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# CONTAINS NOCB1 ( l~

Officle o1 Pokition PWM"" n and Tomd+as ECP''1'), Thomas Mman OM DocunwM

Gotnfti L1Ala (titCQj, EPA East 8kitp.,Rtr1. U01, 1201 CrtAlli'thMOn A11's., NW ., Wa:hinol01"I, DC

. Athfi*1N

: ClOckAt ID Numkisr EIPA-611041111"-M"7q

Dear Tilomas, 

### The Biotechnology Industry Organization (8i0) is the world's largest biotechnology organization, providing advocacy, business development and communicaitions services for more than 1,100 members worldwide. Our mission is to be to champion of biotechnology and the advocate for our member organizations - both large end smog. 610 members are Involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology technologies. Caarporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. We also represent state and regional biotech associations, service providers tothe industry and academic centers. Even though, most chemical* and plastics used today are petroleum-based, the rapid advancement in industrial biotechnology is providing petrochemical alternatives based on renewable feedstocks. These renewable chemicals and bfoplastics are used in a growing number of everyday products such as cups and carpets, deicers, detergents, personal care products, food and favoring ingredients, pharmaceutical Intermediates, composites, adhesives, seaiants, coatings, additives, lubricants, and insulating materials. Renewable chemicals can be engineered to provide innovative solutions that are energy saving and environmentally preferred. BIO members are involved in the synthesis, product development, manufacturing, designation, commercialization, distribution, and use of products with sustainable benefits. BIO and its members commend the EPA for gathering input from stakehoiders as it works to define the Agency's role and to develop a strategy for EPA to make a meaningful contribution to the development, manufacture, designation, and useof sustainable products. 

### 1 . What do you see as the major policy and research challenges, opportunities, and trends impacting the development, manufacture, designation, and use of sustainable products? There is an opportunity to transformthe multi-trillion dollar chemical industry which will result in everyday materials being made fromrenewable resources rather than oil and natural gas ; reduce a huge industry's energy use and environmental footprint; and create clean techjobs in the United States. Consumer sentiment and demand for renewably sourced products is 

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1201 Maryland Ave SVV, 5uae '.100 W,)~~~ Cti . ~0024-2149 202.962 .9200 -Fax 202.488.6301 ~ www .bio .org

### growing; see "Industrial Blotoch+~aio~y: More than Gram Fuel in a DiAy Economy,wproduced by theWorld Wildrft Fund, Chemicals made fromrenew" rescx+roes have been shown to be produced using signiflcantly less energy, resuAng in s lower carbon lootprint ; and may oost less to produce than petroleum based alternatives. Thousands of chemicals, chemical infierrnedistss and everyday materials tike nylon, spandex, call phone coon and trsa can be made starting fromrenewable resources. Policy end Industrial ef1orta that support these sustainatale products can have the widest ranging impact In the shorCest time. An environmentally - positive, and well functioning m8" approach can be facilitated by more information, such as consistsnt, readily understood lirtecycis analyaes of products used by consumers and businesses; and by simpler, fasW permittinp of processes and plants. One regulatory reviewprocess that provides a major opportunity to Improve development and manufacture of sustainable products is TSCA 'r'-'V - snwnufac~+e Notkation (PI1MN)

. There are several areas of the PNIN reviewprocess that provide opportunities for Improvement . These include the following: Source and process specific identifiers in TSCA chemical irrventory nomenclature (e.g. "petroleumderived") which serve as a barrier tosubstitution of chemically identical or very similar products derived fromsustainable renewable resources. Need for focused collaborative effort to characterize biobaoed process streams and products. s Improvement and validation of Quantitative Struc,~ture Activity Relationship (QSAR) and modeling tools for chemical classas relevant to sustainable renewable resources (e.g. fatty acids and their esters) . " Optimizing use of hazard date and assessrr~ents fromall available sources worldwide. Z. What do you sea EPA's ovomll Me In addressing Ow" challenges mid oppordrnllies? Source md process specific Identifiers in TBCA chWnfcai inventory nomenclature (e.g. "petroiirurn derived") which *am as a barrier to substitution of chemically identical or very similair products derived trom sustdnsbie biosouroes. EPA plays the central policy rote in addressing this barrier to sustainable product development . Fromthe standpoint of TSCA inventory reviewit seems that the focus should be on product chemistry and associated risk assessment, and that descriptors of source and process that do not add meaningfully to these determinations should not be a barrier to product substitution. We implore EPA to consider this topic as a policy barrier to sustainable product development, and to develop guidance and processes to remove this barrier. One thought is to develop a post-manufacturing notification process whereby source and process specific Identifiers could be tracked for chemically identical or very similar products as determined by the Inventory Expert Service. Need for focused collaborative sffort to characterize biobased process streams and products. It is noteworthy that a major collaborative effort was undertaken between EPA and industry at the time of the original TSCA inventory (197Qs) to assemble the listing of petroleum refinery streams. Transformation of the fuels industry to renewable sources poses an equal or even

### greater chiMenge given the variety of potential source malleriais. A fmsed collaborative effort

to tupport this transfomwtion, similar to that undeltaken to characterize the petroleumrefinery streams, is needed and can only be led by EPA . 1knnp~ WW

v~a~t of tiEAit and awdN~toots for ahsraiVOsi do"" rstevant to susto!nmbte biosowttars (e.p . hRly acliis sAd f!a!k 1afto) . EPA is seen iniernaticswlly as a leader in the tlsvelopment of QSAR and modeling tools to support risk assessment of duroicals. By virbre of their access to daft for model development and validation EPAhas a unitire opportunity to advance these toole in areasof chemistry most relevant to biosources. Expsirience to4ate uppstg that the emsting models am riot robust for fatty acads and theW

esters, as an exampie. Conftious improvement of these tools by EPA is an important component of effective regulatory reviews for sustainable renewable cheri*als and products. OpUraiainE use of rrHlsbie haarrd date and assl~ss~nnretts hqm *d! toarohs worldwide

. The~worfd has changed since TSCA was enacted in 1976 . Daft requirements and collection practices to support product development have evolved around the world. Hazard data for a chemical or chemical class is fungible inf+mation and practices should be encouraged to optimize the use of existing data fromaM reliable sources. Examples of major Programs include the EPA and OECD HPV program, and national ! regional chemical registration programs in Canada, Asia and the EU . EPA should promote pd1cies which encourage the sharing and application of data from all reliable sources. The emphasis going forward should be on optimizing the use of existing hazard data mid models, and understanding product use and exposure c~nsic~tions and building this database for renewable chemicals and biobased products for the U

.S. 

### 3. In partiaular, how

doyou am

FPA's role in: s Assarnbfing tntonnaUm auW dabbsses Renewable chemicals are very real and direct sibstitute or drop-in replacements for petrochemicals. Comparing renewable chemicals to petrochemicals- particularly for production of the high-volume drop-in replacement chemicals produced in the U.S

. (acrylic acid, 1,4B00, adipic acid, 1,2 " propylene gfyooi, 1,3-propanediol, etc) would show howindustrial biotechnology is reducing consumption of non-renewable energy, reducing waste, end improving sustainabikty. Presently, there are nostrong standardized metrics. If the EPA had energy data or would generate such data, for benchmarking the petrochemical processes that industrial biotechnology processes are attempting to displace as well as prepare a model for life cycle analyses (LCA) that could apply to then processes, then renewable chemical companies could show substantial cost, environment and efficiency benefits . These quantified metrics could be added to partnering and investment stories, and further encourages the development of sustainable products in the U.S. EPA's active participation is needed in conducting cost and energy assessment for resource exploration, removal, transport and conversion for petroleumproducts in order to accurately see the benefits of sustainable product manufacturing. As an example, LCAstudies for poiyhydroxyaikanoates (PHA) and potyiactic acid (PLA) includes the corn plant, harvest, transport and conversion . EPAis well positioned for this role since they are familiar with green house gas (GHG) emissions frommanufacturing, and could

### easily obtain data on oil and gas eyoloiration mid conversion. This would slow EPAto take a leadership role in defining and memurirq sustaaability. +~ kh"Altyltv susti"611114 "hoqpoft," and no" product sasMOM" SOing product sustainability prior" bated on daft an always useful, ova it gives direction to research and dsvelopment and emphasizes Me value to research. C,ovensnenta! lists we consilderied, very relevant for detsrmining new research targets, and become even awe significant when these Mts we Incentivizsd by grants or research arid development incentives. * Etrahattr9thf nuritiPfe hapaab o1 Produeft acms tlwir aft+! Nthr cyab EPA's active participation is needed in tfie development of standardized Iifecyde analyses for renewable chemicals in the value chain tromcradle to gft and cradle to grave. 

## " Dell" eriWa br mon sustafs+wbtt pr+oduols EPA is a key stakehaider for renewable, chemicals that amnew moiecules, which require T3CA listing (unlike green versions of existing molecules or drop-in replacements) . 810 members are working with EPA on the WE program (Design for Environment) in the context of new

platformmolecules. In addition to this, EIOmembers would request that TSCA reform legislation recognize the importance of the industrial biotechnology emerging sector and place priority on the approval of new renewable chemicals and give provisions to drop-in replacement renewable chemicals. 

## " +3eneraHeig eco-labols ancVor stowkrds 1. Labeling of renewable chemicals arid biobesed products is being implemented by USDA (BioPr+eferredT" Program) ; therefore another labeling poky may not be required. EPAshould be careful that ec;o-labels do not cause consumer confusion . 11. Develop clear standards for renewable chemicals (possibly a rating system) that are not costprohbitive. Anumber of retailers and brand-owners are developing their own *m

cards, which is not very efficient since produoers will have to go through ` ~- r6mero0s scoring systems, and these wig require slightly different data. " Estabtishing ft schntMk foundstbn !Cr thae eW-tibe1s andtor standards industrial biotechnology can help actually prevent Pollution before it ever occurs and it can help remediate existing pollution. EPA gives awards for green chemistry that often involves industrial biotechnology, but EPA has not done enough with its R&D Office or Pollution Prevention Office to integrate the benefits of industrial biotechnology into the total environmental R&D and pollution control infrastructure. EPA needs more skilled regulators with education in biotechnology and they need to help build the capacity of industry to deploy industrial biotechnology to provide solutions to pollution prevention. " Verifying that products +neet standarde EPA could gather life cycle analysis data or have a databank for renewable chemicals and biobased products and offer standardized tools to conduct analyses. These approaches would provide reliable basis for evaluating products against standards. " 3timuiatirig the market Funding R&Dto develop biorefinery and integrated biorefinery processes to produce renewable chemicals that reduce emissions, reduce carbon footprint, and use lower

### energy. Fast tnaickiinp permiainQfor innavative dean *chnok)gies, which demonwate

environmental benefita. EPA can contribute an building a biabesed eaonomy, through Prnrno+'t9creation of Ww jobs and fomatian of appropriate policies. 

## DoveiepinE snd"oir-I1%nrnpSnw11t sySUM trwaet, roct*416Oft) Develop quideiYnea for sustainable deagn (soo-design, green design, and environmental design) which would reduce the overall environmental anpect of producing products and facilRIee in a way that reduces use of nonrenewable resouinces. +~ Il~mwferE r+atft, ivslal*p pi alpwas Educate the public on sale use of renewable cherrkals and bbbased MdWW through public reigtions campaign and public awararm" educabonal programs. Emphasize quantit'lable biodegradable properties for ronewsible chemicals and biobased products by developing standard tammethods. Positioning nnetirable chemicals and blobased products under a "austainabiNty unbrea pisttorm," inwhich dMerentl8tion and measurable entirironmenteat berieft for renewable chemicals and biotmised products we provided and compared 1a petrochemic,els and paboOwlenviiiced bend prodxta. Overall, EPA's rote is very releverd in the growth of austaineble products and building of integrated biaefnories. EPA policies could enoourap market aoosptance and ceontrtwte to the bobased economy, which would result in creating both direct and indirectjobs, maintaining innovation in the U.S, and having continued global badership in the irKkn*W biotechnology sector. Conducting a search to seewhich policies are undertaken by other agencies and organizations would help identily the more pressing needs for EPA in developing a sustainable biobaased economy. 610and 810 menders would welcome the opportunity to furthet engage in dialogue and assist in the development of policies for sustainable products. Sincerely,

Brent Er+ckson Executive Vice President Biotechnology Industry Organization

### 88328 Fed" 14gieftr IVol . 75, No

. 179IThursday, September 16, 3010INotices 586-5271) or e-mail (alethea.)ennings®eia.doe.gov) is also recommended. The mailing address is Statistics and Methods Group (EI-70), Forrestal Building, U

.S. Department of Energy, 1000 Independence Ave, SW ., Washington, DC20585-OS70. Ms. Jennings may be contacted by telephone at (202) 586-5879

. WlPPt.MWTAAtt INFOlIIIAflOtk This section contains the following information about the energy information collection submitted to OMBfor review

: (1) Thecollection numbers and title

; (2) the sponsor (i .e., the Department of component) ; (3) the current OMB det number (if applicable) ; (4) the type of request (i .e., new, revision, extension or reinstatement) ; (5) response obligation (i .e., mandatory, voluntary, or required to obtain or retain benefits) ; (6) a description of theneed for and proposed use ofthe information; (7) a categorical description of the likely respondents; (8) estimate number of respondents and (9) an estimate ofthe total annual reporting burden (f .e., the estimated number of likely respondents times the proposed frequency of response per year times the average hours per response) . 1 . Forms EIA-63A, "Annual Solar Thermal Collector Manufacturers Survey," EIA-638, "Annual Photovoltaic Module/Cell Manufacturers Survey,- and the EIA902, "Annual Geothermal Heat Pump Manufacturers Survey." 2 . Energy Information Administration. 3 . OMB Number 1905-0196 . 4 . Three-year extension to an existing approved request. 5. Mandatory

. 6 . Forms EIA-63Aand EIA-63B collect data on the manufacture, shipment, stocks, and import/export of solar thermal collectors and photovoltaic modules/cells and the status ofthe industry. The data are used by the private sector, the renewable energy industry, the DOE, and other government agencies. Respondents are U . S. companies that manufactured, shipped, and/or imported solar thermal collectors end/or photovoltaic modules and cells. The EIA-902 is used to collect data about the manufacture, shipment, stocks, and import/export of geothermal heat pumps and thestatus of the industry. The information collected will be used by public and private analysts that are interested in geothermal heat pumps and related energy issues. 7. Business or other for-profit institutions. 8. 283 respondents. 9. 1,415 hours. Please refer to the supporting statement as well as the proposed forms and instructions for more information about the purpose, who must report, when to report, where to suitanit, the elements to be reported, detailed instructions, provisions for possible (i ncl uding po ~ iafxmatfon. For instructions on obtaining materials, see the no nYRT11gR 9OOII~Ilipli OOIwACt section. SIMOoy AndOtfy: Section 13(b) ofthe Federal Energy Adwiaistrat3on Act of 1974, Public Law

D3-27S, codified at 15 U.S.C. 772(b) . Issued in Washington, DC, on September 9, 2010 . slorbob bow DineCtor. Statistics and Methods Group, EherVtnfarmQtionAdmintstmrion . (FR Doc . 2a1o-23115 Filed 9-15-30',S'45am] @NAM cam Sam" 

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: Pft-"47->> EP'A~'s *6In Ad-a-0 q Suslabuft AOEIiC11 : Environmental Protection Agency (EPA) . AC'Tf0ft Notice. 8LqftVff: EPAis interested in soliciting individual stakeholder input regarding theAgency's role in the "green" or sustainable products movement . The Agency will consider the information gathered fromthis notice and other sources as it works to define its role and developa strategy that Identifies how EPAcan make a meaningful contribution to the development, manufacture, designation, and use of sustainable products. DAM : Comments must be received on or before October 19, 2010 . ItOONEWp: Submit your comments, identified by docket identification (ID) number EPA-HQ-0PPT-2010-0768, by one of the following methods: + Federal eRirlemaldng Portal : http:// www .regulations.gov. Follow the on-line instructions for submitting comments. " Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW

., Washington, DC 20460- 0001 . " Hand Delivery

: OPPT Document Control Office (DCO), EPA East Bldg., Rm . 6428, 1201 Constitution Ave., NW ., Washington, DC

. Attention: Docket ID Number EPA-HQ-OPPT-2010-0768. The DCO is open from8 a.m

. to 4 p.m

., Monday through Friday, excluding legal holidays. The telephone number for the DCO is (202) 5B4-893U. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions:Direct your comments to docket ID number EPA-HQ-OPPT2010-0788=I

EPA's policy is that all comments ed will be included in the docket without change and may be made available on-line at http:I/ www .maulnTions.gov, inciuding any k&rmstion provided, unless the comment includes information claimed to be Confidential Business Information (C8I) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations .gov or email . The regnlations .gov Website is an "anonymous access" system, which means EPAwill not know your identity or contact information unless you provtde it in the body of your comment. Jfyou send an e-mail comment directly to EPAwithout going through ations .gov, your e-mail address be automaticall y captured and included as part of the comment that is placed in the docket and made available on the Internet . Ifyou submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment andwith any disk or CD-ROM you submit. If EPAcannot read your comment due to technical difficulties and cannot contact youfor clarification, EPA may not be able to consider your comment Electronic files should avoid the use of special characters, any form ofencryption, and be free of any defects or viruses. Docket : All documents in the docket are listed in the docket index available at http://www

.regulativns .gov. Although listed in the index, some information is not publicly available, e .g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted materiel, is not placed on the Internet and will be C ublicly available only in hard copy rm . Publicly available docket materials are available either in the electronic docket at http:// www .regulations .gov, or, if only available in hard copy, at the OPPT Docket . The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm . 3334, EPA West Bldg., 1301 Constitution Ave., NW ., Washington, DC . The EPA/DC Public Reading Room hours of operation are 8:30 a .m . to 4:30 p.m ., Monday through Friday, excludingFeieirnd ~hlet i Vol . 75. Na i?9i Thurada , Se maber 18, 2010/ Notices

legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 586-1744, and the telephone number for the UPPT Docket is (202) 566-0280. Docket visitors are required to show photographic Identification, pass through a metal detector, and sign the EPAvisitor log

. All visitorbegs are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DCbad ge that must be visible at all times in the building and returned upon departure . F00FURTHER81FOF1K71Qli CON'tACt : For technical information contact : Thomas Tillman, Pollution Prevention Division Mail Code (7409M), Office Pollution Prevention andToxics, Environmental Protection Agency, 1200 Pennsylvania Ave

., NW ., Washington, DC 20480-0001 ; telephone number: (202) 564-8283; e-mail address: tillman.thamaa@~-pa .gov . Forgeneralinforrnatfan contact: The Pollution Prevention Information Clearinghouse (7409M, 1200 Pennsyl vania Ave

., NW ., Washington, DC 20460-0001 ; telephone number : (202) 568-0799; e-mail address: PPIG'oepa.gov. SU'lLt0NUITi1N INPOIIIIAT10q: 1 . Gas" lahwantion A. Does this action apply to me? You may be potentially affected by this action ifyou manufacture, distribute, label, certify, verify, and purchase or use consumer, commercial, or industrial products that may be considered as "greea " "sustainable," or "environmentally preferable:" Potentially affected entities may include, but are not limited to ; * Manufacturing (NAICS codes 31- 33) . " Construction (NAICS code 23) . " Wholesale trade (NAICS code 42) . " Retail trade (NAICS codes 44-45) . " Professional, scientific and technical services (NAICS code 54) . " Accommodations and food services (NAICS code 72) . " Other services, except public administration (NAICS code 81) . " Public administration (NAICS code 92) . This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The NorthAmerican Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular enti ty, consult the technical person listed under MN 10111"19A 111f+01lA1ATIt111 c01iRACr. H . What should Iconsfderas Iprepare my commentsfi)r EPA? i . Subntftting CBE Do not submit this information to IiPA through regulations,gov or e-mail . Clearly mark the part or alt of the information that you claimto be CBI . For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM

as CBI and then identify electronically within the disk or CD-RUM

thespecific inforluation tisat is claimed as C81. In addition to one complete version of the comment that includes information claimed as CBI . a copy ofthe comment that does not contain the information claimed asCBI must be submitted for inclusion in the public docket. U&rmation so marked will notbe disclosed except in accords" with procedures set forth in 44 CFRpart 2

. 2 . Tipsforpreparingyour cornmenta. When submitting comments, remember to: t. Identify the document by docket ID number and other identi information (subject heading,- Faderd Regiow date and page number) . ii . Followdirections. The Agency may ask you to respond to specific questions or organize comments by referencing a Code ofFederal Regulations (CFR) part or section number . Iii . Explain whyyou agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assunp tuons aad provide any technical information and/ or data that you used. v, If you estimate potential casts or burdens, explain how

y ou arrived at your estimate in sufficient detail to allow for it to he reproduced. vi . Provide specific exam ples to illustrate your concerns and suggest alternatives. vii . Explainyour views as clearly as possible, avoiding the use of profanity or personal threats. viii . Make sure to submit your comments by the comment period deadline identified. H . Background A . What action is the Agency taking? EPAis interested in soliciting individual stakeholder input regarding theAgency's role in the "green" or sustainable products movement . The Agency will consider the information gathered from

this notice and other sources as it works to define its role and develop a strategy that identifies how 

### 38529 EPAcan make a meaningful contribution to the development, manufacture, designation, and use of sustainable products. More specifically, EPA would appreciate your individual views regarding the following types of questions: 1 . What do you see as the major policy and research challenges, opportunities, and trends impacting the development, manufacture, designation, and use ofsustainable products? 2 . What do you see as EPA's overall role in addressing these challenges and opportunities? 3 . In particular, how

do you see EPA's role in: * Assembling information and databases. and setting product sustaun'~abili~ty s~» priorities. " Evaluating the multiple impacts of products across their entire life cycle. " Defining criteria for more sustainable products. " Generating eco-labels and/or standards

. " Establishing the scientific foundation for these eco-labels and/or standards

. ~~ Verifying that products meet " Stimulating the market. + Developing end-of-life management systems (reuse, recycling, etc.). " Measuring results, evaluating programs. B . What is theAgency's authorityfor taking this action? Section 13103(b) of the Pollution Prevention Act of 1990requires the Administrator of EPAto facilitate the adoption of source reduction techniques by businesses and to identify opportunities to use Federal procurement to encourage source reduction. List ofSubjects Environmental protection, environmentally preferable products, green products, procurement, sustainable products. Dated: September 10, 2010 . Wendy Cleland-Hamnett, Director, Office ofPollution Prevention and Toxics. [FR Doo. 2010-23123 Filed 9-15-10; 8:45 am] BILLINO CODE l660-60-P