Negotiated Rule-Making Would Be A Constructive Step in Inspection Process
by Gary Jay Kushner
The House of Representatives Appropriations Committee sent a strong signal to USDA in late June when it approved an amendment to the appropriations bill instructing USDA to engage in negotiated rule-making as part of the development of its proposed rule on pathogen reduction and the Hazard Analysis and Critical Control Point program, the so-called "mega-reg."
The appropriations bill would prohibit the department from spending any money to implement a final rule developed from that proposal until it engages in negotiated rule-making.
It is an extraordinary move. But what the inspection proposal would impose on the meat and poultry industries, if promulgated into a final rule, is also extraordinary.
As proposed Feb. 3, the inspection proposal would require slaughter and processing facilities to implement several processes and actions, including the use of at least one antimicrobial treatment during the slaughter process prior to chilling, chilling requirements for parts and carcasses, the establishment of interim target levels for pathogen reduction, and mandatory microbial testing in slaughter establishments. It would also require all packers and processors to develop and implement a HACCP program.
Unlike its sister agency, FDA, which first invited comment on a proposed HACCP system for foods other than meat and poultry products through an Advanced Notice of Proposed Rule-Making, FSIS never published an advanced notice in order to gauge the effect its proposal might have. Instead, FSIS went directly to a proposed rule for what is one of, if not the most significant rule-making proceedings in the industry in at least 25 years.
Significantly, after the inspection proposal was published, USDA also announced it would be initiating a complete review of all current regulations to determine whether any of those regulations are obsolete and if so, which ones; whether any regulations need modification to ensure that the inspection system is founded on the best scientific evidence; and what regulations should remain as written.
That regulatory review was expected to be published in early June, ironically, as an Advanced Notice of Proposed Rule-Making. In response to the inspection proposal and separate from the Appropriations Committee's action, two petitions were filed with USDA Secretary Dan Glickman requesting that the process be converted to include negotiated rule-making.
One petition was filed by a coalition of several trade associations, including the National Meat Association and the American Association of Meat Processors, representing generally smaller meatpackers. The other was filed by the National Association of State Departments of Agriculture, an organization comprised of the top agriculture officials in the states and territories.
Both petitions expressed concern about the regulatory process and about the willingness of USDA to allow the inspectors union to participate in the rule-making process after the comment period closed.
Negotiated rule-making is a process, created by statute, that provides for the establishment of a committee representing everyone interested in an issue. The committee's goal is to work together to develop a report that forms the basis for a proposed rule that satisfies all interested parties.
Those who support negotiated rule-making contend that the inspection proposal and USDA's regulatory review are inextricably intertwined. They believe the inspection proposal should be part of a comprehensive regulatory initiative in which all interested parties are allowed to participate in the development of a proposed rule that will redefine the inspection process to make it a science-risk based system, not one relying on antiquated processes.
The opponents of negotiated rule-making claim it will delay for years the implementation of what they consider to be a critical regulatory effort. Such a delay cannot be tolerated, they say.
Under the Negotiated Rulemaking Act, however, USDA would control how long it takes to develop a rule based on the efforts of the negotiated rule-making committee. The Appropriations Committee's bill mandated that the committee not take longer than nine months to report back to USDA.
USDA was moving in the right direction when it held the HACCP Roundtable last year. Ideally, the department would have moved from the effort directly into negotiated rule-making. Instead, it dragged its feet in replying to an industry petition seeking mandatory HACCP, and then dropped the inspection proposal on everyone. For this, USDA has little right to complain about delays when the sole objective is to get a cooperative process back on track in the hopes of coming up with a system everyone can embrace.
Utilization of the negotiated rule-making process, in an effort to develop a consensus among all the parties, should prove to be a constructive step toward the design of an inspection process that relies more on scientific principles.
The piecemeal approach currently being followed by USDA seems neither efficient nor intended to result in meaningful reform. It will only yield a patchwork of new regulatory requirements on top of the outdated current system.
As an old adage says: If you don't have time to do it right the first time, when will you have time to do it over?