Summary of Federal
Regulations Impacting Research and Development Activities
|
Regulation
|
Type of Regulation
|
General Requirements
|
Applicability to R&D
|
| Occupational
Health and Safety (OSHA) |
Worker
protection from chemicals and hazards |
Laboratory Standards
(including Chemical Hygiene Plan)
Hazard Communication
Standard
Standards for Exposure
to Hazardous Chemicals
Hazardous Materials
Standards (compressed gases, flammable and combustible liquids,
explosives, anhydrous ammonia)
Standards for personal
protective equipment, medical services, worker protection from
electrical, energy, mechanical hazards and radiation.
|
Laboratory Standards
are the central requirements for R&D. An extensive Chemical
Hygiene Plan must be developed for each laboratory, including
work practice standards for handling chemicals, control measures,
and additional protection when handling toxic and carcinogenic
materials.
Laboratories and other
R&D must comply with other OSHA requirements where applicable.
OSHA laboratory regulations
do not apply to pilot plants.
OSHA regulations for
laboratories refer to the "Prudent Practices in the Laboratory"
developed by the National Research Council. The practices may
reduce air emissions.
|
| Resource
Conservation and Recovery Act (RCRA) |
Waste disposal
and reduction |
"Cradle-to-grave"
hazardous waste management (includes regulation of generation,
transport, treatment, storage, and disposal of hazardous waste).
Requirements for handling
and disposal of hazardous wastes, including solvents commonly
used in research laboratories and facilities.
Requirements for controlling
air emissions from tanks and containers
Underground storage
tank protection against soil and groundwater contamination.
|
R&D facilities
must comply with RCRA similar to other facilities.
R&D facility,
rather than each lab, generally viewed as the "generator"
of hazardous waste.
On-site transportation
not regulated under RCRA.
Treatability studies
can be exempted.
|
| Superfund
Amendments and Reauthorization (SARA) |
Planning
for emergencies and reporting of hazardous materials |
Emergency planning
and notification for extreme hazardous materials and unplanned
releases
Community Right-to-Know
reporting of hazardous chemicals in use
Requirements for reporting
toxic chemical releases [SARA 313 Toxic Release Inventory (TRI)]
|
R&D exempted from
federal Community Right-to-Know regulations, but some States regulate.
SARA 313 exemption is for laboratory operations, product testing
(including equipment and component testing), and R&D support
activities.
Requirements for reporting
toxic chemical releases are for manufacturing only, but States
may vary.
A hazardous chemical
is exempt "to the extent it is used in a research laboratory...under
the direct supervision of a technically qualified individual."
Nonlaboratory uses
are not exempt.
|
| Toxic
Substances Control Act (TSCA) |
Protection
of human health and environment by requiring testing and restriction
of certain chemicals |
Reporting and recordkeeping
Record of allegation
that chemical substance or mixture caused significant adverse
effect for health or the environment
Premanufacture notification
(PMN) for any chemical not on TSCA Inventory
Definition of a technically
qualified individual
Prohibits the manufacture,
process, distribution, and use of polychlorinated biphenyls (PCBs)
|
R&D may be exempt
from reporting and recordkeeping if R&D requirements are met.
R&D is exempted
from PMN regulations for small quantities that are manufactured
or imported for R&D use only, or a use regulated by another
agency (i.e., medical use regulated by the Food and Drug Administration).
There are requirements to be met for R;amp;D exemption regarding
quantity, exposure/risk, labeling, and Material Safety Data Sheets
(MSDS). PMN exemption also defines ;quot;test marketing.;quot;
Limited laboratory
use of PCBs is permitted.
|
Clean Air Act
(CAA) |
|
| Air
quality protection and improvement |
Regulation of emissions
of "criteria pollutants," including ambient air and
control technology standards
Provisions for pollutants
causing acid rain
National emissions
standards for hazardous air pollutants (NESHAP) by source category
(i.e., industry)
Control of ozone-depleting
compounds
Permitting requirements
for existing and new major sources of hazardous air pollutants
(HAP) and other pollutants
|
Listing of R&D
as a source category of HAP currently under consideration by the
EPA
Applicability of other
NESHAP to R&D is determined on case-by-case basis.
State permitting requirements
sometimes exempt minor source R&D.
Many States regulate
additional air toxic air pollutants.
Reduced requirements
for shipping small amounts (e.g., # 30 ml)
|
Federal
Water Pollution Control Act (FWPCA) |
| Water
quality protection and improvement |
National pollutant
discharge elimination system (NPDES) limitation of discharge to
public waters
Pretreatment regulations
to control the discharge of pollutants from public treatment works
|
Pretreatment regulations
generally implemented by local authorities.
Some R&D facilities
will be subject if they meet the applicability requirements.
|
Hazardous
Materials Transportation Act (HMTA) |
| Controls
movement of hazardous materials |
Regulation of hazardous
materials packaging, labeling, placarding, and transporting
Requirements for the
training of all persons involved in transportation of hazardous
materials
|
Applies to R&D,
including receiving or shipping hazardous materials.
Shipment of small
laboratory samples may be regulated.
|
National
Environmental Policy Act (NEPA) |
| Ensures
consideration of all environmental effects |
Establishes requirements
for Environmental Impact Statement (EIS)
Requires environmental
impact assessment before construction of a new building
Environmental assessment
includes evaluation of anticipated air emissions from the building
|
Applies to R&D
State rules may have
more detailed requirements.
|
Uniform
Fire and Building Codes (UFC/UBC) |
| Applies
to the storage, dispensing, use, and handling of hazardous materials |
Regulations regarding
treatment systems for accidental release and continuous monitoring
of toxic and highly toxic compressed gases above exempt amounts
Detailed requirements
for spill control, drainage, containment, ventilation, emergency
power, special controls for hazardous gases, fire prevention and
building height
Includes precautions
against fire, open flames or burning, fire protection systems,
emergency planning, operation and maintenance of equipment, processes
and occupancies, materials handling
Some of requirements
are met by using control devices that also reduce air pollutant
emissions
|
Several versions are
currently being drafted into one international version.
UBC applies to new
and renovated laboratories, while UFC applies to new and exiting
structures.
Low exemptions for
flammable and highly toxic materials.
Current codes do not
distinguish laboratories from production or manufacturing facilities.
|
Food and
Drug Administration (FDA) |
| Regulations
on preparation of food and drugs |
Good management practices,
including laboratory standard operating procedures
Recordkeeping and
reporting for all phases of product development and sale
|
Applies where R&D
facility involved with regulated substances (e.g., pharmaceutical
industry).
|
Air
Force Regulations |
| Regulation
of Air Force activities |
Controlling Exposure
to Hazardous Materials
Occupational Exposure
to Hazardous Chemicals in Laboratories
Flammable and Combustible
Liquids
Chemical Safety
Process Safety Management
of Highly Hazardous Chemicals
Air Quality Compliance
Storage Tank Compliance
Hazardous Materials
Management
|
Air Force only.
|
|
