IST Measures Raise Concern for the Pharma Supply Chain

Published on: 

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-03-05-2008, Volume 4, Issue 3

Draft federal legislation that would require high-risk chemical facilities to use inherently safer technology for reducing their risk may present potential problems for custom and batch manufacturers supplying the pharmaceutical industry.

The issue of "inherently safer technology" (IST) in relation to chemical-site security took center stage last month as a member company of the Synthetic Chemical Manufacturers Association (SOCMA) testified before Congress. SOCMA and its members are urging Congress to avoid changes to recently adopted chemical-site security standards, in particular measures that would include an IST mandate. IST is a conceptual framework that covers chemical processing procedures, equipment, protection, and when feasible, the use of safer substances. SOCMA is the US-based trade association that represents batch and custom manufacturers, including producers of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates.

Proposed legislation sets the debate

At issue is proposed legislation, "The Chemical Facility Anti-Terrorism Act of 2008," particularly the bill's IST provisions. Last year, the Department of Homeland Security (DHS) issued regulations [The Chemical Facility Anti-Terrorism Standards (CFATS)] that established risk-based performance standards for the security of US chemical facilities. The regulations require chemical facilities covered under the regulations to prepare security vulnerability assessments that identify a facility's security vulnerability. The rule further requires chemical facilities to develop and implement site-security plans that identify measures that satisfy the identified risk-based performance standards. The regulation also contains associated provisions addressing inspections and audits, recordkeeping, and the protection of information that may be characterized as chemical-terrorism vulnerability information.

These measures went into effect June 8, 2007, except for Appendix A, which contained a tentative list of chemicals of interest. Last November, DHS adopted the final list of chemicals, along with information that identifies the security issues associated with each chemical. In promulgating the rule, DHS said that it would periodically update the list of chemicals and may add or remove chemicals based on additional information.

CMOs offer input on IST

CFATS will expire in October 2009, and the US House of Representatives' Committee on Homeland Security reviewed and listened to testimony on a committee print of the proposed legislation, the Chemical Facility Anti-Terrorism Act of 2008, in late February. (A committee print is a draft of a bill not yet introduced). The bill would make CFATS permanent and provide further Congressional guidance for the future implementation of CFATS. Requirements for high-risk facilities to reduce their risk by IST is one issue under debate in the draft bill.


SOCMA opposes an IST mandate. "SOCMA applauds the Committee's intention to make these standards permanent, and we have no objections to select portions of the discussion draft; however, we are concerned with substantive portions, particularly the draft's IST provisions," said SOCMA in a Feb. 27, 2008, release. "No matter how simple IST concepts appear on paper, they are quite complicated in practice... In some cases, a mandated change under the auspices of security 'IST' could delay by two years or more the availability of consumer products that the public relies on every day such as pharmaceuticals."

David C. Pulham, PhD and director of compliance for Siegfried (USA) (Pennsville, NJ), a SOCMA member and contract manufacturer of APIs, testified before the House Committee on Homeland Security to offer an industry perspective on the proposed bill, including the IST measures. Prior to joining Siegfried, he spent 27 years as a national expert investigator with the US Food and Drug Administration.

"Siegfried supports DHS's existing Chemical Facility Anti-Terrorism Standards, which do not include any IST mandates," said Pulham in his testimony on Feb. 26, 2008. "These rules require comprehensive vulnerability assessments and security plans, and those plans have to meet almost 20 rigorous security performance standards. We encourage this Committee to support the current approach."

A point raised by Siegfried and by SOCMA is that the member companies of SOCMA are required to adhere to the principles of the "ChemStewards" program, which is an environmental, health and safety, and security management system. This program incorporates SOCMA's security-vulnerability-assessment methodology, which is recognized by the Center for Chemical Process Safety (an industry organization formed by the American Institute of Chemical Engineers) and is accepted by the DHS for Tier-Four facilities under DHS's chemical facility antiterrorism standards.

An IST mandate poses problems

"An IST mandate would complicate, and in some cases could undermine, existing practices or compliance," said Pulham. "Mandating IST for companies like Siegfried that manufacture hundreds of batches of specialty batch products every year is a much greater exercise than what may appear on the surface. Having to debate which approach is inherently safe in any given case would slow down our ability to meet customer needs, and it could be dangerous, if we are compelled to accept, or go along with, an approach that we personally think may not be the lowest-risk approach. With all due respect, this issue is vastly more complicated than most people appreciate."

SOCMA is also urging the committee to reconsider an IST mandate. "Many SOCMA members are highly regulated under existing environmental and process safety standards that incorporate principles of IST," said SOCMA in the Feb. 27 release. "We urge Congress to spend more time thoroughly studying the IST provisions being proposed while immediately ensuring that DHS receives the necessary funds to carry out the current authority Congress gave it in 2006 under the Chemical Facility Anti-Terrorism Act."

In testimony to the House Committee on Homeland Security's Subcommittee on Transportation Security and Infrastructure Protection provided by William E. Allmond, director of government relations at SOCMA and Jeffrey Gunnulsfen, senior manager of government relations at SOCMA last December, SOCMA detailed the problems with an IST mandate (2). "Supporters of regulatory IST measures within the context of chemical security either ignore industry's commitment to this everyday process safety measure or they misunderstand its purpose. In the name of security, IST is being used to support environmental agendas and not security."

SOCMA emphasized that IST is an established chemical engineering philosophy that was launched by the industry in the late 1970s, and its main goal is to reduce risks to health and the environment. "The concept of risk reduction, practiced through IST, pollution prevention, and other environmental management systems is an important feature of the business model employed by chemical producers. The same principle applies for those who use, store, or distribute chemicals. In many ways, IST is already built into the chemical supply chain," according to SOCMA's testimony.

NJ IST provisions are part of the debate

A factor entering into the viability of federally mandated IST are state provisions requiring IST in relation to chemical-site security. A case in point is the adoption of IST measures under New Jersey law. New Jersey recently amended its "Toxic Catastrophe Prevention Act" to require existing facilities to complete an IST review.

Industry members, however, point out the practical implementation of the New Jersey measures compared with a federal IST mandate.

"Siegried's assessment of this process [the New Jersey IST provision} is that it was essentially a paperwork exercise to document in great detail, steps, and considerations that we take as a normal part of our process," said Pulham. "Simply put, inherent safety is a concept that the chemical industry invented, and we consider it continuously as we design and modify our production processes."

As the IST measures are debated, other chemical industry groups raise concern on what direction the proposal may go. "While we share the same goal of establishing permanent chemical security regulations, we need to be sure the draft legislation being considered by the Committee will not undermine the important work that is already underway," said American Chemistry Council (ACC) President and CEO Jack N. Gerard in a prepared statement. "We look forward to working with the Committee and Congress as they continue their oversight of this critical program."

The ACC is the US-based trade association of chemical manufacturers, primarily large chemical manufacturers. The ACC asserts that under the direction of DHS, more than 30,000 facilities that use or store chemicals are moving to meet the requirements of CFATS and that it will cost more $8 billion in additional enhancements to meet the requirements of CFATS over the next eight years.