January 2015

January Feature: The regulatory arena…

cover-comp
As we usher in 2015, many questions arise as to what the regulatory arena will look like. In an effort to bring readers a variety of perspectives, SPRAY surveyed regulatory experts and researched various sources to bring together a comprehensive look at what lies ahead in the aerosol and related industries.

Fratz

Fratz

D. Douglas Fratz, Senior Science Fellow & Aerosol Products Division Executive, The Consumer Specialty Products Association (CSPA)

Aerosol and other consumer products will face a number of challenges at the state, federal and international levels in 2015, many carried over from 2014.

At the state level, the California Dept. of Toxic Substances Control (DTSC) will continue implementing the Safer Consumer Products Regulation. The department has released a work plan identifying product categories of interest and intends to name five to ten products each year, in addition to the three priority products that were announced in 2014.

Another carry-over from 2014 action in California is the Consumer & Commercial Products Survey, because companies will continue to dedicate significant time and resources in responding to this activity. The scope of the survey is unprecedented both in terms of the expanded number of products and the scope of data being required. Many companies will be challenged to meet the March 2, 2015 deadline for completing the initial year’s reporting of 2013 products because they will also need to begin the second-year reporting of 2014 products by the end of this year.

A new action in 2015 will be the updated ozone State Implementation Plan. The South Coast Air Quality Management District (SCAQMD) and the California Air Resources Board (CARB) will begin developing the plan for submission to the U.S. Environmental Protection Agency (EPA) in 2016. The plan will contain new commitments for volatile organic compounds (VOC) reductions from consumer products.

Data gleaned from the CARB survey will help form the extent of the commitments, as will the results of ongoing research projects conducted by CARB and the industry on the impacts of Low Vapor Pressure (LVP) and VOCs on ozone and particulate matter. For example, the survey covers over 500 categories of consumer products, some of which have never been surveyed before.

Federal
At the federal level, the EPA will finalize its rule under the Significant New Alternatives Policy (SNAP) Program to eliminate many current uses of the aerosol propellant HFC-134a. The CSPA filed extensive comments on the August 2014 proposal, seeking a few more allowed uses and additional time beyond the January 2016 proposed phase-out deadline.

The EPA will continue implementing its Work Plan Chemical Program to evaluate the safety of specific chemical uses under the existing Toxic Substances Control Act (TSCA), as efforts continue to modernize it.

The U.S. Occupational Safety & Health Administration (OSHA) will continue implementing its 2012 Hazard Communications Rule, with critical 2015 deadlines for revised labeling and Safety Data Sheets. The rule implements the Globally Harmonized System of Classification & Labeling (GHS) in the U.S. workplace.

The U.S. Dept. of Transportation (DOT) is planning to issue a major proposed transport rule that would be the most extensive update in many years.

Retailers as regulators
Non-traditional regulators will continue to emerge in 2015; retailers are establishing new requirements for consumer products. One common theme so far is the desire for ingredient communication. Wal-Mart will require certain consumable products it sells to have ingredients communicated on a website starting January 2015, and Target will base 20% of its product sustainability score on ingredient disclosure. The CSPA Consumer Product Ingredients Dictionary can assist companies in compliance with these retailers’ policies. The CSPA has been communicating with various retailers to assure that their sustainability initiatives result in improvements to our member companies’ products, rather than conflicting standards that deter innovation.

Aerosol recycling
The CSPA also continues efforts to encourage increased recycling of used aerosol products consistent with good product stewardship and numerous retailers’ sustainability goals. All empty aerosol containers are fully recyclable and rates continue to climb. A caution, however, is the Federal Trade Commission (FTC) interpretation that the phrase “please recycle when empty” is an environmental marketing claim. Therefore, data is needed to show a substantial majority of consumers have access to aerosol recycling before companies can place such a claim on their product labels.

The CSPA has already partnered with the Steel Recycling Institute to obtain the necessary data for steel aerosol containers. The goal for 2015 is to obtain the additional data for aluminum aerosol containers to show their recyclability.

NFPA
As a final challenge, the National Fire Protection Association (NFPA) recently issued its 2015 edition of NFPA Code 30B, which covers the manufacturing, warehouse storage and retail display of aerosol products. The update is extensive. It will be phased into use by local and state fire and building officials in 2015. The CSPA worked to ensure that the new fire code requirements are science-based and provide cost-effective protection against aerosol fire risks.

Quinonez

Quinonez

Nicole Quinonez, Randlett/ Nelson/ Madden, consultant to the National Aerosol Association (NAA)

It’s amazing what an impact one building can have on businesses across the globe. The California Dept. of Environmental Protection (Cal EPA) headquarters in Sacramento, CA, is one such building. Cal EPA is the home to the Dept. of Toxic Substances Control (DTSC), CalRecycle, California Air Resources Board (CARB) and the Office of Environmental Health Hazard Assessment (OEHHA), to name a few. These departments are actively pursuing programs which promise to have major impacts on business. Most readers are likely familiar with activities at CARB, so I will focus on the other three departments.

The Safer Consumer Products program, run by DTSC, released its first set of three priority products/chemical combinations in March 2014. The first three priority products were:

  • Spray Polyurethane Foam (SPF) systems containing unreacted diisocyanates,
  • Children’s Foam Padded Sleeping Products containing Tris(1,3-dichloro-2-propyl) phosphate or TDCPP
  • Paint and Varnish Strippers with methylene chloride

DTSC plans to place these priority products into regulation in early 2015. Once they are placed into regulations, manufacturers of these priority products will have approximately two years to perform an Alternative Analysis (AA) report. Based on the AA, DTSC may pursue a number of regulatory responses ranging from product labeling to sales prohibition.

DTSC also released a draft work plan laying out potential priority product listings for the next three years. This report included six broad product categories they would be looking at to determine future priority products. One product category is building products, which includes paints, primers and graffiti removers. The draft plan is expected to be finalized in early 2015 and the next set of priority products will be identified at that point.

For the past two years, CalRecycle has been developing a plan to reach its required 75% recycling goal. A workshop was held in November 2014 to continue its discussions of how California will meet its goal through recycling, composting or source reduction of solid waste by 2020. CalRecycle stated in their background paper that they intend to focus on paper and plastic products and its preference to implement mandatory Extended Producer Responsibility (EPR) programs (a strategy designed to promote the integration of environmental costs associated with goods throughout their life cycles into the market price of the products) to meet the aggressive requirement of 75%. CalRecycle did say they currently do not have the authority to implement mandatory programs, which should lead to legislation in 2015 designated to give them that power.

OEHHA is pursuing changes to the Prop 65 regulations that require businesses to list warnings on their products if they contain chemicals known to cause cancer or birth defects or other reproductive harm. The department has shared draft regulations for stakeholders to review and share feedback. These draft regulations included a requirement to identify up to 12 specific chemicals in a warning, foreign language requirements for warnings and changes to the safe harbor provisions. The formal regulation process is expected to begin in early 2015.

Raymond

Raymond

Doug Raymond, Raymond Regulatory Resources (3R), LLC

I have been accused of being a bearer of bad news; so as to not to disappoint anyone, here is my outlook for 2015. Two areas of regulation I see ramping up are volatile organic compounds (VOC) and Green Chemistry. The U.S. Environmental Protection Agency (EPA) is likely to pass a new, stricter ozone standard early in 2015. This means that numerous states will be trying to find more emission reductions. Therefore, more states are likely to follow the Ozone Transport Commission’s (OTC) and California Air Resources Board’s (CARB) lead on Consumer Product regulations. Likewise, CARB and OTC will then need to find more emission reductions. CARB will likely start new Consumer Product rule developments in late 2015 and early 2016.

Regarding Green Chemistry regulations, California has taken the lead on these types of regulations calling them the Safer Consumer Products regulations. I believe most states will hold off on these types of regulations until they see how California handles its current regulation. This current draft regulation will likely take a year to finalize, which means very late in 2015. Green Chemistry-type regulations are new for the industry and affect how products are formulated. Currently, California has a three-year plan that includes a majority of our [aerosol] products. Therefore, for the foreseeable future, Green Chemistry will be another regulation that the industry will need to deal with on an ongoing basis. This adds another dimension to the formulation of Consumer Products.

Another extremely important issue involves trying to comply with the Global Harmonization System (GHS) by the 2015 deadlines. Likewise, the Significant New Alternatives Policy (SNAP) amendments will be finalized in 2015 and we will have to deal with that regulation as well.

Ahmed

Ahmed

Farah K. Ahmed, Associate General Counsel & Tom Myers, Associate General Counsel, The Personal Care Products Council (PCPC)

Sunscreens are an important over-the-counter (OTC) drug used to protect individuals from the damaging effects of the sun. Sunscreen sprays are a popular means of administering sunscreens on children, especially because we know that one bad sunburn in childhood doubles the risk of developing skin cancer later in life.

The U.S. Food & Drug Administration (FDA) is in the process of developing regulations addressing the use of spray sunscreens. In 2011, FDA published an advance notice of proposed rulemaking (ANPR) acknowledging sprays as an appropriate sunscreen dosage form and requested additional data to support their effectiveness and safety, as well as comments on potential changes in labeling of sunscreen sprays (e.g., hold container four to six inches from the skin to apply; do not spray directly into face; spray on hands then apply to face; do not apply in windy conditions; use in a well-ventilated area).

Myers

Myers

PCPC provided data and information supporting the efficacy and safety of sunscreen sprays, and supported FDA’s proposed labeling changes. In addition, PCPC has worked to scale back the scope of a consumer product survey being conducted by the California Air Resources Board (CARB), which requires companies to report formulations and sales data over a three-year period in an effort to develop a baseline for volatile organic compound (VOC) emissions in the California marketplace. Sunscreens, and other OTC drugs, are included within the scope of the survey. Although the survey continues to be challenging for reporting companies, it is far less onerous than originally proposed thanks to an engaged business community.

Likewise, PCPC continues to focus on challenges presented by California’s Proposition 65, which lists chemicals that have been identified by an authoritative body as carcinogenic or reproductive toxicants. In 2012, titanium dioxide (TiO2), an important sunscreen ingredient, was listed as a carcinogen. After many rounds of intense negotiations with CARB, we were successfully able to ensure that certain “qualifiers” were included in the Prop 65 listing, limiting TiO2 to only that which is airborne, respirable and unbound.

In 2015, PCPC will work with the FDA to make progress on advancing the ANPR towards finalization of regulations on sunscreen spray dosage forms; help companies as they seek to comply with the onerous CARB survey; and take steps to ensure that ingredients important to sunscreen formulations—and other personal care product formulations—are not listed to Prop 65, or if they are, to ensure an appropriate “safe harbor” level is established.

McAuliffe

McAuliffe

Heidi McAuliffe, Senior Counsel, Government Affairs, American Coatings Association (ACA)

In California, the amendments to the aerosol coatings reactivity regulation have become final and aerosol coatings manufacturers must comply with the first deadline of Jan. 1, 2015 for products in Specialty Category B along with general labeling requirements for all categories. In addition, since the compliance verification issues for aerosol coatings have been addressed in these amendments, the industry should expect renewed and aggressive enforcement efforts. Many of the category definitions have been modified and the “restrictive limit” requirement will be aggressively reviewed by the California Air Resources Board’s (CARB) Enforcement Division.

Until now, the aerosol coatings industry has enjoyed uniform standards as the U.S. Environmental Protection Agency (EPA) agreed to adopt the CARB standards in 2008. With the recent amendments, this uniformity has disappeared and the industry must comply with a California rule and an EPA rule that have different standards, definitions, categories and, most importantly, reactivity values for calculating compliance.

In the global marketplace, it is difficult to predict the “regulatory future” for aerosol coatings. To date, efforts to convince the EPA to expedite changes to its rule have fallen on deaf ears. Accomplishing this will require a long term effort. This leads to the question of how other governmental bodies will react to CARB’s more stringent standards. Because CARB amendments have eliminated the consistent and uniform standards for aerosol coatings, and it will likely be years before EPA initiates a rulemaking to address this disparity, it leaves open the possibility that state agencies may again revisit the aerosol coatings for potential rulemaking— especially if the ozone standard is further reduced—placing more pressure on the states to find emission reductions.

A few years ago, ACA and the Canadian Paint & Coatings Association convinced Environment Canada to forgo any regulatory action for aerosol coatings specifically because CARB was in the process of a rulemaking. Consequently, Environment Canada may be considering its “regulatory options” for this source category.

Given all these considerations, the regulatory environment for aerosol coatings will likely include enhanced enforcement from California and the potential for further regulatory activity at the EPA, potentially some state agencies and Canada.

Moffat

Moffatt

Mike Moffatt, PhD, Director of Communications, Nexreg Compliance Inc.

The big regulatory battle in North America (and around the world) in 2015 and beyond will be concern the issue of ingredient disclosure. The Canadians have followed the lead of countries around the world with the implementation of the Globally Harmonized System of Classification & Labeling of Chemicals (GHS), removing the disclosure exemption for flavors and fragrances. Companies who wish to keep this information secret will have to apply for trade secret status at considerable expense. For products that are in dozens of markets, the costs rise exponentially as trade secret status must be claimed in every jurisdiction.

Due to the rising costs of preventing ingredient disclosure and increased demand from consumers, companies may decide that it is simply cheaper and easier to release this information. Expect to see more companies follow the lead of Clorox and disclose the particular fragrances in each of their products. As more large firms in the chemical industry go down that path, legislators will feel more comfortable requiring complete ingredient disclosure, particularly for consumer chemicals. Do not be surprised, when both the U.S. Consumer Product Safety Commission (CPSC) and the Canadian Consumer Chemicals & Containers Regulations (CCCR) consumer chemical regulations are updated (which will likely happen before the end of the decade), that the rules around ingredient disclosure are far less forgiving than they are now.

Troutman

Troutman

Douglas Troutman, VP & General Counsel, Government Affairs, The American Cleaning Institute (ACI)

Setting the Record Straight on Minnesota’s Triclosan Debate

During the public policy debate in Minnesota over efforts to ban the antibacterial ingredient triclosan, the group Friends of the Mississippi River (FMR) pushed for this ban in the face of a great deal of information showing triclosan to be a safe and effective ingredient.

The group’s post-mortem (as posted on its website by FMR’s Trevor Russell) is as misleading as the information and arguments they used to get the law that passed. This law will effectively restrict consumer choice of antibacterial soaps and washes with triclosan as of January 1, 2017.

FMR claims that they worked with “the soap industry” to “develop a negotiated compromise” leading to legislative language that narrowed a ban to “include just consumer cleaning products used for hand and body cleansing.”  FMR has the facts wrong.

Let the record be clear: the American Cleaning Institute opposed the legislation that became the enacted law on behalf of its interested member companies. ACI was in no way involved in this so-called compromise. No one here ever heard from Mr. Russell.

As we testified in the legislature and communicated to Minnesota Gov. Mark Dayton, triclosan is the most reviewed and researched active ingredient used in antibacterial soaps and body washes. Manufacturers are providing real-world scientific data and information that demonstrates what we already know: antibacterial soaps with triclosan are safe and effective.

While triclosan has been found in trace amounts in sediments in aquatic environments, there is no evidence of significant risk to humans or the environment. Research has consistently shown that triclosan and its breakdown products do not pose a risk to aquatic or terrestrial environments, nor do they pose a threat of accumulation in drinking water or food.

Use of triclosan in antibacterial soaps is regulated by the U.S. Food & Drug Administration (FDA), who has proposed new rules governing antibacterial soaps and their ingredients and is in the midst of an extensive public comment period on these proposals. Yet the Minnesota legislative ban on triclosan ignores this reality.

Instead of letting federal regulators do their job, the law would take safe, effective and beneficial products off the shelves of Minnesota grocery, convenience and drug stores.

As there will be further public policy discussions over regulating antibacterial soaps, the ACI and our members remain committed to advocacy based on valid, real-world science and solid data.

We ask FMR to refrain from distorting the facts about antibacterial product safety and how they characterize how the legislative debate transpired in Minnesota.

DeLeo

DeLeo

Paul DeLeo, Associate VP of Environmental Safety, ACI

Triclosan & pregnancy
Analysis of research showing trace elements of antibacterial ingredients in pregnant women and fetuses is distorting the safety profile of the materials, which have been extensively researched and reviewed for decades. The research in question was presented at the American Chemical Society national meeting and reported that trace elements of the antibacterial ingredients triclosan and triclocarban were detected in the urine of pregnant women, as well as some umbilical cord blood samples.

Some of the researchers’ public comments—as well as news media headlines about the research—may mislead the public about the ingredients’ safety.

“The levels of these ingredients they found are extremely small and are excreted from the body,” said Dr. Paul DeLeo, ACI Associate VP of Environmental Safety. “There’s a wide margin of safety between these levels and the levels deemed unsafe based on standard safety evaluation. The weight of evidence supports the conclusion that these ingredients are not causing adverse effects on the endocrine system. The continued ‘suggestions’ that the presence of these substances are leading to health risks are not borne out by the data and years of safe use by consumers.”

In comments submitted last year to the FDA on the safety of triclosan, ACI stated “Triclosan-containing consumer antiseptic wash products play a beneficial role in the daily hygiene routines of millions of people throughout the U.S. and worldwide. They have been and are used safely and effectively in homes, hospitals, schools and workplaces every single day. Furthermore, triclosan and products containing it are regulated by a number of governmental bodies around the world and have a long track record of human and environmental safety which is supported by a multitude of science-based, transparent risk analyses.”