Updates on Salmonella Linked to Tempeh and Pet Food and the Importance of Supplier Control

Here are updates for two ongoing outbreak investigations/recalls. Interestingly, both cases indicate the importance of supplier control – in the case of tempeh, it was an ingredient bought from an on-line supplier, and with the pet food, a co-packer has impacted other retail brands.
Salmonella in Tempeh (original post - http://pennstatefoodsafety.blogspot.com/2012/05/outbreak-of-salmonella-paratyphi-b-in.html)

The number of Salmonella cases associated with contaminated tempeh has increased to 63 according to the NC Department of Ag. In testing, it was found that the starter culture used was responsible for the contamination. The company who sold the starter culture was Tempeh Online, which one can guess is a small, web-based company. (If we think about Supplier Control – it can be difficult for one buying an important component on the web from a unknown entity, where there is limited opportunity to investigate the supplier. Starter culture is an ingredient that needs tight process control in that if the process is contaminated, that contaminate, in this case Salmonella, may grow right along with the designated culture, or can contaminate the culture through cross contamination if handling procedures are not good).

Salmonella-tainted culture shipped from Maryland company
 Test confirms tempeh salmonella source
 http://www.citizen-times.com/article/20120511/NEWS/305110037/Tainted-food-salmonella-outbreak-traced-Md-?odyssey=tab%7Ctopnews%7Ctext%7CFrontpage

Salmonella News Update 5/10/12
 http://buncombecounty.org/news_detail.aspx?newsID=12319
 On Thursday, May 10, Buncombe County Department of Health received final test results from the NC Department of Public Health laboratory confirming that the unopened bag of culture that was added to the tempeh tested positive for the matching strain of Salmonella Paratyphi B linked to the current disease outbreak.
The US Food and Drug Administration is already involved in tracing the origin of the ingredient to identify source of contamination as well as the potential for other Salmonella outbreaks in the US.
As of May 10 at 2 PM, Buncombe County Department of Health reports 58 cases associated with salmonella outbreak. Please keep in mind that this number does not include cases being reported in other counties or states.
NC Department of Public Health reports 63 cases, which includes cases in NC and other states; however there is a slight delay in reporting.
To listen to information, call the HOTLINE: 828.250.5300 (English, Spanish and Russian).
 To report symptoms of Salmonella Paratyphi B, call Communicable Disease Nurses: 828.250.5109.

Pet Food and Salmonella (Original Post - http://pennstatefoodsafety.blogspot.com/2012/05/diamond-pet-foods-linked-to-salmonella.html)

As of 5/11/12,CDC reports there are now 16 related illnesses.
http://www.cdc.gov/salmonella/dog-food-05-12/index.html

A total of 15 individuals infected with the outbreak strain of Salmonella Infantis have been reported from 9 states. Additionally, one ill person has been reported from Canada.

• The number of ill persons identified in each state is as follows: Alabama (1), Connecticut (1), Michigan (1), Missouri (3), North Carolina (3), New Jersey (1), Ohio (2), Pennsylvania (2), and Virginia (1). One new ill person was reported from Pennsylvania.
• Among the 10 patients with available information, 5 (50%) were hospitalized. No deaths have been reported
• Multiple brands of dry dog food produced by Diamond Pet Foods at a single manufacturing facility in South Carolina have been linked to some of the human Salmonella infections.

The FDA news releases state that additional companies are recalling product made by Diamond Pet Food. The pet food has been linked to 14 cases of Salmonella. Companies that use Diamond to co-pack product must now react in the event that their product to may be linked to Diamond. Here again, another supplier control issue. Co-packing is an important part of the food supply chain. Many retailer branded products are produced by co-packers and must rely on these companies food safety systems. If there is an issue with co-packer produced product, and it may be a different brand such as in this case, it may result in a major blow to the retailer’s brand as well. 

From the FDA Recall notice.

http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm302904.htm
 http://www.cdc.gov/salmonella/dog-food-05-12/index.html

May 9, 2012
Diamond Pet Foods has expanded its recall of some brands of dry dog and cat food manufactured in its Gaston, South Carolina facility between December 9, 2011 and April 7, 2012 because it has the potential to be contaminated with Salmonella.

The FDA, CDC and state and local officials are collaborating to investigate cases of human illness linked to some brands of dry pet food produced by Diamond Pet Foods at the South Carolina facility.
Consumers should check the company’s website, Diamond Pet Foods Recall Information6 , for information on how to read lot codes and “best by” dates involved in the recall, as well as specific states where the following products were distributed:

· Chicken Soup for the Pet Lover’s Soul
· Country Value
· Diamond
· Diamond Naturals
· Premium Edge
· Professional
· 4Health
· Taste of the Wild
· Apex (distributed only in the state of South Carolina)
· Kirkland Signature (Costco)
· Kirkland Signature Nature’s Domain (Costco)
· Canidae
Several other companies with products manufactured at the Gaston, S.C. facility have issued voluntary recalls, since some of their products were produced at the Gaston facility during the time frame of the recalls and have the potential to be contaminated with Salmonella. Those companies include:
Dick Van Patten's Natural Balance7
Apex Pet Foods8
Canidae9, Wellpet LLC10
Solid Gold Health Products for Pets11

Diamond Pet Foods continues to work directly with distributors and retailers where the recalled products are carried to remove them as quickly as possible from the marketplace. FDA will provide updates on the recall and the investigation as new information becomes available. Complete information on the recalled products, including photos, lot numbers, and distribution information on each is located at Diamond Pet Foods Recall Information.

Reusable grocery bag responsible for transferring norovirus in Oregan outbreak

A reusable grocery bag was found to be the carrier of norovirus that was responsible for girls on an Oregon soccer team getting ill. Investigators conducted tests on the bag and found norovirus on the sides of the bag, below the handle.

Reusable grocery bags have increased in usage as people look try to become more ‘green’. It is important however, that these bags be recognized as a potential source of contamination. Much concern with reusable grocery bags is usually directed to the potential contamination from raw meats (purge from raw meats dripping onto the bags, carrying potential pathogens such as Salmonella or STEC E. coli along with it). Thus it is important to wash afterward. In this case however, a sick individual transferred norovirus to the bag and then the norovirus was transferred from the bag to other individuals who became ill. 

Norovirus has a low infectious dose (it does not take a lot of viral particles to make one ill) and is relatively resistant to normal environmental conditions (it has been shown to survive for weeks on carpets, so it probably would be the same with grocery bags). Typical symptoms of norvirus infections are vomiting (acute onset) diarrhea and stomach cramps.  Symptoms can occur within 18 to 48 hours of exposure.



Oregon norovirus traced to reusable grocery bagUSA Today 5/10/12
http://www.usatoday.com/news/health/story/2012-05-10/Oregon-norovirus-grocery-bags/54874814/1?csp=34news

PORTLAND, Ore. (AP)–Oregon investigators have traced an outbreak of norovirus to a reusable grocery bag that members of a Beaverton girls' soccer team passed around when they shared cookies.

The soccer team of 13- and 14-year-olds traveled to Seattle for a weekend tournament in October 2010.

Diamond Pet Foods Linked to Salmonella Outbreak

For Update (http://pennstatefoodsafety.blogspot.com/2012/05/updates-on-salmonella-linked-to-tempeh.html)

CDC reports that there are 14 cases of Salmonella linked to dry dog food produced by Diamond Pet Foods. People become ill from handling the pet food itself and from interaction with the pet who ate the food (yes, and there are probably a few people who may take a little bite themselves).

From the CDC information, it appears that cases could have been seen as early as late 2011, but cases have been coming in sporadically over a 5 or 6 month period. FDA released the first recall notice by Diamond on April 6, (http://www.fda.gov/Safety/Recalls/ucm299606.htm) but indicated no illnesses were reported. Diamond expanded the recall again on April 26th (http://www.fda.gov/Safety/Recalls/ucm302137.htm) and again on April 30th (http://www.fda.gov/Safety/Recalls/ucm302514.htm) to include puppy formula, but in both recall notices did not indicate whether people were affected. Much of this delay is probably related to the low level of cases that occurred over the last 5 months in that connecting illnesses to a product becomes difficult. Couple that with the slow movement of pet food from manufacture to store shelf to purchase to use and to illness. The company started the recall when they got test results back from Michigan Department of Ag , but that expanded the recall as Ohio Dept of Health found Salmonella in product during an illness investigation.  It appears then that CDC had sufficient information to link illnesses with product.

From past incidents with Salmonella in dry dog food such as the Mars Pet Foods in 2008, Salmonella can establish itself in pet food plants and be very difficult to eliminate. This Mars facility that was linked to the Salmonella outbreak was eventually shuttered. If one had to determine how this occurs, Salmonella comes in on the raw materials, and ross contaminates (through air movement via dust particles, personnel movement, etc) the post process side or finished product side of the operation (after the heating step known as extrusion). Once there, Salmonella can make its way into the nooks and crannies and slowly be released into the final product. This can be seen in the Diamond Pet Foods case because there is not just one product implicated, but rather a number of products.

If consumers have Diamond Pet Foods, they should cease use and return to store or dispose.  

Multistate Outbreak of Human Salmonella Infantis Infections Linked to Dry Dog Food
CDC News Release Posted May 3, 2012 5:15 PM ET
http://www.cdc.gov/salmonella/dog-food-05-12/index.html

· A total of 14 individuals infected with the outbreak strain of Salmonella Infantis have been reported from 9 states.

· The number of ill persons identified in each state is as follows: Alabama (1), Connecticut (1), Michigan (1), Missouri (3), North Carolina (3), New Jersey (1), Ohio (2), Pennsylvania (1), and Virginia (1).
· Among the 9 patients with available information, 5 (56%) were hospitalized. No deaths have been reported.
· Multiple brands of dry pet food produced by Diamond Pet Foods at a single manufacturing facility in South Carolina have been linked to some of the human Salmonella infections.
· Consumers should check their homes for recalled dog food products and discard them promptly. People who think they might have become ill after contact with dry pet food or with an animal that has eaten dry pet food should consult their health care providers.

Has Artisanal Become the New Natural for Food Products?

In an article by Jillian Eugenios, she asks the question, “Does ‘artisanal’ even mean anything anymore?”. (http://bites.today.msnbc.msn.com/_news/2012/05/02/11503731-does-artisanal-even-mean-anything-anymore). It is in reference to a lawsuit filed against Dunkin Donuts and their new ‘artisan’ line of bagels. The lawsuit claims that this term should be limited to “products produced by hand, using traditional methods in small quantities”. My guess is that each Dunkin Donuts shop is not hand making bagels in the back of the store.

However, if I indeed want bagels made by hand in small batches, I will go to a family owned bakery. The term ‘artisinal’ in of itself, will not drive my purchase. My other guess is that the DD ‘artisanal’ bagels are probably pretty good. And if they were called by another name, say ‘really good bagels’ , they would still be pretty good bagels, regardless of the name.

And who is to decide what is ‘artisinal’? If a chain of family owned bagel shops makes bagels in the back of each store, can they call that artisanal? What if they centralize production to reduce costs and improve quality by making these same bagels in one location and then distributing them to the other shops…is this still ‘artisinal’? We have the same issue with term ‘organic’, and there are actually federal rules on what is considered, ‘organic’.

At this point, ‘artisanal’ is destined to become the new ‘natural’, or the new ‘gourmet’. We probably should spend more time on finding that quality product we like, or establishments we choose to buy from, rather than on what we call it.

Outbreak of Salmonella paratyphi B linked to Organic Tempeh

For Update (http://pennstatefoodsafety.blogspot.com/2012/05/updates-on-salmonella-linked-to-tempeh.html)

A North Carolina company, Smiling Hara Tempeh, is recalling unpasteurized Tempeh (fermented bean product) which has tested positive for Salmonella and linked to at least 34 cases of salmonellosis. The company has taken complete responsibility for this outbreak, and is recalling the product.  The product was produced in a shared commerical kitchen of a food incubator.

I think this case shows that no matter the size of the company, or the image they have (see website excerpt below), there is the potential for foodborne illness if all necessary preventive measures are not enacted. Too often, companies that are local, or that claim organic status, or that process foods in a traditional way consider themselves as being inherently safer than larger or conventional companies. Many consumers believe this as well. Salmonella does not read the internet, nor does it care about where those food products are made. If there is an opening, whether it is a processing error, less than hygienic personnel pracitces, or contaminated raw materials, Salmonella will simply take advantage of it.

The strain responsible for this illness was Salmonella paratyphi B which causes an illness similar to Typhoid Fever. It is a very serious infection with symptoms that include a high, sustained fever, headache, diarrhea, abdominal pain, and enlarged liver or spleen. Symptoms can last up to a week or longer, and patients are usually treated with antibiotics. There is also a longer incubation period (time of consumption to the time symptoms are seen) of 7 to 14 days or longer. (Because of this, there may be additional cases.)

Some people eat tempeh raw, but it is normally cooked, often through frying cubes cut from the block.   One would expect the cause to be either cross contamination (raw product contaminating clean surface or other food item) or through undercooking of the product.

Excerpt from Smiling Hara Tempeh website:
http://www.smilingharatempeh.com/
Smiling Hara(meaning “happy belly”) was created in 2009 and spawned from a passion to provide Western North Carolina with an organic, GMO-free, UNpasteurized, local source of Tempeh. We are committed to providing the most nutritious and fresh Tempeh possible, giving our customers the healthiest option and at the same time providing a market for local, organic farmers. We have developed a unique line of Tempehs, including not only the traditional soy Tempeh, but also a variety of legumes such as Black Bean and Black-Eyed Peas! We produce our Tempeh fresh every week right here in Asheville, NC.
Whether you are vegan, vegetarian, pescatarian, or omnivorous, do your body a favor and incorporate local, unpasteurized Tempeh into your regular diet.
 A Intro to Tempeh From Wikipedia

Tempeh (English pronunciation: /ˈtɛmpeɪ/; Javanese: témpé, IPA: [tempe]), is a traditional soy product originally from Indonesia. It is made by a natural culturing and controlled fermentation process that binds soybeans into a cake form, similar to a very firm vegetarian burger patty.

Tempeh begins with whole soybeans, which are softened by soaking and dehulled, then partly cooked. Specialty tempehs may be made from other types of beans, wheat, or may include a mixture of beans and whole grains.

A mild acidulent, usually vinegar, may be added in order to lower the pH and create a selective environment that favors the growth of the tempeh mold over competitors. A fermentation starter containing the spores of fungus Rhizopus oligosporus is mixed in. The beans are spread into a thin layer and are allowed to ferment for 24 to 36 hours at a temperature around 30 °C (86 °F). In good tempeh, the beans are knitted together by a mat of white mycelia.
 Salmonella traced to Asheville tempeh
Tests confirm bacteria in Smiling Hara product as outbreak worsenshttp://www.citizen-times.com/article/20120501/NEWS/305010037/Salmonella-traced-area-tempeh?odyssey=tab%7Ctopnews%7Ctext%7CFrontpage
10:08 PM, Apr. 30, 2012
Joel Burgess Citizen-Times.com

ASHEVILLE — A local maker of fermented bean product confirmed Monday evening that its product tested positive for salmonella. as an outbreak caused by the bacteria worsens.

Smiling Hara Tempeh, which makes a soy, black bean and black-eyed pea version of the product, according to its website, had pulled the food from shelves earlier Monday.

Tests by the N.C. Department of Agriculture confirmed the bacteria was present in a sample collected from a routine inspection by the Food and Drug Protection Division, according to a statement from Smiling Hara Tempeh. Further testing is being done, it added.

FSIS issues verification testing for Non O157 STECs

FSIS has just issued the Verification Testing for Non-O157 STEC for Beef Trimmings. While this new wrinkle in the E. coli-Beef trim issue has caused a lot of concern, the anticipated outcome may not come anywhere close to the hype.  

Domestic product http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/29-12.pdf
Imported http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/30-12.pdf

Background - On June 4th, FSIS will begin testing for six non-0157 serogroups (O26, O45, O103, O111, O121, and O145) in addition to O157:H7. Like E. coli O157:H7, these E. coli serogroups are viewed as adulterants in non-intact raw beef products and product components (raw ground beef and beef trim).

A few interesting notes:
1) FSIS does not expect establishments to reassess their HACCP plans because of this testing implementation. (Facilities should address non-O157 STEC in their Hazard Analysis.)

2) FSIS will not schedule a for-cause FSA in response to a non-O157 positive sample result. Outside of that, FSIS will follow Directive 10,010.3 Rev 3 including resampling. (And corrective action for positive product, which will include holding and dispositioning of positive product). http://www.fsis.usda.gov/OPPDE/rdad/FSISDirectives/10010.1Rev3.pdf

3) “FSIS recognizes that establishments will begin taking steps to address non-O157 STECs in their HACCP systems and performing activities to gather data to validate that their food safety systems are adequately designed to control non-O157 STECs. Establishments are to document and identify in their initial validation activity plans the time frame in which they will have accumulated sufficient data to conclude that their food safety systems are demonstrated to be adequate to control for the relevant non-O157 STECs”.

4) FSIS will not require establishments to adjust their existing testing programs for non-O157 STEC.

5) A confirmed positive is an isolate that has stx and eae genes and one or more of the target serogroup genes (O45, O26, O113, etc.). A positive is not just a positive for the genes, but the bacterium must be isolated and biochemically confirmed, so establishments should be prepared to deal with false positives.

FDA's Reportable Food Registry Report Provides Important Insight into Food Supply Issues

The FDA just released the second annual report for the Reportable Food Registry, RFR.

http://www.fda.gov/Food/FoodSafety/FoodSafetyPrograms/RFR/ucm200958.htm?source=govdelivery

The Reportable Food Registry is an electronic portal where food companies report issues with a food where that food is likely to cause illness. So if Company A ships nuts to Company B, and Company B tests those nuts and finds Salmonella, then by law, Company B must report this incident to the FDA via the Reportable Food Registry.

This has been a great tool in keeping unsafe food out of commerce. It allows FDA to use industry information to police the food supply chain.

Industry professions can see an important aspect of this RFR report is that it indicates where in the food system issues have occurred. Accordingly, companies who purchase products can look at this list and find issues with products or ingredients they use and then ensure these items are addressed through HACCP or a supplier control program. Here are some examples (Table 6) – undeclared allergens in bakery products, Salmonella in nuts, spices/seasonings, and produce, Listeria in prepared foods and dairy. Reports on Imported foods (Table 13) shows a slight increase from year 1 to 2 in total recalls, but certainly an increase in the number of Salmonella related issues coming in on imported foods. 

It is also important to note that the RFR can put companies at risk of being pulled into a recall. This was the case last year when Salmonella was discovered in hydrolyzed vegetable protein. And even with companies whose process rendered the ingredient as no risk (these companies were going to put the HVP into a product that was to be cooked), they still recalled product. Traceability is paramount in being able to quickly respond to a supplier issue that gets reported to FDA by another company.

Case of BSE, or Mad Cow, found in California

A cow in California was diagnosed with BSE, or Mad Cow. This is the fourth documented case of BSE in a cow in the US.

It poses no real risk to the US food supply.

The cow, more than 30 months old of age, had died and was to be rendered. Because the cow died, it was tested for BSE. Analysis resulted in what is being called an atypical case, and thus is believed to have occurred spontaneously through a mutation.

BSE is a neurological disease causing brain and spinal cord degeneration. It is caused by a prion which is misfolded protein, that aggregates in the brain to form plagues. These prions can arise in animals that have a specific gene variant, and then this disease can be transmitted to other animals that come in contact with infected tissue of the diseased animal. This transmission occurs because the infectious prion causes a protein in the normal animal’s brain to deform into the infectious state.

BSE in cows has been a problem in the past when animal byproducts were used to supplement animal feed. In the UK more than 180,000 cows may have been infected (starting in 1986) and resulted in as many as 165 people dying within 10 years afterward (up to 2009). In humans, the CJD variant can occur when people consume infected tissue.  

The practice of feeding animal by-products to ruminants is banned in the United States. Additionally, the US has an active monitoring system for all suspect animals and older animals as well as controls for the removal of SRMs (specific risk materials), including spinal and brain tissue, during slaughter.


New case of mad cow disease in California

http://www.philly.com/philly/health/20120424_ap_newcaseofmadcowdiseaseincalifornia.html?page=2&c=y
SAM HANANEL and LAURAN NEERGAARD
The Associated Press
WASHINGTON - The first new case of mad cow disease in the U.S. since 2006 has been discovered in a dairy cow in California, but health authorities said Tuesday the animal never was a threat to the nation's food supply.

The infected cow, the fourth ever discovered in the U.S., was found as part of an Agriculture Department surveillance program that tests about 40,000 cows a year for the fatal brain disease.

No meat from the cow was bound for the food supply, said John Clifford, the department's chief veterinary officer.

"There is really no cause for alarm here with regard to this animal," Clifford told reporters at a hastily convened news conference.
Mad cow disease, or bovine spongiform encephalopathy (BSE), is fatal to cows and can cause a fatal human brain disease in people who eat tainted beef. The World Health Organization has said that tests show that humans cannot be infected by drinking milk from BSE-infected animals.

Update - Salmonella linked to tuna used in sushi

Update 5/3/12
CDC reports that there is now close to 260 people infected with two different strains of Salmonella.

CDC Release 5/2/12
http://www.cdc.gov/salmonella/bareilly-04-12/index.html

Based on an epidemiologic link and results of laboratory testing, CDC has combined this Salmonella Bareilly investigation with an ongoing multistate outbreak investigation of Salmonella serotype Nchanga infections. The two associated PFGE patterns have been grouped together as the "outbreak strains."

A total of 258 persons infected with the outbreak strains of Salmonella Bareilly (247 persons) or Salmonella Nchanga (11 persons) have been reported from 24 states and the District of Columbia.

• 32 ill persons have been hospitalized, and no deaths have been reported.

4/17/12
According to the CDC, the Salmonella Bareilly that caused close to 150 illnesses has been linked to tuna used in sushi. The raw tuna served was frozen, but of course, was not cooked. While freezing will eliminate parasites, it will not eliminate Salmonella. The majority of tuna linked to this outbreak was from India. The US importer, Moon Marine, has begun recalling close to 59,000 lbs of tuna.

When producing a ready-to-eat food such as sushi grade tuna, the highest degree of sanitation and operating cleanliness must be maintained. This requires that the producer maintain tight production controls and procedures each and every day. This tuna meat, or tuna scrape, is a lower grade product and is essentially meat that was scrapped from the backbone of the tuna and had the look of a ground product.

A lawsuit has already been filed against the importer.  As an importer, they have the responsibility for ensuring the processing plants they purchase from have adequate quality and safety systems in place.

Multistate Outbreak of Salmonella Bareilly Infections Associated with a Raw Scraped Ground Tuna Product
http://www.cdc.gov/salmonella/bareilly-04-12/index.html
CDC Release  4/17/2012

A total of 141 persons infected with the outbreak strain of Salmonella Bareilly have been reported from 20 states and the District of Columbia.
The number of ill persons identified in each state is as follows: Alabama (2), Arkansas (1), Connecticut (6), District of Columbia (2), Florida (1), Georgia (6), Illinois (13), Louisiana (3), Maryland (14), Massachusetts (9), Mississippi (2), Missouri (4), New Jersey (8), New York (28), North Carolina (2), Pennsylvania (6), Rhode Island (5), South Carolina (3), Texas (4), Virginia (8), and Wisconsin (14).  21 ill persons have been hospitalized, and no deaths have been reported.

Collaborative investigation efforts of state, local, and federal public health agencies indicate that a frozen raw yellowfin tuna product, known as Nakaochi Scrape, from Moon Marine USA Corporation is the likely source of this outbreak of Salmonella Bareilly infections. Nakaochi Scrape is tuna backmeat that is scraped from the bones of tuna and may be used in sushi, sashimi, ceviche, and similar dishes. The product looks like raw ground tuna. 

Consumers should not eat the recalled product, and retailers should not serve the recalled raw Nakaochi Scrape tuna product from Moon Marine USA Corporation.
This investigation is ongoing. CDC and state and local public health partners are continuing surveillance to identify new cases.

U.S. NEWS  WSJ
Updated April 16, 2012, 6:48 p.m. ET
Tuna Blamed in Salmonella Outbreak Is Recalled
By BILL TOMSON WSJ 4/15/12
http://online.wsj.com/article/SB10001424052702304299304577348030392954406.html?mod=googlenews_wsj

The Food and Drug Administration said Monday a California supplier of raw tuna used in sushi was behind a salmonella outbreak that has sickened more than 100 people in 20 states.
Moon Marine USA Corp. in Cupertino, Calif., has begun recalling 58,828 pounds of raw yellowfin tuna because it may be contaminated, the FDA said. Many of the people who became ill reported eating an item known as spicy tuna, the agency said, and most of the illnesses occurred in New York.