Federal Development Update for October 2018


Register now for our Wednesday webinar -- “Keeping up with FSMA -- Rules, Obligations, and Key Compliance Dates,” October 17, 2018, 1:00 p.m. - 2:00 p.m. (EDT).

With the pending implementation dates of several core elements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), many manufacturers are challenged in addressing efficiently and smartly supply chain complexities. This webinar will help you prepare for the forthcoming deadlines and explain how the intended use of a substance impacts regulatory obligations. The webinar will consist of a 45-minute presentation followed by a 15-minute Question & Answer session. Complimentary registration is available online.

B&C® Consortia Management Fall 2018 Forecast: Regulatory, Testing, And Policy Trends For Chemical Consortia: Now more than ever, chemical industry stakeholders with shared business and advocacy interests are urged to consider collaborating on regulatory, testing, and related advocacy opportunities. Two years post-passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) means the U.S. Environmental Protection Agency (EPA) is well underway with implementation of the amended Toxic Substances Control Act (TSCA). By the end of this year, EPA is required to identify the next set of high priority chemicals subject to prioritization and evaluation under TSCA Section 6. Industry fees assessed by EPA for such evaluation are expected to exceed $1,000,000 per chemical. We anticipate that EPA will soon begin to utilize its expanded testing authorities under TSCA Section 4, which will have its own set of fees that must be paid in addition to the actual testing costs. EPA has expressed repeatedly and clearly in its rulemaking preambles that it anticipates these types of TSCA obligations will be shared collaboratively and addressed by consortia groups.

This year’s B&C® Consortia Management, L.L.C. (BCCM) forecast highlights our groups’ interests and activities on these and other issues that can and should be addressed under a consortia canopy. While we enjoy sharing our success stories, the goal of the forecast is to highlight the critical importance of leveraging resources by sharing the load through organizing groups of interested stakeholders, to summarize activities pertinent to our existing BCCM consortia, and to encourage you to consider allowing us to help with the formation of a new group to address issues of particular interest.

Lynn L. Bergeson, Richard E. Engler, Charles M. Auer, and Kathleen M. Roberts Publish “New Chemicals Under New TSCA—Stalled Commercialization,” in Bloomberg Environment Insights: Bergeson & Campbell, P.C. (B&C®) has written extensively about EPA’s implementation of the 2016 Amendments to TSCA occasioned by enactment of Lautenberg. On the whole, EPA implementation efforts have been timely, balanced, and defensible. Implementation of Section 5 (new chemicals) revisions has been less successful. To date, EPA’s approach has impeded the commercialization of more sustainable new chemical technologies and thus has, ironically, extended the market presence of often less-sustainable legacy chemicals. This article was originally published as a three part series analyzing the implementation of TSCA Section 5 and its impact on chemical innovation.

TSCA/FIFRA/TRI

EPA To Host Best Practices For Ground Application Webinar: On September 20, 2018, EPA announced it would be hosting a webinar titled “Best Practices for Ground Application” on October 25, 2018, from 2:00 p.m. to 3:30 p.m. (EDT). The announcement states that this webinar is tailored for “growers, pesticide applicators, pest management professionals, and other interested stakeholders who work in crop production.” The webinar will be presented by Dr. Greg Kruger, a weed science and application technology specialist from the University of Nebraska-Lincoln and will cover different methods of ground application, best practices for reducing pesticide spray particle drift when using ground application equipment, and a discussion of the optimization of weed control. Registration is available online.

EPA Petitions For En Banc And Panel Rehearing In Ninth Circuit Chlorpyrifos Case: On September 25, 2018, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit), respondents EPA and Acting EPA Administrator Andrew Wheeler (collectively EPA) petitioned for an en banc and panel rehearing concerning the Ninth Circuit’s August 9, 2018, decision that granted judicial review of EPA’s initial order denying an administrative petition by the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) to revoke all tolerances and cancel all registrations for chlorpyrifos, and that specifically directed EPA to revoke all tolerances and cancel all registrations for chlorpyrifos within 60 days. More information regarding the August 9 decision is available in our blog item “Ninth Circuit Directs EPA to Revoke all Tolerances and Cancel All Registrations for Chlorpyrifos.” EPA’s petition for rehearing sets forth three discrete procedural arguments as to why rehearing should be granted. The first argument is that the panel erred because “an initial decision denying an administrative petition under 21 U.S.C. § 346a(d)(4)(A)(iii) is simply not within the jurisdiction of this Court to review ….” EPA contends that the decision to grant judicial review of the initial EPA order, without waiting for EPA to respond to objections or to issue a final order, conflicts with the applicable precedent in both the Ninth Circuit and the U.S. Court of Appeals for the Second Circuit (Second Circuit). More information on chlorpyrifos issues, including further proceedings in this case, is available on our blog under key word chlorpyrifos.

EPA OIG Issues Report Addressing EPA’s Emergency Exemptions: On September 25, 2018, EPA’s Office of Inspector General (OIG) issued a report entitled “Measures and Management Controls Needed to Improve EPA’s Pesticide Emergency Exemption Process” that details the results from its audit done to determine whether EPA has a comprehensive pesticide emergency exemption approval process that maintains environmental and human health safeguards. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 allows EPA to “grant federal and state lead agencies the authority to approve -- in certain emergency situations -- the limited application of a pesticide not registered for that particular use. These short-term pesticide use approvals are called emergency exemptions.” OIG states that the scope of the audit “focused on the emergency exemption management process and the internal controls necessary to consistently implement and administer it.” OIG did not “evaluate the science used to review emergency exemptions or the subsequent emergency exemption application decisions.” OIG’s main criticisms of EPA’s emergency exemption program listed in the report are:

  1. EPA’s Office of Pesticide Programs (OPP) collects human health and environmental data through its emergency exemption application process, including the total acres affected, the proposed and actual quantities of the exempted pesticide applied, and the estimated economic losses but it does not use these data to support outcome-based performance measures that capture the scope of each exemption, to measure the potential benefits or risks of each exemption, or to determine how well the emergency exemption process maintains human health and environmental safeguards.
     
  2. OPP does not consistently communicate emergency exemption information with its stakeholders. OPP previously sent a “year in review” letter to states that summarized the emergency exemption activity for that year and provided additional information regarding the emergency exemption process. OPP has not sent this letter since 2015, however.
     
  3. There were significant deficiencies in OPP’s online database management, in its draft Section 18 emergency exemption standard operating procedure and application checklist, and in its reports to Congress and the Office of Management and Budget (OMB).

More information is available at http://pesticideblog.lawbc.com/entry/epa-oig-issues-report-addressing-epas-emergency-exemptions.

EPA Issues Final TSCA Fees Rule: On September 27, 2018, EPA issued a final fees rule under TSCA. The final rule largely tracks the proposed rule. In its press release, EPA states that the fees collected from chemical manufacturers “will go toward developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and other information; reviewing Confidential Business Information (CBI); and making determinations in a timely and transparent manner with respect to the safety of new chemicals before they enter the marketplace.” The final rule is effective the day after publication in the Federal Register and the fees will apply to all submissions received starting on October 1, 2018. Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees. EPA will host a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The first webinar was held on October 10, 2018. The other webinars will be held on October 24 and November 7, 2018. EPA has posted a pre-publication version of the final rule, as well as its response to public comments on the proposed rule. B&C’s memorandum provides an overview of the final rule with specific information about final fee amounts and timing and a commentary.

EPA Requests Public Nominations For FIFRA SAP; Requests Independent Scientific Advice On Health And Safety Issues: On September 28, 2018, EPA announced it was accepting public nominations of scientific experts to be considered for ad hoc participation on the FIFRA Scientific Advisory Panel (SAP) through membership on the Food Quality Protection Act (FQPA) Science Review Board (SRB). 83 Fed. Reg. 49091. EPA states that “[a]ll nominees will be considered for ad hoc participation providing independent scientific advice to the EPA on health and safety issues related to pesticides” and requests that any individuals nominated have expertise in one or more of the following areas: biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; aquatic modeling; pharmacology; ecological risk assessment; environmental exposure and fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; statistics; water quality monitoring; hydrologist; Geographic Information Systems (GIS) specialist; computational toxicology; entomology; veterinary entomology; medical entomology, insect ecology, allergenicity, research veterinarian; inhalation toxicology; volatile organics; endocrinology, alternative testing methods, high throughput testing approaches, adverse outcome pathways, cross species extrapolation, and systematic review. The Designated Federal Officer to whom nominations should be provided is listed in the Federal Register notice. Nominations are due by November 13, 2018. More information is available in our blog.

EPA Releases Working Approach For Identifying Potential Candidate Chemicals For Prioritization Under TSCA: On October 5, 2018, EPA issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA. 83 Fed. Reg. 50366. EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified pursuant to TSCA Section 6(b)(2)(B). Comments are due by November 15, 2018. The document, “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization,” lays out EPA’s thinking regarding a near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA. The approach document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape that, according to the portion of the TSCA Chemical Substance Inventory (Inventory) that includes the substances designated as active (TSCA Active Inventory), is expected to include over 38,000 chemicals reported as “active” under the TSCA Inventory Notification (Active-Inactive) Requirements final rule. More information is available in our memorandum “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under TSCA.”

EPA OPP Announces PPDC Public Meeting And Biotechnology Seminar: On October 10, 2018, EPA’s OPP announced that it will be holding a public meeting of the Pesticide Program Dialogue Committee (PPDC) on October 31, 2018, from 8:30 a.m. to 5:00 p.m., and on November 1, 2018, from 8:30 a.m. to 12:00 p.m.,there will be an informational seminar on biotechnology-pesticide issues held for stakeholders. 83 Fed. Reg. 50921. The PPDC meeting and informational seminar will be held at 1 Potomac Yard South, 2777 S. Crystal Dr., Arlington, VA, in the lobby-level Conference Center. EPA states that a draft agenda will be posted by October 19, 2018, on EPA’s website.

RCRA/CERCLA/CWA/CAA/SDWA

Court Of Appeals Schedules Oral Arguments In Two CAA Cases: The U.S. Court of Appeals for the District of Columbia Circuit has scheduled oral arguments in two cases involving Clean Air Act (CAA) issues. On September 21, 2018, the court issued an order setting November 7, 2018, as the date for oral argument in a lawsuit brought by environmental groups’ challenge to State Implementation Plans (SIP) monitoring requirements. In Sierra Club v. EPA, et al., environmental petitioners challenged EPA over a 2016 rule revising SIP monitoring requirements and notice and comment procedures related to them. 81 Fed. Reg. 17247 (Mar. 28, 2016). Prior to the 2016 rule, states were required to make their monitoring plans available for public inspection for 30 days. As a result of the rule, states must make these monitoring plans available for public inspection for 30 days and must also accept public comments on those plans and address those comments, as appropriate, in their submissions to EPA. The Sierra Club advocated that both states and EPA use the same public notice and comment requirements for submission and approval of air quality monitoring plans that are required for submittals of SIPs. EPA rejected those comments in the March 2016 rule and environmental groups filed suit, arguing that the rule denies the public the opportunity for full notice and comment on states’ monitoring programs by unlawfully excluding those plans from the scope of formal SIPs. EPA in the case has countered that monitoring plans require SIP revisions under the CAA. In its final brief EPA stated: “For decades, EPA has reviewed and approved State monitoring plans apart from its review and approval of SIP submissions. As such, EPA has not required States’ monitoring plans -- and changes to those monitoring plans -- to go through the same public notice and comment requirements as SIP submissions at both the state and federal level.” The court on September 24, 2018, also scheduled oral argument on December 18, 2018, on litigation related to EPA’s 2015 National Ambient Air Quality Standard (NAAQS) for ozone. In the case, Murray Energy Corp. v. EPA, some states and industry are seeking to repeal the 2015 ozone NAAQS. The current limit is 70 parts per billion (ppb). The petitioners argue that the standard is too stringent and argue for a return to the previous 75 ppb limit.

EPA Expands List Of Acceptable Substitutes Under SNAP Program: EPA on October 4, 2018, expandedthe list of acceptable substitutes under EPA’s Significant New Alternatives Policy (SNAP) program under the CAA. 83 Fed. Reg. 50026. This action is limited to listing as acceptable additional substitutes for use in the refrigeration and air conditioning, foam blowing, fire suppression, cleaning solvents, and aerosols sectors. This action presents EPA’s most recent decision to list as acceptable several substitutes throughout different SNAP end-uses. New substitutes are: R-448A in ice skating rinks (retrofit equipment only); R-449A in ice skating rinks (retrofit equipment only); R-449B in ice skating rinks (retrofit equipment only); R-450A in ice skating rinks (new and retrofit equipment); R–513A in ice skating rinks (new and retrofit equipment); Acetone/isopentane blend in rigid polyurethane and polyisocyanurate laminated boardstock; Powdered Aerosol E in total flooding fire suppression (normally occupied areas); and HFO–1336mzz(Z) in electronics cleaning, metals cleaning, and precision cleaning and aerosol solvents.

EPA Requests Nominations For Drinking Water Contaminant Candidate List: EPA on October 5, 2018, issued a notice requesting nominations of chemical and microbial contaminants, that are not currently regulated, for possible inclusion on the fifth drinking water Contaminant Candidate List (CCL). 83 Fed. Reg. 50364. EPA requests that nominations include information showing the nominated contaminant is known or anticipated to occur in public water systems and indicating the nominated contaminant may require regulation due to the potential for adverse effects on the health of persons. The CCL is a list of contaminants that are currently not subject to any proposed or promulgated national primary drinking water regulations, that are known or anticipated to occur in public water systems, and that may require regulation under the Safe Drinking Water Act (SDWA). EPA uses this list to prioritize research and data collection efforts and help it determine whether to regulate a specific contaminant. The SDWA requires that EPA publish the CCL every five years (Section 1412(b)(1)). The SDWA also requires EPA to determine whether to regulate at least five contaminants from the CCL every five years (Section 1412(b)(1)). To regulate a contaminant, the SDWA specifies that EPA must determine that: the contaminant may have an adverse effect on the health of persons; the contaminant is known to occur, or there is a substantial likelihood that the contaminant will occur, in public water systems with a frequency and at levels of public health concern; and in the sole judgment of EPA, regulation of such contaminant presents meaningful opportunity for health risk reduction for persons served by public water systems. EPA last revised the CCL on November 17, 2016. 81 Fed. Reg. 81099. EPA included 97 chemicals or chemical groups and 12 microbial contaminants. The list includes, among others, chemicals used in commerce, pesticides, biological toxins, disinfection byproducts, pharmaceuticals, and waterborne pathogens. Nominations must be submitted to EPA by December 4, 2018.

EPA Denies CAA Petitions From Delaware And Maryland: EPA on October 5, 2018, denied CAA petitions from Delaware and Maryland seeking action on pollution from upwind states. 83 Fed. Reg. 50444. EPA denied petitions submitted by the two states under CAA Section 126(b). Delaware submitted four petitions requesting that EPA make a finding that emissions from individual sources in Pennsylvania or West Virginia are significantly contributing to Delaware’s nonattainment of the 2008 and 2015 8-hour ozone NAAQS. Maryland’s petition requested that EPA make a finding that emissions from 36 electric generating units in Indiana, Kentucky, Ohio, Pennsylvania, and West Virginia are significantly contributing to ozone levels that exceed the 2008 8-hour ozone NAAQS in Maryland, and, therefore, are interfering with nonattainment and maintenance of the 2008 ozone NAAQS. EPA denied the petitions “based on the best information available to the agency at this time, and particularly in light of an existing regulation already addressing emissions from these facilities: The Cross-State Air Pollution Rule Update for the 2008 ozone NAAQS (CSAPR Update).” EPA’s denial finds that Delaware has not demonstrated that the named sources emit or would emit in violation of the CAA’s “good neighbor” provision. Further, EPA’s independent analysis indicates that the identified sources in Delaware’s and Maryland’s petitions do not currently emit and are not expected to emit pollution in violation of the good neighbor provision for either the 2008 or 2015 ozone NAAQS. The action was effective immediately.

Supreme Court Declines Review Of SNAP Ruling: The Supreme Court on October 9, 2018, declined to review an appellate court decision that largely vacated EPA's rules restricting the use of hydrofluorocarbons (HFC). The court denied certiorari in Mexichem Fluor v. EPA, et al. At issue is a 2015 rule issued by EPA under the CAA’s SNAP. In the rule, EPA limited HFCs in a variety of end uses. The U.S. Court of Appeals for the D.C. Circuit, in a split decision, vacated the rule in August 2017. The Trump EPA has announced its plans to replace the rule with a revised SNAP rule.

FDA

FDA Announces Fees For The Accredited Third-Party Certification Program: On August 30, 2018, FDA announced the fiscal year (FY) 2019 annual fee rate, effective October 1, 2018, for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by FDA’s FSMA. 83 Fed. Reg. 44277. FDA also announced the fee rate for certification bodies that are applying to be directly accredited by FDA.

FDA Requests Comments On Food Contact Substance Notification Program: On September 13, 2018, FDA announced an opportunity for public comment on the information collection associated with the Food Contact Substance Notification Program. 83 Fed. Reg. 46493. FDA is requesting comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility; (2) the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Comments are due by November 13, 2018.

FDA Releases Information For Qualified Facilities Under Preventive Controls Rules: On September 17, 2018, FDA announced the availability of a final guidance for industry: “Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.” 83 Fed. Reg. 46878. This guidance includes answers to frequently asked questions about requirements for qualified facilities that manufacture, process, pack, or hold human food; and requirements for qualified facilities that manufacture, process, pack, or hold animal food, including definitions, calculations to determine status, and examples of calculations to determine market values. FDA’s requirements include the submission of a form to attest to the facility’s status as a qualified facility, and attest that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations. The required attestation forms, Form FDA 3942a for facilities subject to the human food rule, and Form FDA 3942b for facilities subject to the animal food rule, were also released in September, along with instructions on how to fill them out and how they should be submitted. Starting October 1, 2018, FDA states that facilities will be able to submit these attestation forms electronically at https://www.access.fda.gov/ via the Qualified Facility Attestation Module. FDA states also that facilities subject to the human food rule must submit their first attestation to FDA by December 17, 2018, if they began manufacturing, processing, packing, or holding food before September 17, 2018. Facilities subject to the animal food rule must submit their first attestation by December 16, 2019, if they began manufacturing, processing, packing, or holding animal food before September 17, 2019. Beginning in 2020, attestation forms will need to be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.

FDA Solicits Businesses To Volunteer For Two-Tier Inspections: On September 24, 2018, FDA announced that it is soliciting businesses with multiple food processing facilities that implement centrally-developed supply-chain programs and recall plans to volunteer for two-tier inspections. For participating facilities, FDA will assess the adequacy of the supply-chain program and recall plan in a single Tier 1 inspection and then will assess implementation of the supply-chain program and compliance with other applicable requirements during separate Tier 2 inspections. FDA states it will consider the results of this two-tier inspection approach to:

  • Determine the feasibility of using this approach on a broader scale;
  • Develop and refine an internal process for FDA to implement this inspection approach in the future if deemed worthwhile; and
  • Obtain data on inspection efficiency when centrally-developed programs are assessed at one facility rather than at multiple facilities.

The potential benefits of the two-tier inspection approach are:

  • Decreased inspection time in facilities;
  • Improved public health protection by addressing food safety issues across multiple facilities; and
  • Greater opportunities for education, outreach, and communication between FDA food safety staff and industry.

FDA states that businesses that volunteer to be inspected under the two-tier inspection approach should have two or more domestic registered food facilities that are now subject to the preventive controls for the human food rule, and have a required supply-chain program and recall plan that have been centrally-developed. Businesses that satisfy the “Criteria to Participate” and wish to participate in a two-tier inspection approach should send an e-mail expressing their interest to FDA at TwoTierInspections@fda.hhs.gov by October 31, 2018, that includes the names, addresses, and contact persons for each business interested in participating, the facility that would participate in the Tier 1 inspection, the facilities available for Tier 2 inspections, the number of facilities implementing the centrally-developed programs, and the categories or types of products at each facility.

FDA Releases Draft Guidance For Industry On Public Availability Of Lists Of Retail Consignees: On September 27, 2018, FDA announced the availability of a draft guidance for industry and FDA staff, “Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.” 83 Fed. Reg. 48825. The draft guidance, when issued in final, will establish “guidance for industry and FDA staff on how and when FDA intends to collect, compile, and publicize retail consignees that may have received recalled foods.” FDA states that its goal is to “publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.” FDA is requesting comments on the draft guidance by November 26, 2018.

FDA Opens VQIP Application Portal Early: On October 1, 2018, FDA opened the Voluntary Qualified Importer Program (VQIP) application portal, a full three months earlier than originally scheduled, to allow importers to submit their Notice of Intent to Participate and their completed VQIP applications early for the FY 2020 benefit period. FDA held a webinar on September 20, 2018, for importers interested in participating in VQIP. A recording of that webinar is available online.

FDA To No Longer Authorize The Use Of Benzophenone, Ethyl Acrylate, Eugenyl Methyl Ether, Myrcene, Pulegone, And Pyridine As Synthetic Flavoring Substances: On October 9, 2018, FDA announced it was amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. 83 Fed. Reg. 50490. FDA is making this change pursuant to a petition that it is partially granting and partially denying. As to why it is amending its regulations, FDA states:

[It is] taking this action because, despite FDA's scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food.

In terms of its partial denial of the petition, FDA states:

[It is] denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.

Objections and requests for a hearing on the final rule amending FDA’s regulations are due by November 8, 2018.

NANOTECHNOLOGY

EC Publishes Success Story On Controlling Light At The Nanoscale Thanks To Graphene: The European Commission (EC) has published a success story, “Controlling light at the nanoscale thanks to graphene.” The two-year research initiative aims to identify, develop, and demonstrate ways to solve that problem, targeting a solution based on the use of switchable phase change materials to control graphene plasmons with non-volatile, ultrafast, and all-optical switching functionalities.

Germany Publishes Comparison Of Inhalation And Intratracheal Instillation As Testing Methods For Characterization Of Granular Biopersistent Particles: Germany’s Federal Institute for Occupational Safety and Health (BAuA) published a report entitled Comparison of Inhalation and Intratracheal Instillation as Testing Methods for Characterisation of Granular Biopersistent Particles (GBP). More information is available in our September 20, 2018, blog item.

Slides Available From Scientific Workshop On Grouping Of Nanomaterials: On September 12-13, 2018, the Organization for Economic Cooperation and Development (OECD), NanoReg2, and GRACIOUS hosted a “Scientific Workshop: Grouping of Nanomaterials.” The Workshop brought together 120 nanotechnology specialists from Europe, North America, and Asia to discuss a bottleneck in nanomaterials development and testing. The agenda and a number of slides from the workshop have been posted online.

NIOSH Publishes Revised Draft CIB On Health Effects Of Occupational Exposure To Silver Nanomaterials, Will Hold Online Meeting: On September 18, 2018, the National Institute for Occupational Safety and Health (NIOSH) published a Federal Register notice announcing the availability of a draft document entitled Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. 83 Fed. Reg. 47174. According to the notice, the revised draft Current Intelligence Bulletin (CIB) provides an updated scientific literature review of information pertaining to occupational exposure to silver nanomaterials. Based on an assessment of the data, NIOSH developed a recommended exposure limit (REL) for silver nanoparticles (<100 nanometers (nm) primary particle size) of 0.9 micrograms per cubic meter (μg/m3) as an airborne respirable eight-hour time-weighted average (TWA) concentration. The draft REL would apply to processes that produce or use silver nanomaterials. Comments on the draft CIB are due November 30, 2018. NIOSH will hold a public online meeting on October 30, 2018, 1:00 p.m.-4:30 p.m. (ET), or until the last public commenter has spoken, whichever occurs first. More information is available in our September 19, 2018, blog item, “NIOSH Publishes Revised Draft CIB on Health Effects of Occupational Exposure to Silver Nanomaterials, Will Hold Online Meeting.”

OECD Publishes Case Study On Grouping And Read-Across For The Genotoxicity Of Nano Titanium Dioxide: On September 21, 2018, OECD announced four new case studies on integrated approaches for testing and assessment (IATA), including a Case Study on Grouping and Read-Across for Nanomaterials -- Genotoxicity of Nano-TiO2. The European Union (EU) Joint Research Center (JRC) developed the case study for the genotoxicity of nano-titanium dioxide for illustrating the practical use of IATA. Overall, the case study shows the practical application of the ECHA guidance for grouping and read-across of nanomaterials, which was slightly adapted for the case study. Furthermore, the case study states, it demonstrates the usefulness of cheminformatics techniques to support the grouping hypothesis by identifying the differences between nanoforms and by supporting the weight of evidence.

CPSC’s FY 2019 Operating Plan Includes Collaborative Nanotechnology Research Activities: On September 26, 2018, the U.S. Consumer Product Safety Commission (CPSC) will discuss the Fiscal Year 2019 Operating Plan. According to the Operating Plan, in FY 2019, CPSC will continue supporting nanotechnology research and working with other federal agencies under the National Nanotechnology Initiative (NNI) to minimize duplication and overlap of existing research efforts. The Operating Plan states that CPSC intends to establish or maintain three collaborations with other organizations to work on nanotechnology research or issues affecting consumer products and to produce reports on the collaborations. In FY 2019, CPSC intends to release an updated nanotechnology statement. A decisional meeting for the FY 2019 Operating Plan was scheduled to be held October 10, 2018.

EU-OSHA Posts Info Sheet On Manufactured Nanomaterials In The Workplace: On October 3, 2018, the European Agency for Safety and Health at Work (EU-OSHA) published an info sheet on “Manufactured nanomaterials in the workplace.” According to the info sheet, “[t]he requirements for managing nanomaterials in the workplace are the same as those for managing other hazardous chemicals, including the provision of information and training for workers, carrying out risk assessments and taking action to ensure a safe workplace.” The prerequisites for fulfilling these demands are different for nanoparticles than for most other chemicals, however. The info sheet notes that knowledge about the risks associated with nanomaterials is still limited, and “there are no occupational exposure limits (yet) for any nanomaterials, although reference values have been suggested.” Therefore, the info sheet states, the precautionary principle needs to be applied to keep exposure at a level at which the risk can be expected to be under control, even if the nanomaterial should prove to be more hazardous than it is currently known to be. The info sheet gives general, practical advice on how to apply the precautionary principle in managing nanomaterials.

EPA Publishes SNUR For Carbon Nanomaterial (Generic): EPA published on October 3, 2018, a direct final rule promulgating significant new use rules (SNUR) for 26 chemical substances, including carbon nanomaterial (generic), that were the subject of premanufacture notices (PMN). 83 Fed. Reg. 49806. The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. According to the SNUR, the generic (non-confidential) use of carbon nanomaterial (generic) will be in printing applications. EPA states that it identified concerns for pulmonary toxicity and carcinogenicity based on analogy to carbon black. The direct final rule is effective December 3, 2018. Written adverse comments on one or more of the SNURs must be received by November 2, 2018. If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date. In addition to the direct final rule, EPA published a proposed rule on October 3, 2018. 83 Fed. Reg. 49903. Comments on the proposed rule are due November 2, 2018. More information is available in our October 2, 2018, blog item.

NanoReg2 Publishes Grouping And Read Across Article In Nanotechnology: The Nanotechnology Industries Association (NIA) announced on October 5, 2018, that the NanoReg2 project, of which NIA is a partner, has published a comprehensive review of EU legislation addressing chemical substances and the potential for grouping and read across in nanomaterials. The article, “Insights into possibilities for grouping and read-across for nanomaterials in EU chemicals legislation,” considers both the overarching regulation of chemical substances under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and the Classification, Labeling and Packaging of Substances and Mixtures (CLP) regulation, and the sector-specific pieces of legislation for cosmetic, plant protection, and biocidal products, and legislation addressing food, novel food, and food contact materials.

Berlin Declaration On Nanomaterials Submitted To Environment Council Of The Council Of The EU: The Environment Council of the Council of the EU met on October 9, 2018. According to the outcome of the Council meeting, the items debated under any other business included the “Berlin Declaration” on nanomaterials, submitted by the German delegation and supported by the French and Luxembourg delegations. The Berlin Declaration summarizes the conclusions and recommendations of the 12th International Nano-Authorities Dialogue of Germany, Liechtenstein, Luxembourg, Austria, and Switzerland, and was acknowledged by the environment ministers of those countries at their annual meeting in June 2018. The Declaration “acknowledges the progress that has been made in the regulatory framework for nanomaterials in the last few years, and especially the European Commission’s Decision to adapt the annexes of the REACH Regulation to the requirements of nanomaterials. It also sets out the needs identified for further activities in this field, most of which will have to be addressed at EU level.”

EPA Publishes SNUR For Single-Walled Carbon Nanotubes: EPA published on October 10, 2018, a direct final rule promulgating SNURs for 28 chemical substances, including single-walled carbon nanotubes, that were the subject of PMNs. 83 Fed. Reg. 50838. The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. According to the SNUR, the generic (non-confidential) use of the single-walled carbon nanotubes will be as an additive in composite materials for mechanical, thermal, and conductivity improvements. According to the SNUR, based on analysis of analogous carbon nanotubes, EPA identified concerns for pulmonary toxicity, as well as potential toxicity to aquatic organisms if the PMN substance is released to water. The direct final rule will be effective December 10, 2018. Written adverse comments on one or more of the SNURs must be received by November 9, 2018. If EPA receives written adverse comments, it will withdraw the relevant sections of the direct final rule before its effective date. In addition to the direct final rule, EPA published a proposed rule on October 10, 2018. 83 Fed. Reg. 50872. Comments on the proposed rule are due November 9, 2018. More information is available in our October 10, 2018, blog item.

Germany Publishes Study On Health Effects Of Ultrafine Particles: The German Environment Agency (UBA) in October 2018 published a study entitled Health Effects of Ultrafine Particles: Systematic literature search and the potential transferability of the results to the German setting. Prepared on behalf of UBA and the Swiss Federal Office for the Environment, the aims of the study were to review systematically the scientific literature on the health effects of ultrafine particles, to evaluate the quality of the selected studies, and to assess the transferability of the results to the situation in Germany. The search strategy yielded 85 references of original articles. The study states that the evidence on health effects remains inconclusive or insufficient for most of the studied outcomes. The study states that a future challenge is the development of enhanced spatiotemporal models that can contribute to a more precise exposure assessment across larger areas, as well as incorporating multipollutant models to become clear of independent effects.

BIOBASED/RENEWABLE PRODUCTS

BRAG Biobased Products News And Policy Report: B&C consulting affiliate, 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

PFAS Federal Facility Accountability Act Introduced In House: On September 17, 2018, Representative Fred Upton (R-MI) introduced a bill to encourage federal agencies to enter into or amend cooperative agreements with states for the removal and remedial actions to address perfluorinated compounds (PFAS) contamination in drinking water, surface water, ground water, sediment, and soil. The PFAS Federal Facility Accountability Act of 2018 (H.R. 6835) is intended to facilitate the testing, monitoring, removal, and remediation when PFAS compounds are detected in the water and soil. Federal agencies would be required to come up with a plan of action within one year of a request from the state. The bill sets minimum remediation standards for these cooperative agreements. The agreements must require that the contaminated drinking water, surface water, ground water, sediment, or soil meet or exceed each of the following standards, if applicable to the contaminated media:

  • A state standard, requirement, criteria, or limitation, in effect in the state, for drinking water, surface water, ground water, sediment, or soil, identified pursuant to Section 121(d)(2)(A)(ii) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA);
     
  • A health advisory level published pursuant to SDWA Section 1412(b)(1)(F); and
     
  • Any federal standard, requirement, criterion, or limit, including a standard, requirement, criterion, or limit issued under TSCA, SDWA, CAA, the Clean Water Act (CWA), or the Resource Conservation and Recovery Act (RCRA).
     

Senate Subcommittee Holds Hearing On PFAS: The Senate Homeland Security and Governmental Affairs Subcommittee on Federal Spending Oversight and Emergency Management on September 26, 2018, held a hearing entitled “The Federal Role in the Toxic PFAS Chemical Crisis.”Per- and polyfluoroalkyl substances (PFAS) are a group of man-made chemicals that includes perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), and other fluorinated chemicals. EPA maintains a website on general PFAS information. PFAS have been manufactured and used in a variety of industries in the U.S. and elsewhere since the 1940s. PFOA and PFOS have been the most extensively produced and studied of these chemicals. Both chemicals are persistent in the environment and in the human body. There is evidence that exposure to PFAS can lead to adverse human health effects. Witnesses testifying before the Committee were Peter Grevatt, Ph.D., Director of EPA’s Office of Ground Water and Drinking Water; Maureen Sullivan, Deputy Assistant Secretary of Defense, Environment, Safety and Occupational Health, U.S. Department of Defense; Linda Birnbaum, Ph.D., Director, National Institute of Environmental Health Sciences and National Toxicology Program; Brian J. Lepore, Director, Defense Capabilities and Management, U.S. Government Accountability Office; Andrea Amico, Co-Founder, Testing for Pease; Arnolid Leriche, Community Co-Chair, Wurtsmith Restoration Advisory Board; and Timothy Putnam Jr., Vice President, Tidewater Federal Firefighters Local F-25, International Association of Fire Fighters. A webcast of the hearing, member statements, and witness testimonies are available online.

Bill Would Abolish ATSDR: On October 9, 2018, Representative Andy Biggs (R-AZ) introduced a bill that would abolish the Agency for Toxic Substances and Disease Registry (ATSDR). This could be a complicated legislative effort, as ATSDR is authorized under several statutes. ATSDR was created in 1980 under CERCLA. Congress charged ATSDR with implementing the health-related sections of laws that protect the public from hazardous wastes and environmental spills of hazardous substances. As the lead agency within the Public Health Service for implementing the health-related provisions of CERCLA, ATSDR assesses the presence and nature of health hazards at specific Superfund sites, to help prevent or reduce further exposure and the illnesses that result from such exposures, and to expand the knowledge base about health effects from exposure to hazardous substances. The 1984 Hazardous and Solid Waste Amendments (HSWA) to RCRA authorized ATSDR to conduct public health assessments under RCRA. HSWA further authorized ATSDR to assist EPA in determining which substances should be regulated and the levels at which substances may pose a threat to human health. With the passage of the Superfund Amendments and Reauthorization Act (SARA) of 1986, ATSDR received additional responsibilities in environmental public health. This Act broadened ATSDR’s responsibilities in the areas of public health assessments, establishment and maintenance of toxicologic databases, information dissemination, and medical education. The bill, H.R. 7051, was referred to the Energy and Commerce Committee.

Senate Passes Legislation Reauthorizing The SDWA: On October 10, 2018,the Senate passed the America’s Water Infrastructure Act of 2018, which reauthorized the SDWA for the first time in 20 years. The bill provides new funding to state and local governments to improve drinking water infrastructure. It nearly doubles funding for the State Revolving Fund (SRF), from $1 billion to $1.95 billion in 2021, which provides funding to states and localities to improve water infrastructure. The legislation also creates a grant program for replacing leaded drinking water fountains in schools and directs the government to conduct a national inventory of lead service lines and to develop a cost estimate to replace them. Under the bill, water utilities must provide more frequent drinking water quality reports to consumers. The legislation also provides assistance to water utilities to improve resiliency to extreme weather and provides $100 million for grants to extend access to safe drinking water into areas impacted by natural disasters.

MISCELLANEOUS

California DPR Proposes Rule To Designate Chlorpyrifos As A Toxic Air Contaminant: On September 19, 2018, the California Department of Pesticide Regulation (DPR) proposed a regulation to designate chlorpyrifos as a toxic air contaminant (TAC). DPR states that this proposal is being presented “after an extensive period of scientific and public review.” The proposed rule is based on a final evaluation issued in July 2018, in which DPR’s Human Health Assessment (HHA) Branch determined that chlorpyrifos meets the quantitative criteria for designation as a TAC. To make that determination, DPR utilized an inhalation reference concentration (RfC) based on new animal studies with chlorpyrifos that reported neurodevelopmental effects at exposure levels well below the threshold for acetylcholinesterase (AChE) inhibition. More information on DPR’s final TAC evaluation is available in our blog item “California DPR Releases Final Toxic Air Contaminant Evaluation for Chlorpyrifos.” In August 2018, DPR posted the Scientific Review Panel on TAC’s findings on chlorpyrifos and the Director’s Proposed Determination Concerning Chlorpyrifos as a TAC. DPR is providing a 45-day public comment period (until November 9, 2018) on the proposed regulation to list chlorpyrifos as a TAC. Written comments may be submitted to dpr18002@cdpr.ca.gov. In addition, DPR is holding a hearing to receive oral comments on this issue on November 8, 2018, at 2:00 p.m. (PT) at the California Environmental Protection Agency headquarters, 1001 I Street, in Sacramento, California. DPR states that it anticipates that the proposed regulation to list chlorpyrifos as a TAC will be effective in 2019. Even though DPR is proposing to list chlorpyrifos as a TAC, DPR states that “possible mitigation measures to protect human health and the environment will be considered through a subsequent process involving consultation with other state and local agencies including the Office of Environmental Health Hazard Assessment (OEHHA) and the California Air Resources Board (CARB).”

PHMSA Issues First Of Its Kind ICR To Collect Feedback On Service: The Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) on September 21, 2018, issued an Information Collection Request (ICR) seeking to collect qualitative feedback on the services it provides. 83 Fed. Reg. 47969. This is the first time PHMSA has issued such an ICR request. This information collection will be contained in 49 C.F.R. Section 171.6 of the Hazardous Materials Regulations (HMR). PHMSA wishes to garner qualitative customer and stakeholder feedback in accordance with DOT’s commitment to improving service delivery. The ICR defines “qualitative feedback” as information that provides useful insights on perceptions and opinions, not statistical surveys that yield quantitative results that can be generalized to the population of study. This feedback will provide insight into customer or stakeholder perceptions, opinions, experiences, and expectations, as well as an early warning of issues with service or focus attention on areas where communication, training, or changes in operations might improve delivery of products or services, PHMSA states. And it adds that these collections will allow for ongoing, collaborative, and actionable communications between PHMSA and customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program management. Interested persons are invited to submit comments on or before October 22, 2018.

Peter Feldman Appointed As CPSC Commissioner: On September 25, 2018, the U.S. Senate confirmed Peter Feldman, Senior Counsel to the U.S. Senate Committee on Commerce, Science, and Transportation as a Commissioner of the CPSC. Feldman replaces former Commissioner Joseph Mohorovic and will finish out his term, which expires on October 26, 2019. Feldman has also been nominated to serve a seven year term beginning October 27, 2019.Prior to his appointment, Feldman served as a key advisor on consumer product safety, data security, and privacy issues to U.S. Senator John Thune (R-SD), Chair of the Senate Commerce Committee. Feldman received his B.A., cum laude, from Colgate University, and his J.D., cum laude, from American University’s Washington College of Law.

EPA Appears Poised To Eliminate Office Of Science Advisor: The New York Times is reporting that EPA will eliminate the Office of Science Advisor (OSA). According to OSA’s website, OSA “provides leadership in cross-Agency science and science policy development and implementation to ensure the best possible use of science . . . These efforts help ensure regulations are interpreted and enforced in a manner consistent with the science supporting them and strengthen EPA’s overall scientific performance.” The office rests within EPA’s Office of Research and Development (ORD). ORD is currently without a Congressionally-approved Assistant Administrator. Instead, it is led by Acting Assistant Administrator Dr. Jennifer Orme-Zavaleta, who also is EPA’s Science Advisor and heads OSA. Dr. Orme-Zavaleta is an expert on the risks of chemicals to human health and has worked at EPA since 1981, according to EPA’s website. It was unclear whether she would remain at EPA once the decision takes effect. Dr. Orme-Zavaleta stated in a prepared statement that the decision to dissolve OSA would “combine offices with similar functions” and “eliminate redundancies.”

PHMSA/OSHA To Host Two Public Meetings On Harmonizing International Standards On The Transport Of Dangerous Goods: DOT’s PHMSA and the Occupational Safety and Health Administration (OSHA) on November 13, 2018, will host two public meetings on harmonizing international standards for the transportation of dangerous goods. The first meeting -- led by PHMSA -- will solicit public input on current proposals and discuss potential new work items for inclusion in the agenda of the 54th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG). The second meeting -- led by OSHA -- will discuss proposals in preparation for the 36th session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS). Both meetings will be held at DOT Headquarters, 1200 New Jersey Avenue, SE, West Building, Conference Center, Washington, DC 20590. The PHMSA meeting will take place from 9:00 a.m. to 12:00 p.m. and the OSHA meeting from 1:00 p.m. to 4:00 p.m.. Those interested in attending should register for the meetings at https://www.surveymonkey.com/r/XGN8J7X.

EPA OIG Releases Five Year Strategic Plan: EPA’s OIG on October 4, 2018, released its Five Year Strategic Plan. The plan covers the years 2019-2023. OIG will strive to increase its effectiveness by ten percent during the five years addressed by the plan. According to the plan, OIG will focus on three strategic goals.

  • Assist EPA and the U.S. Chemical Safety and Hazard Investigation Board (CSB) with programs designed to help human health and the environment and that enhance safety. (OIG also has jurisdiction over CSB.) To that end, OIG, among other things, will audit and assess EPA’s progress towards reducing the number of areas that fail to meet NAAQS.
     
  • Improve EPA and CSB’s business practices and accountability.
     
  • Work to improve its own methods of allocating resources and systems of accountability.
     

Senate Confirms New AAG For DOJ Environment Division: Some 16 months after he was nominated in June 2017, onOctober 11, 2018, the Senate confirmed Jeffrey Bossert Clark as the new Assistant Attorney General (AAG) for Department of Justice’s (DOJ) Environment and Natural Resources Division (ENRD). The 52-45 vote was largely along party lines. Mr. Clark is a partner in the Washington, D.C. office of Kirkland & Ellis LLP. The White House described him as “a complex trial and appellate litigator with especially deep experience in administrative law, cutting across dozens of statutes and numerous agencies.” Mr. Clark has been with Kirkland since 1996, with the exception of his period of service from 2001 to 2005 when he served as the Deputy AAG for ENRD. While there, he supervised the Appellate Section and the Indian Resources Section. Also during that period, he reviewed, edited, or contributed to virtually every brief ENRD filed in the Courts of Appeals, including several cases of exceptional significance he personally briefed and argued. He also worked on every Supreme Court environmental or natural resource case during this same period.

Amazon Chemicals Policy Includes Restricted Substance List: As part of Amazon’s commitment to responsible sourcing, Amazon has posted its chemicals policy, which includes its first Restricted Substance List (RSL). Amazon states that it defines chemicals of concern as those chemicals that: (1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or (2) are persistent, bioaccumulative, and toxic. Amazon “strategically prioritize[s] which chemicals of concern to focus on based on product type, customer concerns, and the availability of safer alternatives.” The baseline list of chemicals of concern included on the RSL are those chemicals that Amazon seeks to avoid in Amazon-owned Private Brand Baby, Household Cleaning, Personal Care, and Beauty products in the U.S. According to Amazon, it will expand the policy to additional brands, product categories, and geographies over time. Amazon’s Chemical Policy includes the following actions:

  • Reduce Usage of Chemicals of Concern: Amazon encourages manufacturers to phase out potentially hazardous chemistries and adopt green chemistry alternatives, such as those defined in EPA’S Safer Choice Safer Chemical Ingredients List, “which can reduce impacts to human health and the environment.” Amazon states that it began its reformulation efforts towards this goal with Private Brand formulated products because it has the most control over how these products are developed; and
     
  • Enable Transparency: According to Amazon, its transparency efforts are “grounded in the belief that Amazon should provide customers with information that helps them make informed purchasing decisions.” Amazon’s goal is to make product health and sustainability data as easy for customers to access and interpret as price and customer reviews. Amazon states that this is why it is working on website features that will make it easier for customers to access comprehensive information about product ingredients and third-party certifications, including Safer Choice, Made Safe, Green Seal, and Cradle to Cradle. Amazon “hope[s] that making this information more readily available for customers will encourage additional brands to move away from potentially hazardous chemistries in their products and adopt safer chemistries.
     

More information is available in our October 12, 2018, memorandum, “Amazon Chemicals Policy Includes Restricted Substance List.”

ATSDR Requests Comments On Information Collection Project Prenatal Assessment Of Environmental Risk: On September 6, 2018, ATSDR announced it was soliciting comments from the general public and other federal agencies on a proposed and/or continuing information collection project titled “Prenatal Assessment of Environmental Risk (PAER).” 83 Fed. Reg. 45241. ATSDR’s notice states that this web-based data collection will provide information on behavioral risks for environmental exposures for patients seeking preconception and prenatal care, and for their reproductive health care clinicians (RHCC). The notice states that OMB is particularly interested in comments that will help:

  1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
     
  2. Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
     
  3. Enhance the quality, utility, and clarity of the information to be collected;
     
  4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and
     
  5.  Assess information collection costs.
     

Comments are due by November 5, 2018.

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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