This document summarizes a presentation by Ronald W. Brown on the Genetic Information Nondiscrimination Act (GINA). It discusses how GINA prohibits employment discrimination based on genetic information. It provides a hypothetical case study involving an employee named Carol who fears discrimination due to her risk of Huntington's disease. It then analyzes the case based on GINA's protections and requirements. Additional topics covered include direct-to-consumer genetic testing, GINA enforcement, and steps employers must take to comply with GINA.

1. AMERICAN ASSOCIATION FOR AFFIRMATIVE ACTION In partnership with New Jersey Affirmative Action Officers’ Council (NJAAOC) Access, Equity and Diversity Summit The Atlantic City Convention Center A PRESENTATION BY RONALD W. BROWN, ESQ.

2. Presentation by Ronald W. Brown, Esq. Recent Legal Developments: A Presentation on the Genetic Information Non-Discrimination Act

3. AN OVERVIEW OF THE GENETIC INFORMATION NONDISCRIMINATION ACT Presentation by Ronald W. Brown, Esq.

4. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO While on break at a work water cooler, Carol tells her coworker Bob about the battle her mom is having with Huntington’s disease. Carol tells Bob that “Huntington’s disease is a progressive, degenerative disease” that causes certain nerve cells in the brain to waste away. As a result,” a person may experience uncontrolled movements, emotional disturbances and mental deterioration.” Carol tells Bob that she fears she is at risk for this genetic disease and that she periodically uses in the rest room at work, a Direct To Consumer testing kit she purchased over the Internet. Presentation by Ronald W. Brown, Esq.

5. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO continued Carol’s supervisor, Ted, walks by and overhears the conversation. Carol becomes concerned that she may be treated differently by Ted or fired due to her risk for developing HD. Carol starts reading about the disease during her lunch time at work. Presentation by Ronald W. Brown, Esq.

6. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO continued Presentation by Ronald W. Brown, Esq. Carol starts using “sick days” in order to take her mom to the doctor. At her annual performance review, Ted gives Carol numbers that are so low they will preclude her qualifying for the promotion she wanted and would otherwise get. Carol had always had stellar reviews in the past. When Carol asks Ted about the numbers, Ted tells her “Carol, you are no longer a team player. Whenever I really need you here working you are out sick.” He also says, “Carol, you are not as mentally sharp as you used to be. You seem to be emotionally disturbed and deteriorating mentally. What’s wrong with you?”

7. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO #1 continued Furious, Carol leaves the performance review, goes back to her cubicle. Saying “He does not know who he is messing with!”, she proceeds to put up two posters. One reads” Power to the People”. Every time she passes it she starts chanting: “United, the people, can never be defeated!” The other is A Genetic Bill of Rights poster that reads “All People Have The Right To Be Free From Genetic Discrimination.” Presentation by Ronald W. Brown, Esq.

8. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO #1 continued Carol also starts coming to work wearing Jeans for Genes with a button that reads “How my jeans fit or my genes behave is none of this company’s business!” Presentation by Ronald W. Brown, Esq. Carol comes to you as EEO-AA officer to file a G.I.N.A. claim. What do you do?

9. Four Answers to the Question: What Do You Do? 1. If you need it, ask for help from functional “superheroes” with SME, e.g. legal, medical, etc. . 2. Familiarize yourself with what G.I.N.A. is, what it covers, and what it does not cover. 3. Determine if you need to adapt your normal investigative procedures to fit G.I.N.A. Presentation by Ronald W. Brown, Esq. 4. Focus on answering at least the following two important questions.

10. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’s disease? Q2. If Carol needs to take a leave under FMLA to care for her mom, can the employer use the information on the forms to discriminate against Carol?” Presentation by Ronald W. Brown, Esq.

11. G.I.N.A. Title I Title II Prohibits discrimination in health coverage based on genetic information. Prohibits discrimination in employment based on genetic information. Presentation by Ronald W. Brown, Esq.

13. The Use and Misuse of Genes and Genetic Information Have Popped Up In A Variety of Older Sci-Fi and Film Contexts Presentation by Ronald W. Brown, Esq.

14. Genetic Testing Issues Have Popped Up In A More Recent Film Context “Officially they are called ‘In-valids’…They are the ‘healthy ill’. They don’t actually have anything yet—they may never have. But since few of the pre-conditions can be cured or reversed, it is easier to treat them as if they were already sick.” Pre-G.I.N.A.? Presentation by Ronald W. Brown, Esq.

15. Genetic Testing Issues Have Popped Up In A Variety of Contexts: Major League Baseball In July, 2009, Major League Baseball used DNA testing to determine if Miguel Sano, a prospect from the Dominican Republic, was really 16 years old. MLB said that testing in the Dominican Republic is used“ in very rare instances and only on a consensual basis to deal with the identity fraud problem that the league faces in that country.” The statement added that the results of the tests were not used for any other purpose. Presentation by Ronald W. Brown, Esq. Also in July 2009, the New York Yankees voided the signing of an amateur from the Dominican Republic after a DNA test conducted by Major League Baseball’s department of investigations showed that the player had misrepresented his identity.

16. G.I.N.A. In A Nutshell The law forbids discrimination on the basis of genetic information when it comes to any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. Genetic information includes information about an individual’s genetic tests and the genetic tests of an individual’s family members, as well as information about any disease, disorder, or condition of an individual’s family members (i.e. an individual’s family medical history). “An employer may never use genetic information to make an employment decision because genetic information doesn’t tell the employer anything about someone’s current ability to work.” Presentation by Ronald W. Brown, Esq.

17. G.I.N.A In A Nutshell Title II of G.I.N.A. prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information. Presentation by Ronald W. Brown, Esq.

18. G.I.N.A. IN A Nutshell—What Is and What Is Not A Genetic Test? “Genetic test” refers to “analysis of human DNA, RNA, chromosomes, proteins, or metabolites that detects genotypes, mutations, or chromosomal changes.” “Tests to determine whether an individual carries the genetic variant evidencing a predisposition to breast cancer, colorectal cancer are genetic tests.” “Tests for infectious and communicable diseases that may be transmitted through food handling, complete blood counts, cholesterol tests, and liver-function tests are not genetic tests.” Presentation by Ronald W. Brown, Esq.

19. G.I.N.A. IN A NUTSHELL Information about race and ethnicity that is not derived from a genetic test is not “genetic information” for purposes of GINA. Presentation by Ronald W. Brown, Esq.

20. Gene Testing and State Intervention Overall, 24 states prohibit or limit so-called direct access testing without a doctor or other medical professional’s involvement”—Forbes Presentation by Ronald W. Brown, Esq.

21. Gene Testing and State Intervention “New York State’s Department of Health sent letters raising the specter of fines and jail time to six online gene-testing firms that offer consumers the ability to pear into their genome to assess the risk of getting disease. Often, it turns out, the services offering these DNA deep-dives are doing so without the involvement of a doctor. That puts them on the wrong side of the law.”--Forbes Presentation by Ronald W. Brown, Esq.

22. Gene Testing and State Intervention “California’s Department of Public Health sent cease-and-desist letters to 13 companies that offer gene testing to consumers via the Web. California law requires that a licensed physician order any lab tests, including genetic tests, All lab tests must also be validated for accuracy and medical utility. These businesses are apparently operating without a clinical laboratory license in California. And they are scaring a lot of people to death.”--Forbes Presentation by Ronald W. Brown, Esq.

23. Genetic Testing Legislation : There Are A Number of State Proposals G.I.N.A. sets a floor, not a ceiling. States can go beyond G.I.N.A ., and some states are proposing legislation doing just that. Presentation by Ronald W. Brown, Esq.

24. The Legislative Landscape:Proposed Laws--Massachusetts The Massachusetts Genetic Bill of Rights, (“MAGBR”)introduced on 1/21/11 seeks “to place genetic information on a par with medical records” MAGBR declares GI “to be the exclusive property of the individual from whom the information was obtained” and prohibits use of GI for marketing or determining creditworthiness.” Presentation by Ronald W. Brown, Esq.

25. The Legislative Landscape: Proposed Laws--California SB 559 seeks to “expand the bases upon which discrimination is prohibited” under California law to include genetic information. Provides that California has a “compelling public interest in” both “realizing the medical promise of genetics” and “relieving the fear of discrimination and in prohibiting its actual practice.” Would prohibit discrimination based on genetic information “in the areas of housing, employment, education, public accommodations, health insurance coverage, life insurance coverage, mortgage lending and elections,”

27. Genetic Testing and the Direct To Consumer Market Today Direct-to-consumer (DTC) genetic tests are available from retailers and the Internet. DTC is rapidly expanding market. There are now some 1,300 things you can be genetically tested for – including a genetic susceptibility to cystic fibrosis, muscular dystrophy, hemophilia, Huntington's chorea, sickle cell disease, multiple sclerosis, Cohn's disease, breast cancer, diabetes, heart disease and Alzheimer's. Presentation by Ronald W. Brown, Esq.

28. Presentation by Ronald W. Brown, Esq.

29. The Food and Drug Administration In March 2011, the FDA’s Molecular and Clinical Genetics Advisory Panel recommended that “Certain types of genetic tests that are available for at-home use without a prescription should not be used without the involvement of a physician or genetic specialist . The panel wasn’t clear on whether that would mean a physician would have to order the test, or if a physician would have to interpret the test, or both. That will ultimately be up to the FDA to decide.” http://abcnews.go.com March 12, 2011. Presentation by Ronald W. Brown, Esq.

30. Three Upshots from the Growth in Genetic Testing in the DTC Market #1. A lot more information is going to be available to users of the tests. Presentation by Ronald W. Brown, Esq.

31. Upshot from the Growth in Genetic Testing in the DTC Market #2. The meaning of DTC genetic test results may be misinterpreted. (False Negatives and False Positives) Presentation by Ronald W. Brown, Esq.

32. Upshot from the Growth in Genetic Testing in the DTC Market #3. Users of the test may tell someone their test results at work. That information could be overheard, and misused. Presentation by Ronald W. Brown, Esq.

33. G.I.N.A. IN THE WORKPLACE: CASE SCENARIO Q1. Can Carol be fired or denied a promotion due to her risk of Huntington’s disease? Q2. If Carol needs to take a leave under FMLA to care for her mom, can the employer use the information on the forms to discriminate against Carol?” Presentation by Ronald W. Brown, Esq.

34. Answers To The Case Study No, Carol can not be fired or denied a promotion due to her risk of Huntington’s disease. No, the employer can not use information on a FMLA form to discrimination against Carol. Case and answers from the Genetics and Public Policy Center website Presentation by Ronald W. Brown, Esq.

35. Answers To The Case Study “GINA indicates when an employer can legally have genetic information about an employee. Two examples: (1) An employer accidentally becomes aware (overhearing a conversation); (2) When an employee provides information for family and medical leave.” “When an employer has genetic information, the employer can not use it to discriminate against an employee, and the information must be kept in a separate and confidential file.” Case and answers from the Genetics and Public Policy Center website Presentation by Ronald W. Brown, Esq.

36. FINAL REGULATIONS UNDER G.I.N.A.—THE WATER COOLER EXCEPTION The `water cooler problem' arises when an employer unwittingly receives otherwise prohibited genetic information in the form of family medical history through casual conversations with an employee” or by overhearing conversations among co-workers. Congress did not want casual conversation among co-workers regarding health to trigger federal litigation whenever someone mentioned something that might constitute protected family medical history. Presentation by Ronald W. Brown, Esq. The Commission's proposed regulation therefore noted that a covered entity “inadvertently acquires family medical history” where a manager or supervisor overhears a conversation among co-workers that includes information about family medical history (e.g., a conversation in which one employee tells another that her father has Alzheimer's disease or her mother has Huntington’s disease).

37. THE SAFE HARBOR PROVISION “The Equal Employment Opportunity Commission included a safe harbor for information accidently received as part of a request for documentation to support requests for reasonable accommodation or FMLA requests.” Presentation by Ronald W. Brown, Esq.

38. THE SAFE HARBOR PROVISION However, “in order for the safe harbor to apply, requests for information from healthcare providers must clearly warn the healthcare provider that requests for health information should notinclude genetic information. “ Presentation by Ronald W. Brown, Esq.

39. SAMPLE LANGUAGE A COVERED ENTITY MIGHT USE TO PROVIDE THE NOTICE THAT WOULD BRING IT WITHIN THE SAFE HARBOR ‘‘The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of employees or their family members. In order to comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. ‘Genetic information,’ as defined by GINA, includes an individual’s family medical history, the results of an individual’s or family member’s genetic tests, the fact that an individual or an individual’s family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual’s family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.’’ Presentation by Ronald W. Brown, Esq.

40. EEOC FINAL REGULATIONS UNDER G.I.N.A. EFFECTIVE JANUARY 10, 2011—”REQUESTING” INFOMATION An employer who does the following would be in violation of GINA: “conducting an Internet search on an individual in a way that is likely to result in a covered entity obtaining genetic information; actively listening to third-party conversations or searching an individual’s personal effects for the purpose of obtaining genetic information; and making requests for information about an individual’s current health status in a way that is likely to result in a covered entity obtaining genetic information.” Presentation by Ronald W. Brown, Esq.

41. SIX THINGS EVERY EMPLOYER MUST DO #1. Understand what G.I.N.A. requires you to do and not to do. #2. Map out a compliance strategy engaging key individuals with leadership skills to serve on a cross-functional compliance team: Management, Legal, Human Resources, and EEO-AA. If you have a corporate Medical Department, engage a leader from that group as well. Presentation by Ronald W. Brown, Esq.

42. SIX THINGS EVERY EMPLOYER MUST DO #3. Update your non-discrimination policies and procedures to include G.I.N.A. Presentation by Ronald W. Brown, Esq.

43. SIX THINGS EVERY EMPLOYER MUST DO #4. Incorporate the safe harbor language into the forms you utilize for requesting business related health information (including ADA accommodation, FMLA or state equivalent). Presentation by Ronald W. Brown, Esq.

44. SIX THINGS EVERY EMPLOYER MUST DO #5. Do not discriminate or retaliate against a person on the basis of protected genetic information in any employment context. Presentation by Ronald W. Brown, Esq.

45. SIX THINGS EVERY EMPLOYER MUST DO #6. Do not request, require, or purchase genetic information about an individual or their family members, for example, a wellness program with a premium discount or waiver if the participant takes a health risk assessment. Presentation by Ronald W. Brown, Esq.

46. G.I.N.A. AND Corporate Wellness and Disease Management Programs Presentation by Ronald W. Brown, Esq.

47. G.I.N.A. AND Corporate Wellness and Disease Management Programs This is a potential minefield. However, an employer is allowed to collect genetic information for corporate wellness and disease management programs with three provisos. #1: That employees give “prior, knowing, voluntary, and written consent”. #2: That the employer only receives the genetic information in aggregate form. #3: That the employee does not have to fill out a health risk assessment form in order to get a reward. Presentation by Ronald W. Brown, Esq.

48. The E.E.O.C. Most of the GINA complaints received by the Equal Employment Opportunity Commission involve situations in which an employer had improperly acquired or had disclosed genetic information. Presentation by Ronald W. Brown, Esq.

49. The Pre-G.I.N.A. Legal Landscape EEOC v, Burlington Northern Santa Fe (2002 Settlement) (Alleged violation of ADA) Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998

50. The Current G.I.N.A Landscape: CHARGES WITH THE E.E.O.C. IN 2010 Presentation by Ronald W. Brown, Esq.

51. Fink v MXEnergy Company The first case alleging termination because of genetic information Fink's attorney, Gary Phelan, of the Stamford- and New York-based law firm Outten & Golden, said Fink is the first person in Connecticut to file a complaint under the new law, known as GINA. Fink filed complaints with both state employment officials and the Equal Employment Opportunity Commission (EEOC). Presentation by Ronald W. Brown, Esq.

52. Fink v MXEnergy Company The first lawsuitunder the Genetic Information Nondiscrimination Act (GINA) has been filed. (June ,2010) Fink was the public relations director for MXenergy from 2006 until her dismissal in March. Presentation by Ronald W. Brown, Esq.

54. The tests showed all three carried the BRCA2 gene.

55. That gene predisposed them to developing breast cancer.Presentation by Ronald W. Brown, Esq.

56. Fink v MXEnergy Company Both of Fink’s sisters developed breast cancer, but survived with treatment. After several biopsies and frightening false alarms, Fink opted for a preventative double mastectomy last year. Feeling comfortable in what she described as a supportive work environment, on her own initiative, she told her bosses at MXenergy about her genetic tests and the surgery. "I'd had great reviews, I had merit increases, I had bonuses. I really felt it was a place where I could be comfortable and confident and be honest with them, and that was a mistake,“ Fink said. Presentation by Ronald W. Brown, Esq.

58. Fink says she started to receive negative performance reviews, which hadn’t been the case in her previous four years with the company. Finally, after she had taken an additional ten days off for a second procedure, she was fired.Fink said "I was a great employee and I did really great work.” "The only thing that changed from the time that I had a great review to when I didn't was my two surgeries." Presentation by Ronald W. Brown, Esq.

60. GINA, bars discrimination against an employee based on the person’s genetic information and medical history. “Genetic information” is defined under federal law as “information about an individual’s genetic tests, the genetic tests of that individual’s family members, and the manifestation of a disease or disorder in family members of the individual.”Company spokesman Todd Miller said MXenergy “emphatically and categorically” denies the allegations, but has a policy not to discuss personnel matters and will not comment further. Presentation by Ronald W. Brown, Esq.

61. THREE VIEWS FROM THREE LAWYERS AND A FINAL WORD FROM MRS. FINK 1. “The purpose of GINA is to offer protections from companies trying to purge their workforce of people who drive up health insurance costs, or those who could drive up costs based on test results that show they’re susceptible to certain diseases.” 2. “I can see [litigation] happening with more and more people as genetic testing becomes less costly and more available”. 3. The chairwoman of the board of the national Women’s Law Project says: “Unfortunately, I think in today’s day and age people have started sharing a lot more personal information about themselves, whether it’s in social media or in the workplace. I think it may behoove people to keep some of that information closer to the vest” . Presentation by Ronald W. Brown, Esq.

62. Fink v MXEnergy Company Presentation by Ronald W. Brown, Esq.