U.S. Code » Title 7 » Chapter CHAPTER 94— ORGANIC CERTIFICATION

7 U.S.C. § 6517

National List

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(a) In general

The Secretary shall establish a National List of approved and prohibited substances that shall be included in the standards for organic production and handling established under this chapter in order for such products to be sold or labeled as organically produced under this chapter.

(b) Content of list

The list established under subsection (a) shall contain an itemization, by specific use or application, of each synthetic substance permitted under subsection (c)(1) or each natural substance prohibited under subsection (c)(2).

(c) Guidelines for prohibitions or exemptions(1) Exemption for prohibited substances in organic production and handling operationsThe National List may provide for the use of substances in an organic farming or handling operation that are otherwise prohibited under this chapter only if—(A) the Secretary determines, in consultation with the Secretary of Health and Human Services and the Administrator of the Environmental Protection Agency, that the use of such substances—(i) would not be harmful to human health or the environment;(ii) is necessary to the production or handling of the agricultural product because of the unavailability of wholly natural substitute products; and(iii) is consistent with organic farming and handling;(B) the substance—(i) is used in production and contains an active synthetic ingredient in the following categories: copper and sulfur compounds; toxins derived from bacteria; pheromones, soaps, horticultural oils, fish emulsions, treated seed, vitamins and minerals; livestock parasiticides and medicines and production aids including netting, tree wraps and seals, insect traps, sticky barriers, row covers, and equipment cleansers; or(ii) is used in production and contains synthetic inert ingredients that are not classified by the Administrator of the Environmental Protection Agency as inerts of toxicological concern; and(C) the specific exemption is developed using the procedures described in subsection (d).(2) Prohibition on the use of specific natural substancesThe National List may prohibit the use of specific natural substances in an organic farming or handling operation that are otherwise allowed under this chapter only if—(A) the Secretary determines, in consultation with the Secretary of Health and Human Services and the Administrator of the Environmental Protection Agency, that the use of such substances—(i) would be harmful to human health or the environment; and(ii) is inconsistent with organic farming or handling, and the purposes of this chapter; and(B) the specific prohibition is developed using the procedures specified in subsection (d).(d) Procedure for establishing National List(1) In general

The National List established by the Secretary shall be based upon a proposed national list or proposed amendments to the National List developed by the National Organic Standards Board.

(2) No additions

The Secretary may not include exemptions for the use of specific synthetic substances in the National List other than those exemptions contained in the Proposed National List or Proposed Amendments to the National List.

(3) Prohibited substances

In no instance shall the National List include any substance, the presence of which in food has been prohibited by Federal regulatory action.

(4) Notice and comment

Before establishing the National List or before making any amendments to the National List, the Secretary shall publish the Proposed National List or any Proposed Amendments to the National List in the Federal Register and seek public comment on such proposals. The Secretary shall include in such Notice any changes to such proposed list or amendments recommended by the Secretary.

(5) Publication of National List

After evaluating all comments received concerning the Proposed National List or Proposed Amendments to the National List, the Secretary shall publish the final National List in the Federal Register, along with a discussion of comments received.

(6) Expedited petitions for commercially unavailable organic agricultural products constituting less than 5 percent of an organic processed product

The Secretary may develop emergency procedures for designating agricultural products that are commercially unavailable in organic form for placement on the National List for a period of time not to exceed 12 months.

(e) Sunset provision

No exemption or prohibition contained in the National List shall be valid unless the National Organic Standards Board has reviewed such exemption or prohibition as provided in this section within 5 years of such exemption or prohibition being adopted or reviewed and the Secretary has renewed such exemption or prohibition.

(Pub. L. 101–624, title XXI, § 2118, Nov. 28, 1990, 104 Stat. 3946; Pub. L. 102–237, title X, § 1001(6), Dec. 13, 1991, 105 Stat. 1893; Pub. L. 109–97, title VII, § 797(b), Nov. 10, 2005, 119 Stat. 2165.)Editorial NotesAmendments

2005—Subsec. (c)(1). Pub. L. 109–97, § 797(b)(1)(A), inserted “in organic production and handling operations” after “substances” in heading.

Subsec. (c)(1)(B)(iii). Pub. L. 109–97, § 797(b)(1)(B), (C), struck out cl. (iii) which read as follows: “is used in handling and is non-synthetic but is not organically produced; and”.

Subsec. (d)(6). Pub. L. 109–97, § 797(b)(2), added par. (6).

1991—Subsec. (c)(1)(B)(i). Pub. L. 102–237 substituted “parasiticides” for “paraciticides”.

Notes of Decisions
Cited in 13 cases (1 in the last 5 years), 2005–2021 · leading case: Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005).
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Harvey v. Veneman, 396 F.3d 28 (1st Cir. 2005). · cites it 4× “7 U.S.C. § 6517 . OFPA requires the Secretary to establish a National Organic Standards Board to develop the National List and to recommend exemptions for otherwise prohibited substances.”
Harvey v. Johanns, 494 F.3d 237 (1st Cir. 2007). · cites it 2× “In Harvey I, we also rejected the Secretary’s reliance on 7 U.S.C. § 6517 , noting that section 6517(cXl)(B)(iii) specified that the National List may provide for the use of otherwise prohibited substances only if the substance “is used in handling and i[s] non-synthetic but is…”
In Re Aurora Dairy Corp. Organic Milk Mktg., 621 F.3d 781 (8th Cir. 2010). “2007) (citing 7 U.S.C. § 6517 ). The purposes of the OFPA are not furthered by preempting state law claims like those at issue here.”
Organic Consumers Ass'n v. Hain Celestial Grp., Inc., 285 F. Supp. 3d 100 (D.C. Cir. 2018). “7 U.S.C. § 6517 ; 7 C.F.R. § 205.600 - 607 (the National List).”
Organic Trade Ass'n v. U.S. Dep't of Agric., 370 F. Supp. 3d 98 (D.C. Cir. 2019). · cites it 2× “7 U.S.C. § 6517 (d)(1) and (2). Nothing requires the Secretary to adopt recommendations made by the National Organic Standards Board in other areas related to the OFPA.”
Cornucopia Inst. v. U.S. Dep't of Agric., 884 F.3d 795 (7th Cir. 2018). “The Board's principal task is advising the Secretary what belongs on the "National List of approved *796 and prohibited substances that shall be included in the standards for organic production and handling" ( 7 U.S.C. § 6517 (a) ). See 7 U.S.C. § 6518 (k)(2).”
Cornucopia Inst. v. United States Dep't of Agric., 260 F. Supp. 3d 1061 (W.D. Wis. 2017). “See 7 U.S.C. § 6517 (a), (e). . The Federal Advisory Committee Act (“FACA”) requires that federal advisory committees be “fairly, balanced in terms, of the points of view represented and the functions to be performed[.”
Harvey v. Johanns, 462 F. Supp. 2d 69 (D. Me. 2006). · cites it 2× “” 7 U.S.C. § 6517 (c)(1) (Emphasis added). The text then provides: “The National List may provide for the use of substances in an organic .”
Ctr. for Food Saf. v. Perdue, 320 F. Supp. 3d 1101 (N.D. Cal. 2018). · cites it 4× “at 2; 7 U.S.C. § 6517 (b) - (c). The OFPA requires the National Organic Standards Board ("NOSB") to develop the National List for submission to the Secretary.”
Birdsong v. Nurture, Inc., 275 F. Supp. 3d 384 (E.D.N.Y 2017). “” 7 U.S.C. § 6517 (a). *389 . The Secretary relies on USDA-accredited certifying agents to certify that organic operations “produce and handle” products in compliance with the OFPA and the NOP regulations.”
Organic Consumers Ass'n v. Hain Celestial Grp., Inc. (D.D.C. 2018). “As contemplated by the OFPA, the National List contains a comprehensive “item_ization, by specific use or applicationl’ of permitted synthetic ingredients 7 U.S.C. § 6517 ; 7 C_F.R_ § 205.600-607 (the National List).”
Organic Trade Ass'n v. United States Dep't of Agric. (D.D.C. 2019). “7 U.S.C. § 6517 (d)(1) and (2). Nothing requires the Secretary to adopt recommendations made by the National Organic Standards Board in other areas related to the OFPA.”
Show all 13 citing cases →
— 7 U.S.C. § 6517(a) — 1 case
S. Agric. Insecticides, Inc. v. Taylor (D. Or. 2021).
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