EPA
Federal regulations for air, water, waste environmental protection
ISO 37301
Certifiable international standard for compliance management systems.
Quick Verdict
EPA mandates environmental compliance via statutes like CAA/CWA/RCRA for U.S. industries, enforced by fines. ISO 37301 offers voluntary CMS certification for all organizations globally, building risk-based governance and culture for broader integrity.
EPA
Title 40 CFR: Protection of Environment Regulations
ISO 37301
ISO 37301:2021 Compliance management systems – Requirements
Key Features
- Certifiable requirements replacing guidance-only ISO 19600
- High-Level Structure alignment for IMS integration
- Risk-based compliance obligations assessment and planning
- Leadership commitment and organizational culture emphasis
- Confidential whistleblowing channels with anti-retaliation
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
EPA Details
What It Is
EPA standards comprise a family of legally binding regulations in Title 40 of the Code of Federal Regulations (40 CFR), implementing statutes like Clean Air Act (CAA), Clean Water Act (CWA), and Resource Conservation and Recovery Act (RCRA). This regulatory framework protects human health and environment across air, water, and waste media through risk management blending health-based endpoints (e.g., NAAQS) and technology-based controls (e.g., MACT, effluent guidelines).
Key Components
- Numeric limits, thresholds, performance criteria (e.g., 95% reduction)
- Permitting mechanisms (NPDES, Title V, RCRA permits)
- Monitoring, recordkeeping, reporting with QA/QC
- Enforcement pathways: civil penalties, settlements, criminal liability Built on statutory authority with federal-state delegation; no single certification but permit compliance and audits required.
Why Organizations Use It
Mandatory for regulated entities to avoid multimillion penalties, shutdowns, liabilities. Drives risk reduction, operational efficiency, ESG alignment, stakeholder trust via transparent data (e.g., ECHO, ICIS-NPDES). Enables innovation in controls, grants access.
Implementation Overview
Phased approach: gap analysis, regulatory mapping, controls deployment, training, digital monitoring. Applies to industrial facilities US-wide; involves cross-functional teams, state coordination, ongoing audits for adaptability to rulemakings.
ISO 37301 Details
What It Is
ISO 37301:2021, officially Compliance management systems – Requirements with guidance for use, is a certifiable international standard specifying requirements for establishing, implementing, maintaining, and improving a Compliance Management System (CMS). It replaces guidance-only ISO 19600, using a risk-based PDCA cycle and High-Level Structure (HLS) applicable to all sizes and sectors.
Key Components
- HLS clauses: context, leadership, planning, support, operation, evaluation, improvement
- Identify obligations, assess risks, set objectives, embed controls
- Core elements: whistleblowing, competence (ISO 37303), measurement (ISO 37302)
- Certification via accredited bodies (e.g., ANAB), 3-year cycles
Why Organizations Use It
- Reduces compliance risks, fines, reputational harm
- Builds stakeholder trust, supports ESG/SDGs
- Enables IMS integration (ISO 9001/14001/27001)
- Demonstrates integrity culture, leadership commitment
Implementation Overview
- Phased: gap analysis, register building, training, audits, reviews
- Risk-based, scalable for SMEs/enterprises globally
- Optional certification; continual improvement mandatory (176 words)
Key Differences
| Aspect | EPA | ISO 37301 |
|---|---|---|
| Scope | Environmental statutes (CAA, CWA, RCRA) | All compliance obligations (legal, regulatory, voluntary) |
| Industry | Regulated industrial sectors (energy, manufacturing) | All organizations, all sectors worldwide |
| Nature | Mandatory U.S. federal regulations | Voluntary certifiable management system standard |
| Testing | Government inspections, self-monitoring | Third-party certification audits, internal audits |
| Penalties | Civil/criminal fines, enforcement actions | Loss of certification, no legal penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about EPA and ISO 37301
EPA FAQ
ISO 37301 FAQ
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