| 2018 Justification for Change #0581-0191 Q15 Breakout | ||||||||
| SUMMARY OF 2017 INFORMATION COLLECTION - Currently Approved (Subparts C - F) Organic System Plan (OSP) | SUMMARY OF 2017 INFORMATION COLLECTION - Revised Burden (Subparts C - F) | |||||||
| REGS | REG Text | Previously Approved Burden | REGS | REG Text | New Burden & Format | Difference Between New and Previous Burden | Type of Change | |
| Subpart C - Production & Handling -- Operators submit initial application or update existing Organic System Plan (OSP) | Subpart C & E - Production & Handling -- Operators submit initial application or update existing Organic System Plan (OSP) | |||||||
| 205.201(a)(1) - (6),205.400(b), 205.401d, 205.406(a)(1)(i) 205.406(a)(3) | Initial Application: Operators applying for organic certification for the first time list practices and procedures to be performed and maintained, substances used, monitoring practices & procedures, describe recordkeeping systems, practices to prevent commingling & contact with prohibited substances, and other information as necessary. | 56,800.00 | 205.201(a)(1) - (6),205.400(b), 205.401d, 205.406(a)(1)(i) 205.406(a)(3) | Initial Application consists of: Operators list practices and procedures to be performed and maintained, substances used, monitoring practices & procedures, describe recordkeeping systems, practices to prevent commingling & contact with prohibited substances, and other information as necessary.Consolidated all Organic System Plan regs for operations applying for certification for the first time attributed with corrected hours. | 152,000.00 | 95,200.00 | ADJ | |
| 205.201(a)(1) - (6),205.400(b), 205.401d, 205.406(a)(1)(i) 205.406(a)(3) | Annual Update: Certified operators update lists of practices and procedures to be performed and maintained, substances used, monitoring practices & procedures, describe recordkeeping systems, practices to prevent commingling & contact with prohibited substances, and other information as necessary. | 1,286,500.00 | 205.201(a)(1) - (6),205.400(b), 205.401d, 205.406(a)(1)(i) 205.406(a)(3) | Annual Update: Operators update lists of practices and procedures to be performed and maintained, substances used, monitoring practices & procedures, describe recordkeeping systems, practices to prevent commingling & contact with prohibited substances, and other information as necessary. Consolidated all Organic System Plan regs for certified operations updating their OSPs annually with corrected hours | 1,240,000.00 | -46,500.00 | ADJ | |
| Below items are consolidated into the above Subpart C - Production & Handling -- Operators submit initial application or update existing Organic System Plan (OSP) | ||||||||
| 205.400(b) 205.406(a)(1)(i), 205.201(a)(1) | Operators list practices & procedures to be performed & maintained (application) Inc.in respondents and hrs per response |
32,300.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(1) | Operators practices & procedures to be performed & maintained (update). Incr. in hours per response | 527,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(2) | Operators list substances used (application). Inc.in respondents | 3,800.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(2) | Operators list substances used (update) Inc.in respondents | 124,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(3) | Operators list monitoring practices & procedures to be performed & maintained (application). Inc.in respondents | 7,600.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(3) | Operators list monitoring practices & procedures performed & maintained (update) Inc.in respondents | 217,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(4) | Operators describe recordkeeping system implemented to comply with 205.103 (initial) Inc.in respondents | 3800.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(4) | Operators describe recordkeeping system implemented to comply with 205.103 (update) Inc.in respondents | 124,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(5) | Operators list practices & procedures to prevent commingling & contact with prohibited substances (initial). Inc.in respondents | 3,800.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(5) | Operators list practices & procedures to prevent commingling & contact with prohibited substances (update) Inc.in respondents | 124,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(6) | Operators provide additional information as necessary (initial) Inc.in respondents |
3,800.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.201(a)(6) | Operators provide additional information as necessary (update) Inc.in respondents | 124,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| Subpart D - Labels and Labeling | Subpart D - Labels and Labeling | |||||||
| 205.303- 205.311 | Certified handlers for food design labels in accordance with requirements for products to be labeled. Inc.in respondents | 2,626,800.00 | 205.303- 205.311 | Certified handlers, including livestock feed handlers, design labels in accordance with requirements for products to be labeled. Changed to reflect labeling design attributed to organic compliance only - not the entire label design process which is already responsive to FDA and other USDA rules | 526,360.00 | -2,101,440.00 | ADJ | |
| 205.306 | livestock feed handlers design labels in accordance with requirements for products to be labeled | 1,000.00 | ||||||
| Subpart E - Appli. for Cert. of Operations Annual Update as Appropriate | ||||||||
| Below items are consolidated into the above Subpart C & E - Production & Handling -- Operators submit initial application or update existing Organic System Plan (OSP) | ||||||||
| 205.406(a)(2), 205.401(b) | Operators submit names, business names, addresses, & phone numbers of cert. applicants & persons authorized to act on appli. behalf. Inc.in respondents (All) | 15,500.00 | Function is part of both Initial application and update so consolidated and corrected into Intial & Update above | 0.00 | ADJ | |||
| 205.401d 205.406(a)(3) | Operators submit other information as needed for certification, annual (initial). Inc.in respondents | 1,700.00 | Consolidated into above burden for all all new applicants for organic certification with corrected hours | 0.00 | ADJ | |||
| 205.401(d) 205.406(a)(3) | Operators submit other information as needed for certification (update) Inc.in respondents | 31,000.00 | Consolidated into above burden for all certified operations updating their OSP's annually with corrected hours | 0.00 | ADJ | |||
| Review of Application | Review of Application | |||||||
| 205.402 | Agents review applications; communicate findings; sched. on-site inspec. Decr. in respondents | 141252.00 | 205.402, 205.402(b)(2) | Agents review applications; communicate findings; sched. on-site inspec. ; Corrected to reflect the annual application review and update processing of the paperwork of 100% operations annually. The 141,252 hours for certifying agent desk review of new organic applications and annual updates received from operations were inaccurately calculated at 75% of total operations when it should have been 100%. In addition, these certifying agent reporting hours were calculated with the total reporting hours of operations’ incorrectly in previously reported burden. | 205,400.00 | 58,262.50 | ADJ | |
| 205.402(b)(2) | Agents provide copy of on-site inspec. reports. Dec. in respondents | 5,885.50 | Consolidated into above and corrected to reflect the inspection of 100% of operations annually | 0.00 | ADJ | |||
| 205.403 205.406(b) | Inspectors provide on-site inspection reports to certifying agent, (annual). Inc. in respondents | 267,500.00 | 205.403 205.406(b) | Inspectors provide on-site inspection reports to certifying agent, (annual). Corrected to reflect the inspection of 100% of operations annually | 329,000.00 | 61,500.00 | ADJ | |
| 205.404(b), 205.406(d) | Agents issue certificates of operation; annual & updated certificates. Decr. in respondents | 11,755.20 | 205.404(b), 205.406(d) | Agents issue certificates of operation; annual & updated certificates. Corrected to reflect the inspection of 100% of operations annually | 16,450.00 | 4,694.80 | ADJ | |
| Denial of Certification of Operators | Denial of Certification of Operators | |||||||
| 205.405(c)(1)(ii) | Agents deny certification when applicants noncompliance is not corrected; notification of applicants rights. Dec. in respondents. | 19.75 | 205.405(c)(1)(ii) 205.405(c)(2) | Agents deny certification when applicants noncompliance is not corrected or if applicants fail to respond. Notification of applicants rights. Consolidated with below and corrected to all certifying agents | 79.00 | 39.50 | ADJ | |
| 205.405(c)(2) | Agents deny certification if applicants fail to respond. Dec. in respondents. | 19.75 | 205.405(c)(2) | Consolidated with above and corrected to all certifying agents | 0.00 | ADJ | ||
| Subpart F - Accreditation of Certifying Agents | Subpart F - Accreditation of Certifying Agents Application, Evidence of Expertise, and Annual Updates | |||||||
| 205.501 (a)(2-4), (6-7), (11)(v), (15) & (20-21); 205.503 (a -b), (d)(1-2) & (c-e); 205.504(a -e); 205.510(a)(1-2), and 205.642 | Accreditation of Certifying Agents - Form TM-10CG - Provide Policies, Procedures, Evidence of Expertise and Ability, describe organizational units, primary location, areas of certification (crops, livestock, & handling), States & foreign countries where they operate, lists of currently certified operations, conduct & provide results of performance evaluations of personnel & inspectors, conduct program evaluations of their certification activities, provide procedures for residue testing, and other information that will assist in evaluating their application, and comply with any other requirements | 4,684.50 | 205.501 (a)(2-4), (6-7), (11)(v), (15) & (20-21); 205.503 (a -b), (d)(1-2) & (c-e); 205.504(a -e); 205.510(a)(1-2), and 205.642 | Accreditation of Certifying Agents - Form TM-10CG - Provide Policies, Procedures, Evidence of Expertise and Ability, describe organizational units, primary location, areas of certification (crops, livestock, & handling), States & foreign countries where they operate, lists of currently certified operations, conduct & provide results of performance evaluations of personnel & inspectors, conduct program evaluations of their certification activities, provide procedures for residue testing, and other information that will assist in evaluating their application, and comply with any other requirements. Consolidated Accreditation application activities & 100% annual updating activity common to all certifying agents | 4,740.00 | 55.50 | ADJ | |
| Below items are consolidated into the above Subpart F - Accreditation of Certifying Agents Application, Evidence of Expertise, and Annual Updates | ||||||||
| 205.501(a)(2) & (a)(3) | Agents demonstrate ability to comply with & implement requirmts. for accrediation. Dec. in respondents. | 790.00 | 0.00 | ADJ | ||||
| 205.501(a)(4), 205.501(a)(6) | Agents conduct & provide results of performance evaluations of inspectors & other personnel.Dec. in respondents. | 1,264.00 | 0.00 | ADJ | ||||
| 205.501(a)(7) | Agents have prog. Evaluations conducted of certfication activities (annual). Dec. in respondents. | 632.00 | 0.00 | ADJ | ||||
| 205.501(a)(11)(v) 205.504(c)(2) | Agents provide procedures to prevent conflict of interes & req. emp. To compleete conflict of interest disclosure repts. (annual) Dec. in respondents. | 197.50 | 0.00 | ADJ | ||||
| 205.501(a)(15)(ii) 205.504(d)(1) | Agents provide & send lists of currently certified operations w/application (annual) Dec. in respondents. | 158.00 | 0.00 | ADJ | ||||
| 205.501(a)(21) | Agents comply with other terms & conditions. Decrease in respondents; inc. in responses per respondent; inc. in response time | 632.00 | 0.00 | ADJ | ||||
| 205.503(a), 205.510(a)(1-2) | Agents provide info about their primary location. Dec. in respondents. TM-10CG | 19.75 | 0.00 | ADJ | ||||
| 205.503(b) | Agents provide info about their organization units. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.503(c), 205.501(a)(15), 205.642 | Agents identify areas of certification (crops, livestock, handling) & file certification fee sched. w/Secretary. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.503(d)(1) | State agents document their official authority | 4.00 | 0.00 | ADJ | ||||
| 205.503(d)(2) | Private agents identify their organizational purpose. Dec. in respondents. | 19.50 | 0.00 | ADJ | ||||
| 205.503(e) | Agents list States/foreign countries where they operate or intend to operate. Dec. in respondents. | 19.75 | 0.00 | ADJ | ||||
| Evidence of Expertise and Ability | ADJ | |||||||
| 205.504(a)(1) | Agents list personnel policies & procedures. Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(a)(2) | Agents list names & position descriptions of personnel they intend to use. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.504(a)(3) | Agents list qualifications of insp. & emp. Who review/evaluate applications. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.504(a)(4) | Agents list training provided to personnel. Dec. in respondents. | 158.00 | 0.00 | ADJ | ||||
| 205.504(b)(1) | Agents provide procedures to evaluate applicants, make decisions, issue certificates. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.504(b)(2) | Agents provide procedures to rev. compliance & report violations. Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(b)(3) | Agents provide procedures to comply w/recordkeeping requirements.Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(b)(4) | Agents provide procedures to maintain confidentiality. Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(b)(5) | Agents provide procedures to make inf. Available to the public & provide the info. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.504(b)(6) | Agents provide procedures to sample & do residue testing. Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(c)(1) | Agents provide procedures to prevent conflicts of interest. Dec. in respondents. | 39.50 | 0.00 | ADJ | ||||
| 205.504(e) | agents provide other info they feel will assist in evaluating application. Dec. in respondents. | 79.00 | 0.00 | ADJ | ||||
| 205.501(a)(18) | Agents notify insp. Of certifying agents decision - granting or denying certification of operation that inspector evaluated. Dec. in respondents. | 3,950.00 | 205.501(a)(18) | Agents notify inspectors of 100% of certifying agents decisions - granting or denying certification of operation that an inspector evaluated. Corrected to reflect the inspection of 100% of operations annually | 8,225.00 | 4,275.00 | ADJ | |
| 205.504(d)(2) | Agents provide inspec. Repts. & evaluation documents for operations certified - prev. yr. Decr. In respondents | 23510.40 | 205.504(d)(2) | Agents provide inspec. Repts. & evaluation documents for operations certified. Agents only provide examples of 3 inspection reports each year, not all operations. | 237.00 | -23,273.40 | ADJ | |
| Export Certificates | Import/Export Certificates | |||||||
| 205.505(b) | private agents provide additional assurances with statements of agreement. Dec. in respondents.. | 19.50 | 205.505(b) | private agents provide additional assurances with statements of agreement. Corrected so calculation is based on the number of private agents that are not state programs | 15.75 | -3.75 | ADJ | |
| 205.621(c) | State Programs: States submit revised or amended State organic certification program to the Secretary. | 15.00 | 205.621(c) | State Programs: States submit revised or amended State organic certification program to the Secretary. Corrected for actual number of state programs | 16.00 | 1.00 | ADJ | |
| 205.670(d) | Testing State officials or agents submit results of residue testing to Administrator or Governing State officials |
150.00 | 205.670(d-e)) | Testing State officials or agents submit results of residue testing to Administrator or Governing State officials |
296.25 | -150.00 | ADJ | |
| 205.670 (e) | State officials or agents submit lab results fo residue testing to the AMS Administrator or Governing State Officials | 296.25 | Corrected duplicate interpretation of regulations & Consolidated into above | 0 | ADJ | |||
| TOTAL | 4430157.85 | TOTAL | 2,482,819.00 | -1,947,338.85 | ||||
| File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |