Review of EPA's Draft IRIS Assessment of Formaldehyde

Closed

December 13 - 14, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Jonathan Samet (chair), Andrew Olshan, John Bailer, Sandra Baird, Richard Corley, Harvey Checkoway, David Dorman, Charles Hobbs, Michael Laiosa, Ivan Rusyn, Mary Alice Smith, Leslie Stayner, Helen Suh, Yiliang Zhu, and Patrick Zweidler-McKay.

The following topics were discussed in the closed sessions:

1) Draft report and report organization.
2) Committee conclusions and recommendations.
3) Committee assignments and report review schedule.

The following materials (written documents) were made available to the committee in the closed sessions:

55. Swenberg, J. 2010. New materials for consideration in the NRC Review of EPA’s draft IRIS assessment of formaldehyde. Letter dated December 3, 2010, including the following attachments: (a) Lu, K., B. Moeller, M. Doyle-Eisele, J. McDonald, and J.A. Swenberg. Molecular dosimetry of N2-hydroxymethyl-dG DNA adducts in rats exposed to formaldehyde. Submitted to Chemical Research in Toxicology on December 1, 2010 and in press; (b) Moeller, B.C., K. Lu, M. Doyle-Eisele, J. McDonald, A. Gigliotti, and J.A. Swenberg. Determination of N2-hydroxymethyl-dG adducts in nasal epithelium of bone marrow of non-human primates following 13CD2-formaldehyde inhalation exposure. Submitted to Chemical Research in Toxicology and under review; (c) Swenberg, J.A., K. Lu, B.C. Moeller, L. Gao, P.B. Upton, J. Nakamura, and T.B. Starr. Endogenous versus exogenous DNA adducts: their role in carcinogenesis, epidemiology and risk assessment. Submitted to Toxicological Sciences on December 1, 2010 and in press.

Date of posting of Closed Session Summary:

December 20, 2010

Contact

Panola Golson

202.334.1669
pgolson@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Review of EPA's Draft IRIS Assessment of Formaldehyde

October 12 - 13, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Jonathan Samet (chair), Andrew Olshan, John Bailer, Sandra Baird, Richard Corley, Harvey Checkoway, David Dorman, Charles Hobbs, Michael Laiosa, Ivan Rusyn, Mary Alice Smith, Leslie Stayner, Helen Suh, Yiliang Zhu, and Patrick Zweidler-McKay.

The following topics were discussed in the closed sessions:

1) Draft report materials and organization of report.
2) Committee conclusions and recommendations.
3) Committee assignments, agenda for future meeting, and report review schedule.

The following materials (written documents) were made available to the committee in the closed sessions:

44. Andersen et al. 2010. Formaldehyde: Integrating dosimetry, cytotoxicity and genomics to understand dose-dependent transitions for an endogenous compound. Toxicological Sciences (in publication). Email received September 4, 2010.

45. ENVIRON. 2010. Comments on the United States Environmental Protection Agency’s Draft Review Entitled, “IRIS Toxicological Review of Formaldehyde-Inhalation Assessment.” August 31, 2010.

46. Schwilk et al. 2010. Formaldehyde and leukemia: An updated meta-analysis and evaluation of bias. Journal of Occupational and Environmental Medicine (in publication). Email received September 8, 2010.

47. Letter from Lorraine F. Meisner, Ph.D., Cell Line Genetics. Letter dated September 24, 2010.

48. Mundt et al. 2010. Summary of Key Concerns Regarding the Epidemiological Studies Reported in the IRIS Draft Formaldehyde Document. Letter from public speakers at the August 9, 2010, meeting of the NRC Formaldehyde Committee. Letter dated September 27, 2010.

49. Letter from the American Chemistry Council, including attachments below. Letter dated September 30, 2010.
a. Nielsen and Wolkoff. 2010. Cancer effects of formaldehyde: A proposal for an indoor air guideline value. Archives of Toxicology 84: 423-446.
b. Wolkoff and Nielsen. 2010. Review: Non-cancer effects of formaldehyde and relevance for setting an indoor air guideline. Environmental International 36: 788-799.

50. Letter from the American Chemistry Council, including attachment below. Letter dated October 1, 2010.
a. A Synopsis of Federal and State Agencies’ Scientific Concerns with the Draft EPA IRIS Formaldehyde Inhalation Assessment

51. Letter from Environ re: Lack of Evidence of Biological Plausibility for a Causal Association Between Exposure to Formaldehyde and the Incidence of Mortality from Myeloid Leukemia. Letter dated October 4, 2010.

52. Letter from Environ re: Summary of Critical Concerns Regarding Reliance on Zhang et al, Cancer, Epidemiology, Biomarkers & Prevention, Vol. 19(1), pp 80-88 (2010) as reported in the Draft IRIS Formaldehyde Assessment. Letter dated October 4, 2010.
a. Supporting references were received on a CD.

53. Email from John Whalen, EPA, including attachments below. Email received September 21, 2010.
a. Schripp et al. 2010. Interferences in the determination of formaldehyde via PTR-MS: What do we learn from m/z 31? International Journal of Mass Spectrometry 289: 170-172.
b. Riess et al. 2010. Experimental setup and analytical methods for the non-invasive determination of volatile organic compounds, formaldehyde and NOx in exhaled human breath. Analytica Chimica Acta 669: 53-62.

54. Letter from the American Forest & Paper Association, American Home Furnishings Alliance, American Institute of Timber Construction, American Wood Council, APA – The Engineered Wood Association, Composite Panel Association, Hardwood Plywood and veneer Association, Kitchen Cabinet Manufacturers Association, Northeastern Retail Lumber Association, and Virginia Forest Products Association. Letter dated October 15, 2010.

Date of posting of Closed Session Summary:

October 22, 2010

Contact

Panola Golson

202.334.1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Review of EPA's Draft IRIS Assessment of Formaldehyde

August 9 - 10, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Jonathan Samet (chair), Andrew Olshan, John Bailer, Sandra Baird, Harvey Checkoway, David Dorman, Charles Hobbs, Michael Laiosa, Ivan Rusyn, Mary Alice Smith, Leslie Stayner, Helen Suh, and Patrick Zweidler-McKay.

The following topics were discussed in the closed sessions:

1) Key studies highlighted in EPA’s draft IRIS assessment of formaldehyde.
2) Information presented during the public session.
3) Outline of the committee’s report and committee assignments.
4) Schedule and agendas for future meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

12. Batelle Columbus Laboratories. 1981. A chronic inhalation toxicity study in rats and mice exposed to formaldehyde.

13. CIIT. 1982. A chronic inhalation toxicity study in rats and mice exposed to formaldehyde.

14. CIIT. 1999. Hazard characterization and dose-response assessment for carcinogenicity by the route of inhalation: revised edition.

15. Kitaeva et al. 1996. Genotoxic effect of formaldehyde in somatic human cells in vivo. Genetika 32(9):1287-1290. Translation.

16. Kitaeva et al. 1990. Cytopathic and cytogenic effects of chronic inhalation of formaldehyde on the female rat’s germ and marrow cells.

17. Kitaev et al. 1984.Embryonic development and some indices of reproductive function in rats after inhalation exposure to formaldehyde before impregnation. Akush. Ginekol. (Mosk.) 10: 49-52. Original.

18. Kitaev et al. 1984.Embryonic development and some indices of reproductive function in rats after inhalation exposure to formaldehyde before impregnation. Akush. Ginekol. (Mosk.) 10:49-52. Translation.

19. Senichenkova. 1991. Embryotoxic effect of pollutants in the industrial environment: Formaldehyde and gasoline. Original.

20. Senichenkova. 1991. Embryotoxic effect of pollutants in the industrial environment: Formaldehyde and gasoline. Translation.

21. Senichenkova and Chebotar. 1996. Effect of gasoline and formaldehyde on prenatal development of rats with induced micronutrient disorder (iron deficiency). Ontogenez 27(2): 108-113. Original.

22. Senichenkova and Chebotar. 1996. Effect of gasoline and formaldehyde on prenatal development of rats with induced micronutrient disorder (iron deficiency). Ontogenez 27(2): 108-113. Translation.

23. Sheveleva. 1971. Study of the specific effect of formaldehyde on the embryogenesis and progeny of white rats. Toksikologiya novykh promyshlennykh khimicheskikh veshchestv 12: 78-86. Translation.

24. Xing et al. 2007. Toxic effect of formaldehyde on reproduction and heredity in male mice. Journal of Jilin University (Medicine Edition) 33(4):716-718.

25. Zhou et al. 2006. The protective effect of vitamin E against oxidative damage caused by formaldehyde in the testes of adult rats. Asian J Androl 8(5): 584–588.

26. Shipp, Annette. 2010. Letter submitted on behalf of Hexion Specialty Chemicals, Inc., containing “Comments to the NAS Panel Evaluating the USEPA IRIS Technical Support Document for Formaldehyde: Initial Meeting, June 7, 2010. Letter dated July 21, 2010.

27. Shipp, Annette. 2010. Letter submitted on behalf of Hexion Specialty Chemicals, Inc., containing various letters and comments related to the NTP expert panel evaluation of the listing status for formaldehyde in the 12th Report on Carcinogens. Letter dated July 21, 2010.

28. Shipp, Annette. 2010. Letter submitted on behalf of Hexion Specialty Chemicals, Inc., containing copies of PowerPoint presentations by James A. Swenberg entitled “Distribution and Molecular Dose of Inhalation-Derived and Endogenous Formaldehyde DNA Adducts Support the Induction of Nasal Carcinoma, but not Leukemia; by Philip Cole entitled “Formaldehyde and Lymphohematopoietic Cancers: A Review of Two Recent Studies; by Kenneth A. Mundt entitled “Occupational Formaldehyde Exposure and Leukemia Risks; and by Annette M. Shipp entitled “Formaldehyde-Induced LHP: Is There Sufficient Evidence to Conclude a Causal Association?” Letter dated July 29, 2010.

29. Shipp, Annette. 2010. Letter submitted on behalf of Hexion Specialty Chemicals, Inc., containing written version of comments made by Jack Mandel to the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010, in Washington, DC. Letter received August 5, 2010.

30. Mason, Ann. 2010. Letter dated August 5, 2010, submitted on behalf of the American Chemistry Council’s Formaldehyde Panel. Attachment: Comments to the National Research Council Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde: Key Issues Related to Charge Questions.

31. Mason, Ann. 2010. Letter dated August 5, 2010, submitted on behalf of the American Chemistry Council’s Formaldehyde Panel, containing summaries of findings from selected publications.

32. Lu et al. 2010. Distribution of DNA adducts caused by inhaled formaldehyde is consistent with induction of nasal carcinoma but not leukemia. Toxicological Sciences, http://toxsci.oxfordjournals.org.

33. Lehman-McKeeman. 2010. Paracelsus and formaldehyde 2010: The dose to the target organ make the poison. Toxicological Sciences 116(2): 361-363.

34. Speit et al. 2010. Occupational exposure to formaldehyde, hematotoxicity and leukemia-specific chromosome changes in cultured myeloid progenitor cells – letter. Cancer Epidemiol. Biomarkers Prev. 19(7): 1882-1884.

35. Zhang et al. 2010. Occupational exposure to formaldehyde, hematotoxicity and leukemia-specific chromosome changes in cultured myeloid progenitor cells – response. Cancer Epidemiol. Biomarkers Prev. 19(7): 1884.

36. Dhareshwar and Stella. 2007. Your prodrug releases formaldehyde: Should you be concerned? No! Journal of Pharmaceutical Sciences DOI 10.1002/jps.21319.

37. Riess et al. 2010. Experimental setup and analytical methods for the non-invasive determination of volatile organic compounds, formaldehyde and NOx in exhaled human breath. Analytica Chimica Acta 669: 53-62.

38. EPA. 2010. EPA Formaldehyde Assessment: Derivation of Reference Concentration. Presentation to the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on August 9, 2010 in Washington, DC.

39. Golden, R. 2010. Some Critical Issues Pertaining to EPA’s Draft IRIS Assessment of Formaldehyde. Slides used during the public comment period of the meeting of the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on August 9, 2010 in Washington, DC.

40. Thirman, M. 2010. Slides used during the public comment period of the meeting of the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on August 9, 2010 in Washington, DC.

41. Cole, P. 2010. Slides used during the public comment period of the meeting of the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on August 9, 2010 in Washington, DC.

42. Marsh, G. 2010. Comments to NAS Committee Reviewing EPA IRIS Draft Toxicological Review of Formaldehyde. Slides used during the public comment period of the meeting of the NRC Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on August 9, 2010 in Washington, DC.

43. Carraro et al. 1997. Immune response prevalence to formaldehyde-human serum albumin molecular adduct in a healthy population. Journal of Environmental Pathology. Toxicology and Oncology 16(2&3): 215-218.

Date of posting of Closed Session Summary:

August 16, 2010

Contact

Nola Golson

202.334.1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Review of EPA's Draft IRIS Assessment of Formaldehyde - Teleconference

July 6, 2010

12:00 AM - 12:00 AM (ET)

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Jonathan Samet (chair), John Bailer, Sandra Baird, Richard Corley, Harvey Checkoway, Charles Hobbs, Michael Laiosa, Ivan Rusyn, Mary Alice Smith, Leslie Stayner, Helen Suh, and Patrick Zweidler-McKay

The following topics were discussed in the closed sessions:

1) The EPA draft IRIS assessment for formaldehyde.
2) The agenda for the August committee meeting.
3) Action items and committee assignments.

The following materials (written documents) were made available to the committee in the closed sessions:

8. EPA. 2010. List of references that were cited in presentation to the committee during its first meeting on June 7th in Washington, DC.

9. EPA. 2010. List of references pertaining to formaldehyde in exhaled breath.

10. Ward, E.M., et al. 2010. Research recommendations for selected IARC-classified agents. Environmental Health Perspectives. Available at http://dx.doi.org/.

11. EPA. 2010. Response to the committee’s question about the criteria EPA used for evaluation of noncancer effects in the formaldehyde assessment. Attachment: Excerpt from EPA 2002.

Date of posting of Closed Session Summary:

July 07, 2010

Contact

Panola Golson

202/334-1669
pgolson@nas.edu

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Closed

Review of EPA's Draft IRIS Assessment of Formaldehyde

June 7 - 8, 2010

Past

Additional Information

Is it a Closed Session event?

Institution Closed

The following committee members were present at the closed sessions of the event

Jonathan Samet (chair), Andrew Olshan, John Bailer, Sandra Baird, Richard Corley, Harvey Checkoway (via teleconference), David Dorman, Charles Hobbs, Michael Laiosa, Ivan Rusyn, Mary Alice Smith, Leslie Stayner, Helen Suh (via teleconference), Yiliang Zhu, and Patrick Zweidler-McKay.

The following topics were discussed in the closed sessions:

1) Standard NRC discussion of policies, procedures, potential bias, and conflict of interest.
2) Committee’s statement of task and its approach to its task.
3) Information presented in public session and the draft IRIS assessment of formaldehyde.
4) Schedule and agendas for future meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

1. Preuss, P. 2010. Formaldehyde Draft Iris Assessment. Presentation to the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

2. Fowler, B.A. 2010. ATSDR’s Perspective on Formaldehyde Review. Presentation to the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

3. Rhomberg, L. 2010. Formaldehyde Weight of Evidence. Slides used during the public comment period of the meeting of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

4. Andersen, M. 2010. Formaldehyde: Biochemistry and Dosimetry in the Nasal Epithelium and throughout the Body. Slides used during the public comment period of the meeting of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

5. Collins, J.J. 2010. Formaldehyde Epidemiology. Slides used during the public comment period of the meeting of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

6. Golden, R. 2010. Formaldehyde and Leukemia: Emerging and New Data. Slides used during the public comment period of the meeting of the Committee to Review EPA’s Draft IRIS Assessment of Formaldehyde on June 7, 2010 in Washington, DC.

7. Toloczko, S. 2010. E-mail from Steven Toloczko on formaldehyde exposure and acute myeloid leukemia. Received June 3, 2010.

Date of posting of Closed Session Summary:

June 18, 2010

Contact

Nola Golson

202.334.1669
pgolson@nas.edu

Location

Keck Center

500 5th St NW

Washington DC 20001, USA

Disclaimer

It is essential to the National Academies mission of providing evidence-based advice that participants in any of our meetings or events avoid political or partisan statements or commentary and maintain a culture of mutual respect. The statements and presentations during our meetings or events are solely those of the individual participants and do not necessarily represent the views of other participants or the National Academy of Sciences, which is a non-partisan, tax exempt organization that includes under its Charter the National Academy of Engineering and National Academy of Medicine, and that operates the National Research Council.

Log In

Sign in to access your saved publications, downloads, and email preferences.

Former MyNAP users: You'll need to reset your password on your first login to MyAcademies. Click "Forgot password" below to receive a reset link via email. Having trouble? Visit our FAQ page to contact support.

Members of the National Academy of Sciences, National Academy of Engineering, or National Academy of Medicine should log in through their respective Academy portals.

Email (required)
Password (required)

Don't have an account?

Register

Email (required)
New password (required)
Retype password (required) Password must be at least 8 characters
I accept the terms of use
terms of use

Thank You

Thank you for creating a MyAcademies account!

Enjoy free access to thousands of National Academies' publications, a 10% discount off every purchase, and build your personal library.

Forgot Password

Enter the email address for your MyAcademies (formerly MyNAP) account to receive password reset instructions.

Reset Requested

We sent password reset instructions to your email . Follow the link in that email to create a new password. Didn't receive it? Check your spam folder or contact us for assistance.

Reset Password

New password (required)
Retype password (required) Password must be at least 8 characters

Reset Password

Your password has been reset.

Log In

Verify email

Verify Your Email Address

We sent a verification link to your email. Please check your inbox (and spam folder) and follow the link to verify your email address. If you did not receive the email, you can request a new verification link below

Subscribe

First Name
Last Name
Email (required)
I agree to receive emails from the National Academies (required)

We respect your privacy and will never share your information.

My Academies

Review of EPA's Draft IRIS Assessment of Formaldehyde

Dropdown items