January 19, 2017
Supporting Statement for an Information Collection Request (ICR)
Under the Paperwork Reduction Act (PRA)
Title: Proposed Rule: Procedures for Chemical Risk Evaluation under TSCA
ICR Numbers: EPA ICR No.: 2559.01; OMB Control No.: 2070-NEW.
EPA Form Numbers: tbd
Docket ID Number: EPA-HQ-OPPT-2016-0654
The information collection request (ICR) that explains the information collection activities and related burden and cost estimates, as well as other supporting documents related to the ICR, are available in the docket established for the rulemaking. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave., N.W., Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about EPA’s public docket, visit http://www.epa.gov/dockets.
This is a new ICR that addresses the information collection activities that are contained in a proposed rule, entitled “Procedures for Chemical Risk Evaluation under the Amended Toxic Substances Control Act. Under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid control number issued by the Office of Management and Budget (OMB). The OMB control numbers are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in 40 CFR part 9.
Before submitting an ICR to OMB for review and approval under the PRA, an agency must solicit comments pursuant to PRA §3506(c)(2)(A) and 5 CFR 1320.8(d)(1). After considering comments received on the draft ICR, the agency must submit the ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. In announcing the submission of the final ICR to OMB for review and approval, the agency must provide another opportunity for public review and comments on the revised ICR pursuant to 5 CFR 1320.12(c).
The Environmental Protection Agency (EPA) is developing a proposed rule in response to new provisions outlined in the Frank R. Lautenburg Chemical Safety of the 21st Century Act passed in June 2016. The proposed rule establishes the process the Agency will adhere to in conducting chemical risk evaluations. Chemicals that will undergo this evaluation include chemicals the Agency has prioritized, as well as chemicals for which EPA has granted requests made by manufacturers to have the chemicals evaluated under EPA’s risk evaluation process. The proposed rule outlines the criteria and information chemical manufacturers must provide for EPA to consider a chemical substance for risk evaluation. The proposed rule only outlines what information must be provided, the formats acceptable, and provides details on the risk evaluation process and the commitment a chemical manufacturer makes to the process when submitting a chemical substance for evaluation consideration. Related fees triggered by submitting a chemical substance for consideration for a risk evaluation is being addressed in a separate rulemaking. The portions of the proposed rule that trigger this Information Collection Request (ICR) consist of the submission package of information and criteria required for the Agency to determine whether or not to conduct a risk evaluation of the requested chemical substance.
Legal authority: The Toxic Substances Control Act (TSCA), 15 U.S.C. § 2605(b).
Respondents/affected entities: Entities potentially affected by this ICR include persons that manufacture chemical substances and request a chemical be considered for risk evaluation by EPA.
Respondent’s obligation to respond: Respondents are not obligated to respond or report to EPA. Submitting under this ICR is completely voluntary.
Confidentiality of responses: Responses may contain confidential business information but persons submitting a response are subject to EPA confidentiality regulations at 40 CFR part 2, subpart B.
Estimated total number of potential respondents: 10
Frequency of response: On occasion. Submission by a manufacturer is completely voluntary.
Estimated total annual burden: 960.3 hours. Burden is defined at 5 CFR 1320.3(b).
Estimated total annual costs: $69,353
Changes in the estimates: Not applicable. This is a request for a new OMB Control Number.
TSCA – Under section 6(b)(4) of TSCA (15 U.S.C. §2605(b)(4)), EPA is required to establish, by rule, a process to conduct risk evaluations. Specifically, EPA is directed to use this process to “determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator under the conditions of use.” (15 U.S.C. §2605(b)(4)(A). Sections 6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements, under TSCA, applicable to this process, including provisions that direct which chemical substances must undergo evaluation, the development of criteria for manufacturer-requested evaluations, the minimum components of an Agency risk evaluation, and the timelines for public comment and ultimate completion of the risk evaluation. Section 6(b)(4) authorizes EPA to:
Conduct risk evaluations pursuant to specific requirements in the statute and the promulgated risk evaluation rule on chemicals prioritized by the Agency or chemicals for which EPA has granted requests made by manufacturers to have the chemicals undergo EPA’s risk evaluation;
Develop a process of risk evaluation;
Establish the form and manner and criteria that govern manufacturer requests that a substance they produce undergo EPA’s risk evaluation; and
Make a final unreasonable risk determination on a chemical substance under the conditions of use
This proposed rule:
Establishes a process to conduct risk evaluations to determining whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use;
Establishes the form and manner and criteria that govern manufacturer requests that a substance they produce undergo EPA’s risk evaluation;
Enumerates the requirements and deadlines that must be adhered to in completing a risk evaluation; and
Provides opportunity for public comment during two stages of a risk evaluation process.
The information collection activities covered by this ICR are necessary in order for EPA to review information provided by chemical manufacturers and determine if the chemical substance is suitable for risk evaluation. Without collecting the information outlined in the proposed rule, there would not be a way for EPA to determine if enough data and information meeting the standards in TSCA section 26(h) are available to perform a risk evaluation of the requested chemical substance within the timeframe outlined in the new legislation.
EPA. This information collection will provide EPA with information necessary to conduct a risk evaluation on a chemical substance and each submission request must comply with all procedures and criteria outlined in the proposed rule. A request meets EPA’s criteria if it includes or references all of the information necessary for the Agency to conduct a risk evaluation addressing all the circumstances constituting conditions of use of the chemical substance within the meaning of TSCA section 3.
EPA will use this information collection to (1) determine if the criteria has been meet for risk evaluation requests and (2) conduct the risk evaluation if the request is granted.
The EPA’s collection pursuant to the TSCA section 6(b) regulations do not duplicate any other collection. There is no other Federal program that requires the information collection activities related to the prohibitions under the proposed rule.
The notice of proposed rulemaking serves as the public notice for this ICR. Interested parties should submit comments referencing Docket ID No. EPA-HQ-OPPT-2016-0654 to the address listed at the end of this document. Responses will be taken into account in developing the final rulemaking.
On August 9, 2016, the Agency held a one-day public meeting to hear from stakeholders to better understand their viewpoints on the development of the chemical risk evaluation rule. Forty-seven commenters provided oral comments, and 57 written comments were received in the docket. The commenters included representative from industry, environmental groups, academics, private citizens, trade associations, and health care representatives, and provided a diversity of perspectives. The Agency has held additional meetings with interested stakeholder groups to review some of the more specific interpretations of the law language.
Due to the nature of the triggering events that initiate information collection activities under the proposed rule, less frequent collection is not feasible. The proposed rule only applies to voluntary actions by chemical manufacturers. Submission of information thus is on an as-needed, on-occasion basis, as initiated by respondents. EPA cannot control when or how often respondents elect to submit a chemical substance for risk evaluation consideration. Less frequent collection would mean respondents are not being required to submit data at all. However, without such data, EPA would not be able to consider chemical substances for risk evaluation at the request of chemical manufacturers as mandated in TSCA.
EPA believes that the submission requirements do not unduly burden small businesses. EPA concludes that the proposed information collection request has no significant impacts on any of the entities subject to this ICR as firms self-select to report and when doing so have a cost-revenue impact of less than 1 percent.
This ICR is consistent with OMB’s general guidelines. Companies will only submit information under this ICR on a completely voluntary basis if the company submits a chemical substance for consideration of a risk evaluation. Therefore, this ICR does not exceed the Paperwork Reduction Act guidelines at 5 CFR 1320.5.
Large portions of the information required as part of the risk evaluation request submission may be considered by the submitter to be a trade secret, proprietary, or “confidential business information” (CBI). However, EPA requires the submission of such information because it is essential for providing a basis to determine unreasonable risk. EPA cannot draw conclusions or make assumptions concerning toxicological effects and potential risks without examining physicochemical structure, methods of production, byproducts, potential uses, exposure data, etc.
The Agency’s policies allow public involvement while preserving confidentiality. TSCA section 14(a) prohibits, except in limited circumstances, the disclosure of trade secret information. TSCA section 14(d) allows disclosure of health and safety studies, including underlying data, unless these studies disclose confidential process or mixture information. Under 40 CFR 720.85 and 720.87(See also 40 CFR part 2), when the specific chemical identity or use data are claimed confidential, the Agency requires the submitter to provide generic descriptions for inclusion in Federal Register notices and the public file. Additionally, the submitter must provide a “sanitized” copy of all health and environmental effects data, with confidential information deleted, for placement in the public docket. Within the Agency, only personnel with the required clearance may handle CBI.
Based on its experience, EPA expects that most information included in requests for risk evaluations notices will be CBI. EPA has developed an elaborate system to prevent unauthorized disclosure of CBI. This system includes procedures for logging material in and out of the Confidential Business Information Center (CBIC) at EPA headquarters and procedures for photocopying and transmitting CBI. These procedures apply to CBI submitted by manufacturers, as well as CBI generated by EPA staff in the course of their review. Access to CBI is restricted to persons who need the information for their work. No one is allowed access to CBI without first undergoing instruction on procedures for handling CBI. Special procedures have been instituted to restrict access to computerized CBI. These procedures are detailed in the “TSCA CBI Protection Manual,” October 2003. EPA believes these procedures protect confidential information while providing the public with as much information as possible.
Any information being sent via Central Data Exchange (CDX) is transmitted using secure technologies to protect CBI. The software encrypts company submissions using a Federal Information Processing Standards (FIPS) compliant encryption module. The encryption module employs a public key algorithm which converts readable text into encrypted text. This public key is downloaded from CDX to the submission software, and the corresponding private key is sent to EPA’s New Chemical System (NCS). The encryption remains while the submission is transmitted via CDX to NCS. The file can be decrypted only with the NCS's private key when it has reached its final destination. The NCS is the only party that possesses the private key, which converts the encrypted text back into readable text.
The same thing will occur for all correspondence going back to the submitter. The NCS and submission software are also provided with a set of public and private keys, so that correspondence containing any potential confidential business information will remain encrypted during transmission via CDX and can be opened only by the submitter within the appropriate software.
The information collection activities do not include questions of a sensitive nature.
In connection with administering the TSCA mandated review of chemical substances submitted by chemical manufacturers for risk evaluation consideration, EPA performs the following activities:
Evaluates the request to make a preliminary determination as to whether it complies with the requirements described in the proposed rule
Within 15 days of receiving a request, publishes the request in the Federal Register and provides a minimum public comment period of 30 days
Within 9 months of the end of the comment period, determines whether the request meets the criteria and requirements and notifies manufacturer(s) of its determination
Does not apply to this information collection. Submission of information under this collection is on an as-needed, on-occasion basis, initiated by the respondents.
EPA will make use of existing technology to simplify the submission process. Respondents will submit the initial request package and any supplemental information to the Agency via CDX. This is the same system used for section 5 submissions to EPA. Therefore, respondents may already be familiar with the system and the system has the capabilities to receive and send information claimed as CBI.
For each respondent category, this section of the ICR describes the respondents, the information collection activities and related estimates for burden and costs associated with those activities.
The collection specifies submissions to EPA when a chemical manufacturer elects to submit a chemical substance for potential risk evaluation by the Agency. The North American Industrial Classification System (NAICS) codes associated with industries most likely affected by the paperwork requirements are described below:
3222 3241 |
Converted Paper Products Manufacturing Petroleum and Coal Product Manufacturing |
3251 |
Basic Chemical Manufacturing |
3252 |
Resin, Synthetic Rubber, and Artificial Synthetic Fibers and Filaments Manufacturing |
3255 |
Paint, Coating, and Adhesive Manufacturing |
3256 |
Soap, Cleaning Compound, and Toilet Preparation Manufacturing |
3259 |
Other Chemical Product and Preparation Manufacturing |
3261 |
Plastics Product Manufacturing |
3262 |
Rubber Product Manufacturing |
3271 |
Clay Product and Refractory Manufacturing |
3272 |
Glass and Glass Product Manufacturing |
3273 |
Cement and Concrete Product Manufacturing
|
The proposed rule provides the information and criteria chemical manufacturers are required to meet when submitting a chemical substance to EPA for risk evaluation consideration. The submissions outlined in the proposed rule and covered by this ICR are completely voluntary and no chemical manufacturer is mandated to submit a chemical substance for risk evaluation consideration.
The rule requirements include the following:
Name, mailing address, and contact information of the entity (or entities) submitting the request. If more than one manufacturer submits the request, all individual manufacturers must provide their contact information.
Full information on the chemical identity of the chemical substance that is the subject of the request. At a minimum, this includes, all known names of the chemical substance, including common or trades names, chemical identity, CAS number, and molecular structure of the chemical substance.
A complete list of the reasonably available information that is consistent with the standards in TSCA section 26(h) and that is relevant to whether the chemical substance presents an unreasonable risk of injury to health or the environment. The list must be accompanied by an explanation as to why such information is adequate to permit EPA to complete a risk evaluation addressing all the circumstances that constitute conditions of use of the chemical substance within the meaning of TSCA section 3 (i.e., all circumstances under which the chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of). The request need not include copies of the information; citations are sufficient. The request must include or reference all reasonably available information on the health and environment hazard(s) of the chemical substance, health and environmental exposure(s), and exposed population(s). At a minimum this must include information relevant to the following:
(A) The chemical substance’s hazard and exposure potential;
(B) The chemical substance’s persistence and bioaccumulation;
(C) Potentially exposed or susceptible subpopulations they believe to be relevant and that EPA should evaluate in the risk evaluation;
(D) Whether there is any storage of the chemical substance near significant sources of drinking water;
(E) The chemical substance’s conditions of use or significant changes in conditions of use;
(F) The chemical substance’s production volume or significant changes in production volume; and
(G) Any other information relevant to the risks potentially presented by the chemical substance.
The request must include a commitment to provide to EPA any referenced information upon request. In addition, if the manufacturer previously conducted its own risk assessment of the chemical substance, or possesses or can reasonably obtain any other pre-existing risk assessment, the request must include a commitment to provide such assessments to EPA upon request.
A signed certification that all information contained in the request is accurate and complete, as follows:
I certify under penalty of law that this document and all attachments were prepared under my direction or supervision and the information contained therein, to the best of my knowledge is, true, accurate, and complete and I have not withheld any relevant information. I am aware there are significant penalties for submitting incomplete, false and/or misleading information, including the possibility of fine and imprisonment for knowing violations.
Optional Elements. A manufacturer may provide evidence to demonstrate that restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce or health or the environment, and that as a consequence the request is entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).
Confidential Business Information.
(A) Persons submitting a request under this subpart are subject to EPA confidentiality regulations at 40 CFR part 2, subpart B.
(B) In submitting a claim of confidentiality, a person must certify the truth of the following statements concerning all information claimed as confidential:
I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate. I further certify that, pursuant to 15 U.S.C. 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that
(i) My company has taken reasonable measures to protect the confidentiality of the information;
(ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
(iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
(iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
(C) Each claim of confidentiality, other than a claim pertaining to information described in TSCA section 14(c)(2), must be accompanied by a substantiation in accordance with 40 CFR 2.204(e)(4).
(D) Manufacturers must supply a structurally descriptive generic name where specific chemical identity is claimed as CBI.
(E) Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001.
Number of Entities Affected
EPA developed estimates for number of manufacturers who are likely to elect to submit a chemical substance for risk evaluation. Submissions of this nature have never been collected by the Agency before, so the actual number of expected submittals is relatively unknown. However, EPA is limited to performing 10 risk evaluations per year. Until actual data based on the number of submissions received per year is available, a maximum estimate is assumed. The total number of entities affected by the recordkeeping and reporting requirements of the rule, therefore, is estimated to be 10 chemical manufacturers.
Rule Familiarization Burden
EPA assumes that each manufacturer who elects to submit a chemical substance for risk evaluation consideration is assumed to spend one hour becoming familiar with the requirements of the rule and developing an understanding of what actions are necessary to complete the forms and submission package. This cost is included as part of the burden of completing the submission package.
CDX Electronic Reporting Burden
Manufacturers requesting a chemical substance be considered by EPA for risk evaluation are required to provide the submission package to the Agency via the CDX electronic system. While several manufacturers may be familiar with the CDX system and are registered users because the same system is used for new chemical submissions to the Agency (e.g., pre-manufacture notice, significant new use notice, low volume exemptions), there is no way to estimate which manufacturers submitting risk evaluation requests are familiar with CDX and which are new to the system. Therefore, EPA assumes submissions under this information collection are performed by new users of CDX, which may result in an overestimate of burden.
The CDX electronic reporting burden includes registration to CDX, familiarization with the subscriber agreements, potential use of the help desk, and problem resolution. The burden estimates used in this ICR are based off of estimates in EPA ICR No. 2502.02, resulting in a burden of 2.83 hours per respondent.
Submission Package Burden
Chemical manufacturers electing to request that EPA consider a chemical substance for risk evaluation must provide a submission package including the following information: contact information of requesting entity(s), full chemical identity information, a complete list of reasonably available information consistent with TSCA section 26(h) standards that is relevant to an unreasonable risk determination, all the circumstances that constitute conditions of use within the meaning of TSCA section 3, a commitment to provide EPA any referenced information upon request of the Agency, and a signed certification that all information in the submission is accurate and complete.
While submissions of this nature have never been required or requested by EPA in the past, the submission package is not dissimilar from the information required in pre-manufacture notices collected under TSCA section 5. Data on the length of time it takes companies to prepare and submit pre-manufacture notice is well documented in other rule makings and ICRs. Until specific data becomes available on the burden involved in developing and submitting risk evaluation requests, the reporting burden for pre-manufacture notices will be used as a proxy estimate (EPA ICR No. 0574.16). Therefore, the estimated burden for developing and submitting a risk evaluation request is 92.2 hours per respondent.
Costs
EPA assumes no direct costs are associated with this collection. Any fees to be collected as part of the risk evaluation requests will be covered under the fees rule making required under TSCA and accompanying ICR. Labor costs are based on fully loaded wage rates. The estimated wage for manufacturers is $72.22. More detail on the calculation of wage rates is presented in Attachment 1.
Information Collection Activities
The proposed rule provides the information and criteria chemical manufacturers are required to meet when submitting a chemical substance to EPA for risk evaluation consideration. The submissions outlined in the proposed rule and covered by this ICR are completely voluntary and no chemical manufacturer is mandated to submit a chemical substance for risk evaluation consideration.
Chemical manufacturers electing to request EPA consider a chemical substance for risk evaluation must provide a submission package including the following information:
Contact information of requesting entity(s),
Full chemical identity information,
A complete list of reasonably available information consistent with TSCA section 26(h) standards that is relevant to an unreasonable risk determination,
All the circumstances that constitute conditions of use within the meaning of TSCA section 3,
A commitment to provide EPA any referenced information upon request of the Agency, and
A signed certification that all information in the submission is accurate and complete.
A manufacturer may provide evidence to demonstrate that restrictions imposed by one or more States have the potential to have a significant impact on interstate commerce or health or the environment, and that as a consequence the request is entitled to preference pursuant to 15 U.S.C. 2605(b)(4)(E)(iii).
In submitting a claim of confidentiality, a person must certify that all information entered on the form is complete and accurate and further certify that pursuant to 15 U.S.C. 2613(c), and for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct.
Activities chemical manufacturers may be required to perform as a result of this proposed rule:
Rule Familiarization.
Familiarize themselves with the requirements of the rule and develop an understanding of what actions are necessary to complete the forms and the submission package. This entails reading the rule and understanding the procedures, requirements, criteria, and deadlines.
Prepare Request.
Collect all required information. The information must be collected and reviewed internally before submission.
Complete the request form.
Complete the commitment to provide EPA with any referenced information upon request.
Complete and sign the certification.
Complete and sign the claim of confidentiality.
Submit the request package to EPA
IC# 1. Chemical Manufacturer Chemical Substance Risk Evaluation Submission Request |
||||||
Activity/Respondent
|
Number of Respondents |
Responses per Respondent |
Total Responses |
Burden per Response (hours) |
Total Burden (hours) |
Cost |
CDX Electronic Reporting Burden |
||||||
Chemical manufacturers submitting request |
10 |
1 |
10 |
2.83 |
28.3 |
$2,044 |
Rule Familiarization and Submission Package Burden |
||||||
Chemical manufacturers submitting request |
10 |
1 |
10 |
93.2 |
932 |
$67,309 |
Total Burden for all Activities by Respondent |
||||||
Chemical manufacturers submitting request |
10 |
1 |
10 |
96.03 |
960.3 |
$69,353 |
Total |
10 |
|
10 |
|
960.3 |
$69,353 |
Under the PRA, burden is defined at 5 CFR 1320.3(b).
This is a new, rule-related information collection. The total burden requested for this ICR is 960.3 hours per year. The total annual cost burden requested for this ICR is $69,353. You may submit comments regarding the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques. Comments, referencing Docket ID No. EPA-HQ-OPPT-2016-0654 and OMB Control No. 2070-[NEW] (EPA ICR No. 2559.01), may be submitted to EPA electronically through http://www.regulations.gov and to OMB, addressed to “OMB Desk Officer for EPA” and referencing OMB Control No. 2070-[new] (EPA ICR No. 2559.01), via email to [email protected].
U.S. Census Bureau (2012a). 2012 Statistics of U.S. Businesses- Number of Firms, Number of Establishments, Employment, Annual Payroll, and Estimated Receipts by Enterprise Employment Size for the United States, All Industries: 2012.
U.S. Census Bureau (2012b). Geographic Areas Series: U.S. Nonemployer Statistics 2012.
Attachments to the ICR supporting statement are available in the public docket established for the rulemaking under docket identification number EPA-HQ-OPPT-2016-0654. These attachments are available for online viewing at http://www.regulations.gov or otherwise accessed as described in the following listing.
Attachment 1: |
Calculation of Wage Rates |
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| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Angela Hofmann |
| File Modified | 0000-00-00 |
| File Created | 2021-01-23 |