Difference between revisions of "Template:LIMSpec/Document management"
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[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/7 21 CFR Part 7 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/58 21 CFR Part 58 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211 21 CFR Part 211 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212 21 CFR Part 212 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225 21 CFR Part 225 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226 21 CFR Part 226 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/312 21 CFR Part 312 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606 21 CFR Part 606 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/810 21 CFR Part 810 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/812 21 CFR Part 812 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/820 21 CFR Part 820 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br /> | ||
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[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br /> | ||
[https:// | [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC (throughout)]<br /> | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br /> | [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br /> | [https://www.iso.org/standard/56115.html ISO 15189:2012 4.3]<br /> | ||
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[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2 (throughout)] | ||
| style="background-color:white;" |'''7.1''' The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls. | | style="background-color:white;" |'''7.1''' The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls. | ||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.law.cornell.edu/cfr/text/7/331 7 CFR Part 331 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/7/part-331 7 CFR Part 331 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/9/121 9 CFR Part 121 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/9/part-121 9 CFR Part 121 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/7 21 CFR Part 7 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-7 21 CFR Part 7 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/58 21 CFR Part 58 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-58 21 CFR Part 58 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/211 21 CFR Part 211 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-211 21 CFR Part 211 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212 21 CFR Part 212 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-212 21 CFR Part 212 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/225 21 CFR Part 225 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-225 21 CFR Part 225 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/226 21 CFR Part 226 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-226 21 CFR Part 226 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/312 21 CFR Part 312 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-312 21 CFR Part 312 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/606 21 CFR Part 606 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-606 21 CFR Part 606 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/810 21 CFR Part 810 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-810 21 CFR Part 810 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/812 21 CFR Part 812 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-812 21 CFR Part 812 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/820 21 CFR Part 820 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/21/part-820 21 CFR Part 820 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.134 29 CFR Part 1910.134 (c)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1030 29 CFR Part 1910.1030 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (e)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1200 29 CFR Part 1910.1200 (e)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/29/1910.1450 29 CFR Part 1910.1450 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/73 42 CFR Part 73 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/42/part-73 42 CFR Part 73 (throughout)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1200 42 CFR Part 493.1200]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1232 42 CFR Part 493.1232]<br /> | ||
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[https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1291 42 CFR Part 493.1291 (j)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/42/493.1773 42 CFR Part 493.1773 (c–d)]<br /> | [https://www.law.cornell.edu/cfr/text/42/493.1773 42 CFR Part 493.1773 (c–d)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/45/ | [https://www.law.cornell.edu/cfr/text/45/160.310 45 CFR Part 160.310]<br /> | ||
[https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br /> | [https://www.law.cornell.edu/cfr/text/45/part-164 45 CFR Part 164 (throughout)]<br /> | ||
[https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br /> | [https://www.aafco.org/Publications/QA-QC-Guidelines-for-Feed-Laboratories AAFCO QA/QC Guidelines for Feed Laboratories (throughout)]<br /> | ||
| Line 96: | Line 96: | ||
[https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br /> | [https://www.epa.gov/sites/production/files/documents/erln_lab_requirements.pdf EPA ERLN Laboratory Requirements (throughout)]<br /> | ||
[https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br /> | [https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-qag-5 EPA QA/G-5 (throughout)]<br /> | ||
[https:// | [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC (throughout)]<br /> | ||
[https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br /> | [https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/haccp-principles-application-guidelines FDA Hazard Analysis Critical Control Point (throughout)]<br /> | ||
[https://www.iso.org/standard/56115.html ISO 15189:2012 (throughout)]<br /> | [https://www.iso.org/standard/56115.html ISO 15189:2012 (throughout)]<br /> | ||
| Line 106: | Line 106: | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Data and Instrumentation for PDP (throughout)]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Sample Processing and Analysis Procedures for PDP (throughout)]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2 (throughout)] | ||
| style="background-color:white;" |'''7.2''' The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials. | | style="background-color:white;" |'''7.2''' The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials. | ||
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[https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br /> | [https://www.iso.org/standard/66912.html ISO/IEC 17025:2017 8.3.2]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 5.5]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.5] | ||
| style="background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions. | | style="background-color:white;" |'''7.3''' The system shall be able to clearly provide the most current version of a document and archive prior versions. | ||
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| style="padding:5px; width:500px;" | | | style="padding:5px; width:500px;" | | ||
[https://www.law.cornell.edu/cfr/text/21/211. | [https://www.law.cornell.edu/cfr/text/21/211.160 21 CFR Part 211.160]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br /> | [https://www.law.cornell.edu/cfr/text/21/212.20 21 CFR Part 212.20 (c)]<br /> | ||
[https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (c)]<br /> | [https://www.law.cornell.edu/cfr/text/21/212.60 21 CFR Part 212.60 (c)]<br /> | ||
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[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br /> | [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.14] | ||
| style="background-color:white;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation. | | style="background-color:white;" |'''7.5''' The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation. | ||
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[https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br /> | [https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf New York Department of Health ELAP Microbiology Protocol]<br /> | ||
[https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br /> | [https://www.ams.usda.gov/datasets/pdp/pdp-standard-operating-procedures USDA Administrative Procedures for the PDP 8.4]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 4.11]<br /> | ||
[https:// | [https://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_986/en/ WHO Technical Report Series, #986, Annex 2, 15.13] | ||
| style="background-color:white;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input. | | style="background-color:white;" |'''7.6''' The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input. | ||
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[https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br /> | [https://www.aavld.org/accreditation-requirements-page AAVLD Requirements for an AVMDL Appendix 1]<br /> | ||
[http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> | [http://www.abft.org/files/ABFT_LAP_Standards_May_31_2013.pdf ABFT Accreditation Manual Sec. B]<br /> | ||
[https://www.aihaaccreditedlabs.org/ | [https://www.aihaaccreditedlabs.org/policies AIHA-LAP Policies 2018 (various parts)]<br /> | ||
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 4.13.2.12]<br /> | ||
[http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br /> | [http://des.wa.gov/sites/default/files/public/documents/About/1063/RFP/Add7_Item4ASCLD.pdf ASCLD/LAB Supp. Reqs. for the Accreditation of Forensic Science Testing Laboratories 5.2.1.1–3]<br /> | ||
| Line 195: | Line 195: | ||
[https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br /> | [https://www.astm.org/Standards/E1578.htm ASTM E1578-18 E-1-6]<br /> | ||
[https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br /> | [https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/annex11_01-2011_en.pdf E.U. Annex 11-2]<br /> | ||
[https:// | [https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:262:0022:0026:en:PDF E.U. Commission Directive 2003/94/EC Article 7.4]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br /> | [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. III, Sec. 10 and 17]<br /> | ||
[https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br /> | [https://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=30006MXP.PDF EPA 815-R-05-004 Chap. IV, Sec. 1]<br /> | ||
