Pharmaceutical Manufacturing Statutory and Regulatory ...

United States

Environmental Protection

Agency

Enforcement and

Compliance Assurance

(2224A)

EPA-305-S-97-001

December 1997

Pharmaceutical Manufacturing

Statutory and Regulatory Summaries

EPA Office of Compliance

Chemical Industry Branch

Printed on paper that contains at least

20 percent postconsumer fiber.

Background: The pharmaceutical manufacturing industry is subject to numerous

Federal regulations that have been enacted to protect human health and the

environment. A complex web of requirements results from the fact that little correlation

exists among regulations that target the same medium or activity. Industrial facilities

are responsible for understanding and complying with these requirements. Historically,

EPA has relied on a command and control approach to regulate industrial facilities, but

now is combining its traditional method with innovative compliance assessment

techniques such as self-assessments and facility management systems.

Many industrial facilities have found that using a complete facility Environmental

Management System (EMS) approach uncovers cost effective solutions for tackling all

the requirements as a whole instead of as individual components. In line with this

discovery, EPA is encouraging self-assessments using a complete facility EMS

approach to evaluate compliance with environmental regulations. A facility¡¯s drive to

identify cheaper, more effective ways to achieve compliance is consistent with EPA¡¯s

mission of clarifying and simplifying environmental regulatory control.

Purpose of document: This guide is a resource on Federal environmental regulations

for pharmaceutical manufacturing facilities. This manual identifies and clarifies

industry-specific regulatory information necessary to conduct a self-assessment. This

document describes portions of environmental statutes that may apply to the

pharmaceutical manufacturing industry and summarizes regulatory requirements of

each (including applicability, exemptions, monitoring, record keeping, and reporting

requirements).

Approach:The statutes are discussed in the following sections:

C

Clean Air Act (CAA): Clean Air Act Titles I, III, V, and VI are summarized in this

section. Topics include NAAQS, NESHAPs, MACTs, permitting, chemical

accident protection, and stratospheric ozone protection. This appendix also

includes a section on assessment considerations that should be evaluated

during the on-site facility assessment. Regulatory summaries are provided for

performance standards, national emission standards, provisions for prevention

of chemical accidents, and protection of stratospheric ozone.

C

Safe Drinking Water Act (SDWA):This section describes the public water

system program, underground injection control program, considerations for

assessors, and regulatory requirements. Detailed descriptions of the regulatory

requirements include national primary and secondary drinking water regulations

which may be applicable to facilities that produce their own potable water and

the underground injection control program.

C

Resource Conservation and Recovery Act (RCRA):

This section delineates

the requirements for generation, transportation, treatment, storage, and disposal

of hazardous waste. Land disposal restrictions and underground storage tank

regulations are discussed, as are specific RCRA assessment considerations.

RCRA legislation summarized for pharmaceutical manufacturers includes

classification of generators; requirements for hazardous waste generators and

transporters; regulations for hazardous waste treatment, storage, and disposal;

and restrictions on land disposal and underground storage tanks.

C

Emergency Planning and Community Right-to-Know Act (EPCRA):

The

EPCRA section describes four regulatory programs applicable to pharmaceutical

manufacturers: hazardous substance notification, emergency planning and

notification, hazardous chemical reporting to the community, and toxic chemical

release inventory. The section also suggests key areas to evaluate during

compliance assessments. Regulatory summaries are included for the following:

designation, notification, and reportable quantities of hazardous substances;

emergency planning and notification; and reporting of hazardous chemicals and

toxic chemical releases.

C

Clean Water Act (CWA):This section includes effluent limit guidelines,

categorical pretreatment standards, NPDES and pretreatment programs, effluent

trading, spills and pollution prevention of oil and hazardous substances, and

reportable quantities of hazardous substances. This chapter also includes a

section on assessment considerations and summaries of regulations pertaining

to pretreatment and discharge of effluent, discharge and pollution prevention of

oil, and designation of hazardous substances and reportable quantities.

This manual may not include all the Federal environmental regulations that an

pharmaceutical manufacturer must comply with, but it should serve as a starting point.

Site assessors should be aware that, in many instances, State or local regulations may

be more stringent than Federal requirements. Also, site-specific Federal, State, or

local permits may contain additional requirements beyond those specified in the

regulations. As such, part of a facility¡¯s EMS should be to check Federal, State and

local regulations regularly and keep abreast of pending legislation that may impact the

facility.

DISCLAIMER

This document is intended as an aid to compliance with federa l

regulatory requirements. The document does not, however, substitute

for EPA¡¯s regulations, nor is it a regulation itself. Thus, it cannot impose

legally binding requirements on EPA, States, or the regulate d

community. Because circumstances vary, this document may not apply

to a particular situation based on the circumstances, and facilities may be

subject to requirements that are different from or in addition to thos e

described in this document. EPA may change this guidance in the future,

as appropriate.

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