Issue of the Month
Time to Review Your Environmental Sampling Program

It has come to our attention that many food processors are not fully aware of new environmental sampling protocols introduced by the Food and Drug Administration last spring for use by its field inspectors.

Although the revised sampling instructions were directed at District Offices and inspectors, if you have an environmental monitoring program that predates spring 2010, it is possible that it would no longer be acceptable to the agency.

The March 2010 revised document, DFI Field Bulletin #30 – Food Program Area Instructions for Environmental Sampling (which is available through our EAS-e-Docs service) includes an explanatory note by Don Zink, senior science advisor for the Center for Food Safety and Applied Nutrition, who says the agency had “extensive internal discussions” about the optimal method for environmental sampling.

“On the one hand, it is exciting that the agency is making a major commitment to sampling certain food plant environments at risk of Salmonella contamination and this fact alone will cause the food industry to focus on Salmonella. I think the industry will respond by placing greater emphasis on their own sampling programs and plant sanitation...,” Zinc says.

Sponges - Not Swabs

Zinc acknowledges uncertainties about the best way to conduct environmental sampling, but says “there is widespread consensus that it is more productive to take the largest possible environmental sample, and this means that sampling with suitable hand sponges or sponges on a stick designed for this purpose are far preferable to using cotton or Dacron swabs.”

“It is our expectation that the vast majority of environmental samples will be collected with either sponges on a stick or hand-held sponges,” Zinc says. In some cases, it may be necessary to use a cotton or Dacron swab to collect a sample from an area too confined to use sponges, he says.

Investigators should “make every effort to collect as much sample material as possible, generally between 100 and 300 swabs,” the bulletin says.

During the initial phases of the inspection, investigators are told to observe and map operations, including the location of equipment, flow of the product, foot traffic of employees, forklift/mule traffic patterns, and segregation of raw material versus finished products and determine the environmental zones to be sampled. Investigators are then instructed to use the following environmental monitoring zones when deciding where to take samples. Zone 1 refers to all direct food contact surfaces such as slicers, mixers, conveyors, utensils, racks and work tables. Zone 2 includes all non-food contact surfaces in the processing area, such as the exterior of equipment, framework, food carts, equipment housing, gears, ventilation, air handling equipment and floors. Zone 3 includes corridors and doorways leading to food production areas, as well as walls, phones, forklifts - even if they are located inside Zone 2. Zone 4 includes employee locker rooms (if not immediately adjacent to food production rooms), a dry goods storage warehouse, a finished product warehouse, cafeterias, hallways and the loading dock area.

A large majority of the environmental samples collected should be taken from zones 1 and 2, depending on the microorganism in question. Fewer samples should be taken from zone 3 and very few, if any, should be taken from zone 4, the bulletin explains. If Salmonella is the pathogen of concern, food contact surfaces are not normally sampled, unless specifically requested. But if Listeria monocytogenes is the pathogen of concern, sampling of food contact surfaces is essential.

“The successful conduct of the environmental sampling assignment will require a certain amount of ingenuity and resourcefulness on the part of our investigators,” Zinc says. “I have no doubt that we will find positive results and will be able to take appropriate regulatory action based on our findings,” he says.

According to the bulletin, when positive or negative environmental samples are reported, the firm will be notified within 48 hours and advised of the findings. It is important to report negative findings, it says, as some firms may hold product pending results.

If positive findings are reported, regulatory action under section 402(a)(4) of the Federal Food Drug and Cosmetic Act, would have to be based on sufficient evidence (such as routes of cross-contamination) to show that the food was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

With the advent of the Food Safety Modernization Act, FDA is becoming very proactive with regard to prevention. So industry will need to keep abreast of changes in FDA regulatory policies to assure continued compliance.

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FSMA Perspective
A Timeline for Hazard Analysis and Prevention

The January 4, 2011 signing of the FDA Food Safety Modernization Act set the clock ticking for the implementation of new requirements for hazard analysis and preventive controls by facilities registered with the Food and Drug Administration.

Section 103 of the FSMA adds a new section to the Food, Drug & Cosmetic Act—Section 418—requiring all facilities registered with FDA to conduct a hazard analysis and to implement preventive controls. Documentation of compliance is also required.

Section 418 will go into effect 18 months after the FSMA’s enactment—that is in June 2012. For small businesses, the section will go into effect six months after the effective date of FDA’s implementing regulations. And for very small businesses, it will go into effect 18 months after the effective date of the implementing regulations.

In the meantime, FDA has until July 3, 2011 to study, in collaboration with USDA, a possible exemption for small businesses from the hazard analysis and preventive control plans. The agency is also tasked with clarifying the terms “small business” and “very small business” for the purposes of any exemption. In addition, under Section 103, the agency has until July 3, 2011 to issue a small entity compliance guide for a hazard analysis plan, using “plain language.“

Although hazard analysis and prevention are key components of the historic legislation, the act does not explicitly call for the use of a hazard analysis and critical control point (HACCP) system. Other food safety systems such as ISO 22000--which includes similar concepts, and which may evolve as the international standard--could be used for compliance with the new law.

Until now, HACCP (or HACCP principles) has been required by FDA for low acid canned foods, seafood, juice, and eggs, and by USDA for meat and poultry. Now, processors of all types of FDA-regulated food will be required to evaluate the hazards in their operations, to implement and monitor effective measures to prevent contamination, and to have a plan for corrective actions.

This may sound intimidating, but the basic steps of creating a HACCP plan are well-understood. Most readers will be familiar with HACCP’s seven key principles: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) verification, and (7) record keeping procedures. Because every food establishment is different, it is not possible to simply adopt a generic HACCP plan or use “off the shelf” software. But models are useful. And developers of HACCP plans have learned over time to avoid mistakes such as the inclusion of too many critical control points in a plan. Such plans were found to be too unwieldy in practice. These days, a HACCP plan may have just one critical control point.

What to Do

What should you do at this time to ensure that your company will be in compliance with the new FSMA requirements? If you are already required by FDA to have a HACCP plan, you may simply revisit the plan—which you should do regularly in any event. Similarly, if you have voluntarily introduced HACCP, perhaps in response to demands by customers, you may not need to change what you do to achieve compliance with the FSMA. But if you know that your company will be required to introduce new controls, or if you are unsure—because of your company’s size—whether the agency will require you to introduce HACCP-like controls, this would be a good time to begin that process.

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Who's Who at EAS
Meet EAS Senior Consultant Len Steinborn

Len Steinborn is an expert in quality assurance for pharmaceuticals and medical devices with more than 40 years of experience. For more than half of that time, he served in quality assurance roles for Abbott Laboratories in Abbott Park, Ill., including that of manager of quality systems training and internal audit systems.

In 2002, he joined AAC Consulting in Rockville, Md., as a senior consultant, where his work included GMP training at medical device facilities, review of non-conformance investigations and supply of guidance in corrective and preventive action to multiple facilities of a major pharmaceutical firm. He has since joined the EAS network of consultants.

As an independent ISO/GMP consultant, he has developed courses on GMP requirements and FDA inspection preparedness to domestic and foreign drug and device firms. He has also audited numerous drug, medical device and dietary supplement manufacturing operations.

Mr. Steinborn is a member of The GMP Institute’s Hall of Fame. He has written numerous articles for FDA News and Information Newsletters on GMP training and auditing. He has also developed GMP/ISO Quality Audit Manuals and is an ISO-certified QMS Lead Auditor.

“Len is an acknowledged expert in his field and a most valuable asset for our clients,” says EAS President Ed Steele. “I am very pleased to have him on our growing team of pharma consultants.”

Stephen Spinak and Ilene Heller Join EAS Consulting Team

EAS Consulting Group is please to announce the addition of Stephen Spinak and Ilene Heller to its team of consultants

Mr. Spinak is an expert in aseptic processing and packaging whose career has included 18 years with FDA’s Center for Food Safety and Applied Nutrition and more than a decade with USDA’s Food Safety and Inspection Service. He served as project manager for FDA's international cannery inspection program and for filing and evaluation of thermal processes for acidified and low-acid canned foods. From 1980 through 1991, he served in FSIS, where he was the National Field Coordinator for USDA’s HACCP development project. He is a former long-time member of the U.S. Delegation to the Codex Committee on Food Hygiene and he chaired the Codex Aseptic Processing and Packaging work group.

Ms. Heller is a food law attorney with more than 20 years experience, most recently with the Center for Science in the Public Interest, where she was CSPI’s regulatory expert on food labeling and dietary supplements. Previously, she was an associate at the law firms Arnold & Porter and, prior to that, at Keller and Heckman in Washington, D.C. Early in her career, she was a staff reporter with the Legal Times of Washington.

“I am very pleased to welcome Stephen and Ilene to EAS; their diverse backgrounds and skills will provide a very useful perspective for our clients,” says EAS President Ed Steele.

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What's New on FDA's Website
February Updates

Listed below are links to new additions to the FDA website for the month of February, 2011. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

• FDA approves Edarbi to treat high blood pressure February 25, 2011


• FDA and Georgetown University Medical Center announce partnership February 24, 2011


• FDA: U.S. Marshals seize food products at Tennessee company February 24, 2011


• FDA: Advanced genomic test helps trace sources of foodborne illness outbreak February 24, 2011


• FDA permits marketing of first test for most common cause of gastroenteritis outbreaks February 23, 2011


• FDA approves product to prevent bleeding in people with rare genetic defect February 17, 2011


• FDA warns against certain uses of asthma drug terbutaline for preterm labor February 17, 2011


• U.S. Marshals seize Auralgan Otic Solution February 16, 2011


• FDA seeks to invest in foodborne illness prevention, medical product safety and countermeasures February 14, 2011


• FDA finalizes regulation for certain software, hardware used with medical devices February 14, 2011


• FDA approves first 3-D mammography imaging system February 11, 2011


• FDA clears test to help patients with kidney transplants February 11, 2011


• FDA approves 1st pacemaker designed to work safely during some MRI exams February 08, 2011


• FDA launches Medical Device Innovation Initiative February 08, 2011


• FDA orders postmarket surveillance of certain TMJ implants February 07, 2011


• FDA clears first diagnostic radiology application for mobile devices February 04, 2011


• FDA approves drug to reduce risk of preterm birth in at-risk pregnant women February 04, 2011


• FDA reminds health care professionals about safe use of non-sterile alcohol prep pads February 01, 2011

• Wellpet LLC Voluntarily Recalls Certain Lots Of Canned Cat Food February 28, 2011


• E&J Brandy Announces A Nationwide Recall Of Stainless Steel Flasks Due To Possible Lead Risk February 25, 2011


• Taylor Farms Pacific Announces Precautionary Recall of Broccoli items with an Expiration Date(s) 2/7/11 to 3/7/11 due to a Possible Health Risk February 24, 2011


• Urgent Recall on Asian Gourmet Cheese Rice Crackers Which May Contain Undeclared Milk and Undeclared Food Coloring Additives. February 23, 2011


• BIOTAB NUTRACEUTICALS, INC. Issues a Voluntary Recall of Specific Lots of the Nutritional Supplement EXTENZE (Men’s Regular) February 22, 2011


• Roche Insulin Delivery Systems announces recall of ACCU-CHEK® FlexLink Plus infusion sets February 21, 2011


• Consumer Alert: Undeclared Peanuts In Dry Fruit "Kachori" February 18, 2011


• Natural Choice Distribution Company Inc. Voluntarily Recalls Certain Lots Of Fare And Square Sandwiches, Superfresh Sandwiches, And Real Wraps Burritos Due To The Presence Of Undeclared Allergens February 18, 2011


• Upsher-Smith Laboratories Announces Expansion of Voluntary Nationwide Recall. Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven® and Oxybutynin February 18, 2011


• Pacific American Fish Co. Recall Shishamo Roe Capelin 4L Due To Potential Of C. Botulinum February 17, 2011


• W H & GROUP, LLC. Issues An Alert On Uneviscerated Fish February 17, 2011


• Hua Shing International Trading Corp Issues an Alert on Uneviscerated Fish Photo February 16, 2011


• Upsher-Smith Laboratories Announces The Voluntary Nationwide Recall Of Jantoven® Warfarin Sodium Tablets, USP, 3mg, Due To Mislabeled Bottles February 16, 2011


• Hua Shing International Trading Corp Issues an Alert on Uneviscerated Fish February 16, 2011


• Prime Choice Foods Corporation Voluntarily Recalls Certain Lots Of Garden Of Eatin'® Multi Grain Tortilla Chips Due To The Presence Of Undeclared Allergens February 14, 2011


• f’real® foods Expands Voluntary Recall Of Strawberry Banana Smoothies Due To Potential Peanut Content February 11, 2011


• Magic Valley Fresh Frozen, Inc. Foods Issues Allergy Alert On Undeclared Milk In Breaded Okra February 10, 2011


• f’real® foods Issues Voluntary Recall of Strawberry Banana Smoothies Due to Potential Peanut Content February 10, 2011


• Svelte 30 Nutritional Consultants Issues a Voluntary Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient February 09, 2011


• Martin's Famous Pastry Shoppe, Inc. Issues Allergy Alert On Undeclared Soy Protein In Certain "Nibble With Gibble's" And "Kay And Ray's" Branded Products February 08, 2011


• Biosan Laboratories Issues Allergy Alert on Undeclared Soy in Vitamin and Nutritional Supplements February 07, 2011


• Neuro Resource Group, Inc. Informs Customers of Important Information about Triad Group's Alcohol Prep Pads February 07, 2011


• Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets, USP 10 MG / 500 MG, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E And T023M10A And Phenobarbital Tablets, USP 32.4 MG, NDC 0603-5166-32, 1000 Count, Lot Numbers T150G10B, T120J10E And T023M10A February 05, 2011


• Watson Announces Important Action Related to Nationwide Recall of Triad Alcohol Prep Products Included in Products February 04, 2011


• St James Smokehouse, Inc, Announces Voluntary Recall of Scotch Reserve Whiskey & Honey Smoked Salmon 4oz Retail Packs Due To Possible Health Risk February 04, 2011


• Rouses Markets Voluntarily Recalls Frozen Yellow Fin Tuna Steaks Due To Possible Health Risks February 04, 2011


• American Spoon Foods Brand Apple Chipotle Salsa, Maple BBQ Grilling Sauce, And Pumpkin Chipotle Roasting Sauce May Contain Undeclared Wheat Flour And May Put Certain Consumers At Risk For Wheat Or Gluten Sensitivities Or Allergies. February 03, 2011


• American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium 5 mL Single Dose Vial, Lot# 0048 Due to Translucent Visible Particles February 03, 2011


• American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP 10% (100 mg/mL) 10 mL Single Dose Vials Lot# 0056 Due to Translucent Visible Particles February 03, 2011


• Undeclared Soy And Anchovy Puree In "Mooney's Kentucky Bourbon Cheese" and "Valumarket's Beer Cheese Spread" February 01, 2011

• February 23, 2011
• February 16, 2011
• February 09, 2011
• February 02, 2011

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

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EAS in Action

EAS VP Campbell to Review Front of Packaging Labeling

EAS Vice President Elizabeth (Betty) Campbell will present a session on Front of Packaging Labeling at the 23^rd Annual Federal Food Regulatory Conference in Washington, D.C., April 4-5, 2011. This popular event is sponsored by Prime Label Consultants. The presentation will review what has happened so far, what FDA is currently doing, and what the agency is likely to do in the future with regard to this complex issue. She will suggest that companies will need to be prepared for changes.

Still No Margin for Error

A video produced for the Food and Drug Administration more than 40 years ago dramatized what can happen when production demands or other pressures lead to shortcuts in the manufacture of drugs. The 34-minute video, titled “No Margin for Error” is just as instructive and relevant today.

In a documentary-style report, a young girl with chronic kidney disease is depending on a hydrocortisone-based drug. But the manufacturer, through a combination of deliberate shortcuts and avoidable errors, produces a sub-potent and probably contaminated batch.

In the case of the fictitious Steroid 47, multiple failures in Good Manufacturing Practices result in an expensive recall. The video reviews the various steps at which the errors could have been corrected--or at least identified--so the sub-potent product would not have been sent out of the facility.

We believe this 1967 video is still a useful tool for demonstrating the consequences of not following GMPs, and we are offering copies in DVD format. See below for details.

EAS Takes Part in SIDI Working Group Meeting

EAS Vice President Dean Cirotta participated in a meeting of the Joint Standardized Information on Dietary Ingredients (SIDI) Working Group, held in Washington, D.C., February 23. The group is developing a voluntary industry-wide ingredient supplier qualification program for the dietary supplement industry.

SIDI’s member organizations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Counsel for Responsible Nutrition, the Natural Products Association, the Food and Drug Administration, the National Science Foundation, and the United States Pharmacopeia. The group’s company members include Albion, A.M. Todd, BASF, Bayer, Beijing Ginkgo Group, Colorcon, DSM, EAS Consulting Group, Embria Health Sciences, GNC, Joy QM Systems, Kemin, Kyowa Hakko, NBTY, Nutramax, and Nutrilite.

Cirotta Co-presents at FDLI Introduction to Drug Law and Regulation

EAS Vice President Dean Cirotta was a co-presenter of a workshop on the Regulation of Drug Manufacturing at the Food and Drug Law Institute’s Introduction to Drug Law and Regulation, held in Washington, D.C., February 9-10. He joined attorney Cathy Burgess of the law firm Crowell & Moring for a session covering requirements for registration and drug listing, public disclosure, adulteration and misbranding, current GMPs, FDA inspections, Field Alert report requirements, and FDA’s enforcement actions.

Limited Space Available Food Labeling Compliance Review Seminar

There is still space available in the upcoming Food Labeling Compliance Review Seminar, which will be held at the EAS headquarters in Alexandria, Va., March 29-30. This popular seminar offers instruction from labeling experts who helped to develop the regulations. Instructors for this event include EAS Vice President Elizabeth (Betty) Campbell, who served as head of FDA's Office of Food Labeling, EAS Senior Consultant James E. Hoadley, a former senior regulatory scientist at FDA; and EAS Consultant Gisela Leon, who has an extensive background in U.S., European and other international labeling requirements.

Click here for more details. If you have questions, contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

Registration Now Open for Dietary Supplement GMP and Laboratories Seminars

Registration is now open for two popular EAS dietary supplement training seminars--on regulatory compliance of dietary supplement laboratories and on dietary supplement GMPs.

The next Dietary Supplement GMP Seminar will take place April 12-13, 2011 at the EAS training facility in Alexandria, Va. This intensive program will provide all the information needed to comply with the Food and Drug Administration’s final GMP rule, covering the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements. Click here for details.

In addition, a seminar titled Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar, will be held April 14-15, 2011, at the EAS training facility in Alexandria, Va. Laboratory control deficiencies are among the most frequently cited observations during FDA inspections. This two day course will provide you with the knowledge and skills for evaluating, auditing, managing, and improving the CGMP compliance of your in-house and/or contract laboratory. You will be provided with examples of lab CGMP deficiencies from FDA-483 drug citations and recommendations for practices and procedures to ensure and demonstrate CGMP compliance. Click here for more details.

If you have questions about these seminars, contact Cathryn Sacra at 703-684-4438 or csacra@easconsultinggroup.com.

EAS Supports FDLI Annual Conference

EAS Consulting Group will participate in the Food and Drug Law Institute’s Annual Conference in Washington, D.C., April 5-6, as a sponsor, an exhibitor and as a presenter. EAS Senior Consultant James Hoadley, formerly a senior regulatory scientist at FDA, will speak about the latest developments in labeling claims for dietary supplements.

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Upcoming Events

Food Labeling Compliance Review Seminar
March 29-30, 2011
Alexandria, Va.

23rd Annual Federal Food Regulatory Conference
April 4-5
Washington, D.C.

FDLI Annual Conference
April 5-6, 2011
Washington, D.C.

Dietary Supplement GMP Seminar
April 12-13, 2011
Alexandria, Va.

Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar
April 14-15, 2011
Alexandria, Va.

Supply Side East
May 2-4, 2011
Secaucus, N.J.

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Order Publications and Regulatory Tools

	EAS Labeling Type Size Guide A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.	$ 9.00
	Dietary Supplement GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	Pharmaceutical GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 210, 211 and 11 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	No Margin for Error – GMP Training Video A 1967 video produced by FDA demonstrating the consequences of not following GMPs. An excellent training tool to motivate employees to follow drug GMPs. 25 minute video in DVD format	$ 99.00
	Dietary Supplement Labeling Compliance Review, 3rd edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell Hardbound book	$ 194.99
	Food Labeling Compliance Review, 4th edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell. Hardbound book and CD	$ 229.00 / set
To purchase any items listed above download our

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