Compliance Monitoring: Finding a Middle Ground

The “good old days” is a phrase that means something different to everyone. People usually use the term in a nostalgic sense looking for a return to previous times they remember as being better. Today when we consider regulatory affairs that influence adhesives, coatings, and inks: Were the good old days better?

Converters and their suppliers may remember some years ago when regulatory affairs seemed to be the main concern on everyone's mind. Did an adhesive comply with FDA regulations? Was the VOC content of a particular coating acceptable? Did an ink comply with the Toxic Substances Control Act?

Today we don't hear these questions with such frequency. The regulations still exist, and government agencies are enforcing them with perhaps even more vigor. The regulations appear to have less visibility today because many companies routinely hire experts, consultants, or specific organizations to ensure their products and processes meet all applicable government regulations.

Transferring the duties regarding regulatory affairs from an in-house operation to someone outside the formal organization of a converter or its supplier probably signifies the extent to which the regulations have increased and become more stringent.

An employee devoting some or all of his time to regulatory affairs may not be sufficient. Many companies simply opt to rely totally on someone who has access to all the regulations, knows the people in the regulatory agencies, works with a broad spectrum of similar industries, etc.

A big advantage to using an outside organization to keep watch on regulatory affairs is these organizations often have involvement in the preparation of rules. Government agencies may consult with such organizations when they are writing new regulations. Personnel from the organizations may consult with converters and suppliers to keep them advised of pending regulations and allow them to give input regarding provisions of the regulations.

Working with regulatory bodies during the drafting of new rules not only provides advance notice of new restrictions but also offers the opportunity to influence the drafters of the rules.

A significant disadvantage to farming out the regulatory work is the fact that you might tend to become lazy or negligent. Not being concerned with the intricacies of regulatory affairs during the course of daily business can lead to a lack of direct awareness. That means someone might make a technical or marketing decision that could require rescinding in the future.

A middle ground is probably the best approach. If your organization can afford it, hire an expert to advise you and watch over the various aspects of your operation. However, you should supplement this expert assistance with sufficient internal knowledge regarding regulatory affairs. This way a converting operation or a supplier has the best of both worlds.

Government agencies will continue to write new regulations and modify old regulations. Unfortunately, this is the business of government. Perhaps more unfortunate is the fact that people in government who draft the rules often are not experts in the converting industry. As a result, some rules they consider may not be practical or easy to implement. In those cases, everyone involved in the converting business must educate the rulemakers immediately to explain why the rule under consideration is not appropriate. A compromise often is necessary.

Technology changes over time for many reasons. One reason is to make compliance with regulatory affairs easier. Then the regulations often change to restrict the new technology as it proliferates or as more information on it becomes available. It is a never-ending cycle. It is also a cycle of which converters and their suppliers are a part. The best educated cope best during the course of the cycle.

David J. Bentley Jr. is a recognized industry expert in polymers, laminations, and coatings with more than 30 years of experience in R&D and technical service. Contact him at dbentley@unm.edu.


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