WATCHING WASHINGTON

By The Vision Council
The Vision Council serves as an umbrella for a large core of members in diverse segments of the optical industry, from family-owned businesses to global companies. It promotes the growth of the industry and positions its members to be successful in a competitive marketplace through education, advocacy, consumer outreach, strategic relationship building and industry forums. As the global voice for the supply side of the optical industry, The Vision Council also serves as a liaison with consumers and provides education about the importance of vision care and the options in vision care products. Membership is available to any person, firm or corporation whose primary business is the manufacturing or distribution of ophthalmic-related products and/or services.

In 2011, The Vision Council expanded its membership to include the Optical Laboratories Association (OLA). The final merger agreement between the two associations was signed during The Vision Council’s Executive Summit, re-naming OLA the new Optical Lab Division of The Vision Council and combining the activities of both associations to benefit their respective members.

One of the key benefits of being a member of The Vision Council is having access to its Government & Regulatory Affairs outreach. The Vision Council takes an active role in advocating for stronger public policy to protect Americans’ vision and improve access to vision care products. From lobbying on Capitol Hill to monitoring federal and state legislation and regulations, The Vision Council is a policy resource for its members.

On behalf of Optical Lab Division members, The Vision Council is currently monitoring several public policy issues, including: Food & Drug Administration (FDA) Establishment Registration Process, California Proposition 65, Food & Drug Administration (FDA) Impact Resistance Guidelines, U.S. Registration & Manufacturing Standards Covering Medical Devices Sold in the U.S., Medical Device Excess Tax, Occupational Safety and Health Administration (OSHA) & Hazard Communication Standard (HCS) Requirements, and California Medical Device Registration. Domestically, The Vision Council is the secretariat for the important ASC Z80 group, which manages the familiar ANSI ophthalmic standards. Internationally, the organization is the ISO Technical Advisory Group Leader to Technical Committee 172, Subcommittee 7. Updates for all of these issues, and more, can be found on The Vision Council’s website at www.thevisioncouncil.org/members under “Government & Regulatory Affairs.”

Fda Establishment Registration Process: As of Fiscal Year 2013 (Oct. 1, 2012), the FDA now requires all entities to pay an annual filing fee of $2,575 when filing their annual establishment registrations with the FDA. To help members of Optical Lab Division better understand the change and determine whether or not they would be impacted, The Vision Council hosted an exclusive, 30-minute webinar on Oct. 9, 2012. During the webinar, Rick Van Arnam, The Vision Council’s regulatory legal counsel, stated that when optical labs are functioning as labs, they do not have to register with the FDA and under this new rule that would not change. However, if a lab were to also function as an initial distributor or importer of medical devices (e.g. if they directly imported lenses for use or resale) then those companies would have to register with the FDA and pay the filing fee. In other words, if you are a lab that has registered with the FDA in the past based on importing activities, then you must continue registering but you will also need to start paying the fee.

In 1986, the State of California passed the “Safe Drinking Water and Toxic Enforcement Act,” better known as Prop 65. It was implemented to regulate the presence of certain chemical substances found in products sold in California or present in the workplace in California. The goals of Prop 65 are to protect California’s drinking water sources from contamination by these chemicals and to provide California consumers, residents and workers with the information necessary to take precautions and to make informed choices about the products they purchase.

If a business sells a product in California containing a substance or substances that are on the Prop 65 list in excess of the “de minimis” level for that substance, then a “clear and reasonable” warning must be provided to the public. The same is true for environmental or workplace exposures, such as optical labs. A clear and reasonable warning must be provided for its employees and the public.

Prop 65 requires the Governor of California to publish a list of chemical substances that are known to the State of California to cause cancer, birth defects or other reproductive harm. The list is updated quarterly so businesses that are subject to Prop 65 should review the list on a quarterly basis to ensure they remain compliant. To make it easier for members to find, The Vision Council maintains the Prop 65 list on its website, www.thevisioncouncil.org/members.

With the ever-increasing litigious environment in California, The Vision Council has become much more engaged in monitoring this issue in the State of California because tort lawyers in the state look for and litigate Prop 65 claims against companies believed to be in violation of the law. Over the past couple of years, several cases have been brought based on allegations that certain eyewear, including sunglasses and reading glasses, are in violation of Prop 65, resulting in several members of The Vision Council being subject to such suits.
Fda Impact Resistance Guidelines: In 2010, the Food and Drug Administration revised its Question and Answer guidance for the vision industry’s Impact-Resistant Lenses.

This guidance answers questions for manufacturers, importers, and testing laboratories on such topics as test procedures, lens testing apparatus, record maintenance, and exemptions to testing. In addition to maintaining the Question and Answer document on its website, The Vision Council’s technical experts are also available to assist Optical Lab Division members with specific questions and concerns.

U.S. Regulations & Manufacturing Standards Covering Medical Devices Sold in the U.S.: In May 2013, The Vision Council published the “Guide to U.S. Regulations & Manufacturing Standards Covering Eyeglass Frames, Prescription Lenses and Finished Eyewear Sold in the U.S.”

The guide is a tool offered to members of The Vision Council who manufacture, export, import, retail, and deliver to eye care providers. It provides pertinent information about the U.S. regulations and national manufacturing standards that affect the manufacture and sale of eyeglasses, eyeglass frames and prescription lenses (products regulated as “medical devices”) in the United States.

The prescription eyewear industry in the U.S. is a 17.9 billion dollar business, and historically, the process of getting corrective eyewear has been fairly clear cut. However, the internet now provides an alternative means through which prescriptions may be filled, with finished eyewear now being delivered to customers in the U.S.

Whether a customer’s prescription is filled by the traditional “3Os” (optician, optometrist and ophthalmologist) or filled on-line, these products are regulated as “medical devices” by the U.S. Food & Drug Administration. If these products are imported, either as components or as finished eyeglasses, then other U.S. federal agencies such as the U.S. Customs and Border Protection would fall under its jurisdiction and regulations.

This guide is intended to provide members of The Vision Council with a better understanding of the regulatory environment when introducing these medical devices into the U.S.

Medical Device Excise Tax: On Dec. 5, 2012, the IRS issued its final rule that provided guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Patient Protection and Affordable Care Act (PPACA) (“Healthcare Reform”).

The Vision Council’s Government and Regulatory Affairs team was instrumental in pushing for the exemption of eyeglasses from this tax. As a result, the final rule confirms that eyeglasses are not a taxable item under this excise tax.

The Vision Council organized a members-only conference call shortly after the final rule was issued to help members better understand how the vision industry might be affected.

OSHA Inspection Guidelines & HCS Requirements: The Occupational Safety and Health Administration (OSHA) has revised its Hazard Communication Standard (HCS), which currently requires employers (labs) to communicate to employees information about hazardous chemicals to which they may be exposed in the workplace.

To help lab members with compliance-related issues, The Vision Council’s legal experts provided an overview of the new rules and prepared a brief how-to guide for handling an OSHA inspection.

Changes to California Medical Device Licensing Process: Since 2008, the State of California has required medical device manufacturers physically located in California to be licensed with the state. Up until 2013, the process involved filing an application, paying a filing fee and allowing state officials to inspect the facility prior to granting the license. However, at the beginning of 2013, the licensing process changed somewhat. Now applicants, including renewal applicants, can avoid the state inspection under certain circumstances. For members of The Vision Council, inspections will not be necessary if the applicant can provide the following:

• Proof of a valid FDA establishment registration and an attestation that a federal inspection was completed within the previous two years; or,
• Documentation proving compliance with audits conducted pursuant to ISO standards, such as ISO 9000 series, ISO 13485:2003, ISO 15378: 2006), or to a quality management system pursuant to 21 CFR §§ 210, 211 or 21 CFR §820.
• A licensing fee remains in place whether or not you are exempt from the inspection. New licenses will cost $1,600. Bi-annual relicensing is $2,600 for the two year period.

The Vision Council strives to keep its members updated on all government and regulatory affairs activities that may impact their businesses. When dealing with new legislation and policy issues, The Vision Council can tap its network of resources and provide its member companies with a better understanding of pertinent regulations and public policy initiatives. For more information, and to download copies of the guides mentioned in this article, please visit www.thevisioncouncil.org/members.


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Labtalk May/June 2018