# Major US Regulatory Agencies Reference Guide

## Overview

This guide provides an overview of major federal regulatory agencies, their statutory authority, enforcement powers, and key compliance considerations.

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## SECURITIES AND EXCHANGE COMMISSION (SEC)

### Statutory Authority
- Securities Act of 1933 (15 USC §§ 77a-77mm)
- Securities Exchange Act of 1934 (15 USC §§ 78a-78qq)
- Investment Company Act of 1940 (15 USC §§ 80a-1 to 80a-64)
- Investment Advisers Act of 1940 (15 USC §§ 80b-1 to 80b-21)
- Sarbanes-Oxley Act of 2002 (Pub. L. 107-204)
- Dodd-Frank Act of 2010 (Pub. L. 111-203)

### Jurisdiction
- Securities registration and disclosure
- Securities exchanges and broker-dealers
- Investment companies and advisers
- Corporate governance and reporting
- Insider trading and market manipulation
- Accounting standards enforcement

### Enforcement Division
**Powers**:
- Civil enforcement actions in federal court
- Administrative proceedings
- Cease and desist orders
- Industry bars
- Civil monetary penalties
- Disgorgement of ill-gotten gains

**Penalty Framework** (Inflation-adjusted):
| Violation Tier | Individual | Entity |
|---------------|------------|--------|
| Tier 1 (Technical) | Up to $11,524 | Up to $115,241 |
| Tier 2 (Fraud, Deceit) | Up to $115,241 | Up to $576,209 |
| Tier 3 (Substantial Losses) | Up to $230,483 | Up to $1,152,418 |

Or the gross amount of pecuniary gain, whichever greater.

### Key Regulations
- Regulation S-K (17 CFR Part 229) - Disclosure requirements
- Regulation S-X (17 CFR Part 210) - Financial statement requirements
- Regulation FD (17 CFR § 243.100-103) - Fair disclosure
- Rule 10b-5 (17 CFR § 240.10b-5) - Antifraud
- Proxy Rules (17 CFR § 240.14a) - Proxy solicitation

### Whistleblower Program
- Awards: 10-30% of sanctions over $1 million
- Anti-retaliation protections
- Anonymous reporting permitted

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## FEDERAL TRADE COMMISSION (FTC)

### Statutory Authority
- Federal Trade Commission Act (15 USC §§ 41-58)
- Clayton Act (15 USC §§ 12-27)
- Hart-Scott-Rodino Act (15 USC § 18a)
- Various consumer protection statutes

### Jurisdiction
- Unfair or deceptive acts or practices (UDAP)
- Unfair methods of competition
- Merger review (with DOJ)
- Consumer protection
- Privacy and data security
- Advertising and marketing practices

### Enforcement Authority

**Section 5 (15 USC § 45)**:
- "Unfair or deceptive acts or practices in or affecting commerce"
- "Unfair methods of competition"

**Administrative Enforcement**:
- Cease and desist orders
- Civil penalty actions for order violations
- Trade regulation rules
- Industry guides

**Civil Penalties**:
- Up to $50,120 per violation (inflation-adjusted)
- Each day of continuing violation = separate offense

### Bureau of Consumer Protection
Focus areas:
- Advertising and marketing
- Privacy and identity protection
- Financial practices
- Consumer education

### Bureau of Competition
Focus areas:
- Merger review
- Non-merger antitrust
- Monopolization
- Vertical restraints

### Key Rules and Guides
- FTC Act Section 5 interpretations
- Telemarketing Sales Rule (16 CFR Part 310)
- CAN-SPAM Rule (16 CFR Part 316)
- Children's Online Privacy Protection Rule (16 CFR Part 312)
- Health Breach Notification Rule (16 CFR Part 318)
- Made in USA standards

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## ENVIRONMENTAL PROTECTION AGENCY (EPA)

### Statutory Authority
- Clean Air Act (42 USC §§ 7401-7671q)
- Clean Water Act (33 USC §§ 1251-1387)
- RCRA (42 USC §§ 6901-6992k)
- CERCLA (42 USC §§ 9601-9675)
- TSCA (15 USC §§ 2601-2697)
- FIFRA (7 USC §§ 136-136y)
- SDWA (42 USC §§ 300f-300j-27)
- EPCRA (42 USC §§ 11001-11050)

### Jurisdiction
- Air and water pollution control
- Hazardous waste management
- Toxic substances regulation
- Pesticide registration
- Superfund cleanups
- Environmental permitting

### Enforcement Authority

**Administrative**:
- Compliance orders
- Administrative penalties (up to $59,017/day per violation for most statutes)
- Permit denial, suspension, revocation
- Information requests (§ 104, § 114 letters)

**Civil Judicial**:
- Injunctive relief
- Civil penalties
- Cost recovery
- NRD claims

**Criminal** (referred to DOJ):
- Knowing violations
- Knowing endangerment
- False statements
- Imprisonment up to 15 years for knowing endangerment

### Key Programs
- National Pollutant Discharge Elimination System (NPDES)
- Title V Air Operating Permits
- RCRA Hazardous Waste Program
- Superfund (CERCLA)
- Toxic Release Inventory (TRI)

### Penalty Policies
- Civil Penalty Policy guidelines
- Economic benefit component
- Gravity component
- Adjustments for cooperation, ability to pay

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## FOOD AND DRUG ADMINISTRATION (FDA)

### Statutory Authority
- Federal Food, Drug, and Cosmetic Act (21 USC §§ 301-399i)
- Public Health Service Act (42 USC §§ 201-300mm-61)
- Fair Packaging and Labeling Act (15 USC §§ 1451-1461)
- Various specific product statutes

### Jurisdiction
- Drugs and biologics
- Medical devices
- Food safety (excluding meat, poultry)
- Cosmetics
- Tobacco products
- Radiation-emitting products

### Enforcement Authority

**Administrative**:
- Warning letters
- Import alerts/detention
- Product recalls (mandatory and voluntary)
- Consent decrees
- Debarment
- Civil monetary penalties (for certain violations)

**Civil**:
- Seizures
- Injunctions
- Civil money penalties (specific contexts)

**Criminal**:
- Misdemeanor (strict liability, up to 1 year)
- Felony (intent to defraud, second offense, up to 3 years)
- Drug trafficking penalties (much higher)

### Key Regulatory Programs
- New Drug Applications (NDA)
- Biologics License Applications (BLA)
- Premarket Approval (PMA) for devices
- 510(k) Premarket Notification
- Current Good Manufacturing Practice (cGMP)
- Adverse event reporting

### Inspections
- For-cause and routine inspections
- FDA-483 observations
- Warning letters for significant violations
- Consent decrees for persistent violations

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## DEPARTMENT OF JUSTICE (DOJ)

### Statutory Authority
- Broad criminal enforcement authority
- Civil Rights Act
- Antitrust laws (Sherman Act, Clayton Act)
- Environmental statutes (criminal referrals)
- False Claims Act
- FCPA

### Criminal Division
**Key Sections**:
- Fraud Section (corporate fraud, FCPA)
- Environmental and Natural Resources Division
- National Security Division
- Public Integrity Section

### Antitrust Division
- Criminal cartel enforcement
- Civil merger review (with FTC)
- Civil monopolization cases

### Civil Division
- False Claims Act litigation
- Consumer protection enforcement
- Civil rights enforcement

### Corporate Enforcement Policies

**Corporate Criminal Enforcement Policies**:
- Voluntary self-disclosure credit
- Cooperation credit
- Remediation credit
- Corporate compliance program evaluation

**Monaco Memo (2022)**:
- Individual accountability focus
- Full disclosure of individual wrongdoing for cooperation credit
- Prior misconduct consideration
- Independent compliance monitors

**Evaluation of Corporate Compliance Programs**:
- Is program well designed?
- Is program adequately resourced and empowered?
- Does program work in practice?

### False Claims Act (31 USC §§ 3729-3733)
- Treble damages
- Civil penalties: $13,946 - $27,894 per claim (inflation-adjusted)
- Qui tam provisions (whistleblower suits)
- 60-day seal period (extendable)

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## CONSUMER FINANCIAL PROTECTION BUREAU (CFPB)

### Statutory Authority
- Dodd-Frank Act, Title X (12 USC §§ 5481-5603)
- Consumer financial protection laws transferred to CFPB

### Jurisdiction
- Consumer financial products and services
- Banks, credit unions (over $10 billion assets - exclusive)
- Non-bank financial companies
- Mortgage servicers and originators
- Payday lenders
- Debt collectors
- Consumer reporting agencies

### Enforcement Authority

**Supervisory Authority**:
- Examinations of covered entities
- Compliance assessments

**Enforcement Powers**:
- Civil investigative demands
- Administrative proceedings
- Civil actions
- Consent orders

**Remedies**:
- Restitution
- Disgorgement
- Injunctions
- Civil money penalties (up to $1 million/day for knowing violations)

### Key Regulations
- Regulation Z (Truth in Lending)
- Regulation E (Electronic Fund Transfers)
- Regulation X (RESPA)
- Regulation B (Equal Credit Opportunity)
- Regulation F (Fair Debt Collection Practices)
- Regulation V (Fair Credit Reporting)

### UDAAP Authority
Prohibition on "unfair, deceptive, or abusive acts or practices" (12 USC § 5531)

**Unfair**: Causes substantial injury not reasonably avoidable, not outweighed by benefits

**Deceptive**: Misleading representation or omission likely to mislead reasonable consumer

**Abusive**: Materially interferes with ability to understand terms, or takes unreasonable advantage of lack of understanding, inability to protect interests, or reliance

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## OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (OSHA)

### Statutory Authority
- Occupational Safety and Health Act of 1970 (29 USC §§ 651-678)

### Jurisdiction
- Private sector employers (most)
- Federal agencies
- State and local government (in state plan states)

**Excluded**:
- Self-employed
- Family farms (family members only)
- Workplaces covered by other federal agencies

### Enforcement Authority

**Inspections**:
- Programmed (scheduled)
- Unprogrammed (complaints, referrals, fatalities)
- Follow-up inspections

**Citations**:
| Violation Type | Maximum Penalty (2024) |
|---------------|----------------------|
| Serious | $16,131 |
| Other-Than-Serious | $16,131 |
| Willful | $161,323 |
| Repeat | $161,323 |
| Failure to Abate | $16,131/day |
| Posting Requirement | $16,131 |

**Criminal Penalties**:
- Willful violation causing death: Up to $250,000 individual/$500,000 organization; 6 months imprisonment (first offense)
- False statements: Up to $10,000 and/or 6 months

### Key Standards
- General Duty Clause (29 USC § 654(a)(1))
- Hazard Communication (29 CFR § 1910.1200)
- Lockout/Tagout (29 CFR § 1910.147)
- Permit-Required Confined Spaces (29 CFR § 1910.146)
- Personal Protective Equipment (29 CFR § 1910.132-138)
- Recordkeeping (29 CFR Part 1904)

### Recordkeeping Requirements
- OSHA 300 Log (Log of Work-Related Injuries)
- OSHA 300A Summary (Annual Summary)
- OSHA 301 Form (Injury and Illness Incident Report)
- Electronic submission for establishments 250+ employees

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## CROSS-AGENCY CONSIDERATIONS

### Parallel Proceedings
- Multiple agencies may investigate same conduct
- Coordination between agencies common
- DOJ typically leads criminal matters
- Civil proceedings may be stayed pending criminal resolution

### Cooperation and Self-Disclosure
Most agencies provide credit for:
- Voluntary self-disclosure
- Cooperation with investigation
- Remediation efforts
- Compliance program implementation

### Whistleblower Programs

| Agency | Program | Award Range |
|--------|---------|-------------|
| SEC | Dodd-Frank Whistleblower | 10-30% of >$1M sanctions |
| CFTC | Dodd-Frank Whistleblower | 10-30% of >$1M sanctions |
| IRS | Tax Whistleblower | 15-30% of >$2M collected |
| DOJ | False Claims Act Qui Tam | 15-30% of recovery |
| OSHA | SOX Whistleblower | Reinstatement, back pay |

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## KEY CITATIONS

- **SEC**: 15 USC §§ 77-80; 17 CFR Parts 200-299
- **FTC**: 15 USC §§ 41-58; 16 CFR Parts 0-999
- **EPA**: Various; 40 CFR Parts 1-1799
- **FDA**: 21 USC §§ 301-399i; 21 CFR Parts 1-1499
- **DOJ**: 28 USC; 18 USC (criminal); 31 USC §§ 3729-3733 (FCA)
- **CFPB**: 12 USC §§ 5481-5603; 12 CFR Parts 1000-1099
- **OSHA**: 29 USC §§ 651-678; 29 CFR Parts 1900-1999

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*Last Updated: March 2026*
*This reference is for informational purposes only and does not constitute legal advice.*