Inside this Issue:
November 2017  VOLUME XV ISSUE 3A
An ISO/IEC 17025 Accredited Laboratory

COOLetterFrom the COO's Desk
Excitement is growing here at Q Laboratories as construction of our new 30,000 sq.ft. laboratory building is taking shape and our team can see the future home of our laboratory operations nearing completion. The facility under construction, along with the 25,000 sq.ft. administration building we purchased adjacent to the lab building, and maintaining operations in the newer section of our current facility, built in 2010, will expand our footprint from the current 25,000 sq.ft. to a total of 65,000 sq.ft.  As with everything we do here, this expansion is designed to help us serve our clients better, by allowing for larger more complex projects as well as allowing for a more efficient work-flow leading to minimal turn-around times. Our goal of providing one-stop shopping for laboratory services also becomes more of a reality as the additional space will allow for added capabilities. The new facility is scheduled to be competed in Spring 2018 and we will begin to move operations as soon as allowable. Keep an eye out on our website and future editions of this newsletter for photos and updates on our new headquarters.

David G. Goins, Chief Operations Officer

In August, the FDA made available a useful tool for helping food producers comply with regulations. As per the FDA website, "to help businesses meet the requirements of the Food Safety Modernization Act (FSMA) Final Rule for Preventive Controls for Human Food, the U.S. Food and Drug Administration is releasing a new software tool to help owners and operators of food facilities create a food safety plan specific to their facilities. The Food Safety Plan Builder (FSPB) is a free software application, developed by FDA, that businesses can download from the FDA's website to guide them, step-by-step, through the creation of a food safety plan, as required by FSMA." The downloadable software takes the user through 15 sections, each with a corresponding YouTube video that assists in completing that section. Sections include: Good Manufacturing Practices (GMP) & Prerequisite Programs, Hazard Analysis & Preventive Controls Determination, Process Preventive Controls, Food Allergen Preventive Controls, Sanitation Preventive Controls, Supply-Chain Preventive Controls, Recall Plan, Recordkeeping Procedures and Food Safety Plan Report.  There is a link to the FSPB tool on the  Q Labs website at:

The FDA recently released a guidance document entitled, "Menu Labeling: Supplemental Guidance for Industry." According to the document, "this guidance document addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments including expanded and new interpretations of policy." The regulations are scheduled to become effective on May 7, 2018 for "covered establishments" defined as "a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that voluntarily registers (or opts-in) with FDA to be covered by the federal menu labeling requirements."  The Guidance offers several examples and presents graphical depictions of how to present nutritional information for items such as buffet foods, grab-n-go items and self-service beverages and options for providing nutritional information for "build-your-own" items such as pizza and sandwiches.
     The Menu Labeling regulation requires the following to be displayed: the number of calories contained in each standard menu item listed on the menu or menu board, as usually prepared and offered for sale. Two statements are also required to be present, ''2,000 calories a day is used for general nutrition advice, but calorie needs vary," and "Additional nutrition information available upon request."  The "additional nutritional information" must include, but is not limited to: Calories from fat, Total fat, Saturated fat, Trans fat, Cholesterol, Sodium, Total carbohydrate, Dietary fiber, Sugars, and Protein.
     The Rule allows for gathering individual ingredient nutritional information from suppliers and tallying up the total for posting on menus and/or menu boards as a way of keeping costs down for the restaurants and food service entities affected by the rule.

On September 29th, the FDA announced a proposed rule extending the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule from July 26, 2018, to Jan. 1, 2020, for large manufacturers ($10 million or more in annual food sales) and Jan. 1, 2021 for small manufacturers (less than $10 million in annual food sales). The new rule includes a new label format as well as adding Potassium and Vitamin D levels and requiring manufacturers to declare any Added Sugars on the label.

Animal food GMPs are required by the Food Safety Modernization Act (FSMA) in order to more align with regulations governing human food safety.  Published in September 2015, the cGMPs cover domestic and foreign facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act (the FD&C Act) that manufacture, process, pack, or hold animal food for consumption in the U.S. Since being published, the rules have been implemented gradually, starting with larger manufacturers and allowing smaller manufacturers more time to comply.  As with many of the stipulations of FSMA, the cGMPs are intended to be implemented, along with an effective Preventive Control program, to provide a solid foundation for producing safe products.  According to the FDA, "cGMPs serve as baseline standards for producing safe animal food, including preventing insanitary conditions in the production of animal food.  Full compliance with the cGMP provisions should reduce the likelihood that the animal food will be manufactured/processed, packed, or held under insanitary conditions or be otherwise unfit for food."   
Q Laboratories can provide versatile laboratory services to help manufacturers comply with animal food cGMPs.

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