Document xz45mYG4gmMBMGvaVk8x53M0m

A M S l6 - i 0 9 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY (J WASHINGTON, D.C. 20460 I f f UL 2 - 2002 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Mr. J.D. Dunne The 8N Corporation 223 Carthage Street, Suite 2 Sanford, NC 27330 Dear Mr. Dunne: On June 10, 2002, the Office of the Surgeon General referred to the Adm inistrate o f the U.S. Environmental Protection Agency (EPA) your letter of January 8, 2002 to Surgeon General Dr. David Satcher, concerning the medical monitoring of fire fighters for effects from exposure to perfluorooctyl sulfonates (PFOS) in fire fighting foam. The EPA Administrator has requested that I respond on her behalf. Direct occupational health monitoring is not generally a function of the Office of the Surgeon General, and the Office has not implemented a medical monitoring program for fire fighters. EPA is not aware at this time o f any federal medical monitoring programs for fire fighting exposures to PFOS. Were any such programs to be instituted at the federal level, the agencies most likely to be involved would be the Department of Defense, the National Institutes for Occupational Safety and Health, or the Centers For Disease Control and Prevention. To EPA's knowledge, 3M was the only producer of PFOS-based aqueous film forming foam (AFFF), and 3M has ceased the production and sale of its PFOS-based AFFF products. Other companies produce AFFF products utilizing other fluorinated compounds similar to PFOS, including fluorinated telomer products, and EPA is continuing its investigation of these fluorinated chemistries to determine whether they may pose issues similar to those raised by PFOS. EPA's investigation is on the base chemistry rather than on fire foam products, however, because these chemicals are employed in a wide variety of products and uses. If EPA were to obtain any health monitoring information on fire fighter exposures to PFOS or to telomer-based AFFF, it would include that information in the Administrative Record for the fluorinated compounds, AR-226: PFOS, PFOA, Telomers, and Related Chemicals. We must note that some of the information in your letter to Dr. Satcher was not correct. Although there have been deaths following exposure to PFOS in rat reproductive and monkey systemic toxicity studies, the effects you reported - including pancreatic cancer and brain tumors - were not among the effects noted in those studies. In mortality studies on manufacturing and processing workers exposed to PFOS, who have the highest blood levels that have been reported CO NTAIN NO CBS Internet Address (URL) http://www.epa.gov Recycled/Recyclable Printed with Vegetable Oil Based Inks on Recycled Paper (Minimum 50% Postconsumer content) I 2 in humans, a statistically significant risk of death from bladder cancer was reported in male employees who worked at the plant in high exposure jobs for more than 20 years. In addition, changes in thyroid levels have been reported in some workers with high PFOS exposure. However, there are several limitations to these studies, such as the small number of participants, which make interpretation of these data difficult. Additional studies are underway, and the results of those studies will be made available in AR-226 as they are submitted to the Agency. At the public meeting in March 2001, in response to a question from Joseph Wright of ARFF Technical Services, I noted that having data on firefighter blood levels would be useful as an indicator of exposure if they were available, but that the Agency did not have an answer to the question of what might be the long term effects of exposure on fire fighters. The Agency's investigation of fluorinated compounds, including other perfluoroalkyl sulfonates, perfluorooctanoic acid and its salts, and the fluorinated telomers, will continue, and additional regulatory actions or voluntary programs may be instituted, as appropriate. This could include referral to the appropriate agency or agencies of any recommendations for monitoring or risk management activities deemed necessary to protect human health and the environment. I note that you have already subscribed to our email notification service for information on Agency actions with respect to these chemicals, so you will continue to receive EPA assessment documents and notices of EPA action as this investigation continues. If you have any questions concerning this matter, please feel free to contact Mary Dominiak of my staff by telephone at 202-564-8104 or by email at dominiak.marv@epa. gov. Sincerely, Charles M. Auer, Director Chemical Control Division cc: Dr. Kenneth Moritsugu, Acting Surgeon General Office of the Surgeon General 5600 Fishers Lane Room 18-66 Rockville, MD 20857 EPA Administrative Record File AR-226 .2 RECEIVED S EPA OFFICE OF THE EXECUTIVE SECRETARIAT CONTROL SLIP CONTROL NO: FILE CODE: STATUS: FROM: ORG: SALUTATION: CONSTITUENT: AX-0205971 PRIG. DUE DATE: 07/05/2002 roo PO CORR 127 PENDING DUNNE J D GENERAL CORR-PRIVATE CORRES. DATE: ORGANIZATIONS 01/07/2002 (PO) cci--_r RECEIVED DATE: 06/10/2002 CD ASSIGNED DATE: 06/20/2002 CLOSED DATE: T} ro 8N CORPORATION THE DEAR MR. DUNNE MR. J D DUNNE CO o~o -a o TO: TO ORG: SUBJECT: SATCHER DAVID PUBLIC HEALTH AND SCIENCE MONITORING EFFECTS OF PFOS ON FIRE FIGHTERS ASSIGNED: OFFICE OF PREVENTION, PESTICIDES & TOXIC SUBSTANCES COPIES OF INCOMING PROVIDED TO: AO-CAROLINE PETTI {/ /' V4 L i t C,-' SIGNATURE: DIRECT REPLY // . INSTs: DIRECT REPLY. SEND COPY OF REPLY TO OEX. COMMENTS: IMS: IMT: PLW BETTY WATKINS/DC/USEPA/US Assigned Lead O PPTS Date Assigned 0 6 /2 0 /2 0 0 2 C o d e /S ta tu s ACTION Date C o m p leted by Assignee - Date Returned to OEX: - AX Correspondence Control No: AX-0205971 Office of the Surgeon G enerai O ffice of P ublic H ealth a n d Science SG T r a c k i n g //: __ R e f e e r a t ,D a t e : To: SG DSG COS ASH Bennett T hompson SCHOENFEIT) B. L e e A. Noonan J. Savers B. Dorr C. Jones D. I.ITTS M oscicki P-DASH DASH DASH- 0 DAS-OMH DAS-DPHP DAS-OWH DAS-OPA DCP L. BEAUCH K, HAYES D ue D ate: RHAs OHIV-AP ORI PCPFS OEP OGHA OGC OML&VA OHRP NVPO ES: U u J. EAST Smith Persun iTthcr: Action instructions: SG Signature DSG Signature COS Signature ASH Signature Direct Reply Signature Review/ Clearance Necessary Action For Your Information Special: OPUS- M7S OSG Phone: (301) 113-1000 Routed Hy: F t 'if; c ; O ICO I U l' UO' U L io n x - FRON : < V. V UV PHONE NO. : 919 7?4 I0a7 g* jfiMo 2 V4 t Jan. 08 2002 12:40PN PI # / * / ? S T oJ M - 7 January 2002 Mr. David Satcher US Surgeon General Department o f Health and Human Services Fax: 202-690-6960 Subject: EPA recommended medical monitoring o f fire fighters for effect o f PFOS exposure. Dear Mr. Satcher: A public m eeting regarding the EPA proposed SNUR for PFOS compounds was held on March 27, 2001 in Crystal City (Arlington), VA. (Ene. 1) In response to a question, Mr. Charles M. Auer, Director, Chemical Controls Division, USEPA, recommended that the ARFF Industry (Aircraft Rescue Fire Fighting) immediately start medical monitoring o f fire fighters for effects o f PFOS exposure. This w ould establish a base line reference for the long tenn effect o f exposure to AFFF (a PFOS compound) and primary fire fighting agent within DOD and the industry. He did not recommend what functions to monitor, but directed us to the EPA web site for that guidance. Has the Surgeon General's office made any effort to implement such a m edical monitoring program? I would greatly appreciate any information on the matter you can supply. I don't find much impetus for such a program within the industry. I plan to use any response to educate the industry and for public benefit regarding these very serious occupational health issues. There is a need to provide proper protection, for fire fighters and other personnel at the incident site. It may also be time to consider alternative safer, COMMERCIAL-OFF-THE-SHELF (COTS) solutions for these AFFF applications. Please note the following: 1. In May, 2000 both the EPA and 3M Corporation issued a N ew s R elease (Enc. 2 & 3) about Environmental, Safety and Health risk from these persistent (PFOS) compounds. The 3M Corp. also announced it would cease production o f its AFFF fire fighting agent (a PFOS compound) by the end o f 2000. This is significant because the 3M Corp. is the major supplier to the US Government and Industry. It represented a significant, profitable business market, yet it was considered in the public's interest, also "it's in the best interest o f ail our constituencies, our employees, customers, communities and investors" to reallocate corporate resources. 2. A check o f the EPA web site provides several laboratory animal exposure tests with 100% fatality rates. The dead animals showed figos o f pancreatic cancer, liver cancer, and brain tumors. These appear to he obvious functions for m edical monitoring, but are not the only areas o f concern gleamed from the published reports to dare. (Enc. 4. pg. 1) 3. In the Semiconductor Industry the PFOS compounds are handled in a controlled atmosphere (clean room) within a closed loop system, separate from the operator, and incinerated on site. Very limited quantities are used in the process, (e.g. 500 gallon per year) FROM : < PHONE NO. : 919 774 1047 J a n . 08 2002 12: 41PM P2 4. By nature an aircraft crash fire is uncontrolled, may require a substantial quantity o f AFFF agent (per ASC (Enc. 5) up to 40,000 gallons o f agent for a large frame aircraft fire alone) and the effluent is discharged to the atmosphere. Even after the fire is out, rescue crews and clean-up crews are exposed and the site is effected for decades. (Note: This is what prompted the question in the March 27, 2001 meeting.) If the issue o f this specific medical monitoring o f fire fighters for occupational health exposure is not the responsibility o f your activity; I would greatly appreciate your direction to the appropriate activity. I w ill follow-up on any lead you provide. Please contact m e i f you need more information to respond to my inquiry and I w ill try to be helpful. I appreciate your consideration o f my request for status information. Very truly yours, J.D. Dunne The 8N Corporation 223 Carthage St., Suite 2 Sanford, NC 27330 Phone: 919-774-1187 Fax: 919-774-1047 2. & U .L' O ' Ui, i l X i A. -* FROM : < 4 VJ V I -* im U PHONE NO, : 919 774 1047 'XLi ' v Jan. 00 2002 12:41PM P3 EAJC - I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON. D-C. 20460 APR 26 2D01 T E E OF PREiemoN, P E sn caxs and TOOKSUBSTANCES Dear M eeting Participant: Enclosed w ith this letter is a copy o f the summary o f the PFOS Proposed SN U R Public Meeting, which took place on March 27,2001 in Crystal City, Virginia. A copy o f the attendee list is also enclosed. These documents have been entered into the docket file for the proposed Significant N ew U se Rule (SNU R ) ort perfluorooctyl sulfonates (PFOS), D ocket OFPTS-50639, and -will form part o f the official record for this rulemaking proceeding. Several attendees at the m eeting expressed w illingness to provide additional information to the docket in the w eeks im m ediately follow ing the meeting. These subm issions w ill also be entered into the docket record. If you w ould like to obtain copies o f comments or other information from D ocket OPPTS-50639, the rulemaking record for th t proposed PFOS SNUR, or from A R -226, the public administrative record for non-rulemaking activity on PFOS, PFOA, the telom ers, and related chemicals, please contact the TSCA Nan-Confidential Information Center by email at QpRtjicic@epf.gov. or by calling 202-260-7099 between noon, and 4:00 PM Eastern tim e, Monday through Friday. If you have any questions concerning these materials, please contact Mary Dominiak. Her telephone number is 202-260-7768, her facsim ile number is 202-260-1096, and her email address is dqpiniak marv@ gna.gov. I would like to thank you again for your participation in this m eeting. W e look forward to continuing to work w ith all o f you on the complex issues presented by PFOS. Sincerely, Enclosures Charles M. Auer, Director Chemical Control Division. RacysM/Ttaqrdabla Mmg4fchSof/Canobiinkenw V* oMWn*fata SOXneyOMita 3 u i ' UO ' Ui 1 U L Jl FRON : < ;\a PHONE NO. : 919 7 7 A 1047 Jan. 00 2002 12:42PN P4 C 5 / 2 2 / 2 0 0 0 1 1 : 1 9 : 2 8 AM P . l Page I of 2 HAIC- 2. n l f M A Urn.itoeed. sSttaatte s % r C l M EnviroriftdfiUi; Froleuliun Agency Headquarters Press Release Waahhtgion, IK' Date P u b lish e d : Title; 05/16/2000 BPA and 3M FOR RELEASE: TUESDAY, M AY 16, 2000 Following negotiations between KPA and 3M. the company today announced that it will voluntarily phase out and find subsliiuies for periluorooetany1 sulfonate (Fl'Q S) chemistry used to produce a range o f products, including, som e o f their Scotchgard lines. 3M data supplied to UFA indicated that these chem icals arc very persistent, in the environment, have a strong tendency to accumulate in human and animal tissues and could potentially pose a risk to human hcallh and the environment over the long term. FTa supports the company's plans to phase out and develop substitutes by year's end for (he produclion o f their involved products. "Today's phaseout announcement by 3M w ill ensure lha.1 future exposure to these chemicals will be elim inated, and public health and the environment will be protected," said UFA Administrator Carol M. Browner. "hPA w ill work w iili h e company on the development o f substitutes to ensure that those chem icals are safe for [he environment. 3M deserves great credil for identifying this problem and coming forward voluntarily." FT'OS chem icals are used to produce a range o f products from fire fighting loam s, coatings for- fabrics, leather, and some paper products, to industrial uses such as mist suppressants in ucid bulks. The company is continuing a major research cllort on these chem icals to enhance the understanding o f any potential risks that may be associated with this class o f chem icals. liF A w ill also be evaluating the chem icals Lo determ ine how individuals and the environment a: exposed and what potential adverse effects may exist, if future regulatory actions arc required, JiPA w ill Lake them. A t present, 3M is the only US manufacturer o f PlOiS. 1FA ill be con toe-ring foreign governments and other' chemical manufacturers, both dom estically and internationally, to seek their support for a voluntary phascouL o f Fl'OS and related chem icals. R-69 mm filc://C:VMy Documctxts\Ab>opa afff.htoi 05/22/2000 t UX ` Ua ''UL l u t , I L - .o r : i . v , u i i . U K j t - k i . o UrVOil FR0M - < PHONE NO. : 919 774 1047 <*.;OMM'k-lwi|^FMirMUtDxWM) F: eiO*.'.Wfl V-t-:fWOJBffl T,JOepUNKE 083 Box'- 3M Phaoitig put so m of n SpcLa)ty Matonaia : wnme*rf " ENC Jan. 00 2002 12:42PM P5 >t i 0(3vmnnatr,Mmi,2aoa attajtau* fil:/;/Cl/ffpdcco/*Trruffnloorochem. 3 Imnwtu uirTwr 1 FOR IM M ED IATE RELEA SE 3M Phasing O u t Som o f its S p aeialty M atarais S T . PAUL, M innesota - May 16, 2 00 0 --3M today announced it ts phasing out of the perfluerooctanyl chemistry used to produce certain repellents'and surfactant products. The affected product tines represent about two percent of 3 M's nearly $ 16 billion In annual sales, These include many Scotchgard products, such as soil, oil and water repellent products; coatings used tor oil and grease resistance on parser packaging; fire-fighting foams; and specialty components tor other products. 3M said It plans to substantially phase out production by the end of the year and will work with customers to accomplish a smooth transition. "Our decision anticipates increasing attention to the appropriate use and management of persistent materials," said Or. Charles Raich, executive vice president. Specialty Material Markets. "White this chemistry has been used effectively for more than 40 years and our products are safe, our decision ro phase out production Is based on our principles of responsible anvironmfental management." "We're reallocating resources to accelerate Innovation in more sustainable opportunities and technologies, This decision is not only in the public interest, it's in the beat interests of ell our constituencies ... our employees, "customers, communities and investors, " Reich said. Sophisticated testing capbtllties - some developed In only the last few years - show that this persistent compound, tote other materials In the environment, can be detected broadly at extremely low levels in the environment and in people. All existing scientific knowledge indicates that the presence of these materials at these very law levels does not pose a human health or environmental risk. 3M expects to meet oonaensus earnings estimates for the rest of 2000. This excludes a one-time charge on the order of 5200 million, that will be taken sometime this year. "Our growth engine are more powerful than ever and we re confident in our ability to oontinue delivering on expectations.'' said L.0. DeSimone, chairman and CEO. "Many of our naw technology platforms directly address the fastest-growing segments of the new economy such as electronic, telecommunications arid fiat-panel displays." `W e expect the positive momentum in our financial performance to continue into 2001 with earnings somewhat above current analyst estimates," DeSimone'said. : 3M is a leading manufacturer of innovative products for industrial, consumer, tranB-portatjon. safety, health cam and other markets, with operations In more than 60 countries worldwide. The company is well known tor its 'Pollution Prevention Pays" environmental initiative, and its emission reduction programs including water-baaed replacement of solvents in manufacturing and replacements for ozone-depleting chlorofluorocarbon* (CFCsl. Pennatd-Leoklag S k k i w * Cm ttaln aadhm e e t jMl n a w mlaaam *)' da a t mfatm to nletarioml fin a n cia l to& am nfian eorafflute fb n re ttA la o kin g fta la m a n tt. T h a st ton m yt-km atog M tta m a n u a m auQ/adt to emmain fla ke a n d atw M M *. A etua i M u m m su tts an d fm n d * m ay d tftm maraftaMy from fu s t ic * ! ra o u t e rftm a a aapaem d em ponsing em a aa ifm y o f factors. includ ing: (1) uraridwAta a o a m m e cenckHorm; (S) fom ign c fw nga ** and flu c tu a tio n , tn th a ta ra m r (3} IS tim in g a m t ae eafta rum o r i h firo d tm o tfa rin g *; (* ) ram rrn>fartale, inem dtog sho rtag e* and tm m a m t In tfta c o w c th a y raw m tta rim fx; and (S i lu g o l f r u o m dlngs. S e o tc ftjfa ra la a v a tfem m k o f 3 M a e m paa y. From: 3M Public Relations 3M Center, Building 2 2 5 -1 S-15 St, Paul, MN 55144-1000 Phone; (651)733 -8 805 E-mail; www.3m.oom i ii 2 OS/17/OOG FROM : <: PHONE NO. : 919 774 1047 Jan. 08 2002 12:43PM PS A J C - H- htfpiVwvrw.epa^crv/fedrgstE/EPA-TOX/200Q/OctDbci/Day-l8/126751 .to n UMHiwimM (`rwoson R ela ted M a te r ia l Other RdatRdJ3Qcura<sate Federal Register ~-"rEaviwmnwa triiP o t ^ ^ t s [Federal Register: October 18, 2000 (Volume 65, Number 202) ] [Proposed RulesJ [Page 62319-62333] >Fraa the Federal Register. Online via GPO Access [wais -access.gpo.gov] [DOCXD:frl8oc00-23] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 0PPTS-50639; FRL-S745-5 RTN 2070-AD43 Perfluorooctyl Sulfonates; Proposed Significant New Use Rule AGENCY: Environmental Protection Agency (ERA) . ACTION: Proposed rule. SUMMARY: ERA is proposing a significant new use rule (SNUR) under section 5(a)(2) of'the Toxic Substances Control Act (TSCA) for the following chemical substances: Perfluorooctanesulfonic acid (PFOSA) and certain of its salts (PFOSS), parfldorooctanesulfonyl fluoride (PFOSFJ, certain higher and lower homologues of PFOSA and PFOSF, and certain other chemical substances, including polymers, that contain PFOSA andi its homologues as substructures.. All of these chemical substances are! referred to collectively in. this proposed rule aa perfluorooctyl ! sulfonates, or BFOS. This proposed rule would require manufacturers and. importers to notify EPA at least 90 days before commencing the ' manufacture or import of these chemical substances for the significant new uses described in this document. ERA believes that this action is ! ; 11/8/2000 & \o v ' 1111 < rAA i.<Ji. i-uu 1-ki.o PHONE NO. : 919 774 1047 Jan. 08 2002 12:44PM Pi m M n FOB FIBE HBTECnOR F B IS B E 1BKES iim m 314 V. m ir r it i lr f w Aim-* Sta I4 Egtin m PL 32542-5717 SUBJECT: R 9 2 , PY93 4 rY94 CoaaarcUT TadmaTogjr qrfaHtstloo (CTE) Mb m tbm cm i i r t FYSZ* FYSB, -ad 54 tXB 14stin g - Ear qurdttaas er eoncorns contact Hr- lob R attle, ASC/tOC, OSH 87Z-4697, o r K r. Paul SBtpbin, ODNEC, a t OHS S33-4S5S. BOB RETTIE FROM : f iiAjprru 8SSOKPL3E Of PHONE NO. : 919 774 1047 Jan. 08 2002 12:45PM P2 s xp L o rp sx o N m m a s x v s s KBSCOE jjTO T O O . FTGEQCHKC 1994 f a j c ~ s fld 2 x. A3C/TOC w ill Ident i f y fear tastjporpo to rapidly rwsupply ASP? vehicles with fir fighting on mcmam at an aircraft fix* or iacddnat. On day largo cano aquippad. fix i t w P-2c, on P-lS, an P-26,1 and/or P-18 dapaadlagT anraiiabxlity, and a weriaJl aeoorraairfc of pparataa. 1th the wehieliks ad ongowior arrailabLa, and tha boot possible ccmditiara the agent on-1 to 16,540 gallona for in itia l attack. he najority of large 6 0 ,0 0 0 gallons of goat far -- in iti al attack capability in only 41* of the to aeefciagni wh tbe ax, x t in obvieoc tha far rapid, rmspply in p a n r a a t to bringing th iacxdast to a satisfactory coturIonian. Additional. vehicles w ill oot satisfy as in inanfficiw nt aanpownr to apaxata tb. (ASC/TOC, l,, Bsn 72-469?, 929K} ? /I/LC/T F tA F T F S T - IT ,0 0 0 F T FAA * D0D AfiALte# T/0/0 / Z y e o , /3 G A/f / F S / F 7 l &.coo F 7 Z* a Kf 3 GAS'/f s /f-? * - cal/f s [-loliS L F A C F Ia/ A S A C T U A L . F t A - ? . 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C A /* A c * 7 y T/=- S / J - T F A 7 7 c r t AS0 1 .0 c y Ur, c. <_ /AS* A F S tG F JZ *< C I Z0O ~ Z , CSS/ASC F l t / S T / A S & 7 * C A T F ^ A S ^ T $ , /so T F - D aD f FAA OA 7/4 0AJ Ac r isA <t , a A 4TAT S U S - C A A F T F * F <s s P r . o o o F r l ] A t * * ? s * r '<~ y yy F AP P. r< & V /< C 0 A A S a ICA 7 /4 9 ^ / / Z A / 7 F rs-A F Y / J x S / A / O s y s 7 , s r S_j ^ a ui' uo u IUL J.4~ju t rv-%. i. i.VJ it FAX TRANSMISSION OFFICE OF THE ASSISTANT SECRETARY FOR HEALTH OFFICE OF PUBLIC HEALTH AND SCIENCE DEPARTMENT OF HEALTH AND HUMAN SERVICES 200 Independence Avenue, S.W., Room 716G Washington, D C. 20201 202-690-7694 Fax: 202-690-6960 IF YOU DO NOT RECEIVE ALL PAGES, PLEASE CALL: 202-690-7694 13