Compliance Regulations and Guidance Affecting your Industry

Scope. This section contains requirements for the control of grain dust fires and explosions, and certain other safety hazards associated with grain handling facilities. It applies in addition to all other relevant provisions of Part 1910 (or Part 1917 at marine terminals).

1910.272(b)

Application.

1910.272(b)(1)

Paragraphs (a) through (n) of this section apply to grain elevators, feed mills, flour mills, rice mills, dust pelletizing plants, dry corn mills, soybean flaking operations, and the dry grinding operations of soycake.

1910.272(b)(2)

Paragraphs (o), (p), and (q) of this section apply only to grain elevators.

1910.272(c)

Definitions.

"Choked leg" means a condition of material buildup in the bucket elevator that results in the stoppage of material flow and bucket movement. A bucket elevator is not considered choked that has the up-leg partially or fully loaded and has the boot and discharge cleared allowing bucket movement.

"Flat storage structure" means a grain storage building or structure that will not empty completely by gravity, has an unrestricted ground level opening for entry, and must be entered to reclaim the residual grain using powered equipment or manual means.

"Fugitive grain dust" means combustible dust particles, emitted from the stock handling system, of such size as will pass through a U.S. Standard 40 mesh sieve (425 microns or less).

"Grain elevator" means a facility engaged in the receipt, handling, storage, and shipment of bulk raw agricultural commodities such as corn, wheat, oats, barley, sunflower seeds, and soybeans.

"Hot work" means work involving electric or gas welding, cutting, brazing, or similar flame producing operations.

"Inside bucket elevator" means a bucket elevator that has the boot and more than 20 percent of the total leg height (above grade or ground level) inside the grain elevator structure. Bucket elevators with leg casings that are inside (and pass through the roofs) of rail or truck dump sheds with the remainder of the leg outside of the grain elevator structure, are not considered inside bucket elevators.

"Jogging" means repeated starting and stopping of drive motors in an attempt to clear choked legs.

"Lagging" means a covering on drive pulleys used to increase the coefficient of friction between the pulley and the belt.

"Permit" means the written certification by the employer authorizing employees to perform identified work operations subject to specified precautions.

1910.272(d)

Emergency action plan. The employer shall develop and implement an emergency action plan meeting the requirements contained in 29 CFR 1910.38.

..1910.272(e)

1910.272(e)

Training.

1910.272(e)(1)

The employer shall provide training to employees at least annually and when changes in job assignment will expose them to new hazards. Current employees, and new employees prior to starting work, shall be trained in at least the following:

1910.272(e)(1)(i)

General safety precautions associated with the facility, including recognition and preventive measures for the hazards related to dust accumulations and common ignition sources such as smoking; and,

1910.272(e)(1)(ii)

Specific procedures and safety practices applicable to their job tasks including but not limited to, cleaning procedures for grinding equipment, clearing procedures for choked legs, housekeeping procedures, hot work procedures, preventive maintenance procedures and lock-out/tag-out procedures.

1910.272(e)(2)

Employees assigned special tasks, such as bin entry and handling of flammable or toxic substances, shall be provided training to perform these tasks safely.

Note to paragraph (e)(2): Training for an employee who enters grain storage structures includes training about engulfment and mechanical hazards and how to avoid them.

1910.272(f)

Hot work permit.

1910.272(f)(1)

The employer shall issue a permit for all hot work, with the following exceptions:

1910.272(f)(1)(i)

Where the employer or the employer's representative (who would otherwise authorize the permit) is present while the hot work is being performed;

..1910.272(f)(1)(ii)

1910.272(f)(1)(ii)

In welding shops authorized by the employer;

1910.272(f)(1)(iii)

In hot work areas authorized by the employer which are located outside of the grain handling structure.

1910.272(f)(2)

The permit shall certify that the requirements contained in 1910.252(a) have been implemented prior to beginning the hot work operations. The permit shall be kept on file until completion of the hot work operations.

1910.272(g)

Entry into grain storage structures. This paragraph applies to employee entry into bins, silos , tanks, and other grain storage structures. Exception: Entry through unrestricted ground level openings into flat storage structures in which there are no toxicity, flammability, oxygen-deficiency, or other atmospheric hazards is covered by paragraph (h) of this section. For the purposes of this paragraph (g), the term "grain" includes raw and processed grain and grain products in facilities within the scope of paragraph (b)(1) of this section.

1910.272(g)(1)

The following actions shall be taken before employees enter bins, silos, or tanks:

..1910.272(g)(1)(i)

1910.272(g)(1)(i)

The employer shall issue a permit for entering bins, silos, or tanks unless the employer or the employer's representative (who would otherwise authorize the permit) is present during the entire operation. The permit shall certify that the precautions contained in this paragraph (1910.272(g)) have been implemented prior to employees entering bins, silos or tanks. The permit shall be kept on file until completion of the entry operations.

1910.272(g)(1)(ii)

All mechanical, electrical, hydraulic, and pneumatic equipment which presents a danger to employees inside grain storage structures shall be deenergized and shall be disconnected, locked-out and tagged, blocked-off, or otherwise prevented from operating by other equally effective means or methods.

1910.272(g)(1)(iii)

The atmosphere within a bin, silo, or tank shall be tested for the presence of combustible gases, vapors, and toxic agents when the employer has reason to believe they may be present. Additionally, the atmosphere within a bin, silo, or tank shall be tested for oxygen content unless there is continuous natural air movement or continuous forced-air ventilation before and during the period employees are inside. If the oxygen level is less than 19.5%, or if combustible gas or vapor is detected in excess of 10% of the lower flammable limit, or if toxic agents are present in excess of the ceiling values listed in Subpart Z of 29 CFR Part 1910, or if toxic agents are present in concentrations that will cause health effects which prevent employees from effecting self-rescue or communication to obtain assistance, the following provisions apply.

..1910.272(g)(1)(iii)(A)

1910.272(g)(1)(iii)(A)

Ventilation shall be provided until the unsafe condition or conditions are eliminated, and the ventilation shall be continued as long as there is a possibility of recurrence of the unsafe condition while the bin, silo, or tank is occupied by employees.

1910.272(g)(1)(iii)(B)

If toxicity or oxygen deficiency cannot be eliminated by ventilation, employees entering the bin, silo, or tank shall wear an appropriate respirator. Respirator use shall be in accordance with the requirements of 1910.134.

1910.272(g)(1)(iv)

"Walking down grain" and similar practices where an employee walks on grain to make it flow within or out from a grain storage structure, or where an employee is on moving grain, are prohibited.

1910.272(g)(2)

Whenever an employee enters a grain storage structure from a level at or above the level of the stored grain or grain products, or whenever an employee walks or stands on or in stored grain of a depth which poses an engulfment hazard, the employer shall equip the employee with a body harness with lifeline, or a boatswain's chair that meets the requirements of subpart D of this part. The lifeline shall be so positioned, and of sufficient length, to prevent the employee from sinking further than waist-deep in the grain. Exception: Where the employer can demonstrate that the protection required by this paragraph is not feasible or creates a greater hazard, the employer shall provide an alternative means of protection which is demonstrated to prevent the employee from sinking further than waist-deep in the grain.

Note to paragraph (g)(2): When the employee is standing or walking on a surface which the employer demonstrates is free from engulfment hazards, the lifeline or alternative means may be disconnected or removed.

..1910.272(g)(3)

1910.272(g)(3)

An observer, equipped to provide assistance, shall be stationed outside the bin, silo, or tank being entered by an employee. Communications (visual, voice, or signal line) shall be maintained between the observer and employee entering the bin, silo, or tank.

1910.272(g)(4)

The employer shall provide equipment for rescue operations which is specifically suited for the bin, silo, or tank being entered.

1910.272(g)(5)

The employee acting as observer shall be trained in rescue procedures, including notification methods for obtaining additional assistance.

1910.272(g)(6)

Employees shall not enter bins, silos, or tanks underneath a bridging condition, or where a buildup of grain products on the sides could fall and bury them.

1910.272(h)

Entry into flat storage structures. For the purposes of this paragraph (h), the term "grain" means raw and processed grain and grain products in facilities within the scope of paragraph (b)(1) of this section.

1910.272(h)(1)

Each employee who walks or stands on or in stored grain, where the depth of the grain poses an engulfment hazard, shall be equipped with a lifeline or alternative means which the employer demonstrates will prevent the employee from sinking further than waist-deep into the grain.

Note to paragraph (h)(1): When the employee is standing or walking on a surface which the employer demonstrates is free from engulfment hazards, the lifeline or alternative means may be disconnected or removed.

..1910.272(h)(2)

1910.272(h)(2) 1910.272(h)(2)(i)

Whenever an employee walks or stands on or in stored grain or grain products of a depth which poses an engulfment hazard, all equipment which presents a danger to that employee (such as an auger or other grain transport equipment) shall be deenergized, and shall be disconnected, locked-out and tagged, blocked-off, or otherwise prevented from operating by other equally effective means or methods.

1910.272(h)(2)(ii)

"Walking down grain" and similar practices where an employee walks on grain to make it flow within or out from a grain storage structure, or where an employee is on moving grain, are prohibited.

1910.272(h)(3)

No employee shall be permitted to be either underneath a bridging condition, or in any other location where an accumulation of grain on the sides or elsewhere could fall and engulf that employee.

1910.272(i)

Contractors.

1910.272(i)(1)

The employer shall inform contractors performing work at the grain handling facility of known potential fire and explosion hazards related to the contractor's work and work area. The employer shall also inform contractors of the applicable safety rules of the facility.

1910.272(i)(2)

The employer shall explain the applicable provisions of the emergency action plan to contractors.

1910.272(j)

Housekeeping.

..1910.272(j)(1)

1910.272(j)(1)

The employer shall develop and implement a written housekeeping program that establishes the frequency and method(s) determined best to reduce accumulations of fugitive grain dust on ledges, floors, equipment, and other exposed surfaces.

1910.272(j)(2)

In addition, the housekeeping program for grain elevators shall address fugitive grain dust accumulations at priority housekeeping areas.

1910.272(j)(2)(i)

Priority housekeeping areas shall include at least the following:

1910.272(j)(2)(i)(A)

Floor areas within 35 feet (10.7 m) of inside bucket elevators;

1910.272(j)(2)(i)(B)

Floors of enclosed areas containing grinding equipment;

1910.272(j)(2)(i)(C)

Floors of enclosed areas containing grain dryers located inside the facility.

1910.272(j)(2)(ii)

The employer shall immediately remove any fugitive grain dust accumulations whenever they exceed 1/8 inch (.32 cm) at priority housekeeping areas, pursuant to the housekeeping program, or shall demonstrate and assure, through the development and implementation of the housekeeping program, that equivalent protection is provided.

..1910.272(j)(3)

1910.272(j)(3)

The use of compressed air to blow dust from ledges, walls, and other areas shall only be permitted when all machinery that presents an ignition source in the area is shut-down, and all other known potential ignition sources in the area are removed or controlled.

1910.272(j)(4)

Grain and product spills shall not be considered fugitive grain dust accumulations. However, the housekeeping program shall address the procedures for removing such spills from the work area.

1910.272(k)

Grate openings. Receiving-pit feed openings, such as truck or railcar receiving-pits, shall be covered by grates. The width of openings in the grates shall be a maximum of 2 1/2 inches (6.35 cm).

1910.272(l)

Filter collectors.

1910.272(l)(1)

All fabric dust filter collectors which are a part of a pneumatic dust collection system shall be equipped with a monitoring device that will indicate a pressure drop across the surface of the filter.

1910.272(l)(2)

Filter collectors installed after March 30, 1988 shall be:

1910.272(l)(2)(i)

Located outside the facility; or

1910.272(l)(2)(ii)

Located in an area inside the facility protected by an explosion suppression system; or

..1910.272(l)(2)(iii)

1910.272(l)(2)(iii)

Located in an area inside the facility that is separated from other areas of the facility by construction having at least a one hour fire-resistance rating, and which is adjacent to an exterior wall and vented to the outside. The vent and ductwork shall be designed to resist rupture due to deflagration.

1910.272(m)

Preventive maintenance.

1910.272(m)(1)

The employer shall implement preventive maintenance procedures consisting of:

1910.272(m)(1)(i)

Regularly scheduled inspections of at least the mechanical and safety control equipment associated with dryers, grain stream processing equipment, dust collection equipment including filter collectors, and bucket elevators;

1910.272(m)(1)(ii)

Lubrication and other appropriate maintenance in accordance with manufacturers' recommendations, or as determined necessary by prior operating records.

1910.272(m)(2)

The employer shall promptly correct dust collection systems which are malfunctioning or which are operating below designed efficiency. Additionally, the employer shall promptly correct, or remove from service, overheated bearings and slipping or misaligned belts associated with inside bucket elevators.

..1910.272(m)(3)

1910.272(m)(3)

A certification record shall be maintained of each inspection, performed in accordance with this paragraph (m), containing the date of the inspection, the name of the person who performed the inspection and the serial number, or other identifier, of the equipment specified in paragraph (m)(1)(i) of this section that was inspected.

1910.272(m)(4)

The employer shall implement procedures for the use of tags and locks which will prevent the inadvertent application of energy or motion to equipment being repaired, serviced, or adjusted, which could result in employee injury. Such locks and tags shall be removed in accordance with established procedures only by the employee installing them or, if unavailable, by his or her supervisor.

1910.272(n)

Grain stream processing equipment. The employer shall equip grain stream processing equipment (such as hammer mills, grinders, and pulverizers) with an effective means of removing ferrous material from the incoming grain stream.

1910.272(o)

Emergency escape.

1910.272(o)(1)

The employer shall provide at least two means of emergency escape from galleries (bin decks).

1910.272(o)(2)

The employer shall provide at least one means of emergency escape in tunnels of existing grain elevators. Tunnels in grain elevators constructed after the effective date of this standard shall be provided with at least two means of emergency escape.

..1910.272(p)

1910.272(p)

Continuous-flow bulk raw grain dryers.

1910.272(p)(1)

All direct-heat grain dryers shall be equipped with automatic controls that:

1910.272(p)(1)(i)

Will shut-off the fuel supply in case of power or flame failure or interruption of air movement through the exhaust fan; and,

1910.272(p)(1)(ii)

Will stop the grain from being fed into the dryer if excessive temperature occurs in the exhaust of the drying section.

1910.272(p)(2)

Direct-heat grain dryers installed after March 30, 1988 shall be:

1910.272(p)(2)(i)

Located outside the grain elevator; or

1910.272(p)(2)(ii)

Located in an area inside the grain elevator protected by a fire or explosion suppression system; or

1910.272(p)(2)(iii)

Located in an area inside the grain elevator which is separated from other areas of the facility by construction having at least a one hour fire-resistance rating.

1910.272(q)

Inside bucket elevators.

1910.272(q)(1)

Bucket elevators shall not be jogged to free a choked leg.

..1910.272(q)(2)

1910.272(q)(2)

All belts and lagging purchased after March 30, 1988 shall be conductive. Such belts shall have a surface electrical resistance not to exceed 300 megohms.

1910.272(q)(3)

All bucket elevators shall be equipped with a means of access to the head pulley section to allow inspection of the head pulley, lagging, belt, and discharge throat of the elevator head. The boot section shall also be provided with a means of access for clean-out of the boot and for inspection of the boot, pulley, and belt.

1910.272(q)(4)

The employer shall:

1910.272(q)(4)(i)

Mount bearings externally to the leg casing; or,

1910.272(q)(4)(ii)

Provide vibration monitoring, temperature monitoring, or other means to monitor the condition of those bearings mounted inside or partially inside the leg casing.

1910.272(q)(5)

The employer shall equip bucket elevators with a motion detection device which will shut-down the bucket elevator when the belt speed is reduced by no more than 20% of the normal operating speed.

1910.272(q)(6)

The employer shall:

..1910.272(q)(6)(i)

1910.272(q)(6)(i)

Equip bucket elevators with a belt alignment monitoring device which will initiate an alarm to employees when the belt is not tracking properly; or,

1910.272(q)(6)(ii)

Provide a means to keep the belt tracking properly, such as a system that provides constant alignment adjustment of belts.

1910.272(q)(7)

Paragraphs (q)(5) and (q)(6) of this section do not apply to grain elevators having a permanent storage capacity of less than one million bushels, provided that daily visual inspection is made of bucket movement and tracking of the belt.

1910.272(q)(8)

Paragraphs (q)(4), (q)(5), and (q)(6) of this section do not apply to the following:

1910.272(q)(8)(i)

Bucket elevators which are equipped with an operational fire and explosion suppression system capable of protecting at least the head and boot section of the bucket elevator; or,

1910.272(q)(8)(ii)

Bucket elevators which are equipped with pneumatic or other dust control systems or methods that keep the dust concentration inside the bucket elevator at least 25% below the lower explosive limit at all times during operations.

[52 FR 49625, Dec.. 31, 1987; 53 FR 17697, May 18, 1988; 61 FR 5507; Feb. 13, 1996; 61 FR 9227, March 7, 1996; 61 FR 9577, March 8, 1996; 67 FR 67965, Nov. 7, 2002]

Note: The following appendices to 1910.272 serve as nonmandatory guidelines to assist employers and employees in complying with the requirements of this section, as well as to provide other helpful information.

No additional burdens are imposed through these appendices.

1910.1025(a)

Scope and application.

This section applies to all occupational exposure to lead, except as provided in paragraph (a)(2).

This section does not apply to the construction industry or to agricultural operations covered by 29 CFR Part 1928.

Definitions.

"Action level" means employee exposure, without regard to the use of respirators, to an airborne concentration of lead of 30 micrograms per cubic meter of air (30 ug/m(3)) averaged over an 8-hour period.

"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

"Director" means the Director, National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health, Education, and Welfare, or designee.

"Lead" means metallic lead, all inorganic lead compounds, and organic lead soaps. Excluded from this definition are all other organic lead compounds.

Permissible exposure limit (PEL).

The employer shall assure that no employee is exposed to lead at concentrations greater than fifty micrograms per cubic meter of air (50 ug/m(3)) averaged over an 8-hour period.

If an employee is exposed to lead for more than 8 hours in any work day, the permissible exposure limit, as a time weighted average (TWA) for that day, shall be reduced according to the following formula:

Maximum permissible limit (in ug/m(3))=400 divided by hours worked in the day.

When respirators are used to supplement engineering and work practice controls to comply with the PEL and all the requirements of paragraph (f) have been met, employee exposure, for the purpose of determining whether the employer has complied with the PEL, may be considered to be at the level provided by the protection factor of the respirator for those periods the respirator is worn. Those periods may be averaged with exposure levels during periods when respirators are not worn to determine the employee's daily TWA exposure.

Exposure monitoring -

General.

For the purposes of paragraph (d), employee exposure is that exposure which would occur if the employee were not using a respirator.

With the exception of monitoring under paragraph (d)(3), the employer shall collect full shift (for at least 7 continuous hours) personal samples including at least one sample for each shift for each job classification in each work area.

Full shift personal samples shall be representative of the monitored employee's regular, daily exposure to lead.

Initial determination. Each employer who has a workplace or work operation covered by this standard shall determine if any employee may be exposed to lead at or above the action level.

Basis of initial determination.

The employer shall monitor employee exposures and shall base initial determinations on the employee exposure monitoring results and any of the following, relevant considerations:

Any information, observations, or calculations which would indicate employee exposure to lead;

Any previous measurements of airborne lead; and

Any employee complaints of symptoms which may be attributable to exposure to lead.

Monitoring for the initial determination may be limited to a representative sample of the exposed employees who the employer reasonably believes are exposed to the greatest airborne concentrations of lead in the workplace.

Measurements of airborne lead made in the preceding 12 months may be used to satisfy the requirement to monitor under paragraph (d)(3)(i) if the sampling and analytical methods used meet the accuracy and confidence levels of paragraph (d)(9) of this section.

Positive initial determination and initial monitoring.

Where a determination conducted under paragraphs (d)(2) and (3) of this section shows the possibility of any employee exposure at or above the action level, the employer shall conduct monitoring which is representative of the exposure for each employee in the workplace who is exposed to lead.

Measurements of airborne lead made in the preceding 12 months may be used to satisfy this requirement if the sampling and analytical methods used meet the accuracy and confidence levels of paragraph (d)(9) of this section.

Negative initial determination. Where a determination, conducted under paragraphs (d)(2) and (3) of this section is made that no employee is exposed to airborne concentrations of lead at or above the action level, the employer shall make a written record of such determination. The record shall include at least the information specified in paragraph (d)(3) of this section and shall also include the date of determination, location within the worksite, and the name and social security number of each employee monitored.

Frequency.

If the initial monitoring reveals employee exposure to be below the action level the measurements need not be repeated except as otherwise provided in paragraph (d)(7) of this section.

If the initial determination or subsequent monitoring reveals employee exposure to be at or above the action level but below the permissible exposure limit the employer shall repeat monitoring in accordance with this paragraph at least every 6 months. The employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least 7 days apart, are below the action level at which time the employer may discontinue monitoring for that employee except as otherwise provided in paragraph (d)(7) of this section.

If the initial monitoring reveals that employee exposure is above the permissible exposure limit the employer shall repeat monitoring quarterly. The employer shall continue monitoring at the required frequency until at least two consecutive measurements, taken at least 7 days apart, are below the PEL but at or above the action level at which time the employer shall repeat monitoring for that employee at the frequency specified in paragraph (d)(6)(ii), except as otherwise provided in paragraph (d)(7) of this section.

Additional monitoring. Whenever there has been a production, process, control or personnel change which may result in new or additional exposure to lead, or whenever the employer has any other reason to suspect a change which may result in new or additional exposures to lead, additional monitoring in accordance with this paragraph shall be conducted.

Employee notification.

The employer must, within 15 working days after the receipt of the results of any monitoring performed under this section, notify each affected employee of these results either individually in writing or by posting the results in an appropriate location that is accessible to affected employees.

Whenever the results indicate that the representative employee exposure, without regard to respirators, exceeds the permissible exposure limit, the employer shall include in the written notice a statement that the permissible exposure limit was exceeded and a description of the corrective action taken or to be taken to reduce exposure to or below the permissible exposure limit.

Accuracy of measurement. The employer shall use a method of monitoring and analysis which has an accuracy (to a confidence level of 95%) of not less than plus or minus 20 percent for airborne concentrations of lead equal to or greater than 30 ug/m(3).

Methods of compliance -

Engineering and work practice controls.

Where any employee is exposed to lead above the permissible exposure limit for more than 30 days per year, the employer shall implement engineering and work practice controls (including administrative controls) to reduce and maintain employee exposure to lead in accordance with the implementation schedule in Table I below, except to the extent that the employer can demonstrate that such controls are not feasible. Wherever the engineering and work practice controls which can be instituted are not sufficient to reduce employee exposure to or below the permissible exposure limit, the employer shall nonetheless use them to reduce exposures to the lowest feasible level and shall supplement them by the use of respiratory protection which complies with the requirements of paragraph (f) of this section.

Where any employee is exposed to lead above the permissible exposure limit, but for 30 days or less per year, the employer shall implement engineering controls to reduce exposures to 200 ug/m(3), but thereafter may implement any combination of engineering, work practice (including administrative controls), and respiratory controls to reduce and maintain employee exposure to lead to or below 50 ug/m(3)

TABLE I

Industry	Compliance dates(1): (50 UG/M(3))
Lead chemicals, secondary copper smeting. Nonferrous foundries. Brass and bronze ingot manufacture.	July 19, 1996. July 19, 1996(2). 6 years(3).

Footnote(1) Calculated by counting from the date the stay on implementation of paragraph (e)(1) was lifted by the U.S. Court of Appeals for the District of Columbia, the number of years specified in the 1978 lead standard and subsequent amendments for compliance with the PEL of 50 ug/m(3) for exposure to airborne concentrations of lead levels for the particular industry.
Footnote(2) Large nonferrous foundries (20 or more employees) are required to achieve the PEL of 50 ug/m(3) by means of engineering and work practice controls. Small nonferrous foundries (fewer than 20 employees) are required to achieve an 8-hour TWA of 75 ug/m(3) by such controls.
Footnote(3) Expressed as the number of years from the date on which the Court lifts the stay on the implementation of paragraph (e)(1) for this industry for employers to achieve a lead in air concentration of 75 ug/m(3). Compliance with paragraph (e) in this industry is determined by a complance directive that incorporates elements from the settlement agreement between OSHA and representatives of the injury. are required to comply within five years.

Respiratory protection. Where engineering and work practice controls do not reduce employee exposure to or below the 50 ug/m(3) permissible exposure limit, the employer shall supplement these controls with respirators in accordance with paragraph (f).

Compliance program.

Each employer shall establish and implement a written compliance program to reduce exposures to or below the permissible exposure limit, and interim levels if applicable, solely by means of engineering and work practice controls in accordance with the implementation schedule in paragraph (e)(1).

Written plans for these compliance programs shall include at least the following:

A description of each operation in which lead is emitted; e.g. machinery used, material processed, controls in place, crew size, employee job responsibilities, operating procedures and maintenance practices;

A description of the specific means that will be employed to achieve compliance, including engineering plans and studies used to determine methods selected for controlling exposure to lead;

A report of the technology considered in meeting the permissible exposure limit;

Air monitoring data which documents the source of lead emissions;

A detailed schedule for implementation of the program, including documentation such as copies of purchase orders for equipment, construction contracts, etc.;

A work practice program which includes items required under paragraphs (g), (h) and (i) of this regulation;

An administrative control schedule required by paragraph (e)(6), if applicable;

Other relevant information.

Written programs shall be submitted upon request to the Assistant Secretary and the Director, and shall be available at the worksite for examination and copying by the Assistant Secretary, Director, any affected employee or authorized employee representatives.

Written programs must be revised and updated at least annually to reflect the current status of the program.

Mechanical ventilation.

When ventilation is used to control exposure, measurements which demonstrate the effectiveness of the system in controlling exposure, such as capture velocity, duct velocity, or static pressure shall be made at least every 3 months. Measurements of the system's effectiveness in controlling exposure shall be made within 5 days of any change in production, process, or control which might result in a change in employee exposure to lead.

Recirculation of air. If air from exhaust ventilation is recirculated into the workplace, the employer shall assure that (A) the system has a high efficiency filter with reliable back-up filter; and (B) controls to monitor the concentration of lead in the return air and to bypass the recirculation system automatically if it fails are installed, operating, and maintained.

Administrative controls. If administrative controls are used as a means of reducing employees TWA exposure to lead, the employer shall establish and implement a job rotation schedule which includes:

Name or identification number of each affected employee;

Duration and exposure levels at each job or work station where each affected employee is located; and

Any other information which may be useful in assessing the reliability of administrative controls to reduce exposure to lead.

Respiratory protection.

General. For employees who use respirators required by this section, the employer must provide each employee an appropriate respirator that complies with the requirements of this paragraph. Respirators must be used during:

Periods necessary to install or implement engineering or work-practice controls.

Work operations for which engineering and work-practice controls are not sufficient to reduce employee exposures to or below the permissible exposure limit.

Periods when an employee requests a respirator.

Respirator program.

The employer must implement a respiratory protection program in accordance with § 1910.134(b) through (d) (except (d)(1)(iii)), and (f) through (m), which covers each employee required by this section to use a respirator.

If an employee has breathing difficulty during fit testing or respirator use, the employer must provide the employee with a medical examination in accordance with paragraph (j)(3)(i)(C) of this section to determine whether or not the employee can use a respirator while performing the required duty.

Respirator selection.

Employers must:

Select, and provide to employees, the appropriate respirators specified in paragraph (d)(3)(i)(A) of 29 CFR 1910.134.

Provide employees with full facepiece respirators instead of half mask respirators for protection against lead aerosols that cause eye or skin irritation at the use concentrations.

Provide HEPA filters for powered and non-powered air-purifying respirators.

Employers must provide employees with a powered air-purifying respirator (PAPR) instead of a negative pressure respirator selected according to paragraph (f)(3)(i) of this standard when an employee chooses to use a PAPR and it provides adequate protection to the employee as specified by paragraph (f)(3)(i) of this standard.

Protective work clothing and equipment -

Provision and use. If an employee is exposed to lead above the PEL, without regard to the use of respirators or where the possibility of skin or eye irritation exists, the employer shall provide at no cost to the employee and assure that the employee uses appropriate protective work clothing and equipment such as, but not limited to:

Coveralls or similar full-body work clothing;

Gloves, hats, and shoes or disposable shoe coverlets; and

Face shields, vented goggles, or other appropriate protective equipment which complies with 1910.133 of this Part.

Cleaning and replacement.

The employer shall provide the protective clothing required in paragraph (g)(1) of this section in a clean and dry condition at least weekly, and daily to employees whose exposure levels without regard to a respirator are over 200 ug/m(3) of lead as an 8-hour TWA.

The employer shall provide for the cleaning, laundering, or disposal of protective clothing and equipment required by paragraph (g)(1) of this section.

The employer shall repair or replace required protective clothing and equipment as needed to maintain their effectiveness.

The employer shall assure that all protective clothing is removed at the completion of a work shift only in change rooms provided for that purpose as prescribed in paragraph (i)(2) of this section.

The employer shall assure that contaminated protective clothing which is to be cleaned, laundered, or disposed of, is placed in a closed container in the change-room which prevents dispersion of lead outside the container.

The employer shall inform in writing any person who cleans or launders protective clothing or equipment of the potentially harmful effects of exposure to lead.

The employer shall assure that the containers of contaminated protective clothing and equipment required by paragraph (g)(2)(v) are labeled as follows: CAUTION: CLOTHING CONTAMINATED WITH LEAD. DO NOT REMOVE DUST BY BLOWING OR SHAKING. DISPOSE OF LEAD CONTAMINATED WASH WATER IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, OR FEDERAL REGULATIONS.

The employer shall prohibit the removal of lead from protective clothing or equipment by blowing, shaking, or any other means which disperses lead into the air.

Housekeeping -

Surfaces. All surfaces shall be maintained as free as practicable of accumulations of lead.

Cleaning floors.

Floors and other surfaces where lead accumulates may not be cleaned by the use of compressed air.

Shoveling, dry or wet sweeping, and brushing may be used only where vacuuming or other equally effective methods have been tried and found not to be effective.

Vacuuming. Where vacuuming methods are selected, the vacuums shall be used and emptied in a manner which minimizes the reentry of lead into the workplace.

Hygiene facilities and practices.

The employer shall assure that in areas where employees are exposed to lead above the PEL, without regard to the use of respirators, food or beverage is not present or consumed, tobacco products are not present or used, and cosmetics are not applied, except in change rooms, lunchrooms, and showers required under paragraphs (i)(2) - through (i)(4) of this section.

Change rooms.

The employer shall provide clean change rooms for employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators.

The employer shall assure that change rooms are equipped with separate storage facilities for protective work clothing and equipment and for street clothes which prevent cross-contamination.

Showers.

The employer shall assure that employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators, shower at the end of the work shift.

The employer shall provide shower facilities in accordance with 1910.141 (d)(3) of this part.

The employer shall assure that employees who are required to shower pursuant to paragraph (i)(3)(i) do not leave the workplace wearing any clothing or equipment worn during the work shift.

Lunchrooms.

The employer shall provide lunchroom facilities for employees who work in areas where their airborne exposure to lead is above the PEL, without regard to the use of respirators.

The employer shall assure that lunchroom facilities have a temperature controlled, positive pressure, filtered air supply, and are readily accessible to employees.

The employer shall assure that employees who work in areas where their airborne exposure to lead is above the PEL without regard to the use of a respirator wash their hands and face prior to eating, drinking, smoking or applying cosmetics.

The employer shall assure that employees do not enter lunchroom facilities with protective work clothing or equipment unless surface lead dust has been removed by vacuuming, down draft booth, or other cleaning method.

Lavatories. The employer shall provide an adequate number of lavatory facilities which comply with 1910.141(d)(1) and (2) of this part.

Medical surveillance -

General.

The employer shall institute a medical surveillance program for all employees who are or may be exposed above the action level for more than 30 days per year.

The employer shall assure that all medical examinations and procedures are performed by or under the supervision of a licensed physician.

The employer shall provide the required medical surveillance including multiple physician review under paragraph (j)(3)(iii) without cost to employees and at a reasonable time and place.

Biological monitoring -

Blood lead and ZPP level sampling and analysis. The employer shall make available biological monitoring in the form of blood sampling and analysis for lead and zinc protoporphyrin levels to each employee covered under paragraph (j)(1)(i) of this section on the following schedule:

At least every 6 months to each employee covered under paragraph (j)(1)(i) of this section;

At least every two months for each employee whose last blood sampling and analysis indicated a blood lead level at or above 40 ug/100 g of whole blood. This frequency shall continue until two consecutive blood samples and analyses indicate a blood lead level below 40 ug/100 g of whole blood; and

At least monthly during the removal period of each employee removed from exposure to lead due to an elevated blood lead level.

Follow-up blood sampling tests. Whenever the results of a blood lead level test indicate that an employee's blood lead level exceeds the numerical criterion for medical removal under paragraph (k)(1)(i)(A), of this section, the employer shall provide a second (follow-up) blood sampling test within two weeks after the employer receives the results of the first blood sampling test.

Accuracy of blood lead level sampling and analysis. Blood lead level sampling and analysis provided pursuant to this section shall have an accuracy (to a confidence level of 95 percent) within plus or minus 15 percent or 6 ug/100 ml, whichever is greater, and shall be conducted by a laboratory licensed by the Center for Disease Control, United States Department of Health, Education and Welfare (CDC) or which has received a satisfactory grade in blood lead proficiency testing from CDC in the prior twelve months.

Employee notification. Within five working days after the receipt of biological monitoring results, the employer shall notify in writing each employee whose blood lead level exceeds 40 ug/100 g:

of that employee's blood lead level and (B) that the standard requires temporary medical removal with Medical Removal Protection benefits when an employee's blood lead level exceeds the numerical criterion for medical removal under paragraph (k)(1)(i) of this section.

Medical examinations and consultations -

Frequency. The employer shall make available medical examinations and consultations to each employee covered under paragraph (j)(1)(i) of this section on the following schedule:

At least annually for each employee for whom a blood sampling test conducted at any time during the preceding 12 months indicated a blood lead level at or above 40 ug/100 g;

Prior to assignment for each employee being assigned for the first time to an area in which airborne concentrations of lead are at or above the action level;

As soon as possible, upon notification by an employee either that the employee has developed signs or symptoms commonly associated with lead intoxication, that the employee desires medical advice concerning the effects of current or past exposure to lead on the employee's ability to procreate a healthy child, or that the employee has demonstrated difficulty in breathing during a respirator fitting test or during use; and

As medically appropriate for each employee either removed from exposure to lead due to a risk of sustaining material impairment to health, or otherwise limited pursuant to a final medical determination.

Content. Medical examinations made available pursuant to paragraph (j)(3)(i)(A)-(B) of this section shall include the following elements:

A detailed work history and a medical history, with particular attention to past lead exposure (occupational and non-occupational), personal habits (smoking, hygiene), and past gastrointestinal, hematologic,renal, cardiovascular, reproductive and neurological problems;

A thorough physical examination, with particular attention to teeth, gums, hematologic, gastrointestinal, renal, cardiovascular, and neurological systems. Pulmonary status should be evaluated if respiratory protection will be used;

A blood pressure measurement;

A blood sample and analysis which determines:

Blood lead level;

Hemoglobin and hematocrit determinations, red cell indices, and examination of peripheral smear morphology;

Zinc protoporphyrin;

Blood urea nitrogen; and,

Serum creatinine;

A routine urinalysis with microscopic examination; and

Any laboratory or other test which the examining physician deems necessary by sound medical practice. The content of medical examinations made available pursuant to paragraph (j)(3)(i)(C) - (D) of this section shall be determined by an examining physician and, if requested by an employee, shall include pregnancy testing or laboratory evaluation of male fertility.

Multiple physician review mechanism.

If the employer selects the initial physician who conducts any medical examination or consultation provided to an employee under this section, the employee may designate a second physician:

To review any findings, determinations or recommendations of the initial physician; and

To conduct such examinations, consultations, and laboratory tests as the second physician deems necessary to facilitate this review.

The employer shall promptly notify an employee of the right to seek a second medical opinion after each occasion that an initial physician conducts a medical examination or consultation pursuant to this section. The employer may condition its participation in, and payment for, the multiple physician review mechanism upon the employee doing the following within fifteen (15) days after receipt of the foregoing notification, or receipt of the initial physician's written opinion, whichever is later:

The employee informing the employer that he or she intends to seek a second medical opinion, and

The employee initiating steps to make an appointment with a second physician.

If the findings, determinations or recommendations of the second physician differ from those of the initial physician, then the employer and the employee shall assure that efforts are made for the two physicians to resolve any disagreement.

If the two physicians have been unable to quickly resolve their disagreement, then the employer and the employee through their respective physicians shall designate a third physician:

To review any findings, determinations or recommendations of the prior physicians; and

To conduct such examinations, consultations, laboratory tests and discussions with the prior physicians as the third physician deems necessary to resolve the disagreement of the prior physicians.

The employer shall act consistent with the findings, determinations and recommendations of the third physician, unless the employer and the employee reach an agreement which is otherwise consistent with the recommendations of at least one of the three physicians.

Information provided to examining and consulting physicians.

The employer shall provide an initial physician conducting a medical examination or consultation under this section with the following information:

A copy of this regulation for lead including all Appendices;

A description of the affected employee's duties as they relate to the employee's exposure;

The employee's exposure level or anticipated exposure level to lead and to any other toxic substance (if applicable);

A description of any personal protective equipment used or to be used;

Prior blood lead determinations; and

All prior written medical opinions concerning the employee in the employer's possession or control.

The employer shall provide the foregoing information to a second or third physician conducting a medical examination or consultation under this section upon request either by the second or third physician, or by the employee.

Written medical opinions.

The employer shall obtain and furnish the employee with a copy of a written medical opinion from each examining or consulting physician which contains the following information:

The physician's opinion as to whether the employee has any detected medical condition which would place the employee at increased risk of material impairment of the employee's health from exposure to lead;

Any recommended special protective measures to be provided to the employee, or limitations to be placed upon the employee's exposure to lead;

Any recommended limitation upon the employee's use of respirators, including a determination of whether the employee can wear a powered air purifying respirator if a physician determines that the employee cannot wear a negative pressure respirator; and

The results of the blood lead determinations.

The employer shall instruct each examining and consulting physician to:

Not reveal either in the written opinion, or in any other means of communication with the employer, findings, including laboratory results, or diagnoses unrelated to an employee's occupational exposure to lead; and

Advise the employee of any medical condition, occupational or nonoccupational, which dictates further medical examination or treatment.

Alternate Physician Determination Mechanisms. The employer and an employee or authorized employee representative may agree upon the use of any expeditious alternate physician determination mechanism in lieu of the multiple physician review mechanism provided by this paragraph so long as the alternate mechanism otherwise satisfies the requirements contained in this paragraph.

Chelation.

The employer shall assure that any person whom he retains, employs, supervises or controls does not engage in prophylactic chelation of any employee at any time.

If therapeutic or diagnostic chelation is to be performed by any person in paragraph (j)(4)(i), the employer shall assure that it be done under the supervision of a licensed physician in a clinical setting with thorough and appropriate medical monitoring and that the employee is notified in writing prior to its occurrence.

Medical Removal Protection -

Temporary medical removal and return of an employee -

Temporary removal due to elevated blood lead levels -

The employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that a periodic and a follow-up blood sampling test conducted pursuant to this section indicate that the employee's blood lead level is at or above 60 ug/100 g of whole blood; and,

The employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that the average of the last three blood sampling tests conducted pursuant to this section (or the average of all blood sampling tests conducted over the previous six (6) months, whichever is longer) indicates that the employee's blood lead level is at or above 50 ug/100 g of whole blood; provided, however, that an employee need not be removed if the last blood sampling test indicates a blood lead level at or below 40 ug/100 g of whole blood.

Temporary removal due to a final medical determination.

The employer shall remove an employee from work having an exposure to lead at or above the action level on each occasion that a final medical determination results in a medical finding, determination, or opinion that the employee has a detected medical condition which places the employee at increased risk of material impairment to health from exposure to lead.

For the purposes of this section, the phrase "final medical determination" shall mean the outcome of the multiple physician review mechanism or alternate medical determination mechanism used pursuant to the medical surveillance provisions of this section.

Where a final medical determination results in any recommended special protective measures for an employee, or limitations on an employee's exposure to lead, the employer shall implement and act consistent with the recommendation.

Return of the employee to former job status.

The employer shall return an employee to his or her former job status:

For an employee removed due to a blood lead level at or above 60 ug/100 g, or due to an average blood lead level at or above 50 ug/100 g, when two consecutive blood sampling tests indicate that the employee's blood lead level is at or below 40 ug/100 g of whole blood;

For an employee removed due to a final medical determination, when a subsequent final medical determination results in a medical finding, determination, or opinion that the employee no longer has a detected medical condition which places the employee at increased risk of material impairment to health from exposure to lead.

For the purposes of this section, the requirement that an employer return an employee to his or her former job status is not intended to expand upon or restrict any rights an employee has or would have had, absent temporary medical removal, to a specific job classification or position under the terms of a collective bargaining agreement.

Removal of other employee special protective measure or limitations. The employer shall remove any limitations placed on an employee or end any special protective measures provided to an employee pursuant to a final medical determination when a subsequent final medical determination indicates that the limitations or special protective measures are no longer necessary.

Employer options pending a final medical determination. Where the multiple physician review mechanism, or alternate medical determination mechanism used pursuant to the medical surveillance provisions of this section, has not yet resulted in a final medical determination with respect to an employee, the employer shall act as follows:

Removal. The employer may remove the employee from exposure to lead, provide special protective measures to the employee, or place limitations upon the employee, consistent with the medical findings, determinations, or recommendations of any of the physicians who have reviewed the employee's health status.

Return. The employer may return the employee to his or her former job status, end any special protective measures provided to the employee, and remove any limitations placed upon the employee, consistent with the medical findings, determinations, or recommendations of any of the physicians who have reviewed the employee's health status, with two exceptions. If -

the initial removal, special protection, or limitation of the employee resulted from a final medical determination which differed from the findings, determinations, or recommendations of the initial physician or

The employee has been on removal status for the preceding eighteen months due to an elevated blood lead level, then the employer shall await a final medical determination.

Medical removal protection benefits -

Provision of medical removal protection benefits. The employer shall provide to an em

On August 2, 2004, President George W. Bush signed into law The Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Senate Bill S.741.

On January 1, 2006, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) became effective. This law requires manufacturers to clearly identify on their food labels if a food product has any ingredients that contain protein derived from any of the eight major allergenic foods and food groups: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, or soybeans. These eight foods and food groups account for 90 percent of all food allergies. Other allergenic foods (e.g., sesame) are not required to be
declared in accordance with FALCPA.

Unfair or deceptive acts or practices.

In connection with the sale of offering for sale by retail food stores of food, grocery products or other merchandise to consumers in or
affecting commerce as ``commerce'' is defined in section 4 of the Federal Trade Commission Act, 15 U.S.C. 44, it is an unfair or deceptive act or practice in violation of section 5(a)(1) of the Federal Trade Commission Act, 15 U.S.C. 45(a)(1), to offer any such products for sale at a stated price, by means of an advertisement disseminated in an area served by any stores which are covered by the advertisement, if those stores do not have the advertised products in stock and readily available to customers during the effective period of the advertisement, unless the advertisement clearly and adequately discloses that supplies of the advertised products are limited or the advertised products are available only at some outlets.
 

No violation of Sec. 424.1 shall be found if:
    (a) The advertised products were ordered in adequate time for delivery in quantities sufficient to meet reasonably anticipated demand;
    (b) The food retailer offers a ``raincheck'' for the advertised products;
    (c) The food retailer offers at the advertised price or at a comparable price reduction a similar product that is at least comparable
in value to the advertised product; or
    (d) The food retailer offers other compensation at least equal to the advertised value.
 

The Fair Packaging and Labeling Act (FPLA) of 1966 was enacted to ensure that customers are provided enough information to choose wisely among competing products. The Act is enforced by both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

This Draft guidance describes the qualification process for drug development tools (DDTs) intended 18 for potential use, over time, in multiple drug development programs. DDTs include, but are not 19 limited to, biomarkers and patient reported outcome (PRO) instruments. The guidance provides 20 a framework for interactions between CDER and DDT submitters.

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current  thinking on this topic . It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

Introduced by James Madison to the First United States Congress in 1789, the Bill of Rights is the first ten amendments of the United States Constitution. The Rights of Bill were first introduced as a series of articles and became effective as Constitutional Amendments on December 15, 1791.

The Unemployment Compensation Extension Act of 2010 amends the Supplemental Appropriations Act, 2008. The Act further extends the final date for entering a federal-state agreement under the Emergency Unemployment Compensation (EUC) program through November 30, 2010 and postpones the termination of the program until April 30, 2011. Also, the Act amends the Assistance for Unemployed Workers and Struggling Families Act to extend until December 1, 2010, requirements that federal payments to states cover 100% of EUC.

Issuing Date: Jul 22, 2010

This would amend the Internal Revenue Code of 1986 to extend the funding and expenditure authority of the Airport and Airway Trust Fund, to amend title 49, United States Code, to extend airport improvement program project grant authority and to improve airline safety.

Improving Access to Clinical Trials Act of 2010 amends title XVI (Supplemental Security Income) (SSI) of the Social Security Act (SSA) to exclude from income for SSI eligibility purposes any compensation in the amount of the first $2,000 per year received by an individual for participation in clinical trials involving research and testing of treatments for rare diseases or conditions.

H.R. 6190, the “Airport and Airways Extension Act of 2010, Part III”, extends aviation programs, taxes, and expenditure authority for three additional months, through the end of the calendar year (December 31, 2010), pending completion of a multi-year Federal Aviation Administration (FAA) reauthorization bill. Without this short-term extension, the FAA’s capital, research, and airport grant programs would shut down after September 30, 2010, and several thousand FAA employees would be furloughed.

The National Aeronautics and Space Administration Authorization Act of 2010 is signed by President Obama on October 11, 2010. The Act authorizes appropriations for FY2011-FY2013 for the National Aeronautics and Space Administration (NASA) and also authorizes programs, activities, and reports respecting NASA, including those with regard to the International Space Station (ISS), the Space Shuttle, commercial crew and cargo transportation, earth and space science, aeronautics and space technology, space traffic management, near-Earth object threats, space weather and national and international orbital debris mitigation. The Act will introduce an additional shuttle flight before the fleet retires, and would extend the life of the International Space Station through at least 2020. Also, the Act establishes a NASA launch support and infrastructure modernization program, a science, technology, engineering, and mathematics (STEM) commercial orbital platform program, and an information security awareness and education program at NASA.

Secure and Responsible Drug Disposal Act of 2010 - Amends the Controlled Substances Act to allow an ultimate user of a controlled substance (or, if deceased, any person lawfully entitled to dispose of the ultimate user's property) who has lawfully obtained such substance to deliver that substance to another person, without being registered, for disposal if:

(1) the person receiving the controlled substance is authorized to engage in such activity; and (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances.