🇺🇸 Live Food Safety & Manufacturing

FSMA Produce Safety (21 CFR 112)

Establishes science-based standards for the growing, harvesting, packing, and holding of produce for human consumption. Applies to farms that grow, harvest, pack, or hold covered fruits and vegetables.

View official source document

102

Rules extracted

585

Obligations decomposed

5.7x

Avg obligations per rule

🇺🇸 United States

Jurisdiction

What AuditDSS covers

Source

Regulation

Extracted

102

Rules

Decomposed

585

Obligations

5.7x

Decomposition ratio

Each rule is decomposed into an average of 5.7 atomic obligations — the smallest testable units that can be independently violated.

Fully extracted & scored

All 585 obligations have been decomposed, titled, risk-scored, and embedded for semantic matching.

Risk scoring

Every obligation in FSMA Produce Safety is scored across independent risk dimensions:

Obligation Weight

How critical within the regulatory framework

Violation Likelihood

How often breached in practice

Enforcement Evidence

Regulator enforcement history and penalties

Cascade Dependency

How many obligations depend on this one

Regulatory details

Full title: FSMA Produce Safety (21 CFR 112)
Regulatory body: Food and Drug Administration
Jurisdiction: 🇺🇸 United States
Document type: regulation
Effective date: November 27, 2015
Industry: Food Safety & Manufacturing
Official source: View source document ↗

Who this applies to

farms growing covered producemixed-type facilitiesproduce packers

Key requirements

agricultural water quality
biological soil amendments
worker health and hygiene
equipment and tools sanitation
growing and harvesting practices
sprout safety

Frequently asked questions about FSMA Produce Safety

What is FSMA Produce Safety?

Who does FSMA Produce Safety apply to?

FSMA Produce Safety applies to farms growing covered produce, mixed-type facilities, produce packers.

How many obligations does FSMA Produce Safety contain?

AuditDSS has decomposed FSMA Produce Safety into 585 atomic obligations from 102 rules. Each obligation is independently testable and risk-scored.

What are the key requirements of FSMA Produce Safety?

The key requirements include: agricultural water quality, biological soil amendments, worker health and hygiene, equipment and tools sanitation, growing and harvesting practices, sprout safety.

How can I assess my FSMA Produce Safety compliance?

Upload your compliance policy to AuditDSS. The platform maps your document against all 585 FSMA Produce Safety obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Which jurisdiction enforces FSMA Produce Safety?

FSMA Produce Safety is enforced in United States by Food and Drug Administration.

When did FSMA Produce Safety come into effect?

FSMA Produce Safety became effective on November 27, 2015.

What industry does FSMA Produce Safety apply to?

FSMA Produce Safety is primarily relevant to the Food Safety & Manufacturing industry. AuditDSS covers 61 regulations in this industry sector.

Build a FSMA Produce Safety compliance pack

Don't have a compliance policy yet? AuditDSS generates a complete compliance pack for FSMA Produce Safety — alone or combined with other regulations your business needs. Every clause is mapped to specific obligations.

Policy

High-level commitments and governance framework covering FSMA Produce Safety requirements.

Procedures

Step-by-step operational procedures to implement each policy commitment.

Forms & checklists

Ready-to-use forms, registers, and checklists for day-to-day compliance operations.

Multi-regulation

Combine FSMA Produce Safety with other regulations into a single unified compliance pack for your business.

Build FSMA Produce Safety compliance pack

Already have a policy? Assess it against FSMA Produce Safety

Upload your document

Upload your compliance policy, program manual, or operational document. AuditDSS accepts any text-based document.

AI maps against 585 obligations

Your document is scored against every obligation in FSMA Produce Safety. Each claim is mapped to the obligation tree and evaluated for coverage.

Risk-scored gap report

Receive every gap ranked by risk priority with remediation guidance, enforcement evidence, and cascade impact analysis.