NJDHSS FOOD AND DRUG OO UG SAFETY PROGRAM
2008 ANNUAL REPORT
CONSUMER AND ENVIRONMENTAL HEALTH SERVICES PUBLIC HEALTH SERVICES EPIDEMIOLOGY, ENVIRONMENTAL AND OCCUPATIONAL HEALTH
table of contents
• MISSION STATEMENT AND UNIFYING PRINCIPLES………………………………………….….2 • 2008 PROGRAM RESUME………………………..3-4 • INTRODUCTION……………………………….……5-6 • WHAT’S NEW IN 2009!.............................................7 • PROGRAM REVENUE DISTRIBUTION…………….9 • SUMMARY OF LICENSING AND ACTIVITIES…...10 • PROJECT ACCOMPLISHMENTS………...…….11-19 • ASSOCIATIONS: MAJOR BOARDS AND COUNCILS……………………………………………20-21 COUNCILS 20-21 • EDUCATION AND OUTREACH……………………..22
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mission statement
The Food and Drug Safety Program’s mission is to: • Enforce the State’s food, drug, and cosmetic laws • Reduce the incidence of foodborne illness • Promote consumer food safety •P Provide technical support to the food industry and id t h i l t t th f d i d t d local health departments in matters regarding food safety and food defense The program is divided into six major project areas:
WHOLESALE FOOD AND COSMETIC RETAIL FOOD SEAFOOD AND SHELLFISH FOOD EMERGENCY PREPAREDNESS AND DEFENSE DAIRY, BOTTLED WATER, AND JUICE WHOLESALE DRUG
Unifying principles
TECHNICAL COMPETENCE QUALITY INTEGRITY
RESPONSIVENESS PROACTIVITY CLIENT SERVICES
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2008 program resume
FOOD AND DRUG SAFETY PROGRAM
JANUARY – DECEMBER 2008
MAJOR ACCOMPLISHMENTS:
• In cooperation with New York Health authorities, FDA, and NJDEP, visited 8 NJ wholesalers t ensure $12 168 destruction of camphor, an unregistered pesticide h l l to $12,168 d t ti f h i t d ti id used as a medicine that caused seizures in 5 children • Identified and embargoed/destroyed 26 types of Indian herbal remedies and illegal tobacco products that were misbranded, adulterated, or unapproved drugs; found at 5 NJ wholesalers • Conducted Food Recall Effectiveness Check of contaminated ground beef distributed to 173 school districts FDSP inspectors • Removed from the market and destroyed $44,359 of cheese at a wholesale processing plant; milk that had tested positive for ensured statewide destruction of antibiotics was added to cheese, rendering it adulterated camphor, a • Launched the new “Risk-based Inspection Report” form and p p misbranded guidelines; will enhance REHS’ abilities to focus on evaluating pesticide that high-risk procedures in retail foodservice establishments caused seizures in several children. • The FDSP utilized LINCS to notify local health departments of a total of 82 recalls and warnings, including such major events as the 44-state Salmonella Saintpaul outbreak • Embargoed $40,000 of Chinese unapproved drugs, or misbranded or adulterated herbal remedies; facilitated local health department involvement leading to identification of wholesalers and destruction of problem products • Halted statewide sale of illegal over-the-counter products containing ephedra, a restricted ingredient, at 7-Eleven stores in NJ; notified president and attorney of 7-Eleven and NJ drug wholesalers of legal restrictions y g g • With NJ Fish and Wildlife, performed joint surveillance and enforcement of tarping requirements to deter growth of harmful oyster bacteria; in cooperation with NJDEP, conducted extensive outreach to educate oyster harvesters • Despite retirement of highly skilled milk specialist, dairy inspectors surveyed interstate milk plants to evaluate pasteurization to destroy C. botulinum, a potential weapon for deliberate contamination that produces toxins that could cause approximately over 100,000 casualties
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2008 program resume
MORE MAJOR ACCOMPLISHMENTS:
• In partnership with the NJ Restaurant Association, launched a statewide campaign to educate restaurant staff about the dangers of serving raw or undercooked hamburgers to children and other susceptible populations; included p poster for restaurant workers, blast fax with serving g , g guidelines, and p , press release • Participated in nationwide FDA investigation and initiated statewide investigation to check Asian markets in NJ for Chinese-manufactured infant formula and milk-based products after melamine adulterant sickened over 50,000 infants in China • Halted an illegal sale/distribution of raw milk from PA farm to a NJ resident; issued $1200 fine to PA farmer • Embargoed $11,977 of unapproved Indian drugs, herbal remedies, and tobacco products found at 4 NJ wholesalers • Posted 129 recalls and warnings on NJLINCS in 2008
EDUCATION AND OUTREACH:
• Completed individual train-the-trainer sessions with 1 State and 3 local inspectors, who can now train others to perform standardized retail inspections • In cooperation with NJ Environmental Health Association, conducted 3 workshops for 100 local and 3 State inspectors to coach them on using the Risk-based Inspection form; will ensure more focused and uniform inspections • Educated 225 local inspectors and NJ Environmental Health Association attendees about identifying misbranded imported herbal remedies and unapproved drugs; reviewed inspection procedures and corrective actions • Designed and published “Parts of a Food Label,” a visual poster and guide to assist REHS and retail food establishments understand minimum food labeling requirements; intended to help minimize the number of products embargoed/destroyed in NJ due to misbranding • Designed and published “Keep Your Child’s Smile Beautiful,” a brochure that informs parents about the risks of damage to children’s teeth from consuming soft drinks and sports drinks; these drinks are legally permissible, but not safe when consumed regularly g y
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Our food products pass through several elements of the food supply chain before they reach consumers’ plates Each link in the chain has an important role in consumers plates. ensuring that our food remains wholesome and safe to eat. Whether it is a produce processing facility manager making sure that his employees follow proper equipment cleaning procedures, a delivery truck driver checking that product temperatures are maintained, maintained or a consumer cooking his burger to a safe 155°F, food illness prevention is both a joint effort and a joint responsibility. The Food and Drug Administration’s (FDA) Food Safety Protection Plan, released in November 2007, p p p emphasizes the use of multi-level partnerships to support a risk-based prevention, intervention, and response approach towards food safety. As part of this new cooperative approach, State and local health departments must follow suit and migrate to a more proactive and strategic food protection plan. Compliance and enforcement is only one piece of the puzzle.
introduction
Prevention
In 2008, the Food and Drug Safety Program mirrored the FDA’s initiative by expanding its efforts in prevention, intervention, and response, as well as strengthening partnerships. One example of the Program’s prevention efforts is a partnership with the New Jersey Restaurant Association (NJRA) that led to the joint development of an on-going E li prevention campaign t educate restaurant staff d l t f i E.coli ti i to d t t t t ff on preventing E.coli infections in young children. The campaign included a press release sent out during September’s National Food Safety Education Month and an article in the NJRA quarterly newsletter. The NJRA as well as Rutgers University Agricultural Experiment Station assisted in poster distribution. Additionally, Additionally the Program developed “Keep Your Child’s Smile Beautiful ” an Keep Child s Beautiful, educational brochure for consumers about preventing damage to children’s teeth by limiting consumption of soft drinks and sports drinks. Though these drinks are legally permissible, they are not safe for children when consumed on a regular basis. This brochure is being distributed in cooperation with the Children's Preventive Oral Health Education and Promotion Program.
Intervention
It is impossible to prevent 100 percent of food contamination all the time. (continued)
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However, risk-based interventions can greatly enhance existing food safety measures. measures Chapter 24 the new retail food rules was published in 2007 and since 24, rules, then, the Program has been training New Jersey inspectors to perform targeted, riskbased inspections. In 2008, the Program conducted three risk-based inspection workshops, training about 110 local inspectors. Additionally, the Program standardized 3 local inspectors, who can now train others to perform standardized retail inspections. Standardization promotes uniformity of all retail food inspections in NJ and enhances the ability of inspectors to recognize critical violations and take appropriate corrective action. Finally, all New Jersey inspectors formally began using the Program’s new Risk-based Inspection Check Sheet, another tool that focuses the inspector’s attention on high-risk conditions that could lead to foodborne illness. Response The Food and Drug Safety Program is constantly taking steps to increase its ability to quickly identify and respond to food safety problems. When there is an inherent hazard to the public’s health, the Program responds rapidly, working closely with FDA, local health departments, and other appropriate organizations. In the past year, there were a number of major food safety recalls, such as the recall of melamine contaminated infant formula and milk-based products from China. The Program coordinated a rapid statewide investigation to determine if any suspect products were being sold in NJ. Additional activities include a Food Recall Effectiveness Check of E.coli-contaminated ground beef distributed to 173 school districts. Also, several joint inspections were conducted in cooperation with other agencies such as the FDA NJDEP FDA, Pesticide Control, NJ Department of Agriculture, NJ Fish and Wildlife, and New York City Health Department. Finally, the FDSP worked with the NJ Office of Homeland Security and Preparedness, the NJ Office of Emergency Management, Management the NJ Food Policy Institute, and the NJ Food Institute Council on Operation Food Distribution. An emergency food distribution plan was developed that includes creation of a GIS mapping system with census data, retail food stores and distribution center locations, and shelter information. Other participants included the NJ Department of Human Services, NJ Department of Agriculture, the U.S. Department of Agriculture, and food companies. The combination of the Program’s targeted prevention efforts that educate the food industry and consumers, efforts to enhance quality and effectiveness of retail food inspections through risk-based inspection training, and rapid response capabilities continue to strengthen NJ’s food protection system from field to fork.
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introduction
what’s NEW in 2009!
In 2008, the Food and Drug Safety Program began to build a framework for a more comprehensive program in which the concepts of prevention, intervention, and response are a focus of the Program’s food safety and food defense activities and initiatives. In 2009, the Program plans to introduce these concepts to local health departments. Local health departments can then understand how to incorporate the concepts into their own activities and initiatives. initiatives
ACTIVITIES AND INITIATIVES FOR 2009
• Completion and announcement of the new FDSP website, which organizes the homepage by type of visitor. The new design will help visitors focus more readily on the materials that they are searching for. • Educate local inspectors on the basics of packaged food labeling and introduce them to “Parts of a Food Label” poster and guide • Train staff on the use of the NJ Portal, which will enable field staff to post inspection reports directly into an on-line tracking system. This will greatly reduce the amount of paperwork that administrative staff process on a regular basis. • Printing and dissemination of the brochure “Keep Your Child’s Smile Beautiful” with assistance from the NJDHSS Children's Preventive Oral Health Education and Promotion Program • Preparation of the 2009 Vibrio Parahaemolyticus Contingency Plan that will require certified dealers to provide overnight holding and step up their efforts for better refrigeration of oysters. oysters • Identify and collect back licensing fees from food and cosmetic facilities that have failed to renew their wholesale license, and refer to the Office of Legal and Regulatory Affairs those that should be placed out of business.
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The program maintains and collects a total of eight revenue streams through licensures, permits, registrations, and certificates. The table below illustrates the total funds we collected for each revenue category in 2008.
summary of program revenue eve e
$1,500,000 $1,000,000 $500,000 $0
TOTAL REVENUE FOR 2008: $2,030,305
FOOD AND COSMETIC LICENSES ($1,477,200) DRUG AND MEDICAL DEVICE REGISTRATIONS ($240,430) BOTTLED WATER LICENSES ($151,700) CERTIFICATES OF FREE SALE ($107,775) FROZEN DESSERT LICENSES ($18,850) DAIRY PERMITS ($17,550) NITROUS OXIDE PERMITS ($6,700) REFRIGERATED WAREHOUSE LICENSES($8,050) NON-ALCOHOLIC BEVERAGE LICENSES ($2,050)
NOTE: Between 2007 and 2008, revenue for food and cosmetic licenses, drug and medical device registrations, certificates of free sale, frozen dessert licenses, dairy permits, nitrous oxide permits, refrigerated warehouse licenses, and non-alcoholic beverage licenses increased. Increases ranged from 5 8% (drug and medical device increased 5.8% registrations) to 50.4% (refrigerated warehouse licenses). Total revenue increased 10%.
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program revenue and distribution di t ib ti
Listed below are the revenue sources for the $2,030,305 collected in 2008. The purpose of the chart is to illustrate the limited allocation of funds to directly support Program functions.
SOURCES OF REVENUE • FOOD/COSMETIC LICENSES • DRUG/MEDICAL DEVICE REGISTRATIONS • DAIRY PERMITS • REFRIGERATED WAREHOUSE LICENSES • NON-ALCOHOLIC BEVERAGES • BOTTLED WATER LICENSES • CERTIFICATES OF FREE SALE • NITROUS OXIDE PERMITS FOR FDSP PROGRAM USE $223,333 (11%)
DISTRIBUTION
(100%) TOTAL REVENUE FOR 2008 $2,030,305
11%
NOT FOR FDSP PROGRAM USE $1,806,972 (89%)
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comparative summary of licensing and activities li i d i ii
LICENSES, REGISTRATIONS, PERMITS, VERIFICATIONS, AND CERTIFICATIONS 2008
Food and cosmetic licenses Drug and medical device registrations GMP and Certificates of Free Sale Drug verifications Shellfish certificates Nitrous oxide permits Bottled water licenses Milk and frozen dessert licenses Refrigerated warehouse licenses Non-alcoholic beverage licenses TOTAL 2,303 1,280 1,839 621 146 193 197 401 36 43 7,530
2007
1,840 1,093 1,631 600 145 264 196 257 39 44 6,109
2006
2,482 1,101 1,480 300 153 113 130 506 36 10 6,311
WORK ACTIVITIES 2008
Wholesale food and cosmetic inspections and investigations Food sampling Retail inspections Wholesale food defense industry site visits Shellfish inspections Bottled water, dairy, frozen dessert, and juice inspections Seafood inspections Food defense surveys completed for best practices implementation Critical infrastructure assessments Wholesale drug inspections Embargo activities TOTAL 870 732 950 580 335 325 50 284 1 0 50 4,127
2007
1,063 1,126 1,100 818 335 269 50 269 0 0 58 5,044
2006
1,083 1,144 1,160 998 335 238 50 27 0 0 76 5,111
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Introduction The Wholesale Food and Cosmetic Project is responsible for the licensing and inspection of any facility used in the production, preparation, manufacture, packaging, storage, transportation and handling of food or cosmetic items intended for wholesale distribution. Applicants are issued a license only after receiving a satisfactory inspection of the establishment location based on applicable guidelines and regulations. These guidelines and regulations include the Code of Federal Regulations and good manufacturing procedures, NJ Statutes, and the NJ Administrative Code. The Wholesale Food Project has maintained an agency contract with the Food and Drug Administration for completion of assigned wholesale food establishment inspections in accordance with the contract requirements. The federal contract has been renewed annually and has been in effect for more than thirty years The 2008 years. 20082009 grant specifies inspections of 411 operations which include seafood Hazard Analysis and Critical Control Point (HACCP), juice HACCP, and various other food operations. 2008 Accomplishments • Approximately 870 inspections and investigations were completed • 232,591 lbs. of various food and cosmetic products ($500,000 total value) were embargoed and destroyed • Worked closely with the FDA on a recall involving infant formula from China that was contaminated with melamine. Visited distributors of ethnic foods to determine if infant formula from China was being distributed. Instructed local g health departments to visit retail Asian stores to determine if this product was being sold. • Involved in the recall of green beans suspected of Clostridium Botulinum contamination. Green beans were distributed to over 158 NJ school districts. • Worked closely with the Department’s Communicable Disease Service and the FDA on a salmonella outbreak associated with produce. Conducted site visits to numerous wholesale produce firms to monitor produce handling practices and review recordkeeping. • In cooperation with New York Health authorities, FDA, and NJDEP, visited 8 NJ wholesalers to ensure $12,168 destruction of camphor, an unregistered pesticide used as a medicine that caused seizures in 5 children in NY and NJ NJ. • Oversaw destruction of 16 types of unapproved drugs, herbal remedies, and illegal tobacco products found at two wholesale and one retail establishment • Participated in national recall of dietary supplement containing elevated levels of selenium; two wholesalers and one retailer were selling product, which was destroyed
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project accomplishments: wholesale food and cosmetics
Introduction The Certificate of Free Sale and Labeling Unit, as part of the Wholesale Food and Cosmetics Project, routinely processes export documents and Certificates of Free Sale requests for NJ Department of Health and Senior Services licensed establishments. Typically, foreign governments request the Certificate of Free Sale as an attestation that the products being exported are of the same quality as domestic goods, the manufacturer/distributor are in substantial compliance with State and Federal Regulations, and are not under seizure or embargo. The coordinator reviews the product labels, product quality analysis reports, as well as State and Federal inspection histories for each establishment.
project accomplishments: certificates of free sale
The coordinator of this unit keenly evaluates food labels for health claims and structure-function claims. Labels are also reviewed for proper listing of allergenic ingredients, nutrition/supplement facts, and manufacturer/distributor information. Since the adoption of the Certificate of Free Sale rule in 2005, the unit has reviewed over 6,000 certificate requests, of which approximately 20% were returned for corrections, or in some instances embargoed do to labeling issues, or misbranding/adulteration. 2008 Accomplishments For 2008, a total of 2,075 certificate requests were processed for a total of $116,300. This represents a 27% increase over 2007.
2,500 2,000 1,480 1,500 1,000 500 0 1,635
2,075
2006
1 2007
2008
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Introduction The Retail Food Project is responsible for the promulgation of New Jersey’s retail food rules found under N.J.A.C. 8:24-1 entitled “Chapter 24: Sanitation in Retail Food Establishments and Food and Beverage Vending Machines”. As such, the Project P j t serves as th t h i l resource f th proper i t the technical for the interpretation and t ti d enforcement of the Chapter 24 rules for those Health Officers and Registered Environmental Health Specialists (REHSs) employed by each of New Jersey’s 112 local health departments. REHS are charged with enforcing the Chapter 24 rules in the State’s estimated 60,000 retail food establishments. The Retail Food Project also coordinates and supervises the inspection activities conducted by NJDHSS staff of each of the retail food service facilities operating on State properties under Memorandums of Agreement (MOAs) with other New Jersey State agencies including: • NJ Juvenile Justice Commission • NJ Department of Corrections p • NJ Sports & Exposition Authority • NJ Turnpike Authority • NJ Transit Corporation • NJ Division of Military & Veterans Affairs • NJ Department of Environmental Protection, Division of Parks & Forestry • NJ Department of Agriculture, Summer Lunch Food Service Program • NJDHSS, Division of Aging and Community Services (DACS)
project accomplishments: retail f d il food
East Jersey State Prison, Rahway
The Project also works closely with the Department’s Communicable Disease Service d l S i and local h lth d l health departments i th coordination and i t t in the di ti d investigation of f d ti ti f food related outbreaks occurring in retail food establishments. 2008 Accomplishments In 2008, the Retail Food Project advanced the State’s Retail Food Protection activities conducted by both State and local health departments throughout New Jersey. Jersey These activities included: • Finalizing and disseminating the “Risk-based Inspection form,” a checklist aimed to standardize retail food inspections and focus inspectors on high risk areas; then formally requiring the use of it by State and local health departments for all retail food inspections. continued…
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project accomplishments: retail f d il food
• Providing risk-based inspection standardization training of State and local health department personnel. In 2008, three 2-day “Risk-based Inspection Standardization” workshops were provided (resulting in the training of approximately 110 REHS’s in this new inspection approach. • Despite the loss of two of its three “Retail Food Standardization” trainers who were hired by the FDA, the Project initiated the “field standardization training” of REHS’s from local health departments to certify them as “Retail Food Specialists.” In 2008 seven REHS’s from local health departments REHS’ f l l h lth d t t completed the field standardization program and were certified as “Retail Food Specialists.” Those “Retail Food Specialists” have agreed to train additional REHS’s from their own departments and neighboring health departments in this new inspection approach approach. Bill Manley, Retail Food Project • During 2008, approximately 950 retail food Leader, instructs participants inspections were conducted under the coordination during a recent workshop. of the Retail Food Project under our MOAs. • Several articles on various food safety issues including E. coli in hamburgers and introducing the Risk-based inspection approach “Hamburgers, Kids, and E.coli: prevention of E.coli infections by proper cooking of hamburgers served to children,” was published in the New Jersey Restaurant Association (NJRA) periodical Quality Hospitality Quarterly. The article is part of an ongoing campaign to prevent E.coli infections in E coli children 12 years of age and younger.
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project accomplishments: seafood and shellfish f d d h llfi h
Introduction Under the Seafood and Shellfish Project, wholesale shellfish dealers who handle, process, and ship shellfish are required to maintain sanitary conditions and retain documentation verifying that the shellfish were obtained from approved harvest areas. The surge in consumption of seafood and shellfish has led to a growth in the number of establishments requiring inspections. Inspectors routinely inspect all certified shellfish wholesalers (approx. 360 biannually, quarterly, and monthly as required) under strict, nationally recognized criteria known as the Model Ordinance and adopted by reference in the shellfish rule N.J.A.C. 8:13. 2008 Challenges and Issues The Project has experienced a significant loss of professional standardized inspectional staff that has disabled the necessary and required interval of seafood/shellfish inspections for the National Shellfish Sanitation Program (NSSP). The components identified in the staff reduction include the Shellfish Dealer Certification and Inspection Program The reduction of inspections of the shellfish Program. program component seriously jeopardizes the health of all consumers of New Jersey shellfish. The State of New Jersey would be in non-compliance with the guidelines of the NSSP. Compliance with the NSSP is a prerequisite for shipping shellfish in interstate commerce. 2008 Accomplishments p In 2008, the Project issued a firm-initiated voluntary recall. The cause of this action was two confirmed cases associated with Vibrio parahaemolyticus. Any observed implicated product was embargoed. The Project was in contact with the FDA and all receiving states. Harvesting from the affected waters was temporarily suspended until testing was conducted for Vibrio parahaemolyticus levels in oysters from the implicated oyster beds. In retrospect, to Project suspected temperature abuse had occurred during handling of product.
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project accomplishments: food d f f d defense and d emergency preparedness
Introduction The Food Defense Project coordinates the protection of New Jersey’s food supply from intentional adulteration based on Presidential Homeland Security Directives and the Bioterrorism Act of 2002, as well as other emergency situations such as floods and blackouts. This project is responsible for defining the Critical Infrastructure within the food sector disseminating and monitoring the sector, implementation of the Food Sector Best Practices, and providing training programs for industry and public health officials. This project also assists industry in conducting site-specific vulnerability assessments and development of emergency response plans. 2008 Accomplishments p Operation Food Distribution The FDSP continues to work with the New Jersey Office of Homeland Security and Preparedness, the New Jersey Office of Emergency Management, the New Jersey Food Policy Institute, and the New Jersey Food Council on Operation Food Distribution. Planning meetings continued in February 2008, which led to the development of a Memorandum of Agreement between the New Jersey Office of Homeland Security and Preparedness and the NJ Food Policy Institute to establish a food distribution plan for emergency situations. Part of this project involves the development of a GIS mapping system that includes census data, retail f d stores and di t ib ti center t il food t d distribution t locations, and shelter information. Additionally, the Project coordinated efforts to educate local health departments on pregnancy and responding to emergency situations. Other participants in this project include the NJ Department of Human Services, NJ Department of Agriculture, the U.S. Department of Agriculture, and representatives from private sector food companies.
continued…
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project accomplishments: food d f f d defense and d emergency preparedness
FDSP staff attended a tabletop exercise in Tinton Falls, NJ, covering the preparedness, response to, and recovery from a Category three hurricane strike to the coast of New Jersey in the Monmouth/Ocean County area. The scenario discussions for this tabletop exercise included food distribution issues and provided a mechanism for testing the Operation Food Distribution plans. Preparedness and Response to Agricultural Terrorism On October 28-30, 2008, Gloria Dougherty hosted a course entitled “Preparedness and Response to Agricultural Terrorism” at the Troop C Headquarters in Hamilton, New Jersey. The 32 course attendees included representatives from dairy and fresh produce manufacturing firms, regulatory representatives from State and local health departments, LINCS Coordinators, law enforcement, and the Federal Bureau of Investigation. The course was taught by a team of instructors from the B fI ti ti Th t ht b t fi t t f th National Center for Biological Research and Training and the University of Tennessee. The scenario used during this course involved the intentional adulteration of dairy products (ice cream) at the farm and processing plant levels. Attendees worked together to respond to and recover from the scenario using their current policies and procedures to identify gaps and additional needs in planning for these types of events events.
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Introduction This Project licenses and inspects in-state and licenses out-of-state wholesale milk, frozen dessert, bottled, and bulk water processors, and ensures that in-state juice processors adhere to the provisions of 21 CFR Part 120. The Project also regulates and inspects wholesale establishments which produce cheese products and inspects dairy farms which supply raw milk to Grade A Interstate Milk Shipper listed milk plants. The Project serves as the regulatory agency for ratings and enforcement of the Pasteurized Milk Ordinance (PMO), the nationally-adopted standard of sanitation regulations applicable to Grade A milk plants engaged in interstate commerce. Field staff inspects New Jersey’s milk plants quarterly and samples their products monthly. In-state and out-of-state bottled/bulk water processors and frozen dessert processors are required to be licensed. Juice processors are licensed as non-alcoholic beverage establishments and are required t h i d to have a validated Hazard Analysis and C iti l C t l P i t (HACCP) plan lid t d H dA l i d Critical Control Point l for pathogen reduction. In 2008, 50 bottled water brands were sampled and several were found to exceed secondary drinking water standards with two brands exceeding two different primary drinking water standards deemed to be injurious to health. The bottlers of both brands chose to implement treatment devices that successfully reduced the levels of the contaminants to within state standards. They ultimately received licenses to distribute in New Jersey. Aggressive enforcement of State and Jersey federal bottled water standards has greatly reduced the frequency of encountering noncompliant products.
project accomplishments: dairy, juice, dairy juice and bottled water
2008 Accomplishments • Completed 325 inspections of wholesale bottled water, dairy, frozen dessert, and juice processors • 732 samples were obtained and submitted for laboratory analysis • Embargoed or oversaw voluntary destruction of more than 1,961 gallons of bottled water and 6,486 pounds of fluid milk • Licensed 15 new water bottlers to sell in New Jersey, including 9 foreign bottlers • Investigated 14 dairy, bottled water, frozen dessert, and non-alcoholic beverage complaints • Identified 12 bottled water firms and 1 frozen dessert processing firm distributing their products in New Jersey without a license • Identified 23 occurrences of milk testing positive for antibiotics, totaling 977,596 pounds; oversaw the destruction of these products
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Introduction The Department requires registration of wholesale drug distributors that distribute drugs into NJ. In 2008, the Project issued 1,280 drug and medical device registrations to , , , p , manufacturers, distributors, re-labelers, re-packers, and brokers of wholesale prescription, and over-the-counter drugs. Additionally, 621drug verifications were completed. Amendments in the existing regulation, Food and Drugs, were adopted to strengthen the provisions as they relate to combating counterfeit and diverted drugs. The Project has been undergoing significant rule changes and amendments due to newly adopted legislation. The first of two rule amendments was completed in October 2006. The newly adopted rules are necessary to protect consumers from adulterated and misbranded foods, drugs, cosmetics, and medical devices. A thorough review of the Department’s current statutory authority was conducted to determine its adequacy to address emerging issues associated with recent practices of counterfeiting popular pharmaceuticals. Counterfeit pharmaceuticals drugs have become more prevalent partly because new technologies make it easy to fake prescription labeling and because the high price of drugs have fueled a demand for cheap supplies. 2008 On-going Investigations The New York Attorney Generals Office/USFDA Special Investigations contacted the Project regarding diversion activities of two drug companies. The two companies are in collusion with each other. The Project has initiated revocation of the registration of both companies. The FDA Office of Criminal Investigations informed the Project about a spa owner who pp products to a female customer. The customer then tested had distributed “supplement” p positive for controlled dangerous substances and lost her job. The product is marketed as “ Bio-Emagrecin,” or the Brazilian diet pill. Analysis of the sample obtained and analyzed by the FDA confirmed the existence of controlled dangerous substances. The Project initiated a full investigation of the spa, but it was out of business. An investigator from the FDA Office of Criminal Investigations informed the Project that 5 pharmaceutical companies registered with NJDHSS are all in concert with each other to gray market and money launder prescription drugs. Two companies still possess current registrations while two others have been expired since 2007 and are still operating. The fifth company forged the NJDHSS registration issued by the Project.
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project accomplishments: wholesale d h l l drug
major boards and councils
New Jersey Produce Safety Task Force Mr. Richard Ritota, NJDHSS representative membership Formed in January 2007, the Produce Safety Task Force is committed to improving the food safety of products grown and distributed throughout New Jersey. Members include NJDOA staff, farmers, Rutgers Cooperative Extension Food staff farmers Extension, Policy Institute, NJ Restaurant Association and the NJ Food Council. Mr. Ritota recommended that the NJ Food Processors Association or a large produce wholesaler be invited so the task force would have complete representation from farm to table. Another issue discussed was wholesale and licensure requirements. Discussion centered around raising voluntary standards at NJ farms and the problems associated with third party audits available for the farmers. farmers New Jersey Aquaculture Council Mr. Charles Kuperus, Secretary – NJDOA – Chairman Mr. Richard Ritota, NJDHSS representative Ms. Cali Alexander, NJDHSS alternative representative , p Major topics discussed by the Aquaculture Council in 2008 included: available grant monies from the USDA, issuance of lease bottom for oyster aquaculture in the Delaware Bay, and the need for more acres for clam aquaculture on the Atlantic coast. New Jersey Toxics in Biota Committee Mr. Richard Ritota, NJDHSS representing Commissioner Heather Howard Ms. Cali Alexander, NJDHSS representative Interagency committee consisting of NJDEP, NJDHSS and NJDOA. Committee members review all fish tissue analysis as it becomes available with each sampling round. Each sampling period typically involves a different body of water – marine and freshwater. The Committee agreed on changes in prepared recreational sport fish consumption advisories that will be disseminated to the public recreational and fishing community. Public hearings are held for annual or biennial changes to statewide and specific water body changes.
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major boards and councils
New Jersey Interstate Environmental Committee Mr. Richard Ritota (and James A. Brownlee as the alternate) representing Commissioner Heather Howard The mission of this Agency is to protect and enhance environmental quality through cooperation, regulation, cooperation regulation coordination and mutual dialog between government and citizens in the tri-State region (Connecticut, New York and New Jersey). The Commission receives funding from the above three states, the EPA and several grants. Activities for 2008 included ambient water quality monitoring, NYC solid waste disposal issues, air pollution issues and legal activities concerning the mitigation of negative effects of NYC’s operations at the Fresh Kills Landfill and addressing nitrogen impacts and combined sewer overflows of some NYC sewage treatment plants. Best Practices for Food Protection Committee William Manley, NJDHSS, Chair The Committee is comprised of representatives from DHSS, FDA, and local health departments. The focus was on refining the Risk-based Inspection Check Sheet and its corresponding instructions, to be presented at upcoming pre-standardization workshops. The workshops were offered to REHS from local health departments to introduce the risk-based inspection approach.
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education and outreach
NEW Food and Drug Safety Program Website
The new, user-friendly website will be organized by type of visitor. This simple and efficient format will help visitors focus more easily on materials that they are seeking. A colorful “Consumer Information Page” will offer consumers info about topics such as food allergies, organic foods, and food safety for seniors. Also, a new “Food Safety Education and Outreach” page will showcase the Program’s educational materials.
“Parts of a Food Label” And “What Every REHS Needs to Know About Food Labeling”
The 3-page poster and guide “Parts of a Food Label ” simplifies 3 page guide, Parts Label, 759 pages of food labeling regulation into a visual, educational tool to be used by REHS and small retailers. The power point “What Every REHS Needs to Know About Food Labeling” acts as a more detailed supplement that explains the poster/guide and addresses such topics as the FDA and USDA laws, Country of g g, p (i.e. cloning, irradiation). g, ) Origin Labeling, and hot topics (
E.Coli Prevention Poster for Restaurant Staff
This poster, created in partnership with the NJ Restaurant Association (NJRA), educates restaurant staff on how to prevent E.coli E coli infections in children 12 years of age and under The poster under. is part of an on-going E.coli prevention outreach campaign which also includes a press release sent out during September’s National Food Safety Education Month and an article in Quality Hospitality Quarterly, the NJRA quarterly newsletter.
“Keep Your Child s Smile Beautiful Keep Child’s Beautiful”
This educational brochure, for consumers who have children, informs parents about the risks of damage to children’s teeth from consuming soft drinks and sports drinks that have low pH levels. Though these drinks are legally permissible, they are not safe for children when consumed on a regular basis. This brochure is being distributed i b i di t ib t d in cooperation with th Child ' Preventive ti ith the Children's P ti Oral Health Education and Promotion Program.
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