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FDA Files Three Color Additive Petitions; EPA Proposes South Carolina NOX Rule Changes

The FDA has accepted petitions from three industry groups to expand or establish the use of natural color additives in food, while EPA is proposing to partially approve and partially conditionally approve South Carolina's long-pending nitrogen oxides control regulations.

EPA Proposed Rule: South Carolina NOX Controls

The U.S. Environmental Protection Agency is proposing to partially approve and partially conditionally approve changes to South Carolina's State Implementation Plan (SIP) governing control requirements for stationary sources of nitrogen oxides (NOX) and source testing requirements, acting pursuant to the Clean Air Act. The proposed rule affects 40 CFR Part 52 and covers SIP revisions submitted by the South Carolina Department of Environmental Services (SC DES) on five separate dates: October 1, 2007; July 27, 2016; September 5, 2017; April 24, 2020; and February 4, 2022.

The SIP revisions under review include changes to South Carolina Code of Regulations Regulation 61-62.5, Standard No. 5.2 — Control of Oxides of Nitrogen — as well as changes to Regulation 61-62.1, Section IV — Source Tests, which was submitted in the April 24, 2020 revision. The EPA's evaluation covers applicability provisions, definitions, standard requirements for new and existing affected sources, monitoring, recordkeeping and reporting requirements (including those for Continuous Emissions Monitoring Systems, Predictive Emissions Monitoring Systems, and parametric monitoring), tune-up requirements, and notification requirements for existing sources. Certain source testing provisions and specific CEMS monitoring paragraphs are proposed for conditional approval, with the document noting that South Carolina submitted a conditional approval request on May 13, 2026, and provided a demonstration under CAA Section 110(l). Comments on the proposed rule must be received on or before September 18, 2026.

FDA Color Additive Petitions

The Food and Drug Administration announced the filing of three separate color additive petitions in the same Federal Register issue, each proposing amendments to regulations in 21 CFR Part 73, which governs color additives exempt from certification.

Safflower extract (GNT USA, LLC.): FDA filed petition CAP 5C0338, submitted by GNT USA, LLC., c/o Exponent, Inc., on July 20, 2026. The petition proposes to amend 21 CFR Part 73 to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in 17 food categories, including tortilla wraps, alcoholic beverages, non-alcoholic beverages and beverage bases, colored extruded breakfast cereals, chewing gum, flavored ready-to-drink tea and tea concentrates, pickles and related products, sugar decorations and frostings, salad dressings, frozen dairy desserts, shelf stable ice pops, fillings and ready-to-eat gelatins and puddings, hard candy, flavored milk and yogurt products, soft candy and candy coated nuts, ready-to-use chicken and vegetable broth, and flavored syrups — all at levels consistent with good manufacturing practices. The petitioner claims categorical exclusion under 21 CFR 25.32(k) on the basis that granting the petition would authorize use of a substance intended to remain in food through ingestion and is not intended to replace macronutrients.

Carrot oil / acetone solvent (International Association of Color Manufacturers): FDA filed petition CAP 5C0339, submitted by the International Association of Color Manufacturers, on August 3, 2026. The petition proposes to amend 21 CFR 73.300 to provide for the safe use of acetone as a solvent in the manufacture of carrot oil, and also proposes to add heavy metal limits and secondary names for carrot oil. The agency notes it may also consider other changes to the regulation during its review. Unlike the other two petitions, this filing is accompanied by an environmental assessment that the agency has placed on public display for comment; written or electronic comments on the petitioner's environmental assessment must be submitted by September 18, 2026.

Gardenia (genipin) blue (Gardenia Blue Interest Group): FDA filed petition CAP 6C0343, submitted by Gardenia Blue Interest Group (GBIG), c/o Exponent, Inc., on August 4, 2026. The petition proposes to amend 21 CFR 73.168 to expand the safe use of gardenia (genipin) blue to 20 food categories, including sponge cake, alcoholic mixed drinks, carbonated drinks, powdered beverages, processed breakfast cereals, chewing gum, instant iced tea, wasabi paste and powder, sugar coating, syrup for shaved ice, icing, creamers and whiteners, ice cream and frozen dairy desserts, frozen desserts (edible ices), gelatin and puddings, jams and jellies, flavored milk and yogurt, snack foods, fruit preparations and toppings, and chewable tablets — all at levels consistent with good manufacturing practice. The petition also proposes to lower the specification for arsenic in gardenia (genipin) blue from ≤2 mg/kg (ppm) to ≤1 mg/kg (ppm). The petitioner claims categorical exclusion under 21 CFR 25.32(k) on the same basis as the safflower petition.

AHRQ Information Collection Correction

The Agency for Healthcare Research and Quality issued a correction to a notice that appeared on pages 48112 through 48113 in the Federal Register of Thursday, July 30, 2026. The correction changes the comment deadline in that notice's DATES section from "August 31, 2026" to "September 28, 2026."

What to Watch

  • September 18, 2026 — Deadline for public comments on EPA's proposed partial approval and partial conditional approval of South Carolina's NOX SIP revisions.
  • September 18, 2026 — Deadline for comments on the environmental assessment submitted with the International Association of Color Manufacturers' carrot oil/acetone color additive petition (CAP 5C0339).
  • September 28, 2026 — Corrected comment deadline for the AHRQ information collection notice originally published July 30, 2026.

Related

Sources

21 cited

Every hard fact above is grounded in and cited to a primary source record.

  1. EPA is proposing to partially approve and partially conditionally approve changes to South Carolina's State Implementation Plan for nitrogen oxides control requirements and source testing requirements.

    federalregister.gov
  2. The SIP revisions were submitted by the South Carolina Department of Environmental Services on October 1, 2007; July 27, 2016; September 5, 2017; April 24, 2020; and February 4, 2022.

    federalregister.gov
  3. The proposed rule affects 40 CFR Part 52.

    federalregister.gov
  4. The action is being proposed pursuant to the Clean Air Act.

    federalregister.gov
  5. The SIP revisions include changes to South Carolina Code of Regulations Regulation 61-62.5, Standard No. 5.2 — Control of Oxides of Nitrogen.

    federalregister.gov
  6. The April 24, 2020 SIP revision includes changes to Regulation 61-62.1, Section IV — Source Tests.

    federalregister.gov
  7. South Carolina submitted a conditional approval request on May 13, 2026.

    federalregister.gov
  8. Comments on the EPA's proposed rule must be received on or before September 18, 2026.

    federalregister.gov
  9. FDA filed color additive petition CAP 5C0338, submitted by GNT USA, LLC., c/o Exponent, Inc., on July 20, 2026.

    federalregister.gov
  10. The GNT USA petition proposes to amend 21 CFR Part 73 to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.

    federalregister.gov
  11. GNT USA claims categorical exclusion under 21 CFR 25.32(k) because granting the petition would authorize use of a substance intended to remain in food through ingestion and is not intended to replace macronutrients.

    federalregister.gov
  12. FDA filed color additive petition CAP 5C0339, submitted by the International Association of Color Manufacturers, on August 3, 2026.

    federalregister.gov
  13. The carrot oil petition also proposes to add heavy metal limits and secondary names for carrot oil.

    federalregister.gov
  14. Comments on the petitioner's environmental assessment for the carrot oil petition must be submitted by September 18, 2026.

    federalregister.gov
  15. FDA filed color additive petition CAP 6C0343, submitted by Gardenia Blue Interest Group (GBIG), c/o Exponent, Inc., on August 4, 2026.

    federalregister.gov
  16. The GBIG petition proposes to amend 21 CFR 73.168 to expand the safe use of gardenia (genipin) blue to 20 food categories.

    federalregister.gov
  17. The gardenia blue petition proposes to lower the specification for arsenic in gardenia (genipin) blue from <=2 mg/kg (ppm) to <=1 mg/kg (ppm).

    federalregister.gov
  18. GBIG claims categorical exclusion under 21 CFR 25.32(k) because granting the petition would authorize use of a substance intended to remain in food through ingestion and is not intended to replace macronutrients.

    federalregister.gov
  19. The Agency for Healthcare Research and Quality issued a correction changing the comment deadline in a notice originally published July 30, 2026 from 'August 31, 2026' to 'September 28, 2026'.

    federalregister.gov
  20. The safflower petition covers 17 food categories including tortilla wraps, alcoholic beverages, non-alcoholic beverages and beverage bases, colored extruded breakfast cereals, chewing gum, flavored ready-to-drink tea and tea concentrates, pickles and related products, sugar decorations and frostings, salad dressings, frozen dairy desserts, shelf stable ice pops, fillings and ready-to-eat gelatins and puddings, hard candy, flavored milk and yogurt products, soft candy and candy coated nuts, ready-to-use chicken and vegetable broth, and flavored syrups.

    federalregister.gov
  21. The International Association of Color Manufacturers petition proposes to amend 21 CFR 73.300 to provide for the safe use of acetone as a solvent in the manufacture of carrot oil.

    federalregister.gov