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21 U.S.C. § 2205Food allergy and anaphylaxis management

submitted 15 years ago by Pub. L. 111-353 to r/title-21-FOOD-AND-DRUGS · 1,667 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must create voluntary guidelines for food-allergy and anaphylaxis risk. These guidelines apply to schools and early childhood programs. They cover medical records, care plans, staff training, and epinephrine access. The Secretary may also fund school districts that adopt them. But following the guidelines always stays voluntary.

This section sets up voluntary federal guidelines — and a grant program — to help schools and early childhood programs manage students' food allergies and anaphylaxis risk. (a) Definitions. "Early childhood education program" means a Head Start or Early Head Start program, a state-licensed or state-regulated child care program or school, or a state prekindergarten program serving children from birth through kindergarten. "Local educational agency," "secondary school," "elementary school," and "parent" have the meanings given in section 7801 of title 20. "School" includes public kindergartens, elementary schools, and secondary schools. "Secretary" means the Secretary of Health and Human Services. (b) Establishment of voluntary guidelines. (1) Within 1 year of January 4, 2011, the Secretary, working with the Secretary of Education, had to create voluntary guidelines schools and early childhood programs can use to build individual plans managing a child's food allergy and anaphylaxis risk, and share them with school systems, schools, programs, and other interested parties for voluntary use. Any individual plan built this way counts as an "education record" protected under FERPA. (2) The guidelines must address: (A) that before each school year, parents should give the school or program doctor documentation of a food-allergy diagnosis and any anaphylaxis risk, the allergen involved, prior reaction history, prescribed medication, emergency treatment steps, symptoms to watch for, and the child's readiness to self-administer medication, plus a list of acceptable substitute meals; (B) creating and maintaining, with the parent, an individual management plan for each at-risk child, including letting the child self-administer medication where they're capable and state law allows; (C) communication strategies with emergency medical responders; (D) ways to cut allergen exposure in classrooms and shared spaces; (E) sharing general allergy information with staff, parents, and children; (F) training staff who regularly work with at-risk children; (G) authorizing and training staff to give epinephrine when the nurse isn't immediately available; (H) making sure epinephrine is quickly accessible in that situation; (I) planning for anaphylaxis response during field trips, before- and after-school programs, and weekend school-sponsored events; (J) recordkeeping every time epinephrine is given, with prompt parent notification; and (K) anything else the Secretary decides is needed. (3) Nothing here overrides state law, including state rules on whether at-risk students may self-administer medication. (c) School-based grants. (1) The Secretary may award grants to school systems to help implement the (b) guidelines. (2) To apply, a school system must submit, in the form the Secretary requires: an assurance it has built plans following the guidelines; a description of what the grant will fund — including how the guidelines will work at individual schools, how parents and students will be informed, and how staff will be trained; an itemized budget; a monitoring plan; and a promise to report back as the Secretary requires. (3) Grant money can go toward supplies (including limited medical supplies like epinephrine and disposable wipes), staff training with local health departments, student education programs, parent outreach, or other activities consistent with the guidelines. (4) Grants can run up to 2 years, with second-year funding contingent on a successful first-year evaluation where the Secretary conducts one. (5) A school system can't receive more than 2 years of this grant funding, ever. (6) A single grant can't exceed $50,000 a year. (7) The Secretary must prioritize school systems with the highest share of children counted under the Title I formula in section 6333(c) of title 20. (8) The Secretary can't award a grant unless the school system agrees to provide non-federal matching funds of at least 25% of the grant — cash or in-kind, but not money that ultimately traces back to federal subsidies. (9) A school system can spend up to 2% of its grant on administrative costs. (10) After the grant period, the school system must report to the Secretary how the money was spent and how the guidelines are being implemented. (11) Grant funds must add to, not replace, existing non-federal and federal funding for these activities. (12) Congress authorized $30,000,000 for fiscal year 2011, plus whatever's needed for each of the next 4 years. (d) These guidelines are voluntary. (1) Nothing in this section or the guidelines requires any school system to follow them. (2) The one exception: if a school system agreed to implement the guidelines as a condition of getting a (c) grant, the Secretary can enforce that agreement.

facts

- Codified at 21 U.S.C. § 2205, titled "Food allergy and anaphylaxis management." - Enacted by Pub. L. 111–353, title I, § 112, on January 4, 2011 (124 Stat. 3916). - Amended once by Pub. L. 114–95, title IX, § 9215(jj), Dec. 10, 2015 (129 Stat. 2175), reflecting 2 total amendment references. - Section spans approximately 1,667 words across subsections (a)–(d).
the actual law source: uscode.house.gov ↗public domain
(a) Definitions

In this section:

(1) Early childhood education program

The term “early childhood education program” means—

(A)

a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 et seq.);

(B)

a State licensed or regulated child care program or school; or

(C)

a State prekindergarten program that serves children from birth through kindergarten.

(2) ESEA definitions

The terms “local educational agency”, “secondary school”, “elementary school”, and “parent” have the meanings given the terms in section 7801 of title 20.

(3) School

The term “school” includes public—

(A)

kindergartens;

(B)

elementary schools; and

(C)

secondary schools.

(4) Secretary

The term “Secretary” means the Secretary of Health and Human Services.

(b) Establishment of voluntary food allergy and anaphylaxis management guidelines
(1) Establishment
(A) In general

Not later than 1 year after January 4, 2011, the Secretary, in consultation with the Secretary of Education, shall—

(i)

develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and

(ii)

make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.

(B) Applicability of FERPA

Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 1232g of title 20 (commonly referred to as the “Family Educational Rights and Privacy Act of 1974”).

(2) Contents

The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary:

(A)

Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with—

(i)

documentation from their child’s physician or nurse—

(I)

supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;

(II)

identifying any food to which the child is allergic;

(III)

describing, if appropriate, any prior history of anaphylaxis;

(IV)

listing any medication prescribed for the child for the treatment of anaphylaxis;

(V)

detailing emergency treatment procedures in the event of a reaction;

(VI)

listing the signs and symptoms of a reaction; and

(VII)

assessing the child’s readiness for self-administration of prescription medication; and

(ii)

a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.

(B)

The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where—

(i)

the children are capable of self-administering medication; and

(ii)

such administration is not prohibited by State law.

(C)

Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.

(D)

Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.

(E)

The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.

(F)

Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.

(G)

The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.

(H)

The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.

(I)

The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs,1 and school-sponsored or early childhood education program-sponsored programs held on weekends.

(J)

Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.

(K)

Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.

(3) Relation to State law

Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.

(c) School-based food allergy management grants
(1) In general

The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).

(2) Application
(A) In general

To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

(B) Contents

Each application submitted under subparagraph (A) shall include—

(i)

an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);

(ii)

a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including—

(I)

how the guidelines will be carried out at individual schools served by the local educational agency;

(II)

how the local educational agency will inform parents and students of the guidelines in place;

(III)

how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and

(IV)

any other activities that the Secretary determines appropriate;

(iii)

an itemization of how grant funds received under this subsection will be expended;

(iv)

a description of how adoption of the guidelines and implementation of grant activities will be monitored; and

(v)

an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.

(3) Use of funds

Each local educational agency that receives a grant under this subsection may use the grant funds for the following:

(A)

Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).

(B)

In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.

(C)

Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.

(D)

Outreach to parents.

(E)

Any other activities consistent with the guidelines described in subsection (b).

(4) Duration of awards

The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.

(5) Limitation on grant funding

The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.

(6) Maximum amount of annual awards

A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.

(7) Priority

In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 6333(c) of title 20.

(8) Matching funds
(A) In general

The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.

(B) Determination of amount of non-Federal contribution

Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.

(9) Administrative funds

A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.

(10) Progress and evaluations

At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).

(11) Supplement, not supplant

Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.

(12) Authorization of appropriations

There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2011 and such sums as may be necessary for each of the 4 succeeding fiscal years.

(d) Voluntary nature of guidelines
(1) In general

The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.

(2) Exception

Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).

Source credit: (Pub. L. 111–353, title I, § 112, Jan. 4, 2011, 124 Stat. 3916; Pub. L. 114–95, title IX, § 9215(jj), Dec. 10, 2015, 129 Stat. 2175.)

history & why it existsrecord from the source credit
  • 2011Enacted · Pub. L. 111-353 · 124 Stat. 3916
  • 2015Amended · Pub. L. 114-95 · 129 Stat. 2175
The record shows that this section was enacted as part of Public Law 111–353, title I, section 112, on January 4, 2011, and published at 124 Stat. 3916. The source credit indicates one subsequent amendment, made by Public Law 114–95, title IX, section 9215(jj), enacted December 10, 2015, and published at 129 Stat. 2175. Beyond identifying the enacting and amending statutes and their dates, the source credit does not itself describe the substance of the amendment or the reasons for it. Public Law 111–353 is commonly known as the FDA Food Safety Modernization Act, a broad statute generally understood to have reformed the federal food safety regulatory system in response to a series of high-profile foodborne illness outbreaks in the years preceding its passage. The inclusion of a provision addressing food allergy and anaphylaxis management in schools is consistent with that era's wider public attention to food-related health risks, including rising awareness of childhood food allergies, though the record here does not establish the specific legislative rationale for this particular section. Public Law 114–95 is widely recognized as the Every Student Succeeds Act, a major reauthorization of federal elementary and secondary education law. Its amendment of this section (jj) likely reflects a conforming update tied to that broader education law reauthorization, such as updated cross-references to education statutes, but the source credit does not specify the amendment's content, and no further inference should be drawn about its purpose.

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