facilities both in the United States and abroad. 81 Fed. Reg. 45912. FDA states that the final rule adds new requirements that will improve the food facility registration system, and amend the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with FDA as food facilities. All food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe, however. The rule is effective as of September 12, 2016.

FDA Issues Warning Letter Addressing Drug Claims Made For Products Marketed As Cosmetics: On August 10, 2016, FDA announced its issuance of a number of “Warning Letters” to cosmetic companies, stating that these letters “illustrate an important legal distinction, the difference between a cosmetic and a drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act).” The Warning Letters cite drug claims associated with topical skin care, hair care, and eyelash/eyebrow preparations, as noted on both product labeling and websites. Some examples of the drug claims cited are acne treatment, cellulite reduction, stretch mark reduction, wrinkle removal, dandruff treatment, hair restoration, and eyelash growth.

FDA Issues Draft Guidance On Premarket Safety Notifications For Dietary Supplement Industry: On August 12, 2016, FDA issued a notice of availability of a revised draft guidance for industry, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. 81 Fed. Reg. 53486. FDA believes the draft guidance will improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications submitted to FDA, and that these notifications help the agency identify safety concerns before products reach consumers. FDA is requesting comments by October 11, 2016, so that it may be able to consider all comments before beginning work on the final version.


Canadian Parliament Holds First Reading Of Bill To Create Framework To Regulate Nanotechnology: On June 8, 2016, the House of Commons held its first reading of an Act to amend the Canadian Environmental Protection Act, 1999 (CEPA) (nanotechnology) (C-287). The bill would add Part 6.1 to CEPA primarily to implement procedures for the investigation and assessment of nanomaterials. Member Peter Julian, New Democratic Party of Canada House Leader, issued a June 8, 2016, press release stating that he first introduced the bill in 2010 and is “pleased to see that some of the aspects of this Bill are being considered by Health Canada and Environment Canada, such as the development of a registry for nanomaterials in commerce and use in Canada.” According to the press release, the bill would establish a “balanced approach ensuring the responsible development of nanotechnology and the safe use off [sic] nanomaterials in Canada.” The bill would define nanomaterial as any manufactured substance or product or any component material, ingredient, device or structure that: (a) is within the nanoscale (one nanometer (nm) up to and including 100 nm), in at least one external dimension; or (b) if it is not within the nanoscale, exhibits one or more properties that are attributable to the size of a substance and size effects. The bill mandates a risk assessment process to identify the potential benefits and possible risks of nanotechnologies before nanoproducts enter the market. It would also create a national inventory regarding nanotechnology, including nanomaterials and nanoparticles, using information collected under CEPA Sections 46 and 71 and “any other information to which the Ministers have access.” As reported in our July 27, 2015, blog item, on July 25, 2015, Canada published a notice announcing a mandatory survey under CEPA Section 71(1)(b) with respect to certain nanomaterials in Canadian commerce. Julian first introduced similar legislation in 2010. Previous versions of the bill did not make it past the first reading in the House of Commons.

OECD Publishes Dossier Summaries For Carbon Nanotubes, Fullerenes, And Silicon Dioxide: The Organization for Economic Cooperation and Development (OECD) recently published several dossier summaries for nanomaterials tested as part of its Testing Program of Manufactured Nanomaterials. Under the Program, sponsors tested 11 nanomaterials for: nanomaterial information/identification; physical-chemical properties and material characterization; environmental fate; toxicological and eco-toxicological effects; environmental toxicology; mammalian toxicology; and material safety. The new summaries available include:

EC Amends Cosmetics Regulation To Allow Use Of Titanium Dioxide (Nano) As UV Filter: The European Commission (EC) published on July 14, 2016, a regulation in the Official Journal of the European Union that amends Annex VI, the list of ultraviolet (UV) filters allowed in cosmetic products, of the cosmetics regulation. Under the amendment, the entry for titanium dioxide is revised to state that the combined use of titanium dioxide and titanium dioxide (nano) must not exceed 25 percent maximum concentration in ready-for-use preparation. The amendment also adds an entry for titanium dioxide (nano), stating that it must not exceed 25 percent maximum concentration in ready-for-use preparation. Titanium dioxide (nano) is not to be used in applications that may lead to exposure of the end user’s lungs by inhalation. Only nanomaterials having the following characteristics are allowed:

  • Purity ≥ 99 percent;
  • Rutile form, or rutile with up to 5 percent anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes;
  • Median particle size based on number size distribution ≥ 30 nanometers (nm);
  • Aspect ratio from 1 to 4.5, and volume specific surface area ≤ 460 square meters per cubic meter (m2/cm3);
  • Coated with silica, hydrated silica, alumina, aluminum hydroxide, aluminum stearate, stearic acid, trimethoxycaprylylsilane, glycerin, dimethicone, hydrogen dimethicone, or simethicone;
  • Photocatalytic activity ≤ 10 percent compared to corresponding non-coated or non-doped reference, and
  • Nanoparticles are photostable in the final formulation.

Canada Begins Consultation On Proposed Prioritization Approach For Nanoscale Forms Of DSL Substances, Possible Groupings Include Gold And Silver: On July 27, 2016, Environment and Climate Change Canada (ECCC) and Health Canada (HC) began a consultation on a proposed prioritization approach for nanoscale forms of substances on the Domestic Substances List (DSL). Canada will use the proposed approach to: (1) establish a list of existing nanomaterials in Canada for prioritization; (2) identify how the information available will be used to inform prioritization of nanomaterials for risk assessment; and (3) outline the proposed outcomes of the prioritization process. In 2015, Canada conducted a mandatory survey under CEPA Section 71. The survey applied to persons who manufactured or imported any of 206 nanomaterials at a quantity greater than 100 kilograms during the 2014 calendar year. Based on the results of the survey, ECCC and HC will prepare a final list of confirmed existing nanomaterials in Canada and will use the list for subsequent prioritization. ECCC and HC propose that, where possible, the substances identified via the survey be “rolled up into” their broader parent nanomaterial groups for the purposes of prioritization. According to ECCC and HC, this will allow, when possible, a more robust look at the hazard, volume, and use data as appropriate, rather than considering an individual substance-by-substance approach. ECCC and HC state that further consideration for sub-grouping (such as by use, unique property, or functionalization) may need to be considered for prioritization and/or risk assessment. The 21 possible nanomaterial groupings, based on parent substance, include gold and silver. Comments on the proposed prioritization approach are due September 25, 2016. More information is available in B&C’s August 4, 2016, blog item, “Canada Begins Consultation on Proposed Prioritization Approach for Nanoscale Forms of DSL Substances.”

Comments On 2011 Proposed SNURs Prompt Proposal Regarding Hierarchy Of Controls: On July 28, 2016, EPA proposed changes to the existing regulations governing significant new uses of chemical substances under TSCA to align these regulations with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS), as well as changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. One of the proposed changes would be to make it a significant new use not to implement a hierarchy of controls to protect workers. Persons subject to applicable SNURs would be required to determine and use appropriate engineering and administrative controls before using personal protective equipment (PPE) for worker protection, similar to the requirements in the OSHA standards at 29 C.F.R. Section 1910.134(a)(1) and guidance in Appendix B to Subpart I of 29 C.F.R. Part 1910. According to EPA, this change is being proposed partly due to comments received on recently promulgated SNURs. As reported in our December 28, 2011, blog item, EPA proposed on December 28, 2011, SNURs for 17 chemical substances that were the subject of premanufacture notices (PMN). Of particular interest, seven of the chemical substances were multi-walled carbon nanotubes, while six were fullerenes, and the proposed SNURs prompted significant comment. In the July 28, 2016, proposed rule, EPA states that in response to the December 28, 2011, proposed SNURs, it received comments from 26 public submissions. According to EPA, each of the comments generally stated that EPA’s approach of exclusively identifying the absence of adequate PPE as a significant new use instead of engineering and administrative controls is not following the best occupational health and safety practices. The commenters suggested approaches that EPA could adopt. Several commenters identified the industrial hygiene “hierarchy of controls” approach for workplace health and safety, where elimination, substitution, engineering controls, and workplace or administrative controls should be implemented before use of PPE for worker protection. Several commenters stated that persons subject to SNURs should follow the OSHA requirements to use controls that are higher in the hierarchy of controls before requiring employees to use PPE. Some commenters suggested that EPA should specifically incorporate the OSHA requirements at 29 C.F.R. Section 1910.134(a)(1) into each SNUR or modify standard requirements for SNURs at 40 C.F.R. Section 721.63 to require a hierarchy of controls. EPA promulgated final SNURs on June 26, 2013, and responded to the comments, agreeing that a hierarchy of controls should be applied and that PPE should be the last option to control exposures. More information is available in B&C’s July 29, 2016, blog item, “Comments on 2011 Proposed SNURs Prompt Proposal Regarding Hierarchy of Controls.”

White Paper Describes Nanotechnology-Inspired Grand Challenge For Future Computing: The White House Office of Science and Technology Policy (OSTP) announced on July 29, 2016, that federal agencies released a white paper describing the collective federal vision for the emerging and innovative solutions needed to realize the Nanotechnology-Inspired Grand Challenge for Future Computing announced in October 2015. The white paper, a collaboration by the U.S. Department of Energy, National Science Foundation, Department of Defense, National Institute of Standards and Technology, and the intelligence community, describes the interagency technical priorities, highlights the challenges and opportunities associated with these priorities, and presents a guiding vision for the research and development needed to achieve key technical goals for the challenge. According to the white paper, “(b)y coordinating and collaborating across multiple levels of government, industry, academia, and nonprofit organizations, the nanotechnology and computer science communities can look beyond the decades-old approach to computing based on the von Neumann architecture and chart a new path that will continue the rapid pace of innovation beyond the next decade.” As reported in our October 20, 2015, blog item, the Grand Challenge is to “[c]reate a new type of computer that can proactively interpret and learn from data, solve unfamiliar problems using what it has learned, and operate with the energy efficiency of the human brain.” The new computing capabilities envisioned in the Grand Challenge might address issues such as delivering individualized treatments for disease, allowing advanced robots to work safely alongside people, and proactively identifying and blocking cyber intrusions.

CEN Committee Seeks Responses To Survey On Disposal Practices For Manufactured Nano-Objects In Waste: Under EC funding, the European Committee for Standardization Technical Committee (CEN/TC) 352 — Nanotechnologies is developing guidelines relating to the safe waste management and disposal of deliberately manufactured nano-objects. The TC seeks responses from companies manufacturing or processing manufactured nano-objects by September 5, 2016, to an online questionnaire relating to current disposal practices for manufactured nano-objects in waste. The guidelines are intended to provide guidance for all waste management activities from the manufacturing and processing of manufactured nano-objects. The TC has a separate online questionnaire for waste disposal companies.

Two Workshops Will Be Held Before October 2016 OpenTox Euro Conference: Two workshops, a European Union (EU)-U.S. Nano Environmental and Health Safety (NanoEHS) workshop and a nano modeling workshop, will be held in advance of the October 2016 OpenTox Euro Conference. The EU-U.S. NanoEHS workshop, “Enabling a Sustainable Harmonized Knowledge Infrastructure Supporting NanoEHS Assessment,” will be held October 24, 2016. The objective of the workshop is to facilitate networking, knowledge sharing, and idea development on the requirements and implementation of a sustainable knowledge infrastructure for nanoEHS assessment and communications. The workshop will also facilitate active discussions and identify potential partners for future EU-U.S. cooperation on the development of knowledge infrastructure in the nanoEHS field. The nano modeling workshop will be held October 25, 2016. The objectives are to: (1) give the opportunity to research groups working on computational nanotoxicology to disseminate their modeling tools based on hands-on examples and exercises; (2) present a collection of modeling tools that can span the entire lifecycle of nanotox research, starting from the design of experiments until use of models for risk assessment in biological and environmental systems; and (3) engage workshop participants in using different modeling tools and motivate them to contribute and share their knowledge. The OpenTox Euro Conference, “Integrating Scientific Evidence Supporting Risk Assessment and Safer Design of Novel Substances,” will be held October 26-28, 2016. The current topics for the Conference include: (1) computational modeling of mechanisms at the nanoscale; (2) translational bioinformatics applied to safety assessment; (3) advances in cheminformatics; (4) interoperability in action; (5) development and application of adverse outcome pathways; (6) open science applications showcase; (7) toxicokinetics and extrapolation; and (8) risk assessment.


BRAG Biobased Products News And Policy Report: B&C’s 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


President Signs GMO Bill Creating National Bioengineered Food Disclosure Standard: On July 29, 2016, President Obama signed Senate Bill 764 into law, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes, Pub. L. No. 114-216, which will amend the Agricultural Marketing Act of 1946: Subtitle E: National Bioengineered Food Disclosure Standard, and Subtitle F: Labeling of Certain Food. The national bioengineered food disclosure standard includes a definition for “bioengineering”: “a food (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature,” as well as specifics on how the new standard will be established through requirements and procedures. More information on the specifics of this bill is available in our Monthly Update for July 2016.


California Proposes First “Priority Products” Under Safer Consumer Products Regulations: On July 15, 2016, the California Department of Toxic Substances Control (DTSC) announced the release of its proposed regulation on children’s foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product (PP) under the Safer Consumer Products Regulations (SCPR). DTSC first released information about this PP on March 13, 2014, so this proposed regulation is a major step in the SCPR process and over two years in the making. DTSC will accept comments on the proposal until August 29, 2016. Also on August 29, 2016, DTSC will hold a public hearing at the California Environmental Protection Agency (CalEPA) Building on 1001 “I” Street, Sacramento, California 95814. More information on the SCPR is available on the DTSC website and on the B&C website.

DHS Announced Chemical Facility Anti-Terrorism Standards: On July 20, 2016, the U.S. Department of Homeland Security (DHS or Department) published a document to inform the public of DHS’s actions to implement an improved tiering methodology for the Chemical Facility Anti-Terrorism Standards (CFATS) program that incorporates the relevant elements of risk mandated by Section 2102(e)(2) of Title XXI of the Homeland Security Act of 2002 (as amended). 81 Fed. Reg. 47001. Implementation of the improved tiering methodology required changes to an ICR, which was recently approved by the Office of Management and Budget (OMB). The changes are in response to questions regarding how rigorous DHS’ criteria are for chemical facilities. The basis for how DHS classifies chemical facilities under the Program’s jurisdiction was questioned in a Government Accountability Office (GAO) report last year. Specifically, the GAO report found DHS “used unverified and self-reported data” in determining what risk a plant posed. Under the Program, plants storing chemicals above threshold quantities must complete a top-screen assessment. DHS calculates the risk posed by a facility, which it assigns to one of four tiers. Facilities also must prepare and file site security plans, and the Department can reject plans deemed insufficient. None of this information is disclosed to the public for security reasons. The revisions are expected to help DHS incorporate the relevant elements of risk in determining the risk of terrorism associated with a covered chemical facility. This document went into effect July 20, 2016, or as otherwise specified in the document.

WHO And IARC To Assess Seven Major Chemicals: On August 1, 2016, the World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) announced it would review the potential for seven chemicals in food and consumer products to cause cancer. These chemicals are: 1-tert-butoxypropan-2-ol (Chemical Abstracts Service (CAS) No. 136579-67-4), β-myrcene (CAS No. 123-35-3), furfuryl alcohol (CAS No. 98-00-0), melamine (CAS No. 108-78-1), pyridine (CAS No. 110-86-1), tetrahydrofuran (CAS No. 109-99-9), and vinylidene chloride (CAS No. 75-35-4). Organizations that wish to observe the Panel’s June 6-13, 2017, deliberations should request observer status by February 15, 2017. The agency will accept relevant data through May 8, 2017. BASF Corp., the Dow Chemical Co., DuPont, Koch Industries Inc., and Momentive Performance Materials Holdings LLC were among the U.S. manufacturers of the chemicals in 2012, the most recent year for which EPA has data. IARC will evaluate whether these seven chemicals may cause cancer. IARC requests nominations of scientists as expert panel members by October 12, 2016.

The list of chemicals IARC will evaluate at Meeting 119 and other information is available online.

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.