Monthly Update for February 2018
Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the first webinar in the Bergeson & Campbell, P.C. (B&C®)/ Bloomberg Environment 2018 Chemical Policy Summit Series. This focused discussion featured Nancy B. Beck, Ph.D., D.A.B.T., Deputy Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP), regarding priorities facing OCSPP, Toxic Substances Control Act (TSCA) implementation issues, and many hot topics in the pesticide area, including Endangered Species Act (ESA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) issues such as glyphosate, pollinators, and much more.
Please make plans now to attend other webinars in our 2018 Chemical Policy Summit Series featuring leading figures from government, industry, and private practice analyzing and advising on pressing chemical policy issues to equip regulatory professionals to succeed in an ever-changing regulatory environment.
|Webinar Topic||Webinar Date|
|FIFRA Hot Topics||April 10, 2018|
1:00 – 2:00 EDT
|TSCA at 2: An Update on Implementation and Hot Topics||June 20, 2018|
1:00 – 2:00 p.m. EDT
|TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules||September 18, 2018|
1:00 – 2:00 p.m. EDT
|Chemical Regulation After the|
Mid-Terms: Who’s In, Who’s Out, and What’s Up?
|December 11, 2018|
1:00 – 2:00 p.m. EST
White House Delays Again Common Rule: On January 22, 2018, the White House again delayed the effective date of revisions to the Federal Policy for the Protection of Human Subjects, referred to as the Common Rule. 83 Fed. Reg. 2885. Final revisions were published on January 19, 2017. On September 8, 2015, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies published a Notice of Proposed Rulemaking (NPRM) proposing revisions to each agency’s codification of the Federal Policy for the Protection of Human Subjects, originally promulgated as a Common Rule in 1991. 80 Fed. Reg. 53931. On January 19, 2017, HHS and other federal departments and agencies published a final rule revising the Federal Policy for the Protection of Human Subjects. 82 Fed. Reg. 7149. The revised policy, referred to as the “2018 Requirements,” were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018, with the exception of the revisions to the cooperative research provisions for which the compliance date is January 20, 2020. After publication of the 2018 Requirements, representatives of industry, including organizations representing recipients of federal human subjects research awards, expressed concern regarding its ability to implement all of the 2018 Requirements by the scheduled general compliance date. Stakeholders requested a delay in the general compliance date of the 2018 Requirements with the exception of certain burden-reducing provisions of the 2018 Requirements, including certain carve-outs from the definition of “research,” exemptions, elimination of the continuing review requirements for certain categories of research, and the elimination of the requirement that institutional review boards (IRB) review grant applications. The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) also recommended in August 2017 that implementation of the 2018 Requirements should be delayed. The new effective date is July 19, 2018. Comments are due by March 19, 2018.
EPA Releases 2016 TRI National Analysis: On January 30, 2018, the U.S. Environmental Protection Agency (EPA) announced the publication of the 2016 TRI National Analysis, EPA’s summary and interpretation of the most recent data on chemical releases and pollution prevention activities at more than 21,000 U.S. industrial facilities. The report shows a continued decline in the releases of Toxic Release Inventory (TRI) chemicals through the implementation of pollution reduction activities. Local and national data on TRI chemical releases to air, water, and land, and information about what companies are doing to prevent these releases are available in the analysis.
EPA Makes Available For Comment The Integrated Risk Information System (IRIS) Assessment Plan For Uranium: On January 31, 2018, EPA announced a 30-day public comment period associated with release of the draft IRIS Assessment Plan for Uranium. 83 Fed. Reg. 4479. The document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program’s initial problem formulation activities. Specifically, the Assessment Plan outlines the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. EPA is releasing this draft IRIS Assessment Plan for public comment at least 60 days in advance of a public science webinar planned on March 22, 2018. Comments must be received on or before March, 2, 2018.
EPA Signs MOA On ESA; Establishes Interagency Working Group: On January 31, 2018, Administrator Pruitt announced the establishment of an Interagency Working Group to Coordinate ESA Consultations for Pesticide Registrations and Registration Review. EPA, the U.S. Fish and Wildlife Service, (FWS) and the National Marine Fisheries Service (NMFS) (the Services) signed a Memorandum of Agreement (MOA) on the establishment of the working group. The stated purpose of the working group is that it “will provide recommendations to EPA, FWS, and NMFS leadership on improving the [ESA] consultation process for pesticide registration and registration review (‘pesticide consultation process’) and will ensure that the new process is recorded and formalized as appropriate.” More information is available in our Pesticide Law and Policy Blog®.
EPA Announces Public Teleconference Of Science Advisory Board Chemical Assessment Advisory Committee: On February 1, 2018, EPA Science Advisory Board (SAB) Staff Office announced a public teleconference of the SAB Chemical Assessment Advisory Committee (CAAC) augmented for the review of two EPA draft assessments: Toxicological Review for Ethyl Tertiary Butyl Ether (ETBE) (External Review Draft, dated June 2017); and Toxicological Review of tert-Butyl Alcohol (tert-butanol or tBA) (External Review Draft, dated June 2017) (CAAC augmented for ETBE/tBA Panel or Panel). 83 Fed. Reg. 4654. The Panel will meet to discuss its draft peer review report regarding the two EPA draft assessments. The public teleconference will be held on two dates: Thursday, March 22, 2018, from 9:00 a.m. to 12:00 p.m. (Eastern time) and Tuesday, March 27, 2018, from 2:00 p.m. to 4:00 p.m. (Eastern time).
EPA Releases Guidance On Reduced Residue Chemistry Data Requirements For Seed-Treatment Uses: On February 1, 2018, EPA announced it is publishing new guidance that sets forth a tiered approach intended to help manufacturers and EPA determine when the number of field trials necessary to register seed treatment uses can be reduced. In its memo and attached Seed-Treatment Focus Group (STFG) Guidance Document dated January 26, 2018, EPA states that its Health Effect Division (HED) has received “multiple waiver requests for seed-treatment field-trial residue data and has reviewed multiple field-trial datasets that indicated that there was the potential to reduce the number of field trials required to support the registration of seed-treatment uses.” EPA states that to evaluate this hypothesis, the HED Chemistry Science Advisory Council (ChemSAC), in collaboration with the Health Canada Pest Management Regulatory Agency (PMRA), in accordance with the July 11, 2017, Joint Canada/United States Field Trial Requirements “performed a retrospective analysis of all seed-treatment residue data that have been submitted to EPA/PMRA and has developed a tiered approach for determining if current crop-specific field trial data requirements are required to support new seed-treatment uses, or if a reduction in the number of required field trials is appropriate.” EPA’s announcement states that “the analysis showed that the data required to support registration could be substantially reduced and still be protective of human health.” EPA developed two decision trees detailing the process for determining the residue chemistry field trial data requirements for seed-treatment uses: one for potato seed-piece (PSP) treatments only and another one for all remaining crops. EPA states that this case study demonstrates that application of the guidance set forth in these decision trees can, for both manufacturers and the Agency, “potentially save considerable resources in terms of conducting, submitting, and reviewing the studies while still obtaining the data necessary to support seed-treatment pesticide registrations.” More information is available in our blog.
NAS Ad Hoc Committee Reviews IRIS Advances: On February 1-2, 2018, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NAS) convened a workshop to review advances made to EPA’s IRIS process. Specifically, at EPA’s request, the committee was tasked with assessing changes that have been implemented or that are planned to be implemented in response to recommendations made in previous NAS reports, such as Review of EPA’s IRIS Process issued in 2014 and Review of EPA’s Draft IRIS Assessment of Formaldehyde issued in 2011. The workshop materials are available on NAS’ website. They include an overview of NAS’ review and ten posters prepared by EPA, among other materials. EPA included the following posters:
- Poster 1: New Approach Methods in Human Health Risk Assessment;
- Poster 2: Systematic Evaluations of Physiologically-Based Pharmacokinetic Models for Human Health Risk Assessment;
- Poster 3: Male reproductive toxicity in epidemiology studies of phthalates: a case study application of systematic review approaches;
- Poster 4: Male reproductive toxicity in animal studies of diisobutyl phthalate (DIBP): a case study application of systematic review approaches;
- Poster 5: Mode of action and human relevance evaluation of Dibutyl Phthalate (DBP)-induced male reproductive system toxicity;
- Poster 6: Evidence profile table for DIBP and male reproductive toxicity;
- Poster 7: Quantitative Evaluation of Uncertainty: APROBA and Beyond;
- Poster 8: EPA Dose-Response & Related Software — New & Future Developments;
- Poster 9: Combining data within species: Meta-analysis in IRIS; and
- Poster 10: A New Bayesian Approach to Combining Different Species Data.
EPA Issues Final Rule On Formaldehyde Emission Standards For Composite Wood Products Under TSCA: On February 7, 2018, EPA issued a final rule on Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products that will revise the formaldehyde standards for composite wood products regulations. 83 Fed. Reg. 5340. The revision updates the incorporation by reference of multiple voluntary consensus standards originally published in the TSCA Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016, that have been updated, superseded, or withdrawn, and provides a technical correction to allow panel producers to correlate their approved quality control test method to the ASTM E1333-14 test chamber, or, upon showing equivalence, the ASTM D6007-14 test chamber. EPA withdrew its direct final rule to update voluntary consensus standards for composite wood products in December 2017 due to its receipt of adverse comment on the rule. The final rule was effective immediately.
Administrator Pruitt Signs TSCA User Fee Proposal: On February 8, 2018, EPA announced a proposed rule regarding TSCA user fees. As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” EPA states in its press release that these fees “would 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.” Publication of the proposed rule in the Federal Register will begin a 60-day comment period. EPA has posted a pre-publication version of the proposed rule. More information is available on our website.
EPA Releases Additional Approach For Assigning And Applying “Unique Identifiers”: On February 8, 2018, EPA announced it is releasing for comment a third alternative approach for assigning and applying unique identifiers (UID) to reconcile the competing requirements of TSCA Section 14(g). 83 Fed. Reg. 5623. EPA’s first and second alternative approaches were released for comment in its notice on May 8, 2017 (82 Fed. Reg. 21386). Under amended TSCA, EPA is required to develop a system to assign a “unique identifier” whenever it approves a CBI claim for the specific chemical identity of a chemical substance, to apply this UID to other information concerning the same substance, and to ensure that any non-confidential information received identifies the chemical substance using the unique identifier while the specific chemical identity of the chemical substance is protected from disclosure. Under the third alternative approach, EPA would assign one UID per chemical substance. EPA states that in most cases it would apply the UID to all non-confidential information concerning the same chemical substance from any company except in cases where doing so might reveal the identity of a confidential substance. In those cases, which EPA expects to be rare, EPA would not apply the UID to non-confidential documents if doing so would result in a linkage that undermines the CBI claim. EPA reiterates that the basic criterion for application of the UID to submissions made by different submitters is that EPA’s act of applying the UID must not disclose to the public the confidential specific chemical identity that the UID was assigned to protect. Comments and materials must be submitted to the docket on or before March 12, 2018.
EPA Notices Intent To Submit ICR On FIFRA Adverse Effects Reporting: On February 8, 2018, EPA announced that it is planning to submit an information collection request (ICR), “Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2)” (EPA ICR No. 1204.13, OMB Control No. 2070-0039), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. 83 Fed. Reg. 5625. EPA states that information submitted under FIFRA Section 6(a)(2) “provides an important means of focusing EPA attention on key problem areas regarding the use of a particular pesticide.” EPA states that since the last ICR was approved, it is increasing by 71,778 hours the total estimated respondent burden compared with the ICR currently approved by OMB. This increased estimate is based in part on the number of Section 6(a)(2) submissions, which EPA expects to increase by 16 percent from 93,000 in the last ICR approval to approximately 108,000 for this ICR renewal. According to EPA, the increase is “due to EPA’s revised expectations regarding the number of incident reports that will be submitted to the Agency, which reflects historical information on the number of responses received.” EPA seeks public comments on the proposed ICR by April 9, 2018. More information is available in our blog.
EPA Withdraws “Once-In-Always-In” Policy Under The Clean Air Act: EPA on January 25, 2018, issued a memorandum rescinding its so-called “once-in-always-in” policy under the Clean Air Act (CAA). The withdrawal was published in the Federal Register on February 8, 2018. 83 Fed. Reg. 5543. Under this policy, EPA maintained that once a facility is subject to Maximum Achievable Control Technology (MACT) standards under the CAA, it remains subject to the standards, even if it lowers its emissions below the levels that triggered the standards in the first place. The original policy was first articulated by EPA in a May 1995, memorandum. EPA stated that “facilities that are major sources for HAP [Hazardous Air Pollutant] . . . are required to comply permanently with the MACT standard.” See “Potential to Emit for MACT Standards — Guidance on Timing Issues.” John Seitz, Director, Office of Air Quality Planning and Standards, EPA (May 16, 1995). In the January 25, 2018, memorandum, however, EPA explains that the 1995 policy “is contrary to the plain language of the CAA, and, therefore, must be withdrawn.” EPA further explained that Congress expressly defined the terms “major source” and “area source” in CAA Section 112(a), in unambiguous language. The 1995 policy violated those definitions by regulating area sources as major sources, EPA concluded. Accordingly, EPA has now determined that a major source that takes an enforceable limit on its potential to emit (PTE) and takes measures to bring its HAP emissions below the applicable threshold becomes an area source, no matter when the source may choose to take measures to limit its PTE. “That source, now having area source status, will not be subject thereafter to those requirements applicable to the source as a major source under CAA section 112, including, in particular, major source MACT standards- so long as the source’s PTE remains below the applicable HAP emission thresholds,” EPA states.
EPA Eases Requirements Under Off-Site Waste And Recovery Operations NESHAP: EPA on January 29, 2018, issued a final rule amending the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Off-Site Waste and Recovery Operations (OSWRO). 83 Fed. Reg. 3986. The revisions address continuous monitoring on pressure relief devices (PRD) on containers. This issue was raised in a petition for reconsideration to the 2015 revisions to the NESHAP, which were based on the residual risk and technology review (RTR). Among other things, the 2015 amendments established additional monitoring requirements for all PRDs, including PRDs on containers. For PRDs on containers, these monitoring requirements were in addition to the inspection and monitoring requirements for containers and their closure devices already required by the OSWRO NESHAP. EPA’s January 28, 2018, final rule removes the additional monitoring requirements for PRDs on containers that resulted from the 2015 amendments because EPA determined that they are not necessary. EPA states that this action does not substantially change the level of environmental protection provided under the OSWRO NESHAP, but reduces burden to this industry compared to the current rule by $28 million in capital costs related to compliance, and $4.2 million per year in total annualized costs. The revisions were effective on January 29, 2018.
“Waters Of The U.S.” Judicial And Regulatory Developments Leave Window For Uncertainty: The past month has brought a number of developments in the federal courts and at the agency level relating to the ongoing controversy over the EPA’s and U.S. Army Corps of Engineers’ (Corps) efforts to redefine “Waters of the U.S.” (WOTUS) under the Clean Water Act (CWA). Over the coming weeks, these actions may create some confusion and uncertainty for states and the regulated community about which WOTUS definition EPA and the Corps must adhere to once a nationwide judicial stay of the 2015 WOTUS rule is dissolved.
In 2015, EPA and the Corps issued the WOTUS rule, also known as the Clean Water Rule (CWR), which re-defined WOTUS for the purposes of clarifying the boundaries of CWA jurisdiction over the nation’s rivers, streams, and wetlands. Dozens of industry and environmental groups, and over 30 states brought challenges to the rule in various federal district and appellate courts. The U.S. Court of Appeals for the Sixth Circuit stayed implementation of the final rule nationwide shortly after it went into effect in late 2015. Litigation has yet to reach the merits of the final rule in large part due to a dispute over the threshold issue of whether the federal district or appellate courts have jurisdiction to review the rule. The CWA includes a judicial review provision at Section 509, which enumerates seven categories of agency actions under the CWA that must be challenged in U.S. Circuit Courts of Appeal. On January 22, 2018, the U.S. Supreme Court held unanimously that a rule redefining WOTUS does not meet any of the Section 509 criteria, and therefore legal challenges should be heard in the district court. The Court’s official remand to the Sixth Circuit will occur by February 16, 2018, at which time the Sixth Circuit will be forced soon after to dismiss the matter and effectively dissolve the nationwide stay of the rule that has prevented any implementation to date. It is expected that litigants are preparing to revive petitions challenging the 2015 rule in various district courts and will file requests for an immediate nationwide stay. In 2015, a North Dakota District Court granted a stay of the final rule that prevented implementation in the 13 states that were party to that action, which will continue to cover those states if and when a nationwide stay is lifted.
Meanwhile, on February 6, 2018, EPA and the Corps published a final “applicability date” rule in the Federal Register that will delay any applicability of the 2015 WOTUS definition until 2020. 83 Fed. Reg. 5200. The applicability date rule complements the EPA/Corps ongoing two-step rulemaking process to rescind and replace the 2015 WOTUS rule. Given the potential for regulatory uncertainty when the nationwide judicial stay is no longer in place, EPA/Corps promulgated this rule to provide a two-year grace period where the rule would not apply. The recent rule does not create any new regulatory obligations; rather, it amends the text of the Code of Federal Regulations to add a February 6, 2020, applicability rule. This delay would maintain the regulatory status quo and provide more time for EPA and the Corps to propose and finalize a replacement WOTUS rule. Attorneys general from ten states and the District of Columbia, however, filed an immediate action on February 7, 2018, challenging the applicability date rule. The state petitioners could seek to enjoin the applicability date rule nationwide; blocking the delay.
Activity in the courts and at the agency level will continue to evolve rapidly over the very near term. The regulatory community should closely follow developments that could allow an opening for the 2015 WOTUS rule to be arguably in effect for a brief period of time until the rule is expected to be halted once more by a federal district court. Although the threat of regulatory uncertainty may be looming, the Supreme Court’s unanimous ruling ultimately resolves a long-standing debate over which courts should review the WOTUS rule and any future equivalent rules that define the scope of CWA jurisdiction. This will expedite any future litigation over a replacement WOTUS rule as parties will not have to first engage in a protracted fight about where to have the fight before getting the merits of the rule itself. EPA/Corps have suggested they are on track to publish a proposed replacement WOTUS rule for public notice-and-comment sometime in spring/summer 2018. More background on the EPA/Corps two-step rulemaking is available in this B&C blog post.
EPA Expands RCRA Exemption For Certain Treated Railroad Ties: EPA on February 7, 2018, issued a final rule expanding the types of treated railroad ties that qualify as non-hazardous secondary materials (NHSM) when burned for energy recovery. 83 Fed. Reg. 5317. The rule classifies Processed creosote-borate, copper naphthenate, and copper naphthenateborate treated railroad ties, under certain conditions depending on the chemical treatment, to the list of NHSM. The rule means that these railroad ties may be burned as a fuel without triggering Resource Conservation and Recovery Act (RCRA) hazardous waste requirements. Copper naphthenate-borate and/or copper naphthenate railroad ties can be combusted as non-waste fuels in units designed to burn biomass, biomass and fuel oil, or biomass and coal. Railroad ties containing creosote, including creosote-borate or any mixtures of ties containing creosote, borate, and copper naphthenate, must be burned in combustion units that are designed to burn both biomass and fuel oil to qualify as a NHSM. The rule was effective February 7, 2018.
FDA Issues Five Guidance Documents Under FSMA: On January 24, 2018, the U.S. Food and Drug Administration (FDA) issued five guidance documents to help importers and food producers meet key food safety provisions mandated by the FDA Food Safety Modernization Act (FSMA). The five guidance documents are:
- Draft Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Guidance # 1);
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide (Guidance # 2);
- Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 (Guidance # 3);
- Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry (Guidance # 4); and
- Guidance for Industry: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs (Guidance # 5).
FDA states that Guidances # 1 and # 2 are meant to help industry meet the requirements of the Foreign Supplier Verification Programs (FSVP) regulation. Guidance # 1 provides FDA’s current thinking on how best to comply with the FSVP requirements; and Guidance # 2 offers specific guidance to small businesses. Guidance # 3 addresses the term “same level of public health protection” that is used in both the FSVP regulation and the Produce Safety regulation and aims to provide a framework for determining the adequacy of a process, procedure, or other action intended to provide the same level of protection as those required under the FSMA regulations for produce and for human or animal food. Guidance # 4 is another chapter in the draft guidance that FDA has been issuing to help food processors and manufacturers comply with the regulation implementing FSMA’s requirements for hazard analysis and risk-based preventive controls for human food. It is designed to help food facilities comply with the supply-chain program requirements of that regulation. Guidance # 5 announces FDA’s intention to exercise enforcement discretion with regard to the application of the FSVP regulation to certain importers of grains brought into the United States as raw agricultural commodities (RAC). FDA states that this enforcement discretion is meant to better align the FSVP rule with the exemption for non-produce RACs under the Preventive Controls (PC) rules.
DOJ Issues Policy Prohibiting Using Civil Enforcement Authority To Convert Agency Guidance Documents Into Binding Rules (Big News For FDA): On January 25, 2018, the U.S. Department of Justice (DOJ) issued a new policy entitled Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases, that prohibits DOJ components from “effectively bind[ing] the public without undergoing the notice-and-comment rulemaking process.” Under the guidance policy, DOJ may not:
- Issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch;
- Create binding standards by which [DOJ] will determine compliance with existing statutory or regulatory requirements; or
- Use its guidance documents to coerce regulated parties into taking any action or refraining from taking any action beyond what is required by the terms of the applicable statute or lawful regulation.
Further, DOJ “should not treat a party’s noncompliance with an agency document as presumptively or conclusively establishing that the party violated the applicable statute or regulation … [t]hat a party fails to comply with agency guidance expanding upon statutory or regulatory requirements does not mean that the party violated those underlying legal requirements; agency guidance documents cannot create any additional legal obligations.”
This policy is further confirmation that past approaches to expanding regulations through guidance will not be grounds for enforcement action. The policy states “[g]uidance documents cannot create binding requirements that do not already exist by statute or regulation.” The impacts of the policy, specifically on FDA, will prove interesting. FDA has a long standing practice of producing guidance to “clarify” what is not stated or not clearly stated in a statute. FDA relies heavily on guidance as a mechanism for product approval and often cites guidance in Warning Letters. DOJ’s policy could impact how enforcement actions from FDA are addressed in the future.
FDA Announces Launch Of FSMA Webpage And Produce Safety Rule Webpage: On January 26, 2018, FDA announced the launch of its new FSMA webpage and its new Produce Safety Rule webpage, resources that FDA is providing stakeholders with to access more easily information and resources about the FDA FSMA to help them comply with the rules. The FSMA webpage contains links to rules and related programs; guidance documents; training and technical assistance; compliance and implementation tools; background information; and the Act’s impact on public health. FDA states the Produce Safety Rule webpage has been updated with the most current information on the rule’s requirements, compliance dates, training, technical assistance, and other resources.
FDA Announces New Steps In Oversight Of Imported Foods: On January 31, 2018, FDA made two announcements regarding two aspects of its oversight of imported foods:
- FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by the FSMA, the ANSI-ASQ National Accreditation Board (ANAB), an organization jointly owned by the American National Standards Institute (ANSI), and the American Society for Quality (ASQ) based in Milwaukee, Wisconsin. FDA states this organization is being recognized because it met the applicable FDA requirements, validated through application review and on-site assessment.
- FDA has launched the Voluntary Qualified Importer Program (VQIP), a voluntary fee-based program that offers expedited review and entry of human and animal food into the United States. Importers interested in participating in the VQIP will be required to meet a number of eligibility requirements, which include ensuring the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program.
FDA states that these programs are additional tools it is using “to help ensure that foods imported into the United States are produced in accordance with the same safety standards required of food produced domestically.”
FDA Releases 2017 Edition Of The FDA Food Code: On February 12, 2018, FDA announced the release of the 2017 edition of the FDA Food Code, a “model regulation that provides all levels of government and industry with practical, science-based guidance and manageable provisions for reducing the known risks of foodborne illness.” The 2017 Food Code provides uniform standards for retail food safety, eliminates redundant processes for establishing food safety criteria, and establishes a more standardized approach in controlling food safety hazards within a retail environment. Significant changes to the 2017 Food Code include the following:
- A revised requirement for the Person in Charge (PIC) to be a Certified Food Protection Manager (CFPM) (Section 2-102.12);
- The addition of a new section that addresses the use of bandages, finger cots, or finger stalls (Section 2-401.13);
- Harmonized cooking time/temperature parameters for intact and non-intact meat and poultry in accordance with guidance from the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) (Section 3-401.11); and
- Updated procedures for retail food establishment operations to continue during an extended water or electrical outage if a written emergency operation plan has been pre-approved by the Regulatory Authority, immediate corrective action taken and the Regulatory Authority has been notified upon implementation of the plan (Section 8-404.11).
ECHA Management Board Reviews Strategy On Substances In Nanoforms: During its December 14-15, 2017, meeting, the Management Board of the European Chemicals Agency (ECHA) discussed ECHA’s strategy on substances in nanoforms. In the strategy, ECHA states that in the current situation, it “cannot effectively and systematically verify whether safe use of nanomaterials in the supply chain is demonstrated, and whether additional regulatory risk management measures are needed.” The preliminary conclusions for the meeting state that the Management Board welcomed ECHA’s progress and invited the European Commission (EC) “to conclude as a matter of urgency the revision of the annexes to REACH on the information requirements of nanomaterials.”
EFSA Publishes Safety Assessment Of Selenium Nanoparticles For Use In Active FCMs: The European Food Safety Authority (EFSA) Panel on Food Contact Materials, Enzymes, Flavorings, and Processing Aids evaluated food contact material (FCM) Substance No. 1070, which incorporates selenium nanoparticles into the adhesive middle layer of multilayer laminates. The results of the Panel’s evaluation are published in the January 2018 issue of the EFSA Journal in an article entitled “Safety assessment of the active substance selenium nanoparticles, for use in active food contact materials.” The article states that taking into account current knowledge on the diffusional properties of nanoparticles in polymers, the Panel concluded “there is no safety concern for the consumer if selenium nanoparticles are used in multilayer films and separated from the food by a polyolefin food contact layer for any type of food and under any food contact conditions.”
Belgium Modifies Royal Decree Regarding The Placement On The Market Of Substances Manufactured At The Nanoscale, Requires Registration Of Mixtures: Belgium published in the January 15, 2018, Official Gazette an amendment to the Royal Decree regarding the placement on the market of substances manufactured at the nanoscale. Under the amendment, cosmetic products as defined by the July 2012 Belgian Royal Decree on cosmetic products are exempt from registration, and provisions regarding the registration of mixtures entered into force on January 1, 2018. More information is available in our January 29, 2018, blog item.
NIOSH Will Use Experience In Managing Engineered Nanomaterials To Address Advanced Manufacturing: Charles Geraci, PhD, CIH, FAIHA, Associate Director for Nanotechnology and Advanced Materials at the National Institute for Occupational Safety and Health (NIOSH), and Laura Hodson, MSPH, CIH, FAIHA, Coordinator of the NIOSH Nanotechnology Research Center, co-authored an article entitled “From ‘Just in Time’ to ‘Just Next Door’: 21st-century Manufacturing Challenges and Opportunities for Industrial Hygienists.” The article recommends that the industrial hygiene community keep pace with the changes in processes and the continued introduction of new and more active materials, and leverage resources with others who have greater expertise. NIOSH “will continue to utilize knowledge gained from promoting responsible development of nanomaterials as it seeks to promote responsible development of 21st-century manufacturing.”
NNI Will Hold Meetings In 2018: The Office of Science and Technology Policy published a Federal Register notice on January 23, 2018, announcing that the National Nanotechnology Coordination Office, on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science and Technology Council, “will facilitate stakeholder discussion of targeted nanotechnology topics through workshops, webinars, and Community of Interest meetings between the publication date of this Notice and December 31, 2018.” 83 Fed. Reg. 3193. Meeting information will be posted on the National Nanotechnology Initiative (NNI) website.
French NGO Claims Many Manufacturers Fail To Comply With Nano Labeling Requirement: UFC-Que Choisir, a French non-governmental organization (NGO), announced on January 23, 2018, that it filed complaints against nine manufacturers of food and cosmetic products for failure to comply with the requirement to report the presence of nanomaterials on the product label. In addition to the complaints filed, UFC-Que Choisir requests that the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes and the Ministry of Economy publish a list of food and cosmetic products containing nanomaterials that fail to meet the labeling requirement, prosecute manufacturers that violate the labeling requirement, and continue to monitor compliance.
EC Committee Publishes Final Opinion On Titanium Dioxide (Nano Form) As UV-Filter In Sprays: The Scientific Committee on Consumer Safety (SCCS) published on January 24, 2018, its final opinion on titanium dioxide (nano form) as an ultraviolet (UV)-filter in sprays. SCCS reviewed data submitted by industry in July 2015 and concluded that “the information provided is insufficient to allow assessment of the safety of the use of nano-TiO2 in spray applications that could lead to exposure of the consumer’s lungs.” The final opinion states that the submission “also does not provide adequate toxicological evaluation of nano-TiO2 relevant to the inhalation route, which would allow deriving a point of departure for the safety evaluation using worst-case assumptions.” SCCS notes that it has been made aware by the applicant’s new submission that there are already sprayable products on the market containing nano forms of titanium dioxide. SCCS cautions that “[s]uch uses need to be carefully evaluated so that the chance of harmful effects through consumer’s lung exposure by inhalation is avoided.”
NIOSH Final Research Agenda For Manufacturing Addresses Nanomaterials: NIOSH published a Federal Register notice on January 31, 2018, announcing the availability of the final National Occupational Research Agenda for Manufacturing. 83 Fed. Reg. 4484. The final Agenda includes the following objectives that reference nanomaterials:
- Objective 1: Reduce the burden of acute and chronic occupational illnesses, injuries, and fatalities in manufacturing by: (a) enhancing knowledge of occupational safety and health hazards and their effects; and (b) developing effective interventions to reduce exposure to known occupational safety and health hazards. The final Agenda states: “Exposure to hazards associated with repetitive hand-intensive work, manual material assembling and handling, nanomaterials, excessive noise, and chemicals contribute greatly to debilitating acute and chronic conditions in the manufacturing industry.”
- Objective 3: Examine emerging risks from new technologies and explore ways in which new technologies can advance occupational safety and health in manufacturing. According to the final Agenda, new technologies that are reshaping the manufacturing industry include nanotechnologies.
ACGIH® TLV®-CS Committee Seeks Information On Carbon Nanotubes: The American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Values for Chemical Substances (TLV®-CS) Committee has included carbon nanotubes on its 2018 list of chemical substances and other issues under study. The TLV®-CS Committee seeks substantive data and comments, and will consider only those addressing issues of health and exposure, not economic or technical feasibility. More information is available in our January 31, 2018, blog item.
EUON Links Nanomaterials Used In Cosmetic Products To Registration Data: As reported in our June 19, 2017, blog item, the EC published a catalog of nanomaterials used in cosmetic products on the European Union (EU) market. On February 5, 2018, the European Union Observatory for Nanomaterials (EUON) published a table linking nanomaterials listed in the catalog to their Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) registration data ECHA’s database. EUON notes that as the registration of nanomaterials under the Cosmetics Regulation and the registration of substances under REACH have different scopes, it is not always possible to have a perfect match. EUON cautions that a REACH registration may not specifically cover the nanoforms of the substances used in cosmetics.
NIA Will Hold Webinar On Nanomedicine: Diagnostics And Therapeutics Advancing Through Nanotechnology: On March 7, 2018, the Nanotechnology Industries Association (NIA) will hold a webinar on “Nanomedicine: Diagnostics and therapeutics advancing through nanotechnology.” The webinar will focus on the diagnostic and therapeutic applications of nanotechnology. The webinar is open to all interested applicants and presentations will be available to all attendees. Registration is now open.
BRAG Biobased Products News And Policy Report: B&C consulting affiliate, B&C® Consortia Management, L.L.C. (BCCM), manages the Biobased and Renewable Products Advocacy Group (BRAG®). For access to a weekly summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to http://www.braginfo.org.
Senate Panel Approves Nomination Of DOJ Environment Chief: The Senate Judiciary Committee on January 18, 2018, approved the nomination of Jeffrey Bossert Clark to serve as the Assistant Attorney General for DOJ’s Environment and Natural Resources Division. Mr. Bossert is currently a partner at Kirkland & Ellis. The 11-10 party line vote was met with strong opposition from Democrats on the panel.
Democrats Introduce Cap And Dividend Legislation: On January 29, 2018, SenatorChris Van Hollen (D-MD) and Representative Don Beyer (D-VA) introduced a “cap and dividend” bill seeking to curb greenhouse gas emissions. The Healthy Climate and Family Security Act (S. 2352; H .R. 4889) would cap carbon pollution and reduce carbon dioxide emissions gradually. It would require the auction of carbon pollution permits to the first sellers of oil, coal, and natural gas into the U.S. market, and would remit 100 percent of the auction proceeds each quarter to every American in the form of a Healthy Climate Dividend. The bill would set an initial cap on covered fuels in 2019 that is 12.5 percent below 2005 levels, while setting increasingly strict five-year targets culminating in an 80 percent reduction by 2050. The legislation also would require EPA to promulgate a list of greenhouse gases not addressed by the bill and then promulgate regulations addressing the contribution of these gases to global warming.
Pruitt Addresses Legacy Issues, TSCA Implementation In Oversight Hearing: On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from EPA Administrator Scott Pruitt. In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” TSCA, as being of “significant importance” and a “top priority for ensuring the safety of chemicals in the marketplace.” More information is available in our blog.
Senate Committee Approves EPA Deputy Administrator Candidate; CEQ Nominee Withdraws: On February 7, 2018, the Senate EPW Committee approved the nomination of Andrew Wheeler to serve as EPA Deputy Administrator. The party line vote advances Mr. Wheeler’s nomination for the number two slot at EPA to the full Senate for a vote. Mr. Wheeler is a principal and the head of the energy and environment team at Faegre Baker Daniels Consulting and co-chairs the energy and natural resources industry team within the law firm. Prior to joining Faegre Baker Daniels, Mr. Wheeler worked at the U.S. Senate EPW Committee for 14 years serving in various roles, including as the majority and minority staff director and chief counsel. He started his career at EPA as a special assistant in the toxics office where he received three bronze medals. He has a B.A. from Case Western Reserve University, a J.D. from Washington University in St. Louis, and an M.B.A. from George Mason University. Mr. Wheeler is a member of the District of Columbia bar and an Eagle Scout. The White House also withdrew the controversial nomination of Kathleen Hartnett to head the White House Council on Environmental Quality (CEQ).
President’s Infrastructure Plan Calls For Expedited Environmental Permit Review: PresidentTrump’s sweeping infrastructure plan, revealed on February 12, 2018, seeks to accelerate environmental reviews of construction projects and permits. The Legislative Outline for Rebuilding America’s Infrastructure calls for a “one agency, one decision” review structure for infrastructure projects to limit delays allegedly caused by multiple and overlapping agency jurisdictions and reviews. The plan would require that the lead agency issue a record of decision or a finding of no significant impact within 21 months of a project’s proposal. Federal agencies then would have an additional three months to make permit decisions. This approach would limit the environmental review to two years or less. According to the plan, the model for the “one agency, one decision” approach is the Fix America’s Surface Transportation Act of 2015. To accomplish the expedited review process, President Trump is calling for amendments to several environmental laws, including the National Environmental Policy Act, the CWA, the Safe Drinking Water Act, and the CAA.
President’s Fiscal Year 2019 Budget Request Slashes EPA Budget By 25 Percent: President Donald Trump’s Fiscal Year (FY) 2019 budget request would cut EPA’s funding from its current $8.05 billion $6.1 billion, a decrease of about 25 percent and more than the $5.6 billion the Administration sought in FY 2018. Released on February 12, 2018, the budget reflects three overarching strategic goals:
- Core Mission: Deliver real results to provide Americans with clean air, land, and water, and ensure chemical safety.
- Cooperative Federalism: Rebalance the power between Washington and the states to create tangible environmental results for the American people.
- Rule of Law and Process: Administer the law, as Congress intended, to refocus the Agency on its statutory obligations under the law.
A major component of the FY 2019 budget request is funding for drinking water and clean water infrastructure, as well as for Brownfields and Superfund projects. Resources also are focused on efforts to improve and protect air quality and to ensure the safety of chemicals. This budget seeks to ensure that federal funding supports the highest priority national work. With the understanding that environmental protection is a shared responsibility, funds are provided to state and tribal partners through programs such as the Multipurpose Grants to implement core mission work in a flexible manner. This budget also provides essential resources to equip EPA in delivering vital emergency response services in environmental disasters.
The budget highlights EPA’s six FY 2018-2019 Agency Priority Goals2 (APG) that advance EPApriorities and the Agency’s FY 2018-2022 Strategic Plan:
- Improve air quality by implementing pollution control measures to reduce the number of non-attainment areas: By September 30, 2019, EPA will reduce the number of nonattainment areas to 138 from a baseline of 166.
- Empower communities to leverage EPA water infrastructure investments: By September 30, 2019, EPA will increase by $16 billion the non-federal dollars leveraged by EPA water infrastructure finance programs (Clean Water and Drinking Water State Revolving Funds and the Water Infrastructure Finance and Innovation Act).
- Accelerate the pace of cleanups and return sites to beneficial use in their communities: By September 30, 2019, EPA will make an additional 102 Superfund sites and 1,368 Brownfields sites ready for anticipated use (RAU).
- Meet new statutory requirements to improve the safety of chemicals in commerce: By September 30, 2019, EPA will complete in accordance with statutory timelines (excluding statutorily-allowable extensions): 100 percent of required EPA-initiated TSCA risk evaluations for existing chemicals; 100 percent of required TSCA risk management actions for existing chemicals; and 80 percent of TSCA pre-manufacture notice final determinations.
- Increase environmental law compliance rate: Through September 30, 2019, EPA will increase compliance by reducing the percentage of CWA National Pollutant Discharge Elimination System (NPDES) permittees in significant noncompliance with their permit limits to 21 percent from a baseline of 24 percent.
- Accelerate permitting-related decisions: By September 30, 2019, EPA will reduce by 50 percent the number of permitting-related decisions that exceed six months.
The funding priorities for the budget are infrastructure, improving air quality, clean water, revitalizing the land (Superfund cleanups), ensuring the safety of chemicals, and establishing new fees. As with the FY 2018 budget proposal, the White House seeks to eliminate scores of programs within EPA to achieve its proposed cuts.
States Support Plaintiffs’ Lawsuit That Prop 65 Warning For Products Containing Glyphosate Violates First Amendment: On January 2, 2018, State Attorneys General from eleven states (Idaho, Indiana, Iowa, Kansas, Louisiana, Michigan, Missouri, North Dakota, Oklahoma, South Dakota, and Wisconsin) (collectively the States) filed a friend of the court brief in Nat’l Ass’n of Wheat Growers v. Zeise, E.D. Cal. (No. 2:17-cv-02401) (Brief), a case challenging the California Office of Environmental Health Hazard Assessment’s (OEHHA) decision to list glyphosate as a carcinogen under Proposition 65 (Prop 65). OEHHA listed glyphosate under Prop 65 on March 28, 2017, but the effective date of the listing was delayed until July 7, 2017, following a decision from the Fifth District Court of Appeals that denied Monsanto’s request for a stay of such listing. OEHHA stated that its listing was required under its Labor Code listing mechanism, which OEHHA states requires it to list under Prop 65 certain substances identified by the International Agency for Research on Cancer (IARC) as known to cause cancer. Information about Monsanto’s earlier challenge is available in our blog item California Court Tentatively Dismisses Monsanto’s Lawsuit Against OEHHA to Block Addition of Glyphosate to Proposition 65 List. More information is available in our blog.
DPR Issues Notice Restricting Certain Applications Or Amendments For Products Containing Active Ingredients Under Reevaluation: On January 3, 2018, the California Department of Pesticide Regulation (DPR) issued Notice 2018-01: Expanding Use of Pesticide Products Under Reevaluation. Under Notice 2018-01, effective immediately, DPR will not act upon an Application for Pesticide Registration or an Application to Amend a Pesticide Product if it determines the registration or acceptance would potentially “expand use” of an active ingredient or pesticide product currently under reevaluation until the conclusion of the reevaluation. DPR states that it commences a reevaluation of an existing registered pesticide when it finds, based on an investigation of all reported episodes and information received, that a significant adverse impact to human health or the environment has occurred or is likely to occur. According to DPR, the policy set forth in Notice 2018-1 is needed for pesticides under reevaluation because until DPR reviews existing data for substances under reevaluation, determines whether additional data to satisfy reevaluation data requirements must be submitted, and then receives and assesses additional data applicable to the reevaluation that can mitigate the concern that prompted the initiation of the reevaluation, DPR “is not in a position to determine that an expanded use will not cause a ‘significant adverse environmental impact,’ as required under its certified regulatory program (3 CCR section 6254).” Once the reevaluation process is completed, DPR states that it will then be in a position, in light of its reevaluation determination, to consider applications for product registration or amendment. More information on other California DPR-related issues is available on our blog under key phrase California DPR.
EC Opens Consultation Period On EFSA Risk Assessment And Scientific Advice: Beginning on January 23, 2018, the EC opened a consultation period on the EFSA risk assessment process (scientific advice). The EC states it is seeking feedback on its process both as a “follow-up to the commitments made by the Commission in reply to the European Citizens’ Initiative on glyphosate,” and in response to “citizens [that] have put into question the risk assessment based on studies provided by the industry and this in particular where the industry seeks an authorisation, e.g. for pesticides, GMOs etc.” The General Food Law Regulation established EFSA, an independent scientific agency, to provide the risk assessment component of its risk analysis principle; the other two components are risk management and risk communication. EFSA provides its scientific opinions “which form the basis for the measures taken by the EU in the food chain.” The EC states the General Food Law Regulation “is the cornerstone of the EU regulatory framework covering the entire food chain: ‘from farm to fork.’” The EC is requesting feedback to help it “look into how [the EC] can improve the current system and to address citizens’ expectations about independence and transparency of the EU risk assessment system.” The EC is specifically requesting views and experiences on the following:
- The transparency and independence of the EU risk assessment system with respect to the underlying industry studies and information on which EFSA’s risk assessment/scientific advice is based;
- Risk communication; and
- The governance of EFSA, in particular the involvement of the EU Member States in the EU risk assessment system.
To contribute, interested parties must fill out the online questionnaire available here. All stakeholders and EU, as well as non-EU citizens, are welcome to contribute to this consultation. The consultation period will close on March 20, 2018. More information on glyphosate is available online.
This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.