Completed Peer Reviews

On this page:

• Influential Scientific Information
• Highly Influential Scientific Assessment

Influential Scientific Information

Title	Peer Review Plan	Peer Review Document	Other Related Documents
External Peer Review of the Interagency Working Group on Asbestos in Consumer Products (IWGACP)’s White Paper: Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc	Peer Review Plan	Peer Review Report External Peer Review Comments and FDA Responses (December 2024)	WHITE PAPER: IWGACP SCIENTIFIC OPINIONS ON TESTING METHODS FOR ASBESTOS IN COSMETIC PRODUCTS CONTAINING TALC (December 2021) Appendices to White Paper: IWGACP Scientific Opinions on Testing Methods for Asbestos in Cosmetic Products Containing Talc
External Peer Review of FDA's Draft Toxicological Reference Value for Cadmium	Peer Review Plan	FDA’S Response to Peer Review Comments on the FDA's Toxicology Reference Value for Cadmium  (September 2022) November 2023	Reassessment of the cadmium toxicological reference value for use in human health assessments of foods October 2023
External Peer Review (Letter) of Safety of CBD in Humans - A Literature Review conducted on publicly available data through [December 12, 2019]	Peer Review Plan	External Peer Review Summary Report: Safety of CBD in Humans – A Literature Review (As of December 12, 2019) June 2020 FDA’s Response to External Peer Review of Safety of CBD in Humans – A Literature Review (As of December 12, 2019), September 2021	Safety of CBD in Humans – A Literature Review (As of December 12, 2019) September 2021
Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA – Data Review	Peer Review Plan	Draft Summary Report of the External Peer Review of FDA’s Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA – Data Review March 2016 FDA’s Response to External Peer Review of the Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA - Data Review  August 2020	Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 August 2020
Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA – Model Review	Peer Review Plan	Draft Summary Report of the External Peer Review of FDA’s Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA – Model Review March 2016 FDA’s Response to External Peer Review of the Draft Risk Ranking Model for Product Tracing as Required by Section 204 of FSMA - Model Review August 2020	Methodological Approach to Developing a Risk-Ranking Model for Food Tracing FSMA Section 204 August 2020
Experimental Study on Warning Statements for Cigarette Graphic Health Warnings and Experimental Study of Cigarette Warnings	Peer Review Plan	External Peer Review Report: Quantitative Consumer Research on Cigarette Health Warnings November 2019 FDA Response to External Peer Review on the Quantitative Consumer Research on Cigarette Health Warnings February 2020 FDA Response to External Peer Review on the Quantitative Consumer Research on Cigarette Health Warnings February 2020**	Experimental Study on Warning Statements for Cigarette Graphic Health Warnings - Study 1 Final Report February 2020 Experimental Study of Cigarette Warnings - Study 2 Final Report February 2020
Technical Information on Development of Fish Consumption Advice	Peer Review Form (PDF - 22KB)	External Peer Review Report: FDA-EPA's Technical Information on Development of Fish Consumption Advice  September 2016  FDA and EPA’s Response to External Peer Review on the FDA-EPA’s Technical Information on the Development of Fish Consumption Advice January 2017	Technical Information on Development of Fish Consumption Advice - FDA/EPA Advice on What Pregnant Women and Parents Should Know about Eating Fish  January 2017
Arsenic in Rice and Rice Products Risk Assessment	Peer Review Form (PDF - 66KB)	External Peer Review Report: Arsenic in Rice and Rice Products Risk Assessment: Draft Report, Addendum, and Model (PDF, 582KB)  December 2015 FDA’s Response to External Peer Review on FDA’s “Arsenic in Rice and Rice Products Risk Assessment: Draft Report” (July 2015), “Addendum to FDA’s Arsenic in Rice and Rice Products Risk Assessment,” and “Arsenic in Rice and Rice Products Risk Assessment Cancer Model" (PDF, 113KB)  February 2016	Arsenic in Rice and Rice Products Risk Assessment Report (PDF, 7.3MB) March 2016
FDA-iRisk, Food Safety Modeling Tool (Second Review)	Peer Review Form (PDF: 14KB)	External Peer Review (Letter) of FDA-iRISK® Model and Associated Library of Commodity/Hazard Combinations – Chemical Hazards (PDF - 2MB) June 2015
Multicriteria-based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products	Peer Review Form	External Peer Review Comments and FDA Response: Multicriteria-based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products (PDF - 886KB)  April 2015	Multicriteria-based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products  April 2015
Risk Profile: Pathogens and Filth in Spices	Peer Review Plan (PDF - 18.2KB)	External Peer Review Comments and FDA Responses: Draft Risk Profile: Pathogens and Filth in Spices (PDF: 741KB)  October 2013	Draft Risk Profile: Pathogens and Filth in Spices (PDF - 2.7MB) October 2013
Qualitative Assessment of Animal Food Risk	Peer Review Form (PDF - 86KB)	External Peer Review of the FDA/CVM Draft Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF - 602KB) October 2013	Final Qualitative Risk Assessment - Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 369KB) September 205 Draft Qualitative Risk Assessment: Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF - 370KB) October 2013
Risk Assessment: Arsenic in Apple Juice	Peer Review Plan (PDF - 34KB)	Peer Review Report: Risk Assessment of Arsenic in Apple Juice (PDF - 292KB) December 2012	Quantitative Assessment of Inorganic Arsenic in Apple Juice (PDF - 296KB)  July 1, 2013
Interagency Retail Listeria monocytogenes Risk Assessment	Peer Review Plan (PDF - 30.2KB)	Peer Review Comments and Responses for Interagency Retail Listeria monocytogenes Risk Assessment Model  (PDF - 350KB) January 2013	Draft Interagency Risk Assessment – Listeria monocytogenes in Retail Delicatessens: Technical Report (PDF - 2.7MB)
Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm	Peer Review Plan (PDF - 81KB)	External Peer Review of the FDA/CFSAN Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF - 585KB) August 2012	Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF: 651KB) September 2015 Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm: Response to Public Comments (PDF: 110KB) September 2015 Draft Qualitative Risk Assessment: Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm (PDF - 660KB) August 2012
Listeria monocytogenes in Cheese Risk Assessment	Peer Review Plan (PDF - 18.4KB)	Draft Joint FDA / Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in North America: Answer to the Peer Review (PDF: 933KB) 2012	Joint FDA / Health Canada Quantitative Assessment of the Risk of Listeriosis from Soft-Ripened Cheese Consumption in the United States and Canada Risk Assessment (PDF:3MB) July 2015 Interpretive Summary (PDF: 287KB) July 2015 Response to Public Comments Submitted to the Draft Report (PDF: 633KB) July 2015 Draft Risk Assessment (PDF: 3.1MB) Draft Interpretive Summary (PDF: 276KB)
iRISK, a Comparative Risk Assessment Tool	Peer Review Plan (PDF - 34.8KB)	Peer Review Comment Report iRisk Model Comparative RA Tool November 2011
FDA/CFSAN Draft Health Hazard Assessment for Gluten in Individuals with Celiac Disease: Determination of Tolerance Daily Intake Levels and Levels of Concern for Gluten	Peer Review Plan (PDF - 30.2KB)	Peer Review Report December 2010 (PDF - 246KB)	Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten (PDF - 469KB)  May 2011 FDA’s Responses to Comments on the Report Titled “Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten” December 2012
Ranking Pathogen: Commodity Pairs	Peer Review Plan (PDF - 27KB)	Peer Review Comment Report Risk Ranking Tool October 2009
Interim S/RA of Melamine in Human Foods	Peer Review Plan (PDF - 24 KB)	Peer Review Report December 2009
Risk Profile: Hepatitis A virus in Produce Risk Profile	Peer Review Plan (PDF - 25KB)	Peer Review Report March 2009
Melamine Risk Assessment Peer Review	Peer Review Plan (PDF - 525KB)	Peer Review Report June 2007	Interim Melamine and Analogues Safety/Risk Assessment June 2007 External Peer Review of the FDA/CFSAN Draft Report Interim Safety and Risk Assessment of Melamine and its Analogues in Food for Humans July 2009
Prelim Estimation of Perchlorate Dietary Exposure	Peer Review Plan (PDF - 502KB)	Peer Review Report May 2007	Preliminary Estimation of Perchlorate Dietary Exposure Based on FDA 2004/2005 Exploratory Data May 2007

 

Highly Influential Scientific Assessment

Title	Peer Review Plan	Peer Review Document	Other Related Documents
External Peer Review of FDA’s Scientific Assessment of the Impact of Menthol in Cigarettes	Peer Review Plan	External Peer Review Report: Scientific Assessment of the Impact of Menthol in Cigarettes (PDF - 1.04MB) (March 2022) FDA Response to External Peer Review on the Scientific Assessment of the Impact of Menthol in Cigarettes (PDF - 1.18MB) (April 2022)	Scientific Review of the Effects of Menthol in Cigarettes on Tobacco Addiction: 1980-2021 (PDF - 2.02MB) (April 2022) Review of Studies Assessing the Potential Impact of Prohibiting Menthol as a Characterizing Flavor in Cigarettes (PDF - 1.59MB) (April 2022)
External Peer Review of FDA’s Scientific Assessment of the Impact of Flavors in Cigar Products	Peer Review Plan	External Peer Review: Scientific Assessment of the Impact of Flavors in Cigar Products (PDF - 372KB) (March 2022) FDA Response to External Peer Review on the Scientific Assessment of the Impact of Flavors in Cigar Products (PDF - 643KB) (March 2022)	Scientific Assessment of the Impact of Flavors in Cigar Products (PDF - 981KB) (March 2022)
Qualitative Risk Assessment of Produce Safety	Peer Review Plan (PDF- 24KB)	External Peer Review Report: FDA's Draft Qualitative Assessment of Risk to Public Health from On-Farm Contamination of Product (PDF-  698KB) (April 2013)
Assessment of the Impact of Mentholated Cigarettes on Smoking Initiation, Dependence, and Cessation	Peer Review Plan (PDF - 24KB)	Peer Review Summary Report, External Peer Review of the FDA Scientific Evaluation of the Possible Health Effects of Menthol versus Nonmenthol Cigarettes (PDF - 815KB) (July 2013) Peer Review Comment Table (PDF - 128KB)	Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol versus Nonmenthol Cigarettes (PDF - 1.58MB) Reference Addendum to the Preliminary Scientific Evaluation (PDF - 816KB)
Cloning Risk Assessment Peer Review	Peer Review Plan (PDF: 502KB)	Comments from Peer Reviewers on the Draft Risk Assessment December 2006	Cloning Risk Assessment
Quantitative Assessment of the Net Effects from Eating Commercial Fish on Fetal Neurodevelopment (As Measured by IQ and also by Early Age Verbal Development in Children)	Peer Review Plan (PDF - 27KB) Addendum	Peer Review Report June 2014 Peer Review Report January 2009	Quantitative Assessment of the Net Effects on Fetal Neurodevelopment from the Eating Commercial Fish (As Measured by IQ and also by Early Age Verbal Development in Children) June 2014 Draft Report of Quantitative Risk and Benefit Assessment of Consumption of Commercial Fish, Focusing on Fetal Neurodevelopmental Effects (Measured by Verbal Development in Children) and on Coronary Heart Disease and Stroke in the General Population January 2009
Draft Assessment of Bisphenol A for Use in Food Contact Applications	Peer Review Plan (PDF - 25KB)	Peer Review (PDF - 147KB) October 2008 FDA Response (PDF - 334KB) December 2008 FDA Response  (PDF - 115KB) June 2010*	Draft Assessment of Bisphenol A for Use in Food Contact Applications August 2008 Related Material

 

• **This corrected FDA response to the peer review report, dated February 4, 2020, was posted on April 13, 2020, and replaces the version originally posted on March 18, 2020. We identified an inadvertent error that resulted in two pages being omitted from the version that was posted on March 18, 2020, and are making this correct version, which includes the formerly missing pages, available now.
• *This additional response to the 2008 peer review report was prepared on June 15, 2010. We recognize our oversight in not posting this on our website earlier and are making it available now.