On April 5, 2017, the Trump Administration issued guidance on Executive Order (EO) 13771, “Reducing Regulation and Controlling Regulatory Costs.” The guidance, published by the Office of Information and Regulatory Affairs (OIRA), provides details on the policy established by the January 30, 2017 executive order that requires agencies to repeal two existing regulations for each new regulation they promulgate. This guidance supersedes the previous interim guidance published in February, and it reflects OIRA’s consideration of the comments received in response to the interim guidance.
EO 13771 mandates that for every new regulation issued, at least two prior regulations should be eliminated. For fiscal year (FY) 2017 and moving forward, the heads of all agencies are directed that the total incremental cost of all new regulations, including the cost savings associated with eliminating the two prior regulations, must be no greater than zero—unless otherwise required by law or consistent with written advice of the director of the Office of Management and Budget (OMB). The term ”total incremental cost” means the sum of all costs from EO 13771 regulatory actions minus the cost savings from EO 13771 deregulatory actions.
It appears that the EO is based solely on “cost.” In the interim guidance, the administration dictated that “costs” are to be measured as the “opportunity cost to society” and referenced OMB Circular A-4 to define this concept. In the April guidance, the administration dictated that “opportunity cost” would equal the sum of consumer and producer surplus, minus any fixed costs, and also referenced OMB Circular A-4. OMB Circular A-4, issued Sept. 17, 2003, does not actually define “opportunity cost to society.” Instead, it provides guidance for conducting a cost-and-benefit analysis as required by Executive Order 12866 issued by President Clinton in 1993, which applies to rulemakings that establish new rules as well as those that rescind or modify existing rules. OMB Circular A-4’s only reference to “opportunity cost” describes the concept in terms of “willingness-to-pay,” or the measure of “what individuals are willing to forego to enjoy a particular benefit,” as well as the amount of compensation individuals are “willing to accept” to forego the benefit. The OMB Circular A-4 may well be unhelpful in making a “zero-cost” analysis, as EO 13771’s focus is on monetary costs, and “opportunity costs” are difficult to estimate. Indeed, it is difficult to imagine a situation for implementing a regulation or even deregulating in which the cost is “zero.”
The April guidance notes that, in general, agencies can comply with the requirements of the EO by issuing two “deregulatory actions” for each new “regulatory action.” Beginning with FY 2018 and moving forward, the EO requires OMB to identify for each agency the total amount of incremental costs for all deregulatory and regulatory actions finalized during the fiscal year, based on the information that was submitted to OMB by each agency. The guidance defines “EO 13771 regulatory actions” as either: 1) a “significant regulatory action” (i.e., has an annual effect on the economy of $100 million or more, among other things. See EO 12866 3(f)) that has already been finalized and that imposes total costs greater than zero, or 2) a “significant guidance document” with costs above zero that has been finalized. The guidance further defines a “significant guidance document” as one that is reasonably anticipated to have a major impact on the economy, create inconsistency with an action taken or planned by another agency, materially alter the budgetary impact or entitlements, grants, user fees, or loan programs or the rights and obligations of the recipients thereof, or raise novel legal or policy issues.
The guidance defines a “deregulatory action” as an action that has been finalized and has total costs less than zero. It is unclear from the EO and guidance what “total costs less than zero” means. A “deregulatory action” qualifies as both: (1) one of the actions used to satisfy the provision to repeal or revise at least two existing regulations for each regulation issued, and (2) a cost savings for purposes of the total incremental cost allowance. “Deregulatory actions” can be issued in multiple forms, including rulemaking, guidance or interpretive documents, certain actions related to international regulatory cooperation, and information-collection requests that repeal or streamline recordkeeping, reporting, or disclosure requirements.
EO 13771 applies to each “executive department or agency,” but leaves a number of government regulatory functions outside of its scope. These include agencies involved in military, national security, and foreign affairs functions, as well as any government organization arising from the Legislative or Judicial branches. Also exempt are regulations that are legislative rules that qualify for a “good cause” exemption or for which compliance with the terms of EO 13771 would be impracticable or contrary to the public interest. Importantly, the guidance does not indicate which entity is ultimately responsible for making such determinations. Some other exemptions include expressly exempt actions, emergency actions, statutorily or judicially required actions, and de minimis actions.
On its face, EO 13771 could have a significant impact on the pace of federal rulemaking during the Trump Administration, however it remains to be seen what the practical impact of the EO will be. Further, it appears based on the EO itself and the guidance published thus far, it will be difficult for agencies to determine “cost” of implementing and eliminating regulations.
Note: There will be more guidance forthcoming relating to other aspects of the EO, such as Section 3, which concerns the “Annual Regulatory Cost Submissions to the Office of Management and Budget.” Hopefully the forthcoming guidance will shed more light into the EO and its requirements.
Ninth Circuit Vacates EPA Conditional Approval of Nanoscale Silver Antimicrobial
/in UncategorizedOn May 30, 2017, the Ninth Circuit Court of Appeals vacated EPA’s conditional approval of Nanosilva NSPW-L30SWS, a type of antimicrobial silver registered as a materials preservative for textiles and plastics. NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360 (9th Cir. 2017). The active ingredient in the product is nanoscale silver. The National Resources Defense Council (NRDC), Center for Food Safety (CFS), and the International Center for Technology Assessment (ICTA), appealed the conditional approval. The Ninth Circuit found that EPA had not sufficiently supported its finding that early approval was in the public interest – a requirement for conditional approval under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA). EPA granted conditional approval of the product in May 2015.
Under FIFRA, EPA is permitted to issue conditional registration for a pesticide containing an active ingredient not contained in any currently registered pesticide, only where: 1) use of that pesticide will not cause any unreasonable adverse effect on the environment, and 2) use of the pesticide is in the public interest. 7 U.S.C. § 136a(c)(7)(C). The Ninth Circuit explained that the Agency considers this type of conditional registration when it has not received sufficient data to determine that long-term use of a pesticide is reasonable. Id. In its decision to grant conditional approval of NSPW, EPA found that use of the pesticide is in the public interest because it has the “potential” to reduce the amount of silver released into the environment.
NRDC, CFS, and ICTA disputed the factual premises underlying the EPA’s public-interest finding. Petitioners challenged the Agency’s findings that:
While the Ninth Circuit found that EPA’s analysis supported finding both lower application rate and lower mobility rate, it also found that the Agency “impermissibly relie[d] on unsubstantiated assumptions” to support the finding that the conditional registration of NSPW will reduce the amount of silver pesticides used. EPA had concluded that use of NSPW is in the public interest because it has the “potential” to reduce the amount of silver released into the environment. The Ninth Circuit held that EPA’s conclusion requires two interrelated and unstated assumptions. The Ninth Circuit found that
The Ninth Circuit held that neither assumptions are supported by substantial evidence.[1] In fact, the Ninth Circuit found that if the EPA’s substitution and no-new-products assumptions are incorrect, NSPW may actually increase the amount of silver released into the environment, which would contravene the identified public interest. The Ninth Circuit explained that
EPA may not satisfy the [substantial evidence] requirement by simply finding that a pesticide has the “potential” to be in the public interest—especially where the pesticide also has the “potential” to contravene the public interest. Accordingly, where an essential premise of a public-interest finding is only supported by bare assumptions, as in the present case, we will find substantial evidence lacking.
NRDC v. United States EPA, 2017 U.S. App. LEXIS 9360 (9th Cir. 2017).
[1] The Ninth Circuit held EPA to the substantial evidence standard as dictated by FIFRA. 7 U.S.C. § 136n(b). The Court explained that “[s]ubstantial evidence means more than a mere scintilla but less than a preponderance; it is such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.” Nat. Res. Def. Council v. EPA (NRDC), 735 F.3d 873, 877 (9th Cir. 2013).
NIOSH Actions Threaten Lower Exposure Limits for Carcinogens
/in NIOSHThe National Institute for Occupational Safety and Health (NIOSH), the workplace research arm of the federal Centers for Disease Control, recently has taken two actions likely to lead to much lower occupational exposure recommendations for known or suspected carcinogens. First, in December 2016, the agency finalized its new Carcinogen Policy. The new policy provides “that there is no known safe level of exposure to a carcinogen, and therefore that reduction of worker exposure to chemical carcinogens as much as possible through elimination or substitution and engineering controls is the pri¬mary way to prevent occupational cancer.” NIOSH no longer will use the term recommended exposure limit (REL) for chemical carcinogens; rather NIOSH will only rec¬ommend an initial starting point for control, called the Risk Management Limit for Car¬cinogens (RML-CA). For each chemical identified as a carcinogen, the RML-CA will be set at the level deemed necessary to ensure no more than one excess cancer case in 10,000 workers in a 45-year working lifetime. When measurement of the occupational carcinogen at the RML-CA is not analytically feasible at the 1 in 10,000 risk estimate, NIOSH will set the RML-CA at the limit of quantifi¬cation (LOQ) of the analytical method. This is a major change from the prior NIOSH policy, which recognized that acceptable exposure limits can be established for carcinogens and focused on risks of 1/1000 or greater.
Second, in March 2017 NIOSH published draft guidance for using Occupational Exposure Banding (OEB) to evaluate chemical hazards. The guidance would be used by NIOSH to establish and update RELs and the new carcinogen limits, and also appears intended to allow chemical users and others to set their own internal limits. It includes formulas for deriving upper and lower limit values (bands) on the basis of available data. The preferred databases for carcinogens include EPA’s IRIS listings and the Cal OSHA database, among others.
These two developments, taken together, are likely to lead to major reductions in NIOSH exposure recommendations for known or suspected carcinogens. While NIOSH has no enforcement authority, the NIOSH recommendations can be enforced by OSHA pursuant to the General Duty Clause of the Occupational Safety and Health Act, and they often are used as internal corporate standards.
The Carcinogen Policy is final; therefore, revision likely would require a petition for reconsideration. Comments on the OEB guidance are due by June 13, and could include arguments that it cannot be used to supersede current RELs and that the new Carcinogen Policy should not be applied.
Council of Better Business Bureaus’ National Advertising Division Recommends Kauai Coffee to Modify and Discontinue Environmental-Benefits Claims for Coffee Pods
/in Green MarketingThe National Advertising Division (NAD), of the Council of Better Business Bureaus, recommended that Kauai Coffee Company, LLC, discontinue certain environmental-benefits claims for the company’s single-serve coffee pods. In addition, NAD found that the company’s webpage fails to meet FTC Green Guide requirements for advertising claims. The NAD decision recommends that Kauai Coffee company discontinue and modify several advertising claims. It also requested that the company provide substantiation for a number of express claims.
NAD’s purpose is to provide efficient, cost-effective resolution to disputes between private parties regarding national advertisements. The process is voluntary. This type of voluntary enforcement allows the NAD to use alternative dispute resolution to address and settle disputes within 60 to 90 days. Advertisements challenged under the NAD are subjected to the “claim substantiation” standard promulgated by the Federal Trade Commission (FTC). Companies can appeal the NAD decisions to the National Advertising Review Board, which appoints appellate panels to review decisions issued by the NAD. NAD reserves the right to refer the claims to the appropriate federal agency, usually the FTC, for further action. It is this threat of a potential FTC investigation that incentivizes those to participate in the voluntary NAD process.
Much of the Kauai Coffee NAD decision addresses claims regarding the compostability of the Kauai coffee pods. Although the company obtained third party certification that the pods meet the requirements of ASTM standards D6400 and D6868, the certification does not extend to typical disposal methods. Indeed, the pods will disintegrate and biodegrade swiftly and safely only in a professionally managed industrial composting facility, which is not readily available to most consumers, and the pods are not suitable for home compositing. NAD found that Kauai Coffee must prominently discloses these facts.
According to NAD, the Kauai Coffee webpage violated the FTC Green Guides requirements by not clearly and prominently disclosing both that the pods are not suitable for home composting and that industrial composting programs are not readily available to most consumers. Indeed, NAD noted, “it is well-established that any material disclosures must be clear and conspicuous and appear in close proximity to the claim it is qualifying.”
In addition, NAD has asked the company to substantiate a number of its environmental-benefits claims including:
• “Don’t trash the Earth with your coffee. Brew & Renew.”
• Kauai Coffee comes in “new certified 100% compostable pods that work in all K-Cup brewers.”
• “Compostable in industrial facilities. Check locally, as these do not exist in many communities. Not certified for backyard composting.”
• “Now you can enjoy the great taste and convenience of single-serve coffee without worrying about the environmental impact. Our certified 100% compostable pod is compatible with all K-cup brewers and is designed to go back to the land – not the landfill.”
NAD has also asked that Kauai Coffee discontinue use of the following statements:
• “Don’t trash the Earth with your coffee. BREW & RENEW” along with the image of the trash can imprinted with a green/blue image of the earth.
• “Now you can enjoy the great taste and convenience of single-serve coffee without worrying about the environmental impact. Our certified 100% compostable pod is compatible with all K-cup brewers and is designed to go back to the land – not the landfill.”
NAD reports that Kauai Coffee will comply with NAD’s recommendations.
EPA Grants First ‘Conditional’ Approval Under TSCA Reform
/in TSCA, TSCA ReformEPA recently approved a new chemical additive subject to the conditions of the polymer exemption criteria. The Agency found that the chemical substance is “not likely to present an unreasonable risk” under TSCA (5(a)(3)(C)), so long as it meets the requirements of the polymer exemption as described under 40 CFR §723.250(e)(1). Specifically the Agency found that the substance presents both a low human hazards and a low environmental hazard. The requirement that “the chemical must be manufactured such that it meets the polymer exemption criteria” gives little insight into restrictions that EPA might impose on future conditional approvals.
EPA’s Determination for Premanufacture Notice explains that although the agency estimates that the new chemical substance will be very persistent, it is unlikely that the chemical substance would present an unreasonable risk, given that it has low potential for bioaccumulation, low human health hazard, and low environmental hazard. The Determination’s discussion of potential exposures is particularly interesting. The Agency explained that, although the exposure to a new chemical substance is potentially relevant to whether a new chemical substance is likely to present unreasonable risks, EPA did not estimate the exposure. The Agency elected not to estimate exposure because the substance present low health and environmental hazard. The Determination concludes that, “Due to low hazard, EPA believes that this chemical substance would be unlikely to present an unreasonable risk even if exposures were high.”
The name of the substance was claimed confidential business information, as was the manufacturers name. The generic substance name is 2–alkenoic acid, 2–alkyl–, alkyl ester, polymer with 2–alkyl 2–propenoate and a-(2–alkyl-1-oxo-2-alken-1-yl-[iquest]-alkoxypoly(oxy-1,2-alkanediyl), ester with a–2–alken–1–yl–[iquest]–hydroxypoly(oxy–1,2–alkanediyl).
The approval, announced online on May 12, 2017, was the first time EPA has approved a new chemical with a condition since the Toxic Substances Control Act was amended in June 2016.
EPA Reopens Consultation on TSCA Small Manufacturer and Small Processor Definition
/in TSCA ReformThe EPA reopened its consultation with the public regarding the definition of “small manufacturer” and “small processor” under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA).
TSCA, as amended, requires EPA to review the size standards for small manufacturers and processors, which are currently used in connection with reporting regulations under TSCA Section 8(a). EPA preliminary decided that a revision in the size standards was warranted, but it wanted the public’s input as well. As such, EPA requested public comment on whether a revision of the current size standard definitions is necessary. It also requested a consultation with the Small Business Association to review the definition.
The comment period ended in January, but EPA is now accepting further comment on this issue until May 24, 2017.
New York to Require Manufacturers to Disclose Chemical Ingredients in Cleaning Products
/in Right-to-KnowNew York announced the launch of its Household Cleansing Product Information Disclosure Program on April 25, 2017. This program will require manufacturers of household cleaning products sold in New York to disclose – on their websites – information on the chemical ingredients of those products. The state has issued draft guidance on the disclosure requirements and the Household Cleansing Product Information Disclosure Program Certification Form. Public comment on the form will be accepted through June 14, 2017. Manufacturers are to post all required information by no less than six months following publication of the final guidance document. In a press release announcing the program, the governor’s office noted that this program will serve as a pilot for potential expansion to other consumer products of concern, such as personal care or children’s products.
The Household Cleansing Product Information Disclosure Program is based on New York’s Environmental Conservation Law Article 35 enacted in the 1970s. It authorizes the state to require manufacturers to furnish product information for the public record. These requirements have been codified in the state’s Code of Rules and Regulations (NYCRR) at Part 659.6.
Detailed instructions for posting the information required are provided in the guidance document. The guidance discusses where on a manufacturer’s website the information should be located. It also notes that “information disclosed under this program must not be restricted from indexing by search engines, such as Google and Bing.”
Information requirements include
• Whether the product contains fragrance ingredients, including ingredients added to mask the scent of other ingredients (solvents, surfactants, etc.) in so-called “unscented” products;
• Intentionally added ingredients;
• Trace quantities; and
• Ingredients present only as an unintentional consequence of manufacturing.
Manufacturers will also be required to report on which of the chemicals in their products have been subject to the GreenScreen® comparative chemical hazard assessment (for information on the GreenScreen® Benchmark program see, the Clean Product Action website). In addition, manufacturers must disclose whether their products contain any nanomaterials and whether any of the chemicals in their products are included on a list of chemicals of concern (for information on the lists of chemicals of concern at issue, see the guidance document).
Manufacturers will be required to update their disclosures each time the ingredients in a product are changed, or a new product is introduced to the market.
Petition for Toxicity and Exposure Testing on Flame Retardants Denied
/in TSCAOn April 12, 2017, EPA published a notice in the Federal Register denying a TSCA section 21 petition regarding a group of flame retardants. EPA explained that the petition did not demonstrate that there was insufficient data on these chemicals, and therefore the EPA found that the testing requested was not necessary. The petition was submitted by Earthjustice, Natural Resources Defense Council, Toxic-Free Future, Safer Chemicals, Health Families, BlueGreen Alliance, and Environmental Health Strategy Center (“Earthjustice Petition”).
Under TSCA section 21, any person can petition EPA to initiate a rulemaking for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 4 or 5(e) or (f). The Earthjustice petition asked EPA to issue an order under section 4, requiring toxicity and exposure tests testing on particular flame retardants. The flame retardants at issue are chlorinated phosphate esters (“CPE”). The CPE Cluster is comprised of
These substances had previously been evaluated during EPA’s TSCA Work Plan Chemical Problem Formulation and Initial Assessment. Millions of pounds of the substances are manufactured and imported annually.
The Federal Register notice explained that EPA must make several findings in order to issue a rule or order to require testing under section 4. EPA must find that information and experience are insufficient to reasonably determine or predict the effects of a chemical substance on health or the environment and that testing is necessary to develop the missing information. EPA must also find that the chemical substance may present an unreasonable risk of injury under section 4. EPA did find that the manufacture, distribution in commerce, processing, use, or disposal of the CPE Cluster chemicals may present an unreasonable risk of injury to health or the environment. However, EPA stated that the petitioners failed to demonstrate that the information and experience available to EPA are insufficient to reasonably determine or predict the effects on health or the environment from “manufacture, distribution in commerce, processing, use, or disposal” (or any combination of such activities) of the CPE Cluster chemicals, and therefore the Agency found that the testing requested by the petitioners is unnecessary.
In March, EPA denied a section 21 petition by Earthjustice and others to require additional testing on the flame retardant tetrabromobisphenol A (CAS No. 79-94-7).
Trump Administration Issues Guidance on the Executive Order, “Reducing Regulation and Controlling Regulatory Costs”
/in NewsOn April 5, 2017, the Trump Administration issued guidance on Executive Order (EO) 13771, “Reducing Regulation and Controlling Regulatory Costs.” The guidance, published by the Office of Information and Regulatory Affairs (OIRA), provides details on the policy established by the January 30, 2017 executive order that requires agencies to repeal two existing regulations for each new regulation they promulgate. This guidance supersedes the previous interim guidance published in February, and it reflects OIRA’s consideration of the comments received in response to the interim guidance.
EO 13771 mandates that for every new regulation issued, at least two prior regulations should be eliminated. For fiscal year (FY) 2017 and moving forward, the heads of all agencies are directed that the total incremental cost of all new regulations, including the cost savings associated with eliminating the two prior regulations, must be no greater than zero—unless otherwise required by law or consistent with written advice of the director of the Office of Management and Budget (OMB). The term ”total incremental cost” means the sum of all costs from EO 13771 regulatory actions minus the cost savings from EO 13771 deregulatory actions.
It appears that the EO is based solely on “cost.” In the interim guidance, the administration dictated that “costs” are to be measured as the “opportunity cost to society” and referenced OMB Circular A-4 to define this concept. In the April guidance, the administration dictated that “opportunity cost” would equal the sum of consumer and producer surplus, minus any fixed costs, and also referenced OMB Circular A-4. OMB Circular A-4, issued Sept. 17, 2003, does not actually define “opportunity cost to society.” Instead, it provides guidance for conducting a cost-and-benefit analysis as required by Executive Order 12866 issued by President Clinton in 1993, which applies to rulemakings that establish new rules as well as those that rescind or modify existing rules. OMB Circular A-4’s only reference to “opportunity cost” describes the concept in terms of “willingness-to-pay,” or the measure of “what individuals are willing to forego to enjoy a particular benefit,” as well as the amount of compensation individuals are “willing to accept” to forego the benefit. The OMB Circular A-4 may well be unhelpful in making a “zero-cost” analysis, as EO 13771’s focus is on monetary costs, and “opportunity costs” are difficult to estimate. Indeed, it is difficult to imagine a situation for implementing a regulation or even deregulating in which the cost is “zero.”
The April guidance notes that, in general, agencies can comply with the requirements of the EO by issuing two “deregulatory actions” for each new “regulatory action.” Beginning with FY 2018 and moving forward, the EO requires OMB to identify for each agency the total amount of incremental costs for all deregulatory and regulatory actions finalized during the fiscal year, based on the information that was submitted to OMB by each agency. The guidance defines “EO 13771 regulatory actions” as either: 1) a “significant regulatory action” (i.e., has an annual effect on the economy of $100 million or more, among other things. See EO 12866 3(f)) that has already been finalized and that imposes total costs greater than zero, or 2) a “significant guidance document” with costs above zero that has been finalized. The guidance further defines a “significant guidance document” as one that is reasonably anticipated to have a major impact on the economy, create inconsistency with an action taken or planned by another agency, materially alter the budgetary impact or entitlements, grants, user fees, or loan programs or the rights and obligations of the recipients thereof, or raise novel legal or policy issues.
The guidance defines a “deregulatory action” as an action that has been finalized and has total costs less than zero. It is unclear from the EO and guidance what “total costs less than zero” means. A “deregulatory action” qualifies as both: (1) one of the actions used to satisfy the provision to repeal or revise at least two existing regulations for each regulation issued, and (2) a cost savings for purposes of the total incremental cost allowance. “Deregulatory actions” can be issued in multiple forms, including rulemaking, guidance or interpretive documents, certain actions related to international regulatory cooperation, and information-collection requests that repeal or streamline recordkeeping, reporting, or disclosure requirements.
EO 13771 applies to each “executive department or agency,” but leaves a number of government regulatory functions outside of its scope. These include agencies involved in military, national security, and foreign affairs functions, as well as any government organization arising from the Legislative or Judicial branches. Also exempt are regulations that are legislative rules that qualify for a “good cause” exemption or for which compliance with the terms of EO 13771 would be impracticable or contrary to the public interest. Importantly, the guidance does not indicate which entity is ultimately responsible for making such determinations. Some other exemptions include expressly exempt actions, emergency actions, statutorily or judicially required actions, and de minimis actions.
On its face, EO 13771 could have a significant impact on the pace of federal rulemaking during the Trump Administration, however it remains to be seen what the practical impact of the EO will be. Further, it appears based on the EO itself and the guidance published thus far, it will be difficult for agencies to determine “cost” of implementing and eliminating regulations.
Note: There will be more guidance forthcoming relating to other aspects of the EO, such as Section 3, which concerns the “Annual Regulatory Cost Submissions to the Office of Management and Budget.” Hopefully the forthcoming guidance will shed more light into the EO and its requirements.
Irene Hantman to present at American Chemical Society 253rd National Meeting in San Francisco April 4
/in TSCA ReformThe symposium is titled, “Recent Developments in TSCA Regulation — New Requirements for Chemicals in Commerce.” Ms. Hantman will be presenting with:
The symposium will include an overview of TSCA and the Lautenberg Amendments, discuss regulatory updates from EPA including changes to how the Agency evaluates new chemicals, and discuss implications for chemicals in commerce such as changes to CBI protections and the Nanomaterials Reporting Rule. The program abstract is provided below.
The June 22, 2016 enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act effectuated a sea change in U.S. chemicals regulatory policy and imposed many new requirements on EPA and the manufacturers, importers, and processors of chemical substances. Some requirements took effect the moment President Obama signed the Act; other changes will be implemented over the next few years. Lautenberg mandates that the Agency issue a number of new rules by June 2017. To meet this schedule, EPA will be taking and responding to comments on its proposals during the spring of 2017. Proposed rules will affect the identification of chemicals currently in commerce through a TSCA “Inventory Reset,” and how EPA assesses the risks presented by these chemicals. The Inventory Reset process could have significant impacts on a company’s ability to continue routine manufacturing activities (for example, substances classified as inactive will not be allowed in commerce, or there may be questions about the actual identity of compounds now in commerce). Importantly, the final rules implementing the Prioritization and Risk Assessment processes will determine the processes and criteria that EPA will use to identify high priority chemicals for risk evaluation, how it will evaluate the risks presented by these chemicals and the amount of flexibility that EPA will allow in these processes. In addition, the Agency will revisit the Confidential Business Information (CBI) claims on chemicals presently in commerce, including claims that withhold the actual identity of chemicals. Submitters will be required to substantiate past claims to continue receiving CBI protections.
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For a copy of the presentations contact Ms. Hantman at ihantman@verdantlaw.com.
Processors and Downstream Users Comment on the Inventory Reset Proposed Rule, Asking for Clarity
/in TSCAOn January 13, 2017, the EPA published a proposed rule to reset the TSCA Inventory into separate lists of “active” and “inactive” substances (i.e., inventory reset). The proposal details notification requirements and establishes exemptions and procedures for handling confidentiality claims. Properly notified substances would be designated by EPA as “active,” whereas substances without a valid notification would be designated as “inactive.”
Once designated, “inactive” substances could not properly be manufactured, imported, or processed for a non-exempt commercial purpose under TSCA. For inactive substances, EPA proposed “forward-looking” procedures for notifying inactive substances if and when non-exempt manufacture, import, or processing would resume in the future. Properly notified substances would be converted by EPA to “active” substances.
Many comments to the proposed rule were received from interested parties, including coalitions and trade associations – examples are provided below.
A downstream user coalition has questioned the proposed requirement under the TSCA inventory reset proposed rule that a processor of an inactive substance submit notification to the EPA prior to its use. The Chemical User Coalition (CUC), a cross-industry group of nine major companies, including Intel, Boeing, Honda and Procter & Gamble, said in its comments that the inventory reset provisions should only be relevant to reporting, and a failure to adhere to the notification deadline should constitute a reporting violation, not affect a company’s ability to process substances on the inventory.
IPC, the Association Connecting Electronics Industries, in its comments requested clarification of the term “processors” stating that the definition currently in place is “overly simple and prone to misinterpretation.” Specifically, IPC requested that EPA clarify that processing does not include assembling parts into articles, when it does not involve the preparation of a chemical substance or mixture.
Others pointed out that because processors are not required to report pre-manufacture notices or under the Chemical Data Reporting rule, that many would be wholly unfamiliar with the EPA’s CDX reporting system.
The comment period on the inventory rest proposed rule ended March 14, 2017.