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Docket No. Fda–2011–N–0920 Before the United States Of DOCKET NO. FDA–2011–N–0920 BEFORE THE UNITED STATES OF AMERICA DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION COMMENTS OF THE AMERICAN HERBAL PRODUCTS ASSOCIATION ON PROPOSED RULE for CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD November 22, 2013 Docket No. FDA–2011–N–0920 November 22, 2013 Prefatory remarks ......................................................................................................................................... 1 1. The broad and deep impact of the new regulations necessitates regulatory restraint .......................... 2 2. The same controls are neither necessary nor appropriate for non‐RTE foods as for RTE foods ............. 3 3. Wherever possible, food processors rather than farmers should ensure the biological safety of food 6 3.1 Wherever possible, FDA should avoid burdening farmers and should rely on food processors rather than farmers to ensure biological safety .......................................................................... 6 3.2 Farmers are generally ill‐equipped to comply with either Part 112 or 117 ......................... 6 3.3 Food processors are the appropriate entity to ensure the biological safety of food wherever possible ........................................................................................................................................ 8 4. Comments on the definitions of “farm” and “mixed‐type facility” ....................................................... 10 4.1 Overview of AHPA's comments .......................................................................................... 10 4.2 The proposed definition of “farm” inadvertently includes as farm activities the packing and/or holding of certain processed foods ............................................................................................ 10 4.3 The proposed “farm” definition is confusing ..................................................................... 11 4.4 The proposed “mixed‐type facility” definition is unclear .................................................. 13 4.5 AHPA's suggestions regarding the definitions ................................................................... 13 5. Comments regarding the definition of “harvesting” ............................................................................. 15 5.1 Overview of AHPA's comments .......................................................................................... 15 5.2 Summary of the proposed definition and notes regarding FDA's intent ........................... 16 5.3 Problems with the proposed definition ............................................................................. 16 5.4 Most edible botanical RACs are not produce ..................................................................... 18 5.5 Non‐produce botanical RACs require additional harvest activities ................................... 19 5.6 Additional comments regarding heat treatments ............................................................. 21 5.7 Comments regarding multiple RACs derived from the same plant material ..................... 22 5.8 AHPA's suggestions regarding the definition ..................................................................... 23 6. Comments regarding the definitions of “qualified facility” .................................................................. 25 7. Comments regarding other definitions ................................................................................................. 29 7.1 Comments regarding the definition of “cross‐contact” ..................................................... 29 7.2 Comments regarding the definition of “microorganisms”................................................. 29 7.3 Comments regarding the definition of “packing” .............................................................. 29 7.4 Comments regarding the definition of “pest” ................................................................... 30 ‐ i ‐ Docket No. FDA–2011–N–0920 November 22, 2013 7.5 Comments regarding the definition of “rework” ............................................................... 30 7.6 Comments regarding the definition of “small business” ................................................... 30 7.7 Comments regarding the definition of “very small business” ........................................... 31 7.8 Comments regarding the definition of “lot” and new definitions of “batch” and “production code” ................................................................................................................................................... 32 8. Comments regarding the exemptions in § 117.5(g) and (h) ................................................................ 34 8.1 The goal is to identify low‐risk, rather than no‐risk, activities and foods .......................... 34 8.2 The low‐risk activity criteria developed in the RA should be applied consistently ............ 35 8.3 A definition should be provided for “low moisture food,” and moisture levels should be taken into account more consistently in the draft RA ......................................................................... 35 8.4 The low‐risk activity criteria should be revised with respect to refrigeration and freezing36 8.5 The low‐risk activity criteria should be revised with respect to time controls .................. 37 8.6 The low‐risk activity criteria in the RA should be expanded with respect to chemical hazards ................................................................................................................................................... 37 8.7 The RA should be expanded to consider dietary ingredients ............................................ 37 8.8 Packing, holding, and at least some manufacturing/processing should be uniformly considered low‐risk when applied to low‐moisture solid foods................................................................... 37 8.9 Packing, holding, and manufacturing/processing of concentrated sweeteners should be uniformly considered low‐risk .................................................................................................................... 40 8.10 Cut fruits and vegetables should not be inherently disqualified from the “low risk” category ................................................................................................................................................... 42 8.11 Packing, holding, and manufacturing/processing of other appropriate botanical foods should be considered low‐risk .................................................................................................................... 44 8.12 All activities which are part of harvesting when performed on the farm's own crop should be included in § 117.5(h)(2) ............................................................................................................ 47 8.13 Other food/activity combinations that should be included in § 117.5(g) and (h) ........... 49 8.14 FDA should revisit and expand the draft RA if necessary to create comprehensive and rational lists ............................................................................................................................................. 49 8.15 The qualifier of the phrase “intact fruits and vegetables” used in § 117.5(g)(6) is confusing ................................................................................................................................................... 50 8.16 FDA's use of the word “intact” requires clarification ....................................................... 50 8.17 The introductory paragraph to § 117.5(g) is confusing ................................................... 50 8.18 Other areas requiring clarification ................................................................................... 52 ‐ ii ‐ Docket No. FDA–2011–N–0920 November 22, 2013 8.19 A mechanism should be established to add exempted food/activity combinations to the lists ................................................................................................................................................... 52 9. Comments regarding Subpart B ............................................................................................................ 53 9.1 Comments regarding proposed deletions of optional provisions ..................................... 53 9.2 Comments regarding optional vs. mandatory requirements ............................................ 54 9.3 Comments regarding the introductory language of proposed § 117.10 ........................... 54 9.4 Comments regarding proposed § 117.10(b) ...................................................................... 55 9.5 Comments regarding proposed § 117.10(c) ...................................................................... 55 9.6 Comments regarding proposed § 117.20(a)(4) .................................................................. 56 9.7 Comments regarding proposed § 117.20(b)(1) .................................................................. 57 9.8 Comments regarding proposed § 117.20(b)(2) .................................................................. 57 9.9 Comments regarding proposed § 117.20(b)(5) through (7) .............................................. 58 9.10 Comments regarding proposed § 117.35(a) .................................................................... 58 9.11 Comments regarding § 117.35(b) ...................................................................................
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