Supporting Statement for a Request to Revise a Currently Approved Information Collection Request (ICR) under the Paperwork Reduction Act
                                       
                Proposed Revision to OMB Control No. 1218-0072 
   
1. OVERVIEW 
      
The purpose of this Supporting Statement is to analyze and describe the burden hours and costs associated with the voluntary information collection activities contained in Pesticide Registration (PR) Notice 2012-1, entitled: "Material Safety Data Sheets as Pesticide Labeling," issued by the U.S. Environmental Protection Agency (EPA) on April 9, 2012.  In PR Notice 2012-1, EPA provides guidance on what could be included in the Safety Data Sheets (SDS) that are required by the Occupational Safety and Health Administration (OSHA) under its Hazard Communication Standard (HCS) (29 CFR 1910.1200).  EPA is issuing the clarification of its policy in order to avoid potential inconsistencies between EPA-approved labels for pesticides regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the SDS that OSHA requires for these chemicals under the HCS. 
      
OSHA recently published a final rule that aligns its HCS requirements with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).  Along with the issuance of that final rule, OSHA is revising the existing Hazard Communication collection of information requirements that are currently approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., and OMB's regulations at 5 CFR part 1320. Identified under OMB Control No. 1218-0072, the revised ICR for the final rule is currently pending review and approval by OMB.
      
Although the OSHA ICR that is currently pending review and approval by OMB addresses the information collection activities associated with preparing an SDS as prescribed by the OSHA final rule, the approach provided in the EPA guidance for pesticide registrants was not considered by OSHA at the proposed rule stage, and is therefore not captured specifically by the ICR that was prepared for that rule. The EPA guidance, which was developed in response to public comments received by OSHA on its proposed rule, clarifies that those preparing an SDS for a pesticide may choose to use the section 15 of the SDS to provide additional information about the pesticide, using the pesticide labeling as the source of that additional information.
      
EPA recognizes that its guidance involves an information collection activity covered by the PRA, which applies to voluntary collections (or in this case a disclosure), as well as those imposed.  As such, EPA and OSHA are collaborating on a subsequent revision to OSHA's ICR identified under OMB Control No. 1218-0072, to ensure that it addresses the activities described in the PR Notice.  EPA is first soliciting public comment on this ICR revision as part of its release of the PR Notice.  After considering public comments on the ICR revision, OSHA will revise its existing ICR identified under OMB Control No. 1218-0072 to capture the information collection activities and burden adjustments, if any, related to EPA's PR Notice 2012-1. 
      
OSHA will publish a separate notice in the Federal Register that will announce the result of OMB's reviews.  Under the PRA, a Federal agency cannot conduct or sponsor a collection of information unless OMB approves it under the PRA, and the agency displays a currently valid OMB control number.  Also, notwithstanding any other provision of law, no employer can be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number.


2. NEED FOR AND USE OF THE COLLECTION
 
   .1.    Authority/Need for the Collection

Section 6(b)(7) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 651 et seq., states that any occupational safety or health standard promulgated by the Secretary of Labor under section 6(b) rulemaking authority "shall prescribe the use of labels or other appropriate forms of warning as are necessary to insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use of exposure."  Many chemicals cause acute injuries or illnesses such as rashes, burns and poisoning, or chronic effects such as cancer or liver damage.  Also, chemicals can pose physical hazards to workers by contributing to accidents such as fires and explosions.  To prevent such occupational hazards, OSHA addressed the issue of hazard information transmittal in its existing HCS (29 CFR 1910.1200), and its collection of information requirements are designed to ensure that the hazards of chemicals produced or imported are evaluated and that information concerning these hazards is transmitted to employers and employees.  This purpose is accomplished through hazard determination, labels, safety data sheets, written hazard communication programs and training.

Under FIFRA, every pesticide sold or distributed in the United States must be registered by EPA (FIFRA §12(a)(1)(A)).  In granting a registration, EPA must determine, among other things, that the pesticide's "labeling" complies with the requirements of FIFRA (FIFRA §3(c)(5)(B)). FIFRA defines "labeling" in section 2(p)(2)(A) to include all written, printed, or graphic matter accompanying the pesticide at any time.  FIFRA also requires that pesticide labeling not be false or misleading as described in FIFRA section 2(q)(1)(A), both in terms of its label and labeling.  EPA has also promulgated several requirements for hazard communication on FIFRA labeling.  See, e.g., 40 CFR Part 156, Subpart D.

EPA regards SDS's for pesticides to be labeling when they accompany the pesticide.  PR Notice 92-4 (October, 1992) explains EPA's policy to allow SDS's to accompany pesticides so long as they do not obscure or conflict with the labeling approved by EPA.  Should an SDS conflict with the approved labeling, it could be misleading to users of the pesticide and therefore cause the pesticide to be considered misbranded and unlawful for sale or distribution.  See FIFRA §§ 2(q)(1)(A) and 12(a)(1)(E).

As indicated previously, OSHA's current HCS requires employers to have chemical hazard communication programs that include labeling, SDS's, and worker training.  FIFRA labels approved by EPA pre-empt OSHA's label requirements, but not the requirements for SDS and worker training (except for certified applicators and agricultural workers for whom EPA has training requirements). 

In the past, there was minimal potential for inconsistency between the HCS and FIFRA requirements because OSHA did not prescribe specific hazard statements, signal words, or pictograms.  However, an SDS that complies with OSHA's recently issued final rule that establishes the HCS/GHS requirements, could be viewed as inconsistent with the FIFRA labeling since some of the label elements (e.g., pictogram(s), signal word(s), and/or hazard statement(s)) could differ for the same hazards that are identified in the FIFRA labeling. 

The guidance in EPA's PR Notice 2012-1 is needed in order to clarify that preparers of an SDS for a pesticide may avoid the potential for inconsistency between the HCS and FIFRA requirements.  That is, the preparer may choose to use the section 15 of the SDS to provide additional information about the pesticide, using the pesticide label as the source of that additional information.  Without this guidance, an SDS prepared in compliance with the revised OSHA HCS might be subject to regulatory or enforcement action for misbranding under FIFRA.

As indicated previously, OSHA recently published a final rule that aligns its HCS requirements with the GHS.  The information collection activities contained in that final rule are addressed in an ICR revision entitled: "Supporting Statement For The Revised Hazard Communication Standard  (29 CFR 1910.1200, 1915.1200, 1917.28, 1918.90, 1926.59, and 1928.21) Incorporating Globally Harmonized System of Classification and Labelling of Chemicals (OMB Control No. 1218-0072 (February 2012))." A copy of the OSHA ICR revision for the final rule can be obtained from the RegInfo.gov Web site, http://www.reginfo.gov/public/do/PRAMain.


2.2 Users of the Data

As indicated in the OSHA ICR, the primary users of the SDS are employers and employees in facilities that manufacture, process or use chemicals covered by the OSHA HCS.  The HCS covers over five million workplaces in which employees are potentially exposed to hazardous chemicals. Included in that universe are facilities in the U.S. that manufacture, process or use pesticides.  These entities use the SDS to "insure that employees are apprised of all hazards to which they are exposed, relevant symptoms and appropriate emergency treatment, and proper conditions and precautions of safe use or exposure," consistent with section 6(b)(7) of the OSHA. 

The PR Notice issued by EPA may be used by preparers of an SDS for a pesticide.  According to the National Pesticide Information Retrieval System (NPIRS, 2011) there are 1,723 pesticide registrants, i.e., companies that hold a registration for a pesticide product issued by EPA under FIFRA.  These are the entities that are expected to engage in the information collection activities related to PR Notice 2012-1.

1. NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA
 
   1.1.    Non-Duplication

As indicated in the OSHA ICR for HCS, several regulatory authorities within the U.S. exercise jurisdiction over chemical hazard communication. In addition to OSHA's HCS, the Department of Transportation (DOT) regulates chemicals in transport, the Consumer Product Safety Commission (CPSC) regulates consumer products, and the Environmental Protection Agency (EPA) regulates pesticides, as well as having other authority over labeling under the Toxic Substances Control Act.  Each of these regulatory authorities operates under different statutory mandates, and has adopted distinct hazard communication requirements.

Although some differences across agencies exist due to their statutory mandates, EPA and OSHA are minimizing the potential for inconsistencies related to those differences. EPA's PR Notice 2012-1 clarifies what the preparer of the SDS may do to ensure that they comply with both the revised OSHA HCS and EPA FIFRA labeling requirements. 

   1.2.    Public Notice Required Prior to ICR Submission to OMB

EPA is in the process of soliciting comments pursuant to section 3506(c)(2)(A) of PRA, and will summarize those results in this section of the revised Supporting Statement that is submitted to OMB for review and approval.  Specifically, EPA is soliciting comments and information to enable it to:

   * Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agencies, including whether the information will have practical utility.
   * Evaluate the accuracy of the estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
   * Enhance the quality, utility, and clarity of the information to be collected.
   * Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.  In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

   1.3.    Effects of Less Frequent Collection

There is no submission or collection, and the activities described in PR Notice 2012-1 only provide an option for preparers of an SDS for a pesticide.  It is assumed that anyone that chooses the option outlined in PR Notice 2012-1 would only need to engage in those activities once, when they prepare the SDS that is required by the OSHA regulations. 

   1.4.    General PRA Guidelines

None of the guidelines under the PRA are exceeded by the optional approach outlined in the EPA guidance. 


   1.5.    Confidentiality and Sensitive Questions

Information contained on pesticide labels or as part of pesticide labeling under FIFRA is public information and is not confidential.  The inclusion of this information on the SDS does not involve any information that would be considered to be confidential.  In addition, no information of a sensitive or private nature is involved in this information collection activity.  As such, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.


1. THE RESPONDENTS AND THE INFORMATION COLLECTION ACTIVITY
 
   2.1.    Potential Respondents

For purposes of this Supporting Statement, the universe of potential respondents includes pesticide registrants, as the entities that would likely prepare an SDS if required to do so by the OSHA HCS. Using the North American Industrial Classification System (NAICS) codes, EPA estimates that this universe may include, but is not limited to, facilities within the following industry categories:

                                Type of Entity
                                     NAICS
                   Example of Potentially Affected Entities
Chemical Manufacturers and Importers
325, 32411
Persons who manufacture (defined by statute to include import) one or more of the subject chemical substances.
Processors
325, 32411
Persons who process one or more of the subject chemical substances.
 
 
   4.1.    Information Collection Activity

The information collection activity covered by this Supporting Statement is the voluntary option described in EPA's PR Notice 2012-1.  Specifically, the preparer of an SDS for a pesticide may choose to include in Section 15 of the SDS the hazard information already approved by EPA for the pesticide label. In choosing to do this, a respondent may undertake one or more of the following activities:

      (a) Review EPA's PR Notice 2012-1.

      (b) Determine whether to follow the optional approach and use Section 15 to provide the additional information from the pesticide label. 
            oo             If the optional approach is not chosen, there is no further activity to discuss in this Supporting Statement. 
            oo             If the optional approach is chosen, the respondent would identify which information from the pesticide label they would want to include in the SDS.
         
      (c) Follow EPA's PR Notice 2012-1 to include the explanation and pesticide label information in the SDS.

The overall activities associated with preparing the SDS are addressed in the OSHA's ICR for the HCS.  The activities described here provide additional detail related to including additional pesticide information in section 15 of the SDS.
1. AGENCY ACTIVITIES, COLLECTION METHODOLOGY, INFORMATION MANAGEMENT, AND BURDEN/COSTS

The only EPA activities related to PR Notice 2012-1 involve the potential for answering questions and providing assistance.  As such, there are no Agency activities for which burden, costs or information management considerations apply.


2. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

   2.1.    Overview

The burden and cost related to the SDS requirements in OSHA's HCS are covered by the OSHA ICR identified under OMB Control No. 1218-0072.  The revised ICR submitted to OMB for OSHA's recently issued final rule, presents the burden hours and costs for completing revisions to comply with the recently promulgated requirements related to the SDS and labeling under OSHA's revised HCS. Since employers will have three years to complete the SDS revisions under the OSHA final rule, OSHA annualized those burden hours and costs over a three year period, yielding an estimated 1,138,560 hours at a cost of $76,144,960 to revise the SDS and labeling consistent with the recent OSHA final rule.
      
This Supporting Statement provides additional detail on estimated burden and costs related to the activities associated with the SDS preparer's inclusion in section 15 of the SDS additional pesticide information from the EPA approved labeling, as described in EPA's PR Notice 2012-1.  EPA and OSHA believe that this burden is reflected in the estimate provided by OSHA in its ICR, and EPA is providing this additional information to supplement that estimate. 
      
The following sections explain the assumptions and methods that were used to estimate the burden and costs for this ICR, along with a summary of the cost and burden calculations.


   2.2.    Estimating Total Respondent Burden and Cost

      2.2.1.       Methodology Used

The methodology used for estimating the burden hours and costs in this Supporting Statement, which are limited to the activities described in EPA's PR Notice 2012-1, is based on the methodology  used by OSHA in its revised ICR for the final revisions to the HCS.  Here are some key points from that ICR that guided the estimate provided in this Supporting Statement:

   * Respondent activities to comply with the HCS final rule regarding revisions to the SDS will be incurred as a one-time transition burden over the three-year phase-in period established by the OSHA final rule. 
   * The OSHA ICR considered that for establishments producing hazardous chemicals, the revised HCS would involve reclassifying chemicals in accordance with the new classification system; revising/preparing the SDS; revising labels associated with hazardous chemicals; affixing the new labels to containers holding the chemical; and dispatching new SDSs with new shipments of the chemicals. 
   * The burden hour and cost estimates, including loaded wage rates of $66 an hour, are taken from the OSHA ICR, which based its estimates on the Final Economic Analysis (FEA) prepared by OSHA for the modifications to the HCS.  
         o          For firms with 500 or more employees, OSHA assumes an employer will spend 3 hours per SDS to reclassify their chemicals and change SDS's and labels to a GHS- compliant regulation.  OSHA based this time estimate on the actual experience of three firms, 2 firms that comply with the recent Japanese labeling regulations and one large firm that currently uses a state-of - the-art database system. 
         o          In firms with 100-499 employees, OSHA estimates that an employer will spend a total of 5 hours per SDS to convert to the new system. This estimate includes 3 hours to obtain and reorganize the SDS's information into the 16  -  section format, change the SDS and label formats, and input the data. These employers will spend 2 hours maintaining their SDS's and labels in a commonly used word processing system and are expected to perform chemical classification calculations using simple methods. These firms are already producing 9  -  section performance oriented SDS's. 
         o          OSHA estimates that firms with 20-99 employees have not yet converted to the 16-section SDSs and assumes these firms will spend 7 hours per SDS to reclassify chemicals and make changes to SDSs and labels. 
         o          Firms with 1-19 employees produce fewer products than those firms in the 20-99 and above category, and OSHA assumes it will take these firms 7 hours per SDS to reclassify their chemicals and revise their SDSs and labels.

For purposes of this Supporting Statement, the activities only involve the preparation or revision of the SDS for pesticides, which is a subset of those activities already captured by the OSHA ICR. Although the burden and costs for preparing or revising the SDS are not specifically described in the OSHA ICR, this document estimates the burden and costs for the SDS preparer for a pesticide to include the EPA approved labeling information in section 15 of the SDS.  In addition, EPA will annualize the total potential burden and costs discussed in this Supporting Statement over three years in the same manner that OSHA did in its ICR for the HCS revisions.

      2.2.2. Total Number of Potential Respondents

The PR Notice issued by EPA may be used by preparers of an SDS for a pesticide, which EPA assumes will be the pesticide manufacturer or processor (see discussion in 4.1. of this Supporting Statement). According to NPIRS (NPIRS, 2011), there are 1,723 pesticide registrants, i.e., companies that hold at least one registration for a pesticide product issued by EPA under FIFRA.  Since the guidance provided in PR Notice 2012-1 applies only to those pesticide registrants who choose to follow the EPA guidance in preparing an SDS for one of their products, EPA is not able to provide a precise estimate of the potential number of respondents.  In order to provide a conservative estimate, however, EPA assumes that as many as one third of all pesticide registrants might choose to follow the guidance provided in EPA's PR Notice 2012-1.  Therefore the estimated total number of potential respondents that may choose to include additional pesticide labeling information in section 15 of the SDS is 574 (1,723 / 3).


      2.2.3. Total Number of Potential Pesticide SDSs
      
Under the OSHA HCS, an SDS may be prepared for a specific chemical or on a product basis. At this point, it is difficult for EPA to estimate how many of the approximately 18,580 pesticide products (NPIRS, 2011) might involve an SDS, and of that, how many might be revised as described by PR Notice 2012-1.  In order to provide a conservative estimate, however, EPA assumes that as many as one third of all pesticide products might involve an SDS, and that as many as half of those SDS' could involve the inclusion of additional pesticide information in Section 15 of the SDS as described in EPA's PR Notice 2012-1.  Therefore the estimated total number of potential SDS' that would include the additional pesticide labeling information in section 15 of the SDS is 3,097 (18,580 / 3) / 2). Considering the estimated total number of potential respondents, and assuming only one potential response per chemical, the number of average responses per respondent is 5.4 (3,097 / 574 respondents).

      2.2.4.       Estimated Burden and Costs per SDS

As summarized in 6.2.1. of this Supporting Statement, OSHA estimated the burden and costs for a company to reclassify chemicals in accordance with the new classification system; revise the SDSs and labels associated with hazardous chemicals; affix the new labels to containers holding the chemical, and dispatch new SDSs with new shipments of chemicals.  Varying based on the size of the firm, the OSHA burden estimate for these activities ranges from 7 hours per SDS for small entities to 3 hours for entities with 500 or more employees.  Of course this estimate covers all of the activities, while this Supporting Statement is only intended to estimate how much of that burden could be assigned to revising an SDS prepared for a pesticide based on the EPA guidance in PR Notice 2012-1.

Considering that the EPA guidance consists of the inclusion of language that is already available in the PR Notice and the EPA approved labeling for the particular pesticide, EPA assumes that the preparer of the SDS for a pesticide will simply need to copy that information into the SDS.  Given the nature of this activity, EPA assumes that this burden is not likely to vary based on the size of the firm.  As such, EPA estimates the burden hours for the preparer of an SDS for a pesticide to include additional pesticide labeling information in section 15 of the SDS is approximately 0.25 hours per SDS.  

The OSHA ICR provides a loaded hourly wage rate of $66, which is used to calculate the costs associated with the burden hours.  Using this same wage rate, EPA estimates the cost of the burden hours for the preparer of an SDS for a pesticide to include additional pesticide labeling information in section 15 of the SDS is approximately $16.50 per SDS (0.25 hours x $66).  


   2.3.    Bottom Line Burden Hours and Costs
 
      1.5.1. Total Respondent Burden Hours and Costs

Based on the information and estimates provided in 6.2. of this supporting statement, EPA estimates the total burden to be 774 hours (3,097 pesticides with revised SDSs using the EPA guidance x 0.25 hours burden per SDS), and the estimated per respondent burden is estimated to be 1.4 hours (0.25 hours per response x 5.4 responses per respondent.  EPA estimates the total costs for this burden to be $ 51,084  (774 hours x $ 66 per hour), and the estimated per respondent cost is estimated to be $ 89 ($51,084 / 574 respondents).

Averaged over three years, the estimated annual burden and costs related to the activities described in PR Notice 2012-1 are 258 hours (774.2 hours / 3), and $ 17,028 ($51,084 / 3).

      2.5.2. Total Agency Burden Hours and Costs

Based on EPA's minimal involvement in the implementation of the optional approach described in PR Notice 2012-1, as discussed in chapter 5 of this Supporting Statement, EPA has not estimated any burden and costs for EPA.


   5.1.    Reasons for Change in Burden

This request supplements an existing OSHA ICR, identified under OMB Control No. 1218-0072, to ensure that it addresses the activities described in the EPA PR Notice 2012-1.  This request does not, however, result in any change to the burden estimate that will be in the OMB inventory when it acts on the OSHA ICR revision to the HCS, which was submitted to OMB recently for approval of the burden hours related to the recently finalized HCS revisions.  As such, after considering public comment on the supplemental information for the estimates provided in that OSHA ICR, OSHA intends to submit this request to OMB as a supplement to the existing ICR without changing the burden estimate.


   5.2.    Burden Statement

The annualized public burden for this collection of information, which involves the activities associated with the SDS preparer's inclusion in section 15 of the SDS additional pesticide information from the EPA approved labeling as described in EPA's PR Notice 2012-1, is estimated to average about 1.4 hours per respondent, or 0.25 hours per SDS.  This request supplements an existing OSHA ICR, identified under OMB Control No. 1218-0072, and will be incorporated into that ICR in the future. Burden is defined in 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a current and valid OMB control number. 

For purposes of soliciting public comment on the proposed estimates related to the EPA guidance, EPA established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2012-0176, which is available for online viewing at http://www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is (703) 305-5805.  You may submit comments regarding the Agency's need for providing this guidance, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated techniques.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2012-0176 and OMB Control No. 1218-0072, to (1) EPA online using http://www.regulations.gov (our preferred method), or by mail to: OPP Regulatory Public Docket (7502P), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460 - 0001.  

   5.3.    Next Step in the PRA Process for this ICR
      	
EPA and OSHA will consider the comments received and amend this Supporting Statement as appropriate. The final document will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12.  OSHA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments. 


1. ATTACHMENTS to this SUPPORTING STATEMENT

All of the attachments listed below can be found in the docket for this ICR, identified as Docket ID No. EPA-HQ-OPP-2012-0176, which is accessible electronically through http://www.regulations.gov, or the URL address included in the following listing.

Attachment A:  Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.
http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf. 

Attachment B:  Pesticide Registration (PR) Notice 2012-1, entitled: "Material Safety Data Sheets as Pesticide Labeling," [April 9, 2012]. http://www.epa.gov/PR_Notices/. 

Attachment C:  Pesticide Registration (PR) Notice 1992-4, entitled: "Material Safety Data Sheets as Pesticide Labeling," October, 1992.  http://www.epa.gov/PR_Notices/#1992.


