81 FR 17423 - National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking Proceedings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 60 (March 29, 2016)

Page Range		17423-17424
FR Document		2016-06666
In accordance with section 2114(c)(2)(B) of the Public Health Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given concerning the reasons for not conducting rulemaking proceedings to add food allergies as an injury associated with vaccines to the Vaccine Injury Table.
Federal Register, Volume 81 Issue 60 (Tuesday, March 29, 2016)
[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Proposed Rules]
[Pages 17423-17424]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06666]



[[Page 17423]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100


National Vaccine Injury Compensation Program: Statement of 
Reasons for Not Conducting Rulemaking Proceedings

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Denial of petition for rulemaking.

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SUMMARY: In accordance with section 2114(c)(2)(B) of the Public Health 
Service Act, 42 U.S.C. 300aa-14(c)(2)(B), notice is hereby given 
concerning the reasons for not conducting rulemaking proceedings to add 
food allergies as an injury associated with vaccines to the Vaccine 
Injury Table.

DATES: Written comments are not being solicited.

FOR FURTHER INFORMATION CONTACT: Dr. Narayan Nair, MD, Acting Director, 
Division of Injury Compensation Programs (DICP), Healthcare Systems 
Bureau, Health Resources and Services Administration, 5600 Fishers 
Lane, Room 8N146B Rockville, Maryland 20857, or by telephone 301-443-
6593.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986, Title III of Public Law 99-660 (42 U.S.C. 300aa-10 et seq.) 
established the National Vaccine Injury Compensation Program (VICP) for 
persons found to be injured by vaccines. Under this federal program, 
petitions for compensation are filed with the United States Court of 
Federal Claims (Court). The Court, acting through special masters, 
makes findings as to eligibility for, and amount of, compensation. In 
order to gain entitlement to compensation under the VICP for a covered 
vaccine, a petitioner must establish a vaccine-related injury or death, 
either by proving that the first symptom of an injury or condition, as 
defined by the Qualifications and Aids to Interpretation, occurred 
within the time period listed on the Vaccine Injury Table (Table), and 
therefore, is presumed to be caused by a vaccine (unless another cause 
is found), or by proof of vaccine causation, if the injury or condition 
is not on the Table or did not occur within the time period specified 
on the Table.
    The statute authorizing the VICP provides for the inclusion of 
additional vaccines in the VICP when they are recommended by the 
Centers for Disease Control and Prevention (CDC) for routine 
administration to children. See section 2114(e)(2) of the PHS Act, 42 
U.S.C. 300aa-14(e)(2). Consistent with section 13632(a)(3) of Public 
Law 103-66, the regulations governing the VICP provide that such 
vaccines will be included in the Table as of the effective date of an 
excise tax to provide funds for the payment of compensation with 
respect to such vaccines. 42 CFR 100.3(c)(8). The statute authorizing 
the VICP also authorizes the Secretary to create and modify a list of 
injuries, disabilities, illnesses, conditions, and deaths (and their 
associated time frames) associated with each category of vaccines 
included on the Table. See sections 2114(c) and 2114(e)(2) of the PHS 
Act, 42 U.S.C. 300aa-14(c) and 30aa-14(e)(2). Finally, section 
2114(c)(2) of the PHS Act, 42 U.S.C. 300aa-14(c)(2) provides that:

    [a]ny person (including the Advisory Commission on Childhood 
Vaccines) [the Commission] may petition the Secretary to propose 
regulations to amend the Vaccine Injury Table. Unless clearly 
frivolous, or initiated by the Commission, any such petition shall 
be referred to the Commission for its recommendations. Following--
    (A) Receipt of any recommendation of the Commission, or
    (B) 180 days after the date of the referral to the Commission, 
whichever occurs first, the Secretary shall conduct a rule-making 
proceeding on the matters proposed in the petition or publish in the 
Federal Register a statement or reasons for not conducting such 
proceeding.

    On September 19, 2015, a private citizen submitted an email to the 
Department of Health and Human Services (HHS) and the Commission, 
requesting that food allergies be added to the Table. The email was 
considered to be a petition to the Secretary of HHS to propose 
regulations to amend the Table to add food allergies as an injury 
associated with vaccines on the Table. In support of the request that 
food allergies be added to the Table, the petitioner asserts that food 
proteins present in vaccines cause the development of food allergies.
    Pursuant to the VICP statute, the petition was referred to the 
Commission on December 3, 2015. The Commission voted unanimously to 
recommend that the Secretary not proceed with rulemaking to amend the 
Table as requested in the petition.
    Food allergies are defined as an ``adverse health effect arising 
from a specific immune response that occurs reproducibly on exposure to 
a given food. \1\'' Food allergy reactions are generally classified as 
mediated through immunoglobulin E (IgE), not mediated through IgE, or 
involving both IgE and non-IgE mechanisms. Food allergies are thought 
to result from a failure of the regulatory mechanisms of the immune 
system. IgE mediated reactions cause the severe and rapid responses to 
food known as anaphylaxis. Non-IgE mediated reactions cause slower 
onset skin and gastrointestinal symptoms.
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    \1\ Boyce et al, Guidelines for the diagnosis and management of 
food allergy in the United States: Summary of the NIAID-sponsored 
expert panel report. J Allergy Clin Immunol, Volume 16, Number 6, 
S1-58.
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    When a food allergy occurs, the body's immune system reacts to a 
food as if it was a threat. When people are first exposed to a 
potential food allergen, they do not experience symptoms but, in some 
people, their immune system produces IgE to that food allergen. The 
production of IgE in response to an allergen is called sensitization. 
It is thought that sensitization can occur from exposure to the food 
through the skin and respiratory route, as well as from eating food 
allergens. When sensitized people are exposed to the food allergen 
again, the IgE antibodies may bind to the allergen, resulting in a 
release of chemicals which can trigger a severe allergic response. The 
symptoms of this response can include hives, itching, nausea, vomiting, 
swelling of the mouth and throat, difficulty breathing, and low blood 
pressure.\2\ Not all people who have IgE to a food will have an 
allergic response.
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    \2\ http://www.niaid.nih.gov/topics/foodAllergy/understanding/Pages/allergicRxn.aspx
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    To support the claim that food allergies are caused by vaccines, 
the petitioner cites two sources as evidence including the 2012 
Institute of Medicine (IOM) Report, ``Adverse Effects of Vaccines: 
Evidence and Causality.'' The 2012 IOM report reviewed 8 of the 12 
vaccines covered by the VICP and provided 158 causality conclusions. 
However, the IOM report did not evaluate evidence regarding a causal 
association between vaccinations and food allergies. The report does 
describe case reports of individuals with a history of allergies to 
eggs, lamb, or milk that experienced anaphylaxis or an allergic 
reaction after receiving an immunization.\3\ The IOM report does not 
address whether individuals who receive a vaccination may subsequently 
develop food allergies. This report does not comment on the strength of 
the

[[Page 17424]]

epidemiologic or mechanistic evidence regarding food allergies and 
vaccination. Therefore, the 2012 IOM report does not support the 
petitioner's position for adding food allergies to the Table.
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    \3\ IOM (Institute of Medicine). 2012. Adverse effects of 
vaccines: Evidence and causality. Washington, DC: The National 
Academies Press. pp 170-173.
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    The petition also describes a 2002 paper that appeared in the 
journal, Pediatrics.\4\ The authors of this paper included researchers 
from CDC, the Food and Drug Administration (FDA), and the Mayo Clinic. 
The objective of this study was not to evaluate whether vaccines could 
cause food allergies. Rather, the purpose of the study was to examine 
whether people with anaphylaxis after the receipt of the measles 
vaccines had an unusual profile of self-reported allergies and whether 
they had higher levels of antibodies to gelatin, a compound found in 
both foods and some vaccines. This was a case control study utilizing 
the Vaccine Adverse Event Reporting System (VAERS) database for cases 
of anaphylaxis and individuals from the Mayo Clinic and VAERS who did 
not have an adverse event to the measles vaccine as controls. The study 
had relatively small numbers as only 57 individuals who had anaphylaxis 
agreed to be interviewed and of these, only 22 underwent IgE testing. 
The researchers found that there was a higher proportion of food 
allergies found in the group with anaphylaxis as opposed to the control 
group. However, it was not clear if the food allergies preceded the 
vaccine. They also noted that a number of individuals who had 
anaphylaxis to the vaccine also had the IgE antibody to the gelatin. 
However, none of these individuals reported an allergy to gelatin.
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    \4\ V. Pool, et al. ``Prevalence of anti-gelatin IgE antibodies 
in people with anaphylaxis after measles-mumps-rubella vaccine in 
the United States,'' Pediatrics, 110, 6 (Dec. 2002): e71.
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    This paper is not supportive of adding food allergies to the Table 
for several reasons. First, it was not designed to determine the 
causality of food allergy but rather whether severe allergic reactions 
to the measles vaccines could be due to gelatin. Gelatin is present in 
numerous foods including confectionary products, icings and fillings in 
baked goods, meat products, wine, beer, and juices.\5\ Given that oral 
intake is not necessary for sensitization, a wide array of exposures 
could have led to the development of a food allergy. Second, the 
individuals in this study who had anaphylaxis to the measles vaccine 
and had antibodies to gelatin did not report a food allergy. This 
finding does not support a causal association between vaccines and food 
allergies, nor do the authors contend this in their study. Third, while 
there was a higher proportion of food allergies reported in the 
anaphylaxis group, the authors state the practical significance of this 
is not clear. They conclude that their data could support the 
hypothesis that anaphylaxis to the measles vaccine could be due to 
sensitivity to gelatin but they do not assert that vaccines cause or 
contribute to food allergies. Finally, there are limitations to VAERS, 
which is a passive reporting system, and the primary purpose of VAERS 
is to look for signals for evidence of unexpected adverse events that 
would require other investigations to try to determine causal 
relationships. Thus, most VAERS reports alone cannot be utilized to 
establish conclusions about causality.
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    \5\ http://www.gelatin-gmia.com/images/GMIA_Gelatin_Manual_2012.pdf.
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    In addition to reviewing evidence submitted by the petitioner, HHS 
gathered additional data from the existing medical literature. A 
literature search was conducted of the major medical databases for any 
articles linking the development of food allergies to vaccinations. 
This research was conducted in collaboration with the National 
Institutes of Health (NIH) Library, Office of Research Services. 
Despite an extensive search, no published research was found that 
addressed any linkages or potential causality between vaccinations 
covered by VICP and the development of food allergies in any 
population.
    While none of the publications identified a link between food 
allergies and vaccines, several did address risk factors related to the 
development of food allergies. The NIH National Institute of Allergy 
and Infectious Disease sponsored an expert panel to develop guidelines 
for the diagnosis and management of food allergies. This panel 
consisted of 34 professional organizations, federal agencies and 
patient advocacy groups all with expertise related to food allergies. 
The guidelines, which were published in 2010, discuss prevention of 
food allergies but make no mention of the role of vaccines in 
developing food allergies. They also do not list vaccination as a risk 
factor for developing food-induced anaphylaxis. The Guidelines discuss 
gaps in the scientific knowledge related to food allergies. However, 
they did not identify the role of vaccination in developing food 
allergies as an area where future research is needed.\6\ Several recent 
reviews of the epidemiology and natural history of food allergies have 
been published. None of the publications discuss any role of 
vaccinations in the development of food 
allergies.^{7 8 9 10 11 12}
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    \6\ Boyce et al, Guidelines for the diagnosis and management of 
food allergy in the United States: Summary of the NIAID-sponsored 
expert panel report. J Allergy Clin Immunol, Volume 16, Number 6, 
S1-58.
    \7\ Lack, G. (2012). ``Update on risk factors for food 
allergy.'' Journal of Allergy and Clinical Immunology 129(5): 1187-
1197.
    \8\ Savage, J. and C. B. Johns. (2015). ``Food allergy: 
Epidemiology and natural history.'' Immunol Allergy Clin North Am 
35(1): 45-59.
    \9\ Sicherer, S. H. (2011). ``Epidemiology of food allergy.'' 
Journal of Allergy and Clinical Immunology 127(3): 594-602.
    \10\ Carrard, A., D. Rizzuti, et al. (2015). ``Update on food 
allergy.'' Allergy. 70: 1511-1520.
    \11\ Chin, S. and B. P. Vickery. (2012). ``Pathogenesis of food 
allergy in the pediatric patient.'' Curr Allergy Asthma Rep 12(6): 
621-9.
    \12\ Allen, K. J. and J. J. Koplin. (2015). ``Why Does Australia 
Appear to Have the Highest Rates of Food Allergy?'' Pediatr Clin 
North Am 62(6): 1441-51.
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    In light of the above, I have determined that there is no reliable 
scientific evidence of an association between vaccines and food 
allergies. Therefore, I will not amend the Table to add food allergies 
as an injury associated with any vaccine on the Table at this time.

    Dated: March 17, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-06666 Filed 3-28-16; 8:45 am]
 BILLING CODE 4165-15-P
Federal Register / Vol. 81, No. 60 / Tuesday, March 29, 2016 / Proposed Rules 17423

DEPARTMENT OF HEALTH AND vaccines in the VICP when they are food. 1’’ Food allergy reactions are
HUMAN SERVICES recommended by the Centers for Disease generally classified as mediated through
Control and Prevention (CDC) for immunoglobulin E (IgE), not mediated
Health Resources and Services routine administration to children. See through IgE, or involving both IgE and
Administration section 2114(e)(2) of the PHS Act, 42 non-IgE mechanisms. Food allergies are
U.S.C. 300aa–14(e)(2). Consistent with thought to result from a failure of the
42 CFR Part 100 section 13632(a)(3) of Public Law 103– regulatory mechanisms of the immune
66, the regulations governing the VICP system. IgE mediated reactions cause
National Vaccine Injury Compensation provide that such vaccines will be the severe and rapid responses to food
Program: Statement of Reasons for included in the Table as of the effective known as anaphylaxis. Non-IgE
Not Conducting Rulemaking date of an excise tax to provide funds mediated reactions cause slower onset
Proceedings for the payment of compensation with skin and gastrointestinal symptoms.
AGENCY: Health Resources and Services respect to such vaccines. 42 CFR When a food allergy occurs, the
Administration (HRSA), Department of 100.3(c)(8). The statute authorizing the body’s immune system reacts to a food
Health and Human Services (HHS). VICP also authorizes the Secretary to as if it was a threat. When people are
create and modify a list of injuries, first exposed to a potential food
ACTION: Denial of petition for
disabilities, illnesses, conditions, and allergen, they do not experience
rulemaking.
deaths (and their associated time symptoms but, in some people, their
SUMMARY: In accordance with section frames) associated with each category of immune system produces IgE to that
2114(c)(2)(B) of the Public Health vaccines included on the Table. See food allergen. The production of IgE in
Service Act, 42 U.S.C. 300aa– sections 2114(c) and 2114(e)(2) of the response to an allergen is called
14(c)(2)(B), notice is hereby given PHS Act, 42 U.S.C. 300aa–14(c) and sensitization. It is thought that
concerning the reasons for not 30aa–14(e)(2). Finally, section sensitization can occur from exposure to
conducting rulemaking proceedings to 2114(c)(2) of the PHS Act, 42 U.S.C. the food through the skin and
add food allergies as an injury 300aa–14(c)(2) provides that: respiratory route, as well as from eating
associated with vaccines to the Vaccine food allergens. When sensitized people
[a]ny person (including the Advisory are exposed to the food allergen again,
Injury Table. Commission on Childhood Vaccines) [the
DATES: Written comments are not being Commission] may petition the Secretary to
the IgE antibodies may bind to the
solicited. propose regulations to amend the Vaccine allergen, resulting in a release of
Injury Table. Unless clearly frivolous, or chemicals which can trigger a severe
FOR FURTHER INFORMATION CONTACT: Dr.
initiated by the Commission, any such allergic response. The symptoms of this
Narayan Nair, MD, Acting Director,
petition shall be referred to the Commission response can include hives, itching,
Division of Injury Compensation for its recommendations. Following— nausea, vomiting, swelling of the mouth
Programs (DICP), Healthcare Systems (A) Receipt of any recommendation of the and throat, difficulty breathing, and low
Bureau, Health Resources and Services Commission, or blood pressure.2 Not all people who
Administration, 5600 Fishers Lane, (B) 180 days after the date of the referral have IgE to a food will have an allergic
Room 8N146B Rockville, Maryland to the Commission, whichever occurs first, response.
20857, or by telephone 301–443–6593. the Secretary shall conduct a rule-making To support the claim that food
SUPPLEMENTARY INFORMATION: The proceeding on the matters proposed in the
petition or publish in the Federal Register a
allergies are caused by vaccines, the
National Childhood Vaccine Injury Act petitioner cites two sources as evidence
statement or reasons for not conducting such
of 1986, Title III of Public Law 99–660 proceeding. including the 2012 Institute of Medicine
(42 U.S.C. 300aa–10 et seq.) established (IOM) Report, ‘‘Adverse Effects of
the National Vaccine Injury On September 19, 2015, a private Vaccines: Evidence and Causality.’’ The
Compensation Program (VICP) for citizen submitted an email to the 2012 IOM report reviewed 8 of the 12
persons found to be injured by vaccines. Department of Health and Human vaccines covered by the VICP and
Under this federal program, petitions for Services (HHS) and the Commission, provided 158 causality conclusions.
compensation are filed with the United requesting that food allergies be added However, the IOM report did not
States Court of Federal Claims (Court). to the Table. The email was considered evaluate evidence regarding a causal
The Court, acting through special to be a petition to the Secretary of HHS association between vaccinations and
masters, makes findings as to eligibility to propose regulations to amend the food allergies. The report does describe
for, and amount of, compensation. In Table to add food allergies as an injury case reports of individuals with a
order to gain entitlement to associated with vaccines on the Table. history of allergies to eggs, lamb, or milk
compensation under the VICP for a In support of the request that food that experienced anaphylaxis or an
covered vaccine, a petitioner must allergies be added to the Table, the allergic reaction after receiving an
establish a vaccine-related injury or petitioner asserts that food proteins immunization.3 The IOM report does
death, either by proving that the first present in vaccines cause the not address whether individuals who
symptom of an injury or condition, as development of food allergies. receive a vaccination may subsequently
defined by the Qualifications and Aids Pursuant to the VICP statute, the develop food allergies. This report does
to Interpretation, occurred within the petition was referred to the Commission not comment on the strength of the
time period listed on the Vaccine Injury on December 3, 2015. The Commission
Table (Table), and therefore, is
mstockstill on DSK4VPTVN1PROD with PROPOSALS

1 Boyce et al, Guidelines for the diagnosis and
voted unanimously to recommend that management of food allergy in the United States:
presumed to be caused by a vaccine the Secretary not proceed with Summary of the NIAID-sponsored expert panel
(unless another cause is found), or by rulemaking to amend the Table as report. J Allergy Clin Immunol, Volume 16, Number
proof of vaccine causation, if the injury requested in the petition. 6, S1–58.
or condition is not on the Table or did 2 http://www.niaid.nih.gov/topics/foodAllergy/

not occur within the time period Food allergies are defined as an understanding/Pages/allergicRxn.aspx
specified on the Table. ‘‘adverse health effect arising from a 3 IOM (Institute of Medicine). 2012. Adverse

effects of vaccines: Evidence and causality.
The statute authorizing the VICP specific immune response that occurs Washington, DC: The National Academies Press. pp
provides for the inclusion of additional reproducibly on exposure to a given 170–173.

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Denial of petition for rulemaking.
Dates		Written comments are not being solicited.
Contact		Dr. Narayan Nair, MD, Acting Director, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 8N146B Rockville, Maryland 20857, or by telephone 301-443- 6593.
FR Citation		81 FR 17423
81 FR 17423 - National Vaccine Injury Compensation Program: Statement of Reasons for Not Conducting Rulemaking Proceedings

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 60 (March 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
