Guide to Responsible Nano-Business

ObservatoryNANO recently published a "Guide to Responsible Nano-Business", a brief report written for an audience of "Medium sized companies involved in the development, processing, production, or trade of nanotechnology-enabled materials, components, or applications".

ObservatoryNANO was created and funded by the then extant European Community (EC), the predecessor of today'sEuropean Union (EU),  “to create a European Observatory on Nanotechnologies to present reliable, complete and responsible science-based and economic expert analysis, across different technology sectors, establish dialogue with decision makers and others regarding the benefits and opportunities, balanced against barriers and risks, and allow them to take action to ensure that scientific and technological developments are realized as socio-economic benefits.”

The Guide sets out and briefly discusses four "tools to identify and manage nanotechnology-related priorities":

Tool 1: Set priorities, focusing on the process of framing responsibility measures

Tool 2: Check and complement established internal guidelines and code of conduct

Tool 3: Focus actions, described in the guide as the "strategies and programmes [needed] to be put in place to assure that a guideline is of any practicle use".

Tool 4: Inform transparently, focusing on what to communicate (content), how to communicate to employees of the company, customers and/or the general public, and the choice of communication media, ranging from company websites to product labels.

The Guide has links to "Good Practice Examples", such as BASF's Code of Conduct and to sites where more information can be found.

While the Guide to Responsible Nano-Business is not on the same level as "Guide for the Perplexed" by Moses Maimonides, it is a good short and clearly written work that the owners and managers of nano-businesses would find useful in formulating policies for the workplace and for communicating with the general public.

S.847: The Safe Chemicals Act of 2011

Senator Lautenberg:This isn't a reorganization of the way we function here. It is to be another version of TSCA, far less harmful but having a law that does cover the bases.

Introduced by Senator Frank Lautenberg (D-NJ) on 04/14/2011, S. 847, the "Safe Chemicals Act of 2011", is the third bill introduced in the last two years with the intent of reforming and strengthening the Toxic Substances Cotrol Act . S. 3209, the "Safe Chemicals Act of 2010", also introduced by Senator Lautenberg, and H.R. 5820, the "Toxic Chemicals Safety Act of 2010", introduced by Representives Bobby L. Rush (D-IL-1st) and Henry Waxman (D-CA-30th), were intoduced during the 2nd Session of the 111th Congress, but died in committee when the 111th Congress adjourned sine die.

As was noted by a witness at a hearing of the Senate Environment and Publicworks Superfund, Toxics and Environmental Health Subcommittee on 02/04/2011

. . . while TSCA was an important step when it was first passed in 1976, it is the only major environmental statute that has not been reauthorized since its initial passage. TSCA is clearly showing its age and its limitations.

A recent article in Pediatrics discusses the limitations of TSCA in greater detail than is possible in this posting.

S. 847 would amend TSCA in several ways.

1- Manufacturers and processors would be required to

submit the minimum data set for the chemical substance to the Administrator--

 

        `(A) for new chemical substances, concurrent with the notice required under section (5)(a)(1)(A); and

 

        `(B) for existing chemical substances, on the earlier of--

 

          `(i) 18 months after the date on which the chemical substance is assigned to a priority class under section 6(a); and

 

          `(ii) 5 years after the date of enactment of the Safe Chemicals Act of 2011.

         

 

2- Manufacturers and processors would have restrictions placed on them regarding both new chemicals and new uses of existing chemicals:

SEC. 6. MANUFACTURING AND PROCESSING NOTICES.

 

    Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended to read as follows:

 

`SEC. 5. MANUFACTURING AND PROCESSING NOTICES.

 

    `(a) New Chemical Substances and New Uses of Chemical Substances-

 

      `(1) NEW CHEMICAL SUBSTANCES- Except as provided in subsection (d), no person may manufacture or process a new chemical substance unless--

 

        `(A) the person submits to the Administrator a notice, in accordance with subsection (c), of the intention of the person to manufacture or process the substance;

 

        `(B) the person complies with subsection (b); and

 

        `(C) the Administrator finds that--

 

          `(i) the manufacturers and processors have established that the chemical substance meets the safety standard under section 6(b); or

 

          `(ii) the new chemical substance, or a metabolite or degradation product of the chemical substance, as applicable, is not, and is not expected to be--

 

            `(I)(aa) manufactured in a volume of more than 1,000,000 pounds annually; or

 

            `(bb) released into the environment in a volume of more than 100,000 pounds annually;

 

            `(II) a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor;

 

            `(III) persistent and bioaccumulative;

 

            `(IV) found in human cord blood, or otherwise found in human blood, fluids, or tissue, unless the chemical substance, metabolite, or degradation product is naturally present at the level commonly found in that medium; or

 

            `(V) found in food, drinking water, ambient or indoor air, residential soil, or house dust, unless the chemical substance, metabolite, or degradation product is naturally present at the level commonly found in that medium.

 

      `(2) NEW USES OF EXISTING CHEMICAL SUBSTANCES PRIOR TO SAFETY STANDARD DETERMINATION-

 

        `(A) IN GENERAL- Except as provided in subparagraph (B), with respect to an existing chemical substance for which the Administrator has not made a safety standard determination under section 6, no person may manufacture or process the chemical substance--

 

          `(i) for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2011; or

 

          `(ii) at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2011.

 

        `(B) EXCEPTION- A person may manufacture or process a chemical substance in a manner prohibited by subparagraph (A), if the person--

 

          `(i) submits to the Administrator a new or updated declaration under section 8(a); and

 

          `(ii) complies with subsection (b).

 

      `(3) NEW USES OF EXISTING CHEMICAL SUBSTANCES THAT MEET THE SAFETY STANDARD-

 

        `(A) IN GENERAL- For an existing chemical substance for which the Administrator has determined under section 6(b) that the manufacturers and processors of the chemical substance have established that the substance meets the applicable safety standard, no person may manufacture or process the chemical substance for uses, at production volumes, or in manners other than those the Administrator specified in the safety standard determination, unless--

 

          `(i) the manufacturer or processor submits to the Administrator--

 

            `(I) a notice of the intention of the manufacturer or processor to manufacture or process the substance for a new use, at a new production volume, or in such other manner as is inconsistent with a specified condition or term for that substance; and

 

            `(II) all updates to the minimum data set relevant to the new use, new production volume, or other new manner of manufacturing or processing;

 

          `(ii) the notice under clause (i)(I) indicates that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that chemical substance are revised to encompass the new use, production volume, or other manner of manufacturing or processing; and

 

          `(iii) the Administrator determines that the manufacturer or processor submitting the notice has established that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that substance, are revised to encompass the new use, production volume, or other manner of manufacturing or processing.

         

3- Priority classes of chemical substances would be established:

      `(2) CHEMICAL SUBSTANCES REQUIRING IMMEDIATE RISK MANAGEMENT (PRIORITY CLASS 1)-

 

        `(A) DEFINITION OF PRIORITY CLASS 1- In this section, the term `priority class 1' means a priority class that contains chemical substances that the Administrator determines require immediate risk management.

 

        `(B) ASSIGNMENT TO PRIORITY CLASS 1- The Administrator shall assign a chemical substance to priority class 1 if the Administrator determines that the chemical substance is, or is degraded and metabolized into, a persistent, bioaccumulative, and toxic substance with the potential for widespread exposure to humans or other organisms.

 

        `(C) INITIAL ASSIGNMENT- Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2011, the Administrator shall assign not less than 20, but not more than 30, chemical substances to the initial priority class 1.

       

    . . . (i) EXPEDITED EXPOSURE REDUCTION- As soon as practicable, but not later than 18 months after the date on which a chemical substance is assigned to priority class 1 under this paragraph, the Administrator shall impose conditions in accordance with subsection (c) on the manufacturing, processing, use, distribution in commerce, and disposal of a chemical substance assigned to priority class 1 that the Administrator determines necessary to achieve the greatest practicable reductions in human or environmental exposure to the chemical substance.

      `(3) CHEMICAL SUBSTANCES REQUIRING SAFETY STANDARD DETERMINATIONS (PRIORITY CLASS 2)-

 

        `(A) DEFINITION OF PRIORITY CLASS 2- In this section, the term `priority class 2' means a priority class that contains chemical substances that Administrator determines require safety standard determinations.

 

        `(B) ASSIGNMENT TO PRIORITY CLASS 2-

 

          `(i) IN GENERAL- Subject to clause (ii), if the Administrator determines, based on any more-than-theoretical concern, that there is uncertainty as to whether a chemical substance would satisfy the safety standard in a determination made under subsection (b), the Administrator shall assign that chemical substance priority class 2.

    `(4) CHEMICAL SUBSTANCES REQUIRING NO IMMEDIATE ACTION (PRIORITY CLASS 3)-

       

        `(A) DEFINITION OF PRIORITY CLASS 3- In this section, the term `priority class 3' means a priority class that contains chemical substances that the Administrator determines require no immediate action.

           

            `(B) ASSIGNMENT TO PRIORITY CLASS 3- The Administrator shall assign a chemical substance to priority class 3 if the chemical substance has intrinsic properties such that the chemical substance, as determined by the Administrator, does not and would not, at any stage of the lifecycle of the chemical substance, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

            4- The burden of proving the safety of chemicals would shift from the EPA to manufacturers and processors:

              `(b) Safety Standard Determinations for Chemical Substances-

             

                `(1) IN GENERAL-

             

                  `(A) APPLICATION- This paragraph applies to the determination, or redetermination, of whether a chemical substance meets the applicable safety standard of this title.

             

                  `(B) BURDEN OF PROOF-

             

                    `(i) IN GENERAL- Under this title, the manufacturers and processors of a chemical substance, at all times, bear the burden of proving that the chemical substance meets the applicable safety standard.

             

                    `(ii) DUTIES- Under this title, it shall be the duty of--

             

                      `(I) the manufacturers and processors of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the applicable safety standard; and

             

                      `(II) the Administrator to determine whether the chemical substance meets the applicable safety standard.

                `(2) DUTIES-

             

                  `(A) MANUFACTURER AND PROCESSOR DUTIES-

             

                    `(i) INITIAL SAFETY STANDARD DETERMINATION SUBMISSION-

             

                      `(I) IN GENERAL- By the date that is 30 months after the date on which a chemical substance is assigned to priority class 2 under subsection (a), the manufacturers and processors of a chemical substance shall--

            `(aa) update the minimum dataset, if the data set was submitted prior to the assignment of the chemical substance to priority class 2 under subsection (a);

            `(bb) submit to the Administrator any additional information the Administrator may require to make a safety standard determination, including any information the Administrator determines is necessary to be developed by testing; and

            `(cc) indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified uses, meets the safety standard.

            5- The Administrator of the EPA would be empowered, if a determination is made that a chemical poses a risk to the environmental and/or the public to

            . . .  impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing that chemical substance, in accordance with subsection (b)(2)(B)(ii)(II), including--

             

                `(1) a requirement limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce;

             

                `(2) a requirement--

             

                  `(A) prohibiting the manufacture, processing, or distribution in commerce of the substance for a particular use in a concentration in excess of a level specified by the Administrator in conditions under subsection (b)(2)(B)(ii)(II); or

             

                  `(B) limiting the quantity of the substance that may be manufactured, processed, or distributed in commerce for--

             

                    `(i) a particular use; or

             

                    `(ii) a particular use in a concentration in excess of a level specified by the Administrator in conditions established under subsection (b)(2)(B)(ii)(II);

             

                `(3) a requirement that the substance be marked with or accompanied by clear and adequate warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of such activities, with the form and content of the warnings and instructions prescribed by the Administrator;

             

                `(4) a requirement that manufacturers and processors of the substance--

             

                  `(A) make and retain records of the processes used to manufacture or process the substance; and

             

                  `(B) monitor or conduct tests that are reasonable and necessary to ensure compliance with this Act;

            6- In submitting required information to the EPA, "trade secrets" would still be protected, but information that a manufacturer or processor designated as "confidential business information" would need to have an explanation and justification submiited with it, explaining why the information should be considered as confidential.

            7- Decisions and orders of the EPA regarding chemical substances, as well as data submitted by manufacturers and processors would be posted to the EPA's website, in an effort to make it more readily available to communities that could be affected by exposure to chemical substances.

            8 - States and municipalities would still have the right to enact or adopt regulations affecting chemical manufacturers:

            `SEC. 18. PREEMPTION.

             

              `Nothing in this Act affects the right of a State or a political subdivision of a State to adopt or enforce any regulation, requirement, or standard of performance that is different from, or in addition to, a regulation, requirement, liability, or standard of performance established pursuant to this Act unless compliance with both this Act and the State or political subdivision of a State regulation, requirement, or standard of performance is impossible, in which case the applicable provisions of this Act shall control.'.

            The Environmental Defense Fund has created a chart summarizing how the 2011 act differs from the 2010 act, as well as one summarizing how S. 847 would strengthen TSCA.

            Some of S. 847's language appears to be applicable to the nanotech community:

              `(C) INCLUSIONS- Notwithstanding molecular identity, the Administrator may determine that a variant of a chemical substance is a new chemical substance under section 5(a)(6).';

                `(20) SPECIAL SUBSTANCE CHARACTERISTIC-

             

                  `(A) IN GENERAL- The term `special substance characteristic' means a physical, chemical, or biological characteristic, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting that characteristic.

             

                  `(B) CONSIDERATIONS- In determining the existence of special substance characteristics, the Administrator may consider--

             

                    `(i) size or size distribution;

             

                    `(ii) shape and surface structure;

             

                    `(iii) reactivity; and

             

                    `(iv) any other properties that may significantly affect the risks posed.';

                `(6) CHEMICAL SUBSTANCES EXHIBITING SPECIAL SUBSTANCE CHARACTERISTICS-

             

                  `(A) DETERMINATION- The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics--

             

                    `(i) is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics; or

             

                    `(ii) is a new chemical substance.

             

                  `(B) REQUIREMENTS FOR VARIANTS THAT ARE SEPARATE USES- In the case of a chemical substance that the Administrator determines to be a separate use based on the special substance characteristics of the chemical substance, the manufacturer or processor shall satisfy such further conditions as the Administrator establishes, by order or rule.

             

            While efforts to reform and strengthen TSCA has received support from representives of various large chemical companies, among them Dow Chemical, DuPont, and BASF, chances for the passage of S. 847 should be considered slim at best. S. 847 has been introduced at a time when an anti-regulatory ideology is being openly expressed in the House and Senate, as is evident remarks made by Senator David Vitter (R-LA) during the 02/04/2011 hearing:

            . . . . Two, I think a European registration, evaluation and authorization of chemical substances -- a REACH-style program would threaten to kill innovation in the U.S. and is a real recipe for hamstringing small and medium-size manufacturers in particular.

            . .  . Five, I think the peer review process needs to ensure that the peers are absolutely independent. And this means that cherry-picking of research by activists in federal agencies needs to end as well.

            And six, if EPA is going to decide to utilize resources to re- review a chemical prior to the otherwise established scheduled review period, as it has recently, that needs to be -- again, to come back to my central theme -- based on sound science, not simply a New York Times article that, quite frankly, uses politicized science.

            A note of thanks to Bloomberg Government for supplying a copy of the transcript from the 02/04/2011 hearing.

            California Targets Nanoscale Metal Oxides and Quantum Dots for Data Call Ins

            California's Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins.  Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009. 

            In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked.  We cover each material below.

            CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions. 

            CDTSC plans to issue all of these new data call ins sometime before the end of the year.  Stay tuned . . .

            Nano Silver

            Proposed Questions:  What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?

            Preliminary Recipients:  Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.

            Nano Zero Valent Iron

            Proposed Questions:  What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its lifecycle? How do you sample, measure, and monitor quality? Performance? How do you detect, measure, and monitor releases from facility operations? How do you measure and monitor fate and transport after useful life?

            Preliminary Recipients:  American Elements, AMEC Geomatrix, hepure Technologies, OnMaterials, Quantum Sphere, Stanford Materials, Sun Innovations.

            Nano Titanium Dioxide

            Proposed Questions: What machines and methods do you use to analyze your materials? What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? What is the toxicity when your material is directly contacted with human skin? What is the weathering, liberation rate of your material into the environment? Impacts? What is you actual production amount this year?

            Preliminary Recipients:  DuPont, BASF, Evonik, Ishihara, Altair nano, Huntsman, Kronos, Kemira, Kon Corp., Tronox, Nanocompsix, Nano-oxide, Green millenium, MK nano, Advanced Nano, NanoCo, Pilkington.

            Nano Zinc Oxide

            Proposed Questions:  Describe .specifically the nanostructure, functionalities, and properties (physical, chemical, and biological) of nano zinc oxide material that is produced in the facility.  Describe the in-house instrument and analytical methods you use to determin the presence of nano zinc oxide in the workplace and environment. Describe the chemical information provided by external vendors relative to nano zinc oxide nanostructure, functionalities, and properties.  Describe the instrumentation and analytical methods used by external laboratories that provided the above chemical information.

            Preliminary Recipients:  UC San Diego, UC Berkeley, USC, Ferity Zinc Oxide Inc., APF Laboratories, Atomate Corporation, Stanford Materials, Alpha Enivornmental, Nanophase technologies, Sokang nano, Antaria Corporation, Ocean Nano Tech, LaamScience, Advanced nanotechnology, NanoGate, Inframat Advanced Materials, Reade Advanced Materials, KIA, Nanjing Hi Tech Nano Material Co., ltd., Nanozinc Oxide South Africa, NanoMaterials Technology, UmiCore Group, Horsehead Corporation.

            Nano Cerium Oxide

            Proposed Questions:  What machines and methods do you use to analyze your materials?  What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? Do you know reactions when your material is released into aquatic environment? Do you know reactions when your material is released into air? What is you actual production amount this year?

            Preliminary Recipients:  Saint-Gobain, Evonik, Meliorum Tech., Inframat Advanced materials, Antaria, HEFA Rare Earth Canada, Nanocerox, Nyacol, Energenics, MTI Corporation.

            Quantum Dots

            Proposed Questions:  What are the chemical compositions (purity, concentration, and chemical make-up) of your product's core and shell structures (including organic and inorganic attachments)? Specify its size, hydrodynamic diameter (HD), and surface area.  What analytical detection methods do you use to determine its presence in the workplace and environment? What are the surface properties (surface reactivity, groups, charge) and solubility in water and other solvents? What is the stability of your product in different environments (variable pH, temp, pressure, O2, UV light, water, etc.)? Does it aggregate in aquatic media?

            Preliminary Recipients:  Nanosys/QD Soleil, Bloo Solar, Life Technologies, Stio, Quantum Dot Corporation, Chemicon International, Zymera, Invisage Technologies, University of California schools, Intelligent Optical Systems, Kovlo, NanoGram, Philips Lumileds Lighting Co., Toshiba America Electronics Components, Samsung Semiconductor, SEMI, Ultratech, Shrink Nanotechnologies.

             

            EPA's Nanoscale Materials Stewardship Program Receives New Submissions

            The first phase of EPA's voluntary Nanoscale Materials Stewardship Program (NMSP) closes on Monday.  For those keeping track, the most up-to-date NMSP participation statistics as of July 24, 2008 follow.  It is shaping up to be a very respectable list of participants.

            Submissions Under Basic Program: (9 submissions - covering 68 nanoscale materials) DuPont; Nanophase Technologies Corporation; Nantero; Office ZPI; Quantum Sphere; Strem Chemicals; Swan Chemicals Inc.; Unidym; and one Confidential Business Information Submission.

            Commitments to Submit Information Under Basic Program: (11) Arkema; BASF Corporation; Bayer Material Science; Dow Chemical; Evonik/Degussa; General Electric; International Carbon Black Association; Nanocyl North America; PPG Industries; Sasol North America; and Synthetic Amorphous Silica and Silicate Industry Association.

            Commitments to Participate in the In-Depth Program: (2) Swan Chemicals Inc.; and Unidym.