Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters; Risk Assessment; Availability, 41772-41773 [05-14293]

Download as PDF 41772 Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices grant announcements in the Federal Register. Beginning October 1, 2005, applicants will be able to find a synopsis of all ACF grant opportunities and apply electronically for opportunities via: http:// www.Grants.gov. Applicants will also be able to find the complete text at http://www.acf.hhs.gov/grants/ index.html. Please reference Section IV.3 for details about acknowledgement of received applications. Dated: July 13, 2005. Josephine B. Robinson, Director, Office of Community Services. [FR Doc. 05–14193 Filed 7–19–05; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999N–1075] (formerly 99N– 1075) Quantitative Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Oysters; Notice of Public Meeting AGENCY: Food and Drug Administration, Registration and Requests for Oral Presentation: Send registration information (including name, title, firm name, address, telephone, and fax number), and written materials to the contact person by August 10, 2005. Interested persons may present data, information, or views orally or in writing, on the issue. If you desire to make a formal oral presentation, you should notify the contact person before August 10, 2005, and be prepared to give a brief description of the general nature of the information you wish to present. Time allotted for each presentation may be limited. If you need special accommodations due to a disability, please contact Melissa Ellwanger at least 7 days in advance of the meeting. Transcripts: Transcripts of the meeting may be requested in writing from the Freedom of Information Office (HFI–35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A–16, Rockville, MD 20857, approximately 15 working days after the meeting at a cost of 10 cents per page. Dated: July 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14294 Filed 7–18–05; 8:45 am] BILLING CODE 4160–01–S HHS. ACTION: Notice of public meeting. The Food and Drug Administration (FDA) is announcing a public meeting to present the ‘‘Quantitative Risk Assessment on the Public Health Impact of Vibrio parahaemolyticus in Raw Oysters.’’ This public meeting is intended to provide clarification about the results of the risk assessment and information on how the risk assessment may be utilized. Stakeholders will have an opportunity to ask questions about the risk assessment. Questions may also be submitted in advance of the public meeting (see Contact section of this document). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the risk assessment that is being presented at this public meeting. Date and Time: The meeting will be held on August 13, 2005, from 12 noon to 3 p.m. Location: The meeting will be held at the Grand Hotel Marriot Resort, One Grand Blvd., Point Clear, AL 36564. Contact: Melissa Ellwanger, Center for Food Safety and Applied Nutrition (HFS–417), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301– 436–1401, FAX: 301–436–2599, e-mail: mellwang@cfsan.fda.gov. VerDate jul<14>2003 14:24 Jul 19, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 1999N–1075] (formerly 99N– 1075) Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters; Risk Assessment; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a risk assessment entitled ‘‘Quantitative Risk Assessment on the Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters.’’ The quantitative risk assessment will help the agency evaluate risk mitigation strategies and develop effective guidance for the industry. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to provide clarification about the results of the risk assessment and information about how the risk assessment may be utilized. ADDRESSES: Submit written requests for single copies of the risk assessment PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 document and CD–ROM of the model to Sherri Dennis, Center for Food Safety and Applied Nutrition (see FOR FURTHER INFORMATION CONTACT). Send one selfaddressed label to assist that office in processing your request. You also may request a copy of the risk assessment document and model by fayour name and mailing address with the name of the document you are requesting to the CFSAN Outreach and Information Center at 1–877–366–3322. See the SUPPLEMENTARY INFORMATION section for electronic access to this document. A copy of the risk assessment document may be reviewed at the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food Safety and Applied Nutrition (HFS–006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1903. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 19, 2001 (66 FR 5517), FDA announced the availability of a draft risk assessment on the relationship between Vibrio parahaemolyticus in raw molluscan shellfish, specifically raw oysters, and human health. A public meeting was held on March 20, 2001 (66 FR 13544, March 6, 2001), to receive comments on the technical aspects of the draft risk assessment. Interested persons were given until March 20, 2001, with extensions to May 21, 2001 (66 FR 13546, March 6, 2001), and to July 18, 2001 (66 FR 33101, June 20, 2001), to comment on the draft risk assessment. Nine letters, containing one or more comments, were received in response to the draft risk assessment. The risk assessment has been revised in response to the public comments, newly available data, and updated modeling techniques. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to provide clarification about the results of the risk assessment and information about how the risk assessment may be utilized. II. Risk Assessment The purpose of the quantitative risk assessment is to examine systematically available scientific data and information to estimate the risk of illness associated with consumption of raw oysters that contain pathogenic V. parahaemolyticus. This examination of the current science and the models E:\FR\FM\20JYN1.SGM 20JYN1 Federal Register / Vol. 70, No. 138 / Wednesday, July 20, 2005 / Notices developed from it are among the tools available to FDA to aid in the evaluation of risk mitigation strategies and in the formulation of effective guidance for the industry. The risk assessment focused on raw oysters because that is the food in the United States predominately linked to illness from V. parahaemolyticus outbreaks since 1997. This risk assessment is a quantitative analysis in which the levels of pathogen in oysters were estimated beginning with harvest of the oysters through postharvest handling, processing, and storage to predict exposure from consumption of raw oysters. The likelihood of illness following exposure to pathogenic V. parahaemolyticus from consumption of raw oysters was determined for different geographical areas and for various times of the year. The baseline model was used to develop ‘‘what-if’’ scenarios to evaluate the likely impact of potential intervention scenarios on the exposure to pathogenic V. parahaemolyticus. Elsewhere in this issue of the Federal Register, FDA is announcing a public meeting to provide clarification about the results of the risk assessment and information about how the risk assessment may be utilized. The risk assessment follows the framework recommended both by the National Academy of Sciences and the Codex Alimentarius Commission. This structured framework involves the following steps: • Hazard Identification. The review of data and information on health effects (e.g., gastroenteritis and septicemia) associated with consumption of raw oysters containing pathogenic V. parahaemolyticus. • Hazard Characterization/DoseResponse. Characterization of the relationship between V. parahaemolyticus exposure level (dose) and probability and severity of illness (response) using data from clinical trials and epidemiological surveys. Anyone exposed to V. parahaemolyticus can become infected and develop gastroenteritis; however, individuals with concurrent underlying chronic medical conditions have a greater probability of developing septicemia. • Exposure Assessment. The determination of the likelihood and level of exposure to V. parahaemolyticus from consumption of raw oysters using data on prevalence, water and air temperature, growth and survival of V. parahaemolyticus, oyster landings, and consumption. • Risk Characterization. The integration of the exposure and doseresponse data to estimate both the risk to the public heath and the uncertainty associated with this estimate. The risk VerDate jul<14>2003 14:24 Jul 19, 2005 Jkt 205001 assessment provides estimates of the following: (1) The predicted illness burden as the risk of an individual becoming ill when they consume a single serving of oysters, (2) the predicted number of illnesses (gastroenteritis) in the United States each year, and (3) the predicted number of cases of gastroenteritis that progress to septicemia. The results of the risk assessment identified the following several significant factors that contribute to the probability of illness: (1) Levels of total V. parahaemolyticus in oysters at time of harvest, (2) harvesting and handling practices that allow growth of V. parahaemolyticus in oysters after harvest, and (3) mitigations that reduce levels of V. parahaemolyticus in oysters post-harvest. III. Electronic Access The risk assessment document is available electronically at www.cfsan.fda.gov. Dated: July 11, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–14293 Filed 7–18–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Program Exclusions: June 2005 AGENCY: Office of Inspector General, HHS. ACTION: Notice of program exclusions. During the month of June 2005, the HHS Office of Inspector General imposed exclusions in the cases set forth below. When an exclusions is imposed, no program payment is made to anyone for any items or services (other than an emergency item or service not provided in a hospital emergency room) furnished, ordered or prescribed by an excluded party under the Medicare, Medicaid, and all Federal Health Care programs. In addition, no program payment is made to any business or facility, e.g., a hospital, that submits bills for payment for items or services provided by an excluded party. Program beneficiaries remain free to decide for themselves whether they will continue to use the services of an excluded party even though no program payments will be made for items and services provided by that excluded party. The exclusions have national effect and also apply to all Executive PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 41773 Branch procurement and nonprocurement programs and activities. Subject, city, state Effective date PROGRAM-RELATED CONVICTIONS ALONSO, TERESA .................. HIALEAH, FL BOGGS, CHRISTINA ............... NEWPORT, WA BRACKETT, AMOUEL ............. UNION, SC BRIAR CREST NURSING HOME, INC ........................... GREENWICH, CT CARDELLE, CLARA ................. MIAMI, FL CARNET, GUILLERMO ............ MIAMI, FL COMMUNITY INTEGRATION ASSOCIATES, INC ............... CAMPBELL, NY COOKE, JEFFERY ................... ROCHESTER HILLS, MI COX, KATHLEEN ..................... KINGSTON, WA CRAVEN, ALBERTA ................ COLUMBUS, OH CROOKS, LYNN ...................... GOSHEN, OH DAVIS, MARK .......................... FAIRTON, NJ DONETS, NISON ..................... BAYSIDE, WI EISENBERG, LESTER ............. SOUTHOLD, NY EKONG, AFFIONG ................... RICHARDSON, TX EKONG, PATRICK ................... SEAGOVILLE, TX FERRER, SONIA ...................... MIAMI, FL FLOYD, LINDA ......................... KIMBOLTON, OH FOJON, LILLIAN ...................... MIAMI, FL GEZALYAN, SARKIS ............... GLENDALE, CA GOMEZ, MARIO ....................... MIAMI, FL GOWIN, AMY ........................... NORFOLK, VA GREENBAUM, MARK .............. NEW ROCHELLE, NY GRIGORYAN, KONSTANTIN .. ALTADENA, CA GRIMES, LUMESHIA ............... COLUMBIA, SC HARTER, ANA ......................... MIAMI, FL HERRERA, GILBERTO ............ MIAMI, FL HOWARD, KYLE ...................... LEBANON, OH JACKSON, BETHEARL ............ SAN DIEGO, CA JAGO, ROBERT ....................... JACKSONVILLE, OH JAGO, SHARON ...................... JACKSONVILLE, OH JENKINS, JOHN ....................... CAMPBELL, NY JILES, E .................................... TEXARKANA, TX JONES, NICOLE ...................... E:\FR\FM\20JYN1.SGM 20JYN1 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 3/28/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05 7/20/05

Agencies

[Federal Register Volume 70, Number 138 (Wednesday, July 20, 2005)]
[Notices]
[Pages 41772-41773]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999N-1075] (formerly 99N-1075)


Quantitative Risk Assessment on the Public Health Impact of 
Pathogenic Vibrio parahaemolyticus in Raw Oysters; Risk Assessment; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a risk assessment entitled ``Quantitative Risk 
Assessment on the Public Health Impact of Pathogenic Vibrio 
parahaemolyticus in Raw Oysters.'' The quantitative risk assessment 
will help the agency evaluate risk mitigation strategies and develop 
effective guidance for the industry. Elsewhere in this issue of the 
Federal Register, FDA is announcing a public meeting to provide 
clarification about the results of the risk assessment and information 
about how the risk assessment may be utilized.

ADDRESSES: Submit written requests for single copies of the risk 
assessment document and CD-ROM of the model to Sherri Dennis, Center 
for Food Safety and Applied Nutrition (see FOR FURTHER INFORMATION 
CONTACT). Send one self-addressed label to assist that office in 
processing your request. You also may request a copy of the risk 
assessment document and model by fayour name and mailing address with 
the name of the document you are requesting to the CFSAN Outreach and 
Information Center at 1-877-366-3322. See the SUPPLEMENTARY INFORMATION 
section for electronic access to this document.
    A copy of the risk assessment document may be reviewed at the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 19, 2001 (66 FR 5517), FDA 
announced the availability of a draft risk assessment on the 
relationship between Vibrio parahaemolyticus in raw molluscan 
shellfish, specifically raw oysters, and human health. A public meeting 
was held on March 20, 2001 (66 FR 13544, March 6, 2001), to receive 
comments on the technical aspects of the draft risk assessment. 
Interested persons were given until March 20, 2001, with extensions to 
May 21, 2001 (66 FR 13546, March 6, 2001), and to July 18, 2001 (66 FR 
33101, June 20, 2001), to comment on the draft risk assessment. Nine 
letters, containing one or more comments, were received in response to 
the draft risk assessment. The risk assessment has been revised in 
response to the public comments, newly available data, and updated 
modeling techniques. Elsewhere in this issue of the Federal Register, 
FDA is announcing a public meeting to provide clarification about the 
results of the risk assessment and information about how the risk 
assessment may be utilized.

II. Risk Assessment

    The purpose of the quantitative risk assessment is to examine 
systematically available scientific data and information to estimate 
the risk of illness associated with consumption of raw oysters that 
contain pathogenic V. parahaemolyticus. This examination of the current 
science and the models

[[Page 41773]]

developed from it are among the tools available to FDA to aid in the 
evaluation of risk mitigation strategies and in the formulation of 
effective guidance for the industry. The risk assessment focused on raw 
oysters because that is the food in the United States predominately 
linked to illness from V. parahaemolyticus outbreaks since 1997. This 
risk assessment is a quantitative analysis in which the levels of 
pathogen in oysters were estimated beginning with harvest of the 
oysters through post-harvest handling, processing, and storage to 
predict exposure from consumption of raw oysters. The likelihood of 
illness following exposure to pathogenic V. parahaemolyticus from 
consumption of raw oysters was determined for different geographical 
areas and for various times of the year. The baseline model was used to 
develop ``what-if'' scenarios to evaluate the likely impact of 
potential intervention scenarios on the exposure to pathogenic V. 
parahaemolyticus. Elsewhere in this issue of the Federal Register, FDA 
is announcing a public meeting to provide clarification about the 
results of the risk assessment and information about how the risk 
assessment may be utilized.
    The risk assessment follows the framework recommended both by the 
National Academy of Sciences and the Codex Alimentarius Commission. 
This structured framework involves the following steps:
     Hazard Identification. The review of data and information 
on health effects (e.g., gastroenteritis and septicemia) associated 
with consumption of raw oysters containing pathogenic V. 
parahaemolyticus.
     Hazard Characterization/Dose-Response. Characterization of 
the relationship between V. parahaemolyticus exposure level (dose) and 
probability and severity of illness (response) using data from clinical 
trials and epidemiological surveys. Anyone exposed to V. 
parahaemolyticus can become infected and develop gastroenteritis; 
however, individuals with concurrent underlying chronic medical 
conditions have a greater probability of developing septicemia.
     Exposure Assessment. The determination of the likelihood 
and level of exposure to V. parahaemolyticus from consumption of raw 
oysters using data on prevalence, water and air temperature, growth and 
survival of V. parahaemolyticus, oyster landings, and consumption.
     Risk Characterization. The integration of the exposure and 
dose-response data to estimate both the risk to the public heath and 
the uncertainty associated with this estimate. The risk assessment 
provides estimates of the following: (1) The predicted illness burden 
as the risk of an individual becoming ill when they consume a single 
serving of oysters, (2) the predicted number of illnesses 
(gastroenteritis) in the United States each year, and (3) the predicted 
number of cases of gastroenteritis that progress to septicemia.
    The results of the risk assessment identified the following several 
significant factors that contribute to the probability of illness: (1) 
Levels of total V. parahaemolyticus in oysters at time of harvest, (2) 
harvesting and handling practices that allow growth of V. 
parahaemolyticus in oysters after harvest, and (3) mitigations that 
reduce levels of V. parahaemolyticus in oysters post-harvest.

III. Electronic Access

    The risk assessment document is available electronically at 
www.cfsan.fda.gov.

    Dated: July 11, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14293 Filed 7-18-05; 8:45 am]
BILLING CODE 4160-01-S