Copyright © 2010 Green Seal, Inc. 1

GS-52

BACKGROUND INFORMATION ON THE PROPOSED GREEN SEAL™ STANDARD FOR

DISH AND SPECIALTY CLEANING PRODUCTS

October 8, 2010

Green Seal, Inc. • 1001 Connecticut Ave. NW, Ste 872 • Washington, DC USA 20036-5525 (202) 872-6400 • FAX (202) 872-4324 • www.greenseal.org

©2010 Green Seal, Inc. All Rights Reserved

Copyright © 2010 Green Seal, Inc. 2

BACKGROUND INFORMATION ON THE PROPOSED GREEN SEALTM STANDARD FOR DISH AND SPECIALTY CLEANING PRODUCTS, GS-52

INTRODUCTION Green Seal is a non-profit organization whose mission is to use science-based programs to empower consumers, purchasers, and companies to create a more sustainable world. The development of this sustainability standard for dish and specialty cleaning products is part of Green Seal’s sustainability standards and certification program guided by International Organization for Standardization (ISO) 14020/14024. The Proposed Standard for dish and specialty cleaning products takes into account the life cycle of these products and includes multiple attributes to address the life cycle considerations (e.g., raw materials, manufacturing, packaging, use, and end-of-life). This background document provides information about what is included in the Proposed Standard, but the actual content of the Proposed Standard is not included (refer to the GS-52 Proposed Green Seal Standard for Dish and Specialty Products). The standard is not final. The standard is being proposed to get input from stakeholders to facilitate the development of a draft final standard (and additional stakeholder review). Later, when the standard has completed the stakeholder review and development steps, it will be issued as a final standard and will be available for Green Seal certification. Green Seal sets sustainability standards, such as this one in development, to reduce, to the extent technologically and economically feasible, the environmental, health, and social impacts throughout the life cycle of products, services, and companies. With sufficient commitment by manufacturers and support from purchasers/consumers, the standard identifies the top 15-20% of the category (current and emerging). Green Seal standards may be used for product development, conformity assessment (e.g., Green Seal certification), purchaser specifications, and public education.

STANDARD SCOPE The scope of the Proposed Standard applies to specialty cleaners used by individual consumers, in institutions and industrial settings, and includes specialty surface cleaners and odor removers, such as: dish cleaners (automatic and hand), biologically-active cleaners (enzymatic and microbial products for cleaning and odor control), metal cleaners, graffiti removers, motor vehicle and boat cleaners, deck cleaner, oven cleaners, upholstery cleaners, odor removers and other cleaning products sold for specific uses not covered in the GS-37 Standard for Cleaning Products for Industrial and Institutional Use and GS-8 Standard for Cleaning Products for Household Use. Furthermore, the criteria in this standard include consideration of vulnerable populations in institutional settings such as schools, day-care facilities, nursing homes, and other facilities. Disinfectant products included in this document are also known as hard-surface disinfectants or low-level disinfectants and serve to kill pathogenic microorganisms (bacteria, fungi) on hard, non-porous surfaces. Sporocides and sterilizers or other products for use to sterilize critical or semicritical medical instruments and equipment are not covered in the scope of this document. Sanitizer products labeled to reduce, but not necessarily eliminate microorganisms on hard surfaces, and whose label is registered as a sanitizer under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; 7 U.S.C. Section 136) are also included in the scope of this standard1

This standard applies to specialty cleaners used by individual consumers, in institutions, and in industrial settings. These products do not include household products and products that are incorporated into or used exclusively in the manufacture or construction of the goods or commodities at the site of the establishment. Several products included in the scope of this standard are intended for use outside and have the potential to be discharged with washwater directly to storm drains or the aquatic environment. On the other hand, other product effluents are captured by sanitary sewer systems are discharged into sewage treatment plants (Publicly Owned Treatment Works (POTW)) through household or institutional

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1 United States Code. Title 7 Chapter 6 Section 136. Accessed 3-20-2010. http://frwebgate.access.gpo.gov/cgi-

bin/usc.cgi?ACTION=BROWSE&TITLE=7USCC6&PDFS=YES

Copyright © 2010 Green Seal, Inc. 3

drains prior to eventually leading to larger waterways, while the sludge from such plants are disposed in landfills. Further, other produts may be wiped away with cloths that are subsequently discharged to a landfill. While it is acknowledged that this standard includes a broad range of cleaning products, the products are generally composed of the same classes of chemicals and share common life cyle considerations.

Some dish detergents are labeled as antibacterial. Generally speaking, "antibacterial" or "antimicrobial" describes a substance(s) or product that kills or inhibits the growth of bacteria in or on foods, inanimate surfaces, or hands. Dishwashing soaps that claim to be "antibacterial" and contain biocides are classified and labeled by the manufacturer as hand soaps, which means they are personal hygiene products and fall under the authority of the Federal Drug Administration (FDA). As the FDA has no current testing requirements in place for antibacterial active ingredients, these "antibacterial" labeled dishwashing products are not tested for efficacy as a biocide

Dishwasher and Dish Cleaning Products Automatic dishwater detergents are generally available in three forms: powders, gels, and tablets. Powders are formulated as free-flowing granules. Gels are formulated to provide controlled dispensing, and quick dissolvability. Tablets are formulated for effective cleaning as well as convenience and provide the exact dose for a full load of dishes. Each tablet may be individually wrapped to protect it from moisture, humidity and to extend its shelf life. Depending on their formulation and product form, automatic dishwasher detergents may contain the following classes of ingredients: surfactants, chelators, phosphates, bleaching agents, corrosion inhibitors, enzymes, surface protectants, anitfoamers, thickening agents, polymers, colorants, and fragrances. Surfactants, also known as surface active agents, are used to loosen soils and emulsify fats, helping to hold them in suspension, and leaving surfaces clean and free from spots and film. Detergents for use in automatic dishwashers are generally formulated with surfactants designed to have low sudsing characteristics. Chelating agents tie up water hardness minerals (primarily calcium and magnesium) so that minerals do not interfere with cleaning or deposit on surfaces. Phosphates can also help to keep food soil particles in suspension after removal from the soiled surfaces and prevent their redeposition. Chlorine or oxygen bleaches are added to help prevent spots by leaving a cleaner surface than would be obtained with either surfactants or phosphates alone. Small amounts of bleach help to break down protein soils and aid in removing stains such as coffee or tea. A corrosion inhibitor, such as sodium silicate, helps to provide protection for the dishwasher and the wide variety of materials that are washed. The corrosion inhibitor is also a soil suspending agent and an important source of alkalinity. Many dish cleaners also contain enzymes, naturally occurring proteins that help break down food and soil residue into small particles which are then washed away. Special additives, such as sodium aluminate, boric oxide or aluminum phosphate, may be used to inhibit the removal of overglaze and pattern from fine china. Sometimes antifoams are added to reduce sudsing. Additional alkalis, such as sodium carbonate, hydroxide or trisodium phosphate, may be used to aid in handling greasy food soils. Polymers help prevent film buildup from hard water. Thickening agents are used in gel automatic dishwasher detergents so the product remains in the dishwasher cup(s) until automatically dispensed at the appropriate time. Colorants are added to lend individuality and an appealing appearance to the product. Processing aids, generally inert materials, allow the active ingredients to be combined into a usable form. Fragrance covers the chemical odor of the base product and stale food odors that might come from the dishwasher. Hand dishwashing detergents usually come in the form of liquids, gels or concentrated foam. They serve to lift soil and break down grease, provide stability and dispensing agents to keep the product consistent under varying storage conditions. Other ingredients are added as fragrances and colorants, or to adjust pH or introduce moisturizers, oils and emollients.

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2 Environmental Working Group. 2008. Pesticide in Soap, Toothpaste and Breast Milk - Is It Kid-Safe?: EWG's Guide to

Triclosan.

. Dish cleaners marketed or labeled as antimicrobial are not permitted under this standard because of evidence that they provide little additional benefit compared

http://www.ewg.org/book/export/html/26700

Copyright © 2010 Green Seal, Inc. 4

to water and soap and many disinfecting agents included (triclosan, quaternary ammonium compounds (QAC)) pose potential risks to human health and the environment 3,4,5,6.

Given their organic nature, several product categories covered by this standard cannot maintain shelf life without the use of preservatives to prevent bacteria and/or fungal growth. The function of these preservatives is biostatic. Products covered by this standard that are not FIFRA-registered disinfectants or sanitizers may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone (for hand dishwashing products, machine dishwashing products, and biologically-based/enzymatic cleaning products).

Oven Cleaning Product Oven cleaning products are products that are intended, advertised and formulated for use in removing organic soil (i.e., grease, baked on food, etc.) from the metallic surfaces of ovens, barbeques, fryers, and grills. Organic soils on these surfaces are generally encased in a charred-carbon crust, which is best breached by an organic solvent. For most oven cleaners designed to work in a cold oven, strong ingredients are necessary to remove burned-on soils. A strong alkali, like sodium hydroxide (lye), is the principal agent in such oven cleaning products. During use, the alkali converts the grease to soap. Another product type uses a combination of less alkaline salts plus oven heat to aid soil removal. Surfactant is also present to help penetrate soil and wet the surface. Oven cleaners are formulated to be as thick as possible to allow the product to cling to the soiled, greasy, vertical oven surfaces. Potentially hazardous chemicals used in these products include ingredients such as butane, monoethanolamine, diethylene glycol monobutyl ether, sodium hydroxide, and diethanolamine. There is also concern about inhalation of these products when dispensed via aerosols and with propellants.

Graffiti removal products are typically strong solvents and pose significant employee, occupant (when used indoors), and ecological risk

Graffiti Remover Graffiti removers are used on a wide variety of substrates including wood, concrete, and metal. From a functional perspective, graffiti removers are very difficult to define and warrant their own product category. Because they are designed to work on various surfaces, graffiti remover for porous concrete block has an entirely different set of performance criteria than a product used to remove a tag from a street sign. For instance, a solvent such as a soy methyl ester leaves an oily residue that soaks into the pores of graffiti substrates and cannot be rinsed out, thereby preventing reapplication of a protective coating after the graffiti has been removed. The complications posed by a variety of substrates are only magnified by the myriad types of graffiti-creating materials found in the real world.

7,8

3 Eurpoean Commission. 2006. European Commission Scientific Committee on Consumer Products (SCCP) Opinion on

Triclosan.

. According to a 2009 study of school cleaning supplies by the Environmental Working Group (EWG), traditional graffiti removers release the largest number of air pollutants of any cleaning product category commonly used in schools. Graffiti removal products also frequently contain dimethyl sulfoxide (DMSO), which has capability of penetrating the skin quickly and deeply (without damaging the skin) while carrying other substances with it. The Center for a New American Dream (CNAD), in cooperation with the City of Portland Office of Sustainable Development,

http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_073.pdf

4 United States Food and Drug Administration. 2010. Triclosan: What Consumers Should Know. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm

5 EPA. 2010. REDS Fact Sheet on Triclosan. http://www.epa.gov/oppsrrd1/REDs/factsheets/triclosan_fs.htm

6 Environmental Working Group. 2008. Pesticide in Soap, Toothpaste and Breast Milk - Is It Kid-Safe?: EWG's Guide to Triclosan. http://www.ewg.org/book/export/html/26700

7 Responsible Purchasing Network. 2003. Graffiti Remover Research and Field Test Report: The Search for Safer Products. http://www.responsiblepurchasing.org/publications/Grafitti_Report.pdf

8 Environmental Working Group. 2009. Greener School Cleaning Supplies = Fresh Air + Healthier Kids. New Research Links School Air Quality to School Cleaning Supplies. http://www.ewg.org/files/2009/10/school-cleaners/EWGschoolcleaningsupplies.pdf

Copyright © 2010 Green Seal, Inc. 5

utilized field testing to explore the efficacy of environmentally preferable graffiti removers compared to conventional products. The study found that there were graffiti removers that were less hazardous and performed as well, or better, than the more hazardous products. These environmentally preferable graffiti removers included solvents consisting of ethyl lactate, methyl soyate, and/or one or more of the dibasic ester compounds dimethyl gluterate, dimethyl adipate, and dimethyl succinate instead of more toxic alternatives.

Metal cleaning products are designed primarily to remove tarnish (the oxidation of metal) and other surface impurities. Metal cleaning products are sold as pastes, thick opaque liquids or clear liquids which may hold a fine abrasive in suspension. Surface impurities on most metals are removed more easily in an acidic medium. Metal cleaning products, therefore, usually contain organic acids, such as oxalic, sulfuric, or citric. To aid in mechanical removal of tarnish and soil and contribute to metallic luster, a very mild abrasive is present as a polishing/buffering agent. Clay-like materials, such as kaopolite or finely divided hydrous silica, are common mild abrasives used. Metal cleaning formulations may also contain surfactants for ease of spreading the product as well as an aid in soil removal. Some products also contain an antioxidant, which protects the cleaned metalware against rapid retarnishing

Metal Cleaning Product

9.

Products in this category are designed or labeled to inhibit the ability of soils to create malodors, or functions to entrap, encapsulate, neutralize, convert, or eliminate malodor molecules through a physio-chemical process that is not simply masking or overpowering odors. This product category does not apply to air fresheners that are used to mask or cover an odor using a fragrance. Such air fresheners that mask and cover frequently include formaldehyde, aerosol propellant, petroleum distillates, and p-dichlorobenzene. Air freshener preparations often also include terpenes such as limonene, aldehydes, ketones, esters, alcohols and other synthetic fragrances. A report issued in 2005 by the Bureau Européen des Unions de Consommateurs (BEUC) and a 2007 study by the Natural Resource Defense Council (NRDC) found that many air freshener products emit allergens and toxic air pollutants including benzene, formaldehyde, terpenes, styrene, phthalates, and toluene

Odor Remover

10,11. Research at the University of California found that the prominent products of the reaction of terpenes found in air fresheners with ozone included formaldehyde, hydroxyl radical, and secondary organic aerosol12,13. Air fresheners may also contain phosphates, chlorine bleach, or ammonia. Products that are designed to allow odor-producing molecules to adsorb to them, such as zeolite, activated charcoal or silica gel and those that chemically modify or neutralize odors, such as oxidizers, are included in the scope of this standard. Additionally, products that utilize microbes or enzymes to neutralize odor sources are included and are subject to performance requirements for both odor removers and enzymatic products.

Biologically-based ingredients (enzymes and microbes) are an alternative to petroleum-based surfactants and solvents. Microbial-based cleaning products generally consist of a bacterial culture and water.

Biologically-Based Cleaning Product

9 American Cleaning Institute (formerly the Soap and Detergent Association). 2009. Facts About Household Cleaners.

Accessed 2-15-2010. http://www.cleaning101.com/house/fact/houseclean2.cfm

10 Bureau Européen des Unions de Consommateurs. 2005. Emissions of chemicals by air fresheners: Tests on 74 consumer products sold in Europe. http://www.env-health.org/IMG/pdf/2005-00133-01-E.pdf

11 Natural Resources Defense Coucnil. 2007. Cleaning the Air: Hidden Hazards of Air Fresheners. http://www.nrdc.org/health/home/airfresheners/airfresheners.pdf

12 European Commission’s Scientific Committee on Health and Environmental Risks (SCHER), Opinion on the report Emission of Chemicals by Air Fresheners. Tests on 74 Consumer Products Sold in Europe. January 2005. http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_026.pdf

13 Steinemann, A.C. "Fragranced consumer products and undisclosed ingredients." Environ Impact Assess Rev 2009;29(1): 32-38.

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Certain products may contain additional ingredients to enhance microbial or enzymatic performance. The additional ingredients include surfactants, buffers, emulsifiers, co-substrates, or biostimulants to maximize microbial effects in targeted applications. Microbial cultures included in cleaning products are generally chosen based on their ability to breakdown target soils via production of enzymatic pathways responsible for utilizing a wide range of carbon sources. Lactobacillus (lactic acid bacteria) and Bifidobacterium spp. are commonly used in bacterial cleaning products. Enterococcus, Baccilus, Staphylococcus, and Psuedomonas Spp. are increasingly being utilized as well. Products containing microorganisms often also contain added enzyme components. These additional enzymes components serve to break complex molecules into small pieces that can be metabolized by the microorganisms. The growing bacteria then start to reproduce and generate their own enzymes, thus allowing for enzyme production to become self-sustaining. These microorganisms are capable of determining what organic soils are present in an environment and some can produce specific enzymes to break down those organics. Products with the right microorganism can degrade materials that cause soils to adhere making surfactants more effective in removing them. Once surfactants have done their work and the surface is wiped/mopped, the residual microorganisms remain to provide lingering cleaning as long as conditions allow them to be active. Enzymatic cleaning products utilize enzymatic action to break down protein, starch, and oil-based soils. Based on the type of reaction catalyzed, enzymes are assigned to one of the classifications of the Enzyme Commission of the International Union of Biochemistry and Molecular Biology (formerly the International Union of Biochemistry) and given an Enzyme Commission (EC) number, a systematic name, and a common name. Other names are also provided, if available. The Enzyme Commission of the International Union of Biochemistry and Molecular Biology has classified enzymes into six main classes: oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases14

Although there are no specific U.S. regulations on the use of enzymes in cleaning products, there are regulations on enzymes for use as food additives. The Association of Manufacturers and Formulators of Enzyme Products (AMFEP) lists about 160 enzymes manufactured for use in the food industry, at least 36 of which are produced from genetically modified microorganisms

. Enzymes used in food processing are often referred to by their common or traditional names such as protease, amylase, malt, or rennet. For enzymes derived from microorganisms, the name of the source microorganism is usually specified, for example, “α-amylase from Bacillus subtilis.” For enzymes derived from microorganisms modified by using recombinant DNA techniques (referred to as recombinant-DNA microorganisms or genetically modified microorganisms), the names of both the enzyme source (donor organism) and the production microorganism are provided, for example, “α-amylase from Bacillus licheniformis expressed in Bacillus subtilis.” Enzyme preparations are produced in varying degrees of purity from animal, plant, and microbial sources. They may consist of whole killed cells, parts of cells, or cell-free extracts. They may also contain carriers, solvents, preservatives, and antioxidants. The enzyme preparations may be formulated as liquid, semi-liquid, or dry solid preparations. For many applications, the components of the preparation remain in the finished product.

15. For use in the food industry, enzyme preparations are regulated either as "secondary" direct food additives under Title 21 of the Code of Federal Regulations (CFR), Part 173, or are affirmed as Generally Recognized As Safe (GRAS) substances in 21 CFR Part 18416,17

14 Nomenclature Committee of the International Union of Biochemistry and Molecular Biology (NC-IUBMB). 2010. Enzyme

Nomenclature.

. The regulatory status of food additives or substances affirmed as

http://www.chem.qmul.ac.uk/iubmb/enzyme/

15 AMFEP. 2009. Fact Sheet on Protein Engineered Enzymes. http://www.amfep.org/documents/Amfep%2009%2017%20-%20Amfep%20Fact%20Sheet%20on%20Protein%20Engineered%20Enzymes.pdf

16 CFR. Title 21, Part 173. Accessed 4-4-2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=173

17 CFR. Title 21. Part 184. Accessed 4-4-2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=184

Copyright © 2010 Green Seal, Inc. 7

GRAS is established through the petition process. GRAS exemptions are granted for substances that are generally recognized, among experts qualified by scientific training and experience to evaluate their safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or through experience based on common use in food) to be safe under the conditions of their intended use. Additionally, the FDA has developed chemistry recommendations for enzyme preparations for food additive and GRAS affirmative petitions18.

This standard also applies to car cleaning products used for household car washing, industrial/institutional car washing, and commercial car wash facilities. These products typically contain surfactants, degreasers, chelating agents such as EDTA and NTA, foamers, and color. Environmental impacts particular to motor vehicle cleaners for the household and institutional use category include disposal of the waste effluent into storm sewers and directly to aquatic ecosystems and limited biodegradability of washes and waxes. Discharge from washing can also contain oils, grease, brake lining elements, rust, trace amounts of benzene and possibly chromium, and a few other substances. The runoff from washing cars can have adverse effects on aquatic life and degrade the water quality. However, it is noted that the Clean Water Act (CWA) requires professional car washes to route car wash wastewater to water treatment facilities or to state-approved drainage facilities designed to protect the environment. Filtration of the wastewater through an interceptor may be conducted before discharge to a sanitary sewer. Filtration is recommended so that fewer solids are present in the wash wastewater stream discharge to the sanitary sewer system

Car and Boat Cleaning Product Boat cleaning products are designed to clean, and sometimes wax and polish, aluminum, fiberglass and wood surfaces of boats. Some boat cleaning agents are designed for special uses, such as the removal of alga and shell, or anti-corrosion agents. These products are likely to be directly discharged into aquatic environments. This may require additional consideration for environmental safety. For example, the wax content of some cleaners may not be easily biodegradable and may potentially bioaccumulate.

19.

Disinfectants are used on hard, inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria, but not necessarily their spores. Disinfectants contain active antimicrobial agents, such as acids, alcohols, aldehydes, alkalis (oxidizing agents), biguanides, pine oil, calcium and sodium hypochlorite (halogens), QACs or phenols that kill bacteria and viruses on surfaces. An active disinfecting ingredient that is being increasingly utilized is a mixture of silver ions and citric acid known as silver dihydrogen citrate (SDC). Disinfectant products are divided into three major types: hospital, general use, and disinfectant-cleaners. Hospital-type disinfectants are the most critical to infection control and are used on medical and dental instruments, floors, walls, bed linens, toilet seats, and other surfaces. For hospital-type disinfectants, this standard includes, but is not limited to, products used for non-critical medical devices (those that contact only intact skin during use, e.g. stethoscopes, bedpans, etc). Sporocides and sterilizers or other products for use to sterilize critical medical instruments and equipment are not covered in the scope of this document. General disinfectants are the major category of products used in households, swimming pools, and water purifiers

Disinfectants and Sanitizers

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18 FDA. 2010. Guidance for Industry. Enzyme Preparations: Recommendations for Submission of Chemical and Technological

Data for Food Additive Petitions and GRAS Notices. VERSION 1.1; JANUARY, 1993; Revised July 2010.

. Combined disinfectant-cleaning products contain surfactants and builders to remove soil in addition to antimicrobial agents to kill germs. They include active, dedicated cleaning ingredients such as surfactants, cleaning and buffering acids (phosphoric acid, citric acid, lactic acid), chelating and building agents (ethylenediamaine tetraceticacid- EDTA, nitrotriacetic acid NTA, hydroxy ethyl iminodiactetic acid) solvents, and other non-active

http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/UCM217735.pdf

19 Illinois EPA. 2002. How Do I Handle My Professional Car Wash Wastewater? http://www.epa.state.il.us/small-business/car-wash/car-wash.pdf

20 EPA. 2007. Antimicrobial Product Fact Sheet. http://www.epa.gov/pesticides/factsheets/antimic.htm

Copyright © 2010 Green Seal, Inc. 8

ingredients such as dyes and fragrances. Therefore, they are designed to be effective at cleaning organic soils from surfaces as well as killing germs. Sanitizers do not destroy or eliminate all bacteria or microorganisms, but reduce the number of microbial contaminants on hard surfaces to levels that are considered safe from a public health standpoint. Sanitizers include active ingredients that are effective against target pests, but generally at lower concentrations than are present in disinfectant products. These products may also include detergents, disinfectants, fillers, solvents (including water), baiting materials, propellants or wetting agents, emulsifiers or surfactants. Antiseptics are biocides applied to the surface of living organisms or tissues to prevent or stop the growth of microorganisms by inhibiting or killing the organism and are not covered under this standard21

Several phenols are used as disinfectants. Cresol and thymol are alkyl derivatives of phenol, while hexachlorophene and triclosan are chlorinated phenols. Common commercial preparations contain a 50% solution of mixed cresols in surfactant. Other commercial preparations are formulated with hexachlorophene, 2-benzyl-4-chlorophenol, o-phenylphenol, phenol, 4-tert-amylphenol and thymol. The concentration of thymol in active disinfecting products registered with the EPA ranges from 0.027% to 13%. Thymol, thyme essential oil and thyme (spice) are Generally Recognized As Safe (GRAS) by the FDA

. Acidic disinfectant active ingredients, such as acetic acid, lactic acid, and citric acid, function by destroying the bonds of nucleic acids and precipitating proteins. Acids also change the pH of the environment making it detrimental odor-causing bacteria, mildew, pathogenic fungi, certain bacteria and some viruses. Acetic acid is usually sold as glacial acetic acid (95%) acetic acid) which is then diluted with water to make a working solution concentration of 5%. The concentrated form is corrosive to the skin and lungs, but the typical dilution is considered non-toxic and non-irritating. Alcohols are broad spectrum antimicrobial agents that damage microorganisms by denaturing proteins, causing membrane damage and cell lysis. Alcohols are used for surface disinfection, topical antiseptic, and hand sanitizing lotions. Alcohols can kill most bacteria within five minutes of exposure but are limited in virucidal activity and are ineffective against spores. An important consideration in using alcohols is the concentration used, with 70% to 90% being optimum. Aldehydes such as formaldehyde and glutaraldehyde are highly effective, broad-spectrum disinfectants, which typically achieve sterilization levels. Aldehydes are highly irritating, toxic to humans and animals with contact or inhalation and are listed as known carcinogens by the International Agency for Research on Cancer (IARC), therefore their use is prohibited under this standard. Alkalis, such as sodium or ammonium hydroxide, sodium carbonate, or calcium oxide work by saponifying lipids within the envelopes of microorganisms and are very corrosive. Quaternary Ammonium Compounds (QACs) such as Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC) ,also known as benzalkonium chloride (BAC), benzethonium chloride and didecyl dimethyl ammonium chloride (DDAC) are cationic detergents that are attracted to the negatively charged surfaces of microorganisms, where they irreversibly bind phospholipids in the cell membrane and denature proteins impairing permeability. QACs are highly effective against Gram-negative bacteria, fungi, and enveloped viruses, but not against non-enveloped viruses or mycobacteria. These compounds are considered sporostatic but not sporocidal. Quaternary ammonium compounds are considered acutely toxic to humans and toxic to aquatic life.

22

21 Dvorak, G. 2005. Disinfection 101. Center for Food Security and Public Health, Iowa State University.

. Phenol and salts (sodium phenate), are active ingredients in disinfectant, deodorizer and cleaning formulations. These formulations have bactericidal, virucidal, fungicidal and tuberculocidal properties, kill mold and mildew, and eliminate odor. Phenols and substituted phenols can potentially

http://www.cfsph.iastate.edu/BRM/resources/Disinfectants/Disinfection101Feb2005.pdf

22 EPA. 1993. Reregistration Eligibility Decision for Thymol. Accessed 2-25-2010. http://www.epa.gov/oppsrrd1/REDs/old_reds/thymol.pdf

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cause skin corrosion or severe eye damage23. The most common symptoms reported for cases of dermal exposure to phenol and its salts were skin irritation/burning, rash, itching, skin discoloration/redness and blistering. Additionally, allergic type reactions have been reported. For ocular exposure incidents, eye pain, burning of eyes, conjunctivitis, blurring vision and acute inflammation has been reported. The most common symptoms reported for cases of inhalation exposure were respiratory irritation/burning, irritation to mouth/throat/nose, coughing/choking, shortness of breath, dizziness, flu-like symptoms and headache. Other systemic effects associated with phenol exposure can also occur through oral, dermal and inhalation routes of exposure. Neurologic effects, cardiac effects, nephrology and death have also been reported24

2-phenylphenol and salts (also commonly called orthophenylphenol and salts or OPP) are bacteriostats, microbiostats, nematicides, fumigants, and bactericide chemicals. OPP is used in applications to hard surfaces, agricultural premises and equipment, air deodorization, commercial and institutional premises, medical premises, residential and public access premises (carpet, hard surfaces, crack and crevice treatment), and material preservatives . Phenylphenol has a moderate order of acute toxicity via the oral route of exposure (Toxicity Category III). For dermal irritation, 2-phenylphenol and its sodium salt are severe (Toxicity Category I) and moderate to severe (Toxicity Category II) irritants, respectively. 2-phenylphenol and its sodium salt are not dermal sensitizers. According to the EPA scale, o-Phenylphenol is moderately toxic to freshwater fish and invertebrates with an LC50 between 2.5 and 4.6 mg/L. It is considered moderately toxic to marine organisms with an LC50 of 0.89 mg/L in mysid shrimp and EPA has issued a Data Call In (DCI) for acute toxicity in marine fish

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Ortho-benzyl-parachlorophenol (2-benzyl-4-chlorophenol), and its salts, potassium 2 benzyl-para-chlorophenate and sodium 2-benzyl-4-chlorophenate are broad-spectrum disinfectants/antimicrobials for controlling a variety of bacteria, fungi, algae, and viruses. The use patterns include: indoor medical, indoor nonfood, indoor residential, terrestrial nonfood crop, and aquatic nonfood industrial and residential. Outdoor use sites include swimming pool water related surfaces such as decks, and other hard surface areas surrounding swimming pools for the acid and both salts, refuse/solid waste sites for the acid, air washer water systems for the sodium salt, evaporative condenser water systems and industrial processing water for the potassium salt, and commercial/industrial water cooling systems for both salts. The chemical, ortho-benzyl-para-chlorophenol, is nontoxic to birds and highly toxic to freshwater fish and aquatic invertebrates. With regard to freshwater organisms, o-benzyl-p-chlorophenol is considered highly toxic to freshwater fish and invertebrates having an LC50 between 0.33 and 0.72 mg/L)

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The three peroxy compounds, peroxyacetic acid, hydrogen peroxide, and peroxymonosulfate sulfate are commonly used disinfecting agents and are recognized oxidizing agents and function by denaturing the proteins and lipids of microorganisms. Hydrogen peroxide, in the home is in diluted form (3-10%) whereas industrial use involves concentrated solutions (30% or greater). Hydrogen peroxide (at a 5-20% concentration) is considered bactericidal, virucidal (non-enveloped viruses may be resistant), fungicidal, and at high concentrations sporicidal. Its activity against mycobacteria is limited. Halogens, including

. Ortho-benzyl-para-chlorophenol is Category III for acute oral and dermal toxicity, and Category IV for acute inhalation toxicity. Ortho-benzyl-para-chlorophenol is severely irritating to the eye (Category I), and is corrosive with repeated contact to the skin. In chronic studies, ortho-benzyl-para-chlorophenol induces increases in kidney nephropathy and has been classified as a Group C possible human carcinogen under the EPA IRIS weight of evidence classifaction system and as such is not a permitted active ingredient under the proposed standard.

23 EPA. 2009. Reregistration Eligibility Decision for Phenol & Salts. Accessed 3-26- 2010.

http://www.epa.gov/pesticides/reregistration/REDs/phenol-salts-red.pdf

24 Ibid.

25 EPA. 2006. Reregistration Eligibility Decision for 2-phenylphenol and salts (Orthophenylphenol or OPP). http://www.epa.gov/oppsrrd1/REDs/phenylphenol_red.pdf

26 EPA.1995. Reregistration Eligibility Decision for ortho-benzyl-para- chlorophenol (List B Case 2045). http://www.epa.gov/oppsrrd1/REDs/2045red.pdf

Copyright © 2010 Green Seal, Inc. 10

chlorine or idodine compounds can be very corrosive to the skin and eyes and can also be irritating to mucous membranes. These compounds are corrosive and severely irritating to the eyes, skin and mucous membranes. They have been placed in EPA Toxicity Category I, indicating the greatest degree of acute toxicity, for eye and dermal irritation. It is because of their very reactive properties and moderately low oral toxicity that dilute concentrations of peroxy compounds have found wide applications and use as disinfectants. Based on their chemical reactivity, the peroxy compounds are expected to have biological activity, particularly molecularly. However, the toxic effects of caustic agents is typically dependent upon the concentration, volume, acidity (pH), ability to penetrate tissues, and the duration of contact with the solution, rather than solely based on a mass per unit body weight measurement27

Cleaning programs with environmental disinfection plans are frequently required in institutional settings including health-care facilities, child care centers, schools, hospitals, long-term care facilities (such as nursing homes), military installations and prisons. This is because the opportunity for transmission of infectious agents is high from the confinement of residents/occupants in these institutional settings - a significant proportion of the infectious disease burden is caused by diseases which are hygiene-related (i.e., transmitted via food, water, fecal and other waste material, hands and other surfaces, and via the air). This is compounded by a constantly changing nature and range of pathogenic micro-organisms to which humans are exposed and research and experience now shows that pathogens are highly opportunistic. Thus, the threat posed by emerging diseases such as avian influenza, SARS and swine flu has prompted the realization that, in the event of pandemic, hygiene (including disinfection and sanitizing) is an important first line of defense during the early critical period before mass vaccination becomes available

. Silver has low acute human toxicity, but is highly toxic to aquatic life. It has been placed in the EPA Toxicity Category III for acute oral and dermal toxicity and is not an eye or skin irritant (Toxicity Category IV), and is not a skin sensitizer. The active disinfectant ingredient silver dihydrogen citrate (SDC) has an acute LC50 for freshwater fish ranges from 3.9 to 280 ug/L (ppb). According the 1992 Reregistration Eligibility Decision for silver, it was determined that the available acute toxicity data indicate that silver, which persists in the aquatic environment, is highly toxic to fish, aquatic invertebrates and estuarine organisms. Silver is currently undergoing evaluation for reregistration eligibility under FIFRA.

28

However, it has been estimated that cleaning alone may remove up to 99% of bacteria from surfaces

.

29, 30. Furthermore, resistance of bacterial pathogens to antibiotics has increased worldwide, leading to treatment failures in human and animal infectious diseases31

27 Maine. 2008. Review of Chemical Disinfectants Registered in Maine 2006-2007.

. The use of disinfectant products may create conditions for bacteria expressing resistance mechanisms and their dissemination. For example, some biocides have the capacity to maintain the presence of mobile genetic elements that carry genes involved in cross-resistance between biocides and antibiotics. However, studies of microbial resistance to disinfectants and sanitizer use have produced contrasting results. For example, one study found that cleaning with QACs did not result in antimicrobial (triclosan) drug resistance. In contrast, a 2010 study examined the effect of subjecting populations of P. aeruginosa to increasing levels of ADBAC found that subinhibitory concentrations of this biocide selected for a mutation in the Quinoline-Resistant Determining

http://www.maine.gov/cleangovt/rulesanddocuments/reviewofchemdisinfectants2008.pdf

28 IFH. March 2010. Preventing the spread of infectious diseases in the European Union – targeted hygiene as a framework for sustainable hygiene. International Scientific Forum on Home Hygiene. http://www.ifhhomehygiene.org/IntegratedCRD.nsf/f5236e2da2822fef8025750b000dc985/62812e8ac19247fe802576c60054693f?OpenDocument

29 Dvorak, G. 2005. Disinfection 101. Center for Food Security and Public Health, Iowa State University. http://www.cfsph.iastate.edu/BRM/resources/Disinfectants/Disinfection101Feb2005.pdf

30 Fatheringham VJC. Disinfection of livestock preparation premises. Rev. sci tech. Off. Int. 1995: 14(1):191-205

31 SCENIHR. 2009. Eurpoean Commission Scientific Committee on Emerging and Newly Identified Health Risks. Assessment of the Antibiotic Resistance Effects of Biocides. http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_021.pdf

Copyright © 2010 Green Seal, Inc. 11

Region (QRDR) of P. aeruginosa, thus selecting for flouroquinolone resistance 32. As a result, the European Commission Scientific Committee on Emerging and Newly Identified Health Risks Assessment of the Antibiotic Resistant Effects of Biocides concluded that further research on this topic is required to clearly characterize the risk. Disinfectants and antiseptics should be limited for use when there are scientific studies demonstrating benefit or when there is a strong theoretical rationale for using germicide 33.As a result, for noncritical care areas in hospitals, the Centers for Disease Control and Prevention (CDC) suggest routine use of surface disinfectants on high-touch surfaces only. The transfer of microorganisms from environmental surfaces to patients is largely via hand contact with the surface34

To date, FIFRA-registered pesticides, disinfectants and sanitizers have been prohibited by EPA from bearing third party labels and making environmentally preferable claims

. Although hand hygiene is important to minimize the impact of this transfer, cleaning and disinfecting environmental surfaces as appropriate is fundamental in reducing their potential contribution to the incidence of healthcare or food service-associated infections. Green Seal recognizes that the use of disinfectants and sanitizers is necessary for limited applications, and thus includes these products in the Proposed Standard. If an institution has specific needs for using a disinfectant or sanitizer, personnel must be trained in the proper use of these products. The Proposed Standard includes user training criteria and labeling criteria requiring the inclusion of language describing situations in which the product may be ineffective or inappropriate. Additionally, criteria in the Proposed Standard require that disinfectant and sanitizer labels instruct users to clean surfaces prior to use, thereby signaling to users that disinfectants and sanitizers do not serve a cleaning function.

35. However, as noted above, disinfection is required in some institutional settings and purchasers have expressed a desire for using environmentally-preferable disinfectants in these situation. The EPA policy has left product users uncertain of the products to use. In July 2008, the EPA formed the Work Group on Comparative Claims, as part of the Pesticide Policy Dialogue Committee (PPDC) to develop a policy that would recognize greener disinfectants and sanitizers36

The Proposed Standard allows for combination of disinfectant or sanitizing-cleaners for certain, limited, applications. Combined disinfectant-cleaners generally contain ingredients common to general purpose cleaners (surfactants, builders, chelating agents) for the purpose of cleaning soils in addition to active disinfecting ingredients to destroy pathogenic microbes. Research has shown that combined disinfecting-cleaners are no less effective in disinfecting/sanitizing and they must also go through EPA registration

. The result is a pilot program currently in progress. The pilot is closed to third party labels, by only including an EPA review of the products. Currently, only the following active ingredients are allowed in EPA pilot: citric acid, lactic acid, and hydrogen peroxide. In this Proposed Standard there is no need to limit active ingredients to specific FIFRA classes or ingredients because all active ingredients will need to meet the product-specific health and environmental requirements set forth in the Proposed Standard. It is anticipated that the EPA allowed active ingredients will be permitted in the Proposed Standard.

37

32 Mc Cay, P.H, Ocampo-Sosa, A.A., and Fleming, G.T.A. 2010. Effect of subinhibitory concentrations of benzalkonium chloride

on the competitiveness of Pseudomonas aeruginosa grown in continuous culture. Microbiology. 156: 30-38

33 Weber DJ, Rutala WA. 2006. Use of germicides in the home and the healthcare setting: Is there a relationship between germicide use and antibiotic resistance? Infection Control and Hospital Epidemiology. 27(10): 1107-1119

.

34 CDC. 2003. Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for Infection Control in Healthcare Facilitites. 2003. http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf

35 Garret, R. Designing a Greener Disinfectant. November 2009. Housekeeping Solutions http://www.cleanlink.com/hs/article/Designing-A-Greener-Disinfectant--11495

36 EPA. Pesticide Policy Dialogue Committee (PPDC). Comparative Safety Statements or Logos for Pesticide Product Labeling Workgroup . Accessed 3-12-2010. http://www.epa.gov/pesticides/ppdc/compara-safety/index.html

37 Wilcox, MH; Fawley, W Hospital disinfectants and spore formation by Clostridium difficile, The Lancet, 356, 1324-1324, 2000

Copyright © 2010 Green Seal, Inc. 12

LIFE CYCLE OVERVIEW The life cycle of the range of products included in the scope of this Proposed Standard includes the raw materials used in the product formulas and its packaging, manufacturing of the product and package, distribution of the raw materials and finished product, product use, and the end-of-life of the product and package. One of the leading concerns for specialty cleaning products are product formulas with toxic and hazardous materials that may provide risk to end users and occupants of buildings where products are used as well as hazards to the aquatic environment. The other key life cycle concern is the amount and type of packaging used. PRODUCT-SPECIFIC PERFORMANCE REQUIREMENTS The performance of a cleaning product is an important characteristic for purchasers and users. If the product does not meet its performance expectations, it might be disposed of or used in higher concentrations, thus affecting the total environmental impact of the product. As a result, the global guidance for sustainability-based standards, ISO 14020/14024, like this Proposed Standard, requires performance requirements. The Proposed Standard requires products to demonstrate performance through successful testing under one of a series of cleaning test methods applicable for the product category, or alternatively to demonstrate comparable cleaning performance to any other product currently sold on the market. Each product shall clean common soils and surfaces in its category effectively, at the most dilute/least concentrated manufacturer-recommended dilution level for routine cleaning. Additionally, products (except upholstery cleaners) requiring dilution for use require unheated water directly from the cold tap at no more than 50ºF.

This method is more robust than ISO 7535 “Surface Active Agents- Detergents for Domestic Machine Dishwashing- Guide for Comparative Testing of Performance,” which does not provide adequate criteria for uniform comparative testing

Dish Cleaning Product Automatic Dish Detergent Automatic dish product performance is commonly determined using the IKW (German Cosmetic, Toiletry, Perfumery and Detergent Association) “Methods for Ascertaining the Cleaning Performance of Dishwasher Detergents.” This method requires detergents be tested on four different soil types (bleachable, stubborn/burnt-on, dried on-amylase specific and dried-on/protease-specific). The removal of some of these soils is measured by visual examination based on reference photos (bleachable (tea), stubborn/burnt on (minced meat on glass dishes and milk in the microwave), dried starch containing (oat flakes (porridge), dried protein containing (minced meat on porcelain)). While some are measured using a more quantitative gravimetric approach (dried starch containing (starch mix) and dried protein containing (egg yolk and egg/milk mixture). Automatic dish detergents shall perform as well or better than the reference detergent in removal of all four soil classes. The tested automatic dish cleaning product will fail the performance test if the performance in one or more soil classes is less than the reference detergent. The reference detergent utilized in their standard is the IEC (International Electrotechnical Commission) 436 Reference Detergent Type B (from IEC 60436 ed3.0 “Electric Dishwashers for Household Use - Methods for Measuring the Performance.”

38. For example, the ISO method does not provide standard soils, cleaning methods, nor any specific methods/rating scales for evaluating performance. Other methods available include the ASTM and the Consumer Safety Products Association (CSPA) Standard Test Methods for Deposition on Glassware During Mechanical Dishwashing (ASTM D3556-85 and CSPA DCC-05A)39,40

38 ISO. 1984. ISO 7535: Methods for Ascertaining the Cleaning Performance of Dishwasher Detergents

. These standards are identical, and offer a subjective visual rating system for evaluation of deposition of soil on glassware. Furthermore, these standards fail to measure the removal of test soil from the dishware to which it is applied and instead measure only the extent to which this soil is deposited

39 ASTM. 1985 (Reapproved 2009). Standard D3556-85: Standard Test Methods for Deposition on Glassware During Mechanical Dishwashing

40 CSPA. 1981 (Re-approved in 2003). CSPA Designation DCC-05A Standard Test Methods for Deposition on Glassware During Mechanical Dishwashing

Copyright © 2010 Green Seal, Inc. 13

on clean tumblers. Thus they will not be used for cleaning efficacy. However, these ASTM/CSPA methods can be used for evaluation of rinse aids for mechanical dishwashing, but not for detergents themselves. For rinse aids, a rating of 2 using either of these methods must be achieved.

It is proposed that hand dish detergents be evaluated and perform effectively when tested by a method in compliance with the guidance in International Organization for Standardization (ISO) Document 4189: Surface Active Agents- Detergents for Hand Dishwashing - Guide for Comparative Testing of Performance

Hand Dish detergents

41. Additionally, the foam stability of the hand dishwashing product should be demonstrated using ASTM D 4009 – 92: Standard Guide for Foam Stability of Hand Dishwashing Detergents42.

For oven cleaners, it is proposed that products be tested following CSPA Designation DCC-12: Guidelines for Screening the Efficacy of Oven Cleaners

Oven Cleaning Product

43. This is the only standard for oven cleaning efficacy in the United States issued by an industry-recognized organization. In this method, two artificially applied soils are applied and baked onto porcelain enamel substrates. Following panel aging and curing, 0.16 g of oven cleaner per square inch of panel is applied and allowed to dwell for the time specified by the manufacturer’s directions. Test panels are rinsed under gently running tap water and gently rubbed with a small damp sponge. Percent soil removal is then estimated visually. Oven cleaners shall achieve a 90% soil removal on one of the two test soils described in this test method to be deemed effective.

It is proposed that graffiti remover products shall achieve a color retention (CR) values above 85% using the test methods detailed in ASTM STP 935: Performance Tests for Graffiti Removers

Graffiti Remover

44. As outlined in ASTM STP 935, product performance shall be tested on at least three test surfaces (brick, sandstone, metal (aluminum or steel), and/or wood are recommended). Additionally, the products shall be tested on at least three common soils: black aerosol paint, felt tip pen, and/or lipstick markings. If more than 60 seconds are required to complete removal of all the paints by any graffiti remover, after a dwell time of 0.5 hours, it is considered to be ineffective. A color retention measurement method is used to quantify the extent to which the appearance of a substrate can be restored following defacement by graffiti using a color-difference meter.

For evaluating the efficacy of metal cleaners, it is proposed that ASTM G122: Standard Test Method for Evaluating the Effectiveness of Cleaning Agents be used

Metal Cleaning Product

45. In the G-122 Standard, test coupons are prepared with a desired contaminant and cleaning efficiency is determined by calculating a Cleaning Efficiency Factor (CEF). The cleaning effectiveness factor indicates the fractional contaminant that was removed during cleaning (for example, CEF = 0.9 indicates that 90% of the contaminant was removed), where:

MX2 − MX3 = the mass of contaminant removed, and MX2 − MX1 = the mass of contaminant applied.

Test coupons should be scrubbed manually using a soaked Kimberly Clark Wypall X60 reinforced paper towel for 1 minute. The cleaning method used in this standard may be modified from that which is

41 ISO. 1984. ISO 4189: Surface Active Agents- Detergents for Hand Dishwashing- Guide for Comparative Testing of

Performance

42 ASTM. 1992 (Reapproved 2006). Standard 4009-92. Standard Guide forFoam Stability of Hand Dishwashing Detergents

43 CSPA. 2003. Designation DCC-12 (2003): Guidelines for Screening the Efficacy of Oven Cleaners

44 ASTM. 1986. Special Technical Publication (STP) 935: Cleaning Stone and Masonry

45 ASTM. 1996. Standard G122-96: Standard Test Method for Evaluating the Effectiveness of Cleaning Agents

Copyright © 2010 Green Seal, Inc. 14

referenced in the standard (immersion/ultrasonic) to a method more closely simulating actual practices), but would then would be considered an alternative performance test. CEF is determined gravimetrically.

The product shall remove at least 80% of the particulate soil in ASTM D4488-95, A5 if it is intended and marketed for general-purpose cleaning

Biologically-Based Cleaning Product

46

The primary consideration regarding the performance/efficacy of microbial cleaning products is that the culture, and not other components or ingredients in the formulation are fulfilling an active cleaning role. To this end, the product shall have a plate count that is greater than or equal to 1x107 colony forming units per milliliter as determined through a standard total plant count methodology, such as the methods for microbiological analyses listed in Food Chemicals Codex (FCC) or the Joint WHO/FAO Expert Committee on Food Additives (JECFA) Combined Compendium of Food Additive Specifications

. Although this ASTM standard has been withdrawn and a working group panel has been assembled to revise the standard it is still the most widely recognized and utilized standard addressing removal of common soils from hard surfaces. For biologically-based produces intended and marketed for restroom cleaning, the product shall also remove at least 75% of the soil in ASTM D5343-06. Many dish cleaners are enzymatic and shall meet the performance requirements for both enzymatic cleaners and also dish cleaners. Biologically-based odor removers shall meet performance requirements for biologically based cleaning products and odor removers. Additionally, to determine the efficacy of cleaners with active microbial cultures or enzymes, it is proposed that several aspects of performance and formulation be examined to determine the performance of the microbes or enzymes on a target soil, as opposed to other ingredients or components in the formulation performing the cleaning function. Microbial Cleaner

47,48

The product shall be tested to demonstrate enzyme activity and to demonstrate enzymatic action specific to the target soil and a unit of activity defined according to standardized tests for enzymatic activity laid out in the JECFA and the FCC

. It must be demonstrated that the microbial culture within the product plays an active role in cleaning and/or odor control using an appropriate test method (such as an biological oxygen demand test demonstrating that microbial cultures are more active in the presence of the target soil). For example, if the microbial culture is intended to hydrolyze greasy soils, an assay demonstrating lipolytic activity should be conducted (introducing culture strain and Lipase Reagent, or another lipid source, on Spirit Blue agar and determining the formation of lipolytic colonies). Another example of a test demonstrating that the culture itself is responsible for the cleaning action is a non-emulsification assay demonstrating that there are no emulsifiers in the product responsible for the cleaning function. The product as used shall only contain surfactants that comprise less than or equal to 1% of the product when calculated on a weight basis for solids or a volume basis for liquids. Enzymatic Cleaner

49.

All car and boat cleaning products product shall remove at least 80% of the particulate soil as required in ASTM D4488-95, A5, and if sold as a wax must perform better than the control in a performance test based on ASTM D 3836-94: Standard Practice for Evaluation of Automotive Polish or ASTM D6625-01: Standard Practice for Conducting a Test of Protective Properties of Polish Applied to a Painted Panel

Car and Boat Cleaning Product

46 ASTM. 1995 (WITHDRAWN). Standard D4488-95: Standard Guide for Testing Cleaning Performance of Products Intended for

Use on Resilient Flooring and Washable Walls.

47 USP. 2010. Food Chemicals Codex 7th Edition. U.S. Pharmacopeia

48 JECFA. 2006. Combined Compendium of Food Additive Specifications. Joint FAO/WHO Expert Committee on Food Additives. Food and Agriculture Organization of the United Nations. 2006 Last updated (Web version): July 2009. http://www.fao.org/docrep/009/a0691e/a0691e00.HTM

49 Ibid.

Copyright © 2010 Green Seal, Inc. 15

Using Fluorescent UV-Condensation Light- and Water-Exposure Apparatus50,51,52. Particular boat cleaning agents designed for special uses, such as the removal of alga and shell, or anti-corrosion agents, are included in the scope of this standard though there are no known industry-accepted performance standards and test soils specifically addressing these special soils. Disinfectants and Sanitizers The product shall be in accordance with all appropriate current regulatory requirements, i.e., demonstrate a current registration number with the U.S. Federal Environmental Protection Agency. When a product is FIFRA-registered, it has demonstrated efficacy against target organisms, thus registration of products is taken as evidence by Green Seal of product effectiveness against target organisms. The EPA must pre-approve all “efficacy test methods” used to measure the effectiveness of disinfectants against specific microorganisms. The most common efficacy test prescribed by EPA is the Association of Official Analytical Chemist (AOAC) Use Dilution Confirmation Test. Currently, for a disinfectant cleaner to be registered by EPA as hospital strength, it must be effective at its recommended dilution in killing targeted pathogens in the presence of 400 ppm hard water and 5% organic serum, and it must kill 100% of the targeted test organisms.

Additionally, if marketed as a combined disinfectant cleaner, the product shall remove at least 80% of the particulate soil in ASTM D4488-95. The tests used to measure the effectiveness of disinfectants on various pathogenic (disease causing) organisms are called efficacy tests. Upholstery Cleaning Product Using a standard test method, the manufacturer must demonstrate that its product performs as well as a conventional, nationally recognized product in its category, in both cleaning efficiency and resoiling resistance. Acceptable test methods/procedures to demonstrate performance include, but are not limited to, the following sources: the American Association of Textile Chemists and Colorists (AATCC), ASTM, the Institute of Inspection, Cleaning and Restoration Certification (IICRC), the International Organization for Standardization (ISO), WoolSafe, or laboratory testing conducted as part of a bid evaluation by a government purchasing entity.

Products in this category are subject to the alternative performance requirement and must show results demonstrating effective odor abatement through performance testing using a peer-reviewed, fully documented test protocol that is developed and tested to by a credible third party testing organization and can be used for those product categories where no recognized performance testing methods exist. An Odor Panel Test such as ASTM E544-99 (Reapproved 2004): Standard Practices for Referencing Suprathreshold Odor Intensity may be utilized

Odor Remover

53

PRODUCT-SPECIFIC SUSTAINABILITY REQUIREMENTS The environmental and human health requirements in GS-52 have largely been adopted from the 2007 revision of GS-37 for Industrial and Institutional Cleaning Products. Exceptions or changes to the requirements are noted in each category below.

. These tests utilize a panel of judges who compare the relative intensity of the odor given off by samples, usually as compared to a reference compound.

50 ASTM. 1995 (Reapproved 2001). Standard D4488-95: Standard Guide for Testing Cleaning Performance of Products

Intended for Use on Resilient Flooring and Washable Walls

51 ASTM. 1994 (Reapproved 2007). Standard D3836-94: Standard Practice for Evaluation of Automotive Polish

52 ASTM. 2001(Reapproved 2007) Standard 6625-01: Standard Practice for Conducting a Test of Protective Properties of Polish Applied to a Painted Panel Using Fluorescent UV-Condensation Light- and Water-Exposure Apparatus

53 ASTM. 1999 (Reapproved 2004). Standard D E544-99 Standard Practices for Referencing Suprathreshold Odor Intensity may be utilized

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

Copyright © 2010 Green Seal, Inc. 16

Language has been included within the Proposed Standard to clarify how the GS-52 human health and environmental toxicity requirements relate to the Hazard Categories set forth in the 3rd Edition of the United Nations Globally Harmonized System for the Classification and Labeling of Chemicals54. GHS nomenclature and Hazard Categories pertaining to the GS-52 toxicity criteria have been included due to the United States Department of Labor’s Occupational Safety and Health Administration (OSHA) proposition to modify the existing Hazard Communication Standard (HCS) system to conform with the GHS to improve the quality and consistency of hazard communication within the US55.

This criterion is in-line with other similar standards for oral toxicity measured using the OECD toxicity test for mammals (TG 401) including Environmental Choice CCD-146 and the requirements of the Consumer Product Safety Council found at 16 Code of Federal Regulations (CFR) Chapter II, Part 1500

Acute Toxicity

56,57

The acute inhalation toxicity of a substance is the total of adverse effects caused by a substance following a single uninterrupted exposure by inhalation over a short period of time (24 hours or less) to a substance capable of being inhaled. The proposed approach is intended to address the airborne impact of cleaning products, and has been updated to be more protective of children and vulnerable populations. The approach requires the evaluation of acute toxicity of the product (as dusts, mists, vapors and gases) through inhalation either through testing or through a weighted average calculation of the individual constituents in the product formulation, with the additional requirement of emissions testing for products that fail the initial acute toxicity screening. The GHS recommends that the threshold of LC50 ≤ 20 mg/L for the acute toxicity testing for dusts mists and vapors is required to be at 1 hour, while the threshold LC50 ≤ 20,000 ppmV for gases is tested at four hours. This requirement applies whether the product formulation is evaluated by weighted average or when it is whole product tested. The shorter time frame leads to a more conservative determination of acute product toxicity and is therefore more protective of human health

. The oral toxicity threshold is an Oral LD50 < 5,000 mg/kg. This threshold has been established to account for the decreased body mass of small children which will lead to increased dosages, and the increased sensitivities of vulnerable populations that may become exposed. The threshold of 5,000 mg/kg is consistent with the upper range of the ability to measure and correlate the toxic effects of exposure in mice as indicated by the Organization for Economic Cooperation and Development (OECD).

58

Dermal toxicity criteria are limited to acute exposure and a product is considered to be toxic if the undiluted product has dermal lethal dose 50 (LD50 ) <2,000 mg/kg. This threshold has been established to account for the decreased body mass of small children which will lead to increased dosages, and the increased sensitivities of vulnerable populations that may become exposed. The threshold of 5,000 mg/kg is consistent with the upper range of the ability to measure and correlate the toxic effects of exposure in mice as indicated by the OECD. This brings the standard in-line with other similar standards for dermal toxicity measured using the OECD toxicity test for mammals (TG 402) including Environmental Choice CCD-146 and the requirements of the Consumer Product Safety Council found at 16 Code of Federal Regulations (CFR) Chapter II, Part 1500

.

59,60,61

54 United Nations. 2009. Globally Harmonized System for the Classification and Labeling of Chemicals, 3rd Edition.

. Substances with a dermal LD50 < 2,000 mg/kg

http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/English/00e_intro.pdf

55 US Federal Register. September 20, 2009. Proposed Rule: Hazard Communication. http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=21110

56 Ecologo. 2005. Criteria Document CCD-146: Harsurface Cleaners. http://www.environmentalchoice.com/common/assets//CCD-146%20Hardsurface%20Cleaners%20%28July%2022,%202008%29%20w%20INTERPRETATIONS.pdf

57 OECD. 1987. Guidelines for the Testing of Chemicals: Acute Oral Toxicity. Guideline 401. Adopted February 24, 1987.

58 OECD. 1981. Guidelines for the Testing of Chemicals: Acute Oral Toxicity. Guideline 403. Adopted May 12, 1981

59 Ecologo. 2005. Criteria Document CCD-146: Hardsurface Cleaners. http://www.environmentalchoice.com/common/assets//CCD-146%20Hardsurface%20Cleaners%20%28July%2022,%202008%29%20w%20INTERPRETATIONS.pdf

Copyright © 2010 Green Seal, Inc. 17

body weight are considered acutely toxic under the GHS and fall into Hazard Categories 1 through 4, while those with an LD50 between 2,000 and 5,000 mg/kg fall into toxicity category 5 and are considered to be of relatively low acute toxicity. Criteria for chronic dermal toxicity were considered, however the standard has acted to limit the risk to populations resulting from chromic dermal exposure through the development of criteria for acute dermal toxicity, skin sensitization and skin irritation criteria, skin absorption criteria, and through the inhalation toxicity criteria. It was determined that these criteria are adequate to account for most of the expected exposures to cleaning chemicals making additional criteria for chronic dermal toxicity redundant. Products meeting the above requirements will not fall into Hazard Categories 1 through 5 62 for acute oral and dermal toxicity and will not fall into Hazard Categories 1 through 4 63 for acute inhalation toxicity under the GHS when the whole product is evaluated

The use of chemicals known to cause reproductive toxicity be prohibited and include both male and female reproductive toxins and developmental toxins. California Prop 65 is the most readily available and accepted source for these compounds and shall be cited

Carcinogens, Reproductive Toxins, Mutagens, and Neurotoxins The use of ingredients and intentional additives that are suggestive, likely, potential, possible, probable, reasonably anticipated, or known human carcinogens will be prohibited. Green Seal references carcinogen lists with the priority for international and national lists to follow the guidance of ISO 14024, including IARC, National Toxicology Program (NTP), EPA, OSHA, and GHS. With these lists available, state lists such as California Prop 65, are not referenced for carcinogens. However, the definition of carcinogen within this standard identifies which lists Green Seal’s references. These prohibitions apply to ingredients of the product materials used at 0.01%, as well as any intentionally added components or known contaminants. An intentional component is considered to be a deliberately added product component, where it is added for its continued presence in the final product to provide a specific characteristic, appearance, or quality. These prohibitions follow the common, protective approach for these materials in other ecolabel programs. Since reference lists and GHS classification is used, testing is not needed.

64. The NTP research progress can be used for additional information, though it is not a reference list that is maintained for use like Prop 65. Reproductive toxins also include any substance that falls into category 1 (H360), known or presumed reproductive toxicant, or Category 2 (H362), suspected human reproductive toxicant, under the GHS, and also includes any chemical categorized as having adverse effects on or via lactation (H362)65

Mutagens will also be prohibited and defined according to the GHS criteria for germ cell mutagenicity. These include any substance that meet the criteria for Hazard Category 1 (H340), chemicals known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans, and Hazard Category 2 (H341), substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans, under the GHS. These

.

60 CFR. Title 16, Chapter 2, Part 1500. http://ecfr.gpoaccess.gov/cgi/t/text/text-

idx?c=ecfr&tpl=/ecfrbrowse/Title16/16cfr1500_main_02.tpl

61 OECD. 1987. Guidelines for the Testing of Chemicals: Acute Dermal Toxicity. Guideline 402. Adopted February 24, 1987

62 Testing in animals in Category 5 ranges (2,000-5,000 mg/kg body weight) is discouraged and should only be considered when there is a strong likelihood that the results would have a direct relevance to the protection of human health.

63 The OECD Task Force on Harmonization of Classification and Labeling (HCL) did not include numerical values for inhalation toxicity Category 5, May be harmful if inhaled, but instead specified doses “equivalent to the range of 2000-5000 mg/kg bodyweight by the oral or dermal route.

64 State of California Environmental Protection Agency. 2010. Chemicals Known to the State to Cause Cancer or Reproductive Toxicity. June 11, 2010. http://oehha.ca.gov/prop65/prop65_list/files/P65single061110.pdf

65 United Nations. 2009. Globally Harmonized System for the Classification and Labeling of Chemicals, 3rd Edition. http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/English/00e_intro.pdf

Copyright © 2010 Green Seal, Inc. 18

are consistent with the EU classification and labeling criteria for Category 1 and 2 mutagenic substances, which are required to be labeled as follows: R46 May cause heritable genetic damage66

Neurotoxicity occurs when an exposure to a toxic substance (neurotoxicant) alters the normal activity of the nervous system. This can eventually disrupt or even kill neurons, key cells that transmit and process signals in the brain and other parts of the nervous system. Symptoms may appear immediately after exposure or be delayed. They may include limb weakness or numbness, loss of memory, vision, and/or intellect, headache, cognitive and behavioral problems, and sexual dysfunction. Some neurotoxic effects are short-lived and reversible, however, neurotoxic effects can be permanent and severely debilitating. Many chemicals have been demonstrated to produce neurotoxic effects

.

67

Test methods for evaluating neurotoxicity, particularly developmental neurotoxicity, have been established by the EPA and the OECD

. Grandjean and Landrigan have identified and listed more than 200 specific industrial chemicals which may have such impact. Many of the chemicals are not ingredients in cleaning products such as pesticides, and many are listed as organic substances. In general, many of the other criteria in GS-52 have already restricted or prohibited many of the neurotoxicants. Some neurotoxicants are already listed as prohibited ingredients (e.g. metals such as lead and selenium). In addition, benzene is prohibited because it is also a carcinogen. Ethylene glycol monomethyl ether and ethylene glycol monoethyl ether and their acetates are listed as reproductive toxins and therefore prohibited ingredients. All other substances that have been identified as neurotoxins are prohibited.

68,69. However, toxicity testing for a product’s entire ingredient list would be prohibitively expensive and time-consuming. Thus, it is proposed that rather than require testing for neurotoxicity of a product or its ingredients, that any substances which meet the criteria for Hazard Categories 1, 2 or 3 for specific organ toxicity, single exposure, brain, under the GHS, be prohibited under this standard70

66 Langezaal, I. 2002. The Classification and Labelling of Carcinogenic, Mutagenic, Reprotoxic, and Sensitising Substances.

Ispra, October.

. GHS defines substances placed in Category 1 as those that have produced significant toxicity in humans, or that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following single exposure, based on reliable and good quality evidence from human cases or epidemiological studies, or observations from appropriate studies in experimental animals in which significant and/or severe toxic effects of relevance to human health were produced at generally low exposure concentrations. Substances placed in Category 2 are those that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to be harmful to human health following single exposure. Category 3 includes those substances and mixtures that produce transient target organ effects that may not meet the Criteria for Categories 1 or 2. These are effects which adversely alter human function for a short duration after exposure and from which humans may recover in a reasonable period without leaving significant alteration of structure or function. This category only includes narcotic effects and respiratory tract irritation (but for the purpose of identifying neurotoxins narcotic effects are more relevant).

For all of these prohibitions, existing information is used for the evaluation. Product testing and ingredient testing is not conducted. These prohibitions apply to ingredients of the product, as defined in the standard, as well as intentional components. An intentional component is considered to be a deliberately added product component, where it is added for its continued presence in the final product to provide a specific characteristic, appearance, or quality.

67 Grandjean, P. and P.J. Landrigan. 2006. Developmental neurotoxicity of industrial chemicals. Lancet 368:2167-2178. Available www.thelancet.com/journals/lancet/article/PIIS0140673606696657/abstract

68 U.S. EPA. 1998c. Guidelines for Neurotoxicity Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, 630/R-95/001F. Available http://cfpub.epa.gov/ncea/raf/recordisplay.cfm?deid=12479

69 Organization for Economic Cooperation and Development (OECD). 2007. OECD Guideline for the testing of chemicals. Guideline 426: Developmental Neurotoxicity Study. Available http://titania.sourceoecd.org/vl=1352550/cl=11/nw=1/rpsv/cgi-bin/fulltextew.pl?prpsv=/ij/oecdjournals/1607310x/v1n4/s52/p1.idx

70 United Nations. 2009. Globally Harmonized System for the Classification and Labeling of Chemicals, 3rd Edition. http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/English/00e_intro.pdf

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These prohibitions follow the common, preventative approach for these materials in other ecolabel programs71. This approach is further necessary, especially with regard to considering intentional components, when consideration is given for vulnerable populations, especially for children72. Thus the recommended approach for carcinogens, mutagens, and reproductive toxins it that where an ingredient or component exhibits potentially harmful characteristics, is to specifically prohibit these ingredients in products rather than attempting to determine risk-based acceptable levels. For example, the active disinfecting ingredient ortho-benzyl-para-chlorophenol induces increases in kidney nephropathy and has been classified as a Group C, possible human carcinogen under EPA IRIS, and as such is not a permitted active ingredient under the proposed standard. Other ingredients found in specialty cleaning products that are carcinogens, mutagens or reproductive toxins include, but are not limited to, toluene, formaldehyde, p-dichlorobenzene, benzene, acetaldehyde, styrene, chloroform, 2-butoxyethanol, and trichloroethylene.

Products should not be corrosive to the skin or eyes. The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) includes definitions (see below) and classification criteria for skin corrosion and “serious eye damage”

Skin and Eye Irritants and Skin and Respiratory Sensitizers

73. These definitions are consistent with the definitions used by the US and the European Union for acute dermal irritation/corrosion and for acute eye irritation/ corrosion74,75,76,77

These hazard considerations are important for active ingredients in specialty cleaning products. For example, in a large study carried out by the Swiss Contact Dermatitis Research Group, ADBAC, the most frequently used QAC, was found to be the agent responsible in 5.5% of the cases of contact dermatitis reviewed in the study

. However, the GHS more precisely defines these terms and uses the term “serious eye damage” instead of “eye corrosion.” Further, skin and respiratory sensitizers will not be allowed. The 3rd edition of the GHS includes definitions, testing methods, and classification criteria for these hazards and these are utilized in this standard. Since Green Seal uses existing data to evaluate this criterion, testing is typically not required, unless data is not available or indicate a need for testing. As a result, the cost of testing is not expected to increase.

78. Other active disinfectant ingredients such as phenols and substituted phenols produce severe and marked irritation to the eyes and skin (Toxicity Category I or II)79

71 European Commission. 2005. Establishing Ecological Criteria for the Award of the Community Eco-Label to All-Purpose

Cleaners and Cleaners for Sanitary Facilities. March 23, 2005. 2005/344/EC

72 Jarosinska, D. And D. Gee. 2007 Children’s environmental health and the precautionary princple. Internationa Journal of Hygiene and Environmental health. 2007.07.017.

. Undiluted o-benzyl-p-chlorophenol in potassium and sodium salts exhibit slight skin effects but severe eye effects.

73 United Nations. 2009. Globally Harmonized System for the Classification and Labeling of Chemicals, 3rd Edition. http://www.unece.org/trans/danger/publi/ghs/ghs_rev03/English/00e_intro.pdf

74 U.S. EPA. 1998a. Health Effects Test Guidelines: OPPTS 870.2500 Acute Dermal Irritation. Available: www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Series/870-2500.pdf

75 OECD. 2002a. Guideline for testing of chemicals. Guideline 404: Acute Dermal Irritation/Corrosion. Available: http://miranda.sourceoecd.org/vl=439522/cl=12/nw=1/rpsv/cgi-bin/fulltextew.pl?prpsv=/ij/oecdjournals/1607310x/v1n4/s4/p1.idx

76 U.S. EPA. 1998b. Health Effects Test Guidelines: OPPTS 870.2400 Acute Eye Irritation. Available: www.epa.gov/opptsfrs/publications/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Series/870-2400.pdf

77 OECD. 2002b. Guideline for testing of chemicals. Guideline 405: Acute Eye Irritation/Corrosion. Available: http://oberon.sourceoecd.org/vl=5857828/cl=17/nw=1/rpsv/cgi-bin/fulltextew.pl?prpsv=/ij/oecdjournals/1607310x/v1n4/s5/p1.idx

78 Perrenoud, D., et al., Frequency of sensitization to 13 common preservatives in Switzerland. Swiss Contact Dermatitis Research Group. Contact Dermatitis, 1994. 30(5): p. 276-9.

79 EPA. 2009. Reregistration Eligibility Decision for Phenol & Salts. Accessed March 26 2010. http://www.epa.gov/pesticides/reregistration/REDs/phenol-salts-red.pdf

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Undiluted o-phyenyl phenol and p-tert-amylphenol and their salts demonstrate moderate or severe corrosion/skin effects.

Skin absorption is a very complex process. The potential for skin absorption can be estimated for individual ingredients using lists of chemicals with skin absorption potential from credible scientific sources. There are no such lists from the federal government. However there are lists from the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Values for Chemical Substances (TLV) that includes substances with a high potential for skin absorption (skin notation) and systemic health effects

Skin Absorption Many cleaning products are used such that skin contact with the liquid is common. Some of these formulations contain relatively low toxicity solvents such as isopropanol (rubbing alcohol) and acetone. These solvents, along with water, are known to facilitate the absorption of other more toxic ingredients in the formulation, thus presenting a systemic hazard. Graffiti removal products frequently contain dimethyl sulfoxide (DMSO), which has capability of penetrating the skin quickly and deeply (without damaging the skin) while carrying other substances with it. While DMSO itself is not highly acutely toxic, it has the potential to carry other systemic toxins through the skin.

80. Another list is from the German Deutche Forschungsgemeinschaft (DFG) Maximum Allowable Concentrations (MAK) list for chemicals with a high potential for skin absorption H notation81. As the definitions of skin notations differ from the two organizations, the most conservative listing should be utilized to identify chemicals with high skin absorption potential. Both of these lists will be used to limit use of such substances, to less than 1% of the product formula. Further, there will be a limit of use of substances with the same target end-point to less than 1% of the product formula. The use of these lists removes the need for testing to meet this criterion.

More than 30 articles over the last several years have documented the increased incidence and prevalence of asthma among janitors and other cleaning workers in many countries

Ingredients that Cause Asthma

82,83,84. Henneberger (2005) commented that, “Over the past 15 years, professional cleaners have emerged as one of the high risk groups for work related asthma in industrialized nations85.” This adverse effect is not limited to individuals who professionally perform cleaning tasks; cleaning products also affect other building occupants and bystanders86. Case reports and epidemiologic studies have documented asthma among individuals who use spray cleaners at home87,88. And a new study has documented wheezing and decrements in lung function in children whose mothers had high domestic cleaning chemical exposure during pregnancy89

80 American Conference of Governmental Industrial Hygienists (ACGIH). 2007. Threshold Limit Values for Chemical Substances

and Physical Agents and Biological Exposure Indices. (list, pp 10-65; definition, pp 71-72).

81 Deutche Forschungsgemeinschaft (DFG). List of MAK and BAT Values, 2005..Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area, Report No. 41. Wiley-VCH, Weinheim, 2005. (List pp17-129; definition pp 172-173).

82 Nazaroff WW, Weschler CJ. 2004. Cleaning products and air fresheners: exposure to primary and secondary air pollutants. Atmospheric Environment 38:2841-2865.

83 Rosenman, K., 2006. “Cleaning products-related asthma.” Clinical Pulmonary Medicine 13(4):221-228

84 Henneberger, P.K. 2005. “How “clean” is the cleaning profession?” Occ Environ Med. 62:586-587.

85 Ibid.

86 Nazaroff WW, Weschler CJ. 2004. Cleaning products and air fresheners: exposure to primary and secondary air pollutants. Atmospheric Environment 38:2841-2865.

87 Zock, J-P, Plana, E., Jarvis, D., Antó, J.M., et al. 2007. “The use of household cleaning sprays and adult asthma: An international longitudinal study.” Amer J Respir Crit Care Med 176:735-741.

88 Rosenman, K.D. 2007. “Clean as a whistle, but what about that wheeze?” Amer J Respir Crit Care Med. 176:731-732.

89 Henderson J, Sherriff A, Farrow A, Ayres JG. 2008. Household chemicals, persistent wheezing and lung function: Effect modification by atopy? European Respiratory Journal March 1, 2008 vol. 31 no. 3 547-554

.

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The Association of Occupational and Environmental Clinics (AOEC) provides a list of asthmagens. It is periodically updated through a peer-reviewed process, and new chemicals are added and inaccurate or out-dated listings are deleted or modified. This list contains clear criteria, including the references relied on for listing, is accessible online, and oversight is provided by medical professionals with no financial incentive. Thus, it is sufficiently authoritative to address this very import health concern for cleaning products. As a result, this standard shall use the AOEC list to prohibit ingredients that are known to cause asthma. Testing is not needed to meet this requirement. While eliminating ingredients that cause asthma will reduce the number of new cases of asthma, this change will not necessarily prevent the exacerbation of symptoms among those with preexisting asthma. People with reactive airways may have further airway obstruction (through bronchospasm) triggered by viral infections, exposure to irritants, cold or exercise. Asthma resulting from respiratory sensitization caused by enzymes has been well documented in workers in industrial enzyme production facilities90,91,92.. However, preparations of the enzymes in encapsulated granulated form, which is less readily inhaled, have reduced the likelihood of asthma93. Research has also demonstrated that the quaternary ammonium compound benzalkonium chloride (ADBAC) can cause occupational asthma94,95, 96. Products containing enzymes (at the ingredient or component level) classified as asthmagens by the AOEC and the QACs ADBAC and Didecyl dimethyl ammonium chloride (DDAC), which are also AOEC identified asthmagens will not be permitted under this standard.

Volatile organic compounds include alcohols, aldehydes, straight chain and cyclic alkanes, aromatic hydrocarbons, halogenated hydrocarbons, terpenes, ketones, and esters. VOCs are common ingredients in cleaning products, including ethanol, fragrances, essential oils, and solvents. VOCs have adverse effects on the outdoor environment (e.g., smog production) and indoor environement (e.g., human health impacts). Adverse health responses potentially caused by VOCs in non-industrial indoor environments fall into three categories: 1) irritant effect including the perception of unpleasant odors and mucous membrane irritation, 2) systematic effects such as fatigue and difficulty concentrating, and 3) toxic effects such as carcinogenicity

Volatile Organic Compounds

97. Poor indoor air quality as a result of VOC exposure is also one of the biggest contributors to asthma and other respiratory ailments in school-aged children98

90 Baur, X. 2005. Enzymes as occupational and environmental respiratory sensitizers. May 2005. International Archives of

Occupational and Environmental Health Volume 78, Number 4 279-286

91 Vanhanen, M., Tuomi, T., Tiikkainen, U., Tupasela, o., Voutilainen, R., Nordman, H. 2000. Risk of Enzyme Allergy in the Detergent Industry. Occupational and Environmental Medicine, Vol. 57, No. 2 (Feb., 2000), pp. 121-125

92 Larsen, A.I., Johnsen, C.R., Frickman, J., Mikkelsen, S. 2007.Incidence of respiratory sensitization and allergy to enzymes among employees in an enzyme producing plant and the relation to exposure and host factors.Occup Environ Med 2007;64:763-768

. Setting appropriate levels of VOC content is essential to minimizing the potential environmental and health effects of cleaning products on workers, children, and otherwise vulnerable or sensitive populations..

93 Canadian Center for Occupational Health and Safety. 2005. OSH Answers: Asthma. February 8, 2005. Accessed 4-22-2010. http://www.ccohs.ca/oshanswers/diseases/asthma.html

94 Purohit, A., Kopferschmitt-Kubler, M.C., Moreau, C., Popin, E., Blaumeiser, M., Pauli, G. 2000. Quaternary ammonium compounds and occupational asthma. Int Arch Occup Environ Health. Aug;73(6):423-7

95 Ibid.

96 Preller L, Doekes G, Heederik D, Vermeulen R,Vogelzang PF, Boleij JS. 1996. Disinfectant use as a risk factor for atopic sensitization and symptoms consistent with asthma: an epidemiological study. Eur Respir J 9(7): 1407-1413.

97 Girman, J.R. 1989. Volatile organic compounds and building bake-out. Occupational Medicine: State of the Art Reviews (4), October- December, 1989, pp. 695-712. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=2690381&dopt=Citation

98 Mendell, M.J. 2007. “Indoor residential chemical emissions as risk factors for respiratory and allergic effects in children: a review.” Indoor Air.17:259-277.

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The Proposed Standard has adopted the allowable State of California’s Air Resources Board (CARB) VOC limits for each product category. Generally, many specialty cleaning products are constituted by ingredients similar to those in general purpose cleaners and have CARB VOC criteria of 1% by weight or below. Product categories covered by this standard that potentially have higher VOC levels are graffiti cleaners and metal cleaners, which typically contain volatile solvents, and under CARB have a standard VOC content of 30% by weight. Determination of VOC content can be done by summing the content of volatile materials (i.e., those with a vapor press of 0.1 mmHg or more) or using the CARB Method 310 for determining the acceptable levels of VOC content allowed in the various product classes99. This method is established and extensively used. CARB 310 provides exemptions to VOC requirements for fragrances and low vapor pressure components of a product. The CARB exemption of fragrances from the VOC content is inconsistent with the criteria in this Proposed Standard, which requires that fragrances be treated similarly to all other chemicals thus the designated thresholds for each product class considers all VOC content detected under the test method.

In addition to criteria for VOC content and acute inhalation toxicity, the Proposed Standard includes criteria for chronic inhalation toxicity. The chronic inhalation toxicity criteria are aimed to further minimize the impact of cleaning products on indoor air quality and the associated health risks to building occupants, including school age children. Studies measuring VOCs in schools, home and workplaces often implicate cleaning products as potential sources of the chemicals detected in the air

Chronic Inhalation Toxicity

100, 101. Some epidemiological studies have suggested an association between cleaning chemicals and respiratory ailments102,103,104. Other studies have examined the airborne release of toxic chemicals from cleaning products commonly used in school settings105. These studies continue to raise questions about the impact of cleaning products on indoor air quality and respiratory health. The Proposed Standard outlines two paths for ensuring protection from chronic inhalation hazards. The first paths follows a set of screens that include assessing repeated inhalation exposure hazard levels, and the second path uses a small chamber method to measure product emissions.

The products covered in this standard and their components can end up in the environment and waterways throughout the life cycle including at manufacturing, during use, or after product use. As a result, there will be requirements for aquatic toxicity and additional ecological considerations (e.g., biodegradation, bioaccumulation, and eutrophication). The product shall not be acutely toxic to the aquatic environment, in its as used form (because that is the most likely form of the product to be disposed of to a sewage system, eventually being discharged to surface water). Based on the OECD and GHS criteria, a product with an acute aquatic toxicity above 100 mg/L would not be classified into an acute toxicity Hazard Category. Acute aquatic toxicity is maintained as a distinct criterion, rather than

Toxicity to Aquatic Life

99 California Air Resources Board (CARB). 2005. Determination of Volatile Organic Compounds (VOC) in Consumer

Products and Reactive Organic Compounds in Aerosol Coating Products. http://www.arb.ca.gov/testmeth/cptm/method310.pdf

100 Rumchev, K., Spikett, J., Bulsara, M., Phillips, M., Stick, S., 2004. Association of domestic exposure to volatile organic compounds with asthma in young children Thorax 2004;59:746-751

101 Franke, Deborah L., Eugene C. Cole, Leese, K.E., Foarde, K.K., Berry, M.A. 1997. “Cleaning for Improved Indoor Air Quality: an Initial Assessment of Effectiveness.” Indoor Air 7 (1), 41–54.

102 Vincent, G., Kopferschmitt-Kubler, M.C., Mirabel, P., Pauli, G., Millet, M. 2007. Sampling and Analysis of Quaternary Ammonium Compounds (QACs) Traces in Indoor Atmosphere.

103 Medina-Ramon M, Zock JP, Kogevinas, et al. 2005. Asthma, chronic bronchitis, and exposure to irritant agents in occupational domestic cleaning: a nested case-control study. Occ Environ Med 62:598-606

104 Preller L, Doekes G, Heederik D, Vermeulen R,Vogelzang PF, Boleij JS. 1996. Disinfectant use as a risk factor for atopic sensitization and symptoms consistent with asthma: an epidemiological study. Eur Respir J 9(7): 1407-1413.

105 Environmental Working Group. 2009. Greener School Cleaning Supplies = Fresh Air + Healthier Kids. New Research Links School Air Quality to School Cleaning Supplies. http://www.ewg.org/files/2009/10/school-cleaners/EWGschoolcleaningsupplies.pdf

Copyright © 2010 Green Seal, Inc. 23

combining with biodegradability and possibly other environmental fate considerations, because compounds can cause toxic effects before they biodegrade. To meet this requirement, available information on the weighted average of ingredients is used instead of whole-product testing to keep testing requirements and costs down, and reduces the demand for animal testing. Of greatest concern regarding acute toxicity are several active disinfectant ingredients (see Other Prohibited and Restricted Compound section herein).

The aquatic biodegradability criterion also applies to a product as used because that is the most likely form of the product to be disposed of to a sewage system, eventually being discharged to surface water. The test methods cited in the criterion include currently available ISO test methods 9408 and 14593, and OECD test methods 301 A-F and OECD 310

Aquatic Biodegradability

106,107,108

Biodegradability is maintained as a distinct criterion, rather than combining with toxicity to aquatic life, and possibly other environmental fate considerations, because compounds can cause toxic effects before they biodegrade. However, an exception to the requirement for ready biodegradability is proposed here for natural components that do not have acute aquatic toxicity <100 mg/L, that are not bioaccumulating, and that exhibit inherent, ultimate biodegradability, defined by OECD [2003] as biodegradation rates above 70%, measured as BOD, DOC, or COD

. The criterion applies to specific individual organic ingredients. If a product raw material is a blend of two or more organic ingredients, each of those organic ingredients must meet the biodegradability criterion.

109

Biodegradability and toxicity to aquatic life are also important concerns for biocides (disinfectants and sanitizers). For example, studies have shown that alkyl trimethyl ammonium and alkyl benzyl dimethyl, ammonium compounds, showed very poor primary biodegradation and no evidence of any extent of ultimate biodegradation was observed

.

Direct release ingredients are those that are used in products that are intended for use in applications that result in their immediate discharge to the environment, so that they bypass sewage treatment or septic systems, shortening the time for degradation prior to entering sensitive environments. The aquatic toxicity and biodegradability criteria in this Proposed Standard address this concern and are aligned with the aquatic toxicity requirements of other certification programs, i.e., the Green Seal aquatic toxicity requirements (for both POTW-mediated products and direct release products) are as stringent as these criteria.

110. Other ingredients common to dish and specialty cleaing products with poor biodegradability or high acute toxicity to aquatic life are EDTA, triclosan and other active disinfectant ingredients.

Criteria for acute aquatic toxicity, biodegradation and bioaccumulation have been included in previous Green Seal standards for cleaning products, however, criteria for chronic aquatic toxicity have previously not been included because the combination of criteria for acute toxicity, biodegradation, and bioaccumulation were deemed to be sufficiently protective against potential long-term aquatic hazards.

Chronic Aquatic Toxicity

106 ISO. 1999. ISO 9408: Water Quality – Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous

medium by determination of oxygen demand in a closed respirometer

107 ISO. 1999. ISO 14593: Water Quality – Evaluation of ultimate aerobic biodegradability of organic compounds in aqueous medium -- Method by analysis of inorganic carbon in sealed vessels (CO2 headspace test).

108 OECD. 1992. Guidelines for the Testing of Chemicals, OECD 301(A – F) Ready Biodegradability, Adopted July 17, 1992.

109 OECD. 2003. Introduction to the OECD Guidelines for Testing of Chemicals Section 3, Part 1: Principles and strategies related to the testing of degradation of organic chemicals, July 2003

110 García, M. T., E. Campos, J. Sanchez-Leal and I. Ribosa. 1999. Effect of the alkyl chain length on the anaerobic biodegradability and toxicity of quaternary ammonium based surfactants 1999. Chemosphere. Volume 38, Issue 15, June 1999, Pages 3473-3483

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However, recent research has documented that even chemicals that are not acutely toxic, non-bioaccumulative, and which demonstrate ready biodegradability within a time frame, may still have the potential to pose long-term risk to the aquatic environment. Many of these chemicals are high-production volume chemicals which are ubiquitous in the environment, and which may achieve persistence due to continuous exposure111. It is Green Seal’s intent that the proposed criterion for chronic aquatic toxicity serves to further address these chemicals which may lead to toxicity through continuous exposure and that may not be addressed by other aquatic toxicity criteria included in the standard and criteria for endocrine disruptors. The proposed chronic aquatic toxicity criteria requires that the product as used shall not fall into Hazard Categories 1 through 4 for chronic aquatic toxicity under the 3rd edition of the GHS. The criteria in the GHS allow for the use of data from chronic toxicity tests on individual ingredients in mixtures, or the use of a combination of acute toxicity data and biodegradability/bioconcentration data to determine the chronic aquatic toxicity category of a substance or mixture. This criterion does not require any additional testing, but rather is included to utilize existing data to determine chronic aquatic toxicity and to prevent those mixtures that have been identified as long-term hazards to the aquatic environment from being permitted under this standard.

Phosphorus and phosphorus compounds lead to eutrophication of receiving waters. Given this negative impact to aquatic ecosystems, a voluntary ban on phosphorus (in the form of phosphates) in dishwasher detergents was adopted by 16 U.S. states in July 2010 limiting the phosphate level to 0.5 percent, down from a maximum of 8.7 percent previously

Eutrophication

112,113. The EU Flower Ecolabel Standard for general-purpose cleaners limits phosphorus content to 0.2 g per 100 g of product, or 0.002%. Previously, Green Seal standards for cleaning products have limited phosphorus content to the 0.5 percent level, however, in light of these widely accepted more stringent phosphorus criteria, it is proposed that the allowable phosphorus concentration in this Proposed Standard be lowered to a 0.01% level.

There are several hazardous compounds that may not be prohibited as a result of the other criteria in the Proposed Standard but may warrant exclusion in a more sustainable product. This is especially the situation when considering the protection of health of vulnerable populations. For example, there are several known and suspected endocrine disruptors present in dish and specialty cleaning products, but until recently, no validated testing procedures for identifying endocrine disrupting action existed. In 2010, however, the EPA published the final guidelines for endocrine disruptor screening testing

Other Prohibited and Restricted Compounds

114. The final guidelines are part of a series of test guidelines that have been developed by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in the testing of pesticides and toxic substances. As a result, the Proposed Standard recommends the use of the test guidelines for chemicals that have been identified as priority chemicals by the EPA and EU115

111 National Institute of Environmental Health Services. 2010. Green Chemistry and Environmental Health. Presentation by

Linda S. Birnbaum to the Great Lakes Green Chemistry Network. February 3, 2010. Accessed 6-9-2010.

. The undiluted product shall not contain any ingredients or components that are on the EPA Final List of Chemicals for Initial Tier 1 Screening or the European Commission Endocrine Disruptor Priority List that have been shown to disrupt hormones (e.g., have estrogen- or androgen-mediated effects), tested according to the EPA Series 890 - Endocrine Disruptor Screening Program Test Guidelines. In addition, known endocrine disruptors will be specifically prohibited. By far the largest group of chemicals with endocrine disruptor effects are phthalates including, but not limited to dibutylphthalate, dietylhexylphthalate, butyl benzyl phthalate, and bis-(2-etoxymethyl) phthalate. Because a variety of phthalates have evidence of being endocrine disrupters and because

http://www.glgc.org/sites/default/files/Birnbaum_020310_PhSeminar_GreenChemNetwrk_FINAL.pdf 112 Green Biz. 2010. Household Dish Detergents Now Phosphate-Free.

http://www.greenbiz.com/news/2010/07/02/household-dish-detergents-phosphate-free

113 Consumer Reports. September 2010. Low-Phosphate Dishwasher Detergents That Work. http://pressroom.consumerreports.org/pressroom/2010/08/low-phosphate-dishwasher-detergents-that-work.html

114 EPA. 2010. OCSPP Harmonized Test Guidelines. Accessed 6-16-10. http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series890.htm

115 EU. 2008. Endocrine Disruptors: What is Being Done. Accessed 6-16-10. http://ec.europa.eu/environment/endocrine/strategy/substances_en.htm

Copyright © 2010 Green Seal, Inc. 25

phthalates are not important functional ingredients in cleaning, they should be prohibited ingredients.Further, prohibition of the broad group of pthalates is currently included in other Green Seal standards, GS-40, GS-37, GS-44, and GS-8116,117,118,119. Other classes of chemicals found in products in this standard that may exhibit endocrine disrupting effects are phenolics, such as o-Phenylphenol, which is found on the EPA’s final list of chemicals for Initial Tier 1 Endocrine Disruptor Screening120

Some commonly used QACs will not meet the criteria in the Proposed Standard due to classification as asthmagens by the AOEC (see asthmagen section). Further, recent evidence has shown that nitrosamines form in low yields from quaternary amines, and that the nitrosamines from the quaternary amines themselves, not just lower order amine impurities

.

There are several materials that are prohibited due to their carcinogenicity or developmental toxicity. However, given their widespread use in products they will be explicitly listed as prohibited materials. These include 2-butoxyethanol (EPA Integrated Risk Information System (IRIS) Classification C) and formaldehyde donors (IARC classification 1). For example, formaldehyde is carcinogenic to humans (IARC group 1) and would be a prohibited ingredient according to the carcinogen criterion proposed. However, there are commonly used preservative ingredients that are known to release formaldehyde over time (Bronopol, DMDM-hydantoin, and Tris Nitro). To further limit the content of known carcinogens, these formaldehyde-donor compounds are prohibited. The following chemicals are prohibited specifically due to their aquatic hazards. Musks, nitro-musks and polycyclic musks are prohibited because of their bioaccumualtation and aquatic effects. Nitrilotriacetic acid (NTA) and ethylene diaminetetra-acetic acid (EDTA) are poorly degradable, cyclicize int a persistenct pollutant, and are suspected of remobilizing heavy metals in riverbeds, and NTA is also a suspected carcinogen. There have been issues with the biodegradation, effects on microflora and fish, and skin sensitization or irritation of traditional, fluorescent, optical brighteners. Alkylphenol ethoxylates (APEs) degrade into nonylphenol and other products which are known to persist and bioaccumulate in waterways and aquatic life and act as endocrine disrupters.

121

The biocide triclosan is a chlorinated aromatic compound with both phenol and ether functional groups. It is used as a synthetic broad-spectrum antimicrobial agent. Triclosan is common in antibacterial dish soaps. Under the appropriate settings and conditions, such as in hospitals to prevent hospital-acquired infections, triclosan has been proven to be effective. But no current data demonstrate any extra health benefits from having antibacterial-containing cleansers in ordinary cleaning situations. For example, the Center for Disease Control and Prevention has stated that antibacterial soaps are not necessary in everyday use, and washing hands with ordinary soap and warm water is an effective way to prevent home infections

. Some nitrosamines, such as N- nitrosodimethylamine (NDMA), are listed as probable carcinogens, group 2A, by the IARC. These materials are commonly used in disinfecting products. To provide clarity on their prohibition, they will be explicitly listed as prohibited in the Proposed Standard.

122

116 Green Seal, Inc. 2004. GS-40: Green Seal Environmental Standard for Industrial and Institutional Floor Care Products,

Fourth Edition, November 12, 2004

117 Green Seal, Inc. 2009. GS-37: Green Seal Environmental Standard for Cleaning Products for Industrial and Institutional Use. Fifth Edition, August 28, 2009

118 Green Seal, Inc. 2007. GS-8: Green Seal Environmental Standard for General-Purpose, Bathroom, Glass, and Carpet Cleaners Used for Household Purposes, Second Edition, July 2, 2007

119 Green Seal, Inc. 2009. GS-44: Green Seal Standard for Soaps, Cleansers, and Shower Products, First Edition, May 7, 2009

. Additionally, bacteria resistant to triclosan have been reported in diverse species and

120 EPA. 2010. Endocrine Disruptor Screening Program (EDSP). Final List of Chemicals for Initial Tier 1 Screening. http://www.epa.gov/endo/pubs/prioritysetting/finallist.html

121 Kemper, J.M., Walse, S.S., and Mitch, W.A. Quaternary Amines as Nitrosamine Precursors: A Role for Comsumer Products? 2010. Environmental Science and Technology. Issue 44 pp 1224-1231

122 EC. 2006. European Commission Scientific Committee on Consumer Products (SCCP) Opinion on Triclosan. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_073.pdf

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environments but are not a universal phenomenon. There has been evidence of endocrine disruption by triclosan in animal studies, however, several agencies, including the FDA and EPA, have determined that further study is required on triclosan123 . Scientists recently found triclosan in 58 percent of 85 streams across the U.S., the likely result of its presence in discharges of treated wastewater124. Triclosan has the tendency to bioaccumulate, or become more concentrated in the fatty tissues of humans and other animals that are exposed to this chemical125,126, 127

Sodium and calcium hypochlorite, better known as bleach, are widely used inorganic halogen compounds. Sodium hypochlorite is a strong oxidizer. Oxidation reactions are corrosive and solutions may burn skin and cause eye damage, particularly when used in concentrated forms. They have been assigned to EPA Toxicity Category I, indicating the highest degree of toxicity, for these acute effects

. Due to evidence suggesting that triclosan bioaccumulates and may cause bacterial resistance to biocides, combined with the CDC conclusion that antibacterial soaps are not necessary in everyday use, it is proposed that triclosan be prohibited under this Proposed Standard.

128

Chlorination of drinking water can oxidize organic contaminants, producing trihalomethanes (also called haloforms), which are carcinogenic

. However, as recognized by the National Fire Protection Association (NFPA), only solutions containing more than 40% sodium hypochlorite by weight are considered hazardous oxidizers.

129. A recent European study indicated that sodium hypochlorite and organic chemicals e.g., surfactants, and fragrances, contained in several household cleaning products, can react to generate chlorinated VOCs130. These chlorinated compounds are emitted during cleaning applications, some of which are toxic and probable human carcinogens. The study showed that indoor air concentrations significantly increase (8-52 times for chloroform and 1-1170 times for carbon tetrachloride, respectively, above baseline quantities in the household) during the use of bleach containing products. The increase in chlorinated volatile organic compound concentrations was the lowest for plain bleach and the highest for the products in the form of “thick liquid and gel.” The significant increases observed in indoor air concentrations of several chlorinated VOCs (especially carbon tetrachloride and chloroform) indicate that the bleach use may be a source that could be important in terms of inhalation exposure to these compounds. The authors suggested that using these cleaning products may significantly increase the cancer risk131

123 FDA. 2010. Triclosan: What Consumers Should Know.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm205999.htm

124 Kolpin DW, Furlong ET, Meyer MT, Thurman EM, Zaugg SD, Barber LB, et al. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999–2000: a national reconnaissance. Environ Sci Technol 2002;36(6):1202-1211

125 Samsoe-Petersen L, Winther-Nielsen M, Madsen T. 2003. Fate and Effects of Triclosan. Danish Environmental Protection Agency

. Further, sodium hypochlorite liberates chlorine gas when acidified, i.e., if mixed with acidic cleaning agents. Mixing sodium hypochlorite with ammonia-based solutions gives rise to chloramine compounds. Both chlorine and chloramines are strong respiratory irritants hence contribute to the toxic effects. Based on the high acute toxicity of sodium and calcium hypochlorite and the potential to react with chlorine and chloramines to release carcinogens as well as the potential to react with surfactants and fragrance to generate chlorinated VOCS, it is proposed that these inorganic halogen compounds be prohibited under this Proposed Standard.

126 EWG. 2008. Pesticide in Soap, Toothpaste and Breast Milk - Is It Kid-Safe?: EWG's Guide to Triclosan. http://www.ewg.org/book/export/html/26700

127 Veldhoen N, Skirrow RC, Osachoff H, Wigmore H, Clapson DJ, Gunderson MP, Van Aggelen G, Helbing CC . 2006. The bactericidal agent triclosan modulates thyroid hormone-associated gene expression and disrupts postembryonic anuran development. Aquatic toxicology. 80(3): 217-227

128 Ibid.

129 EPA 1992 Reregistration Eligibility Document for Sodium and Calcium Hypochlorite Salts

130 Odabasi, M. 2008. Halogenated Volatile Organic Compounds from the Use of Chlorine-Bleach- Containing Household Products”, Environmental Science & Technology 42, 1445-1451, (2008). http://pubs.acs.org/journals/esthag/

131 Ibid.

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Heavy metals, including lead, hexavalent chromium and selenium are prohibited as these compounds are known neurotoxins. In addition to strengthen the bioaccumulation and biodegradation requirements in this Proposed Standards, EPA Toxic Release Inventory chemicals identified as Persistent, Bioaccumulative, and Toxic (PBT) will be prohibited132

Limonene, pinacea derivatives (e.g. pinene) and other terpene hydrocarbons (e.g. myrcene) are commonly used in cleaning products. However, these ingredients have increasingly raised concerns because their oxidation products (e.g. hydroperoxides, oxides) are well-recognized as potent skin sensitizers and studies suggest that the oxidation products may be respiratory allergens as well. The International Fragrance Association (IFRA) recognizes these concerns, and the IFRA standard for limonene notes that products should have a peroxide value of less than 20 millimoles of peroxides per liter. For pinacea derivatives, products should have a peroxide value of less than 10 millimoles peroxide per liter. The peroxide value is determined using the Fragrance Materials Association analytical method

. There have been issues with the biodegradation, effects on microflora and fish, and skin sensitization or irritation of traditional, fluorescent, optical brighteners. Thus optical brighteners are prohibited under this proposed standard. Many halogenated organic solvents are known neurotoxins or carcinogens and are, therefore, prohibited in the Proposed Standard.

133. In addition, terpenes are limited in products due to the volatile organic content and other criteria existing in the Proposed Standard.

Combustibility The criterion for combustibility remains largely consistent with other Green Seal standards, Canadian standards, and others. The proposed new language is suggested to make the combustibility language more specific and readily accessible. Testing will continue to not to be necessary to meet this requirement, as there is often data available.

There is evidence that many fragrance materials have undesirable health effects

Fragrances Fragrance materials have commonly been added to cleaning products to provide a pleasant scent to the product. In some cases, cleaning product formulas have inherent off-odors associated with them and a fragrance must be added to make to product acceptable. However, there are uses of fragrances that should not be encouraged such as the use of fragrances for product identification since they are not as reliable as clear labels or color.

134

132 EPA. 2010. TRI Chemicals. Accessed 6-24-10. http://www.epa.gov/tri/trichemicals/index.htm

. As a result, there is a growing trend is in products without added fragrances. The International Fragrance Association (IFRA) Guidelines in the Code of Practice aim to limit the use of fragrance ingredients with undesirable effects. For example, IFRA include limits, directions for antioxidant use, and prohibition of materials. However, the IFRA Code is limited to the substances that have been comprehensively evaluated by the Research Institute for Fragrance Materials (RIFM). As a result, the concerning effects of fragrances are addressed in the Proposed Standard (e.g., phthalate prohibition, VOC limits, allergen labeling), not only to limit the use of such fragrance ingredients, but for other components of the product. In order for Green Seal to review of fragrance materials, disclosure of the fragrance components is required and explicitly stated in the criterion. Finally, since some individuals appear to be sensitive to fragrance materials, it is important that any use of fragrance components be disclosed to the public. As a result, it is recommended that the MSDS identify when fragrance ingredients have been added to a product.

133 Fragrance Materials Association. Analytical Procedures: Peroxide Value. Accessed 5-7-2010. http://www.ifraorg.org/files/documentspublished/1/en-us/Analytical%20Guidelines/22291_Analytical%20Guidelines_2010_04_27_Peroxide_Method.pdf

134 Bridges, B. 2002. “Fragrance: emerging health and environmental concerns.” Flavour and Fragrance Journal. 17: 361-371.

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The FDA is responsible for regulating color additives used in the United States. Color additives permitted for use are classified as "certifiable" or "exempt from certification”

Color Components

135. Color additives that are exempt from FDA certification include pigments derived from natural sources such as vegetables, minerals or animals, and man-made counterparts of natural derivatives. Certifiable color additives are synthetic. The synthetic colors have specifications for purity established by the FDA. This includes limits of heavy metals, due to the common contamination of colors with heavy metals (typically: 20 ppm of lead, 3 ppm of arsenic, and 1 ppm of mercury). All color components in specialty cleaning products shall be one of the following: FDA certified and permitted for ingestion, a natural color (and therefore exempt from FDA certification), or free of intentionally added heavy metals.

Any microbes used in cleaning products should not be capable of causing disease or harm to a healthy human, plant or animal. Microbes should be non toxigenic and non allergenic. For the purposes of determining the potential risk posed by a microbial strain, the CDC defines three biosafety levels for microorganisms based on the health risk posed by organisms

Biologically Based Product Considerations Microorganism Biosafety

136. The American Type Culture Collection (ATCC), a nonprofit Biological Resource Center (BRC) and research organization that authenticates microorganisms and cell lines and manages logistics of long-term preservation and distribution of cultures for the scientific community, classifies bacterial cultures and related products by biosafety level (BSL) for purposes of packaging and safe shipment. Classification is based on assessment of the potential risk using U.S. Public Health Service guidelines, background information on the material provided by the depositor and review of the material by ATCC scientists familiar with the material137. Only products containing bacterial cultures falling into Biosafety Level 1 shall be permitted in the Proposed Standard. Items in Biosafety Level 1 are not known to cause disease in healthy human adults. Materials in BSL-2 present a moderate risk and should be handled under BSL-2 guidelines. Handling of BSL-3 strains requires the use of BSL-3 laboratory practices and containment. For the protection of workers, the EC Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work also catalogues common microorganisms into 4 Biosafety levels that are defined in the same way as those above138

In order to determine the biosafety characterization of a microbial culture, it is vital that all species of microorganisms present in the culture are identified and verified. Microorganisms have been classified and identified on the basis of a variety of characteristics including morphological, growth, tolerance, metabolic, biochemical, and genetic qualities. Recently there has been a tendency to determine definitive classification and taxonomic assignment by nucleic acid hybridization, 16S rRNA sequence analysis, and other molecular genetic techniques. The ATTC utilizes such genotypic techniques as ribotyping and Rep-PCR analysis Under this Proposed Standard it is required that genetic analysis of strain identity shall be conducted on all microbial strains in production batches of the product over a 3-month period to ensure that the identity of microbes is consistent in batches through time. In addition to genetic techniques, the ATTC has 23 different biochemical characterization schemes encompassing nearly 350 individual tests that are performed on a routine basis on newly deposited organisms. These phenotypic techniques include fatty acid methyl ester analysis (FAME), the Biolog system, and matrix-assisted laser desorption

. Microorganism Identity

135 FDA. 2007.Color Additives and Cosmetics. Accessed 5-27-10.

http://www.fda.gov/ForIndustry/ColorAdditives/ColorAdditivesinSpecificProducts/InCosmetics/ucm110032.htm

136 U.S. Department of Health and Human Services Public Health Service Centers for Disease Control and Prevention and National Institutes of Health. “Biosafety in Microbiological and Biomedical Laboratories.” 5th edition. 2007. http://www.cdc.gov/biosafety/publications/BMBL_5th_Edition.pdf

137 ATTC. Biosafety Levels. http://www.atcc.org/CulturesandProducts/TechnicalSupport/BiosafetyLevels/tabid/660/Default.aspx

138 European Commission. 2000. Directive 2004/54/EC on the Protection of Workers from Risks Related to Exposure to Biological Agents at Work. 2000. http://www.biosafety.be/PDF/2000_54.pdf

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ionization time-of-flight mass spectrometry (MALDI-TOF-MS or MALDI)139

Enzymes present in dish and specialty cleaning products shall be accurately identified and documentation of the identity verification analysis shall be provided to the certifying body. This shall include The Chemical Abstract Service (CAS) Registry Number and the EC (Enzyme Commission) classification, according to the Recommendations of the Nomenclature Committee of the International Union of Biochemistry

. Regardless of the technique utilized, test methodology and results must be documented in detail and submitted to the certifying body. Microorganism Culture Purity The microbe preparation should not harbor any known pathogens, including other micro-organisms that could be harmful to human health or the environment. In addition to being classified by the ATCC as a Biosafety Level 1 microorganism, microbes should be analyzed to confirm the absence of pathogenic materials, including other microorganisms, according to the methodologies specified in the Food Chemicals Codex, or the JEFCA Combined Compendium of Food Additive Specifications, or another standard test method conducted under objective, reproducible laboratory conditions. Specifically, a total plate count resulting in a record of the total number of colony forming units should be conducted including plate counts determining the concentration of the following pathogens: Coloforms and E-Coli, Salmonella, Staphylococcus aureus (ATCC 6538) and yeasts and molds. Yeasts and/or molds may be present in products only if they have been designated GRAS by the FDA. For the purposes of this Proposed Standard, test results verifying the identity of all microorganisms present in the product, the total plate count, and the absence of pathogenic organisms shall be submitted to the certifying body.

Due to concerns related to potential pathogenicity and the lack of data availability related to the human and environmental safety of genetically modified microorganisms (GMM) (transgenic hybrids), the use of transgenically hybridized microbes is prohibited (all microbes must be naturally occurring). Enzymes

140. In addition, since there are safety concerns associated with industrial enzymes (due to possible allergenic, irritative and other reactions related to impure enzymes141. To ensure the protection of human health, it is proposed that all enzymes present in dish and specialty cleaning products be designated by the FDA as GRAS. The Chemistry Recommendations for Food Additive and GRAS Affirmative Petitions set by the FDA in 1993 and revised in 2010 state that a substance may be GRAS only if its general recognition of safety is based on the views of experts qualified to evaluate the safety of the substance. GRAS status may be based either on a history of safe use in food prior to 1958 or on scientific procedures, which require the same quantity and quality of evidence as would be required to obtain a food additive regulation142. The UN Food and Agriculture Organization (FAO) and the WHO JECFA have also developed Specifications and Considerations for Enzyme Preparations Used in Food Processing, which contain similar requirements to those required by the FDA for GRAS affirmation143

139 Ibid.

. Conformance should be demonstrated by analyzing at least five production batches of the enzyme preparation. Impurities specific to the source of the enzyme or the manufacturing process should also be identified and measured. Enzyme preparations obtained from microbial sources should not contain any antibiotics, toxins and transformable DNA coding for toxins and/or proteins that inactivate therapeutic antibiotics. Immobilized enzyme preparations must be prepared with fixing agents that are either listed in 21 CFR 173.357 (a)(2) or are generally recognized as safe in food.

140 IUBMB. Recommendations of the Nomenclature Committee of international Union of Biochemistry http://www.iubmb.org/index.php?id=33. Accessed March 13, 2010.

141 Spök, A. 2006. Safety Regulations of Food Enzymes, Food Technology and Biotechnology 44 (2) 197–209 (2006)

142 US FDA, Enzyme Preparations: Chemistry Recommendations for Food Additive and Gras Affirmation Petitions, Version 1.1; January 1993. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm083345.htm

143 JECFA 2006. General Specifications and Considerations for Enzyme Preparations Used in Food Processing Food and Agriculture Organization of the United Nations. http://www.fao.org/ag/agn/jecfa-additives/docs/enzymes_en.htm

Copyright © 2010 Green Seal, Inc. 30

Further, the enzyme use level in a finished product, or range of levels, should be provided for product and expressed as milligrams of total organic solids (TOS) per gram or kilogram of finished product. For enzyme preparations obtained from a source material already in use as a source for other enzyme preparations (e.g., Aspergillus niger var. can be used as a source for several enzymes), information on use and use levels of other enzyme preparations derived from the same source should be provided when possible. Descriptions of methods used to analyze finished products for the presence of the enzyme and the components of the enzyme preparation should also be provided, including the principles, procedures, and the equipment used. Validation tests should be performed for these methods where appropriate, for example, in analyses for migrants from immobilized enzyme preparations.

Enzyme Source Microbes Regarding enzyme source microbes, it is required in this Proposed Standard that all source microbes used to generate enzymes, regardless of whether they are naturally occurring or genetically modified, meet the aforementioned identification and biosafety criteria for microbes, even if the final product is designed to be absent of source microbes. If the product is marketed as a purely enzymatic product, it shall be demonstrated that source microbes are absent from the product and the test methodology used to demonstrate this and its results must be documented in detail and submitted to the certifying body. If the product is marketed as a combined microbial and enzymatic product it shall meet all performance and health and safety requirements for both microbes and enzymes. The Proposed Standard requires that all source microbes used to derive enzymes be classified by the ATCC in biosafety Category I. If Genetically Modified Microorganisms (GMM) are used to generate enzymes in an enzymatic cleaning product, these microbes must be cataloged by the ATTC and fall into biosafety category I and all procedures and steps involved in the construction of the production microorganism should be thoroughly described. Furthermore, if GMM are used to generate source microbes, they shall not be present in the finished product and test methodology and results demonstrating this shall be documented in detail and submitted to the certifying body. Additionally, GRAS affirmation for enzymes derived from microbes containing DNA from other sources requires that these sources should also be identified and taxonomically and genetically characterized, if appropriate. The fermentation process should be described, including all steps and control necessary to maintain the proper growth conditions, cultural purity and genetic stability. The isolation of the enzyme from the cellular material or from the growth medium (depending on whether the enzyme is extracellular or excreted) should also be described, including all chemical and physical treatments and quality controls.

Additionally, regarding the use of GMM in manufacturing enzymes, steps should be taken to ensure the contained and responsible handling of GMM. The products of biotechnology are regulated under the same U.S. laws that govern the health, safety, efficacy, and environmental impacts of similar products derived by more traditional methods. The federal policy that no new laws were needed to regulate the products of biotechnology was first adopted in 1986 by the federal regulatory agencies in the Coordinated Framework for Regulation of Biotechnology. The policy was based on the assumption that the process of biotechnology itself posed no unique or special risks. In the EU, the use of GMM is regulated under EC Directive 2009/41/EC on the Contained Use of Genetically Modified Micro-organisms144

The EU directive contains criteria for establishing the safety of GMM’s for human health and the environment. The general criteria include that the strain identity must be precisely established and that modification must be known and verified; that documented evidence of the safety of the organism must

. This regulation sets criteria for the classification of GMMs into 4 classes in relation to the risk they present for human health and the environment and provides a categorization of contained use activities into 4 classes according to purpose and scale. The directive states that the user shall carry out an assessment of the risks to human health and the environment that the contained use scenario may pose. In this standard it is proposed that all GMM should be handled in accordance with EC Directive 2009/41/EC.

144 EC. 2009. Directive 2009/41/EC. Contained Use of Genetically Modified Micro-organisms.

http://www.bmwf.gv.at/fileadmin/user_upload/forschung/gentechnik/2009-41-EC.pdf

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be provided; documented evidence of the safety of the organism must be provided; and wherever any instability could adversely affect safety, evidence of stability is required. In this standard it is proposed that all GM source microbes should be handled according to the guidelines in EC Directive 2009/41/EC on the Contained Use of Genetically Modified Micro-organisms.

MANUFACTURING SUSTAINABILITY REQUIREMENTS Good Manufacturing Practices (GMPs) shall be followed for all product production in order to minimize adulteration or mislabeling. Guidance of GMPs applicable to specialty cleaning products includes guidelines on the building and facility, equipment, personnel, raw materials, production, laboratory, labeling, records, and complaints. Green Seal realizes that GMPs are required under FDA regulations only for drugs (not cleaning products); however Green Seal is requiring this for all products in the scope145

The most common packaging materials for specialty cleaning products are high-density polyethylene (HDPE) and to a lesser extent paper, polyethylene terephthalate (PET), polypropylene (PP), and polyvinyl

. Transportation of raw materials and finished products can also be a large source of pollution. Emissions produced from international merchant fleets involved in global trade are thought to represent a significant contribution to the global anthropogenic emissions such as NOx, SO2, CO, CO2, and volatile organic compounds (VOC). The environmental costs associated with shipping materials for manufacturing should be taken into consideration, and local sources should be used when possible. If product is being shipped long distances to be manufactured in one locality and then shipped back around the world to be sold, the adverse environmental impacts associated with the transportation could offset the environmental benefits associated with an environmentally preferable product. One approach to address transportation and related emissions could be to perform a life-cycle assessment (LCA) of a company’s carbon footprint. However, preparing an LCA is a complicated process and the results can be quite variable. Therefore, although transportation and related emissions are important in the manufacture of environmentally preferable products, specific criteria have not been included in the Proposed Standard at this time. Rather, reporting of transportation information will be required with the expectation of continuous improvement of this information as it becomes available. In addition, Green Seal will require reporting of energy and water use and waste generation during production. There are no thresholds of performance on these areas since this information has yet to be widely available for manufacturers. The aim is that over time this information will be available and leadership performance will become apparent for future version of the Proposed Standard.

In order to ensure that certified products are made in accordance with reasonable social practices, companies may demonstrate compliance with certification under the International Labour Organisation (ILO). In lieu of this certification, manufacturers can demonstrate that they meet the following requirements: freedom of association and collective bargaining, which means that workers are free to elect to join unions and that their bargaining power is respected, freedom of labor, which prohibits bonded and child labor; freedom from discrimination, which does not allow discrimination based on age, race, sex, political affiliation or social caste that will inhibit opportunities. In addition, freedom from discrimination addresses use or tolerance of corporal punishment or use of physical or verbal abuse or intimidation. Other requirements include occupational health and safety, which establishes minimum safe working conditions and training to minimize injury and accidents as well as conditions of employment that guarantee regular employment, living wages and working hours that are not excessive. This demonstration will need to include: documentation that these requirements are in company policy, providing a written certification statement signed by a legally responsible officer of the company attesting to said requirements, and a review of site conditions by the certifying auditor.

PACKAGING SUSTAINABILITY REQUIREMENTS

145 FDA. 2008. Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist. Accessed 4-19-10.

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm

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chloride (PVC). The production of packaging materials can account for twice as much resource depletion as the production of the ingredients in the product146

Certain specialty cleaning products are sold in disposable wipe format. It is recognized that reusable application tools are typically less wasteful of resources than disposable media, and there is a criterion included in the labeling section (7.4.1) of this Proposed Standard requiring that, for products where a disposable cloth could be used for application, the product shall be accompanied by detailed instructions that specifically recommend the use of reusable media or tools over the use of disposable materials. There are, however, some product categories in this standard, especially disinfectant and sanitizing products, where a reasonable rationale exists for the use of disposable media. According to a 2004 report by the International Scientific Forum on Home Hygiene (IFH) on the prevention of infection and cross infection in the home environment, cleaning cloths that have not been properly sanitized between uses can facilitate the transmission of infections

. As a result, reducing the total packaging and material is a key approach in this standard. In order to reduce the impact of packaging and transporting specialty cleaning products, concentration requirements have been included in the proposed standard. All specialty cleaning products for institutional use shall be concentrated to at least a 1:16 ratio, with an exception for oven cleaning products, graffiti removers, and metal cleaning products that may be sold in a ready-to-use form for both institutional and household. Motor vehicle and boat cleaning products for institutional use shall be concentrated to at least a 1:64 dilution ratio, and deck or outdoor furniture to a 1:32 ratio. These concentration levels were arrived at by surveying product manufacturers and arriving at an average concentration level. Automatic dish cleaning products for both institutional and household use shall be concentrated to a level where at most 18 grams of product are used per 5 liters of water for products without rinse agent and 20 grams of product per 5 liters of water for products with rinse agent. This concentration level is typical of ultra-concentrated products currently on the market automatic dish detergents. For hand dish cleaning products a recommended dosing level of at most 10 milliliters product per 5 liters of product is required in the Proposed Standard. Products for household use may be sold in a non concentrated ready-to-use format aside from car, boat and deck cleaners which shall be concentrated to a 1:32 ratio, and dish cleaners, which shall be dosed as described above. Packaging impacts are further addressed with minimum recovered and post-consumer content requirements (25%). For plastic packaging, there are alternatives to meeting the goal of reduced use of new material (e.g., light-weighting, refill). In addition, compostable packaging is an alternative path for reducing use of new material, since it has been demonstrated to have reduced impacts compared to fossil fuels, provided it is composted. Reusable packaging and corresponding refilling shall be encouraged. Also, it is desired that the package design allows consumers to easily get the desired amount of product out of the bottle, though it is difficult to include criteria to encourage such practices. To attempt to cover these concerns, a note was added to the Proposed Standard to encourages that bulk refills in source-reduced packaging be made available for products sold appropriately in ready-to-use packaging.

147

Packaging shall also not include known toxins such as heavy metals. The Northeastern Governments’ (CONEG) suggested restriction on heavy metals is proposed in this Standard, along with prohibition on the use of endocrine disrupters such as Bisphenol A and phthalates in packaging.

. For this reason, it is proposed under this Standard that disposable towelettes or other disposable wiping materials be allowed if they are made from 100% renewable materials including, but not limited to cellulosic materials, and meet the state-of-the-art amount of recovered material content. Furthermore, criterion in the labeling section of the standard (7.4.1) stipulate that if the product is a towelette or other disposable wipe product, the label shall clearly indicate proper disposal of the wipes.

146 European Union (EU). 2005. EU Eco-Label for Shampoo and Soaps Background Report. Background report for the 3nd

AHWG-meeting EU-Ecolabel for Shampoo and Soaps Ecolabelling Norway. June 6 , 2005.

147 IFH. 2004. Guidelines for Prevention of Infection and Cross Infection in the Domestic Environment. http://www.ifh-homehygiene.org/IntegratedCRD.nsf/861f122a098364b98025750800643950/62812e8ac19247fe802576c60054693f?OpenDocument

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TRAINING AND LABELING REQUIREMENTS Training for the proper use of institutional products is required. This is critical for FIFRA-registered disinfectant and sanitizer products due to the potential for an increase in bacterial resistance to these products (see section on Disinfectants and Sanitizers). The training requirement retains the need for manufacturer’s to provide information on the proper use of the product as well as recommended personal protection equipment for each stage of the product or equipment’s use. Further, product manufacturers shall make the appropriate product and/or equipment training information, including MSDSs and technical data sheets, available electronically as well as in hard copy. As a result, in addition to the training requirement, additional label elements regarding the use of FIFRA-registered products are required under the proposed standard and are discussed in greater detail below. Other products that require unique training considerations include products that are used outdoors and have the potential to bypass the sanitary sewer system to be discharged directly to storm sewers or the aquatic environment. For these products it is important that users are trained in best management practice for the recapture of waste effluent or the diversion of waste effluents to a sanitary sewer. Biologically-based cleaning products containing microbes should not be used on food contact surfaces and may be rendered ineffective in the presence of sanitizers or disinfectants. It is important that a training program take into account the unique considerations pertaining to the use of products in each category in the Proposed Standard. Ingredient disclosure/labeling is required. It is proposed that products adhere to the naming convention of the International Nomenclature of Cosmetic Ingredients (INCI), listing all components in order of predominance, in addition to following any additional labeling regulations that apply to that product category. This information will help ensure the safety of the end user of a product by making readily available important information on product constituents. Additionally, it is required that product labels for both institutional and household use include all label information in English and another language, or English and a graphical representation or icons. This requirement is intended to insure that all critical label elements are conveyed to the broad user groups of these products. For products included in this Proposed Standard that are regulated under FIFRA, additional label elements required under FIFRA must be included. FIFRA stipulates that registrants are allowed to provide part of the label text in the form of a booklet or other “pull off” type labeling, when it is not feasible or possible to literally “fit” the entire label on the container. However, pursuant to the regulations set out at 40 CFR part 156, Subpart A, some label information must be on the label which is on or “securely attached” to the container148

148 CFR. 40 CFR part 156, Subpart A.

. This information includes: name and address of the producer, registrant, or person for whom produced, restricted use statement (if required), product name, brand or trademark, ingredient statement, signal word, including skull and crossbones, if either are required, "Keep Out Of Reach Of Children" (KOOROC), precautionary statements, including hazards to humans, domestic animals and environmental hazards, EPA registration number and EPA establishment number, either directions for use or a referral statement to directions for use in booklet, and net weight or measure of contents. In addition to FIFRA required label elements, under this Proposed Standard the disinfectant and sanitizer products shall include the following information on the product label: the dwell time required for a product to effectively serve its disinfecting or sanitizing function, explicit indication of the organism(s) the product is effective against, and instructions indicating conditions under which the product might not work effectively as a disinfectant. This shall include, at a minimum, reference to any dilutions used only for cleaning and effectiveness in heavy soils. Additionally, if a product is not sold as a combination disinfecting/sanitizing-cleaner product, it shall contain instructions to clean soiled surfaces prior to use. Instructions to rinse surfaces with unheated tap water after use shall be included to eliminate the risk of disinfectant ingredients used on food contact surfaces or high-touch surfaces being ingested by users or building occupants.

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title40/40cfr156_main_02.tpl

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Hand dish detergent products shall convey the recommended dosage for five liters of dishwashing water. This dosage information shall be described in milliliters and another well-known metric. Additionally, hand dish detergent labels shall include language conveying ways to conserve water and energy when washing dishes by hand. Hand dishwashing detergents may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. It is prohibited to claim or suggest on the packaging or by any other communication that the hand dishwashing product has an antimicrobial action. For products sold as biologically-based cleaning products, labels shall contain information that the biological components of the product or the product as a whole may be rendered ineffective in the presence of chemical sanitizers or disinfectants. Additionally, products containing microbes shall contain instructions that they shall not be used on food-contact surfaces. Finally, products in this category shall include instructions on the label that they are most effective when used on an ongoing basis.

Organic claims are made on some specialty cleaning products. Some claims include the USDA seal (and thus meet the USDA regulations), and some do not. The USDA National Organic Program (NOP) is a marketing program housed within the USDA Agricultural Marketing Service and has developed national organic standards and established an organic certification program. According to the NOP, “regulations require that agricultural products labeled as organic originate from farms or handling operations certified by a State or private entity that has been accredited by the USDA149

149 NOP. 2008. National Organic Program Background Information. Accessed 6-14-10.

. While cleaning products are not included in the current regulations (there is consideration for extending it to personal products in progress), Green Seal will require any product that makes an organic claim to follow the NOP standards and if applicable, can use the USDA organic seal for their claims. Specifically, organic ingredients (production and handling) must be certified by a USDA-accredited certifying agent. Claims about the content of organic ingredients include,

"100 percent organic" - must contain only organic ingredients, and may display the USDA Organic seal.

"Organic" - products must consist of at least 95 percent organically produced ingredients and may display the USDA Organic seal.

“Made with organic ingredients” - contain at least 70 percent organic ingredients and list up to three of the organic ingredients on the principal display panel. The USDA seal cannot be used anywhere on the package.

Further, products that contain less than 70 percent organic ingredients cannot use the term “organic” other than to identify the specific ingredients that are organically produced in the ingredients statement.

Natural claims currently are not regulated. As a result, Green Seal has included definitions and criteria for natural claims:

“100 percent Natural” or “All Natural” - can only contain natural ingredients with no synthetic ingredients.

"Natural" - products can contain95% of natural ingredients and not include synthetic fragrances, artificial colors or ingredients from petrochemicals.

"Made with/from Natural Ingredients" - contains at least 70% natural ingredients and not include synthetic fragrances, artificial colors or ingredients from petrochemicals.

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004443&acct=nopgeninfo