Notice of an Expert Panel Workshop on the State-of-the-Science Approaches for Observational Exposure Measurement Studies, 64951-64952 [E6-18655]

Download as PDF rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 71, No. 214 / Monday, November 6, 2006 / Notices baseline fuel additives, and the prominent nonbaseline oxygenated additives for gasoline. The research is structured into three tiers of requirements for each group. Tier 1 requires an emissions characterization and a literature search for information on the health effects of those emissions. Voluminous Tier 1 data for gasoline and diesel fuel were submitted by API and others in 1997. Tier 1 data have been submitted for biodiesel, water/diesel emulsions, and several atypical additives. Tier 2 requires short-term inhalation exposures of laboratory animals to emissions to screen for adverse health effects. Tier 2 data have been submitted for baseline diesel, biodiesel, and water/diesel emulsions. Alternative Tier 2 testing can be required in lieu of standard Tier 2 testing if EPA concludes that such testing would be more appropriate. The EPA reached that conclusion with respect to gasoline and gasolineoxygenate blends, and alternative requirements were established for the API consortium for baseline gasoline and six gasoline-oxygenate blends. Alternative Tier 2 requirements have also been established for the manganese additive MMT manufactured by the Afton Chemical Corporation (formerly the Ethyl Corporation). Tier 3 provides for follow-up research, at EPA’s discretion, when remaining uncertainties as to the significance of observed health effects, welfare effects, and/or emissions exposures from a fuel or fuel/additive mixture interfere with EPA’s ability to make reasonable estimates of the potential risks posed by emissions from a fuel or additive. To date, EPA has not imposed any Tier 3 requirements. Under Section 211 of the Clean Air Act, (1) submission of the health-effects information is necessary for a manufacturer to obtain registration of a motor-vehicle gasoline, diesel fuel, or fuel additive, and thus be allowed to introduce that product into commerce, and (2) the information shall not be considered confidential. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 7,538 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing VerDate Aug<31>2005 17:31 Nov 03, 2006 Jkt 211001 and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/Affected Entities: Manufacturers of Fuels and Fuel Additives. Estimated Number of Respondents: 4. Frequency of Response: On Occasion. Estimated Total Annual Hour Burden: 30,150. Estimated Total Annual Cost: $3.2 million, includes $757,000 annualized capital and O&M costs. Changes in the Estimates: There is a decrease of 30,550 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is the result of reduced activity as the two alternative Tier 2 testing programs near completion. Dated: October 30, 2006. Oscar Morales, Director, Collection Strategies Division. [FR Doc. E6–18658 Filed 11–3–06; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–8240–4] Notice of an Expert Panel Workshop on the State-of-the-Science Approaches for Observational Exposure Measurement Studies Environmental Protection Agency (EPA). ACTION: Notice of meeting. AGENCY: SUMMARY: The Environmental Protection Agency (EPA) is announcing that Eastern Research Group, Inc. (ERG), an EPA contractor, will convene a panel of experts and organize and conduct a meeting to gather information on the most up-to-date methods, approaches, and ethical standards for designing and implementing observational exposure measurement studies. EPA expects to use the information from the workshop in the preparation of a document on the state-of-the-science approaches for observational exposure measurement studies. The meeting will include sessions for discussion by the panel and time will be set aside for public comment. The meeting is open to the public to attend as observers. Observers who wish to make oral comments during the comment periods PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 64951 may sign up on the Eastern Research Group, Inc.’s online registration page. Time slots for comments will be limited to 5-minutes and observers will be scheduled to speak in the order in which they register. The public may also use a separate process to send written comments regarding the planned document electronically to the project Web site at http://www.epa.gov/ nerl/sots/ or by e-mail to the EPA technical contact at Fortmann.roy@epa.gov. The charge to the panel and background materials are available primarily via the Internet on the National Exposure Research Laboratory’s (NERL’s) home page under the Featured Links at http:// www.epa.gov/nerl/sots/. DATES: The workshop will begin on November 28, 2006, at 8:30 a.m. and end at 4 p.m. on November 29, 2006 (Eastern Time). The oral public comment sessions will begin on November 28, 2006, at approximately 10 a.m. and on November 29, 2006 at approximately 1 p.m. ADDRESSES: The workshop will be held at the Hilton Durham at 3800 Hillsborough Rd., Durham, NC 27705. The EPA contractor, Eastern Research Group, Inc., is organizing, convening, and conducting the workshop. Members of the public may attend the workshop as observers. To attend the workshop, register by November 21, 2006, by accessing the online registration page at https://www2.ergweb.com/projects/ conferences/exposure/registerexposure.htm, via telephone by calling Eastern Research Group, Inc. at 781– 674–7374, or sending an e-mail to meetings@erg.com (subject line: Observational Studies). Registration will also be available at the site of the meeting, as space allows. There will be time set aside each day to present brief (no longer than five minutes) oral comments from the public. Please let Eastern Research Group, Inc. know if you wish to make comments during the observer comment period. Space is limited, and registrations will be accepted on a first-come, first-served basis. Observers may also submit written comments regarding the planned document electronically to the project Web site at http://www.epa.gov/ nerl/sots/ or by e-mail to the EPA technical contact at Fortmann.roy@epa.gov. FOR FURTHER INFORMATION CONTACT: Questions regarding registration and logistics for the workshop should be directed to Eastern Research Group, Inc., 110 Hartwell Avenue, Lexington, MA 02421–3136; telephone: 781–674– 7374; facsimile: 781–674–2906; e-mail E:\FR\FM\06NON1.SGM 06NON1 64952 Federal Register / Vol. 71, No. 214 / Monday, November 6, 2006 / Notices meetings@erg.com, subject line: Observational Studies. If you need technical information about the planned document, please contact Roy Fortmann, National Exposure Research Laboratory (NERL); telephone: 919–541– 1021; facsimile: 919–541–0905; e-mail Fortmann.roy@epa.gov. SUPPLEMENTARY INFORMATION: rwilkins on PROD1PC63 with NOTICES Information About the Workshop and Planned Document Observational exposure measurement studies are performed by researchers both within and outside of EPA to measure people’s contact with chemicals in their everyday environments during their normal daily activities. These studies involve measurements of chemicals in environmental media (e.g., air, water, food, soil, and dust); collection of information about the voluntary study participants, their homes, their work environments, and their activities; and analysis of voluntary human samples such as blood or urine to determine the amounts of contact. These observational studies do not involve any additional contact with the chemicals being studied by the people who volunteer to participate in the studies. EPA’s observational studies generally collect information that is critical to meeting the goal of improving public health. In these studies, EPA identifies the chemicals that people are coming in contact with; the concentrations of those chemicals; the most important sources of chemicals in people’s lives; and when, where, how often, and why people come into contact with chemicals in the environment. The information collected in observational studies can be used to better understand potential risks and health effects from chemicals in the environment and to develop risk mitigation strategies and methods. EPA strives to follow the most up-todate approaches in designing and performing observational studies. These approaches are developed by experts in both academia and various Federal agencies. The approaches evolve over time to meet changing and more stringent ethical standards and study requirements. EPA wants to ensure that the observational studies conducted by the Agency for measuring people’s contact with environmental chemicals continue to be based on the most up-todate sound science and the highest ethical standards. Therefore, there is a need to evaluate the latest approaches and ensure that EPA is using the stateof-the-science approaches. In this project, EPA intends to review and VerDate Aug<31>2005 17:31 Nov 03, 2006 Jkt 211001 evaluate the latest methods, techniques, ethical standards, and approaches for design and implementation of observational exposure measurement studies and compile a set of state-of-thescience approaches in a single document. Examples of study elements for which state-of-the-science approaches will be evaluated and compiled in the document include identification of community groups and interactions with communities during the scoping and planning of studies, participant recruitment methods, informed consent procedures, identification and reporting unanticipated results, communication of study results, etc. EPA expects that the final document will be used by EPA researchers and others in the scientific community to design and perform observational exposure measurement studies. Researchers in NERL intend to work with the public and experts from outside of the Agency to evaluate and compile the state-of-the-science approaches. The Workshop announced in this Notice is expected to bring together experts in the areas of human exposure science, community research, ethics, children’s health, and other relevant disciplines to discuss and compile information that EPA can use to develop a draft document. EPA has asked the Panel to provide recommendations on the content of the document, sources of information for the document, and an evaluation of the state-of-the-science for approaches for specific elements of the design and implementation of observational exposure measurement studies. Using information gathered at the Workshop, EPA plans to develop a draft document, tentatively titled ‘‘State-of-the-Science Approaches for Observational Exposure Measurement Studies.’’ When completed, EPA expects to release the draft document as an external review document for public comment. EPA also expects to hire a contractor to conduct an independent external scientific peer review of the draft document. Availability of the document for public comment and the schedule and location of the independent external peer review will be announced in the Federal Register. Dated: October 31, 2006. Lawrence W. Reiter, Director, National Exposure Research Laboratory. [FR Doc. E6–18655 Filed 11–3–06; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 ENVIRONMENTAL PROTECTION AGENCY [FRL–8235–3] Notice of Availability of Final NPDES General Permit for Small Municipal Separate Storm Sewer Systems in the Commonwealth of Puerto Rico and Federal Facilities in the Commonwealth of Puerto Rico Environmental Protection Agency (EPA). ACTION: Notice of Final NPDES General Permits—PRR040000 and PRR04000F. AGENCY: SUMMARY: The Director of the Caribbean Environmental Protection Division (CEPD), Environmental Protection Agency-Region 2, is issuing notice for a final National Pollutant Discharge Elimination System (NPDES) general permit and accompanying response to comments for discharges from small municipal separate storm sewer systems (Small MS4) within urbanized areas to waters of the Commonwealth of Puerto Rico. This NPDES general permit establishes Notice of Intent (NOI) requirements, standards, prohibitions and management practices for discharges of storm water from municipal separate storm sewer systems within urbanized areas owned by the Commonwealth of Puerto Rico, or political subdivisions of the Commonwealth of Puerto Rico (including ‘‘municipios’’), as well as the United States, and other systems located within an urbanized area that fall within the definition of an MS4. These include, for example, State departments of transportation (DOTs), public universities, penitentiaries, military installations and similar institutions with separate storm sewers drainage area. Owners and/or operators of small MS4s that discharge storm water will be required to submit a NOI to EPA–CEPD to be covered by the general permit and will receive a written notification from EPA–CEPD of permit coverage and authorization to discharge under the general permit. The eligibility requirements are discussed in the permit. The municipality must meet the eligibility requirements of the permit prior to submission of the NOI. This general permit does not cover new sources as defined under 40 CFR 122.2. Publication of this final general permit and response to comments complies with the requirements of 40 Code of Federal Regulations (CFR) 124.10. DATES: The effective date of this permit is November 6, 2006. The permit will expire on November 7, 2011. Public Meeting Information: EPA— Region 2 has participated in several E:\FR\FM\06NON1.SGM 06NON1

Agencies

[Federal Register Volume 71, Number 214 (Monday, November 6, 2006)]
[Notices]
[Pages 64951-64952]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18655]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-8240-4]


Notice of an Expert Panel Workshop on the State-of-the-Science 
Approaches for Observational Exposure Measurement Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is announcing that 
Eastern Research Group, Inc. (ERG), an EPA contractor, will convene a 
panel of experts and organize and conduct a meeting to gather 
information on the most up-to-date methods, approaches, and ethical 
standards for designing and implementing observational exposure 
measurement studies. EPA expects to use the information from the 
workshop in the preparation of a document on the state-of-the-science 
approaches for observational exposure measurement studies. The meeting 
will include sessions for discussion by the panel and time will be set 
aside for public comment. The meeting is open to the public to attend 
as observers.
    Observers who wish to make oral comments during the comment periods 
may sign up on the Eastern Research Group, Inc.'s online registration 
page. Time slots for comments will be limited to 5-minutes and 
observers will be scheduled to speak in the order in which they 
register. The public may also use a separate process to send written 
comments regarding the planned document electronically to the project 
Web site at http://www.epa.gov/nerl/sots/ or by e-mail to the EPA 
technical contact at Fortmann.roy@epa.gov. The charge to the panel and 
background materials are available primarily via the Internet on the 
National Exposure Research Laboratory's (NERL's) home page under the 
Featured Links at http://www.epa.gov/nerl/sots/.

DATES: The workshop will begin on November 28, 2006, at 8:30 a.m. and 
end at 4 p.m. on November 29, 2006 (Eastern Time). The oral public 
comment sessions will begin on November 28, 2006, at approximately 10 
a.m. and on November 29, 2006 at approximately 1 p.m.

ADDRESSES: The workshop will be held at the Hilton Durham at 3800 
Hillsborough Rd., Durham, NC 27705. The EPA contractor, Eastern 
Research Group, Inc., is organizing, convening, and conducting the 
workshop. Members of the public may attend the workshop as observers. 
To attend the workshop, register by November 21, 2006, by accessing the 
online registration page at https://www2.ergweb.com/projects/
conferences/exposure/register-exposure.htm, via telephone by calling 
Eastern Research Group, Inc. at 781-674-7374, or sending an e-mail to 
meetings@erg.com (subject line: Observational Studies). Registration 
will also be available at the site of the meeting, as space allows. 
There will be time set aside each day to present brief (no longer than 
five minutes) oral comments from the public. Please let Eastern 
Research Group, Inc. know if you wish to make comments during the 
observer comment period. Space is limited, and registrations will be 
accepted on a first-come, first-served basis. Observers may also submit 
written comments regarding the planned document electronically to the 
project Web site at http://www.epa.gov/nerl/sots/ or by e-mail to the 
EPA technical contact at Fortmann.roy@epa.gov.

FOR FURTHER INFORMATION CONTACT: Questions regarding registration and 
logistics for the workshop should be directed to Eastern Research 
Group, Inc., 110 Hartwell Avenue, Lexington, MA 02421-3136; telephone: 
781-674-7374; facsimile: 781-674-2906; e-mail

[[Page 64952]]

meetings@erg.com, subject line: Observational Studies. If you need 
technical information about the planned document, please contact Roy 
Fortmann, National Exposure Research Laboratory (NERL); telephone: 919-
541-1021; facsimile: 919-541-0905; e-mail Fortmann.roy@epa.gov.

SUPPLEMENTARY INFORMATION: 

Information About the Workshop and Planned Document

    Observational exposure measurement studies are performed by 
researchers both within and outside of EPA to measure people's contact 
with chemicals in their everyday environments during their normal daily 
activities. These studies involve measurements of chemicals in 
environmental media (e.g., air, water, food, soil, and dust); 
collection of information about the voluntary study participants, their 
homes, their work environments, and their activities; and analysis of 
voluntary human samples such as blood or urine to determine the amounts 
of contact. These observational studies do not involve any additional 
contact with the chemicals being studied by the people who volunteer to 
participate in the studies. EPA's observational studies generally 
collect information that is critical to meeting the goal of improving 
public health. In these studies, EPA identifies the chemicals that 
people are coming in contact with; the concentrations of those 
chemicals; the most important sources of chemicals in people's lives; 
and when, where, how often, and why people come into contact with 
chemicals in the environment. The information collected in 
observational studies can be used to better understand potential risks 
and health effects from chemicals in the environment and to develop 
risk mitigation strategies and methods.
    EPA strives to follow the most up-to-date approaches in designing 
and performing observational studies. These approaches are developed by 
experts in both academia and various Federal agencies. The approaches 
evolve over time to meet changing and more stringent ethical standards 
and study requirements. EPA wants to ensure that the observational 
studies conducted by the Agency for measuring people's contact with 
environmental chemicals continue to be based on the most up-to-date 
sound science and the highest ethical standards. Therefore, there is a 
need to evaluate the latest approaches and ensure that EPA is using the 
state-of-the-science approaches. In this project, EPA intends to review 
and evaluate the latest methods, techniques, ethical standards, and 
approaches for design and implementation of observational exposure 
measurement studies and compile a set of state-of-the-science 
approaches in a single document. Examples of study elements for which 
state-of-the-science approaches will be evaluated and compiled in the 
document include identification of community groups and interactions 
with communities during the scoping and planning of studies, 
participant recruitment methods, informed consent procedures, 
identification and reporting unanticipated results, communication of 
study results, etc. EPA expects that the final document will be used by 
EPA researchers and others in the scientific community to design and 
perform observational exposure measurement studies.
    Researchers in NERL intend to work with the public and experts from 
outside of the Agency to evaluate and compile the state-of-the-science 
approaches. The Workshop announced in this Notice is expected to bring 
together experts in the areas of human exposure science, community 
research, ethics, children's health, and other relevant disciplines to 
discuss and compile information that EPA can use to develop a draft 
document. EPA has asked the Panel to provide recommendations on the 
content of the document, sources of information for the document, and 
an evaluation of the state-of-the-science for approaches for specific 
elements of the design and implementation of observational exposure 
measurement studies. Using information gathered at the Workshop, EPA 
plans to develop a draft document, tentatively titled ``State-of-the-
Science Approaches for Observational Exposure Measurement Studies.'' 
When completed, EPA expects to release the draft document as an 
external review document for public comment. EPA also expects to hire a 
contractor to conduct an independent external scientific peer review of 
the draft document. Availability of the document for public comment and 
the schedule and location of the independent external peer review will 
be announced in the Federal Register.

    Dated: October 31, 2006.
Lawrence W. Reiter,
Director, National Exposure Research Laboratory.
[FR Doc. E6-18655 Filed 11-3-06; 8:45 am]
BILLING CODE 6560-50-P