Supreme Court denial upholds FTC on substantiating claims in advertising.

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Green marketers take note: the Federal Trade Commission (FTC) won a recent victory at the Supreme Court on deceptive advertising, which means companies cannot advertise health benefits for their products without sufficient evidence.

On May 2, the Supreme Court denied POM Wonderful’s petition for certiorari, bringing to an end a six-year-long wrangle with the FTC over advertisements that claimed the company’s pomegranate juice was clinically proven as effective in fighting heart disease, prostate cancer, and erectile dysfunction.

The Supreme Court’s denial leaves in place the January 2015 decision [PDF] from the D.C. Circuit Court of Appeals, which upheld the Commission’s decision that POM misled consumers in violation of the FTC Act. Specifically, the D.C. Circuit upheld the Commission’s findings as to (1) establishment and efficacy claims made in POM’s advertising, as well as (2) inadequate substantiation for those claims.

The D.C. Circuit also affirmed the FTC’s cease and desist order [PDF], which requires POM to substantiate any future disease treatment and prevention claims with at least one randomized, well-controlled human trial, while other health benefit claims must be supported by competent and reliable scientific evidence.

In a statement, FTC Chairwoman Edith Ramirez lauded the Supreme Court’s move, saying the conclusion of the case “makes clear that companies like POM making serious health claims about food and nutritional supplement products must have rigorous scientific evidence to back them up.”

Senators reach deal on TSCA reform.

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Senators central to the effort to modernize the Toxic Substances Control Act (TSCA) have reportedly reached a deal that will allow the stalled legislation to move forward. Senate Environment and Public Works Chair Jim Inhofe (R-CA) and Ranking Member Barbara Boxer (D-CA), who has been a fierce critic of the Senate proposal, announced on Friday that they had “reached an agreement on key sticking points of the TSCA reform bill.” The content of the agreement has not yet been made public, but according to Politico’s Morning Energy, it involves “some resolution on Senate language calling for state action on high-priority chemicals to be paused while EPA performs a risk review.” A Senate aide told Politico that the final text will take most of this week to finalize.

The next step will be to win House approval before both chambers get the chance to vote on the negotiated legislation. A bi-partisan group of House Energy and Commerce Committee members also released a statement on Friday, calling the deal “an important step forward” and calling for “keeping the momentum going.”

TSCA reform reconciliation might be ready as soon as May 9.

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Despite perennially familiar optimistic comments, Congress is heading into a weeklong recess with no deal on overhauling the Toxic Substances Control Act (TSCA). As we have previously discussed, both chambers have approved legislation to update the law, but differences between the two bills have yet to be reconciled. Nevertheless, lawmakers continue to claim that progress is being made. While a push to wrap up negotiations before the recess failed, legislators hope to reach an agreement as soon as the week of May 9, when Congress is back in session.

Rep. John Shimkus (R-IL), chair of the House Energy and Commerce Committee’s Environment and the Economy Subcommittee told Bloomberg BNA that legislators are still trying to reach a “middle ground” on state preemption. This month, environmentalists have raised new concerns with the legislation, with the Waterkeeper Alliance opposing to the so-called “Monsanto provision,” flagged in February by the New York Times, and the Natural Resources Defense Council criticizing the legislation’s high standard for the Environmental Protection Agency (EPA) to regulate chemicals in imports, including articles, through Significant New Use Rules (SNURs). Vermont’s Congressional delegation has also written to reconciliation leaders, arguing for the importance of TSCA reform from the perspective of a state currently grappling with reports of drinking and surface water contaminated with perfluorooctanoic acid (PFOA). Their letter [PDF] calls for preserving state authorities and supports letters previously submitted by EPA Administrator Gina McCarthy and state Attorneys General.

Although lawmakers from both parties have insisted that negotiations are not to be held to any timeline, the number of weeks left on the legislative calendar is dwindling rapidly.

EPA seeks input on ecolabels for paints, flooring, and furniture.

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As part of its pilot project to test its “Draft Guidelines for Product Environmental Performance Standards and Ecolabels for Voluntary Use in Federal Procurement,” the Environmental Protection Agency (EPA) is seeking input on private sector environmental performance standards and ecolabels applicable to paints/coatings, flooring, and furniture. According to the Information Collection Request (ICR) submitted to the Office of Management and Budget (OMB), the Agency is expecting responses from standards development organizations, ecolabel programs, and certification entities with environmental performance standards for products. EPA is also asking these entities to participate in self-assessments, using checklists specific to each product category and based on the draft Guidelines, as well as in follow-up interviews with an independent assessor. The ICR was announced in a Federal Register notice published on Monday; public comments on the ICR must be received by May 25, 2016.

EPA developed the draft Guidelines in 2013 to help federal purchasers select appropriate private sector ecolabels and standards for environmentally preferable purchasing. In the ICR, EPA states: “While Federal purchasing policy is clear for the several standards and ecolabels that are listed in statute, regulation, or Executive Order, the lack of independently assessed information about and federal guidance on using other product environmental performance standards and ecolabels often results in an inconsistent approach by Federal purchasers and confusion and uncertainty for vendors and manufacturers.” With this ICR, EPA seeks to address this problem by testing an approach to determine which standards and ecolabels to support “in a fair, transparent, and consistent manner.” Ecolabels and standards will be assessed based on the criteria used in developing and managing the standards and ecolabels as well as “the effectiveness of the standards in ecolabels in protecting environmental and human health.”

EPA is contracting with two companies, Resolve and Industrial Economics, to conduct the pilot project to further refine the draft Guidelines and test how to assess standards and ecolabels. Resolve will “convene a coordinating Governance Committee, product category-specific multi-stakeholder panels,” while Industrial Economics will “develop and pilot test an approach” to assess standards and ecolabels in paints/coatings, flooring, and furniture.

Along with the ICR itself, the pilot project’s survey and assessment criteria are also available in the ICR’s docket (EPA-HQ-OPPT-2014-0838) on Regulations.gov.

FTC enforces on “all natural” claims in personal care products.

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Today, the Federal Trade Commission (FTC) announced proposed settlement agreements and consent orders with four companies for falsely marketing shampoos, sunscreen, and skincare products as “all natural” or “100% natural.” A fifth company was issued an administrative complaint for marketing “all natural sunscreen” that contains “a synthetic ingredient,” dimethicone. Other ingredients cited as “synthetic” by the FTC in the proposed consent orders include ethylhexyl glycol, phenoxyethanol, polyethylene, polyquaternium-37, polyquaternium-7, and caprylyl glycol. The complaints against all five companies allege that using such “synthetic” ingredients renders “all natural” claims false or misleading.

In these cases, the FTC’s proposed orders bar the companies from making misrepresentations in marketing a product about the following:

  • Whether the product is all natural or 100% natural;
  • The extent to which the product contains any natural or synthetic ingredient or component;
  • The ingredients or composition of the product; or
  • The environmental or health benefits of the product.

However, representations about these subjects are allowed under the proposed consent orders if the company “possesses and relies upon competent and reliable evidence” or “competent and reliable scientific evidence” that is “sufficient in quality and quantity based on standards generally accepted in the relevant fields when considered in light of the entire body of relevant and reliable evidence, to substantiate that the representation is true.”

Notably, today’s actions are not accompanied by an Enforcement Policy Statement or other guidance for companies not subject to the consent orders. FTC has raised questions in these enforcement actions such as: Which other commonly used ingredients in personal care products are “synthetic”? How does FTC determine whether a substance is “synthetic” or “natural”? Do plant-based versions of caprylyl glycol, for example, count as “synthetic”? Are processes and production considered as part of the “synthetic” vs. “natural” distinction, or just the sources or raw materials of the ingredients?

“All natural” claims are particularly difficult to substantiate because such claims are interpreted by consumers in a variety of different ways, and the various federal agencies that have jurisdiction over such claims in the United States have not provided much clarity. When issuing the revised Green Guides in 2012, for example, the FTC declined to provide guidance on “all natural” claims, citing the lack of data on how consumers interpret such claims. A December 2015 survey [PDF] by Consumer Reports found that misunderstanding about the meaning of “natural” in the food world was widespread; more than 80% of shoppers thought that in the context of processed foods, “natural” meant no pesticides were applied in production, no chemicals were used in processing, and that the food contained no Genetically Modified Organisms (GMOs) or artificial ingredients or colors. Meanwhile, the Food and Drug Administration (FDA) is still collecting public comments, through May 10, 2016, on using the term “natural” in food labeling.

EPA grants partial exemption from Chemical Data Reporting rule for six biodiesel chemicals.

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Today, EPA announced that six biodiesel chemicals will be partially exempt from certain reporting requirements of the Chemical Data Reporting (CDR) rule, under section 8(a) of the Toxic Substances Control Act (TSCA). The Final Rule amends the list of chemical substances exempt from submitting processing and use information by adding the six chemicals, all of which are involved in the production of biodiesel. These chemicals will still be subject to other CDR reporting requirements, on facility and manufacturing and import volume information.

The affected chemicals and their Chemical Abstract Services Registry Numbers (CASRNs) are:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (CASRN 67762-26-9);
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3);
  • Fatty acids, canola oil, methyl esters (CASRN 129828-16-6);
  • Fatty acids, corn oil, methyl esters (CASRN 515152-40-6);
  • Fatty acids, tallow, methyl esters (CASRN 61788-61-2); and
  • Soybean oil, methyl esters (CASRN 67784-80-9).

This partial exemption was granted as part of the petition process for “Low Current Interest” chemicals developed in 2003. Under this process, EPA considers the “totality of information” available for a particular substance and certain considerations, defined in the regulations, including the availability of other risk screening information and whether potential risks of the substance are adequately managed, in determining the agency’s “current assessment of the need for collecting CDR processing and use information.” The agency stresses that this process is not necessarily based on potential risks, and interest may increase in the future, in which case the agency would reconsider the applicability of the partial exemption.

In this case, EPA determined that it had low current interest in processing and use information for the six substances. The analyses (“Review Reports”) for the individual chemicals are available at docket number EPA-HQ-OPPT-2014-0809.

These chemicals were requested to be added to the partial exemption list in a petition submitted by a biofuels industry group in October 2014. EPA initially granted the petition in a Direct Final Rule published in January 2015, but withdrew the rule in March 2015 after receiving an adverse comment to the Direct Final Rule. The agency proposed to make the same additions to the partial exemption list in a Proposed Rule published July 22, 2015; the Final Rule announced today makes no changes from that Proposed Rule. However, the Final Rule does discuss comments submitted by the petitioner arguing that these biodiesel chemicals should be treated similarly to comparable “petroleum process” chemicals, which the EPA has designated partially exempt because the agency “believes worker exposure is diminished.” The agency made “no determination” on the petitioner’s argument that the biodiesel chemicals should be partially exempt because they share similar manufacturing conditions, properties, and uses as petroleum process chemicals, since the issue is “moot” as the agency is now granting equivalent partial exemption under the “Low Current Interest” process.

The EPA signed the Final Rule on March 22, 2016. The partial exemption goes into effect when the rule is published in the Federal Register, which should be well before the June 1 start of the 2016 CDR reporting cycle.

EPA and others weigh in on TSCA reform, but no reconciliation in sight.

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Although both chambers of Congress approved legislation in 2015 to modernize the Toxic Substances Control Act (TSCA), there has been little proof of progress towards reconciling the two bills, while stakeholders, including the United States Environmental Protection Agency (EPA), have been active in providing feedback and recommendations to legislators. However, Senator James Inhofe (R-OK), Chairman of the Senate Environment and Public Works Committee, recently told Bloomberg BNA that an agreement on merging the bills could happen before the next Congressional recess.

Overall, the EPA prefers the Senate version of legislation to update TSCA, according to a letter [PDF] sent earlier this year to Congressional leaders. EPA Administrator Gina McCarthy provided the Agency’s most comprehensive comments to date on the TSCA modernization bills passed by both houses of Congress in a letter dated January 20, 2016 but not made public until the beginning of March. The letter stops short of expressly recommending that the Senate bill be adopted as the framework for final legislation, but voices the EPA’s preference for various aspects of the Senate version while also approving certain provisions found in both bills. The EPA’s comments are based on the Administration’s previously discussed principles for TSCA reform, and were submitted to help negotiators reconcile the two bills, emphasizing that “[t]he lack of a workable safety standard, deadlines to review and act on existing chemicals, and a consistent source of funding are all fundamental flaws in TSCA that should be addressed.”

In particular, the EPA expressed support for the following aspects of the Senate bill:

  • Deadlines for chemical assessments and a requirement to repopulate the high-priority list until all chemicals on the TSCA Inventory have been evaluated;
  • Considerations EPA must assess in choosing a risk management measure, including costs and benefits of alternative ways to achieve the safety standard, based on reasonably available information;
  • Prioritizing chemicals for review based on manufacturer requests, subject to a cap on the number of manufacturer-initiated evaluations and funding from requestors;
  • Authorizing fee collection for the cost of reviewing confidential business information (CBI) claims, section 5 notices, prioritization decisions, safety assessments, and rulemakings;
  • Regulatory flexibility under a new section 6(d), providing “catch-all” regulatory authorities;
  • Affirmative safety determinations for new chemicals;
  • Strengthened civil and criminal enforcement authorities; and
  • Clarifying the types of state laws that are intended to be protected from federal preemption.

However, the EPA also wrote that it “strongly prefers the House bill” on the matter of implementation, because the Senate version’s deadlines and procedural requirements “may unnecessarily slow progress on more substantive issues, limit the EPA’s flexibility to allocate resources appropriately, and lead to burdensome litigation.” The letter also identifies some areas where both bills need improvement, or where the Senate version was not singled out as preferable, such as new use notification requirements for chemicals in articles.

The Hill reported that, after receiving the letter and incorporating suggestions from it, leaders of the House Energy and Commerce Committee Fred Upton (R-MI) and Frank Pallone Jr. (D-NJ) “sent an offer to the Senate …as the first formal step in negotiating toward a bill.” This offer addressed EPA’s main concerns by, for example, capping the number of industry-initiated risk evaluations, increasing funding for the program, and providing for safety determinations for new chemicals. The offer was reportedly made at the end of February but there have not been any public reports on whether the Senate responded or whether any other progress has been made since early March.

Plans to merge the competing bills might have been thrown off track earlier this month following reporting from the New York Times on a provision in the House legislation that “could help shield [Monsanto] from legal liability” related to its manufacture of polychlorinated biphenyls (PCBs). The article has drawn criticism of the House bill from some NGOs and even Presidential candidate Hillary Clinton.

Meanwhile, even more stakeholders have weighed in with their concerns and priorities. Environmental regulators from eight states, including California and New York, submitted a letter in early February focusing on the bills’ approaches to preemption issues. In late February, the American Alliance for Innovation, an umbrella group of dozens of trade associations, outlined its priorities for consideration in conference discussions.

Although Congress is perhaps closer than ever to passing a TSCA modernization bill, there has been little indication that legislators are making progress in getting legislation to the President’s desk. These most recent stakeholder comments may be just what Congress needs to speed up the process.

Help Wanted: Part-Time Environmental of Counsel Position

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Verdant Law, PLLC seeks an exceptional environmental lawyer for its Washington, DC office.  The firm needs support for its enforcement defense and compliance counseling practice.  Most matters involve internal investigations, audits, defense of agency enforcement actions, or regulatory compliance counseling.  The practice concentrates on product-based environmental, health, and safety requirements under federal laws, including the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the Federal Trade Commission Act (FTC Act), the Federal Hazardous Substance Act (FHSA), and the Occupational Safety and Health Act (OSHA).  (A description of the firm’s practice is available at www.verdantlaw.com.)

The position requires, on average, 25 hours per week and occasional travel.  The hourly rate will be dependent on experience and credentials.

Requirements:

The ideal candidate will have 5 years of experience in environmental law in an administrative or litigation capacity.  Experience in product-oriented fields, such as advertising, toxic tort, product liability, and consumer product regulation will also be considered.

Candidates must possess creative problem-solving skills, good writing skills, strong interpersonal skills, detail orientation, the ability to work independently, and good judgment.  A technical engineering or scientific background is also desirable.

Submittals:

Candidates should submit a resume, two pieces of original written work product that demonstrate the ability to discuss complex issues clearly and concisely in five pages or less, and three references.  To apply, please send application materials to Philip A. Moffat, Managing Principal, at pmoffat@verdantlaw.com.  No calls, please.

Congressional leaders at work on reconciling TSCA reform bills.

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Quickly reconciling the recently passed House and Senate bills overhauling the Toxic Substances Control Act (TSCA) is reportedly a top priority for congressional leaders this year. Earlier this month, Bloomberg BNA reported that House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. John Shimkus (R-IL), chairman of the energy committee’s Environment and the Economy Subcommittee, would be meeting privately to set the subcommittee’s agenda, including how to reconcile the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) and the TSCA Modernization Act (H.R. 2576). Senator James Inhofe (R-OK), chairman of the Senate Environment and Public Works Committee, also told reporters that he was meeting with Rep. Upton to discuss the same topic.

Asked when final legislation might come before Congress, Sen. Inhofe suggested as early as this month or next month. He also noted that priorities for reconciliation include “making sure the EPA does what they’re supposed to be doing in pre-classifying chemicals.” Rep. Upton told Bloomberg BNA that reconciling the two bills is “high on both of our agendas,” and Rep. Shimkus said he was “pretty optimistic.”

It remains unclear, however, if both chambers will hold a formal conference committee or find a compromise in private that would then be approved by the House and Senate.

The bills are supported by a broad range of industry stakeholders, including the 3M, American Apparel & Footwear Association, American Chemistry Council, BASF, Dow Chemical, DuPont, and the National Retail Federation.

However, state and territorial environmental regulators have taken a more critical position. Last week, the Environmental Council of States released an analysis of the two bills highlighting provisions and sections that should be added or retained during reconciliation. Although not an official position of the organization, ECOS said the analysis is meant to be “a guide to selected issues of interest” to state environmental agencies. The analysis focuses mainly on preemption issues, including timing, grandfathering, and waivers, as well as the requirement that EPA share Confidential Business Information (CBI) data with states, and largely favors the Senate bill. However, the analysis also strongly advocates eliminating several provisions from the Senate version, including those authorizing a “regulatory pause” on state action and industry requests for safety determinations.

Yesterday, Chemical Watch reported that the Society of Chemical Manufacturers and Affiliates (SOCMA) sent a letter to key members of Congress expressing its preference for certain features of the House bill. SOCMA, the trade group for specialty chemical manufacturers, cited the House version’s stronger protections for the confidentiality of chemical identity. The trade group argued that the Senate version would have the perverse effect of discouraging submitters of Premanufacture Notices (PMNs) from conducting health and safety studies, which would trigger the disclosure of chemical identity information. SOCMA also wrote in support of the House bill’s provisions on fees, which are linked to recovering costs for the TSCA Section 5 program and do not apply to businesses that are exempt from submitting data, whereas the Senate bill authorizes fees for exemption requests. In addition, the letter urged Congress “to resist calls to adopt an approach that would prevent a [PMN] submitter from commencing manufacture until EPA issued its determination, even if EPA missed its 90/180-day deadline.”

U.S. Senate passes TSCA reform bill.

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Today, the U.S. Senate broke its months-long deadlock on chemical safety reform and approved by voice vote the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (S. 697). The bill, sponsored by Senators David Vitter (R-LA) and Tom Udall (D-NM), overhauls the decades-old Toxic Substances Control Act (TSCA) for the first time. We previously discussed aspects of S. 697 upon its March introduction and approval, a month later, by the Senate Environment and Public Works Committee.

After two years of negotiations, the legislation earned the support of 60 Senators of both parties as well as industry and many environmental groups. However, the bill was held up in October by Senators Richard Burr (R-NC) and Kelly Ayotte (R-NH), who were seeking to renew the Land and Water Conservation Fund. After that hold was lifted earlier this week, Sen. Barbara Boxer (D-CA), who has long criticized the proposal as too weak, placed another hold on the bill. Sen. Boxer reportedly lifted her hold after being promised that the legislation would be changed in reconciliation to more closely match the bill passed by the House (H.R. 2567) in June, which Sen. Boxer considers more protective.

The main issue legislators will face in reconciliation will likely be whether states will be allowed to impose tighter restrictions than federal standards.