식품관련 각종 미국 정부기관 규정안내
Andrew Park, 관세사 & Food Regulatory Consultant
Binex Line Corp. dba iFoodimports.com
September 17, 2020
“…hunting for letters in a bowl of alphabet soup…”
Federal Agency
“Today, we have 2,840,000 federal workers in 15 departments, 69 agencies and 383 nonmilitary sub-agencies…. One study found that in 2007, Congress enacted 138 public laws, while federal agencies finalized 2,926 rules, including 61 major regulations.” *
* “The Rise of the Fourth Branch of Government,”
The Washington Post, May 24, 2013
State Agency
• State agencies also play a role in import regulations.
Example)
1. California’s Prop 65
2. Michigan law requires a “Last Date of Sale”
on certain perishable foods.
Law / 법 Science / 과학
Policy / 정책 Regulation / 규정
Comply / 준수
Principle of U.S. Food Laws
• U.S. food related laws are designed
• to protect consumers’ health and safety apply equally to imported and domestic products.
(‘동등성 원칙’)
• to bear the same informative and truthful
labeling in English
Laws –
Legislative (입법부)
• General Laws Related to Food Safety
• Specific Laws Related to Food Safety
• Laws Related to Packaging and Labeling
General U.S.
Food Laws
• Food and Drugs - 21 U.S.C.
• Sanitary Food Transportation Act - 49 U.S.C. 57
• Public Health Service Act - 42 U.S.C. 6A
• National Environmental Policy Act of 1969 - 42 U.S.C. 55
• Federal Anti-Tampering Act - 18 U.S.C. 65 § 1365 Tampering with consumer products
• Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• Also known as the Bioterrorism Act of 2002.
• Relevant sections include:
• Title III -- Protecting Safety and Security of Food and Drug Supply
• Title IV -- Drinking Water Security and Safety
• Lead-Based Paint Poisoning Prevention Act - 42 U.S.C. 63
* The Code of Laws of the United States of America is the official compilation and codification of the general and permanent federal statutes of the United States. It contains 53 titles.
Specific U.S.
Food Laws
• Federal Food, Drug, and Cosmetic Act (FD&C Act) - 21 U.S.C. 9
• Food Safety Modernization Act (FSMA)
• Federal Meat Inspection Act - 21 U.S.C. 12
• Poultry Products Inspection Act - 21 U.S.C. 10
• Egg Products Inspection Act - 21 U.S.C. 15
• Humane Methods of Livestock Slaughter Act - 7 U.S.C. 48
• Food Quality Protection Act Modifies –
7 U.S.C. 136
U.S.
Packaging
and Labeling Laws
• Federal Trade Commission Act – 15 U.S.C. Chapter 2
• Fair Packaging and Labeling Act – 15 U.S.C. Chapter 39
• Trademark Act - 15 U.S.C. Chapter 22
U.S. Food Regulations
• 21 CFR: Food and Drugs
• 7 CFR: Agriculture
• 9 CFR: Animals and Animal Products
• 42 CFR: Public Health
• 15 CFR: Commerce and Foreign Trade
• 16 CFR: Commercial Practices
• 19 CFR: Customs Duties
• 27 CFR: Alcohol, Tobacco Products, and Firearms
• 49 CFR: Transportation
• 5 CFR: Administrative Personnel
* The Code of Federal Regulations is the codification of the general and
permanent rules and regulations published in the Federal Register by
the executive departments and agencies of the federal government of
the United States. The CFR is divided into 50 titles that represent broad
areas subject to federal regulation.
Major US
Government Agencies
with Their
Roles Related to Food
Safety
• US Department of Health and Human Services (HHS)
• (FDA, Food and Drug Administration)
• Regulates and ensures the safety and accurate labeling for: food products (excluding meat and poultry)
• bottled water
• dietary supplements
• food additives
• infant formula
• US Department of Agriculture (USDA)
• (FSIS, Food Safety and Inspection Service)
• Regulates aspects of the safety and labeling of traditional (non-game) meats, poultry, and certain egg products. (safety standards)
• (APHIS, Animal Plant Health Inspection Service)
• Restricts some products from entering the U.S. due to animal disease conditions in country of origin. (health requirements)
Major US
Government Agencies
with Their
Roles Related to Food
Safety
• US Department of Commerce (USDC)
• (NOAA, National Oceanic and Atmospheric Administration)
• Provides inspection services for fish, shellfish, and fishery products to the industry. The NOAA Seafood Inspection Program is often referred to as the U.S. Department of Commerce (USDC) Seafood Inspection
Program.
• US Department of Treasury (USDT)
• (TTB, Alcohol and Tobacco Tax and Trade Bureau)
• Regulates aspects of alcohol production, importation, wholesale distribution, labeling, and advertising
• Independent executive agency of the US federal government
• (EPA, Environmental Protection Agency)
• Ensures the safety of drinking water
• Regulates the use of pesticides which can contaminate drinking water and/or leave pesticide residue on food.
Post-9/11 Increase Import
Compliance
ACS vs. ACE
PGA vs. OGA
• OGA – Other Government Agencies
• PGA – Partner Government Agencies
The term PGA is used to describe the Federal Agencies that regulate specific commodities imported into the U.S. in conjunction with Customs. Before the designation PGA was established, the term OGA was used to describe these regulatory agencies of the
government that assist Customs in evaluating
imported goods.
When a Violation is Found
• FDA issues a “Notice of FDA Action”
• Pending FDA Review
• Detained
• Reconditioning Request Approved / Denied
• Refuse
• Importer’s option:
• Request a hearing to defend the acceptability of the product
• Apply for permission to relabel or recondition of the product
• Destroy or re-export
• Judicial review
FDA Regulatory Guidance
• Guidance documents represent FDA's current thinking on a topic.
They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.
• Guidance documents describe FDA’s interpretation of our policy on a
regulatory issue (21 CFR 10.115(b)).
FDA COMPLIANCE POLICY GUIDE (CPG) Sec 540.650
Small Fish (less than 5 inches)
• Provided the fish are appropriately handled and processed in a
manner that controls the potential of C. botulinum growth and toxin formation. Processors of
uneviscerated finfish products must demonstrate a process that results in either a water-phase salt level of at least 20 % or a water
activity below 0.85 or a pH of 4.6 or less.
Large Fish (5 inches or more, including head and tail)
• There are no known safe
processing procedures for
uneviscerated large fish.
굴비 대미 수출
• REGULATORY ACTION GUIDANCE:
• FDA will consider regulatory action (seizure or detention) against any uneviscerated fish greater than five inches in length that is salt-cured, dried, or smoked, or any product derived from such uneviscerated fish, in interstate commerce.*
*FDA COMPLIANCE POLICY GUIDE (CPG) Sec 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (Revised)
마른 멸치 수입 사건
• 2015년 3월 한국에서 LA로 멸치를 밀반입 한 혐의로 연방 검찰에 기소된 김씨 사건.
• 연방식품의약국(FDA)은 연방수사국(FBI)과 공조해
김씨가 수산물 수입.통관규정(FDA Import Alert 16-74)을 어겼다며 김씨를 체포했다.
• 유통업체 대표 B씨도 공범으로 체포 함께 기소됨.
한국산 냉이
(Shepherd's Purse)
• 한국산 냉이는 2000년 5월 미국에 수입허용을 요청한 후 13년여만에 수출검역요령이 확정됐다.
• 2011년 한국산 뿌리 달린 냉이의 수입을 허용하는
연방규정(APHIS)이 발효됐지만 냉이를 재배하는 토양의 선충 검사 방법이 합의되지 않아 실제 수입되지
못했었다.
한국 삼계탕 미국 수입
• "한국의 가금육 관련 위생관리 제도가
미국 내 제도와 비슷해야 한다"는 입장이다.
이른바 ‘동등성 원칙'을 내세우고 있는 것이다.
• 미 농무부 식품안전검역청(FSIS)은 2008년 한국을 방문해 수의과학검역원과
닭고기업체들의 작업장을 점검한 뒤 작업장의 위생 실태, 질병관리 상태 등 미비점에 대한 보완을 요청했다. FSIS는 이후에도 몇 차례 방한, 현지조사를 벌였다.
• 2014년 8월 부터 수입 허가.
Top 12
Reasons for Detention
• Microbiological Contamination / 미생물
• Undeclared Allergens (milk, eggs, peanuts, soy & wheat…)
• Banned Antibiotics / 항생제
• Uneviscerated Processed Fish / 내장 제거안된
• Unapproved Food Colors (치자황색소, 홍화황색소)
• Lead Contaminated Foods and Packaging Containers
• Sodium Cyclamate (artificial sweetener)
• Undeclared Preservatives / 방부제
• Mycotoxin / 곰팡이독
• Shelf Stability / 부패 가능성이 높은 제품 – 음료/캔 제품 (FCE/SID)
• Economic Adulteration (pure / 100% olive oil ➔ soybean oil)
• English
