Final Comment Report CCD 170 Jan 19

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					Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard




                                                       Environmental Standard – Comment Report



                                                          CCD-170: Instant Hand Antiseptic Products




                                                   Prepared by TerraChoice Environmental Marketing

                                                                      January, 2010




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Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard


(A) INTRODUCTION

                       th                th
Between September 18 and October 26 , 2009, the EcoLogo Program consulted stakeholders at large regarding CCD-170 Draft 1. This report is the result of
these consultations. In here, you will find:

       Stakeholder Comments
       EcoLogo’s response(s) to stakeholder comments
       EcoLogo Decision(s) for how to address stakeholder comments and whether to include their concerns in CCD-170 Draft 2.

Stakeholders belong to one of the categories below:

 User:
     Individuals representing the end users of the product, material or service and who are not predominantly involved in its production and/or regulation.
 Producer:
     Individuals representing organizations / companies that are involved in the production, manufacture, promotion or distribution of the product, material,
     or service.
 General Interest:
     Individuals not associated with the production, distribution, direct use, or regulation of the product, material, or service.
 Academia, Public Health and Safety, and Regulation:
     Individuals representing public agencies (local, regional, state, federal, or international), regulatory bodies, academia or others representing the public
     good.




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Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                  EcoLogo Response                 Action for
                                                                                                                                               EcoLogo
    1.   Biodegradability           Producer         We suggest being more precise on what is accepted
                                                     or not since some ingredients might be non
         “… be manufactured or                       biodegradables but in so little quantity that it does
         formulated such that all                    not impact the global biodegradability of the            EcoLogo recognizes that some
         organic ingredients                         product. A suggestion: contents of less than 1% of       carbomers type thickeners
         must be readily                             total ingredients should not be considered for           may not be readily
         biodegradable…“                             biodegradability of product.                             biodegradable. As such
                                                                                                                                               Change
                                                                                                              instead of requiring that “all
                                    Producer         We recommend that the criteria be revised to                                              wording to “…
                                                                                                              organic ingredients must be
                                                     specify that the whole formulation be readily                                             be
                                                                                                              readily biodegradable”,
                                                     biodegradable. We believe the criteria should be                                          manufactured
                                                                                                              EcoLogo will now also accept
                                                     expanded to allow demonstration of                                                        or formulated
                                                                                                              that “the whole formulation be
                                                     biodegradability of the whole formulation. This                                           such that all
                                                                                                              readily biodegradable”.
                                                     expansion allows usage of small amounts of non-                                           organic
                                                                                                              Because carbomers thickeners
                                                     readily biodegradable ingredients to enhance                                              ingredients
                                                                                                              are only used in small
                                                     aesthetics or ease of formulation, while still                                            must be readily
                                                                                                              quantities in the product they
                                                     preserving the environmentally safe position of                                           biodegradable,
                                                                                                              should not prevent the whole
                                                     certified instant hand sanitizers. We contend that                                        or “the whole
                                                                                                              formula from being readily
                                                     there are instances where small amounts of non-                                           formulation be
                                                                                                              biodegradable. However, if
                                                     degradable ingredients might be more                                                      readily
                                                                                                              such should be the case then
                                                     environmentally preferred from a life cycle                                               biodegradable”
                                                                                                              EcoLogo will consider
                                                     perspective. For example, with respect to thickeners:    requiring that the whole
                                                     while cellulosic thickeners are readily biodegradable,   formula be “ultimately
                                                     a larger concentration and significantly more energy     biodegradable” instead.
                                                     (with respect to heat and mix time) is required to
                                                     formulate a hand sanitizer with these materials
                                                     versus Carbomer type thickeners.




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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                   EcoLogo Response                  Action for
                                                                                                                                                 EcoLogo
                                    Producer         Prohibiting carbomers and limiting all organic
                                                     ingredients to be “readily biodegradable” severely
                                                     limits the use of thickeners in hand antiseptics. The
                                                     higher viscosity produced by thickeners enhances
                                                     efficacy in that they lengthen contact time by
                                                     increasing evaporation time so that the alcohol is in
                                                     contact with the skin beyond 15 seconds.

    2.   Carbomer Thickners         Producer         This thickener is used at large for every gel sanitizer   EcoLogo initially believed that
                                                     on the market so you will be closing all                  some “naturally-based
         “…not be formulated or                      opportunities for certification unless you are aware      thickeners” could be used to
         manufactured with                           of a replacement product that is available.               formulate all types of hand
         carbomer thickeners…”                                                                                 sanitizing products, but now      Remove the
    3.                              Producer         Carbomer is a generic name for synthetic polymers         recognizes that carbomers         prohibition
                                                     of acrylic acid used as emulsion stabilizers or           type thickeners are               from the
                                                     thickening agents in pharmaceuticals and cosmetic         prominently used in the           standard.
                                                     products. While they are not “readily                     current market for most
                                                     biodegradable”, tests have shown that they do not         products due to its thickening
                                                     inhibit bacteria in the environment. Prohibiting          ability, and for product
                                                     carbomers and                                             aesthetics.




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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                 EcoLogo Response   Action for
                                                                                                                                EcoLogo
    4.                              Producer         We strongly disagree with the exclusion of
                                                     carbomer thickeners from the standard. We strongly
                                                     recommend that carbomer thickeners be removed
                                                     from the prohibited and restricted substances list,
                                                     and allowed under the standard. Carbomer
                                                     thickened gels are the dominant product form for
                                                     commercial hand sanitizers today. There are virtually
                                                     no alternative thickeners with the required
                                                     performance properties of a carbomer, although
                                                     cellulosic based materials are used to a very limited
                                                     extent. Our comments concern the relative
                                                     acceptability of carbomer Vs. cellulosic thickeners.
                                                     From a performance standpoint, carbomers are
                                                     superior to cellulosic thickeners in ease of
                                                     formulation, thickening ability, and product
                                                     aesthetics. From a net environmental standpoint,
                                                     cellulosics have no established advantage over
                                                     carbomers. There are no comparative life cycle
                                                     analyses to suggest one type of thickener over
                                                     another. It is erroneously assumed that cellulosic
                                                     thickeners are 100% natural. Cellulosic thickeners
                                                     are semi-synthetic materials. These raw materials
                                                     contain a synthetic component. The synthetic
                                                     portion of a cellulose thickener is an Ethoxylated
                                                     polymer. Ethoxylated materials can contain 1,4
                                                     dioxane residuals, which are often cited for safety
                                                     and environmental concerns. A gum based
                                                     thickener as an alternative biobased thickener (e.g.
                                                     xanthan gum) is not compatible with a
                                                     hydroalcoholic system.


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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                     Source          Comment                                                  EcoLogo Response                   Action for
                                                                                                                                                 EcoLogo
                                     Producer        Carbomer is a generic name for synthetic polymers
                                                     of acrylic acid used as emulsion stabilizers or
                                                     thickening agents in pharmaceuticals and cosmetic
                                                     products. While they are not “readily
                                                     biodegradable”, tests have shown that they do not
                                                     inhibit bacteria in the environment. Prohibiting
                                                     carbomers and limiting all organic ingredients to be
                                                     “readily biodegradable” severely limits the use of
                                                     thickeners in hand antiseptics. The higher viscosity
                                                     produced by thickeners enhances efficacy in that
                                                     they lengthen contact time by increasing
                                                     evaporation time so that the alcohol is in contact
                                                     with the skin beyond 15 seconds.
    5.   Bottle Size                 Producer        This is a very large container and is not optimal for    Ecologo originally believed
                                                     the use this type of packaging is sold for (office       that 500ml bottles were readily
         “…be sold in bottles of                     desks, doctor offices…) where space is usually           available in the current market.
         at least 500 ml in size…”                   limited. Furthermore, the consumption of the             It now recognizes that the
                                                     product in these types of usages is not as large as in                                      Change 500ml
                                                                                                              largest most currently used
                                                     a dispenser, therefore 500ml for 1 person will last a                                       to 236ml.
                                                                                                              bottle size is 8 oz. (236ml).
                                                     long time. The product has a 1 yr expiry date and        EcoLogo is prepared to use 8
                                                     would then expire. This would cause for a lot of         oz. as it upholds the original
                                                     waste. The ideal size would be around 250 ml.            intent; prohibit very small size




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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                  EcoLogo Response             Action for
                                                                                                                                           EcoLogo
    6.                              Producer         In our discussions with end users in out of home         bottles in order to reduce
                                                     locations in retirements home, day cares and food        waste.
                                                     handling our prospective customers have indicated
                                                     the need to have a size smaller that the 500 mL. The
                                                     500 mL was determined by them to be considered a
                                                     stationary size and a smaller mobile size of 250 mLs
                                                     was needed to allow for mobility to ensure that
                                                     product could be applied between contact with
                                                     patients or children without having to continuously
                                                     return to the base station. We beleive that a 250 mL
                                                     minimum still takes the product out of the typical at
                                                     home use and keeps the product in the realm of the
                                                     professional and institutional market.

    7.                              Producer         500 ml is not a typical size in the current market; a
                                                     reasonable size market product (not to big not to
                                                     small) would be 8 oz (236.5ml).

    8.                              Producer         Requiring at least 500 ml size eliminates “small size
                                                     wearable” packaging originally proposed in the first
                                                     CCD-170 draft. Many food and healthcare
                                                     professionals are not able to visit a centralized hand
                                                     sanitizing station during the day. Our comments on
                                                     the first draft were to include larger packaging; we
                                                     did not intend that to be at expense of smaller
                                                     packages.




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                    EcoLogo Response              Action for
                                                                                                                                              EcoLogo
    9.                              Producer         500 ml appears to be an unfair arbitrary minimum
                                                     size requirement. Understanding that the purpose is
                                                     to try and reduce/eliminate use of packaging, there
                                                     are plenty of pack sizes that meet this requirement,
                                                     yet are only 400 ml. bottles, as is in our case. This is
                                                     marketed not only in a table-top use format, it is
                                                     also marketed with a permanent use bracket. Being
                                                     a market leader and innovator of alcohol hand
                                                     sanitizers, this is a pack format that is marketed and
                                                     accepted globally. Even as low as 250 ml. would be
                                                     considered in the non-retail world as a more “bulk”
                                                     size package, especially as compared to say a 50 ml.
                                                     bottle. Reconsideration on this minimum pack size
                                                     would be greatly appreciated.
    10.                             Producer         I think the limitation on the size of the container is a
                                                     mistake. Encouraging the use of hand sanitizers is
                                                     very valuable in terms of protecting health. But
                                                     many sample sizes are smaller than what you would
                                                     allow. And candidly your restriction is an arbitrary
                                                     size and while I appreciate what you are trying to do
                                                     (reducing the impacts from packaging) I would
                                                     encourage you to rethink this issue.
    11.   Denaturants               Producer         You should regulate denaturant when denatured                                            Add a new
                                                     alcohol is used.                                           EcoLogo recognizes the need   requirement to




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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                EcoLogo Response                Action for
                                                                                                                                            EcoLogo
                                    Producer         We would like to ensure that there would be            to prevent ingestion of         the standard:
                                                     something very specific on the denaturants that are    alcohol-based products.         “Products
                                                     used for the ethanol- SDAG 2 is denatured with         Denaturing alcohol with a       containing 5%
                                                     Methanol ( wood alcohol) It does not change the        bittering (e.g. SDAG-3) agent   or more alcohol
                                                     taste of the ethanol but if consumed would cause       may well be a effective         must contain an
                                                     serious health issues. SDAG 3 is denatured only with   solution, however in the U.S.   ingredient
                                                     bitrex- this would prevent any consumption of          the alcohol usage is heavily    (denaturant) to
                                                     ethanol based hand sanitizer.                          regulated by the Alcohol and    deter ingestion.




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                EcoLogo Response                    Action for
                                                                                                                                                EcoLogo
                                    Producer         The EcoLogo draft standard does not currently          Tobacco Tax and Trade Bureau        The denaturant
                                                     address the need for a denaturant / bittering agent    (TTB) in the Department of          used shall be an
                                                     for a product that contains alcohol. The preferred     Treasury. As such, EcoLogo          appropriate
                                                     go forward path is to keep chemically-specific         recognizes that forcing             denaturant
                                                     criteria regarding denaturant choices to a minimum,    product formulation with            listed with U.S
                                                     in that alcohol usage in the US is heavily regulated   SDAG-3 could unnecessarily          or Canadian
                                                     by the Alcohol and Tobacco Tax and Trade Bureau        delay adoption of the               regulations, or
                                                     (TTB) in the Department of Treasury and any degree     standard. It’s also possible that   have
                                                     of ingredient specificity from EcoLogo could prompt    the resulting product would         safety/toxicolog
                                                     complex formula and/or regulatory work. The            not be able to be                   y data available
                                                     addition of requirements in this area could            manufactured for sale in the        to substantiate
                                                     unnecessarily delay adoption of the standard. It’s     US if the TTB did not approve       its safe use.”
                                                     also possible that the resulting product would not     the formulation as being
                                                     be able to be manufactured for sale in the US if the   sufficiently denatured to TTB
                                                     TTB did not approve the formulation as being           standards. EcoLogo believes
                                                     sufficiently denatured to TTB standards.               the following recommendation
                                                                                                            to be acceptable: Hand
                                                     We recommend the EcoLogo standard include the          Sanitizers containing 5% or
                                                     following criteria: Hand Sanitizers containing 5% or   more alcohol must contain an
                                                     more alcohol must contain an ingredient                ingredient (denaturant) to
                                                     (denaturant) to deter ingestion. If more detail is     deter ingestion. The
                                                     desired in the standard regarding the use of           denaturant used shall be an
                                                     denaturants, we recommend the following: Hand          appropriate denaturant listed
                                                     Sanitizers containing 5% or more alcohol must          with U.S or Canadian
                                                     contain an ingredient (denaturant) to deter            regulations, or have
                                                     ingestion. The denaturant used shall be an             safety/toxicology data
                                                     appropriate denaturant listed with TTB, CIR or         available to substantiate its
                                                     similar or have safety/toxicology data available to    safe use.
                                                     substantiate its safe use.



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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                   EcoLogo Response                  Action for
                                                                                                                                                 EcoLogo
    12.   Biobased Content          Producer         In regards to 73% biobased content per total weight       The EcoLogo Program has
                                                     of the product, why is the USDA program referred          strategically decided to
          “…be formulated or                         to and nothing from CFIA, which is who we are             partner with the USDA             Change the
          manufactured with at                       governed by in Canada? We had previously
                                                                                                                             SM
                                                                                                               BioPreferred program, and         wording to:
                                                                                                                                                 “…be
          least 73% biobased                         requested to know how the 73% content was                 more than 50% of
                                                                                                                                                 formulated or
          content per total                          derived; that “bio-based” is not a regulatory             stakeholders believed that it
                                                                                                                                                 manufactured
          weight of the product                      requirement in Canada, therefore we do not                was an acceptable partnership.
                                                                                                                                                 with at least
          formula as                                 understand the rationale behind the requirement;          The EcoLogo Program will
          demonstrated by ASTM                       and is it really a necessary criteria requirement? In     closely follow the progress of    73% of the total
          D6866-08, OR                               other words, please provide some back-up data that
                                                                                                                                 SM
                                                                                                               the BioPreferred program as       weight of the
                                                                                                                                                 carbon in the
          demonstrate                                may help us understand the reason for this.               to determine whether its
                                                                                                                                                 product
          compliance with the                                                                                  regulations are strict enough
                                                                                                                                                 formula as
          USDA BioPreferred                           We are also seeking clarification, as our                in regards to promoting
                                                                                                                                                 demonstrated
          Program (packaging is                      understanding of ASTM D6866-08, is that this              biobased materials that follow
          not included)…”                            biobased test is only looking at the amount of            sustainable best practices. The   by ASTM
                                                     biobased Carbon vs. fossil based Carbon (it uses          EcoLogo Program may               D6866-08, OR
                                                                                                                                                 demonstrate
                                                     Carbon 14). It does not consider the other elements       propose additional
                                                                                                                                                 compliance
                                                     in the product. In our opinion, the standard you are      requirements in a future
                                                                                                                                                 with the USDA
                                                     seeking should then state something like “73% of          revision of the standard if
                                                                                                                                                 BioPreferred
                                                     the total weight of the carbon in the product”, if this   needed to better define
                                                     is indeed what you are seeking to capture, as             environmental leadership.         Program”
                                                     opposed to the total weight of the product being
                                                     73% biobased.                                             The EcoLogo Program
                                                                                                               recognizes the need to clarify




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                  EcoLogo Response              Action for
                                                                                                                                            EcoLogo
                                    Government/      In your definition of “biobased” you indicate            the criterion because ASTM
                                    Regulator        “renewable domestic agricultural materials.” This        D6866-08 determines the
                                                     appears to be pulled directly from the BioPreferred      carbon value in the sample.
                                                     Program guidelines originally established in 2002.
                                                     Subsequently, the Office of the USTR (United States
                                                     Trade Representative) ruled that any country that
                                                     occupies “most favored nation trading status” with
                                                     the United States can qualify products to be
                                                     included in the BioPreferred program. Your use of
                                                     the modifier domestic could be potentially
                                                     confusing, as it doesn’t necessarily mean agricultural
                                                     materials specific to the United States. Please note
                                                     that BioPreferred is currently re-evaluating the use
                                                     of the modifier “domestic” and the stated, legal
                                                     definition of it and its implication for manufacturers
                                                     of items seeking BioPreferred designation. We are
                                                     likely to remove this modifier when our program
                                                     guidelines are revised in 2010. We recommend the
                                                     definition in your standard be revised to indicate
                                                     “renewable agricultural materials.”
                                    Producer         Be careful when you talk about waterless hand
                                                     sanitizer because these kinds of products do contain
                                                     small amount of water. The need for at least 73%
                                                     w/w of biobased content should be reviewed since
                                                     some product will not even contains this amount of
                                                     organic material.




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                  EcoLogo Response   Action for
                                                                                                                                 EcoLogo
                                    Producer         You indicate that raw materials must “be formulated
                                                     or manufactured with at least 73% biobased content
                                                     per total weight of the product formula as
                                                     demonstrated by ASTM D6866‐08.”
                                                     This statement is technically wrong; the ASTM
                                                     standard reports biobased content as a percentage
                                                     of total organic carbon. For example, if there exists
                                                     a hand cleaner with 25% active ingredients and 75%
                                                     water ASTM would only look at the weight of the
                                                     25%. If you follow the logic of the definition in your
                                                     standard, the product would not qualify for the
                                                     EcoLogo, but since the product could have more
                                                     than 73% biobased content within that 25% it would
                                                     be eligible for BioPreferred. We recommend you
                                                     revise this definition in your standard to read "73%
                                                     biobased content as demonstrated by ASTM
                                                     D6866‐08.”

                                    Producer         Regarding 4a ( 73% bio-based requirement); what
                                                     happens to water based formulations, since the
                                                     main portion (usually more than 73%) of such
                                                     formulations is made of water.




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                 EcoLogo Response                 Action for
                                                                                                                                              EcoLogo
                                    Producer         We recommend that the USDA language regarding
                                                     carbon content be included in the definition of
                                                     “biobased” or in section 4. a).
                                                     “Biobased Content – determined based on the
                                                     amount of biobased carbon in the material or
                                                     product as a percent of weight (mass) of the total
                                                     organic carbon in the material.”
                                                     Unless water is included as “biobased content” or
                                                     excluded from total weight in this section, an
                                                     alcohol hand sanitizer must contain at least 87%
                                                     alcohol by volume to comply. Such high-alcohol
                                                     products have a myriad of safety, irritancy and
                                                     efficacy issues as well as fire code and DOT
                                                     problems.
    13.   Packaging                 Producer         Not be packaged in secondary packaging: does this
                                                                                                             Several definitions need to be
                                                     mean a cartridge in a box in a master box?
                                                                                                             clarified. EcoLogo proposes to
                                    Producer         Many times, bottles of product are packaged into        use the following:
                                                                                                                                              Add and
                                                     corrugated cases and then into larger shipping
                                                                                                                                              change several
                                                     containers. Eliminating such cases would make           "primary packaging" means
                                                                                                                                              definitions in
                                                     pallet sizes smaller and shipping problematic.          the material physically coming
                                                                                                                                              the standard.
                                                     Please clarify “secondary packaging”.                   into contact with and
                                                                                                             containing the product; also
                                    Producer         Shipping packaging containing at least 25% post-                                         Change 25% to
                                                                                                             includes those materials which
                                                     consumer recycled content would make meeting                                             20% for the
                                                                                                             ensure product integrity,
                                                     strength requirements difficult at best. As stated in                                    recycled
                                                                                                             safety, regulatory compliance
                                                     comments on the first draft, we recommend                                                content in the
                                                                                                             (on-package labels, e.g.) and
                                                     Minimum post recycle content for corrugate should                                        packaging.
                                                                                                             prevent illicit tampering
                                                     be 20%. Beyond 20% would necessitate thicker
                                                     walled containers along with corrugated inserts,
                                                                                                             "secondary packaging" means
                                                     which are contrary to the intent of this section.

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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                     EcoLogo Response                    Action for
                                                                                                                                                     EcoLogo
                                    Producer         We agree with the need to distinguish between               any packaging material other
                                                     sealed (both at manufacture and during subsequent
                                                     use) and open refill dispensing systems but find the        than primary packaging,
                                                     use of the term “bulk-refill” products misleading as        including wrappers, boxes, and
                                                     it is currently used in the draft standard to describe      blister packs, but excluding
                                                     systems where a dispensing unit is used with sealed         shipping packaging.
                                                     refill cartridges or pouches. The term “bulk refill” is
                                                     generally used interchangeably with the term “open          "shipping packaging" means
                                                     refill”, both terms describing a system where               any packaging material, such
                                                     product is exposed to the environment and subject           as corrugated containers,
                                                     to both intentional and unintentional                       required to ensure product
                                                     contamination. The draft standard states “bulk refill       integrity during shipping, but
                                                     products” means a system where a dispensing unit is         excluding the pallet and pallet
                                                     used with sealed refill cartridges or pouches. Sanitary     load wrapping.
                                                     sealed systems typically use individual bags that
                                                     come with their own dispensers. The bags are                EcoLogo recognizes the need
                                                     inserted into a casing or “box” — either counter-           to clarify the term “bulk”. As
                                                     mounted or wall-mounted — and are simply                    such, “Bulk refill products” will
                                                     removed and replaced in full when they are empty. In        be restated as “Sealed refill
                                                     addition to sealed dispensers, cartridge refill             products”, where “Sealed refill
                                                     dispensers are also a possible alternative to               products” are products used in
                                                     traditional refill dispensers. Cartridge dispensers are     a sealed cartridge system. The
                                                     counter-mounted or wall-mounted, and contain all            sealed refill cartridges are
                                                     working parts within the refill cartridge, so each refill   individual pouches or bottles
                                                     is really a complete replacing of the working               with their own dispensing
                                                     mechanisms within the dispenser. Open refill systems        pump that are sealed at
                                                     are not accepted since they can lead to product             manufacture. The sealed refill
                                                     contamination.                                              products are inserted into a
                                                                                                                 dispensing unit — either wall-
                                    Producer         The definition provide for “bulk refill products” is
                                                                                                                 mounted or counter-mounted
                                                     not correct. What you have defined here is indeed a
                                                                                                                 — and replaced when empty.
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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                  EcoLogo Response                   Action for
                                                                                                                                                 EcoLogo
                                                     “hygienically sealed non-reservoir” or cartridge         Open refill systems, also
                                                     system. Your last statement of “Open refill systems      referred to as bulk refill, are
                                                     are not accepted since they can lead to product          not accepted since they can
                                                     contamination” is indeed an excellent definition of a    lead to product contamination.
                                                     “bulk refill system”, whereby you are merely topping     “Bag-in-a-box” systems are
                                                     up product in an open reservoir from a larger            also excluded from the
                                                     container. This should not read “bulk refill” product,   standard since they necessitate
                                                     as explained previously. Instead, consideration          excessive corrugated
                                                     should be made to use a statement such as                packaging to encapsulate the
                                                     “hygienically sealed cartridge”. Further details         cartridge”.
                                                     should also include a minimum semi-rigid cartridge
                                                     size of around 1L (1,000 ml) and should not allow        EcoLogo is not prepared to
                                                     for excessive corrugated packaging to encapsulate        limit the size of “sealed refill
                                                     the cartridge (i.e. – also known as a “bag-in-a-box”     products” at this time since
                                                     system). To reduce possible confusion with open          extensive market data is
                                                     refill systems, we recommend that the term “bulk         lacking. EcoLogo will let the
                                                     refill products” be replaced with “sealed refill         current market determine the
                                                     products” and be defined as follows:                     size, but will continue to
                                                     “Sealed refill products” are products used in a          collect data in order to
                                                     sealed cartridge system. The sealed refill cartridges    determine leadership and
                                                     are individual pouches or bottles with their own         establish a minimum size in a
                                                     dispensing pump that are sealed at manufacture.          future revision of the standard.
                                                     The sealed refill products are inserted into a
                                                     dispensing unit — either wall-mounted or counter-        EcoLogo set the proposed
                                                     mounted — and replaced when empty. Open refill           recycled content of 25% based
                                                     systems, also referred to as bulk refill, and are not    on limited initial data. EcoLogo
                                                     accepted since they can lead to product                  is prepared to reduce the
                                                     contamination.                                           amount to 20% in order to
                                                                                                              meet strength requirements in
                                                                                                              some types of packaging
                                                                                                              currently used in the market.
                                                                                                                                                              16
Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                 EcoLogo Response                  Action for
                                                                                                                                               EcoLogo
    14.   Performance /Efficacy     Producer         As you may know, Health Canada does not require         EcoLogo is aware that several     Change the
                                                     testing data to emit the NPN number. They expect        government regulations exist,     performance
                                                     the manufacturer to have it done and available but      or are currently being revised,   /efficacy
                                                     do not ask for it when application is submitted. Will   for hand hygiene products. It     requirement
                                                     EcoLogo be asking for the test data when Health         is the mandate of the EcoLogo     according to
                                                     Canada does not?                                        program to assure consumers       the EcoLogo
                                    Producer         For log reduction, you should add CGSB Canadian         that “green products” are as      response to
                                                     testing if they exists                                  efficient as other traditional    stakeholder




                                                                                                                                                              17
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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                   EcoLogo Response                   Action for
                                                                                                                                                  EcoLogo
                                    Producer         There seems to be a requirement for both the              products, and that label claims    comments (see
                                                     Finger Pad test (ASTM E 2276-03) and the Glove            are accurate. Recently, a study    box to the left)
                                                     Juice test (ASTM E 1174-06). This we do not               showed that in-vitro tests may
                                                     understand for a few reasons. First, it is our            not always represent real-
                                                     experience that it is usually one or the other test       world situations; however in-
                                                     required as a minimum “specification” to meet, not        vivo test can be very costly. In
                                                     both. Secondly, since earlier under General               order to assure consumers
                                                     Requirements on page 6, it states “…meet or exceed        that products are efficient
                                                     all applicable governmental and industrial safety         against a wide spectrum of
                                                     and performance standards…”, there seems to be            organisms and that label
                                                     some contradiction. On the one hand there is a            claims are accurate in real-
                                                     general statement in regards to government                world situation, while limiting
                                                     standards, and then there are specific standards that     costs, EcoLogo will propose
                                                     must be met? And finally, according to the new            minimum performance
                                                     Health Canada draft Guidance Document – Human             requirements by establishing
                                                     Use Antiseptic Drugs now under consideration and          both in-vivo and in-vitro
                                                     already affecting such products as Instant Hand           bactericidal testing. EcoLogo
                                                     Antiseptic Products, they are very specific that either   proposes the following
                                                     test method be used, not both. This then brings           performance tests as
                                                     forth another question – is it not TerraChoice’s          recommended by
                                                     mandate to ensure the environmental safety of a           stakeholders: 2 log reduction
                                                     product and packaging, not what the efficacy is?          with EN 1500 in-vivo test (EN
                                                     Proving how efficacious a product is, and obtaining       1500—Chemical disinfectants
                                                     a DIN or NPN is the auspices of Health Canada.            and antiseptics. Hygienic
                                                     Therefore, should the requirement not merely be as        hand-rub test method and
                                                     per the “general statement”, above? If more detail is     requirements) against a single
                                                     required, then merely stating that the product            indicator organism, E. coli K 12
                                                     submitted must also have either a DIN or NPN              NCTC 10538, and EN 13727
                                                     should suffice (NPN is the required registration for      in-vitro test on Serratia
                                                     alcohol based products, as they are considered to         marcescens (ATCC 14756),
                                                     be derived from natural sources, and hence fall           Escherichia coli (K 12 NCTC
                                                     under the Natural Health Products Directorate of          10538), Staphylococcus aureus                         18
                                                     Health Canada).                                           (ATCC 6538), Staphylococcus
                                                                                                               Epidermidis (ATCC 14990).
Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                EcoLogo Response   Action for
                                                                                                                               EcoLogo
                                    Producer         Performance has already been investigated as part
                                                     of product registration by regulatory authorities.
                                                     Additional performance is not required as it also
                                                     falls outside the EcoLogo mission.
                                    Producer         Please clarify. Are both ASTM E 2276-03 and ASTM
                                                     E 1174-06 required; or, can a company use either
                                                     method?
                                    Producer         We fully support the inclusion of basic performance
                                                     requirements within the EcoLogo hand sanitizer
                                                     standard. This will ensure that only products with
                                                     both the requisite efficacy and an improved human
                                                     health and environmental profile are certified by
                                                     EcoLogo.
                                                     The Draft Standard, CCD-170 references
                                                     performance requirements identified in the Health
                                                     Canada Draft Guidance Document for Human-Use
                                                     Antiseptic Drugs. Since the EcoLogo draft standard
                                                     was issued however, Health Canada has finalized its
                                                     Guidance Document for Human-Use Antiseptic
                                                     Drugs. This final Health Canada standard identifies
                                                     different test requirements from those referenced in
                                                     CCD-170, resulting in a lack of correlation between
                                                     the two standards. The two standards should be in
                                                     relative alignment.




                                                                                                                                            19
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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                               EcoLogo Response   Action for
                                                                                                                              EcoLogo
                                                     We recommend EcoLogo modify its hand sanitizer
                                                     standard to more closely align with the updated and
                                                     final Health Canada guidance specifications for
                                                     bactericidal efficacy for personal and commercial
                                                     use products. A simple change of the draft standard
                                                     that revises the performance and safety
                                                     requirements to require a 2 log reduction with
                                                     either EN 1500 or ASTM E 2276 against the
                                                     organisms listed below (Option A) will accomplish
                                                     this alignment.




                                                                                                                                           20
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CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                   EcoLogo Response   Action for
                                                                                                                                  EcoLogo
                                                     This level of in vivo efficacy testing is sufficient to
                                                     ensure that a product is effective in use against both
                                                     gram negative and gram positive bacteria. We do
                                                     not think it is necessary or appropriate to include
                                                     any additional, mandatory requirements beyond this
                                                     threshold of bactericidal efficacy. Performance at
                                                     this level would insure a certified product passes the
                                                     threshold of antimicrobial efficacy needed for both
                                                     its intended uses and regulatory requirements.
                                                     Additional performance requirements would result
                                                     in confusion and possible conflict with regulatory
                                                     requirements. For example, any additional testing
                                                     would be largely irrelevant for products sold in the
                                                     United States, as organism specific claims (bacteria
                                                     and viruses) are prohibited by the FDA unless a
                                                     product goes through the time-consuming,
                                                     laborious, and expensive New Drug Approval
                                                     process. Organism List for Option A:
                                                     The tests to support Option A may be perceived by
                                                     some stakeholders as cost prohibitive, however, it is
                                                     important to understand that any product sold in
                                                     Canada will now require this testing. While the costs
                                                     can be relatively high, the mandatory nature of the
                                                     testing is not likely to inhibit certification of
                                                     products sold from reputable manufacturers.
                                                     Organism #
                                                     Serratia marcescens ATCC 14756
                                                     Escherichia coli K 12 NCTC 10538
                                                     Staphylococcus aureus ATCC 6538
                                                     Staphylococcus Epidermidis ATCC 14990


                                                                                                                                               21
Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#        Section                    Source           Comment                                                    EcoLogo Response   Action for
                                                                                                                                   EcoLogo
                                                     Performance requirements for a green certification
                                                     however, should simply ensure that a product is not
                                                     deficient in performance relative to non green
                                                     products. EcoLogo could choose a less expensive
                                                     set of threshold efficacy testing requirements to
                                                     meet this requirement. If EcoLogo does choose to
                                                     follow this path in order to decrease costs, we
                                                     recommend a reduced testing plan that is aligned
                                                     with European requirements. In Europe, hand
                                                     hygiene products must meet EN 1500 against a
                                                     single indicator organism, E. coli K 12 NCTC 10538.
                                                     If a lower cost path is necessary, we recommend
                                                     that EcoLogo decrease the total test requirements
                                                     to require a 2 log reduction with either EN 1500 or
                                                     ASTM E 2276 against E. coli only. If there are
                                                     concerns about the broad spectrum efficacy of
                                                     products, we recommend the inclusion an in vitro
                                                     test requirement for the 4 organisms listed above
                                                     for Option A. We recommend EN 13727 be used for
                                                     this testing. Hand sanitizers are regulated as drug
                                                     products by various government entities, and
                                                     subject to a number of guidance documents and
                                                     standards, all of which are subject to change. An
                                                     EcoLogo requirement for performance criteria
                                                     exceeding such bactericidal efficacy requirements
                                                     could add significant, unnecessary cost and may
                                                     even result in conflict with regulations, i.e. virucidal
                                                     efficacy claims in the United States. Therefore, it is
                                                     our recommendation that EcoLogo create
                                                     performance requirements as detailed in one of the
                                                     two above options.
                                                                                                                                                22
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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                 EcoLogo Response                    Action for
                                                                                                                                                 EcoLogo
    15.   Product Category          Producer         This category is questionable because the product       Environmental impacts do not
                                                     evaporates and don't generate a lot of chemical         just occur during the use
                                                     waste compared to other area of industrial cleaning.    phase, they also occur
                                                     In my point of view, this category will have only       throughout the product's
                                                     limited effects on the environment.                     entire lifecycle, which covers
                                                                                                             raw material production and
                                                                                                             acquisition, the manufacturing
                                                                                                             process, packaging and
                                                                                                             distribution, use, and ultimate
                                                                                                             disposal.
                                    Producer         For quaternary ammonium compounds, it's ok to           Each EcoLogo standard is
                                                     ban their use but if they are not accepted in this      developed independently
                                                     category, why they are accepted in the CCD-166          because the ultimate goal is to
                                                     category?                                               establish leadership according
                                                                                                             to the current market
                                                                                                             conditions of a given product
                                                                                                             category. Quaternary                No change
                                                                                                             ammonium compounds were
                                                                                                             deemed adequate to define
                                                                                                             leadership for Disinfectants
                                                                                                             and Disinfectant Cleaners
                                                                                                             (CCD-166), but not for Hand
                                                                                                             Sanitizers.
    16.   Other Comments            Producer         Current market trends have been indicating a
                                                                                                             EcoLogo does not believe this
                                                     movement away for ethanol based products due to
                                                                                                             to be true; ethanol is not listed   No change
                                                     flammability issues, carcinogenicity concerns as well
                                                                                                             on Prop 65.
                                                     as being listed on Prop 65.




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CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                               EcoLogo Response                   Action for
                                                                                                                                              EcoLogo
    17.                             Producer         Based on the standard requirements, products are      Quaternary ammonium
                                                     not to be formulated or manufactured with             compounds and triclosan are
                                                     quaternary ammonium compounds which include           prohibited from the standard,
                                                     alkyl dimethyl benzyl ammonium chloride,              as neither is included in the
                                                     didecyldimethylammonium chloride, benzalkonium        FDA Category 1 classification,
                                                     chloride, benzethonium chloride, and/or               which means these ingredients
                                                     methylbenzethonium chloride. I would like to          have not been proven both
                                                     understand on what grounds quaternary                 safe and effective. In addition
                                                     ammonium compounds are prohibited, since the          to the established risks such as   No change
                                                     Food and Drug Adminstration approves of their use     antibiotic resistance, these
                                                     in instant hand sanitizers within the United States   ingredients are increasingly
                                                     and they have been shown to be “readily               suspected of posing additional
                                                     biodegradable.” In addition, there has been no        risks to human health and the
                                                     cases of health (i..e., adverse effects) or safety    environment. EcoLogo deems
                                                     concerns/issues with end users.                       that these products do not
                                                                                                           meet the definition of
                                                                                                           “environmental leadership”.




                                                                                                                                                           24
Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                                 EcoLogo Response                   Action for
                                                                                                                                                EcoLogo
    18.                             Government/      We are pleased to see that the CCD-170 draft                                               Add a
                                    Regulator        standard includes a prohibition of quaternary                                              requirement so
                                                                                                             EcoLogo has already restricted
                                                     ammonium compounds and hexachlorophene,                                                    that the
                                                                                                             several chemicals known to
                                                     which include known asthmagens. In addition, we                                            products not be
                                                                                                             cause asthma, however adding
                                                     hope that the prohibition of chlorhexidine                                                 formulated or
                                                                                                             a distinct requirement along
                                                     gluconate also includes chlorhexidine itself which is                                      manufactured
                                                                                                             with a definition of
                                                     also an asthmagen. We would also recommend                                                 with substances
                                                                                                             “asthmagens” could help
                                                     adding the assurance that they are free of known                                           designated as
                                                                                                             solidify the intent of the
                                                     asthmagens. Asthmagens could be defined as                                                 asthma causing
                                                                                                             standard in this respect.
                                                     “Substances designated as asthma causing agents                                            agents by the
                                                                                                             Ecologo agrees with the
                                                     by the Association of Occupational and                                                     Association of
                                                                                                             recommendation and
                                                     Environmental Clinics”. This assurance should apply                                        Occupational
                                                                                                             definition. See
                                                     to both active and inactive ingredients.                                                   and
                                                                                                             http://www.aoec.org/aoeccode
                                                                                                                                                Environmental
                                                                                                             .htm for AOEC database.
                                                                                                                                                Clinics”; add
                                                                                                                                                AOEC.
    19.                             Government/      We agree that these products should not include
                                                                                                             Acknowledged                       No change
                                    Regulator        fragrances.
    20.                             Producer         Fragrances and dyes are very common in leave-on         EcoLogo believes that to meet
                                                     formulations, and some users require that. The          the Program’s definition of
                                                     outright ban of all fragrances and dyes from such       product leadership restricting
                                                     products would cause lack of interest and               fragrances and dyes, as well as
                                                     consequently less product application.                  wipes, is necessary. These         No change
    21.                             Producer         Cellulose wipes are compliant with 4. a) in this        restrictions were proposed
                                                     section and readily biodegradable. Including wipes      early on in the process and
                                                     in this statement unnecessarily eliminates an entire    most stakeholders agreed with
                                                     class of products.                                      the criteria. These restrictions




                                                                                                                                                                  25
Comment Report (Stakeholder Comments Pertaining to CCD-170 Draft 1)
CCD-170: Instant Hand Antiseptic Products Standard



CCD-170 Review: Stakeholder Comment Report Regarding Instant Hand Antiseptic Products Draft 1Standard

#         Section                   Source           Comment                                               EcoLogo Response                Action for
                                                                                                                                           EcoLogo
    22.                             Government/      Please consider an addition to your standard that     will lessen the environmental
                                    Regulator        certifies wipes products if they do not contain any   footprint of the product
                                                     of the prohibited or restricted substances.           through resource and waste
                                                                                                           reduction.




                                                                                                                                                        26

				
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