id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2019-N-3325-0007,FDA,FDA-2019-N-3325,"Reference 5: “Action Plan for Import Safety.”  Interagency Working Group on Import Safety.  November 2007.  http://www.itagc.org/docs/ITAGC-2010-11-10-FDA-4.pdf.  Accessed June 17, 2019 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:11:15Z,,0,0,090000648411b183
FDA-2019-N-3325-0029,FDA,FDA-2019-N-3325,"Reference 4: FDA Memo to Administrative Record, “Assessment of DWPE sampling and analysis data to determine what portion of sampling and analysis of food under DWPE is conducted by accredited entities.” From Tyler Scandalios and Toni Morales, November 20, 2018 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:18:12Z,,0,0,090000648411c83c
FDA-2019-N-3325-0022,FDA,FDA-2019-N-3325,"Reference 20: Meeting Record, “FSMA Lab Accreditation/Food Laboratory Alliance Meeting Record August 21, 2015.”  FDA.  July 21, 2015.",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:13:58Z,,0,0,090000648411b207
FDA-2019-N-3325-0028,FDA,FDA-2019-N-3325,"Reference 3: Middlebrook, Ken, “Do accredited laboratories perform better in proficiency testing than non-accredited laboratories?”, Accreditation and Quality Assurance (22) 2017. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:17:34Z,,0,0,090000648411c67a
FDA-2019-N-3325-0018,FDA,FDA-2019-N-3325,"Reference 16: “Accreditation Requirements:  ISO/IEC 17025 Testing Laboratories (Non-Forensics).”  ANSI/ASQ National Accreditation Board.  October 9, 2018.  Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:13:18Z,,0,0,090000648411b1d2
FDA-2019-N-3325-0021,FDA,FDA-2019-N-3325,"Reference 19: FDA Memorandum, “Guidelines for the Validation of Chemical Methods for the FDA FVM Program, 2nd Edition.”  FDA Foods and Veterinary Medicine Science and Research Steering Committee. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:13:48Z,,0,0,090000648411b203
FDA-2019-N-3325-0032,FDA,FDA-2019-N-3325,"Reference 7: Produce Safety final rule, 80 FR 74353, November 27, 2015.Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:19:18Z,,0,0,090000648411c6d8
FDA-2019-N-3325-0034,FDA,FDA-2019-N-3325,"Reference 9: Thompson, Michael; Kenneth Mathieson; Linda Owen; Andrew P. Damant; Roger Wood, “The relationship between accreditation status and performance in a proficiency test,” Accreditation and Quality Assurance, 14, 2009 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:19:39Z,,0,0,090000648411c6da
FDA-2019-N-3325-0011,FDA,FDA-2019-N-3325,"Reference 9: “Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food, Dietary Supplements, and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2005.”  AOAC International.  April 2015.  Copies are available from AOAC International, 2275 Research Blvd, ste. 300, Rockville, MD  20850-3250, USA Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T14:16:50Z,,0,0,090000648411ad7b
FDA-2019-N-3325-0037,FDA,FDA-2019-N-3325,"Reference 12: Minor, Travis, Angela Lasher, Karl Klontz, Bradley Brown, Clark Nardinelli, and David Zorn; “The Per Case and Total Annual Costs of Foodborne Illness in the United States,” Risk Analysis; June 35(6):1125-39, 2014.",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:20:10Z,,0,0,090000648411c451
FDA-2019-N-3325-0017,FDA,FDA-2019-N-3325,"Reference 15: “R103--General Requirements:  Proficiency Testing for ISO/IEC Laboratories.”  American Association for Laboratory Accreditation.  September 19, 2013.  https://portal.a2la.org/requirements/R103_2013.pdf.  Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:13:08Z,,0,0,090000648411b1d1
FDA-2019-N-3325-0002,FDA,FDA-2019-N-3325,Laboratory Accreditation NPRM - REFERENCE LIST,Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T14:02:06Z,,0,0,090000648411b298
FDA-2019-N-3325-0040,FDA,FDA-2019-N-3325,"Reference 20: U.S. Small Business Administration, Table of Small Business Size Standards Matched to North American Industry Classification System Codes. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:21:50Z,,0,0,090000648411c454
FDA-2019-N-3325-0026,FDA,FDA-2019-N-3325,"Reference 1: Sampling proposed rule, 69 FR 23460, April 29, 2004 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:17:07Z,,0,0,090000648411c678
FDA-2019-N-3325-0031,FDA,FDA-2019-N-3325,"Reference 6: Shell-egg Final rule, 74 FR 33029, July 9, 2009. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:18:48Z,,0,0,090000648411c6d7
FDA-2019-N-3325-0006,FDA,FDA-2019-N-3325,Reference 4: “ISO/IEC 17025:2005 “General Requirements for the Competence of Testing and Calibration Laboratories” (withdrawn). Re: Laboratory Accreditation for Analyses of Foods,Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:10:55Z,,0,0,090000648411b181
FDA-2019-N-3325-0030,FDA,FDA-2019-N-3325,"Reference 5: FDA Memo to Administrative Record, “Use of Labs by Shell-Egg Industry.” July 15, 2015 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:18:23Z,,0,0,090000648411c83d
FDA-2019-N-3325-0023,FDA,FDA-2019-N-3325,"Reference 21: FDA.  Accreditation of Laboratories to Conduct Food Testing: Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis, Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:15:08Z,,0,0,090000648411b208
FDA-2019-N-3325-0027,FDA,FDA-2019-N-3325,"Reference 2: FDA Draft Guidance for Industry, “Submission of Laboratory Packages by Accredited Laboratories” (withdrawn). FDA. January 16, 2009.",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:17:20Z,,0,0,090000648411c679
FDA-2019-N-3325-0016,FDA,FDA-2019-N-3325,"Reference 14: Meeting Minutes, “Sampling Accreditation Discussion with ABs.”  FDA.  November 13, 2017. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:12:57Z,,0,0,090000648411b1d0
FDA-2019-N-3325-0025,FDA,FDA-2019-N-3325,PRIA 00 Reference List Re: Laboratory Accreditation for Analyses of Foods,Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:16:52Z,,0,0,090000648411c677
FDA-2019-N-3325-0008,FDA,FDA-2019-N-3325,"Reference 6: GAO Report, “Federal Oversight of Food Safety:  FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical (GAO-08-435T).”  Government Accountability Office.  January 29, 2008.  https://www.gao.gov/assets/120/118821.pdf.  Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:11:27Z,,0,0,090000648411b184
FDA-2019-N-3325-0012,FDA,FDA-2019-N-3325,Reference 10: “IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements): Requirements and Procedures for Evaluation of a Single Accreditation Body.”  International Accreditation Forum/International Laboratory Accreditation Cooperation.  January 2018.  Re: Laboratory Accreditation for Analyses of Foods,Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:12:11Z,,0,0,090000648411b1cc
FDA-2019-N-3325-0038,FDA,FDA-2019-N-3325,"Reference 16: Association of Public Health Laboratories, “Laboratory Costs of ISO/IEC 17025 Accreditation: A 2017 Survey Report.” February 2018",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:21:20Z,,0,0,090000648411c452
FDA-2019-N-3325-0010,FDA,FDA-2019-N-3325,"Reference 8: FDA Draft Guidance for Industry, “Submission of Laboratory Packages by Accredited Laboratories” (withdrawn).  FDA.  January 16, 2009.Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:11:50Z,,0,0,090000648411b186
FDA-2019-N-3325-0033,FDA,FDA-2019-N-3325,"Reference 8: Bottled Water final rule, 74 FR 25651, May 29, 2009. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:19:29Z,,0,0,090000648411c6d9
FDA-2019-N-3325-0005,FDA,FDA-2019-N-3325,"Reference 3: “Private Laboratory Guidance,” ORA Laboratory Manual, Vol. III, Section 7, document number III-07. FDA. January 30, 2013. https://www.fda.gov/media/81810/download. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T14:02:45Z,,0,0,090000648411ad50
FDA-2019-N-3325-0009,FDA,FDA-2019-N-3325,"Reference 7: GAO Report, “Food Safety:  FDA’s Imported Seafood Safety Program Shows Some Progress, but Further Improvements are Needed (GAO-04-246).”  Government Accountability Office.  January 30, 2004.  https://www.gao.gov/assets/250/241327.pdf.  Accessed on June 17, 2019.Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:11:40Z,,0,0,090000648411b185
FDA-2019-N-3325-0035,FDA,FDA-2019-N-3325,"Reference 10: FDA, Serving Size final rule, 81 FR 34000, May 27, 2016 Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:19:48Z,,0,0,090000648411c44f
FDA-2019-N-3325-0036,FDA,FDA-2019-N-3325,"Reference 11: FDA, Modeling the Effects of Food Handling Practices on the Incidence of Foodborne Illness, Final Report” ERG Task No. 0193.16.004.001, March 18, 2009.  Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:19:58Z,,0,0,090000648411c450
FDA-2019-N-3325-0039,FDA,FDA-2019-N-3325,"Reference 18: FDA, Compliance Program Guidance Manual, Program 7303.819, Chapter 3.  Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:21:39Z,,0,0,090000648411c453
FDA-2019-N-3325-0003,FDA,FDA-2019-N-3325,"Reference 1: FDA Memorandum, “Assessment of DWPE Sampling and Analysis Data to Determine what Portion of Sampling and Analysis of Food under DWPE is Conducted by Accredited Entities.” Toni Morales and Tyler Scandalios, FDA. November 20, 2018. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:10:22Z,,0,0,090000648411ad4c
FDA-2019-N-3325-0014,FDA,FDA-2019-N-3325,"Reference 12: “ISO/IEC 17011:2017(E), “Conformity Assessment–Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.”  International Organization for Standardization/International Electrotechnical Commission.  November 2017.  Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:12:32Z,,0,0,090000648411b1ce
FDA-2019-N-3325-0020,FDA,FDA-2019-N-3325,"Reference 18: “Methods, Method Verification and Validation,” ORA Laboratory Manual, Vol. II, Section 2, document number ORA-LAB.5.4.5.  FDA.  August 29, 2014.  https://www.fda.gov/media/73920/download.  Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:13:38Z,,0,0,090000648411b202
FDA-2019-N-3325-0013,FDA,FDA-2019-N-3325,Reference 11: “OMB Circular A–119:  Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities.”  Office of Management and Budget.  January 2016.  Re: Laboratory Accreditation for Analyses of Foods,Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:12:23Z,,0,0,090000648411b1cd
FDA-2019-N-3325-0024,FDA,FDA-2019-N-3325,"Reference 22: FDA Memorandum.  “Proposed Rule:  Amendment of 21 CFR Parts 1, 11, 16, and 129 to Establish a Program for Laboratory Accreditation for Analyses of Foods as Required by FD&C Act.”  Leah D. Proffitt, FDA, June 14, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:15:35Z,,0,0,090000648411b209
FDA-2019-N-3325-0019,FDA,FDA-2019-N-3325,"Reference 17: ISO/IEC 17043:2010, “Conformity Assessment--General Requirements for Proficiency Testing.”  International Organization for Standardization/International Electrotechnical Commission.  February 2010.  Copies are available from the International Organization for Standardization Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T14:04:48Z,,0,0,090000648411b1d5
FDA-2019-N-3325-0004,FDA,FDA-2019-N-3325,"Reference 2: Congressional Hearing, “The Safety of Food Imports: Fraud & Deception in the Food Import Process; Hearings Before the Senate Committee on Governmental Affairs, Permanent Subcommittee on Investigations.” September 10, 1998. https://www.gpo.gov/fdsys/pkg/CHRG-105shrg51562/pdf/CHRG-105shrg51562.pdf. Accessed on June 17, 2019. Re: Laboratory Accreditation for Analyses of Foods",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T13:10:32Z,,0,0,090000648411ad4e
FDA-2019-N-3325-0015,FDA,FDA-2019-N-3325,"Reference 13: ISO/IEC 17025:2017(E), “General Requirements for the Competence of Testing and Calibration Laboratories.”  International Organization for Standardization/International Electrotechnical Commission.  November 2017.  Copies are available from the International Organization for Standardization, Chemin de Blandonnet 8, 1214 Vernier, Geneva, Switzerland, or on the internet at",Supporting & Related Material,Background Material,2019-11-05T05:00:00Z,2019,11,,,2019-11-05T14:04:20Z,,0,0,090000648411b1cf
FDA-2019-N-3325-0001,FDA,FDA-2019-N-3325,Laboratory Accreditation for Analyses of Foods,Proposed Rule,Advance Notice of Proposed Rulemaking (ANPRM),2019-11-04T05:00:00Z,2019,11,2019-11-04T05:00:00Z,2020-07-07T03:59:59Z,2020-07-08T01:02:34Z,2019-23870,0,0,090000648411a07f