Gene synthesis equipment manufacturers and providers.

The maximum civil penalty for a manufacturer or provider violating the gene synthesis screening requirements was increased from $1,000 per day to $5,000 per day that the violation continues (Section 24202(a)). This makes non-compliance five times more costly on a daily basis.

Civil penalty for violations increased from $1,000 per day to $5,000 per day that the violation continues.

Manufacturers and providers must now attest that they comply with the framework (as attestation is described in the framework) and post that attestation on a public internet website. This is a new transparency obligation not present in the Assembly version.

The entire provision allowing the State Department of Public Health to adopt regulations redefining 'framework' to mean one or more federal laws, regulations, or guidance documents (former Section 24203) was deleted. The framework is now fixed to the September 2024 version unless the Legislature expressly amends it.

The requirement for CDPH to submit a report to the Legislature within one year of adopting regulations was removed, consistent with eliminating the regulatory authority itself.

A new provision (Section 24201(d)) states that any provisions in the framework that take effect only on or after October 13, 2026, shall have no effect under this chapter prior to October 13, 2027. This creates a one-year delay for certain future framework obligations.

The customer exemption section (now Section 24203) was clarified to state that the exemption does not apply to a person's activities as a provider or manufacturer, closing a potential loophole where an entity could claim customer status to avoid obligations while also acting as a provider or manufacturer.

Section 24200(a)(2) was rewritten to state that the September 2024 version of the federal framework is the 'sole operative version' and that any subsequent federal revision will not be incorporated unless the Legislature expressly amends the bill. The introduced version had allowed CDPH regulations to redefine 'framework' more freely without this explicit lock-in language.

A new section (numbered 24203, creating a duplicate section number) was added to explicitly exempt customers that are not providers or manufacturers from the chapter's requirements. The exemption specifically covers medical and pharmaceutical research and development, drug screening assays, reagent production, preclinical and clinical studies, biologics manufacturing, gene therapy, and RNA therapeutics.

The definitions in Section 24200(b) were restructured from a simple numbered list into lettered sub-items (a through f), with a redundant '24200' header inserted within the subdivision, likely a drafting artifact from the amendment process.