Justification Request - burden correction

NATIONAL ORGANIC PROGRAM (NOP)

OMB NO. 0581-0191

Justification for Change

October 2018

The National Organic Program (NOP) is requesting consideration of this Justification for Change to revise and simplify the current Information Collection Renewal (ICR) package OMB # 0581-0191 finalized January 17, 2017. The National Organic Program (NOP) recently reviewed the current ICR as part of our ongoing continuous improvement work to assess regulatory burden on operations and certifiers. This process resulted in revising assumptions and calculations in the AMS 71 Grid which are explained below.

Please see the Supplementary document Justification for Change Q15 Breakout that explains the currently approved, and the revised burdens that are changed, side by side and line by line. The revised AMS 71 Grid 09 2018 is also provided. These revisions will decrease the currently approved burden of 7,239,709 hours by 1,947,339 hours so the revised burden is 5,292,370 hours. The total annual responses of 994,966 will decrease by 230,962 so the revised total response burden is 764,004. Only the changes addressed below have been modified. There is no change in the number of respondents, or recordkeeping hours.

1. Revisions in Reporting Burden Hours:

Producers and Handlers

1. The total average reporting (record creation) burden hours for all new and existing producers and handlers (respondents) seeking organic certification for organic system plan (OSP) preparation was calculated at 135 hours in the ICR package finalized in January 2017. This far exceeds the estimated average reporting time of 80 hours per year for operations preparing new OSPs and 40 hours per year for operations updating existing OSPs as described in the Supporting Statement. These estimates of OSP reporting burden have been reviewed and supported through stakeholder comments on previous ICR packages. In addition, because of the complexity of the currently approved AMS 71 Grid, many reporting functions for organic operations were being inadvertently double-counted throughout the AMS 71 Grid.

2. The 2,626,800 hours attributed to certified handlers of food and livestock feed complying with organic label design requirements was excessive. Food and feed label design is primarily responsive to Food and Drug Administration (FDA) and other USDA rules, and is captured in those information collection packages. For instance, FDA attributes about 2 hours of reporting burden to the nutrition statement and ingredient list on a product label. Organic products must identify: 1) each organic ingredient in the ingredient statement with the word, “organic,” or with an asterisk or other reference mark which is defined below the ingredient statement, and 2) the name of the handler and certifying agent on the information panel of package.¹ Organic products may use the word “organic” to modify the name of the product on the main display.

Total Producers and Handlers Correction (a & b): All of the OSP activities for Initial (New) Applications and Annual Updates have been consolidated into two line items – one for new OSP applications for 80 hours and one for annual OSP updates of existing operations for 40 hours. This corrected both double-counting of hours and overestimation of number of responses by operations. Product label design responsive to organic compliance is calculated at 20% of the label design burden (2 hours rather than 10 hours per label) assumed in previously approved burden. This reduced the label design burden by 2,100,440 hours from 2,627,800 to 526,360 hours. This reduces the total reporting hour burden attributed to certified operations by 2,201,242 hours from 4,424,380 to 2,223,138 reporting hours annually. Changes in total responses are explained in 2) Changes in Total Responses below.

Certifying Agents

3. The total reporting burden hours for certifying agents were reassessed and revised using four steps. First, the burden hours for certifying agent review of initial applications and annual updates received from producers and handlers, the scheduling of inspections, and the communication of findings were previously inaccurately calculated at 75% of total operations, when it should have been 100%. Second, these same reporting hours had previously been incorrectly summed with the producers and handlers’ total reporting hours in the AMS 71 Grid. Third, for certifying agent activities related to issuing certificates or denying certification, certifying agent burden hours had been incorrectly calculated at 94% of organic operations annually. Again, activities related to issuing certificates or denying certification should be calculated at 100% of organic operations annually. Fourth, it had previously been calculated that certifying agents were providing copies of all inspection and evaluation reports for all operations to the NOP annually, whereas certifying agents are actually only required to provide examples of three inspection and evaluation reports annually.

4. All Certifying Agent activity related to preparing and maintaining Form TM-10 CG, the application for accreditation, was simplified and consolidated. The consolidation of the burden hours for the accreditation application, evidence of expertise and annual update activities increased burden hours slightly by 56 hours. Certifying agents are fully audited only twice every 5 years. This also corrected the overestimation of the number of responses by certifying agents described below in 2) Changes in Total Reponses.

Total Certifying Agent Burden Hours Correction (c & d): Annual certifying agent review, scheduling of inspections and communication of findings burdens are corrected from 75% to 100% of operations, and those 205,400 hours are now correctly attributed to certifying agents. The annual activities related to issuing certificates to or denying the certification of producers and handers are corrected from 94% to 100% of operations, and increased burden hours by 36,099. Providing copies of three sets of inspection and evaluation reports rather than all reduced burden hours by 23,273. The sum of these corrections and adjustments increased certifying agent reporting burden hours by 192,403 from 54,073 to 246,476 reporting burden hours annually for all certifying agents. There are a total of 79 certifying agents with 16 (20.25%) being State programs.

Inspectors

5. The burden hours for inspectors were previously incorrectly calculated at 82% of total operations when it should have been 100%. Operations are inspected 100% by inspectors annually.

Correction: Annual inspections are corrected from 81% to 100% of operations, and the burden is increased by 61,500 hours from 267,500 to 329,000 hours annually.

2. Changes in Total Responses: The 994,966 total annual responses by 33,254 total respondents is inaccurate. The OSPs prepared by operations seeking or maintaining organic certification are a single document, and should only be counted as a single response. Every component of the OSP should not be counted as an individual response. The same holds true for the Accreditation Applications (Form TM – 10CG) prepared by Accredited Certifying Agents. Their Accreditation Application is prepared only once and then updated as needed. Total annual responses for respondents will decrease by 229,948 responses from 994,966 to 764,004 responses.

1 Organic regulations §205.303, §205.304, & §205.306 Packaged products labeled “100 percent organic”, “organic”, “made with organic (specified ingredients or food group(s))” and labeling of livestock feed. https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=bfa8a5741cd316937027b64f382384d0&mc=true&n=sp7.3.205.d&r=SUBPART&ty=HTML#se7.3.205_1303