EPA Updated the Pesticide Label Review Manual

EPA has substantively updated the General Labeling Requirements, Precautionary Statements, and Net Contents/Net Weight Chapters of the Pesticide Label Review Manual, and made minor editorial changes throughout the rest of the manual. This manual is designed to help industry understand the pesticide labeling process and how labels should be drafted under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

The latest updates are as follows:

General Labeling Requirements — Chapter 3:

  • Web-distributed labeling section now includes container label language example;
  • Label submission requirements section now includes e-submission option;
  • Final printed labeling section now reflects current practices;
  • Updated mode of action symbol reference from PR Notice 2001-5 to PR Notice 2017-1; and
  • First aid statement location now reflects requirements of EPA’s guidance document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68.”

Precautionary Statements — Chapter 7:

  • Added dermal sensitization to acute toxicity categories table (Table 1);
  • Reinstated first aid statements per PR Notice 2001-1, and updated location of first aid statements per the Feb. 27, 2018, First Aid Guidance Document “EPA’s Guidance for Pesticide Registrants on Location of the First Aid Statement per 40 CFR 156.68”;
  • Added Note to Physician statement for products containing zinc phosphide;
  • Updated National Pesticide Information Center NPIC information in first aid statements example in Table 9;
  •  Changed “Labeling Options” section to “Modified precautionary statements for diluted products (aqueous solutions only)”;
  • Removed redundant section on NPIC and referenced Chapter 15 for details; and
  • Removed “Optional Labeling/Deviations” section and moved directions under their respective sections.

Net Contents/Net Weight — Chapter 17:

  • Updated introduction section to include notes on declaring net contents information on application form 8570-1 and leaving net contents information blank on draft label for refillable containers; and
  • Updated labeling requirements for packages that use Bag on Valve technology to reflect 2018 NIST Handbook 130 regulations for net weight measurements.

TSCA Fees Rule — Release of Supplemental Information and Comment Period Extension

On April 24, 2018, EPA released for public comment a supplemental analysis on the definitions of small business size and their effect on Toxic Substances Control Act (TSCA) user fee collection. In the proposed fees rule EPA released in February, small businesses can quality for reduced fee amounts. For the supplemental analysis, EPA requested comment on:

  • Whether an employee-based size standard (how many people are working there) would be more appropriate than a revenue-based size standard (how much revenue comes in), and what that employee level should be (note: the revenue level standard is already in the proposed rule);
  • Whether either size standard should vary from industry to industry for any reason;
  • What other factors and data sources the Agency should consider, besides inflation, when developing the size standard; and
  • What should the new TSCA section 5 fee amounts be if EPA changes the size standard?

EPA is also extending the comment period for the proposed TSCA fees rule until May 24, 2018. This is meant to give interested parties more time to comment on both the rule and the supplemental analysis.

EPA Issues Draft TSCA Inventory With “Active” Substance Designations

Under the Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Inventory Reset Rule, manufacturers and importers were required to report all chemical substances that were active in commerce in the ten year “look-back period” ending June 21, 2016. Based on the information it received, the EPA published a draft version of the TSCA Inventory that contains 38,304 substances with “active” designations.

The draft Inventory designates as active those substances:

  • Substances notified under the 2012 and 2016 Chemical Data Reporting (CDR) rule;
  • Those substances EPA received notices of commencement (NOCs) since June 21, 2006; and
  • Substances reported via notices of activity (NOAs) before the February 7, 2018 Inventory Reset reporting deadline.

Substances listed as “active” in the draft Inventory include 30,972 on the public inventory and 7,332 on the confidential inventory. There are approximately 48,000 substances that have not been reported as active.

“Active” designations may grow in the coming months. The Inventory Reset Rule allows processors to report any substances that did not get reported as active by manufacturers or importers until October 5, 2018. In addition EPA has established a process to “activate” substances that are designated inactive.

Download the draft “active” Inventory here.

EPA Science Advisors Support Current SO2 NAAQS

EPA’s Clean Air Scientific Advisory Committee (CASAC) has now completed its review of the agency’s draft Policy Assessment (PA) for the SO2 NAAQS, and supports the EPA staff recommendation that the current scientific literature does not support revision of the current primary (health based) SO2 NAAQS.

In a draft letter recently released, CASAC notes that “key uncertainties” have emerged since the prior SO2 review, particularly with regard to “at-risk” subgroups such as children who are: obese; of African-American ethnicity; severely asthmatic; and/or live in high density areas near sources of exposure. The Committee believes that while many uncertainties remain in quantifying the sizes of the risks for these groups, they should nonetheless be considered in ensuring that the standard provides an adequate margin of safety. CASAC also recommends that efforts should be made to gather the data necessary to ensure that protection of these groups can be considered with less uncertainty in future reviews of the standard.

According to the draft letter, the Committee believes it possible that the current 75 ppb level may not provide an adequate margin of safety in these groups. However, because there is considerable uncertainty in quantifying the sizes of these higher risk subpopulations and the effect of SO2 on them, the Committee did not recommend reconsideration of the level at this time. CASAC strongly recommends that future assessments better quantify the numbers of individuals expected to be affected at the current (or proposed alternative) standard in these groups so that a more informed judgment about the margin of safety in high risk subgroups can be made. In particular, the Committee suggests that EPA express the size of the at-risk population both in percentage form (which is currently done) and also with numerical estimates, providing the number of people expected to be at risk, given the margin of safety.

The Committee recommended a few changes in the draft PA and stated that with those changes it need not review another draft. We expect that CASAC will finalize its draft letter soon and that EPA will then move to finalize the PA and propose to retain the current standard. We doubt that the current Administration will seize on the “margin of safety” points in the CASAC letter to propose a revised standard (as some prior administrations might have done). However, those issues are likely to be a primary focus of the next review of the SO2 standard.

Apart from SO2, this letter is significant because it is the first official CASAC action under the newly appointed Chair, Anthony Cox, and the other new members appointed by this Administration. It therefore appears that the reported “backlog” of NAAQS reviews caused by CASAC appointment delays will now begin to break.

EPA Releases Draft Guidance on TSCA CBI Disclosures and Requests Comments

On March 13, 2018, EPA released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose TSCA confidential business information (CBI) with an expanded set of people. Comments will be accepted until April 16, 2018.

Amendments to the Toxic Substances Control Act (TSCA) expanded the categories of people who may now access information claimed as CBI under TSCA. Information that a business claims as CBI under TSCA is protected from disclosure until the business withdraws the CBI claim, until the CBI claim expires, until EPA determines that the claim is not entitled to confidential treatment, or as authorized under TSCA and EPA regulations.

The draft guidance documents are:

D.C. Circuit Revises Its Decision on the Definition of Solid Waste

On March 6, 2018, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit or Court) issued an unsigned per curiam opinion revising its July 2017 decision, which struck down portions of the U.S. Environmental Protection Agency’s (EPA) 2015 Definition of Solid Waste (DSW) Rule. American Petroleum Institute v. EPA, D.C. Cir. App., No. 09-1038. This revision followed the Court’s invitation in its July 2017 decision to have parties provide additional briefing. Both industry and EPA took advantage of the invitation and filed petitions for rehearing.

The Court modified its July 2017 opinion in three ways: (1) severing and affirming EPA’s removal of the spent petroleum catalyst bar from the vacated portions of the Verified Recycler Exclusion; (2) vacating the 2015 Rule’s mandatory Factor 4 of the legitimate recycling determination in its entirety; and (3) reinstating the 2008 Rule version of Factor 4 of the legitimate recycling determination. This blog post focuses on the legitimate recycling determination.

EPA has established a legitimate recycling determination for what constitutes legitimate recycling of hazardous materials and described activities it considers to be illegitimate or sham recycling. 40 C.F.R. §260.43. The legitimate recycling determination consists of four factors:

  1. Legitimate recycling must involve a hazardous secondary material that provides a useful contribution to the recycling process or to a product or intermediate of the recycling process.
  2. The recycling process must produce a valuable product or intermediate.
  3. The generator and the recycler must manage the hazardous secondary material as a valuable commodity when it is under their control.
  4. The product of the recycling process must be comparable to a legitimate product or intermediate.

Based on the Court’s 2017 decision, Factors 1, 2, and 3 were upheld as mandatory factors that must be met by a recycler in order for the recycling process to be considered legitimate recycling. However, the Court vacated Factor 4 only as it applied to sham recycling as defined in 40 C.F.R. § 261.2(g). Thus, after its 2017 decision, Factor 4 still applied to those specific exclusions in which Factor 4 was specifically included, for example, the generator-controlled exclusion.

In its amended 2018 opinion, the Court vacated Factor 4 under all circumstances, even those written into specific exclusions. Now, the 2008 version of Factor 4 is reinstated, which requires only that the factor be “considered” and is not mandatory. Therefore, recyclers of hazardous materials must now meet Factors 1, 2, and 3 of the legitimate recycling determination, and must only consider Factor 4.

EPA Proposes to Add Aerosols to the Universal Waste Regulations

On March 16, 2018, the Environmental Protection Agency (EPA or the Agency) proposed adding hazardous waste aerosol cans to the universal waste program under the federal Resource Conservation and Recovery Act (RCRA) regulations. Comments are due by April 16, 2018. Aerosol cans are widely used for dispensing a broad range of products including paints, solvents, pesticides, food and personal care products, and many others.

Any person who generates a solid waste must determine whether the solid waste qualifies as hazardous waste. The waste may be hazardous either because it is listed as a hazardous waste or because it exhibits one or more of the characteristics of hazardous waste. Aerosol cans are frequently hazardous due to the ignitability characteristic, and in some cases may also contain listed or exhibit other hazardous waste characteristics.

The universal waste rules establish a streamlined hazardous waste management system for widely generated hazardous wastes as a way to encourage environmentally sound collection and proper management of the wastes within the system. Hazardous waste batteries, certain hazardous waste pesticides, mercury-containing equipment, and hazardous waste lamps are already included on the federal list of universal wastes. The universal waste regulations are a set of alternative hazardous waste management standards that operate in lieu of regulation under RCRA Subtitle C.

The streamlined universal waste regulations are expected to ease regulatory burdens on retail stores and others that discard hazardous waste aerosol cans, promote the collection and recycling of these cans, and encourage the development of municipal and commercial programs to reduce the quantity of these wastes going to municipal solid waste landfills or combustors.

A copy of the proposed rule can be found here.

New NSR Guidance Considers Emissions Decreases

EPA recently issued new Guidance for determining whether a proposed new or modified source of air pollutants would cause a significant increase in emissions, requiring a major source permit. See Memorandum from Administrator Pruitt to Regional Administrators re: Project Emissions Accounting Under the New Source Review Preconstruction Permitting Program (March 13,2018).

To date, EPA has employed a two-step process for evaluating projected emissions for major source status. Under step 1, the agency determines whether the project by itself – including emission controls – would cause a significant increase in emissions. Under step 2, the agency then looks at other “contemporaneous” projects at the facility – defined as those constructed within the past two years – to determine whether all of the projects combined would result in a “significant net increase” in emissions from the entire facility. If so the facility will require a major source permit.

With a few brief exceptions, the agency throughout its history has not allowed consideration of emissions decreases in step 1. The emissions baseline for the new project is set at zero, and offsets for emissions decreases are not considered until step 2. The practical effect has been to require all major sources to model both steps, even though the modeling in step 1 might show a decrease at that point, precluding the need to move to step 2 (e.g., the project includes new emission controls and also involves shutting down other emissions sources within the plant to produce an emissions decrease).

The new Guidance, effective immediately, revises EPA’s approach to allow consideration of net emissions decreases in step 1. The agency now believes that the prior approach had the practical effect of preventing some projects from proceeding and significantly delaying others, even though those projects would not have resulted in a significant emissions increase. The agency also recognizes that the increased efficiency of new production technologies can result in emission reductions even while expanding production. In such situations, the complexities associated with modeling multi-year contemporaneous netting under Step 2 at a large facility have dissuaded some meritorious projects. The new interpretation is designed to correct this, and the agency believes it is consistent with the relevant language of the Clean Air Act and current NSR regulations.

EPA Publishes TSCA User Fee Proposed Rule

Under the proposed TSCA User Fee Rule, submitters would pay $16,000 for each PMN. This was announced on February 8, 2018, when the U.S. Environmental Protection Agency (EPA) announced that EPA Administrator Scott Pruitt signed a proposed rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). The current fee for a PMN submission is $2,500. EPA estimates the average cost of a PMN for processing, reviewing, making determinations, and taking any regulatory action such as with a SNUR or an order is approximately $55,000. Fees would also apply to submissions related to risk evaluation and EPA mandated testing of chemical substances and mixtures.

The proposed rule was published on February 27, 2018. Comments on the rule must be received on or before April 27, 2018 (Docket Number EPA-HQ-OPPT-2016-0401).

Amended TSCA provides EPA the authority to charge fees to 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.” These fees are to be used for “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.” However, EPA is not proposing to assess greater fees for submissions containing CBI claims.

Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) under section 4;
  • Submit a PMN, SNUR, LVE or other notification under section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation under section 6, including a risk evaluation conducted at the request of a manufacturer.

Beginning in fiscal year (FY) 2019 , EPA will be required to adjust fees every three years to reflect inflation and ensure that fees are sufficient to collect 25 percent of the costs to EPA in administering TSCA sections 4, 5, 6, and 14, up to $25 million. The proposed rule provides a description of proposed TSCA fees and fee categories for FYs 2019, 2020, and 2021, and explains the basis for its proposal.

California Issues Expanded Draft Priority Product Workplan

The California Department of Toxic Substances Control (DTSC) recently issued a Draft Three-Year Priority Product Work Plan (2018-2020) under the state Safer Consumer Products program (also known as the “green chemistry” program). The draft Work Plan would supersede the current plan adopted in 2015, and lists the categories of products that DTSC intends to investigate under the program for the next three years. Public comments on the draft Work Plan will be accepted until March 9.

The new draft Work Plan includes seven product categories. Five were carried over from the prior Work Plan: (1) beauty, personal care and hygiene products; (2) cleaning products; (3) household, school and workplace furnishings; (4) building products and materials used in construction and renovation; (5) consumable office, school, and business supplies. The two new categories proposed are food packaging and lead acid batteries.

The Work Plan does not specifically identify any product as a regulatory priority, but identifies categories from which DTSC will propose future priority products. DTSC is limited to regulation of products within these categories, except for other products identified by legislation, Executive Order or a petition to DTSC that has been granted.

In investigating potential priority products, DTSC intends to solicit information from manufacturers and their supply chain partners as well as trade associations and others with relevant expertise. They also may make targeted information requests to specific industry sectors; gather information through public workshops and comment periods; and issue “information call ins” as described in the state regulations. This information would be available to the public except for trade secrets protected by the regulations. DTSC expects to engage in discussion with industry experts about product formulations, supply chain considerations, and industrial toxicology studies among other topics that can expand and refine their knowledge for the purposes of selecting priority products.