Monthly Update for December 2016


Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

TSCA/FIFRA/IRIS/NTP/TRI

EPA Proposes To Add Nonylphenol Ethoxylates To Section 313: On November 16, 2016, the U.S. Environmental Protection Agency (EPA) proposed to add nonylphenol ethoxylates (NPE) as a category for which reporting is needed under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 81 Fed. Reg. 80624. EPA is proposing to add this chemical category to the EPCRA Section 313 list because EPA believes NPEs meet the EPCRA Section 313(d)(2)(C) toxicity criteria. Specifically, EPA believes that longer chain NPEs can break down in the environment to short-chain NPEs and nonylphenol, both of which are toxic to aquatic organisms. Based on a review of the available production and use information, members of the NPEs category are expected to be manufactured, processed, or otherwise used in quantities that would exceed EPCRA Section 313 reporting thresholds. Comments must be received on or before January 17, 2017.

EPA Issues Final Rule Adding HBCD Category To Section 313 Reporting: On November 28, 2016, EPA issued a final rule adding a hexabromocyclododecane (HBCD) category to the list of toxic chemicals subject to reporting under EPCRA Section 313. 81 Fed. Reg. 85440. EPA added this chemical category to the EPCRA Section 313 list because it determined that HBCD meets the EPCRA Section 313(d)(2)(B) and (C) toxicity criteria. Specifically, EPA has determined that HBCD can reasonably be anticipated to cause developmental and reproductive effects in humans and is highly toxic to aquatic and terrestrial organisms. Based on the available bioaccumulation and persistence data, EPA has determined that HBCD should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical and assigned a 100-pound reporting threshold. This final rule was effective November 30, 2016.

EPA Issues Significant New Use Rules On Certain Chemical Substances: On November 17, 2016, EPA issued a direct final rule on significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 57 chemical substances that were the subject of premanufacture notices (PMN). 81 Fed. Reg. 81250. The applicable review periods for the PMNs submitted for these 57 chemical substances all ended prior to June 22, 2016 (i.e., the date on which President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amends TSCA). Thirty-four of these chemical substances are subject to TSCA Section 5(e) consent orders issued by EPA. The final rule requires persons who intend to manufacture (including import) or process any of these 57 chemical substances (noted below) for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA’s evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required with that determination. This rule is effective on January 17, 2017. If an entity intends to file an adverse comment or notice of intent to submit adverse or critical comment on one or more of the SNURs, the notice is due by December 19, 2016, EPA will withdraw the relevant sections of this direct final rule before its effective date.

57 PMN Chemical Substances in Batch SNUR (EPA-HQ-OPPT-2016-0207)

PMN

Name

CAS RN

5(e) Consent Order

P-11-0482

Carbon nanotubes (generic)

N/A

X

P-12-0292

Coke (coal), secondary pitch

94113-91-4

X

P-13-0718

Single-walled carbon nanotubes (generic)

N/A

X

P-13-0719

Single-walled carbon nanotubes (generic)

N/A

X

P-13-0720

Single-walled carbon nanotubes (generic)

N/A

X

P-13-0721

Single-walled carbon nanotubes (generic)

N/A

X

P-14-0150

Fatty acid amide (generic)

N/A

 

P-14-0151

Fatty acid amide (generic)

N/A

 

P-14-0152

Fatty acid amide (generic)

N/A

 

P-14-0165

Fatty acid amide (generic)

N/A

 

P-14-0166

Fatty acid amide (generic)

N/A

 

P-14-0413

Kaolin, reaction products with polysiloxane (generic)

N/A

X

P-14-0428

Fatty acid amide (generic)

N/A

 

P-14-0429

Fatty acid amide (generic)

N/A

 

P-14-0430

Fatty acid amide (generic)

N/A

 

P-14-0431

Fatty acid amide (generic)

N/A

 

P-14-0523

Copolymer of perfluorinated and alkyl methacrylates (generic)

N/A

X

P-14-0524

Copolymer of perfluorinated and alkyl methacrylates (generic)

N/A

X

P-14-0525

Copolymer of perfluorinated and alkyl methacrylates (generic)

N/A

X

P-14-0526

Copolymer of perfluorinated and alkyl methacrylates (generic)

N/A

X

P-14-0527

Copolymer of perfluorinated and alkyl methacrylates (generic)

N/A

X

P-14-0580

Alkenoic acid, polymer with alkyl alkenoate, alkylalkylalkenoate,
alkenoic acid and tridecafluoro alkylalkenoate, compds. with
alkylaminoalcanol (generic)

N/A

X

P-14-0643

Titanium oxide compound (generic)

N/A

X

P-14-0655

Single-walled carbon nanotubes (generic)

N/A

X

P-14-0656

Single-walled carbon nanotubes (generic)

N/A

X

P-14-0657

Single-walled carbon nanotubes (generic)

N/A

X

P-14-0658

Single-walled carbon nanotubes (generic)

N/A

X

P-14-0688

Fatty acid amide hydrochloride (generic)

N/A

 

P-14-0689

Fatty acid amide hydrochloride (generic)

N/A

 

P-14-0690

Fatty acid amide hydrochloride (generic)

N/A

 

P-14-0691

Fatty acid amide hydrochloride (generic)

N/A

 

P-14-0712

Plastics, wastes, pyrolyzed, bulk pyrolysate (generic)

N/A

X

P-14-0713

Plastics, wastes, pyrolyzed, light distillate (generic)

N/A

X

P-14-0714

Plastics, wastes, pyrolyzed, middle distillate (generic)

N/A

X

P-14-0715

Plastics, wastes, pyrolyzed, heavy distillate (generic)

N/A

X

P-15-0028

Carbon silicon oxide

39345-87-4

X

P-15-0054

Carbon nanotube (generic)

N/A

X

P-15-0149

Sulfonated alkylbenzene salts (generic)

N/A

X

P-15-0267

Substituted quinoline derivative (generic)

N/A

 

P-15-0470

Algal oil amide (generic)

N/A

 

P-15-0485

Bismuth compound (generic)

N/A

X

P-15-0612

Sulfur thulium ytterbium yttrium oxide

180189-40-6

X

P-15-0613

Gadolinium sulfur ytterbium yttrium oxide, erbium- and thulium-doped

1651187-84-6

X

P-15-0614

Neodymium sulfur yttrium oxide

1651158-45-5

X

P-15-0615

Erbium gadolinium neodymium sulfur ytterbium yttrium oxide

1651152-96-3

X

P-15-0616

Erbium gadolinium sulfur ytterbium yttrium oxide

1622295-07-1

X

P-15-0617

Erbium gadolinium ytterbium oxide

1651152-05-4

X

P-15-0618

Erbium gadolinium sulfur ytterbium oxide

934388-91-7

X

P-15-0655, chemical A

2-Ethylhexanoic acid, compound with alkyamino cyclohexane (generic)

N/A

 

P-15-0655, chemical B

2-Ethylhexanoic acid, compound with cyclohexylamine (generic)

N/A

 

P-15-0680

Propenoic acid, alkyl ester, polymer with 1,3-cyclohexanedialkylamine,
reaction products with oxirane(alkoxyalkyl) (generic)

N/A

 

P-15-0691

Acrylic acid, polymer with polyalkylene polyamine (generic)

N/A

 

P-16-0030

1,2-Cyclohexanedicarboxylic acid, 1-(2-phenylhydrazide)

1807977-72-5

 

P-16-0052

2,5-Furandione, dihydro-, polymer with 1,1'-iminobis[2-propanol],
benzoate (ester), N-benzoyl derivs.

592479-38-4

 

P-16-0056

Dialkyl fattyalkylamino propanamide alkylamine acetates (generic)

N/A

 

P-16-0057

Dialkyl fattyalkylamino propanamide alkylamine acetates (generic)

N/A

 

P-16-0058

Dialkylaminopropylaminopropanoate ester (generic)

N/A

 

EPA Proposes SNURs For Two Solvents: On November 28, 2016, EPA proposed SNURs for N-ethylpyrrolidone (NEP) and N-isopropylpyrrolidone (NiPP). 81 Fed. Reg. 85472. Based on these chemicals’ structural similarity to n-methyl-2-pyrrolidone (NMP), EPA is concerned that these chemicals could pose harm to human health. Existing applications of these chemicals will continue under the proposed rule. New uses, however, would be subject to EPA review. Comments are due by January 27, 2017.

EPA Seeks Comment On TSCA Section 12(b) ICR: On November 17, 2016, EPA requested comment on an Information Collection Request (ICR) to support TSCA Section 12(b) export notifications, which expired on September 1, 2016, “due to administrative error.” 81 Fed. Reg. 81094. The action is necessary to reinstate information collection activities. Comments are due by December 19, 2016.

EPA Announces Initial List Of TSCA Section 6(b)(2)(A) Chemicals For Risk Evaluation: On November 29, 2016, EPA announced the initial ten chemical substances on which risk evaluations will be conducted under TSCA Section 6(b)(2)(A). The chemicals, all of which were to be (and were) drawn from the TSCA Work Plan for Chemical Assessments, are:

  • 1,4-dioxane
  • 1-bromopropane
  • Trichloroethylene (TCE)
  • Carbon tetrachloride
  • HBCD
  • Methylene chloride
  • Pigment violet 29
  • Perchloroethylene (PERC)
  • NMP
  • Asbestos

EPA is required under TSCA Section 6(b)(2)(A) to announce the chemicals within 180 days of enactment, or by December 19, 2016. Interestingly, several of the chemicals are the subject of Section 6 rules that are currently undergoing review by the Office of Management and Budget (OMB). These include TCE, methylene chloride, and NMP. Assuming that EPA continues with these rules (relying on the savings provision at TSCA Section 26(p)(3) to use the completed risk evaluations on these chemicals in taking the Section 6 actions), the inclusion of the chemicals on the list may suggest that EPA will broaden the risk evaluations to include other conditions of use beyond those in the completed risk assessments.

EPA Issues Guidance For Testing Pesticides Aimed At Reducing Animal Testing: On November 29, 2016, EPA announced the issuance of new guidance for testing pesticides designed to reduce animal testing for acute dermal toxicity for pesticides, Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations & Supporting Retrospective Analysis, in final. This guidance was issued as part of the Office of Pesticide Programs’ (OPP) Strategic Vision for implementing the 2007 National Research Council’s report on Toxicity Testing in the 21st Century. OPP states that it “receives about 200-300 dermal formulation toxicity tests annually, each of which generally use 10 animals per test,” and “[w]e expect this waiver guidance to save 2,500 or more laboratory animals every year.” Further, as described in OPP Director Jack Housenger’s March 17, 2016, letter to stakeholders, “[t]his new policy represents significant progress toward EPA’s goal of significantly reducing the use of animals in acute effects testing.”

More information on OPP’s Strategic Direction for Adopting 21st Century Science Methodologies is available on EPA’s website and in our blog item EPA’s OPP Releases Guidance Documents Related to Strategic Vision for Adopting 21st Century Science Methodologies.

EPA Proposes Prohibiting Use Of TCE: On December 6, 2016, EPA announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of TCE for certain uses under TSCA Section 6, due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities. The proposed action is significant for several reasons, including that it represents the first use in a very long time of TSCA Section 6, as well as the first Section 6 control action taken under new TSCA. Specifically, EPA is proposing to prohibit the use of TCE in “aerosol degreasing and for use in spot cleaning in dry cleaning facilities; to prohibit commercial use of TCE for aerosol degreasing and for spot cleaning in dry cleaning facilities; to require manufacturers, processors, and distributors, except for retailers of TCE for any use, to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping.” A close reading of the proposed rule is necessary to evaluate the arguments, the policy points, and the evidence EPA provided to satisfy the various legal requirements, including those under TSCA Sections 6(c) and 26. EPA’s online Fact Sheet on TCE lists questions and answers as related to the proposed rule. and ingestion.” The pre-publication of the proposed rule is available on EPA’s website. Comment will be due 60 days after publication in the Federal Register.

EPA Issues Final Formaldehyde Emissions Standard For Composite Wood Products: On December 12, 2016, EPA issued a final rule intended to reduce exposure to formaldehyde vapors from certain wood products produced domestically or imported into the United States. 81 Fed. Reg. 89674. The rule was signed in July of this year, and a pre-publication version of the rule was issued at that time. There is no explanation offered for the four-month delay. Under the Formaldehyde Emission Standards for Composite Wood Products Act of 2010, EPA was directed to establish emission standards for formaldehyde from composite wood products and to issue a 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. By including provisions for laminated products, product testing requirements, labeling, recordkeeping, and import certification, the final rule, according to EPA, ensures that hardwood plywood, medium-density fiberboard, and particleboard products sold, supplied, offered for sale, imported to, or manufactured in the United States are in compliance with the emission standards. The final rule also establishes a third-party certification program for laboratory testing and oversight of formaldehyde emissions from manufactured and/or imported composite wood products. EPA worked closely with the California Air Resources Board to help ensure the final national rule is consistent with California’s requirements for composite wood products. The final rule establishes the manufactured-by date for composite wood products as December 12, 2017.The final rule is effective February 10, 2017.

EPA Requests Public Comment On Revision Of Current Size Standard Definitions Under TSCA: On December 15, 2016, EPA issued a notice requesting public comment on whether a revision of the current size standard definitions for small manufacturers and processors, that are used in connection with reporting regulations under TSCA, is warranted at this time. 81 Fed. Reg. 90840. Under amended TSCA Section 8(a)(3)(C), the EPA Administrator, after consultation with the Administrator of the Small Business Administration (SBA), is required to “(i) review the adequacy of the standards prescribed under subparagraph (B); and (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted.”

EPA states in the notice that its preliminary determination is that revisions to currently codified size standards for TSCA Section 8(a) are indeed warranted due to “the magnitude of the increase in the [Producer Price Index (PPI) for Chemicals and Allied Products] since the last revision of the size standards and the current annual sales standard is comparatively low given current revenue-based size standards developed by SBA.”

The need to review and update the definition is long overdue. Stakeholders have been seeking a more appropriate definition for years recognizing that the existing metric is dated and has not kept pace with the passage of time, posing unintended regulatory consequences. EPA is to be commended for its rapid response to yet another new TSCA mandate. Comments must be received on or before January 17, 2017.

EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA: On December 15, 2016, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act. 81 Fed. Reg. 90843. The NRC will implement the amended TSCA Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.” The notice states that the main purpose of the NRC is to conduct discussions in a good faith attempt to reach consensus on proposed regulatory language. The notice provides a clear and comprehensive discussion of the negotiated rulemaking process and procedures, initially identifies specific parties that may be interested in participation, and requests comment on the extent to which the approaches described in the notice are adequate and appropriate. The notice should be carefully reviewed by any entity having an interest in this issue. Comments are due by January 17, 2017. More information is available in our “EPA To Establish Negotiated Rulemaking Committee Under Amended TSCA” blog.

RCRA/CERCLA/CWA/CAA

EPA Issues Final RCRA Generator Improvements Rule: On November 28, 2016, EPA issued the long-awaited final “Generator Improvements Rule” under the Resource Conservation and Recovery Act (RCRA). 81 Fed. Reg. 85732. The potential scope of the revised regulatory program is significant and the changes likely will affect almost 700,000 facilities that generate hazardous waste. The rule represents the most comprehensive overhaul of the RCRA generator requirements in 30 years. The rule is a hodgepodge of over 60 changes to the existing regulations and the inclusion of new requirements for generators of hazardous waste, along with a handful of technical corrections. The changes include a reorganization of the hazardous waste generator requirements in an effort to make them more user-friendly and thus easier for the regulated community to be in compliance. EPA states that the changes also provide a better understanding of how the hazardous waste generator regulatory program works and address gaps in existing regulations that will bolster environmental protection. Additional flexibility for generators is also built into the changes, EPA states. Among other changes, EPA has eliminated the “conditionally exempt small quantity generator” (CESQG) category and replaced it with the “very small quantity generator” (VSQG). The quantity limits for VSQGs remain the same as for CESQGs, but EPA has added additional regulatory provisions to the VSQG requirements. Of the three score of changes, perhaps the most significant change allows VSQGs to send hazardous waste to a large quantity generator (LQG) that is under the control of the same person, provided the waste is consolidated at the LQG before being transported to a RCRA-designated facility. The rule also addresses the issue of “episodic generation,” where a generator’s category could fluctuate based upon the quantity of hazardous waste generated in a calendar month. The rules now allow a VSQG or Small Quantity Generator (SQG) to maintain its existing generator category if an episodic event occurs that would otherwise bump the generator into a more stringent category. The rule also requires periodic re-notification for SQGs every four years; SQGs only notify once under the current federal rules. EPA’s reorganization of the generator rules fall into four broad categories: (1) integrating the 40 C.F.R. Section 261.5 regulations into 40 C.F.R. Part 262; (2) separating the existing regulations at 40 C.F.R. Section 262.34 for SQGs, LQGs and satellite accumulation areas into three new sections; (3) using subtitles in new sections; and (4) incorporating the text of relevant 40 C.F.R. Part 265 regulations into the new sections, rather than merely cross-referencing them, as is the current approach. Other changes in the rule include revising the regulations that address closure, waste determinations, contingency plans, and emergency preparedness and prevention. The rule is effective on May 30, 2017. Most states, however, are authorized to implement the RCRA program in lieu of EPA. In those authorized states, only those provisions of the rule that are more stringent than existing regulations will become effective on May 30, 2017. RCRA-authorized states may choose to not adopt the other standards in the final rule.

EPA Issues Final Rule Increasing Renewable Fuel Volumes: EPA on December 12, 2016, issued a final rule increasing renewable fuel volume requirements across all categories of biofuels under the Renewable Fuel Standard (RFS) program of the Clean Air Act (CAA). 81 Fed. Reg. 89746. In a required annual rulemaking, the rule promulgates in final the volume requirements and associated percentage standards for cellulosic biofuel, advanced biofuel, and total renewable fuel for 2017, and for biomass-based diesel for 2018. Under the rule, non-advanced or “conventional” renewable fuel increases in 2017, meeting the 15 billion-gallon Congressional target for conventional fuels. The standard for biomass-based biodiesel -- which must achieve at least 50 percent lifecycle greenhouse gas emission reductions compared to petroleum-based diesel -- grows by 100 million gallons. The required volume of biomass-based diesel for 2017 is twice that of the minimum Congressional target. Cellulosic biofuel -- which must achieve at least 60 percent lifecycle greenhouse gas emissions reductions -- grows 35 percent over the 2016 standard. The advanced biofuel standard -- comprised of biomass-based diesel, cellulosic biofuel, and other biofuel that achieves at least 50 percent lifecycle greenhouse gas emissions reductions -- increases 19 percent over the 2016 standard. Total renewable fuel volumes grow 1.2 billion gallons from 2016 to 2017, a 6 percent increase. The CAA requires EPA to set annual RFS volume requirements for four categories of biofuels. By displacing fossil fuels, biofuels are part of the nation’s overall strategy to enhance energy security and address climate change. EPA is using the tools provided by Congress to adjust the standards below the statutory targets, but the steadily increasing volumes in the final rule continue to support Congress’s intent to grow the volumes. EPA implements the RFS program in consultation with the U.S. Department of Agriculture (USDA) and the U.S. Department of Energy (DOE). The final rule is effective on February 10, 2017.

EPA To Hold First Public Meeting Of E-Manifest Advisory Board: On January 10-12, 2017, EPA will hold its first public meeting of the e-Manifest Advisory Board. The meeting is open to the public. The purpose of the meeting, according to EPA, is to address critical policy and system development issues that need resolution prior to launching the e-Manifest system. Specifically, the Advisory Board will provide recommendations to EPA on setting and revising user fees for users of the e-Manifest system. The Advisory Board will also advise EPA on system development matters, such as critical functionality needed on the first day of e-Manifest’s implementation and mechanisms to encourage early adoption of e-Manifest once it becomes available to users. Additional information on the meeting is available on-line.

EPA Issues Final Rule Updating CAA Refrigerant Management Requirements: On November 18, 2016, EPA issued a final rule under the CAA revising refrigerant management requirements. 81 Fed. Reg. 82272. The CAA prohibits the knowing release of ozone-depleting substances (ODS) and substitute refrigerants during the maintenance, servicing, repairing, or disposing of appliances or industrial processes that use refrigeration. Existing regulations require that those persons maintaining, servicing, repairing, or disposing of air conditioning and refrigeration equipment containing more than 50 pounds of refrigerant adhere to practices that reduce the potential for releases of ODS. The final rule updates these requirements and extends them to non-ozone depleting substitute refrigerants such as hydrofluorocarbons (HFC). EPA has strengthened the leak repair requirements, revised the recordkeeping standards, and amended other provisions of the existing regulations. The final rule is effective on January 1, 2017.

EPA Adds Subsurface Intrusion To CERCLA Hazard Ranking System: On December 7, 2016, EPA announced a final rule adding subsurface intrusion (also known as vapor intrusion) as a pathway of exposure to be used under the Hazard Ranking System (HRS) to determine whether sites should be added to the National Priorities List (NPL). The HRS is the scoring system EPA uses under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA or Superfund) to determine whether a site warrants NPL listing. Sites with an HRS score of 28.5 or higher are eligible to be listed on the NPL. Subsurface intrusion is the migration of hazardous substances, pollutants, or contaminants from contaminated groundwater or soil into an overlying building. A pre-publication of the final rule is available at http://semspub.epa.gov/src/document/11/190703. The final rule will be effective 30 days from the date of publication in the Federal Register.

EPA Releases Final Report On Impacts From Hydraulic Fracturing Activities On Drinking Water Resources: EPA on December 13, 2016, issued a final report, entitled Hydraulic Fracturing for Oil and Gas: Impacts from the Hydraulic Fracturing Water Cycle on Drinking Water Resources in the United States, on the impacts of hydraulic fracturing (fracking) on drinking water sources. Abandoning its initial and contentious conclusion that fracking has not caused “widespread, systemic” impacts on sources of drinking water, EPA states that fracking activitiescan impact drinking water resources under some circumstances.The report, done at the request of Congress, “provides scientific evidence that hydraulic fracturing activities can impact drinking water resources in the United States under some circumstances.” As part of the report, EPA identified conditions under which impacts from hydraulic fracturing activities can be more frequent or severe. The report also identifies uncertainties and data gaps. These uncertainties and data gaps limited EPA’s ability to assess fully impacts to drinking water resources both locally and nationally. EPA states that its final conclusions are based upon review of over 1,200 cited scientific sources; feedback from an independent peer review conducted by EPA’s Science Advisory Board; input from engaged stakeholders; and new research conducted as part of the study. EPA identified cases of impacts on drinking water at each stage in the hydraulic fracturing water cycle. Impacts cited in the report generally occurred near hydraulically fractured oil and gas production wells and ranged in severity, from temporary changes in water quality, to contamination that made private drinking water wells unusable. EPA also identified certain conditions under which impacts from hydraulic fracturing activities can be more frequent or severe, including:

  • Water withdrawals for hydraulic fracturing in times or areas of low water availability, particularly in areas with limited or declining groundwater resources;
  • Spills during the management of hydraulic fracturing fluids and chemicals or produced water that result in large volumes or high concentrations of chemicals reaching groundwater resources;
  • Injection of hydraulic fracturing fluids into wells with inadequate mechanical integrity, allowing gases or liquids to move to groundwater resources;
  • Injection of hydraulic fracturing fluids directly into groundwater resources;
  • Discharge of inadequately treated hydraulic fracturing wastewater to surface water resources; and
  • Disposal or storage of hydraulic fracturing wastewater in unlined pits, resulting in contamination of groundwater resources.

A fact sheet, frequently asked questions, and other related information are available online.

FDA

FDA Releases Final Guidance For Voluntary Qualified Importer Program: On November 10, 2016, the U.S. Food and Drug Administration (FDA) released its final guidance for industry on its Voluntary Qualified Importer Program (VQIP), a voluntary, fee-based program to allow the expedited review and importation of foods into the United States from importers with a proven track record of food safety and security. Under the Food Safety Modernization Act (FSMA), FDA is required to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains. The final guidance is in question-and-answer format to explain how this program will work. More information on the VQIP is available on FDA’s website. Comments may be submitted at any time.

NANOTECHNOLOGY

Company Announces First REACH Registration Of Single Wall Carbon Nanotubes: On October 13, 2016, OCSiAl announced that it is the first manufacturer of single wall carbon nanotubes to complete Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration. According to OCSiAl, the registration was successfully completed thanks to the collaboration between OCSiAl’s Health and Safety Department, Envigo, and Intertek, which jointly completed the work involved in demonstrating compliance with the standards and requirements of REACH. Envigo’s press release states that scientists at OCSiAl, Envigo, and Intertek collaborated to research and test the potentially hazardous properties of single wall carbon nanotubes. These efforts resulted in a technical and highly detailed analysis of single wall carbon nanotubes and their nature and potential risks, as well as specifications for particular methods of risk management.

Germany Publishes Report On Nanoview Project: On November 15, 2016, the Federal Institute for Risk Assessment (BfR) published a report, in English, entitled Nanoview -- Influencing factors on the perception of nanotechnology and target group-specific risk communication strategies. In 2007, BfR conducted a survey concerning the public perception of nanotechnology. Given the newness of nanotechnology and that large sections of the population did not have any definite opinions or knowledge of it, BfR conducted a follow-up survey, Nanoview, in 2012. Nanoview also included the additional question of which communication measures for conveying risk information regarding nanotechnology are best suited to reach the majority of the population. The report states that, given the findings from the 2007 representative survey, which confirmed gender-specific differences in the perception of nanotechnology, ideal-typical male and ideal-typical female concepts were developed. Focus groups then reviewed and optimized the conceptual considerations. The report concludes that, with regard to the central communication measure, creating an information portal on the Internet appears to be the most meaningful strategy. The information services and content should be prepared and presented to cater to the specific main gender-sensitive requirements and information needs. The report states: “The ideal-typical male concept is geared towards the provision of information on scientific, technical and application-related aspects of nanotechnology, for example. The ideal-typical female concept focuses on the provision of information on application-related aspects of nanotechnology and support for everyday (purchase) decisions.” More information is available in our December 13, 2016, blog item, “Germany Publishes Report on Nanoview Project.”

FDA CDER Identifies Nanotechnology As Area Of Interest For Site Visit Training Program For OPQ Staff: FDA published a Federal Register notice on November 16, 2016, announcing the 2017 Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. 81 Fed. Reg. 80666. According to the notice, “[a] critical part of the commitment by CDER to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and a drug’s commercial life cycle, including the variety of drug manufacturing operations.” The Site Visit Program is intended to offer experiential and firsthand learning opportunities that will provide OPQ staff with a better understanding of the pharmaceutical industry and its operations, as well as of the challenges that impact a drug’s development program and commercial life cycle. CDER invites pharmaceutical companies interested in participating in the Program to submit a site visit proposal. The notice states that while observation of all aspects of drug development and production would be beneficial to OPQ staff, OPQ identified a number of areas of interest to its staff, including emerging technologies such as nanotechnology. Selection of potential facilities will be based on the priorities developed for OPQ staff training, the facility’s current regulatory status with FDA, and on consultation with the appropriate FDA district office. Proposals are due January 17, 2017.

ISO Standard Provides Overview Of Frameworks For Developing OELs And OEBs For NOAAs: On November 21, 2016, the International Organization for Standardization (ISO) released ISO/TR 18637:2016, “Nanotechnologies -- Overview of available frameworks for the development of occupational exposure limits and bands for nano-objects and their aggregates and agglomerates (NOAAs).” ISO notes that occupational exposure limits (OEL) are generally substance-specific. In some case, there is insufficient data to develop an OEL, especially for substances such as nano-objects and their aggregates and agglomerates (NOAA) used in emerging technologies. Under hazard banding, substances are assigned to a hazard band based on limited toxicity data. ISO states that to date, few OELs and occupational exposure bands (OEB) have been developed for specific NOAAs and none have been formally regulated by a government agency. One of the goals of the document is to identify both the similarities and differences in the methods used to develop OELs. ISO notes that the exposure assessment of nanomaterials, including carbon nanomaterials (such as fullerene, graphene, single-walled carbon nanotubes, and multi-walled carbon nanotubes), metal oxides (titanium dioxide, silicon dioxide, zinc oxide, iron oxide), and metals (silver and gold nanoparticles), remains a challenge in the field of occupational hygiene, as there have been relatively few studies on the characterization of workplace exposures to NOAA. The primary target audience of the document is occupational safety and health professionals in government, industry, and academia, who have the expertise to develop OELs or OEBs based on the document’s guidance.

SCCS Opinion On Additional Coatings For Titanium Dioxide (Nano Form) As UV-Filter Available For Comment: On November 22, 2016, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on additional coatings for titanium dioxide (nano form) as an ultraviolet (UV)-filter in dermally applied cosmetic products. SCCS concluded that the use of the three titanium dioxide nanomaterials coated with either cetyl phosphate, manganese dioxide, or triethoxycaprylylsilane can be considered safe for use in cosmetic products intended for application on healthy, intact, or sunburned skin. SCCS notes that this does not apply to applications that might lead to exposure of the consumer’s lungs to the titanium dioxide nanoparticles through the inhalation route (such as powders or sprayable products), however. SCCS states that the ingredients used in some types of products (e.g., in lipsticks) may be incidentally ingested. SCCS cautions that the potential harmful effects of manganese dioxide should, therefore, be taken into account if the manganese dioxide-coated nanomaterials are to be used for applications that could lead to oral ingestion. SCCS may consider revising its assessment if new evidence emerges to show that titanium dioxide nanoparticles used in a sunscreen formulation can penetrate skin (healthy, compromised, or damaged skin) to reach viable cells. SCCS notes that its opinion does not consider the potential ecotoxicological impacts of nanoscale titanium dioxide when released into the environment. Comments on the opinion are due January 17, 2017.

Australian Draft National Standard For The Environmental Risk Management Of Industrial Chemicals Addresses Nanomaterials: On November 24, 2016, the Australian Department of the Environment and Energy began a public consultation on the Draft National Standard for the Environmental Risk Management of Industrial Chemicals and a supporting Draft Explanatory Document. The National Standard will apply to all industrial chemicals, and is intended to fill a gap identified for the environmental management of industrial chemicals. The Draft National Standard categorizes industrial chemicals into one of seven Environment Schedules depending on their level of concern to the environment. Chemicals will be considered to be low, intermediate, or high concern to the environment, and management responses will be proportionate to this level of concern. The Draft National Standard defines a nanomaterial as “a material intentionally produced, manufactured or engineered to have unique properties or specific composition at the nanoscale, that is a size range typically between 1 nm and 100 nm, and is either a nano-object (i.e. that is confined in one, two, or three dimensions at the nanoscale) or is nanostructured (i.e. having an internal or surface structure at the nanoscale).” Chemicals of intermediate concern categorized into Schedule 3 (hazardous, moderate risk substances) would include substances that “have other characteristics that may result in adverse short or long term effects on the environment.” A footnote states that these characteristics are “e.g. nanomaterials, persistent substances that may have adverse effects on the environment as they accumulate such as chemicals exhibiting endocrine activity but are not identified endocrine disruptors, or chemicals with Global Warming Potential.” Comments on the Draft National Standard are due March 3, 2017. More information is available in our November 30, 2016, blog item, “Australian Draft National Standard for the Environmental Risk Management of Industrial Chemicals Addresses Nanomaterials.”

Obama’s Actions To Promote American Entrepreneurship Include Supporting Nanotechnology Industry: On November 30, 2016, the White House published a blog item, “President Obama’s Top Ten Actions to Accelerate American Entrepreneurship,” and posted a fact sheet on President Obama’s entrepreneurship accomplishments. The tenth action is “Unleashed entrepreneurship in the industries of the future, including clean energy, biotechnology, the commercial space industry, nanotechnology, drones, robotics, advanced manufacturing, and more.” The fact sheet lists several National Nanotechnology Initiative (NNI) programs and states that the NNI invested over $150 million per year in user facilities at federal laboratories and universities that provide entrepreneurs low- or no-cost access to state-of-the-art instrumentation. NNI also cumulatively funded more than $700 million of nanotechnology-related research by small businesses. In addition, NNI catalyzed the creation of a Nano and Emerging Technology Student Network and annual conference with a specific goal of promoting entrepreneurship.

NNI Holds Webinar On “Water Sustainability Through Nanotechnology: Increasing Water Availability”: On December 7, 2016, NNI held a webinar on “Water Sustainability through Nanotechnology: Increasing Water Availability.” NNI states that water demand in the U.S. is projected to increase over the next several decades. In addition to increased demand, many U.S. aquifers are being depleted at unsustainable rates, which may lead to increased challenges in locating usable water sources in the future. During the webinar, panelists Qilin Li (Rice University), Isabel Escobar (University of Kentucky), and David Mazyck (University of Florida) described current technologies and future opportunities related to water treatment and purification. The speakers addressed filtration and membrane separation systems, catalysis, and alternatives to reverse osmosis.

ECHA Announces Signed Agreement For EU Observatory For Nanomaterials: On December 7, 2016, the European Chemicals Agency (ECHA) announced the signing of a delegation agreement between ECHA and the EC on the European Union Observatory for Nanomaterials (EU-ON). According to ECHA, the information sources for the EU-ON will include data generated by various pieces of EU legislation regulating the safe use of nanomaterials (e.g., REACH, biocides, and cosmetics), as well as national inventories, research projects, and market studies. ECHA states that in its first phase, the EU-ON “will only collect information that is already available and not generate any new data.” ECHA will develop the EU-ON in three phases. The first phase will explain what nanomaterials are and how they are used. It will also address safety issues and contain links to research projects. ECHA intends the first phase to go live in summer 2017. Later phases include search functionalities and more detailed product information. ECHA notes that the EC concluded that the EU-ON would be the best tool to increase transparency on nanomaterials on the EU market. While the EC considered an EU-wide registry, the EC “considered that such a registry would be too costly for both industry and authorities.”

Draft REACH Guidance Documents For Nanomaterials Move To Next Consultation Step: ECHA announced in its December 14, 2016, ECHA Weekly that the following drafts for updated ECHA guidance on REACH have moved to the next consultation step and been sent to the Member State Committee for review:

ECHA suggests that potential registrants for the 2018 deadline may be interested in viewing the revised draft documents. As reported in our June 9, 2016, blog item, “ECHA Consults PEGs on Nanomaterial Guidance Documents,” the draft guidance documents were first submitted to Partner Expert Groups (PEG) for consultation. ECHA has posted summaries of the comments received from the PEGs, as well as its responses. The final consultation on the guidance documents will be with the EC and the relevant Competent Authorities.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: Bergeson & Campbell, P.C.’s (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 DEVELOPMENTS

House Passes Midnight Rules Relief Act: The House of Representatives on November 17, 2016, passed legislation that would block exiting Administrations from promulgating so-called “midnight regulations” during the last days in power. By a vote of 240-179, lawmakers passed the “Midnight Rules Relief Act” (H.R. 5982). Introduced by Representative Darrell Issa (R-CA), the legislation would amend the Congressional Review Act (CRA) to allow Congress to disapprove regulations that are promulgated in the waning days of an outgoing President’s Administration. The bill specifically amends the CRA to allow Congress to consider a joint resolution to disapprove multiple regulations that federal agencies have submitted for Congressional review within the last 60 legislative days of a session of Congress during the final year of a President’s term. Congress may disapprove a group of such regulations together (i.e., “en bloc”) instead of the current procedure of considering only one regulation at a time. The White House has issued a Statement of Administration Policy threatening to veto the bill if it is presented to President Obama.

Bill Would Require EPA To Update Lead In Drinking Water Regulations: On November 14, 2016, Representative Dan Kildee (D-MI) introduced legislation that would give EPA nine months to update its lead in drinking water regulations. The National Opportunity for Lead Exposure Accountability and Deterrence Act (NO LEAD Act; H.R. 6311) would lower the action level for utilities to alert residents about lead in drinking water. The current action level is 15 parts per billion (ppb). Kildee’s bill would lower that to 5 ppb by 2026. If an individual building tests above the action level, the building resident and the entire population served by the public water supply must be notified within two days. There must be an onsite investigation at the building within ten business days of the testing to determine the scope of the lead issues.

House Passes Hazmat Railroad Bill: The House of Representatives on November 29, 2016, passed the Railroad Emergency Services Preparedness, Operation Needs, and Safety Evaluation (RESPONS) Act (S. 546). The bill amends the Homeland Security Act of 2002 to direct the Federal Emergency Management Agency (FEMA) to establish the Railroad Emergency Services Preparedness, Operational Needs, and Safety Evaluation (RESPONSE) Subcommittee of the National Advisory Council. The RESPONSE Subcommittee would be tasked with developing recommendations for improving emergency first responder training and resource allocation for hazardous materials (hazmat) incidents involving railroads. Topics the Subcommittee would be required to evaluate include the quality and application of training for local emergency first responders related to rail hazmat incidents, with a particular focus on local emergency responders and small communities near railroads; the effectiveness of funding levels related to training local emergency first responders for rail hazmat incidents, with a particular focus on local emergency first responders and small communities near railroads; and the strategy for integrating commodity flow studies, mapping, rail and hazmat databases and other relevant data for local emergency first responders, and increasing the rate of access to the individual responder in existing or emerging communications technology.

MISCELLANEOUS

OSHA Revises Standards For Walking-Working Services: The Occupational Safety and Health Administration (OSHA) on November 18, 2016, issued a 500 page final rule updating its general industry standards on walking-working surfaces. 81 Fed. Reg. 82494. The rule is intended to prevent and reduce workplace slips, trips, and falls. It includes revised and new provisions addressing fixed ladders, rope descent systems, fall protection systems, training on fall hazards, and the use of personal fall protection systems. The rule is effective on January 17, 2017.

DTSC Proposes New Risk Assessment Regulations: The California Department of Toxic Substances Control (DTSC) drafted regulations to add Chapter 51.3 to the California Code of Regulations, under Title 22, Division 4.5. This rulemaking proposes to require that any human health risk screening or risk assessment must use the most protective of the three federal and state accepted toxicity criteria sources for each cancer and non-cancer contaminant of concern for any site in California. DTSC hosted a public workshop on December 12, 2016, to discuss proposed regulations that would specify toxicity criteria for human health risk-based screening levels, action levels, and remediation goals. The workshop is the first step toward beginning the formal rulemaking process in 2017. In addition to this workshop, DTSC has requested interested stakeholders and the public to ask questions or provide feedback on this proposed regulation during this informal review period. Comments will be accepted until January 16, 2017. All comments received before the January 16, 2017, comment period will be considered.

Safer Consumer Products Releases Draft Alternatives Analysis Guide: On December 12, 2016, the Safer Consumer Products (SCP) program released the Draft Alternatives Analysis Guide. The guide will help responsible entities navigate the SCP Alternatives Analysis process and provide useful approaches, methods, resources, tools, and examples of how to fulfill SCP’s regulatory requirements. This guide is SCP’s holistic Alternatives Analysis guidance that covers all phases of the SCP Alternatives Analysis process. You may download and comment on the Draft Alternatives Analysis Guide through the Safer Consumer Products Information Management System (CalSAFER). The comment period will extend until January 20, 2017. Stakeholder input is important to ensure the utility of the Guide. A webinar will be held on January 10, 2017, to learn about and discuss the Draft Alternatives Analysis guide. Visit SCP’s Alternatives Analysis Guide web page for information on the upcoming webinar.

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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