FDA seeks input on “natural” food labels.

Last week, the U.S. Food and Drug Administration (FDA) announced that it is seeking comments and information on the use of the term “natural” in food labeling. The move is in response to three citizen petitions, from industry stakeholders, requesting that the agency define “natural” for food labeling and one citizen petition, from Consumers Union, asking for a prohibition on the term. The FDA also stated that it is working with the U.S. Department of Agriculture (USDA) to examine “natural” labeling for meat, poultry, and egg products.

The last time the FDA considered establishing a definition for “natural” in food labeling was 1991, when it published a proposed rule on labeling and sought comment on whether the agency “should establish a meaningful definition for ‘natural’ so that this term would have a common consumer understanding, and whether it should prohibit ‘natural’ claims entirely on the grounds that they are false or misleading.” FDA declined to define “natural” by rulemaking in 1993, but has continued to maintain its policy that labeling a food as “natural” means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food.” Critically, the FDA’s policy does not address methods of food production (like genetic engineering or pesticide use) or processing and manufacturing (like pasteurization), nor whether “natural” describes any nutritional or health benefit.

The three petitions to the FDA regarding “natural” labeling all seek guidance on whether “natural” can apply to certain methods of food production, processing, and manufacturing. Two of the petitioners requested better harmonization with the USDA’s Food Safety Inspection Service standards. The Consumers Union petition, seeking a prohibition on “natural” food labeling, argues that “natural” is “vague and misleading,” citing a Consumer Reports National Research Center survey. That survey “suggests that nearly two-thirds of U.S. consumers are currently misled by use of the term ‘natural’ on certain food labels and nearly 90 percent expect it to ‘mean much more than it does.’”

The FDA has posed several specific questions to commenters on when “natural” labeling is misleading to consumers, including input on application to food production, processing, and manufacturing practices, as well as a request for consumer perception data on confusion with terms like “healthy” and “organic.” The agency is accepting comments through February 10, 2016, via docket number FDA-2014-N-1207.

TSCA reform becomes filibuster proof, but floor vote remains elusive.

Last week, the U.S. Senate came closer to passing bipartisan legislation to reform the Toxic Substances Control Act (TSCA) than ever before – but still failed to bring S. 697 to the floor. The bill, co-authored by Senators Tom Udall (D-NM) and David Vitter (R-LA), is still not scheduled for a floor vote, which will have to wait until after Congress returns from its Columbus Day recess.

On Friday, October 2, the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” reached the filibuster-proof level of 60 cosponsors with the added support of Senators Ed Markey (D-MA) and Dick Durbin (D-IL). The new cosponsors came aboard as part of a deal promising changes to the bill, including increases to the annual funding cap for industry fees from $18 million to $25 million and measures to streamline the state preemption waiver process. At the same time, Senator Barbara Boxer (D-CA), who has been a vocal critic of the bill, reportedly agreed to allow S. 697 to advance. On Thursday, a diverse alliance of advocates – including the American Chemistry Council and Environmental Defense Fund – rallied outside the Capitol to support the legislation.

However, the news and optimism was quickly overshadowed by the announcement on Monday, October 5, from Senators Richard Burr (R-NC) and Kelly Ayotte (R-NH) that they would block consideration of the TSCA reform bill unless reauthorization of the Land and Water Conservation Fund (LWCF) was added as an amendment.

The LWCF proposal was met with resistance by Senators Udall and James Inhofe (R-OK), chair of the Environment and Public Works Committee, who are trying to keep out amendments that are not “germane.” In a letter to Senate Majority Leader Mitch McConnell (R-KY), Senate Democratic leaders pushed for separate floor time to address the reauthorization of LWCF, with the hope of clearing the way for TSCA reform.

Instead, the Senate adjourned today for a week-long recess without voting on the matter, meaning the Udall-Vitter bill could not reach the floor until October 19, at the earliest. Senators Udall and McConnell are said to be working on resolving the LWCF roadblock in order to secure the passage of S. 697, which is expected to pass easily once the procedural hurdles of scheduling a floor vote are surpassed.

FTC warns users and providers of environmental certification seals.

Earlier this month, the Federal Trade Commission (FTC) sent warning letters to five providers of environmental certification seals and 32 businesses using those seals on their websites. The FTC is concerned that the seals may be deceptive according to Section 5 of the FTC Act, and may not comply with the agency’s environmental marketing guidelines, known as the “Green Guides.” The letters request that the recipients advise on what steps they are taking to bring their marketing into compliance. The agency is not disclosing the names of the companies that received the warning letters.

According to the Green Guides, unqualified general environmental benefit claims and environmental certificates or seals are likely to convey a wide range of meanings to consumers; i.e., consumers may see a picture of a leaf or the word “green” and assume that means the product is made of recycled materials or manufactured with renewable energy, even if those claims are nowhere to be found. Thus, the Guides caution marketers against using unqualified general environmental benefit claims – like “eco-friendly” – or environmental seals that do not convey “the basis for the certification.”

According to the warning letters, the environmental certification logos at issue do not convey the basis for the certification and are not accompanied by “clear and prominent qualifying language that limits the claim to a specific benefit.” Furthermore, the FTC cites their “.com Disclosures” guidance in noting that such a logo on a company’s website is “not likely an effective hyperlink label leading to the necessary disclosures.”

In its Business Blog, the FTC has a post on “Performing seals” which discusses the matter and advises on the following “key principles” about the use of environmental certifications and seals of approval:

  • Without careful qualification, general environmental benefit claims pose a risk of deception. Under the FTC Act, deception can occur inadvertently if the marketer does not have substantiation for consumers’ interpretations of claims. For example, if a product conveys an unqualified “eco-friendly” claim, and a consumer interprets that to mean that the product is carbon neutral and non-toxic, then the product maker may be on the hook for deception unless it has evidence to prove that the product is, in fact, carbon neutral and non-toxic.
  • Certifications and seals that don’t explain the reason for the thumbs-up may convey broad claims that can’t be substantiated. BecGreen Certification Examples - Good and Badause it is unlikely that companies can substantiate the vast array of claims that consumers can potentially interpret from an unqualified environmental certification seal, the FTC urges against using “seals that do not convey the basis for the certification.” The FTC’s blog post also includes a helpful visual illustrating good and bad examples of using an environmental certification seal (at right):
  • Companies can take steps to reduce the risk of deception. As discussed in the Green Guides, visuals like certification logos should be accompanied with “clear and prominent qualifying language that clearly conveys that the certification or seal refers only to specific and limited benefits.” In the “Good Example” of an environmental certification seal, for example, the words “Biodegradable,” “Recyclable,” and “Compostable,” are clearly displayed next to the certification logo.
  • Logos themselves aren’t likely to be effective hyperlinks. Companies should not assume that readers will click on the logo image, and instead include explanatory information in large, easy-to-understand text, right next to the logo. In cases where not all attributes can be listed next to the seal, companies should display sufficient information upfront to explain why readers should click the clear and prominently placed link.
  • Both the certifier and the advertiser have responsibilities under Section 5 of the FTC Act. In its letters to certifiers, the FTC notes that the certifiers’ websites do not appear to provide instructions to marketers on using qualifying language.
  • The FTC has resources for companies that want to keep green claims clean. Here, the FTC refers to the Green Guides as well as its Statement of Basis and Purpose [PDF] for more detail. More resources are available on the FTC’s Environmental Marketing

The FTC has not determined whether the letter recipients’ claims violate the law and is not taking any law enforcement actions at this time.

California releases draft Alternatives Analysis guidance under Safer Consumer Products program.

Today, California’s Department of Toxic Substances Control (DTSC) released the first part of draft guidance on conducting Alternatives Analysis (AA) under the state’s Safer Consumer Products (SCP) program.

The Draft Stage 1 Alternatives Analysis Guide (AA Guide) covers the first of the two stages of the AA process, which entails an initial screening of alternatives and preliminary analysis. During Stage 1, “the responsible entity identifies the goal, scope, legal, functional, and performance requirements of the Priority Product and the Chemical of Concern, and uses this information to identify an array of alternatives to consider.” At the end of Stage 1, the analysis findings, work plan, and implementation schedule are documented in a Preliminary AA Report which is submitted to DTSC.

DTSC reports that a draft guide for Stage 2 will be released in the first quarter of 2016. In Stage 2, the responsible entity follows the Work Plan approved in Stage 1 and conducts an in-depth analysis considering impacts such as life cycle and cost. This process culminates in selecting an alternative and making a regulatory response recommendation.

The Draft Stage 1 AA Guide also notes that companies have alternative compliance options to the AA process if an AA or similar comparative analysis has already been completed, or if the company prefers a different AA approach. After demonstrating to DTSC that the alternate approach is “adequate for evaluating the Priority Product and the alternatives” and “sufficiently equivalent to the AA process described in the regulations,” responsible entities may choose instead to conduct an Abridged AA or Alternate Process AA, or use a previously completed AA.

The draft AA Guide discusses in detail the following topics:

  • Product Requirements and Alternatives – including product function and performance, legal requirements, and the role of the Chemical of Concern.
  • Relevant Factors – how to use an iterative process to identify “relevant factors” used throughout the AA process to characterize, evaluate, and compare impacts of the Priority Product and its alternatives.
  • Impact Assessments – approaches, tools, and information sources a responsible entity may use to conduct analyses throughout the AA process.
  • Screening Alternatives – considerations for and approach to screening, assessing tradeoffs, and conducting limited screens.

DTSC will hold two webinars to discuss the Draft Stage 1 Alternatives Analysis Guide, on October 7 and October 21. The comment period on the Guide runs through October 23, 2015.

EPA issues final Significant New Use Rule for HBCD in textiles.

EPA has released the prepublication version [PDF] of its final Significant New Use Rule (SNUR) for the brominated flame retardants hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). HBCD is persistent, bioaccumulative, toxic, and poses potential human health concerns, including reproductive and developmental effects. This Final Rule designates the use of HBCD in consumer textiles as a significant new use which must be reported to EPA at least 90 days in advance. Under this SNUR, consumer textiles include “bolts of cloth and draperies, as well as textiles that are part of household furniture and mattresses.” The Rule does not apply to the use of HBCD in motor vehicles or other current uses, such as non-consumer textiles, like firefighters’ suits, and building insulation.

The SNUR partially revokes the usual articles exemption, 40 CFR 721.45(f), meaning that the rule’s notification requirements apply to importers and processors of HBCD as part of a “textile article,” like an upholstered chair. Notably, the SNUR applies to all importers and processors of HBCD as part of a textile article, regardless of whether it is a “consumer textile.” EPA’s rationale is that “if the inapplicability of the exemption was limited to consumer textiles, undifferentiated textiles (e.g., the type of textiles that could be for a consumer use or a non-consumer use), could be imported or processed and distributed in commerce for consumer use without notification to the Agency.”

The SNUR subjects exporters of HBCD in consumer textiles to the export notification requirements of Section 12(b) of the Toxic Substances Control Act (TSCA). However, EPA declined to require § 13 import certification for HBCD as part of articles.

EPA has made two changes to this SNUR since it was first proposed in 2012. First, the agency narrowed the inapplicability of the articles exemption to apply only to importers and processors of HBCD as part of a textile article. Thus, importers and processors of HBCD in non-textile articles are not subject to the SNUR. In addition, EPA made minor clarifying changes to its definition of “consumer textile,” which is now defined as follows:

Consumer textile means any cloth, fabric, or other item produced during a milling process for textiles (including spinning, weaving, knitting, felting, or finishing), that is sold or made available either as a product or as part of a product, to a private individual who uses it in or around a permanent or temporary household or residence, during recreation, or for any personal use or enjoyment. Consumer textiles can include, but are not limited to, bolts of cloth and draperies, as well as textiles that are part of upholstered household furniture and mattresses.

EPA also rejected commenters’ requests to establish a “policy framework by rule for the issuance of article SNURs.” The agency responded that a policy framework was not necessary to reach the conclusion that notification should be required for importing or processing HBCD in consumer textiles.

HBCD has recently been subject to significant scrutiny by EPA and others. Last month, EPA issued initial documents for its TSCA Work Plan risk assessment of HBCD in foam and polystyrene products. In 2014, EPA’s Design for Environment (DfE) program released an Alternatives Assessment for HBCD, identifying safer alternatives in foam insulation applications. The Consumer Product Safety Commission (CPSC) has been petitioned by a coalition of environmental, health, and consumer advocates to ban certain products containing HBCD and related flame retardants. Outside the U.S., HBCD was added as a prohibited substance to the Stockholm Convention on Persistent Organic Pollutants and is being withdrawn in Europe under REACH.


EU court rules on notification requirements for REACH articles.

Under Europe’s Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, notifications are required for components of complex products that meet the 0.1% threshold concentration for certain chemicals, the European Court of Justice (ECJ) has ruled. The court’s decision, issued last week, overturns guidance issued in 2011 by the European Commission and European Chemicals Agency (ECHA). Interpreting Articles 7(2) and 33 of REACH, which require disclosures when an article contains more than 0.1% by weight of Substances of Very High Concern (SVHC), the ECJ found that “there is no need to draw a distinction …between the situation of articles incorporated as a component of a complex product and that of articles present in an isolated manner.” Thus, notification duties apply based on the concentration of SVHCs in component articles that make up a complex product, rather than the complex product’s total weight.

According to the court, a “complex product” is “made up of a number of manufactured objects meeting the criteria laid down in Article 3(3),” which defines an “article” as “an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.” Further,

It is therefore only if the production of an object using a combination of more than one article gives that object a special shape, surface or design which is more decisive for its function than its chemical composition that that object may be classified as an article. Accordingly, unlike a simple assembly process, that production process must alter the shape, surface or design of the articles used as components.

Article 7(2) requires producers and importers of articles to notify ECHA if an SVHC is present at a level greater than 0.1% and totals over one tonne per year. Under Article 33, suppliers must inform recipients of articles containing SVHCs at this level, and provide similar information in response to consumer inquiries within 45 days.

The court ruled that a “producer’s duty to notify covers only those articles which the producer itself has made or assembled,” while third-party assemblers must make notifications for complex products it assembles. Importers are subject to notification duties for articles that comprise components of complex products. Suppliers’ notification duties, which include providing the name of the SVHC, apply “to all operators along the supply chain.”

The ECJ’s decision affirms the position of France, Belgium, Denmark, Germany, Austria, Sweden, and Norway, and is in line with the opinion published in February by an ECJ Advocate General, a legal advisor to the court. According to Chemical Watch, ECHA said it will begin the process of revising its guidance in light of the ECJ’s ruling.

Alternatives Assessments for flame retardants in flexible polyurethane foam and printed circuit boards finalized.

Yesterday, EPA released two final Alternatives Assessment reports, for flame retardants used in flexible polyurethane foam and printed circuit boards, as well as a technical correction to an alternatives assessment report on bisphenol A (BPA) in thermal paper. These reports were developed under the agency’s Design for Environment (DfE) program to characterize chemical hazards and identify safer chemicals, and continue EPA’s scrutiny of flame retardant chemicals.

The final Alternatives Assessment for flame retardants used in flexible polyurethane foam finalizes the draft update, released in June 2014, to a 2005 report on the flame retardant pentabromodiphenyl ether (pentaBDE). PentaBDE was voluntarily phased out by industry in the U.S. in 2004, and is subject to a proposed Significant New Use Rule and section 4 test rule under the Toxic Substances Control Act (TSCA) as part of the EPA’s Polybrominated Diphenyl Ethers (PBDEs) Action Plan. The final report evaluates 19 alternatives, including one non-proprietary mixture and two proprietary mixtures, and covers all upholstered consumer products containing flexible polyurethane foam, including car seats and nursing pillows. In addition, EPA released a document responding to public comments to the draft report [PDF].

EPA also finalized its Alternatives Assessment report for flame retardants in printed circuit boards used in electronic products, like computers and cell phones, and released a response to comments on the 2014 draft report [PDF]. The Alternatives Assessment was published in draft form in December 2014 as an update to a draft first released in 2008. As in the 2014 draft, the final Alternatives Assessment focuses on alternatives to tetrabromobisphenol-A (TBBPA), a commonly used halogenated flame retardant which is also the subject of a recently released TSCA Work Plan Problem Formulation and Initial Assessment. Based on a confidential study and comment submitted following the release of the 2014 draft report, the final Alternatives Assessment changed the skin sensitization designation for magnesium hydroxide from Moderate to Low. Responding to another comment, EPA elaborated on performance testing of halogen-free flame-retardant printed circuit boards, which reportedly “found that the eight halogen-free flame retardant laminates tested generally outperformed the traditional… laminate control.”

The technical correction revises a final Alternatives Assessment report for BPA in thermal paper originally released in January 2014. BPA, a high production volume (HPV) chemical, is commonly used as a developer in thermal paper, like cash register receipts. The correction changes the developmental toxicity designation of one alternative, Pergafast 201, from High to Moderate. The change is based on further analysis of new data submitted in response to the draft report.

EPA releases initial TSCA Work Plan assessments of four flame retardants.

Last week, EPA released preliminary assessment documents for four structurally similar flame retardant chemical clusters. These documents represent the first step in the Toxic Substances Control Act (TSCA) Work Plan Chemical assessment process for these substances, which were all on the Work Plan list. The TSCA Work Plan is the agency’s program to evaluate potential risks of existing chemicals, first introduced in 2012 and updated in 2014. The notice of the availability of these assessments will be published in the Federal Register on August 18.

EPA released Problem Formulations and Initial Assessments for three flame retardant chemical clusters:

  • Tetrabromobisphenol A (TBBPA), also known as Brominated Bisphenol A – used in plastics and printed circuit boards;
  • Chlorinated phosphate esters – used in furniture foams and textiles; and
  • Cyclic aliphatic bromides/hexabromocyclododecane (HBCD) – used in expanded polystyrene foams and polystyrene foam products.

The Problem Formulations and Initial Assessments discuss likely exposure and hazard scenarios to workers and consumers, based on current production, use, and exposure information. These assessments aim to identify scenarios where further risk analysis may be necessary. In the case of these three flame retardants, EPA will conduct assessments of risk to human health (workers and consumers) and the environment. EPA will accept public comment on these Problem Formulations and Initial Assessments for 60 days.

In addition, EPA released a Data Needs Assessment for the Brominated Phthalates (TBB and TBPH) cluster of flame retardants used in polyurethane foam products. After reviewing previous assessments of this cluster, EPA identified critical gaps in existing data on toxicity, exposure, and commercial mixtures. The Data Needs Assessment for brominated phthalates is meant to guide the collection of additional data and information and provide stakeholders and the public with the opportunity to submit data or information that may fill the identified gaps. As information is identified or submitted, the agency will “continue to evaluate the adequacy of the database to conduct a risk assessment that can inform decision making.” Public comment on the Data Needs Assessment will be accepted for 120 days.

EPA to hold training webinars on TSCA section 5 e-PMN electronic reporting system.

Today, U.S. EPA announced a series of webinars to assist submitters with the agency’s new web-based system for Toxic Substances Control Act (TSCA) Section 5 submissions. The new electronic reporting system, finalized by rule last month, applies to premanufacture notices (PMNs) and certain other § 5 notices and support documents. The three webinars will walk submitters through the process of registering with EPA’s Central Data Exchange (CDX) and using the new, cloud-based e-PMN software to complete PMNs and other submissions. The webinars are scheduled for August 26, September 16, and September 30; audio recordings and slides will be posted online for those unable to attend.

OSHA releases Hazard Communication Standard inspection procedures.

The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has released a new Directive outlining the changes in enforcement caused by the modification of the Hazard Communication Standard (HCS 2012) to harmonize with the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The new Directive, titled Inspection Procedures for the Hazard Communication Standard (HCS 2012), describes how to determine if a violation has occurred under the revised standard as well as how it will be enforced both during its transition period and after full implementation.

The Inspection Procedures note that HCS 2012 is based on GHS Revision 3 (2009), not the more recent Revisions 4 or 5 issued by the UN in 2011 and 2013, respectively. The Directive notes that using a more recent version of GHS may result in noncompliance with HCS 2012 “if it contradicts or casts doubt on OSHA required information.” Notably, OSHA requires that precautionary and hazard statements incorporated from GHS be changed to mandatory, e.g., “should” must be replaced with “shall.”

The Directive provides significant discussion on hazard classification under the revised standard. Classification must be based on criteria specific to each hazard class, and evaluations must “consider all available data on the hazards.” Other considerations include quality and quantity of data and positive and negative results in a single weight-of-evidence determination. Detailed evaluation procedures are included in the Directive’s appendices. In terms of inspection guidelines, the Directive notes that “[t]he adequacy of a company’s hazard classification should be assessed primarily by examining the outcome of that classification.”

The HCS 2012 labeling and SDS requirements went into effect on June 1, 2015 (except for distributors, for whom labeling requirements do not apply until December 1, 2015). However, where a company has “exercised ‘reasonable diligence’ and ‘good faith’ to obtain HCS 2012-compliant SDSs from upstream suppliers but have not received them, they will be allowed limited continued use of HCS 1994-compliant MSDSs and labels.”