EPA Reissues FIFRA Guidance on Cleaning Products

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FIFRA:

On January 11, 2011, EPA issued revised guidance regarding the types of claims that would require registration of cleaning products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq.  Readers may recall that, in early 2010, the Agency initially issued guidance that could have made claims such as “removes mold, mildew and algae stains” potentially subject to registration, differing from the established interpretation of the “cleaning agents” exemption set out at 40 CFR § 152.10.  EPA reasoned that, in certain contexts, such statements would constitute claims of pest mitigation.  At the same time, EPA Headquarters was also coordinating with the Agency’s regional offices to undertake an enforcement initiative based in part on that 2010 guidance.  However, a large-scale enforcement initiative did not occur.  Industry trade associations and others were successful in convincing EPA that its expanded application of FIFRA was unnecessary and potentially unlawful.  EPA responded by issuing revised guidance essentially reducing the number of scenarios in which pesticidal intent would be inferred.

Under FIFRA a “pesticide” is “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”  FIFRA § 2(u), 7 U.S.C. § 136(u) (emphasis added).  Unless otherwise exempted from registration under 40 CFR §§ 152.20, 152.25 or 152.30, pesticide products that are intended for a pesticidal purpose must be registered.  In general, a product is considered to be intended for a pesticidal purpose when the person who distributes or sells it claims, states, or implies that the product prevents, destroys, repels or mitigates a pest.  Therefore, once a product label (or other statement made in connection with the sale or distribution of the product) includes any claim of pest mitigation, under 40 CFR § 152.15, the product is one that is intended for a pesticidal purpose and becomes subject to registration.  For cleaning products, claims of pest mitigation are frequently what trigger the registration requirement. 

According to EPA, a product need not act directly on a pest in order for it to mitigate the pest and be considered a pesticide.  See IN THE MATTER OF AQUARIUM PRODUCTS, INC. (IF&R Docket No. 1 1 1 – 4-C) (1995).  However, certain products may have effects that mitigate pests without being intended for a pesticidal purpose.  As noted above, the regulation at 40 CFR § 152.10 sets out three groups of products that are not pesticides because they are not intended to prevent, destroy, repel or mitigate a pest.  One of these includes deodorizers, bleaches and cleaning agents.  However, the regulation provides that these products are not pesticides only if no pesticidal claim, express or implied, is made on their labeling or in connection with their sale and distribution (e.g., web sites, advertising, promotional or sales activities and testimonials, or even website links to research demonstrating pesticidal efficacy).  This includes claims about the use of a cleaning product alone or in combination with other substances.

Some cleaning products claim pest mitigation, noting their ability to affect the habitat or food source of a pest, but others merely claim the ability to remove dirt or other debris.  Although such distinctions may appear subtle, they’re important from a regulatory standpoint.  Moreover, many claims are not so easily categorized, so the context in which they occur must be evaluated.  Thus, with the range of claims occurring in the marketplace, EPA guidance distinguishing between claims subject to registration and those not subject is important. 

EPA offers many examples of claims that would require registration because of a linkage to mitigating a pest, its food, food source, or its habitat.  These include the following:

  • Cleans away, washes away or removes any pest, biofilm or scum, allergen or allergen associated with a pest.
  • Removes pests by suffocating or drowning.
  • Cleans or removes pest habitats or breeding sites.
  • Cleans, precipitates or removes contaminants, nutrients or matter that provide food or habitat for pests.
  • Cleans, reduces or removes scum or sludge where pests breed, feed or live.
  • Out-competes or displaces a pest for nutrition or habitat.
  • Cleans or removes the habitat where biofilm, germs, allergens or microorganisms can hide, thrive or grow.
  • Prevents, blocks, removes, neutralizes or controls bacteria or other pests that cause odors.
  • Sanitizes, disinfects or sterilizes.
  • Images of pests or pest habitats (e.g., nest, hive or web) that imply cleaning or removal of pest habitats, or of nutrition or sources of nutrition for pests.
  • A banner, logo, design, header or any claim on a label or labeling, or through other means such as web sites, advertising, etc. that specifically links the cleaning product to pest control, Integrated Pest Management (IPM), pests or a specific kind of pest. 

In contrast, claims lacking a linkage to mitigation would not require registration.  Examples of such claims include:

  • Cleans or removes stains.
  • Cleans or removes stains from algae, mold, mildew or other non-public health organisms.
  • Cleans or removes dirt, soil, dust, debris, inanimate scum, inanimate nutrients, inanimate organic particulates, or inanimate contaminants.
  • Cleans a site (e.g., ponds, aquariums, etc.).
  • Prevents, blocks, neutralizes, reduces, eliminates, encapsulates or removes odors; deodorizes.
  • Cleans, reduces or removes sludge.
  • Cleans or removes inanimate scum such as “soap scum.”
  • Cleans, washes or prepares the surface for application of a registered disinfectant intended to kill biofilm.
  • Combines suspended inanimate particulates for easy removal by a filtration system.
  • Cleans away or removes inanimate dust-mite matter, non-living matter, or  allergens from non-living sources (e.g., pet dander allergens, cockroach matter allergens, dust mite matter allergens) (emphasis added).

Despite the numerous examples, there are scenarios for which EPA cautions companies to undertake a careful evaluation of the entire context.  These include the following types of scenarios:

  • Catalogs or web sites that list both cleaning products and pesticidal products in close proximity since these could imply that the cleaning products are pesticidal.   
  • Use of references to IPM on a cleaning product’s label.  (Although EPA considers IPM an effective and environmentally sensitive approach to pest management that relies on a combination of common-sense practices, references to IPM could imply by association that a clean product may control or mitigate a pest.)

The Agency’s guidance appears generally consistent with the longstanding practice of many companies.  However, FIFRA’s registration requirement has proven to be a source of confusion for others, so there are undoubtedly companies out there currently evaluating the guidance and adjusting their practices accordingly.

OSHA to Adopt Final GHS Rule by August 2011

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Globally Harmonized System of Classification and Labeling of Chemicals (GHS):

On December 20, 2010, the Occupational Safety and Health Administration (OSHA) released its Fall 2010 Unified Agenda.  75 Fed. Reg. 79604.  The Agenda sets August 2011 as the date for publishing a final rule that will modify the current hazard communication standard (HCS) at 29 CFR 1910.1200 to incorporate elements of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).  Readers will recall that GHS is a system the United Nations (UN) developed for standardizing and harmonizing the classification and labeling of chemicals to help ensure their safe use, transport and disposal.  Publication of the final rule is the culmination of a five-year process that has left the United States behind many countries in its implementation of GHS. 

The UN first published the GHS in 2003 in response to the diverse and sometimes inconsistent hazard classification and communication systems in use around the world.  Governments, industry, and labor, working through the UN, hoped that a harmonized system would increase safety and reduce the regulatory burden associated with the global trade in chemicals.  Under the GHS, labels would include signal words, pictograms, and hazard and precautionary statements and safety data sheets would have a standardized format.  

When the GHS system was first adopted, the goal was implementation in each country by 2008.  However, that has not happened.  Some countries met the deadline while others did not.  Japan required compliance in 2006, and New Zealand and Korea required at least partial compliance in 2008.   The European Union’s GHS regulation entered into force in January 2009.   (Information on other countries’ adoption is available here.)

Adoption in the US has been slower, possibly because several agencies are involved, including the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the Department of Transportation (DOT).  Each agency is evaluating its existing regulations and guidance, and making the necessary changes.  OSHA’s adoption of GHS has been particularly slow.  The Agency first published an advanced notice of proposed rulemaking in September 2006, 71 Fed. Reg. 53617, and then waited almost three years before proposing a rule, 74 FR 50279, and finally initiated several public hearings thereafter.   Some question whether US industry, particularly smaller businesses, have been hurt by the delay since smaller companies sometimes cannot afford to comply with multiple countries’ hazard communication systems and therefore avoid significant international trade.

Multiple aspects of OSHA’s current HCS will be affected by the impending rule.  According to OSHA’s website, the following major areas are subject to significant changes.

  • Hazard classification: Specific criteria for classification of health and physical hazards, as well as classification of mixtures will be adopted.
  • Labels: Chemical manufacturers and importers will be required to provide a label that includes a harmonized signal word, pictogram, and hazard statement for each hazard class and category. Precautionary statements must also be provided.
  • Safety Data Sheets: A prescribed 16-section format will be required for all safety data sheets.
  • Information and training: The GHS does not address training. However, the proposed rule will require workers to be trained on GHS within two years of the publication of the final rule to facilitate recognition and understanding of the new labels and safety data sheets.

Additional details about the proposed changes are available in the Federal Register notices cited above.  For those interested in learning more, OSHA has published a lengthy comparison of the GHS and HCS, and a comprehensive discussion of the GHS also is avaialble on OSHA’s website.

 

Reminder: February 4 Meeting of the Green Ribbon Science Panel for CA DTSC

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Green Chemistry:

The Green Ribbon Science Panel (GRSP) of the California Department of Toxic Substances Control (DTSC) is holding its first meeting of 2011 later this week.  The meeting will be held this Friday, February 4.  Details and links to additional information are set out in the DTSC notice below. 

From the agenda, this meeting does not appear to include discussion of the draft Safer Consumer Product Alternatives (SCPA) regulations.  Readers will recall that Cal-EPA decided on December 23 to delay adoption of those regulations, and reconvene the GRSP to discuss further revisions to the regulations despite a December 31, 2010 statutory deadline for completing the rulemaking process.  A new date for completing the process has not yet been announced publicly.

________________________

DTSC: Green Chemistry Initiative

DTSC will convene a teleconference meeting of the Green Ribbon Science Panel (GRSP) to discuss future process considerations for the GRSP. 

The meeting will be held on February 4, 2011, from 9 a.m. to 10:30 a.m. Pacific Time.

To find out how to participate in person or via teleconference go to:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP-Feb-4-2011-PN.pdf

To view meeting materials and an agenda go to:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/GreenRibbon.cfm#grspmeetings

To subscribe to or unsubscribe from the DTSC Green Chemistry Initiative Listserv or other Listservs, please go to http://www.calepa.ca.gov/listservs/dtsc.  For information on DTSC`s Green Chemistry Initiative, go to http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/index.cfm

 

USDA Launches BioPreferred Product Certification and Labeling Program

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Sustainable Products:

On January 20, 2010, the US Department of Agriculture (USDA) published a final rule announcing its BioPreferred Program, a voluntary product certification and labeling program established under the authority of section 9002 of the Farm Security and Rural Investment Act of 2002 (FSRIA), as amended by the Food, Conservation, and Energy Act of 2008 (FCEA), 7 U.S.C. 8102.  According to the USDA press release, “this new label will clearly identify biobased products made from renewable resources, and will promote the increased sale and use of these products in the commercial market and for consumers.” The rule is effective February 22, 2011.

Under the program, a biobased product, after being certified by USDA, can be marketed using the “USDA Certified Biobased Product’’ label.  Biobased products are those composed wholly or significantly of biological ingredients – renewable plant, animal, marine or forestry materials. The presence of the label will mean that the product meets USDA standards for the amount of biobased content and that the manufacturer or vendor has provided relevant information on the product for the USDA BioPreferred Program web site. The rule applies to manufacturers and vendors who wish to participate in the voluntary labeling component of the BioPreferred Program.  It also applies to other entities, such as trade associations, that want to use the label to promote biobased products. 

With the launch of the USDA biobased product label, the BioPreferred program is now comprised of two parts: a biobased product procurement preference program for Federal agencies, established in 2005, and a voluntary labeling initiative for the broad-scale marketing of biobased products.  According to the USDA’s website, the Agency has already designated approximately 5,100 biobased products for preferred purchasing by Federal agencies. The new label will make identification of these products easier for Federal buyers, and will increase awareness of these high-value products in other markets. USDA estimates that there are 20,000 biobased products currently being manufactured in the United States and that the growing industry as a whole is responsible for over 100,000 jobs.

Lastly, readers will recall that the Federal Trade Commission (FTC) recently proposed revisions to its guidance concerning compliance with section 5 of the FTC Act when making environmental marketing claims – the so-called “Green Guides.”  In that proposal, the FTC elected to defer to the USDA’s BioPreferred labeling program for guidance on marketing products covered by the program.  So, companies making “biobased” marketing claims in compliance with the USDA’s requirements presumably would have a limited safe-harbor from FTC enforcement.  However,  the FTC has reminded marketers that its proposal contains guidance concerning “made with renewable materials” claims, which can be similar to “biobased” claims, so marketers would need to remain mindful of that guidance when making such claims.

Rescheduled: ABA Program on Nano Governance

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Nanotechnology:

Due to scheduling conflicts, this program is being re-scheduled for sometime between mid-March and mid-April.  When a new date is set, program details will be available here.

 

Save the Date: Exciting Upcoming ABA Program on Nano Governance

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Nanotechnology:

For readers interested in the current state of play regarding governance of nanotechnology, the ABA Pesticides, Chemical Regulation and Right-To-Know Committee, along with other committees listed below, is organizing the following half-day event.

____________

SAVE THE DATE

January 27, 2011

NANO GOVERNANCE:  THE CURRENT STATE OF

FEDERAL, STATE, AND INTERNATIONAL REGULATION

Please mark January 27, 2011, on your calendar for an exciting program under development by the Pesticides, Chemical Regulation, and Right-to-Know Committee and the Science and Technology Section, Nanotechnology Committee. Program co-sponsors include the Young Lawyers Division Administrative Law and Environment Energy and Resources Law Committees and the Section on the Environment and Energy Resources, Environmental Disclosure Committee.

Program:  Nano Governance:  The Current State of Federal, State, and International Regulation

Date:  Thursday, January 27, 2011

Time:  1:00 – 5:30 p.m. (EST).  Networking reception immediately following.

Tentative Program Overview:

  1. The Federal Regulatory Outlook
  2. Beyond The Feds:  International/State Regulatory Programs and Strategies for Addressing Nanoscale Materials
  3. Perspectives from the Field

Questions:

More details to follow shortly, but for questions on this tentative program, please contact Irene A. Hantman at ihant001@umaryland.edu.

Also remember that the PCRRTK Committee web page provides you with access to valuable resource materials and analysis from past programs, newsletters, reports, and Practitioners E-reference documents covering a wide range of pesticide, chemical regulation, and right-to-know legal issues.  Please visit us at http://www.abanet.org/environ/committees/pesticides.

 

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EPA Requires Testing of 19 High Production Volume (HPV) Chemicals

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TSCA/HPV Chemicals:

On January 7, 2011, EPA published a final rule under section 4(a)(1)(B) of theToxic Substances Control Act (TSCA), (15U.S.C. 2603(a)(1)(B)), requiring manufacturers, importers, and processors to test 19 high production volume (HPV) chemicals.  The rule, which takes effect on February 7, 2011, requires these persons to obtain screening level data for health and environmental effects and chemical fate, and then provide that data to the Agency.  The rule is one of a series of actions that EPA is taking to ensure that it has the data necessary to adequately review priority chemicals.  In addition, now that the Agency has issued a final test rule, any person (including those required to test) who exports, or intends to export, any of the 19 chemicals will be subject to the export notification requirements in 40 CFR part 707, subpart D.  The chemicals are listed below:

CAS No.

Chemical Name

75-07-0

Acetaldehyde

78-11-5

1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

84-65-1

9,10-Anthracenedione

89-32-7

1H,3H-Benzo[1,2-c:4,5-c’]difuran-1,3,5,7-tetrone

110-44-1

2,4-Hexadienoic acid, (E,E)-

118-82-1

Phenol, 4,4′-methylenebis[2,6-bis(1,1-dimethylethyl)-

119-61-9

diphenylmethanone

144-62-7

Ethanedioic acid

149-44-0

Methanesulfinic acid, hydroxy-, monosodium salt

2524-04-1

Phosphorochloridothioic acid, O,O-diethyl ester

4719-04-4

1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

6381-77-7

D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt

31138-65-5

D-gluco-Heptonic acid, monosodium salt, (2.xi.)-

66241-11-0

C.I. Leuco Sulphur Black 1

68187-76-8

Castor oil, sulfated, sodium salt

68187-84-8

Castor oil, oxidized

68479-98-1

Benzenediamine, ar,ar-diethyl-ar-methyl-

68527-02-6

Alkenes, C12–24, chloro

68647-60-9

Hydrocarbons, C > 4

The 19 chemicals were originally included in the voluntary High Production Volume (HPV) Challenge Program, which “challenged” companies to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities.  HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year.  EPA has determined that HPV chemicals account for approximately 95% of total chemical production in the United States.  As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.  However, no data were provided for the 19 chemicals, making a mandatory test rule necessary.

More information on EPA’s HPV Challenge Program is available here.

DTSC Delays Adoption of its Green Chemistry Regulations for Safer Consumer Product Alternatives

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Green Chemistry Regulations:

After nearly two years of multi-stakeholder collaborative efforts, the California Department of Toxic Substances Control (DTSC) failed to timely adopt its Safer Consumer Product Alternatives Regulations (SCPA Regulations), a key component of California’s Green Chemistry Initiative.  The regulations would have represented a new paradigm in chemicals and products regulation, providing a strong incentive for manufacturers to market products that are “benign by design” through the use of “safer” chemicals and other techniques.  The enabling legislation, AB 1879, required DTSC to complete the rulemaking by January 1, 2011, but that did not happen.  The Department’s parent agency, the California Environmental Protection Agency (Cal-EPA), decided to have DTSC delay adoption in the face of substantial criticism of last-minute changes the Department proposed in November.   No deadline for completing the rulemaking has been announced publicly.

After receiving comments on its first regulatory proposal, released in September, DTSC made substantial changes in November and released them for a 15-day comment period extending over the Thanksgiving holiday.  The changes largely streamlined and clarified the requirements and removed potential impediments to innovation.  However, critics accused DTSC of employing “bait-and-switch” tactics, caving to industry pressure, and violating the California Administrative Procedures Act.   In the face of such criticism, Cal-EPA’s Secretary for Environmental Proection, Linda S. Adams, decided — in consultation with key legislators and the Governor’s Office — to violate the statutory deadline.   She announced her decision in a December 23, 2010 letter to Assembly Member Mike Feuer, the primary author of AB 1879.  The letter states that DTSC will reconvene its Green Ribbon Science Panel — a multidisciplinary advisory body — and revisit the issues raised in the last round of comments. 

The two most controversial changes concern (1) a five-year limitation on the categories of products subject to regulation and (2) the removal of a provision that would have affected manufacturers’ ability to redesign products.  Readers will recall that both the September and November proposals set out a three-step process – (1) identification of chemicals of concern and the priority products containing them, (2) assessment of alternatives to determine whether a viable, safer alternative is available, and (3) imposition of a regulatory response to protect health and the environment from the alternative selected.  In recognition of the challenges of implementing an entirely new regulatory scheme, the Department’s November proposal would have limited (until January 1, 2016) the categories of products from which priority products could be identified.  Only children’s products, personal care products, and household cleaning products would be eligible.   To avoid stifling innovation, the November proposal also would have removed the so-called “Tier I” notification, a streamlined alternatives assessment for a product voluntarily redesigned or reformulated to reduce or remove chemicals of concern prior to the product being identified as a priority product.  Avoidance of “regrettable substitutions” was the goal of the Tier I notification, but the potential cost to innovation convinced DTSC to remove the requirement.

These eleventh-hour developments create considerable uncertainty for the regulated community and others, which have been struggling to understand the full import of the regulations and prepare for their implementation.  The impending debate over November’s changes is certain to be contentious.  Although the changes seem meritorious, they were proposed in a manner that appears to have eroded trust and damaged the spirit of cooperation.  Whether the various stakeholders can reach consensus on the most controversial issues remains to be seen.   

 

Philip Moffat Will Participate on ABA Quick Teleconference on California's Green Chemistry Regulations

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California Green Chemistry Regulations:

Verdant is pleased to announce that Philip Moffat will participate on a “quick teleconference” program sponsored by the American Bar Association (ABA) Section of Environment, Energy, and Resources entitled “California Dreaming or Reality?  California’s New Paradigm in Chemicals and Products Management Could be Coming to a Store Near You.”  The November 15, 2010, teleconference will discuss the regulations recently proposed by the California Department of Toxic Substances Control (DTSC) to implement AB 1879, a new California Green Chemistry Initiative law designed to “accelerate the quest for safer products” in the state.  In addition to discussing the law’s requirements and its implementation, the teleconference will provide both industry and public health perspectives.

Other speakers include:

  • Ann Grimaldi, McKenna Long & Aldridge LLP, San Francisco, CA
  • Doug Fratz, Vice President, Scientific & Technical Affairs, Consumer Specialty Products Association, Washington, DC
  • Dr. Joseph Guth, UC Berkeley Center for Green Chemistry; and the Science and Environmental Health Network, Berkeley, CA
  • Maziar Movassaghi, Acting Director, DTSC, Sacramento, CA

There are two ways to participate in this program, either attending a host site location or individual dial-in.  Participation at a host site location is free of charge for ABA members, and $110 for non-members.  Registration with the host site contact is required, however:

  • Austin, TX
    Brown McCarroll, L.L.P., 111 Congress Ave., Ste. 1400
    RSVP: Keith Hopson, (512) 479-9735 or khopson@brownmccarroll.com
  • Bloomfield Hills, MI
    Butzel Long, Stoneridge West, 41000 Woodward Ave
    RSVP: Beth S. Gotthelf, (248) 258-1303 or gotthelf@butzel.com
  • San Francisco, CA
    McKenna Long & Aldridge LLP, 101 California St., # 41
    RSVP: Cynthia Kelly, (415) 267-4051 or ckelly@mckennalong.com
  • Washington, DC
    McKenna Long & Aldridge LLP, 1900 K Street, NW
    RSVP: Michael Boucher, (202) 496-7729, mboucher@mckennalong.com or Debbie Leitner, (202) 496-7372, dleitner@mckennalong.com

Additional information about the teleconference is available here.  And a copy of the presentation is available here:  Moffat_CAGreenChem