FDA will publish special regulations specifying how 3rd party auditors will be licensed to perform inspections of foreign facilities.
How should management respond?
Is there any good news in the regulations and red tape described above? Is there a silver lining in these cloudy skies? As with much of life and business — it depends on how you look at it and how you respond. First off, the requirements are the law and aren’t suggestions. Fortunately, there will be a comment period where the feed industry will have opportunity to provide input back to FDA before regulations are finalized. Secondly, any process which has as a goal to prevent problems before they occur is probably worth taking a look at, and figuring out how to implement in your feed manufacturing business.
Implementation strategies Stage I
In this new regulatory environment under FSMA, the first order of business should be to educate your management team. You need to become familiar with the requirements — of the law and perform an initial gap assessment of FSMA compliance — i.e. where are there areas you meet the regulations and where are the areas you don’t? Secondly, you as manager should guide your feed business to develop and implement a system to actively manage feed safety to include the following items:
1) Find the balance between the resources you have available and your business objectives;
2) Make a management/executive commitment to feed safety and communicate this to all parties involved (put this commitment in your strategic plan, and communicate this to all stakeholders: employees and customers alike);
3) Establish a budget line item for feed safety and regulatory compliance.
Moving into the stage two strategic response phase involves establishing a regulatory compliance team. This team is charged with implementing compliance to FSMA, developing an emergency response plan to deal with potential feed safety/contamination issues; developing a recall program to inform customers of problems if uncovered and bring back/dispose of product; putting together an internal audit program to track the effectiveness of your feed safety program; and finally tracking and managing whistle blower issues.
After the regulatory team has been established, you need to make sure that your feed safety programs are in place and are continuously monitored. These key areas of best practice will be spelled out in the soon to be released preventive standards mandates by FDA. The controls will need to be documented in a feed safety plan.
The final stage of managing compliance with FSMA involves working with in-house or external counsel to bring them up to speed on compliance issues and associated liability concerns. Another strongly suggested management strategy is to develop a set of written FDA compliance policies and guidelines. The audit program should be built upon a corrective action system (feedback loop) — and one should be developed if you do not have one.. This is the stage when emphasis should be put on education and training, with a focus on awareness of the regulations and working with your staff so that they understand proper compliance methods.
Doing the right thing
Doing the right thing in this environment involves due diligence on your part and a focus on best practices. Management is called upon to set the example, so as to build a culture of feed safety. Attention to this principle will set the stage for continued, prosperous business and fewer problems down the road.
Mr. Kronenberg is a food processing specialist with Cooperative Extension at the University of Idaho, Boise, ID. Dr. Foltz is associate dean, College of Agricultural and Life Sciences and professor, Department of Agricultural Economics and Rural Sociology, University of Idaho, Moscow, ID. Dr. Fulton is professor, Department of Agricultural Economics and Center for Food and Agricultural Business, Purdue University.