Ss_1218-0131-(01-30-12)

SUPPORTING STATEMENT FOR THE

INFORMATION COLLECTION REQUIREMENTS OF THE

STANDARD ENTITLED “OCCUPATIONAL EXPOSURE TO

HAZARDOUS CHEMICALS IN LABORATORIES” (29 CFR 1910.1450)¹

(OMB CONTROL NO. 1218-0131) (January 2012)

A. JUSTIFICATION

1. Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.

The main purpose of the Occupational Safety and Health Act (“OSH Act” or “Act”) is to “assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources” (29 U.S.C. 651). To achieve this objective, the OSH Act specifically authorizes "the development and promulgation of occupational safety and health standards" (29 U.S.C. 651). The Act states further that “[t]he Secretary . . . shall prescribe such rules and regulations as [he/she] may deem necessary to carry out [his/her] responsibilities under this Act, including rules and regulations dealing with the inspection of an employer’s establishment” (29 U.S.C. 651).

To protect employee health, the OSH Act authorizes the Occupational Safety and Health Administration (“OSHA” or “Agency”) to develop standards that provide for “monitoring or measuring worker exposure” to occupational hazards and “prescribe the type and frequency of medical examinations and other tests which shall be made available [by the employer] to employees exposed to such hazards . . . to most effectively determine whether the health of such employees is adversely affected by such exposure” (29 U.S.C. 655). Moreover, the Act directs OSHA to “issue regulations requiring employers to maintain accurate records of employee exposures to potentially toxic materials or other harmful physical agents which are required to be monitored and measured . . . " (29 U.S.C. 657). In addition, the OSH Act mandates that “[e]ach employer shall make, keep and preserve, and make available to the Secretary [of Labor] . . . such records regarding [the employer’s] activities relating to this Act as the Secretary . . . may prescribe by regulation as necessary or appropriate for the enforcement of this Act . . . ” (29 U.S.C. 657).

The Act authorizes the Agency to issue standards that “prescribe 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 or exposure” (29 U.S.C. 655). Additionally, the OSH Act mandates that “[e]ach employer shall make, keep and preserve, and make available to

the Secretary . . . such records . . . as the Secretary . . . may prescribe by regulation as necessary or appropriate for the enforcement of this Act . . . ” (29 U.S.C. 657).

Beginning in the early 1970s, OSHA published numerous health standards to control worker exposure to toxic substances in 29 CFR part 1910, subpart Z (the “subpart Z standards”).² However, OSHA developed the subpart Z standards primarily to protect workers exposed to toxic substances during industrial operations. These operations typically involve exposure to a few toxic substances emitted during a standardized and continuous or repetitive process that uses large quantities of the toxic substances. In laboratories, workers use small quantities of numerous hazardous chemicals³ in a variety of analytic and clinical procedures and operations, each of which they perform infrequently or periodically. In addition, standard laboratory practices often require techniques that control the release of, and exposure to, hazardous chemicals (e.g., extensive labeling, sealed containers, protective clothing, fume hoods).⁴ Moreover, laboratory workers have better knowledge of the hazardous chemicals with which they work than do workers involved in typical industrial operations; based on the high level of training they receive, laboratory workers usually have a thorough understanding of the chemical properties of these substances, as well as the safety and health problems associated with them.

Based on this evidence, OSHA concluded that, in general, laboratory workers have minimal exposures to hazardous chemicals in the workplace (i.e., below the action level (i.e., “AL”) or, in the absence of an AL, the permissible exposure limit (“PEL”) specified by subpart Z for any of these substances). Therefore, under the authority granted by the OSH Act, the Agency published a health standard governing occupational exposure to hazardous chemicals in laboratories (29 CFR 1910.1450; the “Standard”).

2. Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the Agency has made of the information received from the current collection.

The Standard contains a number of paperwork requirements. The following paragraphs describe these requirements, specify who uses them, and what purpose they serve.

A. Employee exposure determination (§1910.1450(d))

Initial monitoring (§1910.1450(d)(1))

The employer shall measure the worker's exposure to any substance regulated by a Standard which requires monitoring if there is reason to believe that exposure levels for that substance routinely exceed the action level (or in the absence of an action level, the PEL).

Purpose: Initial monitoring assists employers in identifying procedures and operations that require modification to reduce exposures to the AL or PEL specified by the appropriate subpart Z standard. In this regard, initial monitoring results enable employers to determine the need for engineering controls, institute new (or modify existing) work practices, and select appropriate respiratory protection to prevent worker overexposure. This information also determines whether or not the employer must perform periodic monitoring.

Periodic monitoring (§1910.1450(d)(2))

§1910.1450(d)(2) - If the initial monitoring prescribed by paragraph (d)(1) of this section discloses worker exposure over the action level (or in the absence of an action level, the PEL), the employer shall immediately comply with the exposure monitoring provisions of the relevant Standard.

Purpose: Employers use periodic monitoring results to evaluate the effectiveness of selected control methods. In addition, these measurements remind both the employer and workers of the need to protect workers against the effects of overexposure to hazardous chemicals in laboratory facilities. These monitoring data will also inform the examining physician of the existence and extent of a worker’s exposure to the hazardous chemical(s) for use in assessing the worker’s medical condition.

Termination of monitoring (§1910.1450(d)(3))

Monitoring may be terminated in accordance with the relevant standard.

Employee notification of monitoring results (§1910.1450(d)(4))

The employer shall, within 15 working days after the receipt of any monitoring results, notify the worker of these results in writing either individually or by posting the results in an appropriate location that is accessible to workers.

Purpose: Notification provides workers with information they can use to assess the effectiveness of the controls their employer implement to reduce their exposures to hazardous laboratory chemicals, and to determine if any medical signs and symptoms they may be experiencing could be the result of their exposure to these chemicals.

B. Chemical Hygiene Plan (CHP) (§1910.1450(e))

§1910.1450(e)(1) - Where hazardous chemicals as defined by this Standard are used in the workplace, the employer shall develop and carry out the provisions of a written Chemical Hygiene Plan which is:

§1910.1450(e)(1)(i) - Capable of protecting workers from health hazards associated with hazardous chemicals in that laboratory, and

§1910.1450(e)(1)(ii) - Capable of keeping exposures below the limits specified in paragraph (c) of this section.

§1910.1450(e)(3) - The Chemical Hygiene Plan shall include each of the following elements and shall indicate specific measures that the employer will take to ensure laboratory worker protection:

§1910.1450(e)(3)(i) - Standard operating procedures relevant to safety and health considerations to be followed when laboratory work involves the use of hazardous chemicals;

§1910.1450(e)(3)(ii) - Criteria that the employer will use to determine and implement control measures to reduce worker exposure to hazardous chemicals including engineering controls, the use of personal protective equipment and hygiene practices; particular attention shall be given to the selection of control measures for chemicals that are known to be extremely hazardous;

§1910.1450(e)(3)(iii) - A requirement that fume hoods and other protective equipment are functioning properly and specific measures that shall be taken to ensure proper and adequate performance of such equipment;

§1910.1450(e)(3)(iv) - Provisions for worker information and training as prescribed in paragraph (f) of this section;

§1910.1450(e)(3)(v) - The circumstances under which a particular laboratory operation, procedure or activity shall require prior approval from the employer or the employer's designee before implementation;

§1910.1450(e)(3)(vi) - Provisions for medical consultation and medical examinations in accordance with paragraph (g) of this section;

§1910.1450(e)(3)(vii) - Designation of personnel responsible for implementation of the Chemical Hygiene Plan including the assignment of a Chemical Hygiene Officer, and, if appropriate, establishment of a Chemical Hygiene Committee; and

§1910.1450(e)(3)(viii) - Provisions for additional worker protection for work with particularly hazardous substances. These include "select carcinogens," reproductive toxins and substances which have a high degree of acute toxicity. Specific consideration shall be given to the following provisions which shall be included where appropriate:

§1910.1450(e)(3)(viii)(A) - Establishment of a designated area;

§1910.1450(e)(3)(viii)(B) - Use of containment devices such as fume hoods or glove

boxes;

§1910.1450(e)(3)(viii)(C) - Procedures for safe removal of contaminated waste; and

§1910.1450(e)(3)(viii)(D) - Decontamination procedures.

§1910.1450(e)(4) - The employer shall review and evaluate the effectiveness of the Chemical Hygiene Plan at least annually and update it as necessary.

Purpose: This requirement commits employers to evaluate worker exposures to hazardous laboratory chemicals and establish an organized and complete program for reducing these exposures to the PEL specified for these chemicals. The requirement to review and update the CHP ensures that employers continue to evaluate workplace conditions, including hazardous-chemical exposures, and to implement the controls required to reduce worker overexposures. Employers are required to develop a written Chemical Hygiene Plan and ensure that they carry out the provisions.

C. Employee Information and Training (§1910.1450(f))

§1910.1450(f)(1) - The employer shall provide workers with information and training to ensure that they are apprised of the hazards of chemicals present in their work area.

§1910.1450(f)(2) - Such information shall be provided at the time of an worker's initial assignment to a work area where hazardous chemicals are present and prior to assignments involving new exposure situations. The frequency of refresher information and training shall be determined by the employer.

§1910.1450(f)(3) - Workers shall be informed of:

§1910.1450(f)(3)(i) - The contents of this standard and its appendices which shall be made available to them;

§1910.1450(f)(3)(ii) - the location and availability of the employer's Chemical Hygiene Plan;

§1910.1450(f)(3)(iii) - The permissible exposure limits for OSHA regulated substances or recommended exposure limits for other hazardous chemicals where there is no applicable OSHA standard;

§1910.1450(f)(3)(iv) - Signs and symptoms associated with exposures to hazardous chemicals used in the laboratory; and

§1910.1450(f)(3)(v) - The location and availability of known reference material on the hazards, safe handling, storage and disposal of hazardous chemicals found in the laboratory including, but not limited to, Material Safety Data Sheets, (MSDSs) received from the chemical supplier.

Training (§1910.1450(f)(4))

§1910.1450(f)(4)(i) - Worker training shall include:

§1910.1450(f)(4)(i)(A) - Methods and observations that may be used to detect the presence or release of a hazardous chemical (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance or odor of hazardous chemicals when being released, etc.);

§1910.1450(f)(4)(i)(B) - The physical and health hazards of chemicals in the work area; and

§1910.1450(f)(4)(i)(C) - The measures workers can take to protect themselves from these hazards, including specific procedures the employer has implemented to protect workers from exposure to hazardous chemicals, such as appropriate work practices, emergency procedures, and personal protective equipment to be used.

§1910.1450(f)(4)(ii) - The worker shall be trained on the applicable details of the employer's written Chemical Hygiene Plan.

Purpose: This requirement is essential to inform workers of the health hazards resulting from hazardous chemical exposure and to provide them with the understanding necessary to minimize these hazards. Training serves to explain and reinforce the information presented to workers on signs, labels, and MSDSs; however, this information will be effective only if workers understand the information and can take the actions necessary to avoid or minimize hazardous chemical exposure. Training also enables workers to recognize operations and locations associated with hazardous chemical exposures, thereby permitting them to limit exposure from these sources.

D. Medical Consultation and Medical Examinations (§1910.1450(g))

General (§1910.1450(g)(1) and (g)(2))

§1910.1450(g)(1) - The employer shall provide all workers who work with hazardous chemicals an opportunity to receive medical attention, including any follow-up examinations which the examining physician determines to be necessary, under the following circumstances:

§1910.1450(g)(1)(i) - Whenever an worker develops signs or symptoms associated with a hazardous chemical to which the worker may have been exposed in the laboratory, the worker shall be provided an opportunity to receive an appropriate medical examination.

§1910.1450(g)(1)(ii) - Where exposure monitoring reveals an exposure level routinely above the action level (or in the absence of an action level, the PEL) for an OSHA regulated substance for which there are exposure monitoring and medical surveillance requirements, medical surveillance shall be established for the affected worker as prescribed by the particular standard.

§1910.1450(g)(1)(iii) - Whenever an event takes place in the work area such as a spill, leak, explosion or other occurrence resulting in the likelihood of a hazardous exposure, the affected worker shall be provided an opportunity for a medical consultation. Such consultation shall be for the purpose of determining the need for a medical examination.

§1910.1450(g)(2) - All medical examinations and consultations shall be performed by or under the direct supervision of a licensed physician and shall be provided without cost to the worker, without loss of pay and at a reasonable time and place.

Purpose: The requirements specified by these paragraphs prevent the development of serious illnesses among workers overexposed or potentially overexposed to hazardous chemicals used in their work areas.

Information provided to the physician (§1910.1450(g)(3))

The employer shall provide the following information to the physician:

§1910.1450(g)(3)(i) - The identity of the hazardous chemical(s) to which the worker may have been exposed;

§1910.1450(g)(3)(ii) - A description of the conditions under which the exposure occurred including quantitative exposure data, if available; and

§1910.1450(g)(3)(iii) - A description of the signs and symptoms of exposure that the worker is experiencing, if any.

Purpose: The examining physicians are provided this information to assist them in evaluating the worker's health and fitness for specific job assignments involving hazardous chemical exposure. The physician also uses this information to determine if an observed health condition is contributed to occupational exposure to hazardous chemicals in the laboratory work area.

Physician’s written opinion (§1910.1450(g)(4))

§1910.1450(g)(4)(i) - For examination or consultation required under this standard, the employer shall obtain a written opinion from the examining physician which shall include the following:

§1910.1450(g)(4)(i)(A) - Any recommendation for further medical follow-up;

§1910.1450(g)(4)(i)(B) - The results of the medical examination and any associated tests;

§1910.1450(g)(4)(i)(C) - Any medical condition which may be revealed in the course of the examination which may place the worker at increased risk as a result of exposure to a hazardous workplace; and

§1910.1450(g)(4)(i)(D) - A statement that the employee has been informed by the physician of the results of the consultation or medical examination and any medical condition that may require further examination or treatment.

§1910.1450(g)(4)(ii) - The written opinion shall not reveal specific findings of diagnoses unrelated to occupational exposure.

Purpose: The purpose of requiring the employer to obtain a physician’s written opinion is to provide the employer with medical information on whether or not the worker has a condition indicating overexposure to hazardous chemicals. If such a condition exists, the employer can implement additional controls to prevent overexposure. The information also allows the employer to plan necessary medical follow-up and treatment. The requirement that the physician’s opinion be in writing ensures that the information is available for future reference. Workers are given a copy of the physician’s written opinion to determine the need for treatments and other interventions. The written opinion allows the physician to make recommendations to remove the worker from the contaminated area or to make recommendations for control measures.

E. Hazard Identification (§1910.1450(h))

§1910.1450(h)(1) - With respect to labels and material safety data sheets:

§1910.1450(h)(1)(i) - Employers shall ensure that labels on incoming containers of hazardous chemicals are not removed or defaced.

§1910.1450(h)(1)(ii) - Employers shall maintain any material safety data sheets that are received with incoming shipments of hazardous chemicals, and ensure that they are readily accessible to laboratory workers.

§1910.1450(h)(2) - The following provisions shall apply to chemical substances developed in the laboratory:

§1910.1450(h)(2)(i) - If the composition of the chemical substance which is produced exclusively for the laboratory's use is known, the employer shall determine if it is a hazardous chemical as defined in paragraph (b) of this section. If the chemical is determined to be hazardous, the employer shall provide appropriate training as required under paragraph (f) of this section.

§1910.1450(h)(2)(ii) - If the chemical produced is a byproduct whose composition is not known, the employer shall assume that the substance is hazardous and shall implement paragraph (e) of this section.

§1910.1450(h)(2)(iii) - If the chemical substance is produced for another user outside of the laboratory, the employer shall comply with the Hazard Communication Standard (29 CFR 1910.1200) including the requirements for preparation of material safety data sheets and labeling.

Purpose: The provision ensures that workers, whether in a laboratory facility or at a downstream facility, receive adequate notice and, if necessary, other information regarding chemicals that are hazardous or potentially hazardous.

OSHA believes that this provision protects workers by alerting them to potential hazardous chemical exposures, thereby allowing them to take appropriate actions to control these exposures. In addition, this provision supplements the information and training requirements contained in paragraph (f) of the Standard.

F. Use of Respirators (§1910.1450(i))

Where the use of respirators is necessary to maintain exposure below permissible exposure limits, the employer shall provide, at no cost to the worker, the proper respiratory equipment. Respirators shall be selected and used in accordance with the requirements of 29 CFR 1910.134.

Purpose: The purpose of this requirement is to ensure that employers and workers select, use, and maintain appropriate respirators if respirators are necessary to protect workers from hazardous chemical exposures.

G. Recordkeeping (§1910.1450(j))

§1910.1450(j)(1) - The employer shall establish and maintain for each worker an accurate record of any measurements taken to monitor worker exposures and any medical consultation and examinations including tests or written opinions required by this standard.

Purpose: This requirement provides both employers and workers with useful information. The information alerts employers to routine overexposures to hazardous chemicals, thereby enabling them to modify controls or take other actions necessary to reduce these exposures. The exposure monitoring and medical information contained in these records assists workers and their physicians in determining the need for, and effectiveness of, medical treatment and other interventions implemented in response to the workers’ exposure to hazardous chemicals in a laboratory facility.

§1910.1450(j)(2) - The employer shall assure that such records are kept, transferred, and made available in accordance with 29 CFR 1910.1020.

Purpose: Workers and their designated representatives may use these records to evaluate worker medical status over the course of employment, to determine the effectiveness of the employer’s exposure reduction program, and for other reasons. An OSHA compliance officer reviews the records to assess the employer’s compliance with the medical and exposure control provisions of the Standard.⁵

Paragraph (h) of § 1910.1020 requires employers who cease to do business to transfer medical and exposure-monitoring records to the successor employer, who then must receive and maintain the records. This paragraph also requires that whenever an employer ceases to do business and there is no successor employer to receive and maintain the records subject to this standard, the

employer shall notify affected current employees of their rights of access to records at least three (3) months prior to the cessation of the employer’s business. OSHA considers the employer’s transfer of records to a successor to be usual and customary communications during the transition from one employer to a successor employer. In this regard, the employer would communicate the location of all records, including employee exposure-monitoring and medical records, at the facility to the successor employer during the transfer of business operations, as a matter of usual and customary business practice. In addition, OSHA accounts for the burden hours and costs resulting from the employee notification requirements under the Information Collection Request (ICR) for its Access to Employee Exposure and Medical Records Standard (§ 1910.1020), OMB Control No. 1218-0065.

3. Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.

Employers may use any available technology to meet the paperwork requirements specified by the Standard. The Agency wrote these provisions in performance-oriented language, i.e., in terms of what information to provide, not how to provide it.

4. Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item A.2 above.

The information collection requirements in the Standard are specific to each employer involved, and no other sources or agencies duplicate these requirements or can make the required information available to OSHA, i.e., the required information is available only from employers.

5. If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.

The information collection requirements specified by the Standard do not have a significant impact on a substantial number of small entities.

6. Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.

The Agency believes that the information collection frequencies required by the Standard are the minimum frequencies necessary to fulfill its mandate “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources” as specified in the OSH Act at 29 U.S.C. 651. Accordingly, if employers do not perform the information collections required by the Standard, or delay in providing this information, workers are at risk of developing serious illnesses resulting from overexposure to hazardous chemicals used in laboratory facilities.

7. Explain any special circumstances that would cause an information collection to be conducted in a manner:

· requiring respondents to report information to the agency more often than quarterly;

· requiring respondents to prepare a written response to a collection of information in fewer than 30

days after receipt of it;

· requiring respondents to submit more than an original and two copies of any document;

· requiring respondents to retain records, other than health, medical, government contract, grant-

in-aid, or tax records for more than three years;

· in connection with a statistical survey, that is not designed to produce valid and reliable results that

can be generalized to the universe of study;

· requiring the use of a statistical data classification that has not been reviewed and approved by

OMB;

· that includes a pledge of confidentiality that is not supported by authority established in statute or

regulation, that is not supported by disclosure and data security policies that are consistent

with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or

· requiring respondents to submit proprietary trade secret, or other confidential information

unless the agency can demonstrate that it has instituted procedures to protect the information's

confidentiality to the extent permitted by law.

Paragraph (d)(4) of the Standard requires that employers notify each worker of their exposure monitoring results within 15 working days after receiving these results. Employers may notify workers either individually in writing or by posting the monitoring results in an appropriate location that is accessible to the workers. Except for this provision, the information collection requirements of the Standard are consistent with 5 CFR 1320.5.

8. If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years, even if the collection-of-information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.

As required by the Paperwork Reduction Act of 1995 (the PRA-95) (44 U.S.C. 3506(c)(2)(A)), OSHA published a notice in the Federal Register on May 4, 2011 (76 FR 25376, Docket No. OSHA-2011-0059) requesting public comment on its proposed extension of the information collection requirements contained in the Standard on Occupational Exposure to Hazardous Chemicals in Laboratories (the Lab Standard; 29 CFR 1910.1450).  The notice was part of a preclearance consultation program that provides interested parties with an opportunity to comment on OSHA’s request for an extension by the Office of Management and Budget (OMB) of a previous approval of the information collection requirements in the Lab Standard.

Previously, when OSHA published the Standards Improvement Project—Phase III (SIP-III) final rule, June 8, 2011 (76 FR 33590), OSHA submitted a revised Lab Standard Information Collection Request (ICR). Submission of the ICR was necessary since the SIP-III final rule removed the requirement that employers transfer worker exposure-monitoring records and medical records (29 CFR 1910.1020(h)(3) and (h)(4)) to the National Institute for Occupational Safety and Health (NIOSH) when they cease to do business. Paragraph (j)(2) of the Lab Standard required employers to transfer records in accordance with §1910.1020. OSHA revised the Lab Standard ICR to remove the estimated burden hours and costs for employers to transfer records to NIOSH. OSHA received one public comment in response to the ICR notice published in the May 4, 2011, Federal Register. That comment was from Ms. Kimberly Blatz (Docket Number OSHA-2011-0059-0003).

On August 11, 2011, OMB issued a Notice of Action (NOA) approving the revised Lab Standard ICR. In addition, the NOA instructed the Department of Labor to publish another notice in the Federal Register to solicit comments on OSHA’s proposal to extend OMB’s approval of all of the collection of information requirements contained in the Lab Standard. In response to the NOA, on November 22, 2011, OSHA published a notice in the Federal Register (76 FR 72216; OSHA Docket Number OSHA-2011-0069). The Agency received no comments in response to this notice.

In her response to the May 4, 2011, notice, Ms. Blatz’s commented that she concurred with the purpose and need for the collection of information requirements contained in the Lab Standard stating:

These requirements for information gathering give employees access to critical information and thus empowers them to be in the best position to protect themselves and their coworkers from harm. At the same time, it creates invaluable records for inspection by the Agency in its function to protect workers, providing evidence that the employer has been diligent in evaluating and mitigating the risks to the employees and information that is needed for accident investigation.

However, Ms. Blatz expressed concern regarding the ICR’s burden hour estimates, questioning OSHA’s eight-hour time estimate for employers to develop an initial Chemical Hygiene Plan (CHP). She estimates that it takes 40 to 80 hours to prepare a CHP.

When determining the eight-hour time estimate for laboratories to develop a CHP in accordance with § 1910.1450 (e), OSHA did not include the time laboratories were already spending preparing safety and health plans. In the final Lab Standard preamble, OSHA noted:

Furthermore, in view of the fact that most laboratory employers already have health and safety programs which include some or most of these elements [of the Chemical Hygiene Plan] the specification does not impose a significant regulatory burden on employers.

Also, the eight-hour time estimate is an average for all sizes of laboratories. While some laboratories may have unusually complex situations, smaller laboratories in general need less time to prepare the plans than larger laboratories because they typically deal with a small number of chemicals; therefore, these laboratories devote less time for inventory and other chemical-management procedures. In addition, many laboratories are likely to be specialized units, working with, for example, organic compounds, metals, or phosphates. Accordingly, these laboratories deal with a less diversified chemical inventory, and likely to spend less time preparing a CHP than nonspecialized laboratories. Also, there are numerous procedures (e.g., analytical) already established for dealing with various chemicals. Appendix A of the Standard provides an outline for the CHP, along with other recommendations. Also, OSHA published the Laboratory Safety Guidance document that can assist laboratories in preparing a CHP. For these reasons, the Agency is maintaining the average eight-hour time estimate for laboratories to develop an initial CHP.

In addition, Ms. Blatz stated that OSHA underestimated the time to prepare training materials. OSHA believes that most of the information and material for training has been developed when preparing the Chemical Hygiene Plan and complying with its Hazard Communication Standard. Therefore, the Agency continues to maintain that a laboratory supervisor requires 15 minutes (.25 hour) to prepare the training material for each training session.

Ms. Blatz also commented on how much time laboratories may spend on implementing the Globally Harmonized System (GHS) and Classification and Labeling of Chemicals in OSHA’s final Hazard Communication Standard (HCS) on GHS. OSHA will take the burden hours and costs for implementing the HCS-GHS in the revised Hazard Communication Standard Information Collection Request (ICR) (OMB Control Number 1218- 0072), which the Agency will submit to OMB for approval when it publishes the HCS-GHS final rule in the Federal Register.

9. Explain any decision to provide any payment or gift to respondents, other than reenumeration of

contractors or grantees.

The Agency will not provide payments or gifts to the respondents.

10. Describe any assurance of confidentiality provided to respondents and the basis for the assurance in

statute, regulation, or agency policy.

To ensure that the personal information in the medical records required by the Standard remains confidential, the Agency developed §1913.10 (“Rules of Agency Practice and Procedure Concerning OSHA Access to Employee Medical Records”) to regulate its access to these records.

11. Provide additional justification for any question of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific

uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.

The paperwork requirements specified by the Standard do not involve sensitive information.

12. Provide estimates of the hour burden of the collection of information. The statement should:

· Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.

· If this request for approval covers more than one form, provide separate hour burden

estimates for each form and aggregate the hour burdens.

· Provide estimates of annualized cost to respondents for the hour burdens for collections of

information, identifying and using appropriate wage-rate categories.

Table 1 below presents information for the different types of laboratories covered by the Standard. For each type of laboratory, the table provides an estimate of the number of facilities that expose employees to hazardous chemicals and the number of employees so exposed.

Table 1: Number of Laboratory Facilities and Employees for Each Type of Laboratory

Type of Laboratory	No. of Facilities	No. of Employees
Industrial
Independent testing[a]	6,819	120,954
Research and development[b]	13,000	1,000,000
Subtotals	19,819	1,120,954
Clinical
Hospital[c]	8,238	186,871
Independent-medical[d]	6,370	146,365
Subtotals	14,608	333,236
Academic (Private)
Post-secondary[e]	2,733	113,504
Secondary[f]	11,076	41,099
Professional and Research Institutes[g]	225	110,000
Subtotals	14,034	264,603
Totals	48,461	1,718,793

^[a]Source: County Business Patterns 2008. U.S. Department of Commerce, Bureau of the Census. Total number of Independent Testing Laboratories (ITLs) calculated as the sum of taxable establishments (6,588 establishments, NAICS 54138) and tax-exempt establishments (231 establishments). The number of tax-exempt establishments estimated as 3.5 percent of total number of ITLs, based on data from 2002 Census. Number of employees calculated as the sum of employees in taxable establishments (111,787 employees) and employees in tax-exempt establishments (9,167 employees). The number of employees in tax-exempt establishments estimated as 8.2 percent of total number of employees in ITLs, based on data from 2002 Census.

^[b]Source: Supporting Statement for the Information Collection Requirements of the Standard Entitled “Occupational Exposure to Hazardous Chemicals in Laboratories” (29 CFR 1910.1450) [ICR 1218-0131 (2005)], based on analysis by DynCorp I&ET of The Directory of American Research and Technology; Industrial Research Labs of the United States; and “Survey of Industrial Research and Development,” National Science Foundation/Division of Science Resources Studies. Because original sources appear to not have been updated, OSHA has no basis to revise 2005 figures.

^[c]Source: Supporting Statement for the Information Collection Requirements of the Standard Entitled “Occupational Exposure to Hazardous Chemicals in Laboratories” (29 CFR 1910.1450) [ICR 1218-0131 (2005)] and Occupational Outlook Handbook, 2008-2009 ed., Bureau of Labor Statistics. Estimate of hospital-based labs derived by adjusting the 2008 ICR estimate by the percentage increase in health care employees between 2005 and 2010 reported by BLS.

^[d]Source: County Business Patterns 2008. U.S. Department of Commerce, Bureau of the Census (NAICS 621511).

^[e]Source: U.S. Department of Education, National Center for Education Statistics, Digest of Education Statistics, 2006. Table 265: Degree-granting institutions, by control and type of institution: Selected years, 1949-50 through 2008-09. The number of employees was calculated by taking the ratio of establishments in 2005 to establishments in 2008 and applying it to the 2008 ICR estimate.

^[f]Source: U.S. Department of Education, National Center for Education Statistics, Digest of Education Statistics, 2006. Table 59: Private elementary and secondary enrollment, number of schools, and average tuition, by school level, orientation, and tuition: 1999-2000, 2003-04, and 2007-08. The number of facilities and number of employees was calculated by taking the ratio of schools in 2004 to establishments in 2008 and applying it to the 2008 ICR estimate.

^[g]Source: 2001 ICR. As OSHA was unable to identify updated establishment and employment figures, estimates from previous ICR updates have been retained.

Burden Hour and Cost Determinations

The Agency adopted the mean wage rates from “Employer Costs for Employee Compensation, September 2010”, Bureau of Labor Statistics, U.S. Department of Labor, http://stats.bls.gov/home.htm pp. 10. Total compensation for these occupational categories includes an adjustment for fringe benefits. On average, fringe benefits represent 29.4 percent (Ibid, pp.3) of total hourly compensation in the private sector. The total hourly compensation costs of labor used in this analysis are:

Administrative Service manager $49.31

Employee $27.88

Office Clerk $22.00

(A) Employee exposure determination (§1910.1450(d))

Initial monitoring (§1910.1450(d)(1)) and periodic monitoring (§1910.1450(d)(2) and (d)(3))

As noted above in Item 1, laboratory employees typically use small quantities of numerous hazardous chemicals in a variety of procedures and operations, each of which they perform infrequently or periodically. In addition, standard laboratory practices require techniques that control the release of, and exposure to, hazardous chemicals (e.g., extensive labeling, sealed containers, protective clothing such a gloves and goggles, laboratory hoods). Therefore, overexposure of laboratory employees to hazardous chemicals is rare. Accordingly, OSHA assumes that only a minimal need exists to conduct initial and periodic exposure monitoring (i.e., once a year per laboratory facility), and that a laboratory supervisor takes, on average, 10 minutes (.17 hour) to distribute and collect exposure-monitoring samples and mail them for analysis. Thus, the estimated burden hours and cost for these requirements each year are:

Burden hours: 48,461 facilities x .17 hour = 8,238 hours

Cost: 8,238 hours x $49.31 = $406,216

Employee notification of monitoring results (§1910.1450(d)(4))

Assuming that employers post exposure monitoring results in an appropriate location, the Agency estimates that an office clerk spends five minutes (.08 hour) developing and posting these results for each facility once a year. Therefore, the estimated annual burden hours and cost of this provision are:

Burden hours: 48,461 facilities x .08 hour = 3,877 hours

Cost: 3,877 hours x $22.00 = $85,294

(B) Chemical hygiene plan (§1910.1450(e))

This paragraph requires new laboratory facilities to develop a chemical hygiene plan (CHP), while existing facilities must review their CHPs at least annually.⁶ The Agency estimates that the number of laboratory facilities increases by 948 each year, and that a laboratory supervisor (acting as the Chemical Hygiene Officer) takes 8 hours to develop a new CHP and one-half (.5) hour to update an existing CHP. The burden hour and cost estimate for this requirement are:

Burden hours: (948 new CHPs x 8 hours) + (48,461 existing CHPs x .5 hours) =

31,815 hours

Cost: 31,815 hours x $49.31 = $1,568,798

(C) Employee information and training (§1910.1450(f))

The Agency assumes that 20% (343,759) of the workers covered by the Standard require information and training as specified by this provision; of this 20%, half consist of new or replacement (turnover) employees who are assuming new assignments, while the remaining half include existing employees who are receiving new exposures.⁷ OSHA estimates that a laboratory supervisor can deliver the required training to 20 employees in a single session, for a total of 17,188 sessions to train 343,759 employees annually (i.e., 343,759 workers  20 workers per session). In addition, the Agency believes that, for each session, the laboratory supervisor requires 15 minutes (.25 hour) to prepare the training material and 45 minutes (.75 hour) to deliver it, for a total of one hour. Accordingly, the estimated yearly burden hours and cost of this information collection requirement are:

Burden hours: 17,188 sessions x 1 hour = 17,188 hours

Cost: 17,188 hours x $49.31 = $847,540

(D) Medical consultation and medical examinations (§1910.1450(g))

General (§1910.1450(g)(1) and (g)(2))

OSHA believes that 8% (137,503) of the workers covered by the Standard receive medical attention. Of these workers, the Agency assumes that: half (68,752) obtain a medical consultation, which OSHA estimates takes 45 minutes (.75 hour) to administer;⁸ one-fourth (34,376) receive a medical examination, which the Agency finds takes 1.5 hours to administer; and the remaining one-fourth get both a medical consultation and medical examination, requiring an estimated total of 2.25 hours to administer. Thus, the estimated annual burden hour and cost to employers of the lost productivity resulting from these provisions are:

Burden hours: (68,752 employees x .75 hour) + (34,376 employees x 1.5 hours) +

(34,376 employees x 2.25 hours) = 180,474 hours

Cost: 180,474 hours x $27.88 = $5,031,615

Information provided to the physician (§1910.1450(g)(3))

OSHA estimates that an office clerk spends five minutes (.08 hour) compiling and sending the required information to the physician prior to each medical consultation or medical examination. Therefore, the yearly burden hour and cost estimates for this paperwork requirement are:

Burden hours: 137,503 employees x .08 hour = 11,000 hours

Cost: 11,000 hours x $22.00 = $242,000

Physician’s written opinion (§1910.1450(g)(4))

The Agency assumes that the physician writes an opinion for each medical consultation and medical examination administered (for a total of 137,503 written opinions annually), and that an office clerk takes five minutes (.08 hour) to distribute the written opinion to an employee.⁹ Thus, the estimated burden hours and cost of this requirement each year are:

Burden hours: 137,503 written opinions x .08 hour = 11,000 hours

Cost: 11,000 hours x $22.00 = $242,000

(E) Hazard identification (§1910.1450(h))

OSHA’s Hazard Communication (HC) Standard (§ 1910.1200) applies to the requirements regarding labels and MSDSs specified by this provision of the Standard.¹⁰ Therefore, the Agency is accounting for the burden hours and cost resulting from these requirements under the Information Collection Request (ICR) for the HC Standard, OMB Control Number 1218-0072

(F) Use of respirators (§1910.1450(i))

The Agency accounts for the burden hours and cost resulting from this paragraph (including the selection, use, and maintenance of respirators, and the development of a written respirator protection program) under the Information Collection Request (ICR) for OSHA’s Respiratory Protection Standard (§1910.134), OMB Control Number 1218-0099.

(G) Recordkeeping (§1910.1450(j))

General (§1910.1450(j)(1))

As noted above in section (A) (“Exposure Monitoring”) of this item, each laboratory facility covered by the Standard develops a record of exposure monitoring results, for an annual total of 48,461 records.¹¹ In addition, the determinations made above in section (D) (“Medical Consultation and Medical Examinations”) show that employers administer 137,503 medical consultations and medical examinations annually, developing 137,503 medical records. Under the requirements of this recordkeeping provision, the Agency estimates that an office clerk spends five minutes (.08 hour) each year establishing and maintaining each of these records. Therefore, the annual burden hours and cost associated with this recordkeeping requirement are:

Burden hours: [(48,461 exposure monitoring records) + (137,503 medical records)] x .08 hour = 14,877 hours

Cost: 14,877 hours x $22.00 = $327,294

Access to records (§1910.1450(j)(2))

The determinations for this provision show that employers spend a total of 14,904 burden hours at a cost of $329,363 providing access to exposure monitoring and medical records to employees, their designated representatives, and OSHA compliance officers.

1. Employee access

For this determination, OSHA estimates that the exposure monitoring requirements of the Standard cover all employees (1,718,793) in laboratory facilities, while 137,503 of these employees have medical records (see previous determinations in this section). Additionally, the Agency assumes that 10% (185,630) of the employees covered by these records request access to them each year ((1,718,793 employees + 137,503 employees) x 10% = 185,630 employees).¹² OSHA estimates that an office clerk takes five minutes (.08 hour) to retrieve and re-file each requested record, resulting in the following annual burden hour and cost estimates:

Burden hours: 185,630 employees x .08 hours = 14,850 hours

Cost: 14,850 hours x $22.00 = $326,700

2. Federal access

The Agency determined that employers receive 678 requests annually for exposure monitoring and medical records during inspections conducted by its compliance officers (see Item 14 below). In addition, OSHA finds that a laboratory supervisor spends five minutes (.08 hour) informing a compliance officer of the location of the requested records. Accordingly, the estimated yearly burden hours and cost of this provision are:

Burden hours: 678 requests x .08 hours = 54 hours

Cost: 54 hours x $49.31 = $2,663

13. Provide an estimate of the total annual cost burden to respondents or recordkeepers resulting from the collection of information. (Do not include the cost of any hour burden shown in Items 12 and 14).

· The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life); and (b) a total operation and maintenance and purchase of service component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.

· If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and

explain the reasons for the variance. The cost of purchasing or contracting out information collection services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondent (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.

· Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

Capital Cost Determinations

Annual Medical Cost Determinations

OSHA found that the annual cost of providing employees with exposure monitoring, medical consultations, and medical examinations is $41,271,276. The following sections describe the cost determinations.

(A) Exposure monitoring

The Agency estimates that employers pay $60 to analyze an exposure monitoring sample. According to the information provided above in section (A) (“Exposure Monitoring”) under Item 12, employers collect 48,460 exposure monitoring samples each year. Thus, the annual cost associated with obtaining exposure monitoring samples is:

Cost: 48,461 samples x $60 = $2,907,660

(B) Medical consultation and medical examinations

OSHA identified the following costs for providing medical attention to employees: Medical consultation (med consult), $148; medical examination (med exam), $336; and a combined medical consultation and med examination (med consult-med exam), $484.¹³ In addition, the determinations made above in section (D) (“Medical consultation and medical examinations”) show that each year employers administer 68,752 med consults, 34,376 med exams, and 34,376 med consults-med exams to employees. Accordingly, the yearly cost of providing medical attention to employees is:

Cost: (68,752 med consults x $148) + (34,376 med exams x $336) +

(34,376 med consults-med exams x $484) = $38,363,616

14. Provide estimates of annualized cost of the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff) and any other expense that would not have been incurred without this collection of information. Agencies also may aggregate cost estimates from Items 12, 13 and 14 in a single table.

The paperwork requirements specified by the Standard cost the Federal government an estimated $2,614 each year. The following sections provide the basis for this cost determination.

OSHA enforcement

The Agency estimates that a compliance officer (GS-12, step 5), at an hourly wage rate of $37.37, spends five minutes (.08 hour) during an inspection reviewing the documents required by the Standard. OSHA determines that its compliance officers will conduct 678 such inspections during each year covered by this ICR.¹⁴ In making this cost determination, the Agency does not account for other occupational costs (e.g., equipment, overhead, and support staff expenses) because it considers these costs to be normal expenses that would occur without the collection of information requirements specified by the Standard. Thus, the estimated yearly cost of these paperwork requirements to the Federal government is:

Cost: 678 inspections x .08 hour x $37.37 = $2,027

15. Explain the reasons for any program changes or adjustments.

OSHA is requesting to increase the existing burden hour estimate for the collection of information requirements in the Standard. In this regard, the Agency is requesting to increase the current burden hour estimate from 281,086 hours to 293,373 hours, a total adjustment of 12,287 hours.

Additionally, the capital cost estimate has increased from $35,978,301 to $41,271,276 a total increase of $5,292,975. This increase is a result of an increase in the cost of medical consultations from $125 to $148 while medical exams increased from $282 to $336, and medical consultations and medical examinations from $407 to $484.

Table 2 below lists the current and requested burden hours of the information collection requirements specified by the Standard, and describes each of the requested burden hour adjustments.

Table 2

Requested Burden Hours and Adjustments

Information Collection Requirement	Current Burden Hours		Requested Burden Hours		Estimated Cost ($)		Adjustment		Explanation of Adjustment
A. Employee exposure determination (§1910.1450(d))
Initial monitoring and periodic monitoring		7,755		8,238		$406,216		483		There was increase in the number of facilities being monitored (from 45,616 to 48,461).
Employee notification of monitoring results		3,649		3,877		$85,294		228		There was an increase in the number of facilities being monitored (from 45,616 to 48,461).
B. Chemical hygiene plan (§1910.1450(e))		28,808		31,815		$1,568,798		3,007		There was an increase in the number of facilities being monitored (from 45,616 to 48,461).
C. Employee information and training (§1910.1450(f))		16,604		17,188		$847,540		584		There was an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793) which increased the number of training sessions (from 16,604 to 17,188).
Medical consultation and medical examinations (§1910.1450(g))
General		174,343		180,474		$5,031,615		6,131		There was an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793).
Information provided to the physician		10,627		11,000		$242,000		373		There was an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793) which increases the number of employees providing information to the physician from 132,833 to 137,503).
Physician's written opinion		10,627		11,000		$242,000		373		There was an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793) which increases the number of written opinions 132,833 to 137,503).
E. Hazard identification (§1910.1450(h))		0		0		0		0
F. Use of respirators (§1910.1450(i))		0		0		0		0
Recordkeeping (§1910.1450(j))
General		14,276		14,877		$327,294		601		There was an increase in the number of facilities being monitored (from 45,616 to 48,461) and an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793).
Access to records		14,397		14,904		$329,363		507		There was an increase in the number of facilities being monitored (from 45,616 to 48,461) and an increase in the number of employees covered by the Standard (from 1,660,408 to 1,718,793).
Totals		281,086		293,373		$9,080,120		12,287

16. For collections of information whose results will be published, outline plans for tabulation, and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection information, completion of report, publication dates, and other actions.

OSHA will not publish the information collected under the Standard.

17. If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be appropriate.

No forms are available for the Agency to display the expiration date.

18. Explain each exception to the certification statement.

OSHA is not requesting an exception to the certification statement.

B. COLLECTIONS OF INFORMATON EMPLOYING STATISTICAL METHODS

This Supporting Statement does not contain any collection of information requirements that employ statistical methods.

1 ^?The purpose of this Supporting Statement is to analyze and describe the burden hours and costs associated with the provisions of this Standard that contain paperwork requirements; this Supporting Statement does not provide information or guidance on how to comply with, or how to enforce, the Standard.

2 ²Employers also have an obligation to protect employees from exposure to toxic substances under the general-duty clause of the Act at 29 U.S.C. 654.

3 ³For the purposes of this Supporting Statement, the term “hazardous chemical” means a chemical for which acute or chronic health effects may occur in exposed employees as demonstrated by statistically significant evidence based upon at least one study conducted in accordance with established scientific principles. (See paragraph (b) of

§ 1910.1450).

4 ⁴Employers institute these practices not only to protect their employees from exposure to the toxic substances, but also to ensure the reliability of the analytic or clinical results.

5_{Upon a thorough review of this ICR, the Agency determined that these provisions were not fully addressed in previous ICRs}^.

6 This paragraph also specifies that employers must, as appropriate, establish designated areas to provide employees with additional protection. This provision does not require employers to establish records or maintain information, so the Agency is not taking any burden for this requirement.

7 OSHA believes that employers do not repeat this training after the employees have been working in these assignments.

8Estimates of administration time include 30 minutes of travel time.

9The five minutes does not include the annual burden for maintaining a record of each written opinion as required by paragraph (j) of the Standard.

10Paragraph (h)(2)(i) of the Standard requires employers to provide training in accordance with paragraph (f), while paragraphs (h)(2)(ii) mandates CHPs specified by paragraph (e); the Agency included the burden-hour and cost estimates for paragraphs (h)(2)(i) and (h)(2)(ii) in the determinations made under sections (C) and (B), respectively, of this item.

11 OSHA assumes that the record is the list of exposure-monitoring results used for posting.

12 The Agency believes that employers receive minimal requests for exposure monitoring and medical records from former employees, employees’ legal representatives, individuals and organizations to whom employees give written authorization to exercise a right of access, and designated employee representatives; therefore, it did not include these requests in this determination.

13 The previous ICR assumed that each medical consultation cost $133, each medical examination $336, and each combined medical consultation and medical examination $484. The Consumer Price Index (CPI) indicated a 11.53% increase in the price of professional medical services from 2006 to 2010; the cost of a medical consultation or examination was assumed to have increased by 11.53% as well.

14 ^? The Agency estimated the number of inspections by determining the inspection rate (1.4%) for all facilities under the jurisdiction of the OSH Act (including both Federal OSHA and approved state-plan agencies) and then multiplying the total number of laboratory facilities (i.e., 48,461) by this percentage (i.e., 48,461 facilities x 1.4% = 678 inspections).

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